But the insurer insisted, so Schulte went on Remicade. It didn’t work either.

What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.

After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.

Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.

Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.

“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”

If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.

PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.

Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.

Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.

Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.

Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.

Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.

PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.

Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.

Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.

“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”

It’s not only patients and doctors who have a stake in which drugs work best for a given person.

When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.

Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.

Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.

“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”

What Testing Could Do

Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.

“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”

Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.

Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.

“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.

How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.

However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.

Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.

Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.

Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.

What Patients Want

Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.

“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The so-called PBMs have long clawed back a fee from pharmacies weeks or months after they dispense a drug. A new rule, which governs Medicare’s drug program, is set to take effect Jan. 1 and requires PBMs to take most of their “performance fees” at the time prescriptions are filled.

The clawbacks have ballooned from about $9 million in 2010 to $12.6 billion in 2021, according to the Medicare Payment Advisory Commission, an agency created to advise Congress on the program for people who are 65 and older or have disabilities.

Performance fees have also boosted Medicare patients’ prescription costs at the pharmacy counter by hundreds of millions of dollars, although insurers assert that the fees enable them to charge lower premiums.

Pharmacist groups supported the Medicare rule change, but they didn’t anticipate the PBMs’ response, which has been to demand they accept new contracts with draconian cuts to their payments for dispensing medicines, said Ronna Hauser, vice president of the National Community Pharmacists Association, which represents independent drugstores. If pharmacies refuse the contracts, they risk losing Medicare customers — likely to the same giant PBM conglomerates, which have absorbed a growing share of the pharmacy business in recent years.

PBMs sit at the center of the U.S. supply chain for drugs, where they say they negotiate lower prices for insurers — including Medicare — and for employers and their workers. But the organizations are loathed by independent drugstores, drugmakers, and patients alike, who accuse them of siphoning money from what is already the world’s most expensive health care system without providing additional value.

PBM practices even put the squeeze on national chains like Rite Aid, Kroger, and Walgreens, which aren’t part of the conglomerates. Even CVS Health, which owns one of the three leading PBMs, has closed stores or trimmed staff as it pushes consumers to mail-order pharmacy services.

The pressure on in-store pharmacists and technicians has led to a series of walkouts this fall by CVS and Walgreens employees who say tight staffing has caused burnout and threatened patients’ safety.

Misery for Small Pharmacies

Under the current system, when a pharmacy fills a prescription, the PBM tells it what the patient owes and what the PBM will pay the pharmacy. The PBM aggregates these payments and sends a check later. Often, however, the PBM will deduct a performance fee from the pharmacy, said Doug Hoey, CEO of the National Community Pharmacists Association.

“When you’re filling the prescription, the PBM tells you the patient pays $20 for this drug, we’ll pay you $100,” Hoey said. “As the pharmacist, I say, OK, I get a total of $120 for a drug that cost me $110 from the wholesaler. Then three months later, the PBM says, ‘Actually, I’m only going to pay you $83.’ So I lost $17 on the sale and I have no ability to object.”

One performance measure is patient adherence. If patients don’t take all their drugs, pharmacists can be slapped with a fee for poor performance, although they have no control over the patient’s actions. Sometimes pharmacists are dinged for the prescribing physician’s mistakes, Hoey said.

In the early fall, PBM giant Express Scripts sent out confidential contracts announcing that in 2024 it will pay pharmacies roughly 10% below what they typically pay to buy wholesale brand-name drugs — meaning they could lose money on every prescription they fill, according to two independent pharmacists who received the documents. They declined to share the contracts because they are subject to nondisclosure agreements with Express Scripts.

In a statement, Express Scripts said that “our reimbursement rates to pharmacies for brand drugs vary based on a number of factors.” The company said nearly 90% of the nation’s 20,000 or so independent pharmacies had accepted its terms.  

Kare Drugs, which runs two New Mexico pharmacies, was among those that refused the Express Scripts contract. As a result, the pharmacy is “preparing for the hardest part, which will be potentially transferring patients away,” said owner Ashley Seyfarth.

Seniors who are currently enrolling in Medicare plans for next year may be confused when they discover that their insurance will no longer allow them to pick up medications at their usual pharmacy, said Ben Jolley, a Salt Lake City pharmacist and consultant to other independent pharmacists. Jolley said his drugstore expects to lose at least 100 customers after refusing a contract with a large PBM.

A Double Whammy

For the first months of 2024, pharmacies will face a double whammy. PBMs will pay them less for the drugs they dispense, while the pharmacies also face clawbacks on drugs dispensed in the last quarter of 2023.

The Jan. 1 rule change was partly designed to relieve Medicare patients, who often pay a fixed percentage of a drug’s price as a copayment. That copay is based on the price the drug plan or PBM promises the pharmacy at the moment of sale. But the clawbacks have resulted in patients overpaying by hundreds of millions of dollars, Hoey said. That’s because their copays at the counter ended up being a higher percentage of the drug’s final pharmacy price, once the performance fees were deducted.

Seyfarth, who said she paid more than half a million dollars in PBM fees last year, said that to deal with the pending pinch her pharmacy was coming up with new ways to earn cash, including charging patients for delivery services and starting an all-cash concierge clinic.

Some pharmacies are setting aside savings or taking out short-term loans to cover losses in the early months of next year. “I’m hoping we’ve made the right calculations and will get through this,” said Marc Ost, co-owner of Eric’s Rx Shoppe in Horsham, Pennsylvania.

The unintended consequences of the rule are likely to aggravate the problems of community pharmacists, who find it increasingly difficult to carry the most popular, expensive new drugs, Hauser said.

Integrated PBM-insurance companies — particularly UnitedHealth Group, CVS Health, and Cigna, each of which is composed of a major insurer, PBM, and other companies — have gained an increasing share of their revenues from specialty pharmacy drugs, which account for more than half of U.S. drug spending.

These behemoth companies have negotiating power with drugmakers that enables them to sell a diabetes drug like Ozempic (sold under the name Wegovy for weight loss), for example, for about $900 a month. “An independent pharmacy can’t even buy it at that price,” Hauser said. “If they dispense Ozempic, they are losing money.”

Express Scripts has said it wants to help independent pharmacies survive, Hoey said, but hasn’t responded to a June letter in which he asked the company to provide breathing space by imposing the 2023 clawbacks gradually over 12 months. CMS this month said it “strongly recommends” but does not require PBMs to come up with payment plans for pharmacies.

In its statement, Express Scripts said it was “committed to reimbursing pharmacies fairly, ensuring Medicare beneficiaries have safe, quality pharmacies in their network, and giving beneficiaries all available discounts at the pharmacy counter.”

After a parade of hearings — and an ad campaign from drugmakers — attacking the PBMs, Senate and House committees have advanced bipartisan bills to tighten controls on the companies. Senate Finance Committee bills would require the Department of Health and Human Services to issue rules ensuring that PBM payments to pharmacies and other contract terms are reasonable, and that PBMs no longer impose unfair pharmacy performance requirements, said Julie Allen, a law firm lobbyist representing the National Association of Specialty Pharmacy. 

“These statutory changes are essential to addressing problems with the Medicare Part D program and to saving specialty pharmacies and other pharmacies,” she said in an email.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Pero aún no ha llegado. Los fabricantes de biosimilares deben trabajar dentro de un sistema de salud en el que no parecen seguirse los principios básicos de la economía.

Para que la competencia real se consolide, los grandes gestores de beneficios farmacéuticos, o PBM, las empresas que negocian los precios y establecen el menú de medicamentos recetados para el 80% de los pacientes con seguro en Estados Unidos, tendrían que posicionar los nuevos medicamentos favorablemente en los planes de salud.

No lo han hecho, aunque la lógica para hacerlo parece evidente.

