Our Take: Eisai, Biogen’s lecanemab slowed clinical decline by 27% in Phase III Alzheimer’s trial
Eisai and Biogen announced positive top-line results from an international Phase III confirmatory trial of lecanemab, an investigational antibody treatment for mild cognitive impairment resulting from early Alzheimer’s disease.
The experimental drug met the primary endpoint of the Clarity AD trial and all key secondary endpoints with highly statistically significant results, the companies said.
The primary endpoint of the trial was the change from baseline on a global cognitive and functional scale called the Clinical Demential Rating-Sum of Boxes (CDR-SB) at 18 months of treatment. Compared with placebo, lecanemab reduced clinical decline by 27%, for a p-value of 0.0005 in the trials’s intent-to-treat population. The companies said the drug showed highly statistically significant changes in CDR-SB from baseline as early as six months after treatment was initiated.
The secondary endpoints included the change from baseline at 18 months compared with placebo in the treatment of amyloid levels in the brain, measured by PET scan, and three other Alzheimer’s disease scales.
The total incidence of amyloid-related imaging abnormalities (ARIA), including edema/effusion and hemorrhages, was 21% in the group treated with lecanemab and 9% in the placebo group. Eisai and Biogen said the drug’s ARIA incidence profile, overall, was “within expectations.”
Nearly 1,800 people with early Alzheimer’s disease were enrolled in the randomized trial, with half receiving lecanemab at a dosage of 10 mg/kg bi-weekly and half receiving placebo. The companies noted that the eligibility criteria permitted patients with a broad range of comorbidities to participate in the trial, including those with high blood pressure, high cholesterol, diabetes and coronary artery disease.
Further, Eisai’s recruitment strategy ensured greater inclusion of ethnic and racial populations in the U.S. As a result, the trial population was “generally comparable” to the Medicare population.
The FDA accepted Eisai’s Biologics License Application for lecanemab in July under the accelerated approval pathway, granting it priority review. The BLA has a decision date of Jan. 6.
The regulatory agency has agreed that the results of the Clarity AD trial can serve as the confirmatory study to verify the drug’s clinical benefit, which means Eisai could swiftly convert the accelerated approval to a traditional approval. Eisai and Biogen said they plan to apply for full approval by March 31.
Our Take: After the Aduhelm calamity, Biogen needs a win. Although Eisai has taken the lead on lecanemab’s development and regulatory filings, the two companies will share profits 50-50.
The Clarity AD trial results aren’t just a boon for Eisai and Biogen — or even other pharma companies developing similar drugs (as in Eli Lilly, with donanemab, and Roche/Genentech, with gantenerumab). The results appear to have breathed new life into Alzheimer’s research in general, giving credence to the theory that eliminating beta-amyloid plaques in the brain can slow progression of the disease.
The timing of the results involved a bit of irony. The Biden administration just announced last week that Medicare premiums would be slightly lower in 2023, largely because the use of Aduhelm was so underwhelming and because Biogen cut the drug’s initial price of $56,000 per year in half just months after it hit the market.
And now, lecanemab has the potential to create the same expensive scenario for Medicare that many feared when Aduhelm was approved. Here we go again. Maybe. Or maybe Eisai will price lecanemab more affordably. Still, if millions end up taking the drug … well, let’s just see what happens.
Disclosure: Eisai is a current Darwin Research Group client.
What else you need to know
A civil antitrust lawsuit against DaVita, Tenet Healthcare, and affiliates of UnitedHealth Group can proceed, a federal judge ruled last week. The plaintiffs in the case are former employees of Surgical Care Affiliates, which UnitedHealth’s OptumCare acquired in 2017. They allege that the defendants violated the Sherman Act, starting in 2010, by agreeing not to recruit or hire each other’s senior executives unless they had already given notice that they were seeking a new job. The defendants claim the companies’ conduct effectively reduced their compensation. The judge dismissed the allegations against UnitedHealth Group but said the plaintiffs could file “an amended complaint that states a viable claim as to [UnitedHealth Group].” (Tenet is named in the lawsuit because it owns Surgical Partners International.) In April, a jury acquitted DaVita of charges related to the anti-poaching agreements in a separate case brought by the Department of Justice. A trial is set for January in the DOJ’s case against Surgical Care Affiliates.
