The commercial introduction of Casgevy (exagamglogene autotemcel) represents a historic milestone in medicine as the first FDA-approved therapeutic product utilizing CRISPR-Cas9 gene editing technology. Developed by Vertex Pharmaceuticals and CRISPR Therapeutics, this autologous, gene-edited hematopoietic stem cell therapy is indicated for the treatment of patients aged 12 years and older with severe sickle cell disease (SCD) who experience recurrent vaso-occlusive crises (VOCs), as well as transfusion-dependent beta-thalassemia (TDT). However, the therapeutic promise of Casgevy is matched by its unprecedented commercial complexity, beginning with a wholesale acquisition cost (WAC) of $2.2 million per patient.
Securing access to a multi-million-dollar, single-dose gene therapy requires navigating a complex web of inpatient and outpatient billing models, outcomes-based contracts, and state-level regulatory policies. Because a significant proportion of the sickle cell disease population in the United States is enrolled in Medicaid, the federal government has launched a coordinated initiative—the Centers for Medicare & Medicaid Services (CMS) Cell and Gene Therapy (CGT) Access Model—to manage the financial risk and clinical administration of these treatments.
This guide provides market access directors, hospital billing departments, government pricing analysts, and clinical coordinators with a detailed roadmap of the reimbursement channels, prior authorization rules, clinical trial data, and operational constraints that govern Casgevy access.
The $2.2 Million List Price: Inpatient DRG vs. Medical Benefit Routing
At a WAC of $2.2 million, Casgevy does not fit into standard pharmacy benefit designs or outpatient drug-dispensing models. Instead, it must be routed through specialized medical and institutional billing pathways. The primary challenge for healthcare providers and payers is determining whether the therapy is administered as an inpatient service, an outpatient service, or a hybrid model that uses a combination of both.
Institutional Inpatient Billing (MS-DRG 018)
When Casgevy is administered in an inpatient hospital setting, the facility bills the payer using a Diagnostic Related Group (DRG) code. Specifically, Medicare and many commercial insurers use MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-Cell or Other Immunotherapy) or a newly designated gene therapy DRG.
The inpatient pathway presents severe financial risks for hospitals:
- Reimbursement Lag and Cash Flow: Under standard DRG payments, the hospital receives a fixed, predetermined fee for the entire inpatient stay, which typically covers room, board, nursing, and standard procedures. A $2.2 million drug acquisition cost immediately dwarfs the standard DRG payment, which may range from $40,000 to $80,000.
- Outlier Payments: To prevent hospital insolvency, Medicare and commercial payers offer "outlier payments" to cover extremely high-cost cases. However, outlier formulas require the hospital to absorb a fixed loss (the "fixed-loss threshold") and only pay a percentage (e.g., 80%) of the costs exceeding that threshold. On a $2.2 million drug, a hospital's uncompensated cost under an outlier formula can easily exceed $200,000.
- New Technology Add-on Payments (NTAP): In the commercial and Medicare spheres, NTAPs have historically been used to provide temporary additional reimbursement (up to 75% of the WAC) for innovative high-cost therapies. However, NTAPs are time-limited (typically two to three years) and do not provide a permanent solution to the underlying structural inadequacy of inpatient DRG rates.
For a broader perspective on institutional cell therapy billing, provider teams should consult established workflows for other high-cost cell therapies, such as CAR-T cell therapy access and billing pathways, which face similar inpatient reimbursement caps and center-certification challenges.
Outpatient Medical Benefit Routing and Carve-Outs
To bypass the financial limitations of the inpatient DRG, many commercial insurers and state Medicaid programs utilize outpatient medical benefit routing or carve-out agreements:
- Payer Carve-Outs: Under a carve-out model, the cost of the gene therapy itself is excluded from the hospital’s global inpatient contract. The hospital purchases the drug, but bills it separately to the commercial payer's specialty drug unit using a J-code (such as J1411 or unclassified biologics code J3490) on a CMS-1500 or UB-04 form. The payer reimburses the hospital at a rate based on WAC or Average Sales Price (ASP), plus a small administration markup (e.g., WAC + 3% or WAC + 4%).
- Single-Case Agreements (SCAs): For commercial patients whose plans do not have a pre-existing gene therapy contract, hospitals must negotiate an SCA on a patient-by-patient basis before initiating stem cell collection. SCAs explicitly outline the payment terms for the drug product, the harvesting procedure, the conditioning chemotherapy (myeloablative busulfan), and the post-transplant inpatient recovery period.
