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Colorado Rocky Mountain Health Plans Reblozyl Coverage Update | OpenPayer

ModifiedColorado Rocky Mountain Health PlansPolicy 2025D0084K

Reblozyl (luspatercept-aamt) — coverage criteria for specified anemia indications

Medical benefit coverage and prior authorization criteria for Reblozyl for adult indications including transfusion-dependent beta thalassemia, symptomatic lower‑risk MDS, MDS/MPN overlap with ring sideroblasts and thrombocytosis, and myelofibrosis-associated anemia under commercial plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyReblozyl (luspatercept-aamt) — coverage criteria for specified anemia indications

Policy CodePolicy 2025D0084K

Change TypeCriteria revision and compendium recognition

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, specialist involvement, FDA‑consistent dosing, and for continuation evidence of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

UnitedHealthcare recognizes indications and uses of injectable oncology medications listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and medically necessary, and Categories of Evidence and Consensus of 3 as unproven and not medically necessary.

Removed language indicating Reblozyl is proven and/or medically necessary for symptomatic anemia in ESA‑naïve MDS patients.

Added and clarified coverage criteria for multiple indications including beta thalassemia, symptomatic lower-risk MDS (with ring sideroblasts and EPO thresholds), MDS/MPN with SF3B1 mutation and thrombocytosis, and myelofibrosis-associated anemia; specified initial and continuation authorization requirements including prescriber specialty, dosing per FDA labeling, documentation of positive clinical response, and authorization durations.

≥6minimum transfusion requirement (24 wk)

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Coverage Criteria for Reblozyl (luspatercept-aamt)

inv-01: Beta thalassemia — Initial Therapy

Covered when ALL of the following are met

Beta thalassemia initial therapy: Diagnosis of anemia due to beta thalassemia (including beta+ thalassemia, beta0 thalassemia, and hemoglobin E/beta thalassemia); patient is ≥18 years of age; transfusion-dependent as evidenced by both of the following in the prior 24 weeks: (1) required regular transfusion of at least 6 units of packed red blood cells (PRBC), AND (2) no transfusion-free period greater than 35 days; prescribed by or in consultation with a hematologist or other specialist experienced in beta thalassemia; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.≥6 units PRBC per 24 weeks; no transfusion‑free period >35 days

inv-02: Beta thalassemia — Continuation Therapy

Covered when ALL of the following are met

Beta thalassemia continuation: Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist or other specialist experienced in beta thalassemia; dosing in accordance with FDA‑approved labeling; reauthorization for no more than 12 months.

inv-03: MDS — Initial Therapy

Covered when ALL of the following are met

MDS initial therapy: Diagnosis of symptomatic anemia due to myelodysplastic syndrome (MDS); lower‑risk disease per IPSS‑R (Very Low, Low, or Intermediate); absence of confirmed del(5q); and one of the following: (A) Both of the following: ring sideroblasts <15% (or <5% with an SF3B1 mutation) AND serum erythropoietin ≤ 500 mU/mL, OR (B) ring sideroblasts ≥15% (or ≥5% with an SF3B1 mutation); prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in MDS; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.Ring sideroblast % thresholds and EPO ≤500 mU/mL

Matches NCCN-defined populations and trial eligibility.

inv-04: MDS — Continuation Therapy

Covered when ALL of the following are met

MDS continuation: Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in MDS; dosing in accordance with FDA‑approved labeling; reauthorization for no more than 12 months.

inv-05: MDS/MPN overlap — Initial Therapy

Covered when ALL of the following are met

MDS/MPN initial therapy: Diagnosis of anemia due to myelodysplastic syndrome/myeloproliferative overlap neoplasm (MDS/MPN); presence of an SF3B1 mutation; thrombocytosis defined as platelet count ≥ 450 × 10^9/L; prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in MDS/MPN; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.SF3B1 mutation; platelets ≥450 ×10^9/L

inv-06: MDS/MPN overlap — Continuation Therapy

Covered when ALL of the following are met

MDS/MPN continuation: Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in MDS/MPN; dosing in accordance with FDA‑approved labeling; reauthorization for no more than 12 months.

inv-07: Myelofibrosis-associated anemia — Initial Therapy

Covered when ALL of the following are met

Myelofibrosis-associated anemia initial therapy: Diagnosis of myelofibrosis‑associated anemia; and one of the following: (A) both symptomatic splenomegaly and/or constitutional symptoms AND used in combination with a JAK inhibitor (examples: fedratinib, ruxolitinib, momelotinib, pacritinib), OR (B) no splenomegaly or constitutional symptoms; prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in myelofibrosis; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.

