Tag: Drug

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In a Reversal, F.D.A. Requires Limits on Who Will get Alzheimer’s Drug

In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

When the FDA approved Aduhelm a month ago, the original label said the drug was “for the treatment of Alzheimer’s disease.” The surprisingly broad label caused a storm of concern among many Alzheimer’s experts, even those who had supported the drug’s approval.

At a forum sponsored by the Alzheimer’s Association last month that urged Aduhelm to be approved, a panel of Alzheimer’s clinics with differing views agreed on whether the drug should have been approved that its use was strong should be restricted.

Many experts say the drug’s label should not only restrict Aduhelm’s use to mild disease stages, but also require two more stringent clinical trial conditions: that suitable patients have evidence of high levels of a key protein, amyloid, in their brain, and that people with certain diseases (so-called “contraindications”) should be prevented from taking the drug or at least classified as a high-risk group, as this can lead to brain swelling and bleeding.

At the forum, Dr. Stephen Selloway, director of the Memory and Aging Program at Butler Hospital in Providence, RI, who helped conduct the Aduhelm studies and is one of the drug’s most ardent medical advocates, when he saw the label had no contraindications to his The reaction was “oy”.

On Thursday, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who also worked on one of the Aduhelm studies and spoke out against the approval of the drug, saying that the new labeling was neglected.

The label should have said, among other things, that people with diabetes, high blood pressure and people who take blood thinners are not allowed to take part in the clinical trials and therefore “no extent is known”. of increased risk ”for these patients.

Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, said the new label was based more on what he and other Alzheimer’s experts believe should originally have been written. But the abrupt revision of the label so soon after a much criticized approval decision was worrying, he said.

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Walmart unveils low-price analog insulin amid rising diabetes drug prices

Walmart unveils low-price analog insulin amid rising diabetes drug costs

Walmart said Tuesday it will offer a less expensive version of insulin that could better fit into the budgets of millions of Americans who don’t have health insurance or struggle to pay for the lifesaving diabetes drug.

Starting this week, the retailer will sell an exclusive private-label version of analog insulin, ReliOn NovoLog, to adults and children who have a prescription. The drug will be available at its membership-based Sam’s Club in mid-July. The insulin will cost about $73 for a vial or about $86 for a package of prefilled insulin pens.

The insulin is the latest addition to Walmart’s private brand of diabetes products, ReliOn. It already sells a low-price version of insulin for about $25 as part of the line, but that is an older formulation that some doctors and advocates say is not as effective at managing blood sugar swings as newer versions of insulin, called analogs.

With the move, Walmart will bring its longtime focus on “everyday low price” to a drug that is a medical necessity for a growing number of Americans. More than 34 million people in the U.S. — or nearly 11% of the population — have diabetes, and about 1.5 million Americans are diagnosed every year, according to the American Diabetes Association. That percentage is about 14% among Walmart shoppers, said Warren Moore, Walmart’s vice president of health and wellness, on a call.

As the number of people with diabetes climbs, the cost of the 100-year-old drug has soared rather than fallen and drawn scrutiny from lawmakers. The annual cost of insulin for people with Type 1 diabetes in the U.S. nearly doubled from $2,900 in 2012 to $5,700 in 2016, according to the most recent data available from the Health Care Cost Institute. Some of the top manufacturers of insulin, including Sanofi and Eli Lilly, have been grilled by politicians during congressional hearings for hiking prices of the critical drug. In some cases, the companies have responded to criticism by rolling out limited, reduced price programs.

Dr. Cheryl Pegus, Walmart’s executive vice president of health and wellness, said Walmart’s version of the drug will expand access to care as it undercuts the typical price and puts analog insulin within reach of more people. She said Walmart worked directly with manufacturer Novo Nordisk to reduce costs. The price difference with branded competitors will be as much as $101 per vial of insulin or up to $251 per pack of prefilled insulin pens, Pegus said.

“This price point, we hope, will improve and hopefully revolutionize the accessibility and affordability of insulin,” she said on a call with reporters. “We know that many people with diabetes struggle to manage this chronic condition because of its financial burden.”

Walmart, already the nation’s largest employer and grocer, has made a bigger push into health care as it tries to leverage its massive reach for other money-making opportunities. It has opened 20 clinics next to its stores with budget-friendly medical care, such as $30 annual checkups or $25 dental cleanings. It bought a telehealth company, MeMD, in May for an undisclosed amount as a way to provide care virtually. And it has pressured the pharmacy industry on price before by launching a prescription program that sells monthly supplies of many widely used generic drugs for $4.

Yet the retail giant is treading in a complex industry that has tripped up other large, influential corporate players. Haven, a joint venture of Amazon, Berkshire Hathaway and JPMorgan Chase, disbanded early this year about three years after the companies heralded plans to disrupt health care with lower costs and improved outcomes.

Walmart has lost some of the key talent it recruited to lead and expand its health and wellness efforts, including Sean Slovenski, formerly senior vice president of Walmart health and wellness; and Dr. Tom Van Gilder, who had become its first full-time chief medical officer.

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Serving to Drug Customers Survive, Not Abstain: ‘Hurt Discount’ Beneficial properties Federal Help

Helping Drug Users Survive, Not Abstain: ‘Harm Reduction’ Gains Federal Support

GREENSBORO, NC – The skinny young man quietly walked into the room while waiting for the free supplies to help keep him from dying: sterile water and a stove to dissolve illegal drugs; clean syringes; Alcohol swabs to prevent infection; and naloxone, a drug that can reverse overdoses. A sign on the wall – “We stand to love drug users for who they are” – felt like a hug.

It was the first day on which the contact point in a residential area here opened its doors since it was closed due to the coronavirus in spring 2020. “I am very happy that you have all opened again,” the man, whose first name is Jordan, said a volunteer who handed him a full paper bag while heavy metal music played over a loudspeaker in the background. He asked for extra naloxone for friends in his rural county, an hour away, where it was in short supply during the pandemic.

The death toll from overdose rose nearly 30 percent to more than 90,000 in the twelve months that ended in November, according to preliminary federal data released earlier this month – suggesting 2020 beat recent records for such deaths Has. The astounding surge during the pandemic is due to many factors including widespread job losses and displacement; decreased access to addiction treatment and medical care; and an illicit drug supply that became even more dangerous after the country was closed.

