Pediatric PRV reauthorization introduced in Senate

The end of last week brought progress on reauthorizing the Pediatric Priority Review Voucher (PPRV) program, and the New York Times turned up the heat on PBMs. (574 words, 2 minutes, 52 seconds)

Pediatric PRV reauthorization introduced in Senate

Sens. Bob Casey (D-PA) and Markwayne Mullin (R-OK) introduced a bill to extend the Pediatric Priority Review Voucher (PPRV) program, which expires Sept. 30. It was co-sponsored by Sens. Sherrod Brown (D-OH) and Susan Collins (R-ME).

Bill S.4583, to reauthorize the Pediatric Priority Review Voucher (PPRV) program, mirrors a bill introduced in the House in February. It extends the program for six years to “provide greater stability to innovators, encourage investment, and spur innovation in rare and neglected diseases that disproportionately impact children,” said Sen. Casey.

How PPRVs work: Companies gaining approval for drugs targeting rare pediatric diseases can be awarded a voucher granting expedited review of another drug in the future. Drug makers can also fund future research by selling the voucher to another company.

Why it matters: “Since its creation in 2012, this program has awarded 53 vouchers for 39 rare pediatric diseases that have led to innovations benefitting over 200,000 patients. 36 of those rare diseases had no previously approved therapies on the market at the time of approval,” said Sen. Mullin.

BIO’s view: “For more than a decade, the rare pediatric disease priority review voucher program has offered immeasurable hope to countless families,” said BIO President & CEO John F. Crowley. “At no cost to taxpayers, the voucher program has helped incentivize the development of nearly four dozen new medicines for children with rare diseases.”

“As a father of two children with a rare disease, I am grateful that lawmakers are working together, on a bipartisan basis, to continue this vital program and hope it’s signed into law as soon as possible,” Crowley continued.

Read more about the issue in STAT News.

NYT explores PBMs, the ‘opaque industry secretly inflating prices for prescription drugs’

Last week, the New York Times highlighted how pharmacy benefit managers (PBMs) drive up drug prices and patient costs.

BIO’s been calling out PBMs for years, explaining how they work, urging legislation to reform them, and launching an action campaign that was followed by reform proposals in the House and Senate.

The NYT noted PBM abuses including:

• Pushing “patients toward drugs with higher out-of-pocket costs.”
• Charging employers and Medicare “multiple times the wholesale price of a drug, keeping most of the difference for themselves.”
• Killing independent pharmacies. “The disappearance of local pharmacies limits health care access for poorer communities but ultimately enriches the PBMs’ parent companies, which own drugstores or mail-order pharmacies.”
• Delaying or preventing prescriptions patients need. “In the worst cases, patients suffer serious health consequences.”

The impact of market concentration: “The modern PBM emerged in 2018” as health insurers “sought to merge with the PBMs, whose profits were soaring,” The New York Times reports. Now, the big three—CVS Health’s Caremark, UnitedHealth’s Optum Rx, and Cigna’s Express Scripts—handle 80% of U.S. prescriptions, compared to 50% in 2012.

The bottom line: “The job of the PBMs is to reduce drug costs. Instead, they frequently do the opposite. They steer patients toward pricier drugs, charge steep markups on what would otherwise be inexpensive medicines and extract billions of dollars in hidden fees,” says the article. 

Read more at the New York Times.

President Biden’s Monday: At Camp David.

What’s Happening on Capitol Hill: On Wednesday, the Energy & Commerce Subcommittee on Innovation, Data, and Commerce has planned a budget hearing with Commerce Secretary Gina Raimondo. Also Wednesday, the Ways & Means Health Subcommittee will hold a hearing, Improving Value-Based Care for Patients and Providers. We’ll be watching for Thursday’s markup by the House Energy & Commerce Committee of the proposed American Privacy Rights Act addressing online privacy.