Criteria for Approval: Casgevy (exagamglogene autotemcel) Prior Authorization
Customize your policy alerts
Sign up for all West Virginia Bureau for Medical Services (Department of Human Services) policy alerts
Know when West Virginia Bureau for Medical Services (Department of Human Services) releases new policies or updates existing guidance.
Monitor payer policy activity
Defines prior authorization requirements and medical necessity criteria for one-time administration of Casgevy (autologous genome-edited HSC gene therapy) for patients with sickle cell disease (SCD) with recurrent vaso-occlusive crises and transfusion-dependent β-thalassemia (TDT), affecting providers and members seeking coverage under West Virginia Bureau for Medical Services.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Therapy / Coverage Criteria
Covered when ALL of the following are met:
Approval may be authorized for a sufficient duration to allow a single course of treatment (one-time infusion) and will not be reauthorized; once approved, the prior authorization will be valid for at least 12 months.
Autologous CD34+ cells are gene-edited to reduce BCL11A expression, increasing fetal hemoglobin (HbF).
The document does not list any specific exclusions for Casgevy. No explicit exclusionary statements or conditions are provided in the policy text regarding patient populations, comorbidities, or prior treatments that would categorically preclude coverage.
The policy does not explicitly designate any situations as "not medically necessary." There are no statements in the criteria or accompanying language that label particular uses or patient scenarios as not medically necessary.
Key Clinical Thresholds and Definitions
Prior Authorization, Documentation, and Denial Risk
Prior authorization required; single course only
Prior authorization is required and, if approved, will be authorized for a sufficient duration to allow a single course of treatment (one-time infusion); the PA will not be reauthorized and will be valid for at least 12 months.
- One-time administration only — PA covers a single course (one-time infusion).
- PA will not be reauthorized; once approved the PA is valid for at least 12 months.
Require prior hydroxyurea use or documented intolerance
Documented prior use of, or intolerance to, hydroxyurea at any point in the past is required, determined per the treating clinician’s judgment.
Required documentation to support prior authorization
Include documentation that the therapy was prescribed by, or in consultation with, a board-certified hematologist with SCD expertise; confirm patient age (≥12), FDA‑approved diagnosis with confirmatory genetic testing, prior hydroxyurea use or intolerance, clinical stability/fitness for transplantation, and the number of VOCs (≥2 per year in the prior 24 months) via provider attestation.
- Prescribed by or in consultation with a board-certified hematologist with SCD expertise.
- Patient is 12 years of age or older.
- FDA-approved diagnosis with confirmatory genetic testing.
- Documented prior use of, or intolerance to, hydroxyurea (per clinician judgement).
- Clinical stability and fitness for transplantation.
- Number of VOCs: ≥2 per year in the previous 24 months (provider attestation).
Denial risk if all criteria are not documented
Failure to document that the patient meets ALL required criteria may result in denial of prior authorization.
- Missing documentation of age (≥12), FDA‑approved diagnosis with confirmatory genetic testing, or board-certified hematologist involvement risks denial.
- Failure to document prior hydroxyurea use or intolerance, clinical stability/fitness for transplant, or recurrent VOCs (≥2 per year in prior 24 months) risks denial.
Therapy Background
Casgevy (exagamglogene autotemcel) is described as an autologous genome‑edited hematopoietic stem cell (HSC) gene therapy in which a patient’s own CD34+ cells are modified to reduce BCL11A expression in erythroid lineage cells, resulting in increased fetal hemoglobin (HbF) production. It is intended as a one-time administration delivered via a hematopoietic stem cell transplant (HSCT) procedure for patients aged 12 years and older with sickle cell disease with recurrent vaso‑occlusive crises or transfusion‑dependent β‑thalassemia.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.