Insurers put squeeze on Biogen Alzheimer’s drug

Call it the first big shot across Biogen’s bow in what may become a multi-billion-dollar war in which the hopes of millions for a way to hold back the ravages of Alzheimer’s disease are colliding with the uncertain benefits of a new drug and the explosion of already sky-high health care costs its widespread use would drive. 

The Cambridge-based pharmaceutical company has been riding high since its new treatment for Alzheimer’s disease, aducanumab, was approved last month by the Food and Drug Administration. It is the first approved drug designed to attack the Alzheimer’s disease process, not just its dementia symptoms. 

But the approval was one of the most controversial in the agency’s history, with an FDA advisory panel that reviewed the evidence opposing approval and lots of other experts questioning whether the drug is actually effective. With a price tag of $56,000 a year for the treatment, which is administered via monthly intravenous injections, widespread use of the treatment will depend on insurers’ willingness to cover its cost — and the first signs of insurer revolt are now in the air.

The Globe reports that six state affiliates of insurance giant Blue Cross Blue Shield say they will not cover the drug’s cost because they believe it is still experimental or has not been shown to deliver any “clinical benefit.” With Alzheimer’s overwhelmingly targeting older people, the bulk of the drug cost would fall to Medicare to cover, but lots of patients, the Globe says, would “rely on secondary private insurance for other costs associated with Aduhelm,” the brand name for aducanumab. 

Blue Cross Blue Shield of Massachusetts is not among the six affiliates drawing a line in the payment sand, and no Massachusetts insurer has yet said whether it will or won’t cover the drug. However, the chief medical officer of Point32Health, the new insurer formed from the merger of Tufts Health Plan and Harvard Pilgrim Health Care, last month accused Biogen of leaning into “excessive corporate profits” and suggested the company might not cover the drug if the company didn’t lower its price. 

Medicare’s decision about whether to cover the drug — which will have a far greater impact than those of private insurers — may not come for nine months, the Globe reports. 

The drug’s approval is a tortured tale of zigzagging decisions, with the heavy lobbying power of the country’s pharmaceutical industry looming over the spectacle. Two Phase 3 trials designed to test the drug’s effectiveness were terminated early when aducanumab appeared to show no benefit. But Biogen subsequently said further analysis of data from one of the trials showed a high dose of the drug could slow cognitive decline by about four months over an 18-month period. 

That set the stage for the FDA’s consideration of approval of its use. The agency ruled on June 7 that there were enough grounds to sanction the drug’s use. 

The decision sent Biogen’s stock soaring 38 percent on the day of the ruling — and it was hailed by patient advocates who are desperate for any measure that can hold back the relentless march of Alzheimer’s. But critics slammed the decision as an ill-informed move that will add billions of dollars to US health care costs, while offering false hope, but little actual benefit, to Alzheimer’s patients and their families.

The Boston-based health news website STAT reported late last month that Biogen worked a “back channel” at the FDA to push hard for the agency’s consideration of the drug. The FDA’s own acting director has now called for an investigation into its approval of the drug, acknowledging the questions raised about Biogen’s influence on the process. 

Three members of the FDA drug advisory panel that urged against approval of aducanumab resigned in protest following the agency’s decision to contravene their recommendation. One of them, Aaron Kesselheim, a professor at Harvard Medical School in the division of pharmacoepidemiology, called it the “worst drug approval in recent US history” in his resignation letter. 

“There is just no good convincing evidence that it works,” he told Jim Braude on GBH’s “Greater Boston” earlier this week. “There is a lot of concerns about side effects.” 

Asked by Braude why the FDA didn’t “follow the science” and whether the decision resulted from undue influence by the pharmaceutical industry, Kesselheim said, “I think that’s a really good question,” adding that he hopes investigation of the approval process will “find out what was going on.” 

MICHAEL JONAS

FROM COMMONWEALTH

Future of work: The Baker administration issues a Future of Work report that projects a third of Massachusetts workers could do their jobs remotely, which, if that occurs on a broad scale, could have a major impact on Boston, office space demand, transportation, child care, and employment.

— Remote work means fewer people commuting into Boston for jobs and fewer people traveling to Logan International Airport for business flights. According to the report, demand for commercial office space could fall by 20 percent and the number of commuter rail riders could decline by as much as 50 percent.

— The shift to remote work with an emphasis on greater automation will depress demand for many service jobs (think restaurant and hotel workers) and require a massive effort to teach new skills to workers facing displacement. The report estimates 300,000 to 400,000 jobs could be phased out over the next decade.

— Even though jobs are being lost and many employees can now work from anywhere — even out of state — the report says Massachusetts needs to address its high cost of housing to remain competitive in this new environment. The report says 200,000 new housing units are needed over the next decade.

— It won’t be all bad. As fewer people commute into Boston, congestion may not be as severe and Main Streets in towns outside the city could see a lot more activity. For more on the attractiveness of Main Streets in small towns across the area, check out Amy Dain’s analysis of their potential. Read more.