Commercial Payer Policies: Designated Networks and Label-Aligned Medical Necessity
Commercial payers route Casgevy exclusively through the medical benefit, because the product must be administered in a specialized inpatient transplant setting and cannot be dispensed through a retail or specialty pharmacy under a pharmacy benefit card. To control both utilization and financial exposure, each major carrier funnels cases through a designated gene-therapy or transplant network and applies medical-necessity criteria that broadly track the FDA-approved label: a confirmed severe SCD genotype, a documented history of recurrent severe vaso-occlusive crises, and prior failure of, or intolerance to, standard disease-modifying therapy such as hydroxyurea. Authorization is typically granted for a single course (one dose).
The criteria summarized below reflect publicly posted medical-policy themes; specific thresholds and the active network name change over time, so hospital access teams must verify the current version of each payer's policy before submission.
Aetna
Aetna requires precertification and administers Casgevy through its Aetna Institutes Gene-Based, Cellular and Other Innovative Therapy (GCIT) Network. Per Aetna's clinical policy bulletin, the SCD criteria include a confirmed SCD genotype (for example, HbSS, HbS/β⁰-thalassemia, HbS/β⁺-thalassemia, or another severe genotype) verified by molecular or genetic testing, a documented history of at least two severe vaso-occlusive episodes per year during the previous two years, and an inadequate response to, or intolerance of, a trial of hydroxyurea (or clinical rationale for exclusion).
Cigna
Cigna manages Casgevy through its LifeSOURCE Transplant and Cellular Therapy Network. Coverage requires label-aligned medical necessity—severe SCD with recurrent VOCs and documented hydroxyurea failure or intolerance—and a psychosocial/readiness review confirming the patient can tolerate the prolonged inpatient conditioning and engraftment recovery. Hospitals outside the LifeSOURCE network typically must negotiate a Single-Case Agreement.
Blue Cross Blue Shield (BCBS)
BCBS medical policies are administered by the independent state and regional licensees, most of which route cell and gene therapies through Blue Distinction Centers for Cellular Immunotherapy. Medical-necessity criteria follow the FDA label (age 12 and older with recurrent severe VOCs and hydroxyurea failure), and the drug is carved out of standard employer pharmacy benefits and billed through the medical benefit, usually under an SCA when the site is not a Blue Distinction Center.
UnitedHealthcare (UHC)
UnitedHealthcare covers Casgevy under its medical-benefit gene therapy and cellular immunotherapy policy and steers members to designated Optum Centers of Excellence (COE) for transplant and cellular therapy. Authorization covers a single course of treatment and requires label-aligned clinical criteria; a documented prior allogeneic transplant or other contraindications to myeloablative conditioning are evaluated as part of the medical-necessity review.
Competitive Comparison: Casgevy vs. bluebird bio's Lyfgenia
A key aspect of market access for sickle cell disease therapies is the concurrent commercial presence of bluebird bio's Lyfgenia (lovotibeglogene autotemcel), which was approved by the FDA on the same day as Casgevy. While both therapies offer potentially curative outcomes, they differ in pricing, clinical mechanism, and safety profile, which directly shapes how payers manage access.
Pricing and Cost Exposure
While Casgevy is priced at a WAC of $2.2 million, Lyfgenia has a higher WAC of $3.1 million. For state Medicaid programs and commercial payers, this $900,000 price difference per patient translates to significantly higher financial exposure, making outcomes-based rebate structures under the CMS model or individual SCAs even more critical for Lyfgenia to demonstrate cost-effectiveness.
Mechanism of Action
- Casgevy: Uses CRISPR-Cas9 to make a targeted double-stranded cut in the erythroid-specific enhancer region of the BCL11A gene. This suppresses BCL11A expression in erythroid cells, releasing the brake on gamma-globin production and enabling the patient's cells to produce fetal hemoglobin (HbF), which prevents cell sickling.
- Lyfgenia: Uses a self-inactivating lentiviral vector to insert a functional, engineered beta-globin gene (βA-T87Q-globin) into the patient's hematopoietic stem cells. The cells then produce a modified hemoglobin that functions similarly to normal adult hemoglobin, reducing sickling.
