CurrentAvMedPolicy Pub. 100-2

Reblozyl (luspatercept-aamt) prior authorization for beta-thalassemia

Forms and clinical criteria for prior authorization and step-edit approval of luspatercept (Reblozyl) for treatment of transfusion-dependent beta-thalassemia in AvMed members; applies to providers requesting medical benefit coverage (J0896).

Policy Summary

PayerAvMed

PolicyReblozyl (luspatercept-aamt) prior authorization for beta-thalassemia

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit supporting documentation including hematology consultation notes, labs, and transfusion history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 moInitial approval

12 moReauth

≥18Min age

6–20/6 moPretreatment transfusions

<11.5 g/dLBaseline Hb

Coverage Criteria for Reblozyl (luspatercept-aamt)

Initial Therapy

Covered when ALL of the following are met:

Provider is a hematologist, has been in consultation with one, or a specialist in treating patients with beta-thalassemia.

Age: Member is 18 years of age or older.>=18 years

Pregnancy prevention: For female patients, a negative pregnancy test has been confirmed prior to start of therapy and effective contraception will continue during treatment and for ≥ 3 months after the last luspatercept dose.

Diagnosis specifics: Documented diagnosis of beta-thalassemia including β+, β0, hemoglobin E/β-thalassemia, or non-deletional Hb H; submit hematologic findings, electrophoresis analysis, and/or molecular analysis where available. (This excludes other alpha thalassemia and hemoglobin S/β-thalassemia variants.)

Policy Summary

PayerAvMed

PolicyReblozyl (luspatercept-aamt) prior authorization for beta-thalassemia

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit supporting documentation including hematology consultation notes, labs, and transfusion history.

SourceLink

On This Page

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Continuation / Reauthorization

Reauthorization / continuation covered when ALL of the following are met:

Toxicity: Member has experienced an absence of any unacceptable toxicity from drug therapy (for example, severe or uncontrolled hypertension or thromboembolic events).

Transfusion response: There has been a reduction in the member's transfusion requirements from pretreatment baseline of at least 2 units while on the maximum titrated dose.>=2 unit reduction

If there is no reduction in RBC transfusion burden after 3 consecutive doses (9 weeks) at 1.25 mg/kg, therapy must be discontinued and the request for continuation will be denied.

Hemoglobin monitoring: Provide current hemoglobin level. If hemoglobin increases by >2 g/dL within 3 weeks in the absence of transfusions, follow dosing modification guidance; if Hb is ≥11.5 g/dL delay dose until Hb ≤11 g/dL.<=11 g/dL to restart

Refer to dosing modification table for specific dose reductions or holds based on predose Hb and rapid rises in Hb.

Coding and Clinical Thresholds

Covered HCPCS / NDC for drugmixedCovered

J0896	Injection, luspatercept-aamt
NDC: 59572-0711-01	Reblozyl single-dose vial
NDC: 59572-0775-01	Reblozyl single-dose vial

Applicable ICD-10 diagnosis codesICD-10

D56.1	Beta thalassemia
D56.5	Other thalassemia

Pretreatment transfusion volume (6 months)

Pretreatment transfusion volume (6 months)Member has regularly received 6 to 20 units of packed red blood cells in the past 6 months (provide pretreatment transfusion requirements).

Transfusion-free interval restrictionMember has never been transfusion‑free for any period >35 days in the past 6 months.

Documentation requiredSubmit most recent chart notes, procedural notes, or therapy orders detailing current and past transfusion requirements for the 6‑month period.

Baseline hemoglobin

Baseline hemoglobin thresholdBaseline hemoglobin (Hb) less than 11.5 g/dL prior to starting therapy (provide lab documentation).

Dose delay guidanceIf Hb is ≥11.5 g/dL, dosing must be delayed until Hb is ≤11.0 g/dL.

Documentation requiredProvide medical laboratory documentation of the hemoglobin level prior to initiating therapy.

Provider Actions, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Reblozyl (J0896) is a medical-benefit drug requiring prior authorization. Initial approval duration: 4 months; reauthorization criteria and duration: 12 months. Provider must ensure hematology specialist involvement and all clinical criteria are met and documented to avoid delay or denial.

J0896 (Reblozyl®)
Initial authorization: 4 months
Reauthorization: 12 months

Billing Rule

Samples Not Acceptable

Samples are not acceptable to satisfy preauthorization or step-edit requirements. Therapy initiated with sample medication will not meet coverage criteria and may result in denial of the request.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the request: hematology consult notes or documentation that provider is a hematologist or was in consultation with one; laboratory results (baseline and current hemoglobin levels, pregnancy test if applicable); transfusion history and pretreatment transfusion requirements (most recent chart notes/procedural notes/therapy orders detailing current and past transfusion units); electrophoresis or molecular analysis where available; and documentation of any prior therapies. Incomplete documentation may delay review or result in denial.

Hematology consult notes or specialist documentation
Baseline and current labs (hemoglobin, pregnancy test if applicable)
Transfusion history and pretreatment transfusion requirements (6 months)
Electrophoresis/molecular analysis and prior therapy records

Documentation Required

Form Completion Requirements

Form completion requirements: the prescribing physician must sign and clearly print their name on the request (preprinted stamps are not valid). Include member identifiers, AvMed member number, date of birth, prescriber name, prescriber signature and date, office contact name, phone and fax numbers, and prescriber NPI. If information is incomplete, incorrect, or illegible, authorization can be delayed.

Prescriber signature (hand-signed) and printed name — stamps not valid
Member AvMed number and date of birth
Office contact name, phone number, and fax number
Prescriber NPI and date of signature

Denial Risk

Insufficient Transfusion Response

Insufficient transfusion response: If there is no reduction in red blood cell transfusion burden after 3 consecutive doses (9 weeks) at 1.25 mg/kg, therapy must be discontinued and the request will be denied. Provide current transfusion requirements to document response.

No reduction after 3 consecutive doses (9 weeks) at 1.25 mg/kg → discontinue therapy and deny
Provide current transfusion requirements (units)

Background and Indication

Luspatercept (Reblozyl) is indicated for adults with transfusion‑dependent β‑thalassemia to reduce transfusion burden. Initial authorization is for 4 months with reauthorization for 12 months when criteria are met. Coverage requires a documented diagnosis of β‑thalassemia, evidence of transfusion dependence (typically 6–20 units packed RBCs in the prior 6 months with no transfusion‑free interval >35 days), baseline hemoglobin <11.5 g/dL, and management by or in consultation with a hematologist or appropriate specialist. Reauthorization also requires absence of unacceptable toxicity and objective evidence of transfusion reduction as described in the policy.

OpenPayer

Reblozyl (luspatercept-aamt) prior authorization for beta-thalassemia

Coverage Criteria for Reblozyl (luspatercept-aamt)

Coding and Clinical Thresholds

Provider Actions, Documentation, and Billing Notes

Background and Indication

Definitions