But the forced isolation for people struggling with addiction and other mental health issues is possibly one of the greatest. Now, with the nation reopening, the Biden government supports the controversial approach the center is taking here known as harm reduction. Rather than giving drug users abstinence, the main goal is to reduce their risk of dying or developing infectious diseases like HIV by providing them with sterile equipment, tools to check their drugs for fentanyl and other deadly substances, or even a safe place to nap Will be provided .

Such programs have long been under attack to facilitate drug use, but President Biden has made expanding harm reduction efforts one of his drug policy priorities – the first president to do so. The American Rescue Act earmarked $ 30 million specifically for evidence-based harm reduction services, the first time Congress has raised funds specifically for that purpose. Funding, while modest, is a victory for the programs, both symbolically and practically, as they often run on tight budgets.

“It’s a tremendous signal to recognize that not everyone who uses drugs is ready for treatment,” said Daliah Heller, director of drug-use initiatives at Vital Strategies, a global health organization. “Harm reduction programs say, ‘Okay, you do drugs. How can we help you stay safe and healthy and alive in the first place? ‘”

Although some programs like this one, run by the North Carolina Survivors Union, managed to keep holding some supplies – handing them through windows, offering roadside collection, or even mailing them – practically all of them stopped during the pandemic To invite drug users. Many customers, like Jordan, stopped coming and lost a trustworthy safety net.

Some former Greensboro Center regulars have died or disappeared. Many lost their homes or jobs. At the same time, the center was flooded with new customers and is now having problems keeping enough supplies on hand.

“The struggle that people are having right now, unrecognized and unanswered, is really difficult,” said Louise Vincent, Executive Director of the Survivors Union.

Yet many elected officials and communities continue to refuse to provide people with medication for drug use, including recently introduced test strips to screen drugs for the presence of illegally manufactured fentanyl, which appears in most overdose deaths. Some also say that syringes from harm reduction programs litter the neighborhoods or that the programs lead to an increase in crime. Researchers deny both claims.

West Virginia has just passed law making syringe service programs very difficult to operate, despite an increase in HIV cases from intravenous drug use. The North Carolina Legislature pondered a similar proposal this spring, and elected officials in Scott County, Indiana, whose syringe exchanges helped contain a major HIV outbreak six years ago, voted this month to end it. Mike Jones, a local commissioner who voted to end the program, said at the time that he feared the syringes being distributed could contribute to overdose deaths.

“I know people who are alcoholics and I don’t buy them a bottle of whiskey,” he said. “And I know people who want to kill themselves and I won’t buy them a bullet for their gun.”

Many harm reduction programs are carried out by people who have previously or are still using drugs, and their own struggles with addiction, mental illness, or other health problems have also flared up during the pandemic. In Baltimore, Boston, New York and elsewhere, beloved movement leaders themselves have died of overdoses, chronic health problems, and other causes in the past year. Her death left gaps in efforts to continue providing services.

Ms. Vincent, whose own opioid addiction stemmed from a long battle with bipolar disorder, made a brief return to illicit drug use this spring. She was keen to prevent withdrawal, she said after trying unsuccessfully to switch from methadone to another anti-craving drug, buprenorphine. She later learned that the small amount of fentanyl she was using was mixed with xylazine – an animal sedative that can cause weeping ulcers on the skin. She ended up in the hospital with her hemoglobin level so low that she needed a blood transfusion.

At the start of the pandemic, Ms. Vincent said street drug prices soared. Then drugs that were sold as heroin, methamphetamine, or cocaine were trimmed with unknown additives. Fentanyl was ubiquitous – including increasingly in counterfeit pills sold as prescription pain relievers or anti-anxiety drugs. But also substances like xylazine, which appears in illegal drugs from Philadelphia to Saskatchewan.

“It’s just poison,” said Ms. Vincent, who is being treated with methadone again. “The drug supply is like nothing we’ve seen before.”

On the afternoon of the center’s reopening, a young woman asked for a refresher on how to inject naloxone and if Ms. Vincent could explain what a meth overdose looks like. An older man asked if there was anything to eat besides clean syringes; a volunteer put a pastry in the microwave for him.

In addition to running the program here, Ms. Vincent is the executive director of the National Urban Survivors Union, a larger nonprofit, promoting harm reduction services across the country. In 2016, her 19-year-old daughter died of a heroin overdose while she was in an inpatient treatment center where naloxone was not available, she said.

Naloxone is more common now, but Ms. Vincent wants another life-saving tool to be disseminated: drug control programs that would allow people to find out exactly what substances are in illicit drugs before using them. Such programs exist legally in other countries including Canada, the Netherlands and New Zealand. Another type of harm reduction program used in other countries – where people use illicit drugs under medical supervision if they overdose – remains illegal here after a group trying to start one in Philadelphia so far lost in court.

“We cWe could have a real-time monitoring system instead of waiting for death reports from the coroner, ”Ms. Vincent said. “It would change the game, wouldn’t it?”

She found the xylazine in the drugs she recently took with a device called a Fourier Transform Infrared Spectrometer that a donor gave to her group this year. It can determine which substances contain samples of street drugs in minutes.

Jordan, who is 23 years old, had traveled from Stokes County, near the Virginia border, where the pre-pandemic overdose rate was nearly double the national average. His cousin, he said, was hospitalized weeks earlier after overdosing on a “really bad batch” of fentanyl that were found to contain traces of heavy metals in tests.

“At least 50 people in my area were rescued from here by Narcan,” he said, picking up several boxes of 10 vials of the injectable form of the antidote. “Even my grandmother knows how to manage it.”

Many harm reduction programs, including this one, help or sometimes even offer people to put people on drug treatment. But Jordan is one of the many drug users who are not interested in this path, at least for the moment. The next programs are in Greensboro or Winston-Salem, each a healthy drive from home. And treating food cravings like buprenorphine or methadone, which have been shown to save lives, “doesn’t really work for me,” he said.

The county that includes Greensboro, North Carolina’s third largest city, had 140 fatal overdoses last year, up from 111 the year before. The numbers don’t include the people who died from infections caused by injecting drugs, including the fiancée of a woman who walked into the center at dusk on the day of the reopening and called out to Ms. Vincent, “Where’s Louise?”