Safety Profiles and Boxed Warnings
The safety differences between the two therapies are a primary driver of clinical and regulatory preference:
- Lyfgenia Boxed Warning: Lyfgenia carries a Boxed Warning for hematologic malignancy (blood cancer). During clinical development, two patients treated with an earlier formulation of Lyfgenia developed acute myeloid leukemia (AML), and one developed myelodysplastic syndrome (MDS). Clinicians must monitor Lyfgenia patients for hematologic malignancies via annual complete blood counts and integration checks for at least 15 years.
- Casgevy Safety: Casgevy does not carry a Boxed Warning for malignancies. The primary safety concerns are neutropenia and thrombocytopenia associated with the busulfan conditioning regimen. For payers, the additional monitoring and malignancy risk associated with Lyfgenia require more extensive post-infusion tracking in registry agreements and can lead to more restrictive prior authorization rules compared to Casgevy.
The CMS CGT Access Model: Outcomes-Based Rebates and State Participation
Recognizing that individual state Medicaid budgets could be overwhelmed by the concurrent approval of sickle cell gene therapies like Casgevy and bluebird bio’s Lyfgenia (lovotibeglogene autotemcel), the CMS Innovation Center developed the Cell and Gene Therapy (CGT) Access Model. Officially launched with a target implementation date of January 1, 2026, the model acts as a centralized negotiation clearinghouse.
| Entity / Actor | Role & Operational Workflow under the CGT Model |
|---|---|
| CMS Innovation Center | Conducts direct, centralized negotiations with gene therapy manufacturers (Vertex) to establish outcomes-based rebate templates. |
| State Medicaid Programs | Opt into the CMS-negotiated contract, carving out cell/gene therapy billing from Managed Care to Fee-for-Service (FFS) units. |
| Authorized Treatment Centers | Administer the therapy to enrolled patients and submit medical claims directly to the state Medicaid FFS program. |
| CIBMTR Registry Database | Tracks patient clinical outcomes for up to 15 years, verifying treatment success or failure criteria. |
| Outcomes Verification Loop | Registry data is reported back to CMS and state Medicaid, triggering manufacturer rebate payments if clinical failure criteria are met. |
Centralized Negotiation and Outcomes-Based Agreements (OBAs)
Under the CGT Access Model, CMS conducts direct, centralized negotiations with drug manufacturers to establish multi-state outcomes-based rebate agreements. Instead of each state Medicaid agency negotiating its own contract, CMS establishes a baseline agreement that defines:
- Rebate Triggers: The clinical endpoints that determine if a therapy has failed. For Casgevy, these are primarily tied to the recurrence of severe vaso-occlusive crises requiring hospitalization or emergency department visits.
- Rebate Percentages: The progressive refund amounts the manufacturer must pay back to the state if a patient experiences a treatment failure within a specified timeframe (e.g., year 1, year 2, through year 5 post-infusion).
- Fertility Preservation Coverage: To resolve a historical gap where state Medicaid programs did not cover fertility preservation services (which are clinically necessary due to the sterilizing effects of the myeloablative busulfan conditioning chemotherapy), CMS negotiated mandatory manufacturer-funded or model-subsidized fertility preservation packages as part of the state opt-in agreements.
State Opt-In and Fee-for-Service Carve-Outs
As of 2026, 33 states, the District of Columbia, and Puerto Rico have formally opted into the CMS CGT Access Model. This covers approximately 84% of the nationwide Medicaid beneficiary population diagnosed with sickle cell disease.
A critical operational requirement of the CGT Access Model is the Managed Care Organization (MCO) Carve-Out:
- In states with high managed care enrollment, the state Medicaid agency "carves out" sickle cell gene therapies from the capitated rates paid to MCOs.
- This means that when a patient enrolled in a Medicaid MCO (e.g., a plan administered by Centene, Anthem, or UnitedHealthcare) is approved for Casgevy, the billing and payment for the gene therapy drug product bypasses the MCO entirely and is processed directly through the state's Fee-for-Service (FFS) program.
- Carving out the drug protects MCOs from sudden, catastrophic financial claims that could destabilize their quarterly actuarial reserves, while ensuring that the state Medicaid program directly receives the outcomes-based rebates negotiated by CMS.
Dataset Evidence: Clinical Trial Baseline and CIBMTR Registry Integration
To validate outcomes and secure reimbursement under the CGT model, patients must be registered in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry database. The baseline clinical efficacy and safety metrics that govern these agreements are derived directly from the registrational clinical trials.
