CurrentMass General Brigham Health PlanPolicy N/A

Reblozyl (luspatercept) coverage criteria

Policy governing prior authorization and coverage criteria for Reblozyl (luspatercept) for members of Mass General Brigham Health Plan under pharmacy/specialty benefits, addressing transfusion-dependent beta thalassemia and certain myelodysplastic syndromes in adults.

Policy Summary

PayerMass General Brigham Health Plan

PolicyReblozyl (luspatercept) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial — added MDS criteriarevised beta thalassemia transfusion requirement

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of diagnosis and transfusion history demonstrating required RBC units.

SourceLink

POLICY UPDATE CHANGES

Added criteria for myelodysplastic syndrome.

Updated initial criteria for beta thalassemia to include baseline transfusion requirements.

6 monthsinitial approval duration

12 monthsreauthorization duration

>=6/24wbeta thalassemia transfusion

>=2/8wMDS transfusion

18+minimum age

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Coverage Criteria for Reblozyl (luspatercept)

Beta Thalassemia

Covered when ALL of the following are met

Beta Thalassemia Approval Criteria: 1) Documented diagnosis of transfusion-dependent beta thalassemia (e.g., medical records, genetic testing); 2) Member is 18 years of age or older; 3) Member requires at least 6 red blood cell units every 24 weeks with no transfusion-free period greater than 35 days; 4) Requested medication is prescribed by or in consultation with a hematologistsee node text

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment and stable

Myelodysplastic Syndromes (MDS)

Covered when ALL of the following are met

MDS Approval Criteria: 1) Member is 18 years of age or older; 2) Documented diagnosis of one of the following: very low- to intermediate-risk MDS, very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS), or MDS/MPN-RS-T; 3) Requested medication is prescribed by or in consultation with a hematologist or oncologist; 4) Member requires at least 2 red blood cell units over an 8 week time period; 5) For MDS-RS or MDS/MPN-RS-T: inadequate response, adverse reaction, or contraindication to an erythropoiesis stimulating agent has been documentedsee node text

Continuation of Therapy / Reauthorization

Reauthorization covered when the following are met

Continuation of Therapy: Documentation that the member has had a positive response to therapy (e.g., decrease in transfusion requirements)positive response documented

Initial approvals: 6 months; Reauthorization: may be granted for 12 months

Authorization requires prior approval. Members new to the plan within 90 days who are already receiving and are clinically stable on the requested medication may be authorized without meeting all initial criteria, provided the product was not obtained as samples or through a manufacturer's patient assistance program. Requests that do not meet the listed authorization criteria or for new members who are not currently treated and stable beyond 90 days may be denied.

Key Clinical Thresholds and Coding-related Values

Beta thalassemia transfusion threshold

Numeric threshold>= 6 red blood cell (RBC) units per 24 weeks

Transfusion-free period limitNo transfusion-free period greater than 35 days

Minimum ageMember is >= 18 years of age

MDS transfusion threshold

Numeric threshold>= 2 red blood cell (RBC) units over 8 weeks

Indication contextApplies to adults with very low- to intermediate-risk MDS, including MDS-RS and MDS/MPN-RS-T

Prior ESA requirement for certain subtypes

Provider Requirements and Operational Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested therapies. New members who have been receiving the requested medication and are stable may be granted authorization if they joined the plan within the past 90 days; this does not apply when the product was obtained only as samples or through manufacturer patient assistance programs.

Prior authorization required for non-emergent use
New-member carveout: authorization may be granted for members new to the plan within 90 days who are currently stable on therapy (exclude sample/PAP-only supply)

Step Therapy

Step Therapy for MDS Indications

For MDS indications, a step therapy requirement applies: members must have had a trial and inadequate response, adverse reaction, or contraindication to an erythropoiesis-stimulating agent (ESA) prior to approval of the requested medication, except where an ESA trial is not appropriate or is medically contraindicated.

Step therapy: documented trial of an erythropoiesis-stimulating agent (ESA) required for MDS-RS or MDS/MPN-RS-T

Background on Reblozyl and Indications

Reblozyl (luspatercept) is an erythroid maturation agent indicated for treatment of anemia in adults with transfusion-dependent beta thalassemia and for certain adults with very low- to intermediate-risk myelodysplastic syndromes (including MDS-RS and MDS/MPN-RS-T) who require regular red blood cell transfusions or have failed erythropoiesis-stimulating agent therapy. It works by promoting maturation of red blood cell precursors to reduce transfusion requirements.

Definitions and Key Terms

Erythroid maturation agent

DefinitionAn agent that promotes maturation of red blood cell precursors to reduce transfusion requirements

Example productReblozyl (luspatercept) is an erythroid maturation agent indicated for anemia in adults with transfusion-dependent beta thalassemia and certain MDS

Clinical purposeUsed to decrease RBC transfusion dependence in eligible adult patients

Transfusion-dependent beta thalassemia

Operational definitionDocumented diagnosis of transfusion-dependent beta thalassemia requiring at least 6 RBC units every 24 weeks

Additional requirementNo transfusion-free period greater than 35 days during that 24-week interval

Policy Summary

PayerMass General Brigham Health Plan

PolicyReblozyl (luspatercept) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial — added MDS criteriarevised beta thalassemia transfusion requirement

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of diagnosis and transfusion history demonstrating required RBC units.

SourceLink

On This Page

For MDS-RS or MDS/MPN-RS-T: documentation of inadequate response, adverse reaction, or contraindication to an erythropoiesis stimulating agent is required

Acceptable exceptions: documented contraindication to ESA, prior adverse reaction preventing continued use, or clinical intolerance; provide supporting clinical rationale and records

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with authorization requests. Documentation should include diagnostic evidence, consult notes, and transfusion history to support medical necessity.

Documented diagnosis (e.g., medical records, pathology, genetic testing) specifying the hematologic condition
Age of member (must be 18 years or older for covered indications)
Specialist involvement: prescription by or consultation with a hematologist or oncologist
Transfusion history: number of red blood cell units and relevant timeframe (e.g., ≥6 units/24 weeks for transfusion-dependent beta thalassemia; ≥2 units over 8 weeks for MDS)
For MDS-RS or MDS/MPN-RS-T: documentation of inadequate response, adverse reaction, or contraindication to an ESA

Denial Risk

Failure to Meet Authorization Criteria

Requests that do not meet the authorization criteria will be denied. For new members not stable on therapy or lacking required documentation, consider deferral pending completion of step-therapy requirements or submission of missing records; provide clear clinical rationale for any exceptions.

Denial risk when required criteria or documentation are missing
Alternate action: request additional records, document ESA trial or exception, or indicate member stability if within 90-day new-member window
For MDS requests without documented ESA trial or acceptable exception, denial is likely unless clinical justification is provided

Prescriber requirementRequested medication prescribed by or in consultation with a hematologist