News & Views: 6/21 - 6/27

June 28, 2022

The Senate Committee on Commerce passed the Pharmacy Benefit Manager Transparency Act out of committee to the full Senate.

The bill will empower the FTC to address common PBM practices, such as clawback fees and spread pricing, that limit competition and increase costs for patients. The package would also increase transparency surround PBM pricing information that is currently considered trade secret. The bipartisan bill, led by Senators Cantwell (D-WA) and Grassley (R-IA), was advanced by a 19-9 vote. To read the full bill, click here.

Senators Shaheen (D-NH) and Collins (R-ME) introduced their bill aimed at lowering the cost of insulin.

The INSULIN Act encourages manufacturers to reduce their list prices to 2021 net Part D prices (after rebates) by requiring commercial and Medicare plans to cover all products with reduced list prices on formulary with no management or prior authorization. This would essentially lock in today’s net prices and would allow for price increases in line with inflation. It is unclear that the bill has enough Republican support to pass the Senate, though at least 3 Republican Senators appear to support the legislation. To read the full bill or a section-by-section summary, click here or here, respectively.

Researchers form PORTAL at Brigham and Women’s Hospital estimated the savings that Mark Cuban’s pharmacy model could save Part D in an Annals of Internal Medicine study.

The Mark Cuban Cost Plus Drug Company is an online pharmacy that sells generic prescriptions for the cost of the ingredients plus a 15% margin and an additional $8 flat dispensing and shipping fee. The study found that Medicare could have saved nearly $4 billion in 2020 by following the same model that Mark Cuban’s company uses. The researchers analyzed 89 drugs sold by Cost Plus in 2022 and compared to the prices that Part D paid for the same drugs in 2020; Medicare paid more on 77 of the 89 drugs. To read the full study, click here.

Researchers from the College of Law at West Virginia University, University of Missouri School of Law, and Harvard Medical School proposed policy solutions to address flaws in the US Patent and Trademark Office (PTO) in a Health Affairs Forefront article.

The article focuses on high-reference patents. High-reference patents refer to patents that supply upwards of hundreds or thousands of references for the PTO examiner to review in the allotted 18 hours they have to review a patent application. High-reference patents are particularly difficult to overturn, as the patent is given the deference as if every reference was considered, while it is highly unlikely that all were even reviewed. The researchers propose applicants with over 50 references create a claim chart to assist patent reviewers in determining which references are most relevant as well as an increased patent application fee. To read the full article, click here.

CIDSA Experts in the News

Sean Dickson analyzed Paragraph IV flaws and proposed policy reforms in a Health Affairs Forefront article. Dickson recommends shifting the litigation burden from the generic manufacturer to the brand manufacturer and to institute a limit on patent infringement damages. To read the full article, click here.

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