The registrations posted on ClinicalTrials.gov for Vertex's exa-cel program document the phase, enrollment, and status of the pivotal trials supporting Casgevy's regulatory package:
| Trial ID (NCT) | Study Name | Phase | Status | Enrollment | Key Focus |
|---|---|---|---|---|---|
| NCT03655678 | CLIMB-111 | Phase 2/3 | Completed | 59 | Efficacy and safety in Transfusion-Dependent Beta-Thalassemia (TDT) patients aged 12–35. |
| NCT03745287 | CLIMB-121 | Phase 2/3 | Completed | 63 | Efficacy and safety in patients with severe Sickle Cell Disease (SCD) aged 12–35 experiencing recurrent VOCs. |
| NCT04208529 | CLIMB-131 | Phase 3 | Enrolling by Invitation | 160 (Target) | Long-term safety and efficacy follow-up (up to 15 years) for patients who received Casgevy in parent trials. |
These trial cohorts establish the historical baseline for outcomes-based tracking. The enrollment figures above reflect the number of participants registered on ClinicalTrials.gov; the U.S. prescribing information reports that 44 patients in the full analysis set received Casgevy in CLIMB-121, of whom 31 were evaluable for the primary efficacy endpoint. In CLIMB-121, the primary efficacy endpoint was the proportion of patients who remained free of severe VOCs for at least 12 consecutive months. Under the CMS CGT model's outcomes-based terms, if a commercialized Medicaid patient experiences a severe VOC requiring hospitalization (resembling the failure criteria in the CLIMB trials), the hospital or state registry submits this event data, triggering the contract's rebate clawback mechanism.
Prior Authorization Hurdles: Clinical Thresholds and ATC Capacity Bottlenecks
Even in states participating in the CMS CGT model, securing prior authorization (PA) for Casgevy is a rigorous, multi-step process that requires extensive documentation of clinical severity, patient compliance, and center certification.
Comparison of State Medicaid Prior Authorization Criteria
Prior authorization policies vary by state, but they generally align with the patient characteristics of the CLIMB-121 and CLIMB-111 trial populations. The table below compares the clinical criteria established by the Ohio Department of Medicaid and the New York State Department of Health (both participating under the CGT model as of 2026):
| Prior Authorization Element | Ohio Medicaid Criteria | New York Medicaid Criteria |
|---|---|---|
| Effective Date | Active (Updated for 2026 CGT Model) | Effective January 1, 2026 |
| Age Requirement | 12 years of age or older | 12 years of age or older |
| Clinical Diagnosis | Confirmed severe Sickle Cell Disease (genotype HbSS, HbS/beta0, or HbS/beta+) | Confirmed severe Sickle Cell Disease (genotypes matching FDA label) |
| Severity Threshold | Minimum of $\ge 2$ severe vaso-occlusive crises (VOCs) per year in the past 24 months, requiring medical intervention (hospitalization, emergency department visit, or outpatient infusion clinic). | Minimum of $\ge 2$ severe VOCs/year in the past 24 months, or a history of stroke or acute chest syndrome. |
| Prior Treatment Failure | Documented failure, intolerance, or contraindication to a minimum 6-month trial of hydroxyurea and L-glutamine (or voxelotor/crizanlizumab). | Documented trial and failure of hydroxyurea (or clinical rationale for exclusion). |
| Facility Restriction | Must be administered at a certified, manufacturer-authorized treatment center (ATC). | Must be administered at a certified ATC that is also enrolled in the state Medicaid program. |
| Registry Enrollment | Agreement to enroll in and comply with the CIBMTR long-term registry (up to 15 years). | Mandatory enrollment in the designated patient-tracking registry. |
Operational Bottlenecks: The Authorized Treatment Center (ATC) Network
Even if a patient meets all clinical criteria and secures prior authorization, the primary bottleneck in the access pipeline is the Authorized Treatment Center (ATC) network. Because Casgevy requires complex cellular processing, it cannot be administered at standard community oncology or hematology clinics.
The operational workflow for Casgevy administration spans several months and places significant strain on hospital capacity:
- ATC Certification: To become an ATC, a transplant center must undergo rigorous training by Vertex, achieve certification under the Foundation for the Accreditation of Cellular Therapy (FACT) standards, and establish specialized protocols for apheresis (stem cell collection), cryopreservation, and transplant coordination.
- Mobilization and Apheresis: The patient undergoes a mobilization regimen to draw stem cells from the bone marrow into the bloodstream. The stem cells are collected via apheresis at the ATC. This process may need to be repeated multiple times to harvest a sufficient number of cells (particularly if the patient has low cell yields).