She met Ms. Vincent when they were both patients in a methadone clinic six years ago and regularly came to the center for injections and naloxone. She and her fiancé had tried to stop drug use during the pandemic, unnerved by the strange new adulterants that were showing up in the stash. But her fiancé started developing a high fever last December and was admitted to a hospital intensive care unit, seriously ill with endocarditis, a heart valve infection that can result from injecting medication. He died just before Christmas.

“Do you all have a meeting tonight?” Asked Ms. Vincent, referring to the self-help groups the center held several times a week before the pandemic.

“You’ll start again soon,” Mrs. Vincent assured her. “Being connected is much more important than any of us thought.”

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New Alzheimer’s Drug Might Value the Authorities as A lot as It Spends on NASA

New Alzheimer’s Drug Could Cost the Government as Much as It Spends on NASA

Es wird erwartet, dass Medicare ein neu zugelassenes Medikament zur Behandlung der Alzheimer-Krankheit in Höhe von mehreren Milliarden Dollar kosten wird. Einer Prognose zufolge könnten die Ausgaben für das Medikament für die Patienten von Medicare am Ende höher sein als die Budgets der Umweltschutzbehörde oder der NASA.

Es gibt wenig Beweise dafür, dass das Medikament Aduhelm das Fortschreiten der Demenz verlangsamt, aber die Food and Drug Administration hat es diesen Monat genehmigt. Analysten gehen davon aus, dass Medicare und seine Teilnehmer, die einen Teil ihrer Kosten für verschreibungspflichtige Medikamente zahlen, in einem einzigen Jahr 5,8 bis 29 Milliarden US-Dollar für das Medikament ausgeben werden.

„Es ist unergründlich“, sagte Tricia Neuman, geschäftsführende Direktorin des Programms zur Medicare-Politik der Kaiser Family Foundation. “Das sind verrückte Zahlen.”

Viele andere Medikamente kosten mehr als Aduhelm, das von Biogen hergestellt wird und jährlich 56.000 US-Dollar kosten wird. Der Unterschied besteht darin, dass es Millionen potenzieller Kunden gibt und das Medikament voraussichtlich über Jahre hinweg eingenommen wird.

Die Zulassung des Medikaments stößt bei Gesundheitspolitikern und Pharmaforschern auf Kritik wegen fehlender nachgewiesener Wirksamkeit. Wirksam oder nicht, wenn es allgemein verschrieben wird, könnte es einen überwältigenden Einfluss auf das Budget von Medicare haben, da das öffentliche Programm die überwiegende Mehrheit der fast sechs Millionen Amerikaner mit einer Alzheimer-Diagnose abdeckt.

Es gibt kaum einen Präzedenzfall für einen plötzlichen Ausgabenruck dieser Größenordnung. Selbst am unteren Ende der Prognosen würde Aduhelm zu einem der teuersten Medikamente von Medicare werden.

Am oberen Ende sagen Analysten, dass das neue Medikament die jährlichen Ausgaben von Medicare für Medikamente, die in Krankenhäusern und Arztpraxen geliefert werden, um 50 Prozent erhöhen könnte (wie es Aduhelm, das intravenös verabreicht wird, sein müsste).

Die Vergleiche hier sind ungefähre Angaben: Ein Drittel der Medicare-Mitglieder ist durch private Medicare Advantage-Pläne abgesichert, die keine detaillierten Informationen zu den in Arztpraxen angebotenen Medikamenten enthalten. Um diese Ausgaben zu schätzen, haben wir die Daten zu den Medikamentenausgaben der Medicare-Teilnehmer des traditionellen öffentlichen Programms verwendet und sie erhöht, um den fehlenden Anteil zu berücksichtigen.

Ausgaben in dieser Größenordnung könnten so plötzlich weitreichende Auswirkungen auf Medicare, seine Nutzer und Steuerzahler haben. Die Hinzufügung von 29 Milliarden US-Dollar ein Jahr des Medicare-Haushalts würde durch Erhöhungen sowohl der Ausgaben der Steuerzahler als auch der von allen Medicare-Nutzern gezahlten Prämien gedeckt. Die Prämien könnten auch für Zusatzpläne steigen, die viele Medicare-Leistungsempfänger kaufen, um Kosten auszugleichen, die das Programm nicht direkt bezahlt. Und die Kosten werden wahrscheinlich auf die Staatshaushalte übergreifen, wo Medicaid Prämien für einkommensschwache Medicare-Mitglieder zahlt.

Kongress, Haushaltsexperten und mehrere Weiße Häuser haben Jahre damit verbracht, Wege zur Reduzierung der Ausgaben für Medicare, einen großen und wachsenden Anteil des Bundeshaushalts, vorzuschlagen. Aber viele dieser Vorschläge sind politisch schwer zu erreichen – und die meisten würden weniger als die prognostizierten Kosten von Aduhelm einsparen.

“Es ist so viel Arbeit, Einsparungen zu erzielen, die wirklich viel kleiner sind, als dieses eine Medikament kosten würde”, sagte Joshua Gordon, der Direktor für Gesundheitspolitik beim Ausschuss für einen verantwortungsvollen Bundeshaushalt, der sagt, dass er sich ständig Gedanken über die Herausforderungen gemacht hat von Aduhelm seit seiner Zulassung erhoben.

Die Kostenprognosen variieren, da Analysten nicht sicher sind, wie viele Patienten das neue Medikament letztendlich verwenden werden. Die Zulassung der FDA könnte für jeden gelten, bei dem Alzheimer diagnostiziert wurde – etwa sechs Millionen Menschen. Das Medikament wurde jedoch für eine kleinere Gruppe von rund 1,5 Millionen Patienten entwickelt, die sich im Frühstadium der Krankheit befinden. Analysten sind sich noch nicht sicher, wem Ärzte die Behandlung empfehlen und welche Familien sie ausprobieren möchten. Die FDA hat Biogen gebeten, das Medikament bis 2030 weiter zu untersuchen, aber die Verschreibung könnte weit verbreitet werden, bevor weitere öffentliche Ergebnisse darüber vorliegen, wie gut es wirkt.

Allison Parks, eine Sprecherin von Biogen, sagte in einer E-Mail, dass sich das Unternehmen darauf konzentrieren werde, die Art von Patienten zu erreichen, die in den klinischen Studien des Unternehmens untersucht wurden, „im frühen symptomatischen Stadium der Krankheit“.

