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Analysis backs up Pelosi drug price idea; FDA provides Right to Try clarity

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Analysis backs up Pelosi drug price idea; FDA provides Right to Try clarity

A plan proposed by House Speaker Nancy Pelosi, D-Calif., for a scaled-back version of Medicare drug price negotiations got some new support from a group of patient advocates last week.

A number of Democrats have long sought letting Medicare negotiate directly with drugmakers on the prices of their medicines — something that is currently prohibited by a 2003 law.

Behind the scenes, however, Pelosi and her aides have been trying to convince Democrats that a more workable plan — and one that may get Republicans on board — would involve only negotiating the prices of a limited number of medicines, potentially as few as 25 per year.

The idea, however, has been met with resistance on Capitol Hill from both sides of the aisle in both chambers.

But a new analysis from the nonprofit Patients for Affordable Drugs may provide Pelosi some back up for her proposal.

SNL ImageHouse Speaker Nancy Pelosi
Source: Associated Press

The analysis found that 1% of the drugs covered by Medicare Part D, which covers medicines for seniors and disabled Americans picked up at the pharmacy counter, accounted for 17% of the program's spending. About 3.5% of the drugs accounted for 60% of Medicare Part D spending.

"The data show that Congress should focus Medicare price negotiations on key drugs for the same reason that Willie Sutton robbed banks — that's where the money is," Ben Wakana, executive director at Patients for Affordable Drugs, said in a May 29 statement. "The greatest savings for beneficiaries and taxpayers will be achieved by negotiating lower prices on the costliest drugs."

The group noted that the nonpartisan Kaiser Family Foundation reported in March that 86% of Americans said the federal government should be allowed to negotiate prices directly with drugmakers.

Lowering Part B costs

Meanwhile, a new analysis by Avalere Health found that if Congress required Medicare under its Part B program to support out-of-pocket costs for lower-cost versions of biologics, or biosimilars, beneficiaries' costs could drop by up to $3.3 billion over 10 years and federal spending would decrease by as much as $5.2 billion.

The analysis was commissioned by a cadre of brand and generic companies, known as the Biosimilars Forum.

The coalition suggested that Congress should pass legislation requiring the Centers for Medicare and Medicaid Services to pursue models designed to increase access to biosimilars, including a shared savings model, in which Medicare savings associated with prescribing the lower-cost biologics over brand-name medicines would be shared with providers.

The forum also said Congress should require CMS to provide an enhanced reimbursement for biosimilars for two years, consisting of either the average sales price plus 8% or the average sales price plus 6% and an additional flat fee.

Clarifying Right to Try

The U.S. Food and Drug Administration provided more clarity last week to patients about a law passed by Congress last year that lets Americans seek experimental treatments without going through the agency's compassionate-use process.

Only two U.S. patients are known to have accessed experimental drugs under the law, which was enacted on May 30, 2018.

On Nov. 8, 2018, the FDA unveiled a website about the Right to Try Act's patient and drug eligibility criteria, though it provided scant details.

Left out was some of the most important information, most notably, the fact that drugmakers are not required by the 2018 law to provide their experimental medicines to patients.

In a May 28 update to the website, the FDA added a list of answers to frequently asked questions, including making it clear that biopharmaceutical manufacturers are not obligated under the Right to Try Act to provide their products to patients.

The FDA also clarified that its role is limited and that it does not review or approve requests for Right to Try Act use.

The agency plans to issue proposed rules around its role in the Right to Try Act in September, according to a May 22 notice from the White House Office of Management and Budget.

Opioid blister packs

Also last week, the FDA asked the public to weigh in on the agency's plan to require makers of certain immediate-release opioids to supply their products in unit-dose, short-duration packages, or blister packs, as part of an effort to reduce exposure to the drugs in the midst of the U.S. addiction crisis.

The FDA gained the authority to require the change in packaging under the SUPPORT Act, which was overwhelmingly adopted by the House and the Senate on a bipartisan basis in 2018.

Blister packs could lead to fewer pills left in medicine cabinets and may lower the rates of new addiction, FDA Acting Commissioner Ned Sharpless said in a May 30 statement.

Accelerator network expansion

The U.S. government is seeking to expand its network of innovation accelerators that are targeting development of new technologies aimed at combating health issues that pose security risks.

Last year, the Biomedical Advanced Research and Development Authority's Division of Research, Innovation and Ventures spent $25 million to fund eight innovation accelerators across the U.S., mostly at academic institutions.

The deadline for applications is July 23.