In June, the Centers for Medicare & Medicaid Services (CMS) will name the participating states for the agency’s new Cell and Gene Therapy (CGT) Access Model.
One state has already started participating, the CMS said, and 35 states are agreeing to participating, reported Bloomberg. These states represent about 84% of Medicaid beneficiaries with sickle cell disease.
Insurers, however, are wary broadly of the financial costs associated with cell and gene therapies, a report from the Pharmaceutical Strategies Group found. The report surveyed individuals on behalf of employers, health plans and unions.
Nearly three-fourths (73%) of respondents said they view the affordability of cell and gene therapies as a moderate or major challenge in the next two to three years. For health plans, that figure rises to 87%. A majority (70%) of people said they were, at best, only somewhat confident they properly understood the financial impact of these therapies.
Innovative gene therapies are meant to better treat rare diseases but are subject to high initial costs. The CGT Access Model encourages states and manufacturers to participate in the model to bring these therapies to individuals and reduce the cost curve over the long term.
First announced in 2023, the model’s initial focus will center around sickle cell disease, but other therapies could be supported in the future.
Treatment for hemophilia B can cost $3.5 million, while treatment for acute lymphoblastic leukemia has a price tag up to $475,000, according to the report. PSG estimates there will be a “dozen new” therapy approvals this year.
“Benefits leaders may need additional education about the CGT pipeline to see value and have interest in CGT financial protection products,” said the authors.
Nine in 10 employer respondents and 60% of health plan representatives say they also do not participate in value-based contracts or warranties through risk sharing financial programs with drug manufacturers. However, 28% of health plan respondents said they have entered into risk sharing financial programs.
President Donald Trump announced an executive order that rescinded a Biden-era executive order in his first week back in office, which instructed the CMS Innovation Center to test three models, including the CGT Access Model. A CMS spokesperson later told Fierce Healthcare the order would not disrupt the CGT Access Model’s operations.
PSG, one of the largest independent pharmacy benefit consulting firms, was acquired by EPIC in 2021.
About 8 in 10 respondents said managing specialty drug costs is one of their top concerns.