Private insurers decline to cover Biogen's new Alzheimer's drug in escalating standoff — report

As the fallout continues from the FDA’s controversial approval of Biogen’s new Alzheimer’s drug Aduhelm, some insurers are reportedly unwilling to cover the high costs associated with the drug.

At least six affiliates of Blue Cross Blue Shield across the country have adopted new policies describing Aduhelm as either “experimental” or “investigational,” the Boston Globe reported Tuesday evening, saying the drug falls outside covered medicines because it remains under clinical review. The report came a day after the Centers for Medicare & Medicaid Services opened a nine-month review process over limiting coverage of Aduhelm, which is priced at $56,000 per year.

Endpoints News has reached out to Blue Cross Blue Shield for comment, as well as other major insurers regarding their coverage plans, and will update accordingly.

Biogen, meanwhile, is slamming the decision. In an emailed statement to Endpoints News, a Biogen spokesperson said the characterization of Aduhelm as experimental is “inaccurate and misleading,” and noted that only a “very small portion” of patients would be affected by the plans.

“Typically, an experimental drug is one that has not yet entered clinical trials, whereas an investigational drug is one that is being studied in trials but has not yet received marketing approval from the FDA,” spokesperson Allison Parks wrote. “Aduhelm is approved by the FDA and is neither experimental nor investigational.”

It’s not entirely clear how the insurers came to their decision, nor why they are describing Aduhelm as an experimental product, given its green light by the FDA on June 7. Their language may be a reference to the accelerated approval pathway upon which regulators used to OK Aduhelm, which requires a study to confirm clinical efficacy be completed by 2030.

Historically, insurers have covered drugs under accelerated approval, although some have objected to certain expensive rare disease medicines. Whether or not insurers would be willing to pay for the drug had been an open question, however, due to Aduhelm’s high price tag. Some insurers also cited negative assessments of the drug to justify their positions, the Globe reported.

In a notice posted by Blue Cross Blue Shield of Minnesota on June 23, the insurer said claims for Aduhelm may be denied while the drug remains “under review.” Another memo from the North Carolina affiliate posted sometime last month described its plans in similar terms, saying it “does not provide coverage for investigational services or procedures.”

The Minnesota group’s “goal is to find the right balance between making new treatments available and guarding against unsafe or unproven approaches,” it wrote. “While the drug is under clinical review, the drug treatment is considered experimental/investigative until the evaluation process has been completed.”

It remains to be seen how the insurers’ plans will play out over time or whether their plans will change once the CMS review is complete. Biogen has said it expects about 80% of patients eligible for Aduhelm are covered by Medicare, and private insurers are likely to follow the federal government’s lead.

CMS has denied only about 3% of claims submitted by hospitals and physicians, typically doing so when the care is, in their opinion, “not reasonable and necessary.”

The Globe report is the latest in an ongoing controversy over the drug, which the FDA OK’ed despite a unanimous vote against approval by its own adcomm. Three of those panel experts have since resigned in protest, with one member — Harvard professor Aaron Kesselheim — calling the decision “probably the worst drug approval decision in recent U.S. history.”

Things have only grown more heated following a report from STAT News about a group of Biogen employees tasked in early 2019 specifically to persuade the FDA to approve the drug.

The report spurred at least two prominent Democratic legislators to call for an investigation into the drug’s approval process, a probe which got underway Tuesday. And interim FDA chief Janet Woodcock has asked the HHS inspector general to investigate her own agency to examine the relationships between FDA officials and Biogen executives.

As public health experts continue to criticize the drug’s approval and call for broader reform, the FDA staff in charge of the OK is standing by their decision. Billy Dunn, Peter Stein and Patrizia Cavazzoni wrote in a JAMA perspective Tuesday that Aduhelm is a perfect fit for the accelerated approval pathway despite the “complexities” surrounding the drug.

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bayer nabs star biotech Vividion with a $2B buyout and an ‘arms-length’ pact, pulling a partner out of the IPO conga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Science pioneer, pharma research chief, global health advocate and biotech entrepreneur Tadataka ‘Tachi’ Yamada has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-investigates Pfizer's eye-popping price gouging on an epilepsy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vaccine developer favored by the UK government in Covid-19 touts a PhIII first in chikungunya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UPDATED: Synbio unicorn Zymergen jettisons founding CEO, cuts guidance as customers report lead product doesn't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Biogen, Eisai are pushing for another accelerated Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymergen's sudden implosion shocked biotech. A lingering loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Janet Woodcock (Bill Clark/CQ Roll Call via AP Images)

HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy

The government investigation into how the FDA approved Aduhelm appears to point well beyond the agency’s ties with Biogen in the leadup to its approval of their controversial Alzheimer’s drug Aduhelm.

The HHS Office of Inspector General posted a notice Wednesday that officials will review the accelerated approval pathway, the regulatory mechanism the agency used to approve the drug in the face of conflicting data over whether it could actually slow Alzheimer’s patients’ mental decline. Now the Aduhelm OK is just one branch of an investigation called for last month by acting FDA commissioner Janet Woodcock.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.