- Manufacturing Lag: Once harvested, the patient's cells are cryopreserved and shipped to Vertex's specialized manufacturing facilities. The manufacturing process—where CRISPR-Cas9 is used to edit the erythroid-specific enhancer region of the BCL11A gene—takes approximately 3 to 4 months. During this period, the hospital must maintain regular contact with the patient to ensure clinical stability.
- Myeloablative Conditioning: When the edited drug product is ready and shipped back to the ATC, the patient is admitted to the hospital for myeloablative conditioning. This involves a high-dose busulfan chemotherapy regimen designed to destroy the patient's remaining unedited bone marrow stem cells, clearing space for the edited cells.
- Engraftment Recovery: The edited Casgevy cells are infused back into the patient via intravenous infusion. The patient must remain in a protective inpatient transplant unit for 4 to 6 weeks waiting for the edited cells to engraft (settle in the bone marrow and begin producing healthy red blood cells). During this time, the patient is at extreme risk for infection, bleeding, and organ toxicity, requiring intensive supportive care.
Because there are fewer than 100 certified ATCs nationwide, patient geographic displacement is common. For Medicaid patients, traveling across state lines to reach an ATC introduces severe administrative barriers, including securing out-of-state Medicaid authorization and coordinating travel and lodging support.
The Manufacturer Hub: Vertex Connects and Patient Coordination
To bridge the operational and financial gaps, Vertex Pharmaceuticals operates the Vertex Connects patient services hub. The hub acts as a central coordinator between the patient, the prior authorization team at the ATC, and the payer.
Role in Prior Authorization Support
Vertex Connects assigns a dedicated case manager to each patient upon enrollment. The hub case manager:
- Initiates benefits verification to determine the patient's primary coverage (commercial, Medicaid, or Medicare) and routes the clinical documentation to the correct review unit.
- Assists the hospital billing department in drafting the Single-Case Agreement (SCA) for commercial plans, providing template language and actuarial data regarding conditioning costs.
- Tracks prior authorization submissions and alerts the ATC when additional clinical details (such as hydroxyurea compliance records) are requested by the payer.
Travel, Lodging, and Ancillary Support
For patients who must travel long distances to access a certified ATC, Vertex Connects provides commercial assistance programs (subject to compliance guidelines, including OIG safe harbor limits for Medicaid beneficiaries):
- Transportation: Covers flight, train, or gas costs for the patient and up to two caregivers to travel to the ATC for apheresis, conditioning, and follow-up visits.
- Lodging: Coordinates and funds hotel stays or short-term apartment rentals near the ATC during the 4-to-6-week inpatient recovery phase when caregivers must remain close to the hospital.
- Ancillary Costs: Provides modest meal and parking stipends to reduce out-of-pocket expenses during cellular collection and treatment visits.
Efficacy and Safety Data: A Deeper Look at CLIMB Trials
Understanding the clinical trial data is essential for administrative and clinical review teams when justifying the clinical necessity of Casgevy over conventional therapies.
Efficacy Findings in Sickle Cell Disease (CLIMB-121)
In the registrational CLIMB-121 trial:
- The primary efficacy outcome was freedom from severe VOCs for at least 12 consecutive months. Per the U.S. prescribing information, 93.5% (29 of 31 evaluable patients) met this primary endpoint.
- The key secondary endpoint was freedom from inpatient hospitalization for severe VOCs for at least 12 consecutive months; 100% of evaluable patients (30 of 30) met this endpoint.
- Efficacy was sustained, with long-term follow-up data in CLIMB-131 showing that patients maintained high levels of fetal hemoglobin (HbF) and total hemoglobin levels (≥ 11 g/dL from month 6 onward) for multiple years after a single infusion, indicating a durable correction of the underlying pathophysiology.
Safety Concerns and Inpatient Resource Utilization
The safety profile of Casgevy is heavily colored by the toxicities associated with myeloablative busulfan conditioning:
- Neutropenia and Thrombocytopenia: Virtually all patients in CLIMB-121 and CLIMB-111 experienced severe, prolonged neutropenia (low white blood cell counts) and thrombocytopenia (low platelet counts) immediately following conditioning chemotherapy. The median time to neutrophil engraftment was 29 days (range 12–56 days), and the prescribing information carries a delayed platelet engraftment warning.