Aktualisiert

21. Juni 2021, 20:11 Uhr ET

Die Bandbreite spiegelt eine Vielzahl von angemessenen Expertenschätzungen wider. Die hohe Schätzung, die sich auf ein Kaiser-Papier stützt, geht davon aus, dass etwa ein Viertel der zwei Millionen Medicare-Eingeschriebenen, die derzeit eine Alzheimer-Behandlung erhalten, diese einnehmen werden. Der niedrige Wert basiert auf einer Schätzung der Analysten von Cowen and Company von einem Gesamtumsatz von 7 Milliarden US-Dollar bis 2023.

Es ist schwierig abzuschätzen, wie viele Patienten das Medikament einnehmen werden. Aduhelm ist nicht nur teuer, sondern auch etwas schwer einzunehmen und erfordert monatliche persönliche Besuche in einem Infusionszentrum zur Behandlung. Patienten, die es einnehmen, müssen während ihrer Behandlungen mehrere Gehirnscans durchführen, um nach Nebenwirkungen zu suchen.

Und die Nebenwirkungen selbst – etwa 40 Prozent der Patienten in einer klinischen Studie zeigten Anzeichen einer Hirnschwellung – können einige Patienten davon abhalten, das Medikament auszuprobieren, und andere dazu veranlassen, die Einnahme abzubrechen. (Die vielen Scans – und Behandlungen für schwerwiegendere Nebenwirkungen – würden auch von Medicare abgedeckt.)

Es gibt sechs Millionen Medicare-Angehörige, die keine Zusatzversicherung abschließen, die möglicherweise 20 Prozent der Arzneimittelkosten bezahlen müssen, in diesem Fall 11.200 USD pro Jahr.

Dennoch kann die Nachfrage von Familien groß sein, die angesichts einer verheerenden Diagnose eine Möglichkeit sehen, einzugreifen. Bisher gab es nur wenige Behandlungsmöglichkeiten für Patienten, die hoffen, den kognitiven Rückgang durch die Krankheit zu verhindern.

„Es ist schon an sich schwer, einen geliebten Menschen zu haben, die Uhr ticken zu sehen und zu sagen: Nun, lass uns einfach warten“, sagte Dr. Steven Pearson, Hausarzt und Präsident des Institute for Clinical and Economic Review (ICER). ). „Es ist sehr schwer, den Drang zu ignorieren, etwas zu tun.“

Bidens Haushalt 202222

    • Ein neues Jahr, ein neues Budget: Das Geschäftsjahr 2022 für die Bundesregierung beginnt am 1. Oktober, und Präsident Biden hat bekannt gegeben, was er ab diesem Zeitpunkt ausgeben möchte. Aber jede Ausgabe erfordert die Zustimmung beider Kammern des Kongresses.
    • Ambitionierte Gesamtausgaben: Präsident Biden möchte, dass die Bundesregierung im Fiskaljahr 2022 6 Billionen US-Dollar ausgibt und die Gesamtausgaben bis 2031 auf 8,2 Billionen US-Dollar steigen. Dies würde die Vereinigten Staaten auf den höchsten anhaltenden Stand der Bundesausgaben seit dem Zweiten Weltkrieg bringen, während sie laufen Defizite von über 1,3 Billionen US-Dollar in den nächsten zehn Jahren.
    • Infrastrukturplan: Das Budget skizziert das gewünschte erste Jahr der Investition des Präsidenten in seinen American Jobs Plan, der darauf abzielt, Verbesserungen von Straßen, Brücken, öffentlichen Verkehrsmitteln und mehr mit insgesamt 2,3 Milliarden US-Dollar über acht Jahre zu finanzieren.
    • Familienplan: Das Budget befasst sich auch mit dem anderen wichtigen Ausgabenvorschlag, den Biden bereits eingeführt hat, seinem American Families Plan, der darauf abzielt, das soziale Sicherheitsnetz der Vereinigten Staaten zu stärken, indem der Zugang zu Bildung erweitert, die Kosten für Kinderbetreuung gesenkt und Frauen in der Arbeitswelt unterstützt werden.
    • Pflichtprogramme: Wie üblich machen obligatorische Ausgaben für Programme wie Social Security, Medicaid und Medicare einen erheblichen Teil des vorgeschlagenen Budgets aus. Sie wachsen, während die Bevölkerung Amerikas altert.
    • Ermessensausgaben: Die Mittel für die einzelnen Budgets der Agenturen und Programme der Exekutive würden im Jahr 2022 rund 1,5 Billionen US-Dollar erreichen, eine Steigerung um 16 Prozent gegenüber dem vorherigen Budget.
    • Wie Biden dafür bezahlen würde: Der Präsident würde seine Agenda weitgehend durch Steuererhöhungen für Unternehmen und Gutverdiener finanzieren, was in den 2030er Jahren beginnen würde, die Haushaltsdefizite zu verringern. Verwaltungsbeamte sagten, Steuererhöhungen würden die Beschäftigungs- und Familienpläne im Laufe von 15 Jahren vollständig ausgleichen, was der Haushaltsantrag unterstützt. In der Zwischenzeit würde das Haushaltsdefizit jedes Jahr über 1,3 Billionen US-Dollar bleiben.

Ärzte, die dieses Medikament verabreichen und für diese Arbeit einen Prozentsatz des hohen Preises des Medikaments von Medicare erhalten, könnten finanzielle Anreize haben, Ja zu sagen, wenn Patienten danach fragen.

“Die Auswirkungen dieses einen Medikaments und der damit verbundenen Verfahren sind enorm”, sagte Rachel Sachs, Rechtsprofessorin an der Washington University in St. Louis und Autorin eines kürzlich in The Atlantic erschienenen Essays, in dem behauptet wird, dass das Medikament “die amerikanische Gesundheit verletzen” könnte Pflege.”

Private Versicherer können Hindernisse für die Behandlung errichten, die von Patienten zusätzliche Tests verlangen oder nachweisen, dass andere Optionen nicht funktioniert haben. Unter normalen Umständen deckt Medicare jedoch Medikamente ab, die von der FDA zugelassen sind. Medicare entscheidet, welche Medikamente abgedeckt werden, basierend darauf, ob sie „angemessen und notwendig“ sind, nicht auf deren Kosten.