Humira lleva 20 años disfrutando de una exclusividad muy cara en el país. Sus competidores podrían ahorrarle al sistema sanitario $9,000 millones y anunciar el ahorro de toda una clase de medicamentos llamados biosimilares, un beneficio imprevisto similar a los cientos de miles de millones que se ahorran cada año con la compra de medicamentos genéricos.

Los biosimilares funcionan igual que Humira, un tratamiento inyectable para la artritis reumatoide y otras enfermedades autoinmunes. Y países como el Reino Unido, Dinamarca y Polonia ha cambiado a más del 90% de sus pacientes de Humira a medicamentos rivales desde que se lanzaron en Europa en 2018.

Kaiser Permanente, que supervisa la atención médica de 12 millones de personas en ocho estados de Estados Unidos, cambió a la mayoría de sus pacientes a un biosimilar en febrero y espera ahorrar $300 millones este año.

Los biológicos —tanto los medicamentos de marca como sus imitadores o biosimilares— se fabrican con células vivas, como levaduras o bacterias. Con docenas de biológicos a punto de finalizar su protección de patente en las próximas dos décadas, los biosimilares podrían generar ahorros mucho mayores que los genéricos, según Paul Holmes, socio de Williams Barber Morel que trabaja con planes de salud para autoasegurados. Esto se debe a que los productos biológicos son mucho más caros que los comprimidos y otras formulaciones elaboradas mediante procesos químicos más sencillos.

Por ejemplo, después de que los primeros genéricos del exitoso medicamento antirreflujo, Nexium, llegaran al mercado en 2015, costaban alrededor de $10 al mes, en comparación con los $100 de Nexium. Coherus BioSciences lanzó su biosimilar de Humira, Yusimry, en julio a $995 por caja de dos jeringas, en comparación con el precio de lista de Humira de $6,600 por un producto casi idéntico.

“El porcentaje de ahorro puede ser similar, pero el ahorro total en dólares es mucho mayor”, señaló Holmes, “siempre y cuando los patrocinadores del plan, los empleadores, se den cuenta de la oportunidad”.

Si es que quieren darse cuenta.

Mientras que un fabricante puede necesitar gastar unos pocos millones de dólares para sacar al mercado una píldora genérica, los fabricantes de biosimilares afirman que su desarrollo puede requerir hasta ocho años y $200 millones. Dicen que el negocio no funcionará a menos que ganen una cuota de mercado significativa.

El mayor obstáculo parecen ser los PBM. Express Scripts y Optum Rx, dos de los tres grandes, han incluido los biosimilares en sus formularios, pero al mismo precio que Humira. Esto ofrece a médicos y pacientes pocos incentivos para cambiar. Así que Humira sigue dominando por ahora.

Keith Athow, director de farmacia del programa de seguros colectivos de Tennessee, que cubre a 292,000 empleados estatales y locales y a sus dependientes, afirmó: “No hemos visto mucha aceptación de los biosimilares”.

La saga de Humira —su peculiar atractivo para los bróker o intermediarios farmacéuticos y las aseguradoras, los pacientes que se han beneficiado, los pacientes que han sufrido cuando su precio de catálogo se multiplicó por seis desde 2003— ejemplifica el enrevesado sistema de salud estadounidense, cuya cobertura de medicamentos con receta puede ser irregular y los gastos mucho más desiguales que en otras economías avanzadas.

Los biológicos como Humira ocupan una parte cada vez mayor del gasto de salud estadounidense, y sus costos han aumentado un 12,5% anual en los últimos cinco años. Estos medicamentos son cada vez más importantes en el tratamiento de cánceres y enfermedades autoinmunes, como la artritis reumatoide y la enfermedad inflamatoria intestinal, que afectan a 1 de cada 10 estadounidenses.

Las ventas mundiales de Humira, valoradas en $200,000 millones, lo convierten en el fármaco más vendido de la historia. Su fabricante, AbbVie, ha defendido agresivamente el fármaco, registrando más de 240 patentes y desplegando amenazas legales y retoques del producto para mantener a raya las protecciones de patentes y a los competidores.

La lucha por Humira no se detuvo cuando finalmente aparecieron los biosimilares. La farmacéutica ha comunicado a los inversores que no espera perder mucha cuota de mercado hasta 2024. “Estamos compitiendo de forma muy eficaz con las distintas ofertas de biosimilares”, declaró Richard González, CEO de AbbVie, durante una conferencia telefónica sobre resultados.

Cómo mantiene AbbVie su cuota de mercado

Una de las estrategias de AbbVie consistió en advertir a los planes de salud de que si recomendaban biosimilares en lugar de Humira perderían los reembolsos en las compras de Skyrizi y Rinvoq, dos medicamentos sin imitadores genéricos que se cotizan cada uno a unos $120,000 al año, según funcionarios de PBM. En otras palabras, la supresión de un medicamento de AbbVie supondría un aumento de los costos para los demás.

Fuentes del sector también afirman que los PBM persuadieron a AbbVie para que aumentara los reembolsos de Humira, es decir, los pagos de fin de año basados en el uso total del medicamento, que los PBM transfieren en su mayor parte a los patrocinadores de los planes de salud. Aunque las cifras de los reembolsos se mantienen en secreto y varían mucho, algunos aumentaron este año entre un 40% y un 60% del precio del medicamento.

Los principales PBM —Express Scripts, Optum y CVS Caremark— son muy poderosos, cada uno de ellos forma parte de un gigantesco conglomerado de salud que incluye una aseguradora líder, farmacias especializadas, consultorios médicos y otras empresas, algunas de ellas con sede en el extranjero por sus ventajas fiscales.

Sin embargo, los desafíos a las prácticas de PBM son cada vez mayores. La Comisión Federal de Comercio (FTC) inició el año pasado una importante investigación sobre estas empresas. Kroger canceló su contrato farmacéutico con Express Scripts el otoño pasado, alegando que no tenía poder de negociación en el acuerdo, y, el 17 de agosto, la aseguradora Blue Shield of California anunció que rescindía la mayor parte de su negocio con CVS Caremark por razones similares.

Los críticos de los principales PBM ven en los biosimilares de Humira un posible punto de inflexión para los herméticos procesos empresariales que han contribuido a unos precios de los medicamentos asombrosamente altos.

Aunque los precios de lista de Humira son muchas veces superiores a los de los nuevos biosimilares, los descuentos y rebajas ofrecidos por AbbVie hacen que su medicamento sea más competitivo. Pero incluso si los planes de salud estuvieran pagando sólo la mitad de la cantidad neta que pagan por Humira ahora —y si varios fabricantes de biosimilares cobraran tan poco como una sexta parte del precio bruto— los costos podrían caer en unos $30,000 al año por paciente, aseguró Greg Baker, CEO de AffirmedRx, un PBM más pequeño que está desafiando a las grandes empresas.

Multiplicado por los 313.000 pacientes a los que se prescribe Humira en la actualidad, el ahorro anual sería de unos $9,000 millones, un 1,4% del gasto farmacéutico nacional total en 2022.

El lanzamiento del biosimilar Yusimry, que se vende a través de la farmacia Cost Plus Drugs de Mark Cuban y en otros lugares, “debería hacer saltar las alarmas entre los empresarios”, dijo Juliana Reed, directora ejecutiva del Biosimilars Forum, un grupo de la industria. “Van a preguntar: ‘Un momento, ¿por qué me cobra un 85% más, señor PBM, que lo que ofrece Mark Cuban? ¿Qué le pasa a este sistema?”.

Los medicamentos más baratos podrían facilitar a los pacientes el pago de sus medicamentos y, presumiblemente, hacerlos más saludables. Una encuesta realizada por KFF en 2022 puso de manifiesto que casi una quinta parte de los adultos afirmaba no retirar una receta debido a su precio. Abundan los informes de pacientes de Humira que abandonan el medicamento por su costo excesivo.