When symptoms/splenomegaly present, use in combination with a JAK inhibitor is specified.

inv-08: Myelofibrosis-associated anemia — Continuation Therapy

Covered when ALL of the following are met

Myelofibrosis continuation: Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist/oncologist or other specialist with expertise in myelofibrosis; dosing in accordance with FDA‑approved labeling; reauthorization for no more than 12 months.

inv-09: Initial Therapy - Beta Thalassemia (alternate/updated criteria block)

Covered when ALL of the following are met

Beta thalassemia initial therapy (alternate): Diagnosis of anemia due to beta thalassemia (including beta+ thalassemia, beta0 thalassemia, hemoglobin E/beta thalassemia); regular RBC transfusion dependence consistent with trial inclusion (e.g., 6–20 units per 24 weeks) with no transfusion‑free period >35 days; prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; initial authorization limited to no more than 12 months.6–20 RBC units per 24 weeks; no transfusion‑free period >35 days

Reflects BELIEVE trial population and policy history updates.

inv-10: Continuation Therapy - Beta Thalassemia (alternate/updated criteria block)

Covered when ALL of the following are met

Beta thalassemia continuation (alternate): Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; reauthorization up to 12 months.

Reflects policy revision requiring documented positive response for continuation.

inv-11: Initial Therapy - Symptomatic Lower-risk MDS — Covered when ALL of the following are met

Covered when ALL of the following are met

MDS initial therapy general: Diagnosis of symptomatic anemia due to MDS; lower‑risk disease per IPSS‑R (Very Low, Low, Intermediate); absence of confirmed del(5q); prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.

MDS ring sideroblast/EPO criteria: Either: (1) ring sideroblasts ≥ 15% (or ≥5% with an SF3B1 mutation), OR (2) ring sideroblasts < 15% (or <5% with an SF3B1 mutation) AND serum erythropoietin ≤ 500 mU/mL.Ring sideroblast % thresholds and EPO ≤500 mU/mL

Matches NCCN and trial-defined populations (MEDALIST, COMMANDS).

inv-12: Continuation Therapy - MDS — Covered when ALL of the following are met

Covered when ALL of the following are met

MDS continuation: Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden or increase in hemoglobin from baseline); prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; reauthorization for no more than 12 months.

Documentation should include IPSS‑R risk category, ring sideroblast percentage, SF3B1 status, and EPO when applicable.

inv-13: Initial Therapy - MDS/MPN (MDS/MPN-RS-T)

Covered when ALL of the following are met

MDS/MPN (MDS/MPN‑RS‑T) initial therapy: Diagnosis of anemia due to MDS/MPN (MDS/MPN‑RS‑T); presence of an SF3B1 mutation; thrombocytosis with platelet count ≥ 450 × 10^9/L; prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; initial authorization per policy (≤12 months).Platelet count ≥450 ×10^9/L; SF3B1 mutation

Reflects NCCN recommendation for MDS/MPN with SF3B1 and thrombocytosis.

inv-14: Initial Therapy - Myelofibrosis-associated anemia — Covered when ALL of the following are met

Covered when ALL of the following are met

Myelofibrosis initial therapy (alternate): Diagnosis of myelofibrosis‑associated anemia; either (A) symptomatic splenomegaly and/or constitutional symptoms AND use in combination with a JAK inhibitor (e.g., fedratinib, ruxolitinib, momelotinib, pacritinib), OR (B) no splenomegaly or constitutional symptoms; prescribed by or in consultation with a hematologist/oncologist; dosing in accordance with FDA‑approved labeling; initial authorization for no more than 12 months.

Use in combination with a JAK inhibitor when symptoms/splenomegaly present.

The following uses are explicitly excluded and considered not proven or not medically necessary: alpha thalassemia; beta thalassemia in pediatric patients; non‑transfusion dependent beta thalassemia; and sickle beta thalassemia (HbS/beta thalassemia). Requests for these indications are not supported by this policy and would be expected to be denied.

Reblozyl is not indicated as a substitute for RBC transfusions in patients who require immediate correction of anemia. It should not be used when rapid hemoglobin correction is clinically necessary; transfusion remains the appropriate intervention in that setting.

Use of Reblozyl for the conditions listed below is considered not medically necessary under this policy: alpha thalassemia, beta thalassemia in pediatric patients, non‑transfusion dependent beta thalassemia, and sickle beta thalassemia (HbS/beta thalassemia). Coverage for these diagnoses is excluded and such requests are not supported by the policy criteria.

Per the policy recognition statement, indications or uses listed as NCCN Category 3 in the NCCN Drugs and Biologics Compendium are considered unproven and are not medically necessary. UnitedHealthcare recognizes NCCN Categories 1, 2A, and 2B as proven and medically necessary, but Category 3 uses do not meet the policy's coverage standard.

Coding and Diagnostic Criteria

Applicable HCPCSHCPCS

J0896

Injection, luspatercept-aamt, 0.25 mg

Relevant ICD-10 Diagnosis CodesICD-10

D46.1	Refractory anemia with ring sideroblasts
D46.20	Refractory anemia with excess of blasts, unspecified
D46.21	Refractory anemia with excess of blasts 1
D46.22	Refractory anemia with excess of blasts 2
D46.B	Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D56.1	Beta thalassemia
D56.5	Hemoglobin E-beta thalassemia

Transfusion requirement — beta thalassemia

Transfusion requirement (24 weeks)At least 6 units of packed red blood cells (PRBC) in the prior 24 weeks

Maximum transfusion‑free intervalNo transfusion‑free period greater than 35 days during the 24‑week window

Prescriber requirementPrescribed by or in consultation with a hematologist or other specialist experienced in beta thalassemia

Age requirementPatient is 18 years of age or older

Authorization durationInitial authorization will be for no more than 12 months

Serum erythropoietin — EPO threshold

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for all indications. Initial authorizations will be limited to no more than 12 months; reauthorizations (continuation requests) will be limited to no more than 12 months.