Baker unsure on Brayton Point: The governor says he isn’t sure who owns what at Brayton Point, even though local officials in Somerset say it is clear that the state owns the deep-water pier and adjacent 12.5 acres at the 308-acre property. Somerset officials want the Baker administration to intervene in a bitter dispute between the town and the property redeveloper, who is running a scrap metal export business and is suing the town in court in a bid to expand into other commodities. Baker seemed sympathetic to Somerset’s plight at Brayton Point, and mentioned $100 million in federal aid he would like to direct to communities like Somerset that are home to properties that could be key to the growth of offshore wind once that industry gets rolling. Read more.

Down to five: Rep. Jon Santiago drops out of the Boston mayoral race, leaving four women and one man still in the hunt. Santiago, who also works as an emergency room physician at Boston Medical Center, had difficulty gaining traction in a city-wide race that extends far beyond his House district. Santiago indicated he may endorse one of the other candidates in the coming days, but it didn’t sound like John Barros would get the nod. “The people of Boston have made it clear, and I look forward to supporting the first elected woman of color to lead Boston,” he said. Read more.

OPINION

No to rent control: Boston mayoral candidate John Barros says rent control is not the answer to Boston’s housing affordability problem. Only one of the mayoral candidates, Michelle Wu, supports rent control. Read more.

FROM AROUND THE WEB

 

BEACON HILL

The Legislature is urged to set rules on compensation for college athletes, after the NCAA dropped its long-standing opposition to letting student athletes be paid for the use of their name, image and likeness. (Eagle-Tribune)

It may take awhile for Beacon Hill to decide how to use billions of dollars in federal ARPA funds, as lawmakers schedule two public hearings in July and talk of holding more later. Gov. Charlie Baker has pressed for quick action. (MassLive)

MUNICIPAL MATTERS

The Amherst Town Council votes 9-4 to reject a petition put forward by 900 residents calling for a 180-day moratorium on projects involving three or more dwelling units in or near downtown. (Daily Hampshire Gazette)

Boston is bringing on a new legal team to handle its ongoing litigation with fired police commissioner Dennis White, with former federal prosecutor Brian Kelly taking the reins from Kay Hodge, who is neck-deep in litigation defending the city’s handling of assignment rule changes for its three exam schools. (Boston Herald

HEALTH/HEALTH CARE

COVID-19 cases by historical standards remain low, but they are rising. (State House News Service).

A summer work program in Provincetown aims to reduce suicide among LGBTQ youth by providing a safe haven for work and play for 18 to 20 year olds facing bullying at home. (South Coast Today)

Unsafe swimming conditions at your local beach? Environmental nonprofits say sewage discharge is to blame. A recent report on water quality at Boston-area beaches showed nearly half the locations tested had dangerously high levels of fecal bacteria. Another allayed the message, saying the report is true but hyperbolic. (Patriot Ledger)

WASHINGTON/NATIONAL/INTERNATIONAL

Senate Democrats reached agreement on a $3.5 billion budget plan that would expand Medicare benefits and extend the reach of other government programs, a proposal that uses the “reconciliation” process in the Senate that requires only majority support to pass, meaning they can pass the initiative without Republican support. (Washington Post

ELECTIONS

Lawmakers are moving forward with a controversial plan for redistricting, which lets the Legislature draw legislative districts before municipalities draw their local districts. (Salem News)

Gov. Charlie Baker said he’s “not surprised” that a number of former big Republican donors are recoiling at the state party’s direction and leadership under chairman Jim Lyons. (Boston Herald)  

BUSINESS/ECONOMY

Massachusetts start-ups are breaking all records for attracting venture capital investments. (Boston Globe)

Condo owners and their building associations are generally on their own in Massachusetts when it comes to carrying out safety reviews and paying for needed repairs, an issue that has gained currency in the wake of the collapse of a 12-story condo building in Florida. (Boston Globe

EDUCATION

Leicester voters at town meeting will be asked to spend $20 million to buy Becker College and use it as a high school campus. (Telegram & Gazette)

The ACLU says the Fall River school committee violates constitutional free speech protections with its rules governing public speaking time at its meetings. (Herald News

ARTS/CULTURE

Actor Sacha Baron Cohen sues Massachusetts cannabis dispensary Solar Therapeutics, which he says used an image of his character Borat on a billboard without his permission. (Associated Press)

TRANSPORTATION

The state Department of Transportation begins a lengthy study examining a possible rail connection between Boston and North Adams running across the northern part of the state. (Berkshire Eagle)

CRIMINAL JUSTICE/COURTS

A death sentence for Boston Marathon bomber Dzhokhar Tsarnaev is once again up for discussion after the Supreme Court agreed to hear oral arguments to reinstate the penalty. (WBUR

Former top Worcester housing official Jacklyn Sutcivni wore a wire for the FBI for years before she was accused of helping a developer steal federal funds, according to testimony at her trial. (Telegram & Gazette)

MEDIAFreelance writer Colman Herman recounts how the Office of Chief Medical Officer repeatedly delayed action on a public records request, a pattern that he says occurs frequently. (New England First Amendment Coalition)