RetiredUnitedHealthcarePolicy CSLA2025D0084K

Reblozyl (luspatercept-aamt) (for Louisiana Only)

UnitedHealthcare Community Plan Medical Benefit Drug Policy for Reblozyl (luspatercept-aamt) applicable to Louisiana members; defines initial and continuation authorization criteria for multiple indications (beta thalassemia, myelodysplastic syndromes, MDS/MPN overlap, myelofibrosis-associated anemia), excluded indications, applicable billing codes, and authorization durations. Policy is retired effective April 1, 2026.

Policy Summary

PayerUnitedHealthcare

PolicyReblozyl (luspatercept-aamt) (for Louisiana Only)

Policy CodePolicy CSLA2025D0084K

Change TypeRetired / Revised Coverage Criteria

Effective DateDec 1, 2025

Next Review Date

Key ActionInitial authorization limited to no more than 12 months and medication must be prescribed by, or in consultation with, a hematologist/oncologist or other specialist with relevant expertise.

POLICY UPDATE CHANGES

Policy retired effective April 1, 2026; Louisiana plan membership disenrolled on Apr. 1, 2026.

Added UnitedHealthcare recognition of NCCN Drugs & Biologics Compendium Categories 1, 2A, 2B as proven and Category 3 as not medically necessary.

Revised beta thalassemia initial therapy wording to require 'anemia due to beta thalassemia' rather than 'diagnosis of beta thalassemia'.

Continuation criteria now require evidence of clinical benefit (e.g., reduced transfusion burden or increased hemoglobin).

New initial and continuation therapy criteria for MDS/MPN overlap were added.

Initial and continuation criteria and combination therapy guidance with JAK inhibitors included.

Policy history indicates removal of prior broader ESA-naïve coverage language.

Covered Indications (listed)

4Not Proven/Not Medically Necessary

Coverage Summary

This UnitedHealthcare Community Plan Medical Benefit Drug Policy covers Reblozyl (luspatercept-aamt) for Louisiana members and defines initial and continuation authorization criteria for multiple indications: beta thalassemia, myelodysplastic syndromes (MDS), MDS/MPN overlap (MDS/MPN-RS-T), and myelofibrosis-associated anemia. The policy lists specific covered and not-proven/excluded indications, applicable billing codes, and authorization durations (initial and reauthorization limited to no more than 12 months). The policy aligns coverage criteria to FDA labeling and to NCCN Drugs & Biologics Compendium categorizations, and it was retired effective April 1, 2026 for Louisiana members.

Key thresholds and status

Effective DateDecember 1, 2025

Last ReviewApril 1, 2026

Policy StatusRETIRED (retired effective April 1, 2026)

Policy NumberCSLA2025D0084K

Authorization maximum months12 months

Scope summaryUnitedHealthcare Community Plan Medical Benefit Drug Policy for Reblozyl (luspatercept-aamt) applicable to Louisiana members; defines initial and continuation authorization criteria for multiple indications (beta thalassemia, myelodysplastic syndromes, MDS/MPN overlap, myelofibrosis-associated anemia), excluded indications, applicable billing codes, and authorization durations. Policy is retired effective April 1, 2026.

Initial Therapy Criteria

Anemia in Adult Patients with Beta Thalassemia - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of anemia due to beta thalassemia including beta+ thalassemia, beta0 thalassemia, and hemoglobin E/beta thalassemia
Patient is 18 years of age or older
Patient is transfusion dependent as evidenced by both of the following in the previous 24 weeks:
- Has required regular transfusion of at least six units of packed red blood cells (PRBC)At least six units PRBC in previous 24 weeks; no transfusion-free period > 35 days

Continuation Therapy Criteria

Anemia in Adult Patients with Beta Thalassemia - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden, increase in hemoglobin from baseline)
Prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of beta thalassemia
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Reauthorization will be for no more than 12 months

Not Proven / Not Medically Necessary Indications

Reblozyl is not proven or medically necessary for the treatment of:

ANY of the following

Non-transfusion dependent beta thalassemia
Beta thalassemia in pediatric patients
Sickle beta thalassemia [hemoglobin S (HbS)/beta thalassemia]
Alpha thalassemia

Applicable Codes

Drug HCPCSHCPCSCovered

J0896

Injection, luspatercept-aamt, 0.25 mg

Relevant ICD-10 Diagnosis Codes (listed for reference)ICD-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

Provider Actions & Authorization Requirements

Prior Authorization

Initial authorization duration and prescriber specialty

Initial authorization is limited to no more than 12 months and the medication must be prescribed by, or in consultation with, a hematologist/oncologist or other specialist with expertise in the diagnosis and management of the condition. Policy status: retired effective April 1, 2026 (Louisiana plan membership disenrolled on Apr. 1, 2026).

