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Wednesday, July 7, 2021

Are pharmaceutical company mergers bad for biotech? - STAT

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You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.

What is the Alzheimer’s Association actually doing to get Biogen to lower its price?

If you’re like me and spend far too much time thinking about the relationships between patient groups and drug makers, you were likely shocked last month when the Alzheimer’s Association called the price of Aduhelm — a drug that the group had been promoting for months — as “simply unacceptable.” It seemed a significant shift in the relationship between drug makers and patient groups, which often are reluctant to criticize drug makers for their prices, especially when those drug makers help keep their lights on.

The statement earned the association respect from some of pharma’s fiercest critics in Washington, but increasingly both drug pricing advocates and industry insiders are beginning to ask what the high-profile Alzheimer’s group is actually doing to make Biogen lower its price, and whether long standing financial ties, like Biogen’s top sponsorship of the association’s convention this month, are compromising the group’s ability to actually hold Biogen’s feet to the fire.

As one advocate put it: “I think they’re crocodile tears … I really don’t believe them that they are actually that concerned.”

For more, check out my story here.

Buckle up: We are in for a health-care heavy Supreme Court term

The Supreme Court announced Friday that it will hear four — yes, four — new health care cases in the upcoming term, which starts in October.

The infamous 340B drug pricing program is getting its day in court, my colleague Rachel Cohrs reports. The justices will take up safety-net hospitals’ challenge of the Trump administration’s proposal to massively cut how much the government reimburses hospitals for these drugs, which they get from drug makers at a hefty discount. The court also took up another case challenging how the federal government determines certain reimbursement rates for safety-net hospitals.

More from Rachel here.

Also catching my attention: The Supreme Court will hear CVS Pharmacy v. Doe, a case asking whether HIV patients can sue CVS for discimination because they’re required to get their medication via mail-order pharmacies if they want to avoid paying out-of-network rates. Insurers and middlemen argue that the case could have hugely negative impacts on their ability to use tools like step therapy and prior authorization, which they say keep drug prices down.

In an amicus brief, PCMA wrote, with uncharacteristic flair, that any ruling that let the patients sue for discrimination “is certain to harm millions of Americans who receive prescription drug insurance coverage … lead to runaway prescription drug costs, which will mean higher premiums, higher cost-sharing, and less generous benefits … and may well render prescription drug benefits too expensive for sponsors to continue offering at all.”

Quite a dire prediction…

So are pharma mergers bad for biotech, or nah?

That’s the question facing the Federal Trade Commission right now, and the answer is wildly different depending on who you ask.

Ask Rep. Katie Porter, the former law professor turned lawmaker, and you’ll hear horror stories about how pharma mergers destroy the innovative culture of small biotechs. “Each year, more and more biotech firms engaging in true research and development are swallowed up by pharmaceutical giants that disband their innovative culture and instead spend profits on salaries and dividends,” Porter wrote in a recent letter to the agency.

But ask the Biotechnology Innovation Organization, the lobbying group in Washington that represents many of the nation’s small biotech companies, and you’ll hear that mergers are one of biotech’s best tools for helping get innovative new drugs on the market.

“There is little desire by industry and patients to revert back to the world order that many in

Washington wish to see,” wrote the Biotechnology Innovation Organization in comments to the FTC. “The biopharmaceutical ecosystem is no longer what it once was, and it is not going back.”

Both missives came as part of a global effort by the FTC to revisit how it evaluates pharma mergers. Beyond just saber rattling, numerous commenters on the FTC’s docket are debating various ways the commission could more closely monitor drug mergers. Porter, drug industry critics, and groups like the American Antitrust Institute are calling on the FTC to block more mergers and impose stricter conditions on merging firms to prevent them from entering into anti-competitive deals like pay-for-delay agreements. PhRMA and BIO, as well as the Chamber of Commerce, argue that the FTC has all the tools they need to deal with mergers.

Want to dive deeper? Check out the comments here.

HHS punts the hard questions on surprise billing

After a massive television ad campaign, a grueling lobbying fight, and nine White House meetings with advocacy groups and industry parties on the Biden administration’s first surprise billing rule, the health care industry’s response to its release was, well, tepid.

That’s because the rule dealt mostly with protections for consumers, which all stakeholders, despite their differences, agree on, in theory. As of deadline, the biggest hospital lobbies hadn’t even put out formal statements, my colleague Rachel Cohrs reports. A coalition including major insurers used its statement to stake out a position in the bigger battle yet to come.

HHS in the coming months will have to set the parameters for an arbitration process that will see insurers and providers duking it out to determine who foots the bill after patients pay their share. The debate has already inspired a spate of letters from lawmakers and questions at congressional hearings. When the Biden administration tackles the issue, expect plenty of fireworks and keep reading STAT, we’ll have you covered.

STAT stories you may have missed

Congress is weighing game-changing bills to curb the tech industry’s monopoly power, and the measures could obstruct Google and Amazon’s ambitions in health care.

Former health secretary Donna Shalala and a chorus of advocates and academics are demanding answers on the close relationship between the FDA and Biogen.

‘This is not enough’: Walmart’s plan to sell another private label insulin is met with skepticism.

12 lessons Covid-19 taught us about developing vaccines during a pandemic.

A new analysis of Biogen’s Alzheimer’s drug says the cost-effective price is $8,400 per year, up from an earlier estimate of $3,000 per year.

STAT’s annual list of summer book and podcast recommendations is out!

This was the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.

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July 07, 2021 at 01:55AM
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Are pharmaceutical company mergers bad for biotech? - STAT
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