Conveniencia, inercia y miedo

Cuando Sue Lee, de los suburbios de Louisville, Kentucky, se jubiló como inspectora de reclamaciones de seguros y pasó a Medicare en 2017, se enteró de que su copago mensual por Humira, que tomaba para tratar la dolorosa psoriasis en placas, había aumentado de $60 a $8,000 al año.

Fue una experiencia particularmente amarga para Lee, que ahora tiene 81 años, porque AbbVie le había pagado durante los tres años anteriores para hacer proselitismo del medicamento charlando con enfermeras dermatológicas en cenas elegantes patrocinadas por AbbVie. Para poder seguir tomando el medicamento, Lee pidió ayuda a la empresa, pero sus ingresos eran demasiado elevados para acogerse a su programa de asistencia.

“Habían terminado conmigo”, afirmó. Lee dejó de tomar el medicamento, y a las pocas semanas la psoriasis volvió con fuerza. Las llagas le cubrían las pantorrillas, el torso e incluso la punta de las orejas. Meses más tarde consiguió alivio al entrar en un ensayo clínico de otro medicamento.

A los planes de salud se les motiva para que sigan con Humira, como opción preferente, por conveniencia, inercia y miedo. Aunque se trata de datos confidenciales, una empresa del Medio Oeste con 2,500 empleados declaró a KFF Health News que AbbVie había reducido efectivamente el costo neto de Humira para la empresa en un 40% después del 1 de julio, día en que se lanzaron la mayoría de los biosimilares.

Uno de los tres principales PBM, CVS Caremark, anunció en agosto que se había asociado con el fabricante de medicamentos Sandoz para comercializar su propia versión reducida de Humira, llamada Hyrimoz, en 2024. Pero Caremark no parecía haber adoptado plenamente ni siquiera su propio biosimilar. Funcionarios del PBM notificaron a los clientes que Hyrimoz estará en el mismo nivel que Humira para “maximizar los reembolsos” de AbbVie, dijo Athow de Tennessee.

La mayoría de los reembolsos se transfieren a los planes de salud, según los PBM. Pero si el estado de Tennessee recibió un cheque de, digamos, $20 millones a finales del año pasado, sólo estaba recuperando parte de los $48 millones que ya había gastado.

“Es un pacto con el diablo”, señaló Michael Thompson, presidente y CEO de la National Alliance of Healthcare Purchaser Coalitions. “El día más feliz del año de un ejecutivo es entrar en el despacho del director financiero con un cheque de varios millones de dólares y decir: ‘¡Mira lo que te he conseguido!”.

Los ejecutivos de los principales PBM han afirmado que sus clientes prefieren los medicamentos de alto precio y alta bonificación, pero eso no es todo. Algunos de los honorarios y otros pagos que perciben los PBM, distribuidores, consultores y mayoristas se calculan en función del precio de un medicamento, lo que les da incentivos igualmente conflictivos, dijo Antonio Ciaccia, CEO de 46Brooklyn, una organización sin fines de lucro que investiga la cadena de suministro de medicamentos.

“Los grandes intermediarios se aferran a precios inflados”, afirmó Ciaccia.

AbbVie ha advertido a algunos PBM que si Humira no se ofrece en el mismo nivel que los biosimilares, dejará de pagar reembolsos por el medicamento, según Alex Jung, un contable forense que asesora al Midwest Business Group on Health.

AbbVie no respondió a las solicitudes de comentarios.

Uno de los biosimilares de bajo costo de Humira, Hadlima de Organon, ha entrado en varios formularios, las listas de medicamentos que los planes de salud ofrecen a los pacientes, desde su lanzamiento en febrero, pero “el acceso por sí solo no garantiza el éxito” y no significa que los pacientes obtengan el producto, apuntó Kevin Ali, CEO de Organon, durante una llamada sobre ingresos en agosto.

Si los precios de los biosimilares no son inferiores a los de Humira en los formularios de los planes de salud, los reumatólogos carecerán de incentivos para recetarlos. Cuando los PBM colocan medicamentos en el mismo “nivel” de un formulario, el copago del paciente suele ser el mismo.

En una declaración enviada por correo electrónico, Optum Rx declaró que al añadir varios biosimilares a sus formularios al mismo precio que Humira, “estamos fomentando la competencia al tiempo que garantizamos la elección y el acceso más amplio posible para aquellos a quienes servimos”.

Según Marcus Snow, presidente del Comité de Atención Reumatológica del Colegio Americano de Reumatología, el cambio de un paciente implica costos administrativos para el paciente, el plan de salud, la farmacia y el médico.

La inercia de los médicos es poderosa

Los médicos parecen reacios a retirar a los pacientes de Humira. Tras años de lucha con las aseguradoras, la mayor preocupación del paciente y del reumatólogo, según Snow, es “el cambio forzado por la aseguradora. Si al paciente le va bien, cualquier cambio le preocupa”. Aun así, el Colegio Americano de Reumatología distribuyó recientemente un vídeo en el que informaba a los pacientes de la disponibilidad de los biosimilares, y “los datos están ahí en el sentido de que prácticamente no hay diferencia”, dijo Snow. “Sabemos que el costo de la atención se está disparando. Pero al mismo tiempo, mi trabajo es hacer que mi paciente mejore. Eso está por encima de todo”.

“En igualdad de condiciones, me gusta mantener al paciente con el mismo fármaco”, dijo Madelaine Feldman, reumatóloga de Nueva Orleans.

Los especialistas gastrointestinales, que a menudo recetan Humira para la enfermedad inflamatoria intestinal, parecen igualmente en conflicto. La portavoz de la Asociación Americana de Gastroenterología, Rachel Shubert, afirmó que las directrices políticas del grupo “se oponen al cambio no médico” por parte de una aseguradora, a menos que la decisión sea compartida por el proveedor y el paciente. Pero Siddharth Singh, presidente del comité de directrices clínicas del grupo, dijo que no dudaría en cambiar a un nuevo paciente a un biosimilar, aunque “estas decisiones dependen en gran medida del seguro”.

HealthTrust, una empresa que adquiere medicamentos para unos dos millones de personas, sólo ha tenido cinco pacientes que se cambiaran de Humira este año, según Cora Opsahl, directora del Fondo de Salud 32BJ del Sindicato Internacional de Empleados de Servicios, un plan del estado de Nueva York que adquiere medicamentos a través de HealthTrust.

Pero las empresas de biosimilares esperan ir ganando terreno en el mercado poco a poco. Empresas como Coherus tendrán un nicho y “podrían estar en la vanguardia de una ola”, pronosticó Ciaccia, dadas las crecientes demandas de los empleadores para cambiar el sistema.

El límite de $2,000 en el gasto farmacéutico de Medicare que entrará en vigor en 2025 en virtud de la Ley de Reducción de la Inflación podría estimular el interés por los biosimilares. Con las aseguradoras asumiendo una mayor parte del costo de un medicamento, deberían buscar opciones más baratas.

Para Kaiser Permanente, el cambio a los biosimilares fue obvio una vez que la compañía determinó que eran seguros y eficaces, dijo Mary Beth Lang, directora de farmacia de KP. El primer biosimilar de Humira, Amjevita, era un 55% más barato que el medicamento original, e indicó que KP pagaba incluso menos desde que se lanzaron más biosimilares con descuentos drásticos. Los pacientes pagan menos por su medicación que antes, señaló, y muy pocos han intentado volver a Humira.

Prescryptive, un pequeño PBM que promete políticas transparentes, cambió al 100% de sus pacientes después de que la mayoría de los otros biosimilares entraran en el mercado el 1 de julio “sin absolutamente ninguna interrupción de la terapia, ninguna queja y ningún cambio”, indicó Rich Lieblich, vicepresidente de servicios clínicos y relaciones con la industria de la compañía.