Initial and reauthorization durations: initial authorization ≤ 12 months; reauthorization ≤ 12 months.
Prior authorization required for all diagnoses covered by this policy.

Denial Risk

Denial Triggers

Requests that do not include the required documentation or that do not meet the clinical sequencing and eligibility prerequisites may be denied. Denial may also be triggered if dosing is not consistent with FDA‑approved labeling or if there is no documentation of positive clinical response for continuation.

Missing documentation of diagnosis or absence of required specialist prescribing/consultation.

Clinical Background and Context

Beta‑thalassemias are hereditary disorders of beta‑globin chain synthesis that produce a spectrum of clinical phenotypes ranging from severe, transfusion‑dependent anemia to asymptomatic carrier states. Management of transfusion‑dependent disease typically involves regular red blood cell transfusions and iron chelation; therapeutic approaches that enhance late‑stage erythropoiesis (such as luspatercept) target anemia associated with these disorders.

Key Definitions Used in This Policy

Transfusion‑dependent beta thalassemia — definition

DefinitionPatient requiring regular transfusion of at least six units of PRBC in the prior 24 weeks with no transfusion‑free period greater than 35 days

Trial inclusion exampleBELIEVE trial population: 6–20 RBC units per 24 weeks with no transfusion‑free period >35 days

Clinical significanceReflects transfusion dependence used to establish eligibility for luspatercept in beta thalassemia

Lower‑risk MDS (per policy)

IPSS‑R categories includedVery Low, Low, or Intermediate (defines lower‑risk MDS for policy)

Exclusion—del(5q)Patients with confirmed del(5q) are excluded from these lower‑risk MDS criteria

Line of Therapy and Positioning

inv-41: informational — 1 top-level node indicating positioning

Positioning: Indication‑specific initial therapy criteria are defined by the policy (including transfusion dependence, disease‑risk scoring, biomarker thresholds, and specialist involvement) rather than explicit numbered lines of systemic therapy.

inv-42: first-line — 1 top-level node

First‑line (ESA‑naive) context: Where specified, policy criteria reflect trial populations for first‑line use in ESA‑naive lower‑risk MDS (COMMANDS trial), including ESA‑naive status and specified transfusion requirements; policy includes ESA‑naive language where applicable.

Biomarker and Laboratory Requirements

SF3B1 — presence and use

SF3B1 — rolePresence of an SF3B1 mutation is required for MDS/MPN‑RS‑T coverage and is used to modify ring sideroblast thresholds for MDS

Threshold modifierWith SF3B1 mutation, ring sideroblast threshold is lowered (e.g., ≥5% vs ≥15% without mutation)

DocumentationSF3B1 mutation status should be documented for indications relying on this biomarker

SF3B1 — mutation as threshold modifier

SF3B1 modifies ring sideroblast criteriaAn SF3B1 mutation allows qualification at lower ring sideroblast percentages (≥5% instead of ≥15%)

Required for MDS/MPN‑RS‑TSF3B1 mutation presence is explicitly required for MDS/MPN overlap indication

Dosing, Administration, and Combination Regimens

Regimen	Indication / Notes	Coverage
Reblozyl (luspatercept-aamt) + JAK inhibitor (examples: fedratinib, ruxolitinib, momelotinib, pacritinib)
Use in combination with a JAK inhibitor when symptomatic splenomegaly and/or constitutional symptoms are present (myelofibrosis-associated anemia); prescribed by or in consultation with a hematologist/oncologist; dosing per FDA labeling; initial authorization ≤ 12 months.

Regimen	Dosing per FDA / Trial	Indication / Coverage
Luspatercept (Reblozyl) administered subcutaneously
Every 3 weeks starting at 1.0 mg/kg with possible titration to 1.75 mg/kg (as evaluated in the COMMANDS trial and per FDA labeling)
ESA‑naive, transfusion‑dependent lower‑risk MDS (patients aged ≥18 years; lower‑risk per IPSS‑R; required RBC transfusions as in trial); prescribed by or in consultation with a hematologist/oncologist; initial authorization ≤ 12 months.

Policy Revision History

2025-09-01revisionLatest

Added language recognizing NCCN Drugs and Biologics Compendium categories (1, 2A, 2B as proven/medically necessary; 3 as unproven/not medically necessary) and removed blanket statement that Reblozyl is proven/medically necessary for ESA‑naïve MDS patients.

revision

Replaced prior blanket coverage language with specific, criteria‑based coverage statements and revised initial and continuation therapy criteria for multiple indications, including addition of requirements for documented positive clinical response on continuation and authorization durations of up to 12 months.