Neighborhood Health Plan RI Reblozyl Coverage Update

Coverage Criteria for Reblozyl (luspatercept-aamt)

Beta Thalassemia Anemia

Covered when ALL of the following are met for Beta Thalassemia Anemia

Beta Thalassemia Initial/Continuation: a) Member has beta thalassemia anemia requiring regular red blood cell (RBC) transfusions defined as 6-20 RBC units within the last 6 months, including the last 30 days; b) Initiate if hemoglobin (Hgb) is less than or equal to 11 g/dL; c) Continue if Hgb is less than or equal to 11 g/dL OR the total number of RBC transfused is not reduced after at least 2 consecutive doses; d) Treatment discontinuation: discontinue Reblozyl if the member has an inadequate response to a therapeutic trial (insufficient Hgb increase) and/or remains transfusion dependent (requiring a transfusion every 8 weeks after 24 weeks of therapy and/or requiring an RBC transfusion every 12 weeks after 48 weeks).see text

All elements required

MDS Initial-line Therapy (Low-Risk MDS)

Covered when ALL of the following are met for Initial-line use in Low-Risk MDS

MDS Initial Therapy: a) IPSS-R risk: Very Low, Low, or Intermediate with <5% blasts in the bone marrow, with or without ring sideroblasts; b) RBC transfusion dependent defined as need for 2-6 pRBC units per 8 weeks prior to starting therapy; c) Baseline serum erythropoietin (EPO) < 500 U/L; d) No prior therapy with an erythropoiesis-stimulating agent (ESA); e) Member does not have del(5q) as the only cytogenetic alteration; f) Treatment discontinuation: discontinue Reblozyl if inadequate response (insufficient Hgb increase) and/or persistent transfusion dependence as defined).see text

All elements required

MDS Subsequent-line Therapy (Low-Risk MDS)

Covered when ALL of the following are met for Subsequent-line use in Low-Risk MDS

MDS Subsequent Therapy: a) Member has lower-risk MDS with symptomatic anemia: either MDS with ring sideroblasts >= 15% OR ring sideroblasts >= 5% plus SF3B1 mutation; b) Serum erythropoietin (EPO) > 500 U/L OR c) Serum EPO < 500 U/L AND failure of a trial of an ESA (generally 3-6 months at epoetin alfa >= 40,000 IU/week or darbepoetin alfa >= 500 mcg every 3 weeks) AND the member required >= 2 RBC units over 8 weeks; d) Member does not have del(5q) as the only cytogenetic alteration; e) Treatment discontinuation: discontinue Reblozyl if inadequate response (insufficient Hgb increase) and/or persistent transfusion dependence as defined).see text

All elements required

Concurrent use of Reblozyl (luspatercept-aamt) with an erythropoiesis-stimulating agent (ESA), any cytotoxic agents, or immunosuppressants is excluded from coverage. This exclusion applies regardless of indication and is intended to avoid overlapping therapies with potentially conflicting mechanisms or safety concerns.

Requests for Reblozyl (luspatercept-aamt) for investigational uses or off‑label indications that are not supported by the FDA label, CMS‑recognized compendia, or acceptable peer‑reviewed literature will be denied. The policy defines sufficient supporting evidence as literature that adequately represents the patient and disease characteristics, the treatment regimen evaluated, and clinically meaningful patient outcomes; randomized or well‑designed nonrandomized trials with substantial subject numbers may support use, whereas single case reports or meeting abstracts without full peer‑reviewed publication generally do not.

Dosing requests that exceed the policy's single‑dose limits are excluded. The policy specifies a maximum single dose of 1.25 mg/kg for Beta Thalassemia Anemia and 1.75 mg/kg for MDS; requests above these thresholds are not eligible for coverage.

Use of Reblozyl (luspatercept-aamt) will be considered not medically necessary when the evidence does not meet the policy's investigational criteria. Examples include off‑label indications lacking adequate peer‑reviewed evidence, reliance on uncontrolled case reports, or abstracts without full publication; such insufficient evidence fails to demonstrate clinically meaningful benefit as required by the policy.

Coding and Measurement Thresholds

Covered HCPCS CodesHCPCSCovered

J0896

Injection, luspatercept-aamt; 0.25 mg

inv-09: RBC transfusion requirement (beta thalassemia)

RBC transfusion requirementMember requires regular RBC transfusions defined as 6-20 RBC units within the last 6 months, including the last 30 days

ApplicabilityThis threshold applies to eligibility for Reblozyl (luspatercept-aamt) for beta thalassemia anemia (initial or continuation).

Documentation neededMedical record evidence of total RBC units transfused over the prior 6 months, including dates to confirm at least one transfusion within the last 30 days.

inv-10: Hemoglobin and response thresholds

Hemoglobin to initiate or continueInitiate or continue Reblozyl if hemoglobin (Hgb) is less than or equal to 11 g/dL.

