A big week for PAHPA

It's a big week for PAHPA—here’s what’s happening (and more to come). Plus, lawmakers explain why the CMS coverage plans for Alzheimer’s drugs will hurt patients and we explain the power of pediatric vaccines. (653 words, 3 minutes, 15 seconds)

A big week for PAHPA

We’ll be watching today and tomorrow as congressional committees make their recommendations for legislation designed to prepare us for the next pandemic. 

What’s happening: Reauthorization of the Pandemic All Hazards and Preparedness Act (PAHPA) will be voted on at today’s House Energy & Commerce Committee markup and discussed tomorrow at the Senate Health, Education, Labor & Pensions (HELP) Committee hearing.

BIO supports a robust PAHPA, as outlined in comments to the HELP Committee. Phyllis Arthur, BIO’s SVP of Infectious Disease and Emerging Science Policy, testified on the need for a stronger PAHPA before the E&C Health Subcommittee last month. The policy was included in the HELP Committee discussion draft released earlier this month.

BIO opposes the proposed “reasonable pricing” clause, which would control prices of innovations developed through PAHPA. In the past, similar measures prevented the vitally important participation of private investors, BIO explained.

BIO’s take: “This is an important moment for our nation as we emerge from a, hopefully, once-in-a-generation pandemic,” Arthur told the E&C Health Subcommittee on June 13. “Are we more prepared today than we were in 2019? Unfortunately, it is not evident that we are.”

We’ll be watching—and BIO encourages you to contact your Members of Congress today to remind them of the need to pass PAHPA.

Lawmakers: CMS Alzheimer’s drug coverage plan hurts patients, innovation

Centers for Medicare and Medicaid Services (CMS) limits access to Alzheimer’s drugs, harming patients and discouraging innovation, said lawmakers and experts during a House Energy & Commerce Health Subcommittee hearing on Medicare yesterday.

The context: CMS confirmed last month that Medicare will cover Alzheimer’s treatments targeting amyloid plaque in the brain only if they receive traditional approval from the Food and Drug Administration (FDA) and patient registration.

“Unpredictability” hurts patients: Patient registries are “costly and burdensome for the doctors, leading to inequities in coverage” and patient uncertainty about whether they can receive care, said Ranking Member Anna Eshoo (D-CA).

Unpredictability stifles innovation: CMS “passing judgment on products that do not yet exist, or whose clinical outcomes were under review” hurts “American leadership in cures and treatments,” said Energy & Commerce Committee Chair Cathy McMorris Rogers (R-WA). VIew clip of her statement.

These drugs save costs by allowing early Alzheimer’s treatment, giving patients “more time with their families until more effective treatments are developed,” said Chair Brett Guthrie (R-KY).

Bureaucrats shouldn’t determine the value of innovation, said Rep. Diana Harshbarger (R-TN). Reps. Robert Latta (R-OH), Gus Bilirakis (R-FL), and Buddy Carter (R-GA) also expressed opposition to registries.

What’s next: CMS’s proposal yesterday to cover amyloid plaque scans indicates an openness to drugs targeting plaque, analysts said. Patient groups like the Alzheimer’s Association want the CMS to remove the “unnecessary barrier” of registries.

According to the CDC, “4 million deaths worldwide are prevented by childhood vaccination every year.” And that could translate to “more than 50 million deaths prevented through immunization between 2021 and 2030.”

But it wasn’t always this way.

Before the measles vaccine, each year, an estimated 400-500 people died from measles, 48,000 were hospitalized, and 1,000 suffered from encephalitis (swelling of the brain).

From 1951-1954, an average of 16,316 paralytic polio cases and 1,879 deaths were reported each year. After the introduction of the polio vaccine, however, incidences declined to less than 1,000 cases in 1962—and remained below 100 cases after.

Untreated bacterial meningitis has a very high death rate; even with treatment, the death rate is about 15-20%. However, getting the two meningitis vaccines available today can reduce the risk of infection.

Recent cases of measles, polio, and other vaccine-preventable diseases highlight the importance of continuing routine vaccination—for the good of our kids and public health as a whole.

President Biden’s Wednesday: Announcing new actions to increase competition, lower prices, and help entrepreneurs and small businesses.

What’s Happening on Capitol Hill: Along with today’s PAHPA markup (see above), we’ll be watching the House Small Business Oversight Subcommittee hearing on “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses.” POLITICO is reporting that the current Farm Bill will likely be extended, as approval by September 30 is unlikely.