AbbVie declinó responderle con un precio competitivo, agregó.

The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.

Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That’s because biologics are much more expensive than pills and other formulations made through simpler chemical processes.

For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, compared with Nexium’s $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira’s $6,600 list price for a nearly identical product.

“The percentage savings might be similar, but the total dollar savings are much bigger,” Holmes said, “as long as the plan sponsors, the employers, realize the opportunity.”

That’s a big if.

While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won’t work unless they gain significant market share, they say.

The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.

“We’re not seeing a lot of takeup of the biosimilar,” said Keith Athow, pharmacy director for Tennessee’s group insurance program, which covers 292,000 state and local employees and their dependents.

The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who’ve benefited, the patients who’ve suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. health care system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.

Biologics like Humira occupy a growing share of U.S. health care spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.

Humira’s $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.

The company’s fight for Humira didn’t stop when the biosimilars finally appeared. The drugmaker has told investors it doesn’t expect to lose much market share through 2024. “We are competing very effectively with the various biosimilar offerings,” AbbVie CEO Richard Gonzalez said during an earnings call.

How AbbVie Maintains Market Share

One of AbbVie’s strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM officials. In other words, dropping one AbbVie drug would lead to higher costs for others.

Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug’s list price.

The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors’ offices, and other businesses, some of them based overseas for tax advantages.

Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.

Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.

Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.

Multiplied by the 313,000 patients currently prescribed Humira, that comes to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.

The launch of the biosimilar Yusimry, which is being sold through Mark Cuban’s Cost Plus Drugs pharmacy and elsewhere, “should send off alarms to the employers,” said Juliana Reed, executive director of the Biosimilars Forum, an industry group. “They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?’”

Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.

Convenience, Inertia, and Fear

When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.

It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for help, but her income at the time was too high to qualify her for its assistance program.

“They were done with me,” she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.

Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told California Healthline that AbbVie had effectively lowered Humira’s net cost to the company by 40% after July 1, the day most of the biosimilars launched.

One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn’t appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to “maximize rebates” from AbbVie, Tennessee’s Athow said.

Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.

“It’s a devil’s bargain,” said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. “The happiest day of a benefit executive’s year is walking into the CFO’s office with a several-million-dollar check and saying, ‘Look what I got you!’”

Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that’s not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug’s price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.

“The large intermediaries are wedded to inflated sticker prices,” said Ciaccia.

AbbVie has warned some PBMs that if Humira isn’t offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.

AbbVie did not respond to requests for comment.

One of the low-cost Humira biosimilars, Organon’s Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but “access alone does not guarantee success” and doesn’t mean patients will get the product, Kevin Ali, Organon’s CEO, said in an earnings call in August.

If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same “tier” on a formulary, the patient’s copay is generally the same.

In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, “we are fostering competition while ensuring the broadest possible choice and access for those we serve.”

Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

Doctors’ Inertia Is Powerful

Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is “forced switching by the insurer. If the patient is doing well, any change is concerning to them.” Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and “the data is there that there’s virtually no difference,” Snow said. “We know the cost of health care is exploding. But at the same time, my job is to make my patient better. That trumps everything.”

“All things being equal, I like to keep the patient on the same drug,” said Madelaine Feldman, a New Orleans rheumatologist.

Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group’s policy guidance “opposes nonmedical switching” by an insurer, unless the decision is shared by provider and patient. But Siddharth Singh, chair of the group’s clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although “these decisions are largely insurance-driven.”

HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union’s 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.

But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and “they might be on the front end of a wave,” said Ciaccia, given employers’ growing demands for change in the system.

The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug’s cost, they should be looking for cheaper options.

For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP’s chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.

Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 “with absolutely no interruption of therapy, no complaints, and no changes,” said Rich Lieblich, the company’s vice president for clinical services and industry relations.

AbbVie declined to respond to him with a competitive price, he said.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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El Comité Asesor sobre Prácticas de Inmunización (ACIP) de los Centros para el Control y Prevención de Enfermedades (CDC) votó 13-1 a favor de la moción después de meses de debate sobre si limitar los refuerzos a grupos de alto riesgo.

Un día antes, la Administración de Drogas y Alimentos (FDA) aprobó la nueva dosis de refuerzo, afirmando que era segura y eficaz para proteger contra las variantes de covid-19 que circulan actualmente en los Estados Unidos.

Después de que se lanzara el refuerzo anterior en 2022, solo el 17% de la población lo recibió, en comparación con aproximadamente la mitad de la nación que recibió la primera dosis de refuerzo en el otoño de 2021.

El cansancio pandémico y la evidencia de que las vacunas no siempre evitan las infecciones por covid-19 jugaron un rol.

Sin embargo, aquellos que se vacunaron tuvieron mucho menos riesgo de enfermarse gravemente o morir, según los datos presentados en la reunión del martes.

El virus a veces causa enfermedad grave incluso en personas sin afecciones subyacentes, provocando más muertes en niños que otras enfermedades prevenibles por vacunas como la varicela, antes de que se recomendara universalmente la vacuna contra este patógeno.

Los datos de los CDC muestran que el número de pacientes hospitalizados con covid-19 ha aumentado un poco en las últimas semanas, y los expertos en enfermedades infecciosas anticipan un alza más adelante en el otoño y el invierno.

Moderna y Pfizer junto con su socio alemán, BioNTech, fabrican las dosis, que costarán hasta $130. Han lanzado campañas de marketing nacionales para fomentar la vacunación. El comité asesor pospuso una decisión sobre una tercera dosis de refuerzo, producida por Novavax, porque la FDA aún no la ha aprobado.

Esto es lo que hay que saber:

¿Quién debe recibir la dosis de refuerzo contra covid-19?

Los CDC aconsejan que todos, desde los 6 meses, la reciban, por el beneficio común. Aquellos con mayor riesgo de enfermedad grave incluyen a bebés y niños pequeños, adultos mayores, mujeres embarazadas y personas con afecciones de salud crónicas, incluyendo la obesidad.

Los riesgos son menores, aunque no nulos, para todos los demás. Se sabe que las vacunas tienden a prevenir la infección en la mayoría de las personas solo durante unos meses. Pero hacen un buen trabajo al prevenir la hospitalización y la muerte, y, disminuyendo las infecciones, pueden frenar la propagación de la enfermedad entre los más vulnerables, cuyos sistemas inmunes pueden ser demasiado débiles para generar una buena respuesta a la vacuna.

Pablo Sánchez, profesor de pediatría en la Universidad Estatal de Ohio y el único disidente en el panel de los CDC, dijo que le preocupaba que las dosis de refuerzo no se hubieran probado lo suficiente, especialmente en niños.

La cepa de la vacuna en las nuevas dosis de refuerzo se aprobó solo en junio, por lo que casi todas las pruebas se hicieron en ratones o monos. Sin embargo, vacunas casi idénticas se han administrado de manera segura a miles de millones de personas en todo el mundo.

¿Cuándo deberías recibirlo?

Los fabricantes de la vacuna dicen que comenzarán a distribuirla la semana del 11 de septiembre. Si estás en un grupo de alto riesgo y no has sido vacunado o has tenido covid en los últimos dos meses, podrías recibirlo de inmediato, según John Moore, experto en inmunología de la Facultad de Medicina Weill Cornell.

Si planeas viajar en esta temporada de vacaciones, Moore sugiere que esperes hasta finales de octubre o principios de noviembre para maximizar el período en el que la protección inducida por la vacuna sigue siendo alta.

¿Quién pagará por las dosis?