Medicare ist verpflichtet, diese Art von Arzneimitteln zunächst zum Listenpreis zuzüglich einer Gebühr von 3 Prozent an den behandelnden Arzt zu zahlen. Und dann, nach etwa einem Jahr auf dem Markt, zahlt es den durchschnittlichen Verkaufspreis plus 6 Prozent. Bei Arzneimitteln mit Konkurrenz kann dieser Durchschnittspreis erheblich unter dem Aufkleberpreis liegen. Aber für ein Medikament wie Aduhelm, das das erste seiner Art ist, darf der Arzneimittelhersteller Ärzten keine Rabatte anbieten.

Medicare, das 61 Millionen Amerikaner ab 65 Jahren abdeckt, hat einige Instrumente, um die Kosten einzudämmen. Es könnte beschließen, das Medikament in einer Weise abzudecken, die eingeschränkter als die FDA-Zulassung ist, eine Abweichung von seiner normalen Praxis.

Oder es könnte etwas noch Ungewöhnlicheres tun: Eine unerwartete Allianz von Befürwortern hat vorgeschlagen, dass Medicare das Medikament einem randomisierten Experiment unterzieht, um zu bewerten, wie gut es wirkt – in einigen Teilen des Landes bezahlen sie für die Abdeckung des Medikaments, in anderen jedoch nicht. Solche politischen Experimente wurden im Rahmen des Affordable Care Act genehmigt, aber noch nie wurde eines verwendet, um die Abdeckung eines Medikaments auf diese Weise einzuschränken.

Andere Länder werden höchstwahrscheinlich die Kosten von Aduhelm kontrollieren, indem sie mit Biogen über einen niedrigeren Preis verhandeln oder einfach den Kauf ablehnen. Die meisten werden die Wirksamkeit des Medikaments berücksichtigen, wenn sie entscheiden, was sie zu zahlen bereit sind. Bisher ist das Medikament nirgendwo sonst auf der Welt zugelassen.

Medicare kann das nicht. Aufgrund der Art und Weise, wie sie nach geltendem Recht für Medikamente bezahlt, hat sie keine Möglichkeit, den Preis herunterzuhandeln. Demokraten unterstützen zunehmend Gesetze, die dies ändern. Das Repräsentantenhaus verabschiedete 2019 ein Gesetz, das Medicare die Befugnis geben würde, einige Preise auszuhandeln, aber es starb im Senat. Im April brachten die Gesetzgeber den gleichen Gesetzentwurf wieder ins Repräsentantenhaus ein.

Präsident Biden unterstützt es, Medicare die Aushandlung von Medikamentenpreisen zu ermöglichen, hat die Richtlinie jedoch nicht in seinen vorgeschlagenen amerikanischen Familienplan aufgenommen.

Dr. Pearson von ICER schätzt, dass, wenn die Wirksamkeit des neuen Medikaments berücksichtigt würde, ein fairer Preis 2.500 bis 8.300 US-Dollar betragen würde.

“Es wird interessant sein zu sehen, ob dies eine Diskussion über faire Preise in den Vereinigten Staaten auslöst”, sagte er. “In den Augen der meisten Leute sieht dies wie ein hervorragendes Beispiel für einen Preis aus, der einfach nicht mit den Beweisen übereinstimmt.”

Methodik: Die geschätzten aktuellen Ausgaben für Medicare-Teil-B-Medikamente wurden vom Centers for Medicare- und Medicaid-Services-Teil-B-Drogenausgaben-Dashboard entnommen und um 54 Prozent angehoben, um Medicare-Leistungsempfänger zu berücksichtigen, die in Medicare Advantage-Plänen eingeschrieben sind. Aufgrund der Demografie, wer an welchem ​​Programm teilnimmt, kann diese Annahme die aktuellen Drogenausgaben überschätzen.)

Die Medikamentenausgaben von Medicare Teil D wurden direkt aus dem CMS Teil D-Drogenausgaben-Dashboard entnommen und stellen möglicherweise eine Überschätzung dar, da diese Zahlen nicht alle an Medikamentenpläne gezahlten Rabatte enthalten.

Die hohe Schätzung der Ausgaben von Aduhelm stammt aus einem Papier der Kaiser Family Foundation. Die niedrige Schätzung wird aus einer Gesamtumsatzschätzung von Cowen and Company abgeleitet und angepasst, um schätzungsweise 80 Prozent der Alzheimer-Patienten zu Beginn ihrer Krankheit zu berücksichtigen, die sich in Medicare eingeschrieben haben – und Medicares anfängliche Zahlung von 3 Prozent an Ärzte für Gemeinkosten und Verwaltung.

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Biogen’s Alzheimer’s drug may value Medicare billions of {dollars} a yr: report

Biogen's Alzheimer's drug could cost Medicare billions of dollars a year: report

A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts on Monday, June 7, 2021.

Adam Glanzman | Bloomberg | Getty Images

Biogen’s expensive new Alzheimer’s drug Aduhelm could cost Medicare billions of dollars, according to an analysis published Thursday by the nonprofit Kaiser Family Foundation.

The Food and Drug Administration on Monday approved the company’s drug, the first U.S. regulator-approved drug to slow cognitive decline in people with Alzheimer’s and the first new drug for the disease in nearly two decades.

The biotech company said it charges $ 56,000 for an annual course of the new treatment, which is higher than the $ 10,000-25,000 price some Wall Street analysts were expecting. This is the wholesale price, and the cost that patients actually pay depends on their health insurance plan.

It is estimated that Alzheimer’s disease affects more than 6 million Americans, the vast majority of whom are 65 years of age and older. Biogen estimates that about 80% of Alzheimer’s patients are covered by Medicare, the state health insurance for the elderly.

It is still unclear how many Medicare beneficiaries will take Biogen’s drug, but even a conservative estimate would result in a “substantial increase” in Medicare spending, according to KFF.

In 2017, nearly 2 million Medicare beneficiaries were using one or more Alzheimer’s treatments that are covered under Medicare Part D, according to KFF. The group said if a quarter of those beneficiaries were instead prescribed Aduhelm, and Medicare paid 103% of $ 56,000 in the near future, “the total spending on Aduhelm in a year alone will be nearly $ 29 billion”.

According to the KFF, Aduhelm is covered by Medicare Part B, which generally covers FDA-approved, physician-administered drugs.