A federal judge ruled that the Department of Health and Human Services must restore full payments for 340B drugs now instead of waiting until the start of 2023, as CMS proposed doing. In June, the Supreme Court ruled that HHS exceeded its authority when it initiated a steep cut in reimbursement rates in 2018 for certain outpatient drugs only for hospitals participating in the 340 discount program. The high court said the reduced payment rates in 2018 and 2019 were unlawful because HHS did not conduct a required survey of hospitals’ acquisition costs for the drugs and therefore could not single out 340B hospitals for the lower rate. SCOTUS did not rule on reimbursement rates paid in 2020 or later (HHS began collecting survey data from 340B hospitals in 2020) and sent the case back to the lower court to address potential remedies. The latest ruling by the district court grants plaintiffs’ motion to immediately vacate the prospective portion of the 2022 reimbursement rate.
Comprehensive Primary Care Plus did not improve spending or quality of care for members of private health plans, according to research published in the September issue of Health Affairs. Researchers with the University of Michigan analyzed claims and enrollment data for two large insurers in the state for the period from 2013 to 2020. They found that CPC+, an advanced primary care medical home model, was not associated with changes in total spending or overall quality performance. The two-track program, which ran from 2017 to 2021, offered incentives to primary care providers to improve patient quality care measures, along with additional care management fees. Primary Care First, a multi-tiered payment model that began in 2021, built on CPC+, increasing the potential performance-based payment bonus and introducing financial risk.
Uninsured patients who cannot afford $2,000 for a dose of Eli Lilly’s bebtelovimab, an antibody drug authorized for COVID-19, may still have access to it. The federal government has been purchasing the drug from Lilly and distributing it to states and U.S. territories, but federal funding for COVID-19 is running out and Congress has not replenished it. In response, Lilly began selling the drug commercially in August. Last week, HHS announced a product replacement initiative for the drug and will make 60,000 dose available to support the program. Health care providers who use a commercially procured dose of bebtelovimab to treat an uninsured or underinsured patient may be eligible to have the dose replaced free of charge through the program.
Cigna is launching a new concierge service called Pathwell that will connect certain plan members with “quality care providers,” with the intention of improving health outcomes and lowering costs for them and their employers. Pathwell merges certain capabilities of Evernorth, Cigna’s health services business, with the insurer’s medical benefits management and provider networks, the company said in a press statement. Pathwell Specialty will support members with complex or rare health conditions who need infused or injectable biologics. Dr. Ajani Nimmagadda, chief medical officer of Cigna Pharmacy, said biologic drugs account for 65% of drug spending but only 4% of Cigna’s members need them. Pathwell Bone & Joint will address the specific needs of members with musculoskeletal conditions, with an eye toward reducing unnecessary surgeries.
Johnson & Johnson has chosen a new name for its consumer health company when it spins off the $15 billion business unit: Kenvue. J&J said the name is a combination of “ken,” meaning knowledge, and “vue,” a variant of view, as in sight. The company also provided a look at the visual branding that will be used for Kenvue in the press release announcing the new name. J&J expects to complete the spinoff late next year, at which time Kenvue will become a stand-alone, publicly traded company.
Implementing The Drug Negotiation Provisions Of The IRA: Considerations For CMS. Health Affairs Forefront, 9.30.22
Raising Lazarus: Hope, Justice, and the Future of America’s Overdose Crisis, by Beth Macy. Just ordered for an upcoming trip. From the description: “A complex story of public health, big pharma, dark money, politics, race, and class that is by turns harrowing and heartening, infuriating and inspiring, Raising Lazarus is a must-read for all Americans.”