Cuando el ACIP recomienda una vacuna para niños, el gobierno está legalmente obligado a garantizar la cobertura gratuita para los niños, y lo mismo se aplica a la cobertura de seguros comerciales para vacunas de adultos.

Para los 25 a 30 millones de adultos sin seguro, el gobierno federal creó el Bridge Access Program,  que pagará por las dosis en centros de salud rurales y comunitarios, así como en Walgreens, CVS y algunas farmacias independientes

Los fabricantes acordaron donar algunas de las dosis, según funcionarios de los CDC.

¿Funcionará esta nueva dosis de refuerzo contra las variantes actuales de covid-19?

Debería. Más del 90% de las cepas que circulan actualmente están estrechamente relacionadas con la variante seleccionada para la dosis de refuerzo a principios de este año, y los estudios mostraron que las vacunas producían suficientes anticuerpos contra la mayoría de ellas.

Las dosis también parecieron generar una buena respuesta inmune contra una cepa divergente que inicialmente preocupaba a las personas, llamada BA.2.86. En la actualidad, esa cepa representa menos del 1% de los casos.

¿Por qué algunos médicos no están entusiasmados con la dosis de refuerzo?

La experiencia con las vacunas contra covid-19 ha demostrado que su protección contra la hospitalización y la muerte dura más que su protección contra la enfermedad, que disminuye relativamente rápido, y esto ha generado escepticismo.

La mayoría de las personas en el país han tenido covid y la mayoría se vacunó al menos una vez, lo que en conjunto suele ser suficiente para prevenir enfermedades graves, si no infecciones, en la mayoría de las personas.

Además, muchos médicos creen que el enfoque debería estar en vacunar a quienes realmente están en riesgo.

Con la nueva dosis de refuerzo, más las vacunas contra la gripe y el virus respiratorio sincitial (VRS), ¿cuántas dosis debo esperar recibir este otoño?

Las personas tienden a enfermarse a finales del otoño porque pasan más tiempo en interiores y pueden viajar y reunirse en grupos familiares grandes. Este otoño, por primera vez, hay una vacuna contra el VRS para adultos mayores.

Kathryn Edwards, pediatra de 75 años de la Universidad de Vanderbilt, planea recibir las tres dosis, pero “probablemente no todas juntas”, dijo.

Covid-19 “puede tener un impacto” y algunas de las vacunas contra el VRS y la gripe recomendadas para mayores de 65 años también pueden causar dolor en el brazo y, a veces, fiebre u otros síntomas.

Un dato reciente que surgió de un análisis reveló que las personas que recibieron las vacunas contra la gripe y covid-19 juntas podrían tener un riesgo ligeramente mayor de accidente cerebrovascular. Esa conexión parece haber desaparecido después de un estudio posterior, pero aún podría ser más seguro no recibirlas juntas.

Pfizer y Moderna están probando vacunas combinadas, con la primera vacuna contra la gripe y covid-19 disponible a partir del próximo año.

¿Se ha utilizado esta versión de la dosis de refuerzo en otras partes del mundo?

No, aunque la vacuna de Pfizer ha sido aprobada en la Unión Europea, Japón y Corea del Sur, y Moderna ha obtenido la aprobación en Japón y Canadá. Los lanzamientos comenzarán en Estados Unidos y otros países esta semana.

A diferencia de períodos anteriores de la pandemia, es poco probable que haya mandatos para la dosis de refuerzo. Pero “es importante que las personas tengan acceso a la vacuna si la quieren”, dijo Beth Bell, miembro del panel y profesora de salud pública en la Universidad de Washington. “Dicho esto, está claro que el riesgo no es igual, y el mensaje debe aclarar que muchas personas mayores y personas con afecciones subyacentes están muriendo y realmente necesitan una dosis de refuerzo”, dijo.

Sarah Long, miembro del ACIP y pediatra en el Hospital Infantil de Philadelphia, votó a favor de una recomendación universal pero dijo que le preocupaba que no fuera suficiente. “Creo que la recomendaremos y nadie la recibirá”, dijo. “Las personas que más la necesitan no la recibirán”.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who should get the covid booster?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When should you get it?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who will pay for it?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines. For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will this new booster work against the current variants of covid?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why are some doctors not gung-ho about the booster?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism. Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

With new covid boosters, plus flu and RSV vaccines, how many shots should I expect to get this fall?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said. Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year.

Has this booster version been used elsewhere in the world?

Nope, although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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Until a week or two ago, William Schaffner read that indifference as a sign the Centers for Disease Control and Prevention should advocate vaccinating only those most at risk from the virus.

But then Schaffner, an infectious disease specialist at Vanderbilt University Medical Center, changed his mind.

Members of the CDC’s Advisory Committee on Immunization Practices won him over to the argument that the vaccine be recommended for all Americans above 6 months of age, he said in an interview. The committee, which sets U.S. vaccination policy and helps determine insurance coverage for vaccines, will vote on the question Tuesday as it weighs the benefits of updated vaccines from Pfizer and Moderna. The FDA, the CDC’s sister agency, approved the two booster shots for use on Monday.

Not all vaccine experts see it quite as Schaffner, a nonvoting liaison representative to the ACIP, does.

“I don’t plan to get it myself,” said Paul Offit, 72, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. He’s had two boosters and got covid last year. Another vaccine might increase his protection against mild infection for a few months, but like most Americans’ immune systems, his is already familiar enough with the virus to protect him from serious disease, Offit believes.

Some of Schaffner’s scientific colleagues argue the government should be recommending the shot only for frail, older, sick, and immunocompromised people. Over 95% of the U.S. population are already covid-immunized through vaccination, infection, or both, and the risks of serious illness for healthy younger people are not great.

Schaffner doesn’t disagree. But lots of not-necessarily-vulnerable Americans do want the shot for themselves and their children, and, without a CDC recommendation, insurance companies wouldn’t have to pay for the vaccine.

It’s “pretty awful” that Pfizer and Moderna, the two main covid vaccine producers, have decided to charge up to $130 a shot, compared with $30 last year for the booster, which was produced under government contract, said Kathryn Edwards, a professor of pediatrics at Vanderbilt and a member of an ACIP working group on covid. (Pfizer spokesperson Amy Rose said the price was “consistent with the value delivered” and reflected higher expenses to provide the shots commercially.)

But a partial recommendation could leave the very groups who suffered most during the pandemic — minorities and other disadvantaged groups — unable to get vaccinated if they want but can’t afford to.

“The last thing we need are financial barriers that would enhance disparities,” Schaffner said.

A 1993 law requires the federal government to pay for childhood vaccines recommended by the ACIP, and more recent legislation requires coverage of adult vaccines within 15 days of an ACIP recommendation.

Pfizer and Moderna continue to make billions of dollars in sales of covid vaccines, although they are producing fewer doses. Moderna CEO Stéphane Bancel told investors in August that the company expected its global covid vaccine sales to be $6 billion to $8 billion this year, depending on uptake in the U.S. Pfizer expects about $14 billion this year.

Within a few years, both companies expect to be producing combination vaccines protecting against influenza, covid, and possibly respiratory syncytial virus. About 170 million flu vaccines were distributed last flu season in the U.S., so a combination product could lock in a large market for covid vaccines as well.

Despite broad recommendations for the updated covid booster shot released last fall, only 17% of the U.S. population got it — and about 43% of those 65 and older. How many will get the vaccine this season is uncertain, as is the benefit of the shot. A study of the new Moderna vaccine showed that it increased antibodies to various covid strains, though it wasn’t clear how much protection against disease it would offer, nor for how long.

The new vaccine is unlikely to be a “game changer,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

For healthier adults and children, “it’s a boost in protection for a few months,” Moore said. Who exactly will benefit most is impossible to predict because the U.S. is “not a cookie-cutter population.” Its people have by now been exposed to a bewildering combination of vaccines, boosters, and different strains of the virus.