Continuation rule (beta thalassemia)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required via Utilization Management for all medication requests for Reblozyl (luspatercept‑aamt). Continuation requests may be exempt when the medication was used within the last year and the member has not experienced disease progression or intolerance to the requested medication.

Continuation exemption: medication used within last 12 months AND no disease progression or intolerance
All other requests: prior authorization via UM required

Step Therapy

Step Therapy for MDS

For treatment of lower‑risk myelodysplastic syndromes (MDS), step‑therapy requirements apply: Reblozyl may be used as a subsequent line of therapy only when the member meets the clinical criteria and, when serum erythropoietin (EPO) is < 500 mU/mL, the member has failed an adequate trial of an erythropoiesis‑stimulating agent (ESA). An adequate ESA trial is generally 3–6 months with epoetin alfa ≥ 40,000 IU/week or darbepoetin alfa ≥ 500 mcg every 3 weeks AND the member required ≥ 2 RBC units over 8 weeks.

Applies to Lower‑risk MDS with symptomatic anemia (RS ≥15% OR RS ≥5% + SF3B1 mutation)

Key Definitions

inv-16: Transfusion-dependent (beta thalassemia)

DefinitionTransfusion-dependent (beta thalassemia) is defined as requiring regular RBC transfusions of 6-20 RBC units within the last 6 months, including the last 30 days.

Use caseApplies to initial and continuation coverage criteria for Reblozyl in beta thalassemia anemia.

VerificationRequire documentation of transfusion history (number of RBC units and dates) covering the prior 6 months, confirming at least one transfusion within last 30 days.

inv-17: Low-risk MDS

IPSS-R risk categoriesLow-risk MDS defined as IPSS‑R categories: Very Low, Low, or Intermediate with <5% blasts in bone marrow.

Ring sideroblastsMay be with or without ring sideroblasts; specific ring sideroblast thresholds apply in subsequent-line criteria but not for this definition.

Initial Therapy Criteria

Initial Therapy (MDS)

Initial-line MDS use criteria

Initial Therapy (MDS): See MDS Initial-line Therapy criteria: IPSS-R risk Very Low, Low, or Intermediate with <5% blasts; transfusion dependence of 2-6 pRBC units per 8 weeks prior to therapy; baseline serum EPO < 500 U/L; no prior ESA therapy; no del(5q) as the sole cytogenetic abnormality.see text

All elements required

Initial Therapy (Beta Thalassemia)

Initial/continuation use for beta thalassemia

Initial Therapy (Beta Thalassemia): See Beta Thalassemia criteria: transfusion requirement of 6-20 RBC units in the last 6 months (including the last 30 days); initiate if Hgb <= 11 g/dL; continuation rules and treatment discontinuation criteria apply as specified.see text

Continuation Criteria

Continuation Therapy

Continuation requests may be exempt if prior use within the last year and no progression or intolerance; criteria for continued use include hemoglobin and transfusion response measures.

Continuation: a) Requested medication was used within the last year AND member has not experienced disease progression and/or intolerance to the medication; b) For beta thalassemia: continue if Hgb <= 11 g/dL OR the total number of RBC transfused is not reduced after at least 2 consecutive doses; c) Treatment discontinuation: discontinue if inadequate response (insufficient Hgb increase) and/or persistent transfusion dependence as defined (transfusion every 8 weeks after 24 weeks of therapy and/or every 12 weeks after 48 weeks).see text

All elements required

Step Therapy Requirements

Step	Requirement	Duration / Threshold
1	Failure of a trial of an erythropoiesis‑stimulating agent (ESA) prior to subsequent‑line MDS use when baseline serum erythropoietin (EPO) < 500 U/L	Generally 3–6 months at epoetin alfa ≥ 40,000 IU/week or darbepoetin alfa ≥ 500 mcg every 3 weeks; member must have required ≥2 RBC units over 8 weeks

Site of Care

Note

No site‑of‑care restrictions specified

The policy does not specify any site‑of‑care restrictions for administration of Reblozyl.

Site‑of‑care entry in the policy: “No site‑of‑care restrictions specified in policy text.”

Background

Reblozyl (luspatercept‑aamt) is an erythroid maturation agent used to reduce transfusion burden in patients with transfusion‑dependent beta thalassemia anemia and to treat symptomatic anemia in certain lower‑risk myelodysplastic syndromes (MDS). Eligibility and treatment intent differ by indication: for beta thalassemia the goal is to decrease required red blood cell transfusions, and for low‑risk MDS the aim is to improve hemoglobin and reduce transfusion dependence according to the defined clinical criteria.

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Reblozyl (luspatercept-aamt) — Coverage Criteria for Beta Thalassemia and Lower‑Risk MDS

Coverage Criteria for Reblozyl (luspatercept-aamt)

Coding and Measurement Thresholds

Provider Actions and Documentation Requirements

Key Definitions

Initial Therapy Criteria

Continuation Criteria

Step Therapy Requirements

Site of Care

Background