Our Take: Eisai, Biogen get another chance with FDA’s accelerated approval of Alzheimer’s drug lecanemab
On Friday afternoon, the FDA granted accelerated approval of Eisai and Biogen’s lecanemab-irmb as a treatment for patients with mild cognitive impairment or the mild dementia stage of Alzheimer’s disease when the presence of amyloid beta pathology has been confirmed.
The drug, which is administered via intravenous infusion every two weeks, will be marketed in the U.S. under the brand name Leqembi. Eisai said it would be priced at approximately $26,500 for a year’s treatment.
The approval is based on the results of a Phase II trial of 856 patients in which Leqembi demonstrated a statistically significant reduction in brain amyloid plaque from baseline to week 79 in comparison with placebo.
Immediately, Eisai submitted a supplemental Biologics License Application requesting conversion of the accelerated approval to a traditional approval. The companies are using the results of the Phase III Clarity AD confirmatory trial to support the sBLA.
In the Clarity AD trial, which included nearly 1,800 participants, Leqembi reduced clinical decline by 27% over a period of 18 months relative to placebo, based on a global cognitive and functional scale.
While the accelerated approval is good news for the companies and for patients living with the disease, the success is tempered somewhat by the legacy of Aduhelm (aducanumab), the predecessor to Leqembi.
Aduhelm also received accelerated approval based on the same biomarker, a reduction in brain amyloid beta plaque, though evidence of the drug’s ability to slow disease progression was inconclusive. Initially, the FDA approved Aduhelm for all patients with Alzheimer’s disease but quickly narrowed the indication to those in the early stages.
Biogen’s decision to price Aduhelm at $56,000 for a year’s treatment added to the controversy surrounding the FDA’s approval of the drug. Although Biogen later cut the price in half, CMS eventually issued a national coverage decision that limited Medicare coverage of Aduhelm to participants in qualified clinical trials. That decision was essentially a death knell for the drug, and CMS applied the restrictions to the entire class of monoclonal antibodies that target amyloid.
There are notable differences between the two drugs. For one, Leqembi targets a different type of amyloid. And, as mentioned, Leqembi demonstrated in the Clarity AD trial the ability to slow mental and physical decline compared with placebo. The differences between Leqembi and placebo were statistically significant on several rating scales in the trial, though it is unclear whether that will translate to a meaningful clinical benefit.
Leqembi also appears to have a better safety profile, though amyloid-related imaging abnormalities (ARIA), or brain bleeding and swelling, are a concern. As with Aduhelm, patients will have to undergo an MRI scan before initiating treatment with Leqembi and then be tested again periodically during treatment to monitor for ARIA.
The FDA noted in its approval announcement that Leqembi’s prescribing information includes a warning (but not a boxed warning) for ARIA, which “usually does not have symptoms, although serious and life-threatening events rarely may occur.” Eisai stated in its press release that symptoms associated with ARIA, such as headache, dizziness, nausea, and confusion, usually resolve over time. The label also includes a caution for prescribing the drug to patients who are on blood thinners.
Eisai is asking that CMS review the Clarity AD trial data at the same time the FDA is conducting its review of the sBLA (provided the FDA accepts the submission), with the hope that CMS will provide broader coverage for Leqembi if and when the drug receives traditional approval. If the FDA grants a priority review, Leqembi could obtain full approval within six months.
According to Eisai, Leqembi will be available during or before the week of Jan. 23.
Our Take: We’ll have to wait and see whether Leqembi becomes the blockbuster that Aduhelm might have been under other circumstances.
Eisai is proceeding with caution, acknowledging that sales of Leqembi will not fully take off unless and until CMS changes its coverage decision. In the meantime, the company is working with Biogen to build out a sales infrastructure that will be ready for a full launch if CMS permits broader coverage.
“At CMS, we will continue to expeditiously review the data on [products for Alzheimer’s disease] as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” CMS Administrator Chiquita Brooks-LaSure said in a press statement.
Eisai has also taken a more cautious approach to pricing Leqembi than Biogen did with Aduhelm. Still, the Institute for Clinical and Economic Review (ICER) released a preliminary report last month on Leqembi stating that a cost-effective price range would be $8,500 to $20,600 per year. Ivan Cheung, Eisai’s global Alzheimer’s disease officer, told Endpoints News the annual price for Leqembi would be less than $15,000 once patients are in the maintenance phase.
Further, the company is offering a support program to help with access and coverage “for eligible and appropriate patients” and is developing an educational initiative for the Alzheimer’s health care community with regard to ARIA.