Christopher Ridley, a Moderna spokesperson, said the updated vaccine was well matched to current viral strains, adding, “We encourage people to get vaccinated for covid when they get their annual flu shot.”

Fearmongering has distorted the threat of the virus, Moore said. He is skeptical of the significance of the recent uptick in covid hospitalizations, and criticized social media posters who have raised fears about new viral strains that don’t seem to pose any fundamental challenge to the new vaccines.

“Editorial FOMO drove summer surge worries,” Moore said, using an acronym for “fear of missing out.” Despite worrying comments and tweets by physicians such as Eric Topol, director of the Scripps Research Translational Institute, about a new covid variant called BA.2.86, “it turned out to be a real nothingburger,” Moore said.

Even Ashish Jha, who coordinated the Biden administration’s covid response until returning to his post as dean of the Brown University School of Public Health this year, agrees there is some ambiguity in the issue. While he recommends that 20-year-olds get the booster, “a reasonable person” could disagree.

Unfortunately, such discussions in the current environment are clouded by “nonsense and bad information” that causes confusion and hurts people, he said in a recent podcast interview.

Whether truly needed or not, the vaccines, proponents say, are safe enough that even the small benefit of taking them will outweigh the risks. The major, though rare, serious side effect of the Pfizer and Moderna vaccines — myocarditis, which particularly affected men in their teens and 20s — appears mainly to have occurred during the first two-shot series.

Paradoxically, those who most need protection from covid are often likely to have weakened immune systems that fail to generate the hoped-for response to vaccination.

So the vaccine is arguably most relevant for healthy people who come in frequent contact with vulnerable individuals. With that in mind, England has announced the new booster would be offered only to people who are 65 or older, in nursing homes, or immunologically vulnerable — or who work or live with members of those groups.

“Any efforts to promote the new boosters should focus squarely on those at high risk,” said Norman Hearst, a family physician in San Francisco. While recommending the vaccine for older patients, he said he wouldn’t advise a booster for young males because of the rare risk of myocarditis and the negligible benefit. “The question is all the other people in between.”

In a commentary last November, infectious disease doctors Shira Doron and Monica Gandhi said vaccination campaigns should be radically honest about the limited value of vaccines for long-term protection against infection. Such a campaign might advocate vaccinating children because even though it won’t protect durably, “it might prevent the rare case of severe disease.”

Meanwhile, the vaccine makers have their own plans for publicizing the vaccines. In its call with investors last month, Moderna said it was focused on increasing sales and solidifying Moderna’s market share with branded promotion. Its “awareness campaigns” will tout ACIP recommendations and “connect covid-19 with seasonal flu vaccines with the goal to drive consumers to get vaccinated this fall,” a company official said.

Moderna is co-sponsoring tennis’ U.S. Open this year and aired a video at the event Sept. 8 honoring Arthur Ashe, the only Black man to win Grand Slam titles, whom it credited with helping destigmatize HIV by revealing he had the virus.

The video presentation suggested that Moderna, like Ashe, has done well by being bold.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Hasta hace poco, el doctor William Schaffner interpretaba esa indiferencia como una señal de que los Centros para el Control y Prevención de Enfermedades (CDC) deberían abogar por la vacunación solo para aquellos con mayor riesgo de contraer el virus.

Pero luego, Schaffner, especialista en enfermedades infecciosas del Centro Médico de la Universidad de Vanderbilt, cambió de opinión.

Los miembros del Comité Asesor sobre Prácticas de Inmunización (ACIP, por sus siglas en inglés) de los CDC lo convencieron de que la vacuna debería recomendarse para todos los estadounidenses a partir de los 6 meses, según dijo en una entrevista.

El comité, que establece la política de vacunación del país y ayuda a determinar la cobertura del seguro para las vacunas, votaría sobre la cuestión el martes mientras evalúa los beneficios de las vacunas actualizadas de Pfizer y Moderna. La Administración de Alimentos y Medicamentos (FDA), la agencia hermana de los CDC, aprobó las dos dosis de refuerzo para su uso el lunes 11.

No todos los expertos en vacunas lo ven de la misma manera que Schaffner, un representante sin derecho a voto ante el ACIP.

“No tengo planeado recibirlo”, dijo el doctor Paul Offit, de 72 años, director del Centro de Educación sobre Vacunas del Hospital Infantil de Philadelfia. Offit tuvo dos dosis de refuerzo y desarrolló covid el año pasado.

Otra vacuna podría aumentar su protección contra una infección leve durante algunos meses, pero, como cree Offit, al igual que los sistemas inmunes de la mayoría de los estadounidenses, el suyo ya está lo suficientemente familiarizado con el virus como para protegerlo de una enfermedad grave.

Algunos de los colegas científicos de Schaffner argumentan que el gobierno debería recomendar la vacuna solo para personas frágiles, mayores, enfermas e inmunocomprometidas. Más del 95% de la población estadounidense ya está inmunizada contra covid mediante la vacunación, por la infección o por ambas, y los riesgos de enfermedad grave para las personas jóvenes y saludables no son muy altos.

Schaffner no está en desacuerdo. Pero muchos estadounidenses que no necesariamente son vulnerables quieren la vacuna para sí mismos y sus hijos, y sin una recomendación de los CDC, las aseguradoras no estarían obligadas a pagar por las dosis.

Es “bastante feo” que Pfizer y Moderna, los dos principales productores de vacunas contra covid, hayan decidido cobrar hasta $130 por dosis, en comparación con los $30 del año pasado por la vacuna de refuerzo, que se produjo bajo contrato con el gobierno, dijo Kathryn Edwards, profesora de pediatría en Vanderbilt y miembro de un grupo de trabajo del ACIP sobre covid.

Amy Rose, vocera de Pfizer, dijo que el precio era “consistente con el valor entregado” y reflejaba mayores gastos para suministrar las dosis comercialmente.

Pero una recomendación parcial podría dejar a los grupos que más sufrieron durante la pandemia (minorías y otros grupos desfavorecidos) sin poder vacunarse, en caso que quieran, porque las dosis no serían asequibles.

“Lo último que necesitamos son barreras financieras que aumenten las disparidades”, dijo Schaffner.

Una ley de 1993 exige que el gobierno federal pague las vacunas infantiles recomendadas por el ACIP, y una legislación más reciente exige la cobertura de las vacunas para adultos dentro de los 15 días siguientes a una recomendación del ACIP.

Pfizer y Moderna siguen ganando miles de millones de dólares con las ventas de vacunas contra covid, aunque están produciendo menos dosis. Stéphane Bancel, director ejecutivo de Moderna, dijo a los inversores en agosto que la compañía esperaba que sus ventas mundiales de vacunas contra covid fueran de entre $6.000 y $8.000 millones este año, dependiendo de la aceptación en Estados Unidos. Pfizer espera alrededor de $14.000 millones en el mismo período.

Dentro de unos años, ambas empresas esperan producir vacunas combinadas que protejan contra la gripe, covid y, posiblemente, el virus respiratorio sincitial (VRS). La última temporada de gripe se distribuyeron alrededor de 170 millones de vacunas contra la gripe en el país, por lo que un producto combinado podría asegurar también un gran mercado para las vacunas contra covid.

A pesar de las amplias recomendaciones para el refuerzo anticovid actualizado publicadas el otoño pasado, sólo el 17% de la población la recibió, y alrededor del 43% de las personas de 65 años o más.

No se sabe cuántos recibirán la vacuna esta temporada, y tampoco sus beneficios reales. Un estudio de la nueva vacuna de Moderna demostró que aumentaba los anticuerpos contra varias cepas de covid, aunque no estaba claro cuánta protección contra la enfermedad ofrecía ni durante cuánto tiempo.

