The Centers for Medicare and Medicaid Services (CMS) said Wednesday that it will increase reimbursements for two newly approved sickle cell gene therapies that could potentially reverse the debilitating effects of the disease.
CMS typically reimburses 65% of the cost of a new technology, but will increase that to 75% for Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, as well as for bluebird bio’s Lyfgenia, according to a proposed rule. The change will take effect in the US government’s 2025 fiscal year and conclude at the end of the two- to three-year so-called “newness” period.
In the 1902-page rule, CMS also says it’s still looking into whether Casgevy and Lyfgenia are substantially similar and should be considered as a single application for purposes of new technology add-on payment.
“If we determine that this technology is substantially similar to Lyfgenia, we believe the newness period would begin on December 8, 2023, the date both Casgevy and Lyfgenia received FDA approval for SCD,” CMS said.
The switch to 75% reimbursement comes as experts have expressed concerns about how state Medicaid programs will pay for the sickle cell gene therapies, with list prices of $2.2 million for Casgevy and $3.1 million for Lyfgenia. About half of all sickle cell patients in the US are covered by Medicaid.
In the drugs’ first year on the market, likely less than 1% of eligible sickle cell disease patients in the US will be able to receive gene therapy, St. Jude Children’s Research Hospital hematologist Alexis Leonard predicted during a presentation last December, just after the approvals.
CMS is now inviting public comments on whether Casgevy is substantially similar to Lyfgenia and whether these technologies should be evaluated as the same technology for purposes of new technology add-on payments.