By 2025, the FDA expects to approve 10 to 20 new cell and gene therapies each year. By leveraging a patient’s own biology, cell and gene therapies are already reversing congenital blindness, curing aggressive forms of pediatric leukemia and may soon grant infants with neurological genetic conditions a second chance at life.
Cell and gene therapies are revolutionizing the field of medicine by offering life-changing benefits to people with rare diseases and cancers. These therapies have been gaining considerable attention recently, both for addressing long-standing unmet needs and for being exceptionally pricey.
Aetna recently announced an initiative to launch a designated network to cover new gene therapies for rare diseases. This follows an initiative by CVS Health in 2019 to provide self-insured employers with a stop-loss program with Aetna health plans and cover gene therapies.
The Gene-Based, Cellular and Other Innovative Therapies (GCIT) network, which will be included as a standard network for Aetna fully insured plans, gives members access to over 75 providers and a clinical team to guide members and providers through the care process.
The network will launch Jan. 1, 2022, and cover three gene therapies—Luxturna, Spinraza and Zolgensma—for inherited retinal disease and spinal muscular atrophy. The new network offers a financial protection program for CVS Caremark clients and Aetna plan sponsors who don’t have stop-loss insurance.
The FDA received more than 230 applications from cell and gene therapy developers to begin clinical trials in 2020, similar to the number it received in 2019.
To regulate cell and gene therapy development, the FDA planned to hire more staff at the Centers for Biologics Evaluation and Research, the division that regulates cell and gene therapies.
The FDA agency finalized six guidance documents for drug makers in the field and may do the same soon for gene editing medicines once the coronavirus pandemic The FDA has approved 22 cellular and gene therapies to date, most for cancers and rare diseases.
Other companies that have similar initiatives include:
- Express Scripts has an arrangement where it ships Luxterna through Accredo Specialty Pharmacy or CuraScript Specialty Distribution to the provider after the patient receives health plan authorization. Novartis has partnered with Accredo to offer a five-year payment plan for Zolgensma.
- Prime Therapeutics launched the PreserveRx program that will pay a per-member per-month fee and in exchange will be shielded from the extremely high one-time cost of new therapies such as Zolgensma. PreserveRx is offered in conjunction with BCS Insurance Company, a reinsurance company backed by Blues plans.
- In November of 2020 Optum introduced Optum Frontier Therapies, a new pharmacy services business with a mission to support people with compassion, while creating access to therapies at the frontier of health care—including rare disease drugs, gene and other advanced therapies, and digital therapeutics.
Takeaway: As gene therapies continue to enter the market, companies are developing initiatives to make it easier for plan sponsors to afford the costs