Affected code: J0896
Policy retired: Apr. 1, 2026

Prior Authorization

Reauthorization requirements

Reauthorization is limited to no more than 12 months and requires documentation of a positive clinical response to Reblozyl (examples of a positive clinical response include reduction in transfusion burden or increase in hemoglobin from baseline).

Clinical Evidence

21.4%BELIEVE: ≥33% transfusion reduction + ≥2 units (wks13–24) vs 4.5% placebo

38%MEDALIST: Transfusion independence ≥8 wks (weeks1–24) vs 13% placebo

59%COMMANDS (interim): Met primary endpoint vs 31% with epoetin alfa

Key randomized trials supporting Reblozyl include BELIEVE (transfusion-dependent beta thalassemia), MEDALIST (lower-risk MDS with ring sideroblasts), and COMMANDS (ESA‑naïve lower-risk MDS vs epoetin alfa); these trials demonstrated reductions in transfusion burden and increased transfusion independence in relevant populations. The policy explicitly acknowledges this evidence base and recognizes NCCN Drugs & Biologics Compendium categorizations (Categories 1, 2A, 2B as proven/medically necessary and Category 3 as not medically necessary) in its coverage rationale.

Background & Definitions

Luspatercept is an erythroid maturation agent indicated by the FDA for anemia in adult patients with transfusion-dependent beta thalassemia and for specified lower‑risk MDS indications (including ESA‑naïve and ring sideroblast/MDS‑RS or MDS/MPN‑RS‑T scenarios per labeling); principal supporting trials cited in the policy are BELIEVE (beta thalassemia), MEDALIST (lower‑risk MDS with ring sideroblasts), and COMMANDS (ESA‑naïve MDS). The policy was retired for Louisiana members effective April 1, 2026.

Definitions and thresholds

Positive clinical responseExamples include reduction in transfusion burden or increase in hemoglobin from baseline.

Lower risk (IPSS-R)IPSS-R categories Very Low, Low, or Intermediate.

Transfusion burden (beta thalassemia)At least six units PRBC in previous 24 weeks; no transfusion-free period > 35 days.

Ring sideroblasts criterion (MDS)Either <15% (or <5% with SF3B1 mutation) with serum erythropoietin ≤ 500 mU/mL, or ≥15% (or ≥5% with SF3B1 mutation).

Revision History

2025-12-01policy_effective

Policy effective date established (policy effective December 1, 2025).

2025-12-01revised

Added UnitedHealthcare recognition of NCCN Drugs & Biologics Compendium Categories 1, 2A, 2B as proven and Category 3 as not medically necessary (coverage rationale language inserted).

2025-12-01revised

Revised beta thalassemia initial therapy wording to require 'anemia due to beta thalassemia' rather than 'diagnosis of beta thalassemia'.

Policy Summary

PayerUnitedHealthcare

PolicyReblozyl (luspatercept-aamt) (for Louisiana Only)

Policy CodePolicy CSLA2025D0084K

Change TypeRetired / Revised Coverage Criteria

Effective DateDec 1, 2025

Next Review Date

Key ActionInitial authorization limited to no more than 12 months and medication must be prescribed by, or in consultation with, a hematologist/oncologist or other specialist with relevant expertise.