Cheung said in an interview with The New York Times that even if CMS broadens Medicare coverage for the drug, Eisai estimates “the number of individuals potentially on Leqembi is probably about 100,000 people” in three years.
The Times reported that approximately 1.5 million of the six million people in this country with Alzheimer’s disease are thought to be in the early phases, with diagnoses of mild cognitive impairment or early-stage Alzheimer’s.
This could prove to be a pivotal year for drugmakers, patients, researchers, and others that have a stake in the battle against the disease.
Disclosure: Eisai is a current Darwin Research Group client.
What else you need to know
Five managed care plans have been awarded contracts to serve Medi-Cal members in 2024: Blue Cross of California Partnership Plan, Blue Shield of California Promise Health Plan, Community Health Group Partnership Plan, Health Net Community Solutions, and Molina Healthcare of California. Through new requirements in the contracts, the California Department of Health Care Services is attempting to transform Medi-Cal, the state’s Medicaid program, to be more “person-centered, equity-focused, and data-driven,” according to a joint statement. For example, the managed care plans will be required to report on primary care spending and review utilization reports to identify members who are not accessing primary care. They will also be required to submit a community reinvestment plan and report, and allocate a percentage of their profits to local community activities that develop infrastructure to support Medi-Cal members.
Humana will close its remaining SeniorBridge home care facilities by March. The Louisville, Ky.-based payer said in late November it would permanently close 16 SeniorBridge branch locations in eight states by the end of 2022, leaving only seven locations in New York open. Those remaining branch locations will be closed by March 5, Becker’s Payer Issues reported last week. Humana acquired SeniorBridge in 2012 to manage complex chronic care for seniors in their home. Subsequently, the payer acquired Kindred at Home, which has more than 350 locations in 38 states, and rebranded that line of business as CenterWell Home Health in September. The decision to discontinue SeniorBridge was part of the restructuring initiative Humana announced a year ago, with the goal of generating $1 billion in savings to reinvest in the company’s Medicare Advantage business.
Baxter International plans to spin off its renal care and acute therapies global business units into a stand-alone, publicly traded company in the next 12 to 18 months and will conduct a review of strategic alternatives for its biopharma solutions business, including a potential sale. The Deerfield, Ill.-based medtech firm is working to finalize and implement a new operating model that will simplify its corporate structure. Baxter said in a news release the simplified structure “should create a more resilient supply chain and greater alignment with the company’s manufacturing footprint, better positioning the organization to deliver against the operational and investment priorities of Baxter’s businesses.”
CommonSpirit Health is being sued by a patient whose data was breached in the ransomware attack that disrupted business at the health system for weeks last fall, multiple news outlets reported last week. The plaintiff, a patient at Seattle-based Virginia Mason Franciscan Health, is among the 623,774 patients who were notified that their data had been breached. The proposed class-action suit claims CommonSpirit failed to implement and follow basic security procedures and follow its own policies to safeguard patients’ protected health information, placing patients at risk for identity theft. The lawsuit was filed in the U.S. District Court for the Northern District of Illinois in late December.
Gilead Sciences’ Sunlenca (lenacapavir) received FDA approval as a twice-yearly treatment for HIV-1 in heavily treatment-experienced adults whose infection is multi-drug resistant, and in those who have no other available treatment options because of intolerance or safety considerations. Sunlenca is the first in a new drug class known as capsid inhibitors to receive FDA approval as an HIV-1 treatment. It is given in combination with other antiretrovirals; initially, it is administered both orally and subcutaneously, and then maintenance injections are given every six months. The drug received priority review, fast track, and breakthrough therapy designations in this indication and is being evaluated in clinical trials for other indications, Gilead noted in its approval announcement. The company told Reuters it expects the drug to cost $42,250 for the first year of therapy and $39,000 in subsequent years.
Allscripts Healthcare Solutions has changed its name to Veradigm. The Chicago-based health care technology firm has streamlined its operations in the last couple of years by divesting various business segments and platforms, and transitioning its solutions to the Veradigm brand. All remaining Allscripts assets, including electronic health records, practice management systems, and patient communication platforms, have been integrated into the Veradigm Network. The corporate name change took effect Jan. 1, according to a press release.
What we’re reading
Michael Dowling: Healthcare leaders’ great return to normalcy. Becker’s Hospital CEO Report, 1.4.23
Best Diets in 2023: Mediterranean Diet Wins Again. Medscape, 1.3.23
Performance of Physician Groups and Hospitals Participating in Bundled Payments Among Medicare Beneficiaries. JAMA Health Forum, 12.29.22