“If 1 million Medicare beneficiaries received Aduhelm, which may be on the lower end of Biogen’s expectations, spending for Aduhelm alone would exceed $ 57 billion in a single year – well above anything else covered by Part B. Medication together, ”group said. The total spend for Part B in 2019 was $ 37 billion.

Biogen has been criticized by Wall Street analysts and advocacy groups for questioning how the company could justify the price, especially as medical experts continue to debate whether there is enough evidence that the drug actually works and criticize the industry for drug prices becomes.

On a call to investors Tuesday morning, Evercore ISI analyst Umer Raffat congratulated the Massachusetts-based company on US approval of the drug before asking executives to explain the price.

“I think there is a discrepancy between some of the words you shared in your press releases like responsibility, access, health equity, and price, especially given the basic care population,” he told executives.

Biogen executives said Tuesday the overall price of the new treatment was “underpinned” by the value it is expected to bring to patients, caregivers and society. They insisted that the price was “responsible” and stated that the disease costs the US billions each year.

The company has pledged not to increase the price of the new drug over the next four years. However, executives said they were “open-minded” and suggested reconsidering price as the company assesses demand over the next few years.

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Biogen Alzheimer’s drug and the brand new battle over dementia remedy

Biogen Alzheimer’s drug and the new battle over dementia treatment

Aduhelm from Biogen

Source: Biogen

The FDA approval of Biogen’s Alzheimer’s drug Aduhelm marked a milestone in Dr. Paul Aisen. The director of the Alzheimer’s Therapeutic Research Institute at USC has focused on the treatment of neurodegenerative disease for the past three decades and in recent years has helped guide this particular drug through the various phases of clinical trials.

But as he sat in his sun-drenched San Diego office in early June, he felt slightly puzzled by the way the Food and Drug Administration approved their use in early June on an “accelerated” basis, normally reserved for cancer drugs. This meant that the clinical benefit was considered likely, but approval for long-term use would be the subject of a larger study in a fourth phase of studies.

Aisen, who works as a paid advisor to Biogen, emphasizes the “unusual nature” of the regulator’s green light, as an advisory board of experts voted and publicly opposed the approval, and insists that there were still “many questions the “I have – they still have no answers.”

Three members of the FDA’s panel that oversees the research have resigned since it was approved this week, including Dr. Aaron Kesselheim, a medicine professor at Harvard Medical School, who said in a letter the agency’s decision on Biogen was “probably the worst drug approval decision in history.” recent US history. “

Last November, that panel said in an 8-1 vote that Biogen’s late-stage phase did not provide “strong evidence” showing that aducanumab is effective in treating Alzheimer’s; two other panellists said the data was “uncertain”.

While Aisen sees Aduhelm as an “effective treatment” for a disease that affects millions of Americans, he also has concerns about the impact of the FDA’s decision on the range of other potential treatment options that are in the late stages of development.

An immediate challenge facing other teams working on a broader Alzheimer’s drug pipeline, he said in a recent video call, would be to keep participants in ongoing studies, let alone attract new ones.

“In most cases,” he said, many people with Alzheimer’s disease would drop out of other drug trials to begin treatment with the newly approved Aduhelm. Leaving them would make the study data for these alternative drugs less useful, even if the drugs in question might one day prove to be safer, more effective, or more suitable for different stages of the disease. But perhaps pervertedly, he still regards Aduhelm’s approval as “a boost to these efforts – a powerful boost”.

Over 6 million Americans suffer from Alzheimer’s

In the past few years, some large pharmaceutical companies have abandoned brain disease research efforts, including Pfizer and Boehringer Ingelheim in 2018 – in fact, Biogen Aduhelm had given up at one point during clinical trials in 2019 before reversing its decision – after decades of failure in search of a breakthrough.

The controversy surrounding the Biogen drug, including its potential cost, is hitting a massive, unmet need for dementia treatment and a disease that costs the US up to $ 259 billion annually. The Alzheimer’s Association estimates that more than 6 million Americans have Alzheimer’s or some other form of dementia, and by 2050 that number could reach over 12 million people, which costs a trillion dollars a year.

Because of this, some dementia drug experts are focusing on the new attention and funding, rather than the potential downsides of Biogen approval, said Dr. Jeffrey Cummings, a neurologist at the University of Nevada, Las Vegas, who does an annual review of. publishes Alzheimer’s drug development pipeline. His research consistently showed that drug failure rates prior to Biogen’s approval were 99.6 percent, a stark contrast to 1 in 5 successful cancer drugs (20%).

Cummings says that any short-term adverse side effect for other drug trials “will be overcome, if at all, by increased interest from companies, venture capital, and biotechnology once they see that there is a way to get approval for a particular drug”. Illness.”

In recent history, the National Institutes of Health spent two to three times more research on heart disease and cancer than they did on dementia, and the lack of qualified participants in clinical trials also slowed progress.

Next in the dementia drug pipeline

For the handful of other Alzheimer’s drugs in development hoping to overcome the same regulatory hurdles and prove their effectiveness – including Eli Lillys Donanemab, Roches Gantenerumab, and Eiseis Lecanemab – there could be a silver lining, the first mover advantage to cede to Aduhelm.

After decades of expensive but largely unsuccessful research attempts, pharmaceutical giant Eli Lilly’s CEO David Ricks said that after a series of positive phase two results for its Donanemab offering, his company is “getting closer and closer to the goal”.

Speaking at CNBC’s Healthy Returns Summit in May, a month before the FDA approved Aduhelm’s rival Biogen, he said his team felt “good about the probability of success” and said he wanted an “accelerated” route too explore what he called “adaptative avenues for the FDA to consider earlier study of data” that “should be used in a serious and widespread disease like Alzheimer’s”.

However, he conceded that recruiting for the next phase of the studies would require a significantly larger cohort of participants, and since it would take 18 months, he did not expect a new approved product until late 2023 at the earliest.

Several experts told CNBC that the Biogen drug’s unique threshold for regulatory approval, with the treatment potential appearing to trump uncertain real-world benefits, efforts of competitors like Lilly, who are focused on drug development on relatively based on similar techniques.

Aduhelm’s own clinical study data had shown that the drug successfully attacked and cleared clusters of a certain type of protein that many researchers believe may be responsible for Alzheimer’s disease. But it didn’t offer enough evidence to prove that the drug provided cognitive benefits to patients.