On This Page

No transfusion free period greater than 35 days

Prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of beta thalassemia

Dosing is in accordance with the United States Food and Drug Administration approved labeling

Initial authorization will be for no more than 12 months

Symptomatic Anemia in Patients with Myelodysplastic Syndromes (MDS) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of symptomatic anemia due to myelodysplastic syndrome (MDS)
Patient has lower risk disease as defined as International Prognostic Scoring System (IPSS-R): Very Low, Low, IntermediateIPSS-R: Very Low, Low, Intermediate
Patient does not have a confirmed mutation with deletion 5q [del(5q)]
ONE of the following
- Both of the following
  - Ring sideroblasts < 15% (or ring sideroblasts < 5% with an SF3B1 mutation)Ring sideroblasts <15% (or <5% with SF3B1)
  - Serum erythropoietin ≤ 500 mU/mL≤ 500 mU/mL
- Ring sideroblasts ≥ 15% (or ring sideroblasts ≥ 5% with an SF3B1 mutation)Ring sideroblasts ≥15% (or ≥5% with SF3B1)
Prescribed by, or in consultation with, a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization will be for no more than 12 months

Anemia in Patients with MDS/MPN Overlap (MDS/MPN-RS-T) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of anemia due to myelodysplastic syndrome/myeloproliferative overlap neoplasm (MDS/MPN)
Presence of a SF3B1 mutation
Thrombocytosis defined as platelet count ≥ 450 x 10^9 /LPlatelet count ≥ 450 x10^9/L
Prescribed by, or in consultation with, a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of MDS/MPN
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization will be for no more than 12 months

Myelofibrosis-Associated Anemia - Initial Therapy

Covered when ALL of the following are met:

Symptomatic Anemia in Patients with MDS - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden, increase in hemoglobin from baseline)
Prescribed by, or in consultation with, a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Reauthorization will be for no more than 12 months

Anemia in Patients with MDS/MPN Overlap - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden, increase in hemoglobin from baseline)
Reblozyl is prescribed by, or in consultation with, a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of MDS/MPN
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Reauthorization will be for no more than 12 months

Myelofibrosis-Associated Anemia - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Reblozyl (e.g., reduction in transfusion burden, increase in hemoglobin from baseline)
Reblozyl is prescribed by, or in consultation with, a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelofibrosis
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Reauthorization will be for no more than 12 months

Affected code: J0896
Examples of acceptable response: reduction in transfusion burden; increase in hemoglobin from baseline

Documentation Required

Transfusion‑dependence documentation (beta thalassemia)

For beta thalassemia, document transfusion dependence by recording at least six units of packed red blood cells transfused in the prior 24 weeks and that there has been no transfusion‑free period greater than 35 days.

Referenced ICD-10 codes: D56.1, D56.5
Thresholds: ≥6 units PRBC in prior 24 weeks; no transfusion‑free period > 35 days

Documentation Required

MDS diagnostic and biomarker documentation

For MDS indications, document the IPSS‑R risk category (Very Low, Low, or Intermediate), presence/absence of del(5q), ring sideroblast percentage and SF3B1 mutation status, and serum erythropoietin level when applicable (e.g., to apply the ≤500 mU/mL threshold for certain ring sideroblast scenarios).

Referenced ICD-10 codes: D46.1, D46.B
Key thresholds: IPSS‑R lower risk = Very Low, Low, Intermediate; ring sideroblasts <15% (or <5% with SF3B1) with serum EPO ≤500 mU/mL, or ring sideroblasts ≥15% (or ≥5% with SF3B1)

Thrombocytosis (MDS/MPN)

Platelet count ≥ 450 x 10^9 /L.

2025-12-01revised

Added requirement for documentation of a positive clinical response (e.g., reduced transfusion burden or increased hemoglobin) for continuation of therapy across beta thalassemia and MDS indications.

2025-12-01added

Added coverage criteria for MDS/MPN overlap (MDS/MPN-RS-T) requiring SF3B1 mutation and thrombocytosis (platelets ≥ 450 x10^9/L).

2025-12-01added

Added coverage criteria for myelofibrosis-associated anemia with multiple paths depending on splenomegaly and concomitant JAK inhibitor use.

2025-12-01removed

Removed prior language indicating Reblozyl was proven/medically necessary for ESA‑naïve MDS patients (broader ESA‑naïve coverage language removed).

2026-04-01retiredLatest

Policy retired effective April 1, 2026; Louisiana plan membership disenrolled on Apr. 1, 2026. (Material change)