Will cost keep new Alzheimer’s drug from patients?

Presented by The Campaign for Sustainable Rx Pricing

Driving the Day

LOOMING QUESTIONS FOR LEQEMBI’S DEMAND — On Friday, the FDA granted accelerated approval to Leqembi, the brand name for lecanemab, the second Alzheimer’s therapy for patients in the early stages of cognitive decline that targets the amyloid proteins thought to cause the disease.

It’s a welcome development in a field with a dearth of options: An estimated 8 to 13.5 million adults over 60 are living with the early stages of cognitive impairment and could be eligible for Leqembi — particularly after Aduhelm, the first anti-amyloid drug approved in 2021, belly flopped on the market due to conflicting trial data and limited insurance coverage.

But it’s unclear whether Leqembi will take off where Aduhelm failed. Eisai and Biogen, Leqembi’s manufacturers, estimate the drug will be available by Jan. 23 and have priced the biweekly infusion at $26,500 annually — slightly less than Aduhelm’s price tag of $28,000 but well above the Institute for Clinical and Economic Review’s estimation of the drug’s value at $8,500 and $20,600.

“The big question will be Medicare coverage,” R. Scott Turner, the director of the Memory Disorders Program at Georgetown University Medical Center, told Prescription Pulse. Getting FDA approval is just the first step, he added.

And at the moment, Medicare won’t foot the bill for beneficiaries seeking Leqembi. When Aduhelm received accelerated approval, the Centers for Medicare and Medicaid Services limited coverage for Aduhelm and drugs like it to patients enrolled in a trial. For those drugs that received accelerated approval, the trial would have to be randomized; for those that received traditional approval, it would have to be an observational patient registry. Since receiving accelerated approval, Eisai and Biogen have already asked the FDA to review additional clinical trial data to give Leqembi traditional approval. No Leqembi trials of any kind are currently planned.

“We have just two or three [patients] willing to pay out of pocket,” said Turner.

Some health experts are concerned that Leqembi’s modest benefits, with the risk of potentially severe side effects, don’t merit the drug’s high cost. Others, including patient advocacy groups like the Alzheimer’s Association, have already formally asked the CMS to update its coverage determination for the drugs, but the agency hasn’t specified a timeline for a response or decision.

“What CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong,” Joanne Pike, the Alzheimer’s Association’s president and CEO, said in a statement.

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. With “Kraken” being the unofficial nickname of the XBB.1.5 strain of Covid-19, we got curious about all the other mythical namesakes of other SARS-CoV-2 subvariants.

Send tips, feedback and your thoughts on variant nomenclature to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, Ben Leonard talks with Lauren about the debate over the Department of Health and Human Services’ directive requiring doctors to send patients test results before doctors have a chance to explain them.

FDA ADVISERS TO MEET ON OTC NALOXONE — The FDA plans to convene a joint meeting of two advisory committees next month to discuss Emergent BioSolutions’ application for an over-the-counter version of its opioid overdose naloxone spray.

Naloxone in all forms is only available with a prescription. Emergent asked the FDA to review a nonprescription form of its nasal spray Narcan shortly after the agency published a notice describing the information it would need to consider OTC applications.

Even though all states and Washington, D.C., have ways for people to access naloxone without visiting a doctor’s office — like allowing pharmacists to prescribe the drug directly — public health experts say removing the prescription requirement for some forms of naloxone would increase access to the drug.

Coronavirus

FDA: EVUSHELD MAY NOT PROTECT AGAINST XBB.1.5 — The rapidly growing XBB.1.5 Omicron subvariant may prove to be an issue for Evusheld because of the strain’s similarity to other variants not neutralized by the treatment, the FDA said Friday.

“This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5,” the agency said in an update. “However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5.”

WHITE HOUSE CONVENING CLINICAL TRIAL ROUNDTABLE — The White House is bringing together a group of experts Thursday at 1 p.m. EST to discuss how to bolster the infrastructure of the U.S. clinical trial ecosystem for emergencies like Covid-19. The event is open to the public, but pre-registration is required.

Participants include FDA Commissioner Robert Califf, NIH National Institute of Allergy and Infectious Diseases deputy director for clinical research and special projects H. Clifford Lane, Walgreens chief clinical trials officer Ramita Tandon and IQVIA vice president of therapeutic strategy Vicky Leamy.

The group is slated to discuss “preparedness, equity, diversity and reestablishing trust in science,” according to the event announcement. We will keep you posted.

Around the Agencies

HHS, DOCTOR GROUPS CLASH OVER DELIVERING TEST RESULTS TO PATIENTS — Tension between HHS and doctors over how and when patients receive potentially upsetting test results underscores digital medicine’s role in evolving health care practices, POLITICO’s Ben Leonard writes.

Congress directed HHS to ensure patients get their medical test results as soon as possible — a practice that doctor groups like the American Medical Association say could inadvertently cause harm if patients get worrying results without context. Patient advocates, and HHS, say patients should, and can, decide when they want their results. But the AMA is pressing HHS to revise its rules — and the trade group for doctors is finding allies in state legislatures.

Coming Up in Pharma

WEDNESDAY: The FDA holds its 100th Covid-19 diagnostics virtual town hall at 12:05 p.m. EST.

Pharma Moves

Novavax has named John C. Jacobs the vaccine maker’s new president and CEO ahead of Stanley Erck’s Jan. 23 retirement. Jacobs joins Novavax from Harmony Biosciences, where he led the company’s first product through FDA review, approval and commercialization.

Rite Aid’s board of directors has appointed board member Elizabeth “Busy” Burr as interim CEO following Heyward Donigan’s departure as president and CEO. The company has launched a search for a permanent CEO.

Susan Monarez has been appointed the deputy director of HHS’ Advanced Research Projects Agency for Health.

Amanda Wheeler is joining the tobacco company Philip Morris International as the company’s Southwest regional director for state government affairs. She previously served as the president of the American Vapor Manufacturers, an e-cigarette trade group. Char Owen and Allison Boughner will step into the president and vice president roles at AVM, respectively.

Quick Hits

Moderna is weighing a price increase for its Covid-19 vaccine in the U.S., increasing the cost to between $110 to $130 a dose, The Wall Street Journal’s Peter Loftus reports. “Lawmakers should demand Big Pharma companies engaging in price hikes on COVID-19 treatments and vaccines ahead of commercial distribution face scrutiny from Congress,” Lauren Aronson, executive director of the Campaign for Sustainable Rx Pricing, said in a statement.

POLITICO’S Krista Mahr explores how medical opioid use disorder treatment in Maine’s prison system has positively caught the eye of federal public health officials.

Former FDA Commissioner Jane Henney discusses FDA’s looser restrictions on abortion pills with STAT’s Eric Boodman.

Pfizer contributed $1 million to the Republican Party of Kentucky’s building fund last month, the Kentucky Lantern’s Tom Loftus reports.