Debate on targeting amyloid beta formations

Known by scientists as aducanumab, it works by offering a set of identical antibodies that are cloned from white blood cells. These antibodies are chosen for their targeting abilities, as they can identify specific proteins called beta-amyloids that have built up certain formations in the body.

There is ample evidence that these beta-amyloid formations, also known as “pathological aggregates” or “plaques,” are a major cause of Alzheimer’s disease, although the exact causal mechanisms are not yet fully understood, according to Christian Pike von USC’s Leonard Davis School of Gerontology. Nonetheless, he says the antibodies can help prevent these plaques from forming before other particles are caused to break them apart, a process that is clearly identifiable in before and after neural imaging.

As an analogy, it may be helpful to think of the amyloid beta proteins as young people walking through a city during the day, where the city is the human body and the day is a human lifespan. In certain cities, when afternoon turns into evening, individual young people gather, and some of these gatherings can become toxic and begin to cause problems. The antibodies supplied by Aduhelm act like police officers arriving at the scene, identifying disruptive gatherings, surrounding them, separating them, and then instructing bystanders to disperse the young people.

“When you say, ‘Well, hey, the FDA is buying in that general concept,'” Pike said on a phone call, “if we can remove beta-amyloid from the brains of people with the disease, even if we can there is limited evidence of cognitive benefits, “he continued,” there could be a variety of different therapies that would qualify under these criteria.

The long string of past failures within the Alzheimer’s pipeline that targeted beta-amyloid will continue to weigh on optimism until conclusive evidence is produced – something this week’s controversy over the first new approved Alzheimer’s drug in decades shows has not yet been done.

“What we’re going to find out by using this drug one way or another is whether or not the amyloid clearing hypothesis is correct,” says USC health economist Darius Lakdawalla, who argues that Biogens will continue to test it Drug will prove useful to this confirmatory experiment.

“If it’s right, then I think it opens the door to a lot of innovation, a lot of drug candidates that will try to remove amyloid in the pursuit of that hypothesis in the future.”

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Three F.D.A. Advisers Resign Over Approval of Alzheimer’s Drug

Three F.D.A. Advisers Resign Over Approval of Alzheimer's Drug

In a strong rejection of the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have stepped down from the independent committee that advised the agency on the treatment.

“This could be the worst regulatory decision the FDA has made that I can remember,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who resigned Thursday after six years on the committee.

He said the agency’s approval of the drug aducanumab, marketed as Aduhelm, a monthly intravenous infusion that Biogen has set at $ 56,000 a year, was incorrect “because of so many different factors, including the fact that there is no good evidence ”. that the drug works. “

Two other members of the committee resigned earlier this week and expressed dismay at the drug’s approval, although the committee overwhelmingly opposed it after reviewing clinical trial data in November.

The committee found that the evidence was inconclusive that Aduhelm could slow cognitive decline in people with the early stages of the disease – and that the drug could potentially cause serious side effects of brain swelling and hemorrhage. None of the eleven committee members thought the drug was ready for approval: ten voted against, one was unsure.

“The approval of an ineffective drug has serious potential to interfere with future research into new treatments that may be effective,” said Dr. Joel Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who first stepped down from the committee.

“In addition, aducanumab therapy will potentially cost billions of dollars to introduce, and those dollars could be better spent developing better evidence for aducanumab or other therapeutic interventions,” added Dr. Mother-of-pearl added.

Shannon P. Hatch, an FDA spokeswoman, said the agency does not comment on matters that affect individual advisory committee members.

Biogen plans to ship the drug in about two weeks. It expects more than 900 locations across the country, usually memory clinics that treat patients with dementia, to be ready to administer the drug soon.

The FDA’s green light decision, announced Monday, marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other drugs for the debilitating disease and they only treat dementia symptoms for a few months.

But since last fall, several respected experts, including some Alzheimer’s doctors who worked on the clinical trials of aducanumab, have said that the evidence available casts significant doubts on the drug’s effectiveness. They also said that even if it could slow cognitive decline in some patients, the proposed benefit – slowing symptoms down for about four months over 18 months – might be barely noticeable to patients and outweigh the risks of side effects on the brain would.

In addition to the high price of the drug, the additional cost of screening patients before treatment and having regular MRIs needed to monitor their brain for problems could add tens of thousands of dollars to the bill. Medicare is expected to cover much of that.

“Giving patients a drug that is not working and of course has great risks that require multiple MRIs costing $ 56,000 a year puts patients in a really challenging position and puts doctors in a difficult position.” said Kesselheim.

Aside from believing that the existing evidence of Aduhelm’s benefits is weak, the resigning advisory committee members – as well as several prominent Alzheimer’s experts – rejected two important aspects of the FDA’s approval decision.

One problem is that the FDA has approved the drug for a much broader group of patients – anyone with Alzheimer’s – than many experts expected. In the clinical trials, the drug was only tested in patients with early-stage Alzheimer’s disease or mild cognitive impairment from the disease.

The other problem is that a key part of the FDA’s rationale for granting the approval was that the drug’s ability to attack the amyloid protein in patients’ brains would help slow their cognitive symptoms.

“This is a big problem,” said Dr. Mother-of-pearl.

While amyloid is considered a biomarker of Alzheimer’s disease because its buildup in the brain is an important aspect of the disease, there is very little scientific evidence that reducing amyloid can actually help patients by relieving their memory and thinking problems.

Clinical studies of other amyloid-lowering drugs for more than two decades have shown no evidence that the drugs slow cognitive decline. As a result, many experts had said it was especially important to have solid evidence of Aduhelm’s ability to treat symptoms.

In November, FDA officials told advisory committee members that the agency would not count the drug’s ability to reduce amyloid as an indication of its effectiveness. But in Monday’s decision, the FDA announced that it did just that.

“The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that reducing these plaques is likely to predict important benefits for patients,” said the director of the Center for Drug Evaluation and Research of the FDA, Dr. Patrizia Cavazzoni wrote on the agency’s website about the decision to make the drug available under a program called accelerated approval.

The advisory committee members said, however, that the committee was never advised that the agency would be considering approval based on amyloid reduction and that their opinion on this significant change was never sought. Dr. Perlmutter said the committee was “unaware of any additional information or statistical analysis to support approval.”