Es poco probable que la nueva vacuna “cambie las reglas del juego”, dijo John Moore, profesor de microbiología e inmunología en el Weill Cornell Medical College.

Para adultos y niños más sanos, “es un aumento de la protección durante unos meses”, dijo Moore. Es imposible predecir exactamente quién se beneficiará más porque Estados Unidos “no es una población estándar”. Su población ya ha estado expuesta a una combinación desconcertante de vacunas, refuerzos y diferentes cepas del virus.

Christopher Ridley, vocero de Moderna, dijo que la vacuna actualizada coincidía bien con las cepas virales actuales y agregó: “Alentamos a las personas a vacunarse contra covid cuando reciban su vacuna anual contra la gripe”.

Moore cree que la alarma ha distorsionado la amenaza del virus. Se muestra escéptico sobre la importancia del reciente aumento de las hospitalizaciones por covid, y criticó a avisos en las redes sociales que han generado temores sobre nuevas cepas virales que no parecen plantear ningún desafío fundamental para las nuevas vacunas.

“El fervor editorial generó preocupaciones sobre el aumento repentino del verano”, dijo Moore, utilizando un acrónimo de “miedo a perderse algo” (FOMO en inglés). A pesar de los comentarios y tuits preocupantes de médicos como Eric Topol, director del Instituto Traslacional de Investigación Scripps, sobre una nueva variante de covid llamada BA.2.86, “resultó ser algo sin importancia”, expresó Moore.

Incluso Ashish Jha, quien coordinó la respuesta a covid de la administración Biden hasta que regresó a su puesto como decano de la Escuela de Salud Pública de la Universidad Brown este año, está de acuerdo en que hay cierta ambigüedad en el tema. Si bien recomienda que los jóvenes de 20 años reciban la vacuna de refuerzo, “una persona razonable” podría no estar de acuerdo.

Desafortunadamente, este tipo de debates en el entorno actual se ven empañados por “tonterías y mala información” que causan confusión y dañan a la gente, dijo en una entrevista reciente en un podcast.

Los defensores de las vacunas dicen que, ya sea que sean realmente necesarias o no, son lo suficientemente seguras como para que incluso el pequeño beneficio de tomarlas supere los riesgos. El principal efecto secundario grave, aunque raro, de las vacunas de Pfizer y Moderna (la miocarditis, que afectó especialmente a hombres adolescentes y de 20 años) parece haber ocurrido principalmente durante la primera serie de dos inyecciones.

Paradójicamente, quienes más necesitan protección contra covid suelen tener sistemas inmunes debilitados que no logran generar la respuesta esperada a la vacunación.

Por lo tanto, podría decirse que la vacuna es más relevante para las personas sanas que entran en contacto frecuente con personas vulnerables. Con eso en mente, Inglaterra ha anunciado que el nuevo refuerzo se ofrecerá solo a personas de 65 años o más, en hogares de adultos mayores o con sistemas inmunes vulnerables, o que trabajen o vivan con miembros de esos grupos.

“Cualquier impulso para promover los nuevos refuerzos debería centrarse directamente en las personas con alto riesgo”, afirmó Norman Hearst, médico de familia de San Francisco. Si bien recomendó la vacuna para pacientes mayores, dijo que no recomendaría un refuerzo para ellos debido al raro riesgo de miocarditis y el beneficio insignificante. “La cuestión son todas las demás personas en el medio”.

En un comentario en noviembre, las infectólogas Shira Doron y Monica Gandhi dijeron que las campañas de vacunación deberían ser radicalmente honestas sobre el valor limitado de las vacunas para la protección a largo plazo contra la infección. Una campaña de este tipo podría abogar por la vacunación de los niños porque, aunque no protegerá de forma duradera, “podría prevenir casos raros de enfermedad grave”.

Mientras tanto, los fabricantes de vacunas tienen sus propios planes para publicitarlas. En su llamada con inversionistas en agosto, Moderna dijo que estaba enfocada en aumentar las ventas y solidificar la participación de mercado de Moderna con promoción de marca.

Sus “campañas de concientización” promocionarán las recomendaciones del ACIP y “conectarán a covid-19 con las vacunas contra la gripe estacional con el objetivo de impulsar a los consumidores a vacunarse este otoño”, dijo un funcionario de la compañía.

Moderna copatrocina el Abierto de Estados Unidos de tenis de este año y transmitió un video en el evento del 8 de septiembre en honor a Arthur Ashe, el único hombre negro en ganar títulos de Grand Slam, a quien le atribuye haber ayudado a desestigmatizar el VIH al revelar que tenía el virus.

El video sugirió que Moderna, al igual que Ashe, ha hecho bien en ser audaz.

Esta historia fue producida por KFF Health News, conocido antes como Kaiser Health News (KHN), una redacción nacional que produce periodismo en profundidad sobre temas de salud y es uno de los principales programas operativos de KFF, la fuente independiente de investigación de políticas de salud, encuestas y periodismo. 

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Under the 2022 Inflation Reduction Act, Congress gave the federal government the power to negotiate prices for certain high-cost drugs under Medicare. The list of drugs selected by the Centers for Medicare & Medicaid Services will grow over time.

The first eligible drugs treat diabetes, blood clots, blood cancers, arthritis, and heart disease — and accounted for about $50 billion in spending from June 2022 to May 2023.

The United States is clearly an outlier on drug costs, with drugmakers charging Americans many times more than residents of other countries “simply because they could,” Biden said Tuesday at the White House. “I think it’s outrageous. That’s why these negotiations matter.”

He added, “We’re going to keep standing up to Big Pharma and we’re not going to back down.”

Democratic lawmakers cheered the announcement, and the pharmaceutical industry, which has filed a raft of lawsuits against the law, condemned it.

The companies have until Oct. 2 to present data on their drugs to CMS, which will make initial price offers in February, setting off negotiations set to end next August. The prices would go into effect in January 2026.

Here are five things to know about the impact:

1. How important is this step?

Medicare has long been in control of the prices for its services, setting physician payments and hospital payments for about 65 million Medicare beneficiaries. But it was previously prohibited from involvement in pricing prescription drugs, which it started covering in 2006.

Until now the drug industry has successfully fought off price negotiations with Washington, although in most of the rest of the world governments set prices for medicines. While the first 10 drugs selected for negotiations are used by a minority of patients — 9 million — CMS plans by 2029 to have negotiated prices for 50 drugs on the market.

“There’s a symbolic impact, but also Medicare spent $50 billion on these 10 drugs in a 12-month period. That’s a lot of money,” said Juliette Cubanski, deputy director of KFF’s analysis of Medicare policy.

The long-term consequences of the new policy are unknown, said Alice Chen, vice dean for research at University of Southern California’s Sol Price School of Public Policy. The drug industry says the negotiations are essentially price controls that will stifle drug development, but the Congressional Budget Office estimated only a few drugs would not be developed each year as a result of the policy.

Biden administration officials say reining in drug prices is key to slowing the skyrocketing costs of U.S. health care.

2. How will the negotiations affect Medicare patients?

In some cases, patients may save a lot of money, but the main thrust of Medicare price negotiation policy is to provide savings to the Medicare program — and taxpayers — by lowering its overall costs.

The drugs selected by CMS range from specialized, hyper-expensive drugs like the cancer pill Imbruvica (used by about 26,000 patients in 2021 at an annual price of $121,000 per patient) to extremely common medications such as Eliquis (a blood thinner for which Medicare paid about $4,000 each for 3.1 million patients).

While the negotiations could help patients whose Medicare drug plans require them to make large copayments for drugs, the relief for patients will come from another segment of the Inflation Reduction Act that caps drug spending by Medicare recipients at $2,000 per year starting in 2025.

