What We’re Reading: Sickle Cell Treatment Access; Patent Thicket Attacks; US Syphilis Cases Rise

Biden-Harris Administration Announces Action to Increase Sickle Cell Treatment Access

The Biden-Harris Administration announced yesterday that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, according to a press release by the US Department of Health and Human Services (HHS). Initially announced in February 2023, the CGT Model is designed to improve health outcomes, increase cell and gene therapy access, and lower health care costs for vulnerable populations. HHS explained that this model has the potential to help improve outcomes for patients and families with SCD while also ensuring taxpayer dollars are used more effectively. The CGT Access Model will begin testing outcomes-based agreements (OBAs) for cell and gene therapies in 2025; successful OBAs will increase affordable access to potentially lifesaving and life-changing treatment. CMS will also negotiate an OBA with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with Medicaid; negotiations will also include a standardized access policy and additional pricing rebates. The CGT Access Model will begin in January 2025, and states may choose to participate between January 2025 and January 2026.

The FTC is Cracking Down on Drugmakers’ “Patent Thickets”

The Federal Trade Commission (FTC) has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines to help increase competition and potentially lower prices, according to KFF Health News. The FTC explained that drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives. The targeted patents cover devices, like the ones that propel medicines for asthma into the lungs, that drugmakers listed in the FDA’s “Orange Book” to help better protect the products from generic competition. Although many medicines are decades old and years off patent, manufacturers often tweak the delivery methods, and each tweak gets a new patent. By challenging Orange Book listings, the FTC is attempting to cut away patent thickets as many drugs today are protected by half a dozen patents or more, which creates additional obstacles for cheaper generics seeking to enter the market; merely listing a patent in the Orange Book automatically triggers a 2.5-year delay of FDA approval of a litigating generic competitor.

US Sees Highest Syphilis Numbers Since 1950

A new CDC report on sexually transmitted diseases (STDs) in adults showed that the rate of infectious syphilis cases in the US rose 9% in 2022, according to the Associated Press. According to data released Tuesday, total syphilis cases surpassed 207,000 in 2022, a 17% increase and the highest count in the US since 1950; the count included infectious cases, latent cases, and cases where pregnant women passed it on to their babies. About 59,000 of these cases involved the most infectious forms of syphilis, a quarter of which affected women, and nearly a quarter of which affected heterosexual men. Although syphilis continues to have a disproportionate impact on gay and bisexual men, the CDC noted that cases are expanding in heterosexual men and women and also increasingly affecting newborns. Additionally, the report showed syphilis cases becoming more prevalent in different racial and ethnic groups, with American Indian and Alaska Native people having the highest rate. Consequently, HHS convened a syphilis task force last year, focused on stopping the spread, especially in the places with the highest syphilis rates.