Medicare, a national health insurance program in the United States covering Americans aged 65 and older as well as younger people with disabilities, has recently announced it will be increasing reimbursement rates and expanding coverage for cell and gene therapy treatments, good news for cancer patients and pharma companies Gilead and Novartis.
Progress in understanding cell and gene therapy has seen astounding growth since the first gene therapy trials took place in 1990, and there is now hope that this therapy will be embraced as a viable treatment for serious disease. CAR-T therapy, a cutting-edge treatment which involves re-engineering of the patient’s own immune cells to fight cancer, was first approved by the US Food & Drug Administration (FDA) in 2017 in two versions. If the treatment works, it can last from months to a lifetime. Though used as a one-time treatment, it carries a hefty price tag, making it largely inaccessible for low and middle-income patients.
This week Medicare officials announced a new coverage rule which aims to make the treatment more accessible. The Centers for Medicare and Medicaid Services (CMS) made the decision to boost reimbursements for treatments from 50% to 65% in a rule known as national coverage determination. In addition to increasing reimbursement rates, the CMS has loosened restrictions around payment, reporting, and covered services. CMS Administrator Seema Verma explained that the agency would be paying not only for CAR-T, but all related services such as administration of the drug, collection of cells, manipulation of cells and readministering them into the patient, as well as outpatient and inpatient care.
Despite some controversy over claims about which groups would be paying for the treatments and restrictions around its administration, the development is welcome, especially for pharma companies Gilead and Novartis, the companies that created the two FDA-approved CAR-T treatments. Gilead’s Yescarta, a cell therapy used to treat non-Hodgkin lymphoma, comes with a price tag of USD 373,000, and Novartis’ Kymriah, which treats lymphoma and childhood leukemia, lists a price of USD 475,000. Both drugs may also be used to treat relapsed or refractory large B-cell lymphoma. Sales of both drugs, though in the millions, have fallen short of industry expectations due to slow adoption rates. The two companies hope that the new coverage policy will boost sales growth.
The decision by the CMS is one step forward in making cell and gene therapies more accessible to patients who need them, though many experts claim that more long-term solutions are needed. It has been debated that the US could do much more to accommodate these therapies.