CurrentMass General Brigham Health PlanPolicy N/A

Adakveo (crizanlizumab-tmca) and Reblozyl (luspatercept-aamt) — Coverage Criteria (MassHealth UPPL)

Defines prior authorization criteria and medical-benefit coverage rules for Adakveo and Reblozyl for members under the MassHealth UPPL plan; applies to medical benefit requests and providers seeking authorization.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdakveo and Reblozyl coverage criteria — MassHealth UPPL medical benefit

Policy CodePolicy N/A

Change TypeClinical and administrative revisions (material change to Reblozyl criteria)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation to support medical-benefit coverage.

SourceLink

POLICY UPDATE CHANGES

Removed requirement for trial with 1 erythropoiesis stimulating agent and documentation of RBC transfusions in past 8 weeks for Reblozyl.

Policy updated to reflect agents with prior authorization on the medical benefit; Endari, Oxbryta, and Siklos removed as pharmacy benefit only.

Policy now distinguishes MassHealth UPPL medical benefit versus pharmacy benefit agents; additional agents available through pharmacy benefit per MassHealth Drug List.

≥16min age Adakveo

≥18min age Reblozyl

≥2 VOCs/12 moAdakveo initiation

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Coverage Criteria

Continuation of Therapy

Reauthorization requires documentation of positive response

Adakveo continuation: Physician documentation of positive response to therapy (e.g., decrease in VOCs, reduction in need for pain management, decrease in hospitalizations)

Reauthorization duration per Limitations

Reblozyl continuation: Physician documentation of positive response to therapy (decrease in transfusion requirements)

Reauthorization duration per Limitations

This medical-benefit policy has been updated to reflect benefit assignment for agents in this therapeutic class. Endari, Oxbryta, and Siklos have been removed from the medical benefit and are available only through the pharmacy benefit. Additional agents in this therapeutic class may be available via the pharmacy benefit; refer to the MassHealth Drug List for coverage and criteria.

Authorization decisions may be affected when the requested medication was obtained as samples or through a manufacturer's patient assistance program. Requests may be reviewed on a case-by-case basis for members new to the plan who are currently receiving treatment, and authorizations may be denied if the medication was acquired as samples or via manufacturer assistance and appropriate documentation is not provided.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required on the medical benefit for Adakveo and Reblozyl per MassHealth UPPL; submit documentation meeting indication.

Applies to medical benefit only
Contact Medical Benefit: Phone: 833-895-2611 • Fax: 888-656-6671

Step Therapy

Hydroxyurea Trial Requirement for Adakveo

For Adakveo, require inadequate response to hydroxyurea at maximally tolerated dose for at least three months OR documentation of adverse reaction/contraindication to hydroxyurea.

Hydroxyurea maximally tolerated dose: up to 35 mg/kg/day or until mild myelosuppression (e.g., ANC 2,000–4,000/µL, platelet count <80,000/µL, reticulocyte count <80 x10^9/L)
Trial duration: ≥ 3 months

Definitions

Vaso-occlusive crisis (VOC) — definition and actionable items

DefinitionA vaso-occlusive crisis (VOC) is an acute painful episode experienced by patients with sickle cell disease characterized by vaso-occlusion leading to pain and potential need for medical intervention.

Clinical relevanceAdakveo (crizanlizumab-tmca) is indicated to reduce the frequency of VOCs in patients aged ≥16 years with sickle cell disease.

Provider documentationPrescriber must be a hematologist or provide hematology consult notes when requesting Adakveo for VOC prevention.

Treatment threshold for Adakveo initiationMember must have experienced ≥2 sickle cell crises in the previous 12 months to meet initiation criteria for Adakveo.

Authorization notePrior authorization on the medical benefit is required and documentation of VOC history and response to prior therapies (e.g., hydroxyurea) may be requested.

Background

Adakveo (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in patients with sickle cell disease aged ≥16 years. Reblozyl (luspatercept-aamt) is indicated for treatment of anemia in adult patients with transfusion-dependent β-thalassemia who require regular red blood cell transfusions, and for certain adult patients with myelodysplastic syndromes (MDS) associated anemia, including MDS with ring sideroblasts. Reauthorization criteria require documentation of clinical benefit: for Adakveo, evidence of decreased VOCs or reduced hospitalizations/pain management; for Reblozyl, evidence of decreased transfusion requirements.

Revision History

2025-06-01policy_revisionLatest

Removed requirement for trial with one erythropoiesis-stimulating agent and documentation of RBC transfusions in past 8 weeks from Reblozyl initial approval criteria; administrative update to reflect agents with prior authorization on the medical benefit and removal of Endari, Oxbryta, and Siklos from the medical benefit (moved to pharmacy benefit).

2023-09-13policy_update

Updated Oxbryta tablet formulation age guidance and added brand preferred/mandatory generic language under Limitations (effective 10/02/23).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdakveo and Reblozyl coverage criteria — MassHealth UPPL medical benefit

Policy CodePolicy N/A

Change TypeClinical and administrative revisions (material change to Reblozyl criteria)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation to support medical-benefit coverage.

SourceLink

On This Page

Documentation Required

Required Documentation

Provide documentation including diagnosis confirmation (e.g., genetic testing or medical records for transfusion dependence), prescriber information, prior treatment history (including hydroxyurea use when applicable), and member's current weight.

For Reblozyl beta-thalassemia: documentation of transfusion-dependent β-thalassemia (genetic test or records of regular transfusions/chronic iron chelation)
Prescriber: hematologist or hematology consult notes required

Denial Risk

Medical Review for Ongoing Therapy

Medical review for ongoing therapy: authorizations for members new to the plan may be reviewed case-by-case and may be denied or rescinded if documentation of current treatment with the requested medication is not provided (excludes products obtained as samples or via manufacturer patient assistance programs).

Ensure submission of recent medical records showing current treatment to avoid denial or rescission

Transfusion-dependent β-thalassemia — definition and required evidence

DefinitionTransfusion-dependent β-thalassemia is evidenced by documentation showing requirement for regular red blood cell transfusions and/or chronic iron chelator use.

Age criterionMember must be ≥18 years of age for Reblozyl treatment for beta-thalassemia.

Required documentationAcceptable documentation includes genetic testing or medical records noting regular transfusion requirement and/or chronic iron chelation therapy.

Prescriber requirementPrescriber must be a hematologist or provide hematology consult notes supporting use of Reblozyl.

Other data requiredMember's current weight must be provided with the authorization request.

Matched MassHealth UPPL criteria; added criteria for Endari, Oxbryta, Reblozyl, and Siklos and updated Adakveo criteria (effective 04/01/23).

2022-11-16policy_review

Reviewed for November P&T and separated MassHealth versus Commercial/Exchange benefit language (no clinical changes).

2020-03-18policy_creation

Policy created and reviewed at P&T meeting (effective 06/01/20).