3. What do the Medicare price negotiations mean for those not on Medicare?

One theory is that reducing the prices drug companies can charge in Medicare will lead them to increase prices for the privately insured.

But that would be true only if companies aren’t already pricing their drugs as high as the private market will bear, said Tricia Neuman, executive director of KFF’s program on Medicare policy.

Another theory is that Medicare price negotiations will equip private health plans to drive a harder bargain. David Mitchell, president of the advocacy group Patients for Affordable Drugs, predicted that disclosure of negotiated Medicare prices “will embolden and arm private sector negotiators to seek that lower price for those they cover.”

Stacie B. Dusetzina, a professor of health policy at Vanderbilt University, said the effect on pricing outside Medicare isn’t clear.

“I’d hedge my bet that it doesn’t change,” she said.

Nonetheless, Dusetzina described one way it could: Because the government will be selecting drugs for Medicare negotiations based partly on the listed gross prices for the drugs — distinct from the net cost after rebates are taken into account — the process could give drug companies an incentive to lower the list prices and narrow the gap between gross and net. That could benefit people outside Medicare whose out-of-pocket payments are pegged to the list prices, she said.

4. What are drug companies doing to stop this?

Even though negotiated prices won’t take effect until 2026, drug companies haven’t wasted time turning to the courts to try to stop the new program in its tracks.

At least six drug companies have filed lawsuits to halt the Medicare drug negotiation program, as have the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, known as PhRMA.

The lawsuits include a variety of legal arguments. Merck & Co., Johnson & Johnson, and Bristol Myers Squibb are among the companies arguing their First Amendment rights are being violated because the program would force them to make statements on negotiated prices they believe are untrue. Lawsuits also say the program unconstitutionally coerces drugmakers into selling their products at inadequate prices.

“It is akin to the Government taking your car on terms that you would never voluntarily accept and threatening to also take your house if you do not ‘agree’ that the taking was ‘fair,’” Janssen, part of Johnson & Johnson, wrote in its lawsuit.

Nicholas Bagley, a law professor at the University of Michigan, predicted the lawsuits would fail because Medicare is a voluntary program for drug companies, and those wishing to participate must abide by its rules.

5. What if a drug suddenly gets cheaper by 2026?

In theory, it could happen. Under guidelines CMS issued this year, the agency will cancel or adjourn negotiations on any drug on its list if a cheaper copycat version enters the market and finds substantial buyers.

According to company statements this year, two biosimilar versions of Stelara, a Johnson & Johnson drug on the list, are prepared to launch in early 2025. If they succeed, it would presumably scotch CMS’ plan to demand a lower price for Stelara.

Other drugs on the list have managed to maintain exclusive rights for decades. For example, Enbrel, which the FDA first approved in 1998 and cost Medicare $1.5 billion in 2021, will not face competition until 2029 at the earliest.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi. In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it.

Patients with early Alzheimer’s disease who took lecanemab in a major clinical trial declined an average of five months slower than other subjects over an 18-month period, but many suffered brain swelling and bleeding. Although those side effects usually resolved without obvious harm, they apparently caused three deaths. The great expense of the drug and its treatment raises questions about how it will be paid for, and who will benefit.

“In the history of science, it’s a significant achievement to slightly slow down progression of dementia,” said John Mafi, a researcher and associate professor of medicine at the David Geffen School of Medicine at UCLA. “But the actual practical benefits to patients are very marginal, and there is a real risk and a real cost.”

To qualify for Leqembi, patients must undergo a PET scan that looks for amyloid plaques, the protein clumps that clog the brains of many Alzheimer’s patients. About 1 in 5 patients who took Leqembi in the major clinical test of the drug developed brain hemorrhaging or swelling, a risk that requires those taking the drug to undergo frequent medical checkups and brain scans called MRIs.

In anticipation of additional costs from the Leqembi drug class, the Centers for Medicare & Medicaid Services in 2021 increased monthly premiums for Medicare patients by 15%, and premiums may rise again in 2024 after a slight decline this year.

Such increases can be a significant burden for many of the 62 million Medicare subscribers who live on fixed incomes. “Real people will be affected,” Mafi said. He contributed to a study that estimated lecanemab and related care would cost Medicare $2 billion to $5 billion a year, making it one of the most expensive taxpayer-funded treatments.

In its analysis, ICER suggested that Leqembi could be cost-effective at an annual price of $8,900 to $21,500. In an interview, David Rind, ICER’s chief medical officer, said $10,000 to $15,000 a year would be reasonable. “Above that range doesn’t seem like a good place,” he said.

Whatever its price, patients may be delayed getting access to Leqembi because of the relative shortage of specialists capable of managing the drug, which will require genetic and neuropsychological testing as well as the PET scan to confirm a patient’s eligibility. A similar drug, Eli Lilly’s donanemab, is likely to win FDA approval this year.

Already there are long waits for the testing needed to assess dementia, Mafi said, noting that one of his patients with mild cognitive impairment had to wait eight months for an evaluation.

Such testing is not readily at hand because of the paucity of effective treatment for Alzheimer’s, which has helped to make geriatrics a relatively unappealing specialty. The United States has about a third as many dementia specialists per capita as Germany, and about half as many as Italy.

“Time is of the essence” for the neuropsychological testing, Mafi said, because once a patient’s cognitive ability declines below a certain threshold, they become ineligible for treatment with the drug, which was tested only in patients in the earliest stages of the disease.

Mafi’s study estimates that patients without supplemental Medicare coverage will have to pay about $6,600 out-of-pocket for each year of treatment. That could put it out of reach for many of the 1 in 7 “dual eligible” Medicare beneficiaries whose income is low enough to simultaneously qualify them for state Medicaid programs. Those programs are responsible for about 20% of physician bills for drug infusions, but they don’t always cover the full amount.

Some practitioners, such as cancer centers, cover their Medicaid losses by receiving higher rates for privately insured patients. But since almost all lecanemab patients are likely to be on government insurance, that “cross-subsidization” is less of an option, said Soeren Mattke, director of the Center for Improving Chronic Illness Care at the University of Southern California.

This poses a serious health equity issue because “dual eligibles are low-income patients with limited opportunities and education, and at higher risk of chronic illnesses including dementia,” Mattke said in an interview. Yet many doctors may not be willing to treat them, he said. “The idea of denying access to this group is just appalling.”

Eisai spokesperson Libby Holman said the company was reaching out to specialists and primary care physicians to make them aware of the drug, and that reimbursement options were improving. Eisai will provide the drug at no cost to patients in financial need, she said, and its “patient navigators” can help lock down insurance coverage.

“A lot of clinicians are excited about the drug, and patients are hearing about it,” said David Moss, chief financial officer of INmune Bio, a company that has another Alzheimer’s drug in development. “It’s a money center for infusion centers and MRI operators. It provides reasons for patients to come into the office, which is a billing thing.”

Outstanding doubts about Leqembi and related drugs have given urgency to efforts to monitor patient experiences. CMS is requiring Leqembi patients to be entered into a registry that tracks their outcomes. The agency has established a registry, but the Alzheimer’s Association, the leading advocacy group for dementia patients, is funding its own database to track those being treated, offering physician practices $2,500 to join it and up to $300 per patient visit.

In a letter to CMS on July 27, a group of policy experts said CMS should ensure that any and all Leqembi registries create and share data detailed enough for researchers and FDA safety teams to obtain a clear picture of the drug’s real-world profile.

The anti-amyloid drugs like lecanemab have created a polarized environment in medicine between those who think the drugs are a dangerous waste of money and those who believe they are a brilliant first step to a cure, said ICER’s Rind, who thinks lecanemab has modest benefits.

“People are as dug in on this as almost anything I’ve ever seen in medicine,” he said. “I don’t think it’s healthy.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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