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U.S. insurers hesitant to cover aducanumab

Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.”

Humana Inc. is, however, covering Aduhelm for patients who are similar to those in the drug’s clinical trials.

Having won conditional FDA approval in June, aducanumab has failed to gain traction as a popular therapy.

Biogen developed the drug in collaboration with Eisai Co., Ltd. (Tokyo, Japan).

The drug has received a flurry of negative headlines in recent months.

FDA called for an OIG investigation into its own dealings when reviewing the drug, and two House committees have launched investigations into its approval as well.

This week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHM…

EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.”

The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December 13-16.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Dr. Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen, in a press release.

In the U.S., aducanumab has seen several setbacks in recent months.

In August, the Department of Veterans Affairs (VA) decided not to include aducanumab in its drug formulary. The VA…

VA shies away from Biogen’s Aduhelm

The Department of Veterans Affairs (VA) will not include Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) controversial Alzheimer’s drug Aduhelm (aducanumab) in its drug formulary, citing what it deemed to be unclear efficacy paired with a significant risk of adverse events.

The department’s pharmacy benefit manager advised against providing the drug given “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal,” according to Endpoints News.

The VA also added Aduhelm to its non-promotable list, which forbids pharmaceutical sales reps from promoting the drug to the VA.

The list price for Aduhelm is approximately $56,000 annually.

The VA, however, included aducanumab in the ‘Place in Therapy’ section of its national drug monograph, which provides an assessment of the drug’s clinical evidence. The document concluded that the VA “recommend[s] against offering this agent to patients with Alzheimer’s dementia (mild o…

HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally.

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

Aducanumab continues to face scrutiny as Biogen aims to woo neurologists and Alzheimer’s patients

Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism.

Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according to research from Spherix Global Insights.

Still, many neurologists are receiving a flood of queries about Aduhelm. “We’ve received a lot of inquiries from patients themselves, a lot more referrals from primary care doctors, geriatrics doctors, internal medicine doctors who actually have no idea what aducanumab is, and they just are referring a bunch of patients themselves,” said private-practice neurologist Dr. Roni Sharon in a briefing note with UBS analysts.

Demand for an effective Alzheimer’s treatment is considerable. “Family members have been coming in inquiring about the medi…

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.

The company’s stock dropped 6.79% to $328.16.

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials. FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug. Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment a…

FDA asks for an independent federal review of its aducanumab approval

Acting FDA Commissioner Dr. Janet Woodcock is responding to criticism about the agency’s controversial decision a month ago to approve aducanumab, Biogen’s and Eisai’s Alzheimer’s drug.

In a letter to Principal Deputy Inspector General Christi Grimm, Woodcock called for an independent investigation into the contacts between Biogen and FDA during the approval process. Biden has nominated Grimm to be inspector general. Grimm has served as the acting HHS inspector general since early 2020.

Woodcock stressed in the letter to Grimm that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making.”

Yesterday, Biogen announced that the agency had limited its prescribing recommendations for the drug to a subset of Alzheimer’s patients. The agency had initially indicated it for all Alzheimer’s pa…

FDA narrows indication of Biogen’s aducanumab

After FDA approved Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Aduhelm (aducanumab) to treat Alzheimer’s disease, the agency faced criticism that the indication was overly broad. While initially indicating aducanumab for all Alzheimer’s patients, the agency has decided to recommend it for patients with mild forms of the disease.

The EMERGE and ENGAGE Phase 3 studies for the drug involved patients with early Alzheimer’s disease.

The revised label recommends the use of the drug in patients with “mild cognitive impairment or mild dementia stage of disease.”

The revised label points out that there are no safety or effectiveness data for people with “earlier or later stages of the disease than were studied” in the Phase 3 trials.

The update came after Biogen’s head of R&D, Dr. Alfred Sandrock, requested that the agency incorporate feedback from physicians and the Alzheimer’s community.

Critics have also lamented that the prospect of mak…

Lilly’s donanemab could outclass aducanumab, but questions remain

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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Unraveling aducanumab’s impact remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact.

There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The need for such PET scans could drive an uptick in PET imaging, according to an investor briefing note from UBS.

As a result, Cardinal Health (NYSE:CAH) could be among the beneficiaries of the aducanumab approval as the company’s Nuclear & Precision Health Solutions division has a significant reach acro…

Unraveling aducanumab’s impact on pharma remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are six million Alzheimer’s people in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The survey bodes well for the early uptake of the drug, according to Jefferies. But the continued success of aducanumab will require winning over skeptical neurologists and psychiatrists. Several physicians have penned op-ed’s voicing their resistance to the drug in outlets ranting from STAT to the Baltimore Sun. Last Novembe…

Three members of FDA advisory committee resign after aducanumab approval

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.

Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)

Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.

The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).

The three have not gone quietly.

In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”

Knopman told The Washington Post that he did not “wish to be part of a sham process.”

Perlmutter was mor…