- Infection Risk: During the pre-engraftment period, patients are highly susceptible to opportunistic bacterial, fungal, and viral infections. This requires prophylactic antibiotics, reverse isolation rooms, and daily laboratory monitoring, contributing significantly to the high cost of the inpatient stay.
- Veno-Occlusive Disease (VOD) Risk: Busulfan conditioning carries a risk of hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome), a potentially life-threatening liver complication. Clinical teams must monitor liver enzymes, weight, and abdominal distension daily during the conditioning and early post-infusion phases.
Frequently Asked Questions (FAQs)
Is Casgevy covered under the pharmacy benefit or the medical benefit?
Casgevy is billed exclusively under the medical benefit (using J-codes and institutional billing forms) because it is a specialized cell therapy that requires inpatient or outpatient hospital administration. It cannot be dispensed through standard retail or mail-order specialty pharmacies under a pharmacy benefit card.
Which states are currently participating in the CMS Cell and Gene Therapy Access Model?
As of 2026, 33 states, the District of Columbia, and Puerto Rico are participating. In these states, the reimbursement of sickle cell gene therapies is typically carved out of Medicaid managed care and billed directly through the state's Fee-for-Service program under the outcomes-based rebate structure negotiated by CMS.
What happens if a patient experiences a vaso-occlusive crisis after receiving Casgevy?
Under the CMS CGT model's outcomes-based contracts, the occurrence of a severe VOC (requiring hospitalization or emergency intervention) within the contract's monitoring period is defined as a treatment failure. The state Medicaid agency reports this event to CMS, which triggers a pre-negotiated rebate or refund from the manufacturer to offset the initial $2.2 million cost.
Does Medicaid cover fertility preservation for patients receiving Casgevy?
Yes, under the CMS CGT Access Model, participating states are required to provide coverage for fertility preservation services (including egg or sperm retrieval and cryopreservation). This is a critical addition, as the myeloablative busulfan conditioning chemotherapy administered prior to Casgevy infusion carries a high risk of permanent infertility.
What is the role of the CIBMTR registry in Casgevy coverage?
Payer and government policies require hospitals to register all Casgevy recipients in the CIBMTR database. This registry tracks long-term outcomes, survival rates, and late-stage adverse events for up to 15 years. Under the CMS CGT Access Model, registry compliance is mandatory for hospitals to receive payment and for manufacturers to fulfill outcomes-based reporting obligations.
Sources
- Centers for Medicare & Medicaid Services (CMS). "Cell and Gene Therapy (CGT) Access Model." CMS Innovation Center. Available at https://www.cms.gov/priorities/innovation/innovation-models/cgt.
- National Institutes of Health (NIH). "Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease (CLIMB-121)." ClinicalTrials.gov Identifier: NCT03745287. Available at https://www.clinicaltrials.gov/study/NCT03745287.
- National Institutes of Health (NIH). "Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent Beta-Thalassemia (CLIMB-111)." ClinicalTrials.gov Identifier: NCT03655678. Available at https://www.clinicaltrials.gov/study/NCT03655678.
- National Institutes of Health (NIH). "Long-Term Follow-up Study in Subjects Who Have Received Vertex CRISPR-Cas9 Modified Products (CLIMB-131)." ClinicalTrials.gov Identifier: NCT04208529. Available at https://www.clinicaltrials.gov/study/NCT04208529.
- Ohio Department of Medicaid. "Medicaid Prior Authorization Criteria for Gene Therapies: exagamglogene autotemcel (Casgevy)." Provider Announcements and Pharmacy Manual. Available at https://www.medicaid.ohio.gov.
- New York State Department of Health. "Medicaid Update: Cell and Gene Therapy Access Model Implementation and Coverage Guidelines." Available at https://www.health.ny.gov.
- Vertex Pharmaceuticals Inc. "Casgevy (exagamglogene autotemcel) U.S. Prescribing Information and Launch Pricing Disclosures." Available at https://www.casgevy.com.
- Aetna Inc. "Clinical Policy Bulletin: exagamglogene autotemcel (Casgevy)." Medical Precertification Program. Available at https://www.aetna.com.
- Cigna Health and Life Insurance Company. "Medical Coverage Policy: exagamglogene autotemcel (Casgevy)." LifeSOURCE Specialty Network Guidelines. Available at https://www.cigna.com.
- UnitedHealthcare Services Inc. "Medical Policy: Gene Therapy and Cellular Immunotherapy." Clinical Guideline Directory. Available at https://www.uhcprovider.com.