Dr. David Knopman, a clinical neurologist at Mayo Clinic, wrote in an email to FDA officials informing them of his resignation from the advisory committee on Wednesday: “Biomarker justification for approval in the absence of consistent clinical benefit 18 months of treatment is “unreasonable.”

Dr. Knopman, who stepped out of the November meeting for serving as the lead investigator for one of the aducanumab trials, added that “the whole aducanumab approval saga, which culminated in accelerated approval on Monday, is a mockery “The role of the advisory board.

Dr. Peter Stein, who heads the Office of New Drugs at the FDA Center for Drug Evaluation and Research, said in a briefing with reporters following the decision that the agency’s reviewers were convinced of what he saw as a strong relationship between plaque reduction and potential clinical benefit described by Aduhelm, which he said had not been seen in previous studies of amyloid-eradicating drugs.

Dr. Stein also defended the agency’s decision to approve the drug in such a broad patient population, saying it could be relevant beyond the early stages of Alzheimer’s.

“Since amyloid is a hallmark of the disease throughout its course, this drug is expected to provide benefits across this spectrum,” said Dr. Stone.

As a condition of approval, the FDA said Biogen would conduct another clinical trial and give the company approximately nine years to complete. These terms apply to some experts as well. They say the drug will be available without restriction during these years, and if the new study doesn’t prove the drug beneficial, the agency may, but is not required to, withdraw its approval and has not always done so for other drugs.

“The timeframe they gave for the so-called confirmatory study of nine years is problematic,” said Dr. Kesselheim, who also directs Harvard Medical School’s regulation, therapy, and law program. “During this time, the product will be used a lot.”

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Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Shares of Biogen surged 38% Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

This is a developing story. Please check back for updates.

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Biogen faces robust questions on $56Okay-a-year worth of latest Alzheimer’s drug

Biogen faces tough questions on $56K-a-year price of new Alzheimer's drug

A person skates past Biogen Inc. headquarters in Cambridge, Massachusetts on Monday, June 7, 2021.

Adam Glanzman | Bloomberg | Getty Images

Biogen faced tough questions from Wall Street analysts Tuesday about the annual cost of $ 56,000 for its newly approved Alzheimer’s drug Aduhelm – a price that executives call “fair” and “responsible”.

Biogen’s shares rose 38% Monday after the FDA announced it had approved the company’s drug scientifically known as aducanumab. It’s the first drug approved by U.S. regulators to slow cognitive decline in people with Alzheimer’s, and the first new drug for the disease in nearly two decades.

The biotech company said it is charging $ 56,000 for an annual course of the new treatment, more than the $ 10,000-25,000 price some Wall Street analysts expected. This is the wholesale price, and the cost that patients actually pay depends on their health insurance plan.

Some analysts and stakeholders immediately questioned how the company could justify the price – about five times higher than expected – especially as medical experts continue to debate whether there is enough evidence that the drug actually works and the industry has been criticized for drug prices .

The FDA departed from the advice of its independent panel of external experts, which unexpectedly declined to approve the drug last fall, citing inconclusive data.

“Our only concern here is the annual cost of aducanumab and whether the sticker shock at $ 56,000 a year (we were at $ 10,000) could further stimulate drug price reviews,” Stifel analyst Jeff Preis told investors Monday in a note.

On a call to investors Tuesday morning, Evercore ISI analyst Umer Raffat congratulated the Massachusetts-based company on US approval of the drug before asking executives to explain the price.

“I think there is a discrepancy between some of the words you shared in your press releases like responsibility, access, health equity, and price, especially given the basic care population,” he told executives.

JP Morgan analyst Cory Kasimov later asked executives how much the state health insurance program Medicare is likely to pay for the drug and how concerned executives are about the “backlash” the industry will face on pricing.

Biogen executives said the overall price of the new treatment is “underpinned” by the value it is expected to bring to patients, caregivers and society. They insisted that the price was “responsible” and stated that the disease costs the US billions each year.

The Alzheimer’s Association estimates that more than 6 million Americans are living with the disease. The company said it currently has the capacity to deliver the drug to 1 million patients annually, with more than 900 locations in the U.S. poised to launch the new drug.

“We want to ensure that Aduhelm is affordable for patients and sustainable for health systems,” said one executive.

The company has pledged not to increase the price of the new drug over the next four years. However, executives said they were “open-minded” and suggested reconsidering the price as the company assesses demand over the next few years.

Michel Vounatsos, CEO of Biogen, joined CNBC on Monday and said the drug’s price will allow the company to continue investing in its pipeline of drugs for other diseases. He added that the company works closely with Medicare as well as private insurers.

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Alzheimer’s Drug Is Bonanza for Biogen, Most Seemingly at Taxpayer Expense

Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

In addition to the United States, Biogen has asked regulators in Australia, Brazil, Canada, the European Union, Japan and Switzerland to review the drug.

The U.S. approval is a crucial victory for a company that has been counting on Aduhelm to make up for stalled or declining revenue from its other products. Competitors last year introduced generic versions of Biogen’s multiple sclerosis drug, Tecfidera, causing the company to miss out on hundreds of millions of dollars in revenue from what had been its top-selling product.

The approval “completely transforms” Biogen, said Brian Skorney, an analyst at Robert W. Baird & Company, who is projecting that the drug will generate $7.5 billion in revenue in 2025. “This changes it from a declining revenue company to a growth company,” he said, and, in so doing, “opens up a bit of Pandora’s box” in terms of pricing and reimbursement.

While only patients with mild cognitive decline were enrolled in the clinical trials, the F.D.A. approved the drug for anyone with Alzheimer’s, a much broader group of patients than many experts were expecting.

Just how lucrative the drug will be for Biogen will depend on how many patients it can reach — and in what circumstances, and for how long, insurers are willing to pay for it.

Dr. Steve Miller, the chief clinical officer at the insurer Cigna, said on Monday that he expected his company and most of its peers would pay for the drug only for patients with mild cognitive symptoms and higher-than-normal levels of the protein amyloid in their brains.

“There’s just no data that more advanced patients will benefit,” he said.

Dr. Miller said he was disappointed that the F.D.A. had made so many patients eligible. “You’re leaving the tough decision-making about who should be covered to the individual payers,” he said.