The FDA approves world’s first Crispr gene-editing drug, Casgevy and Lyfgenia, for the treatment of sickle cell disease. Casgevy, a cell-based gene therapy, utilizes CRISPR/Cas9, a type of genome editing technology. It is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises. The therapy is designed to eliminate recurrent episodes of debilitating pain caused by sickle cell. The long-term safety and efficacy of these gene therapies are still being assessed, and patients will be monitored throughout their lives for potential risks. The FDA’s approval of these gene therapies represents a significant medical advance in the treatment of sickle cell disease.
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Cost of CRISPR Treatments
The FDA has recently approved the first gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease. Casgevy, the first CRISPR therapy approved by the FDA, is priced at $2.2 million, while Lyfgenia, another genetic medicine cleared on the same day, is priced at $3.1 million. These prices make Casgevy and Lyfgenia among the most expensive medicines on the market. The high costs raise concerns about access, particularly for a patient population that has faced discrimination and barriers to care. Additionally, the process of treatment, which involves collecting and genetically modifying patients’ own stem cells, is long and intensive, and patients may face additional out-of-pocket expenses, such as for nearby lodging. The FDA’s approval of these gene therapies represents a significant medical advance in the treatment of sickle cell disease, but the high costs pose challenges for accessibility.
Coverage Criteria for Genetic Treatments:
- Challenges exist in insurance coverage for genetic treatments, including CRISPR-based gene therapies.
- Private health insurers commonly cover genetic counseling and testing with low- or no out-of-pocket costs based on specific criteria.
ACA Guidelines for Genetic Counseling and Testing:
- Under the Patient Protection and Affordable Care Act (ACA), genetic counseling and testing for personal or family cancer history are mandated with no co-payment.
- However, this 100% coverage applies exclusively to in-network health care providers.
Limitations on ACA Coverage:
- Services from out-of-network providers may result in out-of-pocket costs, despite ACA guidelines.
Variations in Coverage Across Insurance Types:
- Medicare, Medicaid, self-funded, and short-term health plans operate under different rules, not required to follow all ACA regulations.
- Policies regarding coverage of genetic services may vary among these different insurance types.
Private Insurance and Genetic Testing:
- Most private insurance companies cover the cost of genetic testing.
- Some insurers have specific criteria for coverage, determining who qualifies for certain types of genetic testing.
Pre-Authorization and Coverage Determination:
- Some insurers may require pre-authorization for certain genetic tests.
- Coverage determination may be contingent on meeting specific criteria set by the insurance provider.
Medicare and Medicaid Coverage Variation:
- Patients with Medicare and Medicaid may have coverage for genetic testing.
- Coverage specifics depend on the state and the nature of the testing ordered.
Individual Responsibility in Determining Coverage:
- It is crucial for individuals to contact their insurer to understand the coverage their plan provides for genetic testing.
- Costs for genetic testing can vary significantly, making it essential for individuals to be informed about their specific coverage.
The FDA has granted approval for the first gene therapies, Casgevy and Lyfgenia, aimed at treating sickle cell disease, and they are anticipated to be available in early 2024. This approval marks a noteworthy medical advance, offering potential cures for individuals grappling with sickle cell disease. The forthcoming availability of these treatments is expected to exert a profound impact on patients dealing with sickle cell disease, presenting a new and innovative approach to addressing this debilitating and life-shortening inherited condition.