Adakveo (crizanlizumab-tmca) coverage
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Medical necessity and prior authorization criteria for Adakveo (crizanlizumab-tmca) for members of Geisinger Health Plan across applicable lines of business (Commercial, Medicare, CHIP).
LOB table, taglines, removed Medicaid business segment.
Coverage Criteria for Adakveo (crizanlizumab-tmca)
Initial therapy criteria (by line of business)
Covered when ALL of the following are met
Authorization duration 12 months; reauthorization requires medical record documentation of continued or sustained improvement in acute complications (number of VOCs, hospitalizations, ACS occurrences).
Authorization duration 12 months; reauthorization requires medical record documentation of continued or sustained improvement in acute complications (number of VOCs, hospitalizations, ACS occurrences).
Eligibility and coverage are subject to the member's specific contract and line of business. Eligibility and contract-specific benefit limitations and/or exclusions will apply, and any coverage statements in the applicable line-of-business benefit document will supersede this policy.
This policy applies to Geisinger Health Plan members in the listed lines of business (Commercial, Medicare, CHIP) and establishes medical necessity criteria and prior authorization requirements for Adakveo (crizanlizumab-tmca) consistent with those contract terms.
Key Clinical & Coding Parameters
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required; 12-month authorization with annual re-review
Prior authorization is required for Adakveo; requests are reviewed by the Medical Director or designee. Authorizations are issued for a 12-month treatment period with re-review every 12 months.
Step therapy: ≥3-month trial of generic hydroxyurea (and Endari for commercial/CHIP)
A minimum 3-month trial of generic hydroxyurea is required prior to approval. Documentation must show intolerance to, contraindication to, or therapeutic failure on that ≥3-month hydroxyurea trial; for commercial and CHIP members, therapeutic failure/intolerance/contraindication to Endari is also required.
- Document minimum 3-month trial duration of generic hydroxyurea
- Document intolerance, contraindication, or therapeutic failure on hydroxyurea
- For commercial and CHIP: document therapeutic failure/intolerance/contraindication to Endari
Required medical record documentation (prescriber, age, diagnosis, VOC history)
Medical records must document that the prescription was written by or in consultation with a hematologist, the member is ≥16 years old, a diagnosis of sickle cell disease, and the number of vaso‑occlusive crises in the prior 12 months. For reauthorization, document continued or sustained improvement in acute complications (VOCs, hospitalizations, ACS occurrences).
- Prescriber specialty: written by or in consultation with a hematologist
- Member age: ≥16 years
- Diagnosis: sickle cell disease
- Clinical history: number of vaso‑occlusive crises in prior 12 months
- For reauthorization: documentation of continued/sustained improvement in VOCs, hospitalizations, and ACS
Denial risk: missing prior authorization or insufficient documentation
Failure to obtain prior authorization from the Medical Director or designee, or failure to provide the required documentation (age ≥16, sickle cell diagnosis, number of VOCs in prior 12 months, ≥3‑month hydroxyurea trial with intolerance/contraindication/therapeutic failure, and for commercial/CHIP also Endari failure/intolerance/contraindication) may result in denial.
- Prior authorization must be obtained from the Medical Director or designee before treatment
- Provide complete documentation of all required elements to avoid denial
Definitions and Policy Terms
Background
Adakveo (crizanlizumab-tmca) is a humanized monoclonal antibody that binds to P-selectin, blocking cell adhesion interactions that contribute to vascular occlusion in sickle cell disease. The agent is used to reduce the frequency of sickle cell–related vaso-occlusive crises in patients meeting the clinical criteria described in this policy.
Use of Adakveo under this policy is focused on patients with sickle cell disease aged >= 16 years who meet the documented clinical requirements (including prior therapies, number of vaso-occlusive crises, and prescriber specialty) and who have received prior authorization as specified.
Policy Revision History
LOB table and taglines updated; Medicaid business segment removed from policy.
LOB carve out applied; Medicaid business segment noted in prior revision history.
References added to the policy.
Policy devised (initial creation).
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