CurrentAetnaPolicy N/A

Reblozyl (luspatercept-aamt) Medication Precertification Request — Coverage Criteria

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Precertification request and required clinical documentation for initiation or continuation of Reblozyl (luspatercept-aamt) for Aetna members; intended for prescribing providers, dispensing providers, and Aetna review staff.

Policy Summary

PayerAetna

PolicyReblozyl (luspatercept-aamt) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed two-page precertification form with required clinical documentation and use Aetna precertification contact numbers or fax for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2pages in the form

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CurrentAetnaPolicy N/A

Reblozyl (luspatercept-aamt) Medication Precertification Request — Coverage Criteria

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Sign up for all Aetna policy alerts

Know when Aetna releases new policies or updates existing guidance.

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Policy Summary

PayerAetna

PolicyReblozyl (luspatercept-aamt) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed two-page precertification form with required clinical documentation and use Aetna precertification contact numbers or fax for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2pages in the form

Coverage Criteria for Reblozyl (luspatercept-aamt)

Initiation Therapy

Covered when ALL of the following are documented (per form fields):

Diagnosis confirmation: Diagnosis of beta thalassemia, hemoglobin E/beta-thalassemia, or MDS/MDS-MPN with ring sideroblasts (including MDS/MPN-RS-T) is documented and confirmed by hemoglobin electrophoresis, HPLC, or molecular genetic testing.

checkboxes on form request confirmation of testing

Symptomatic anemia: Patient has symptomatic anemia prior to starting treatment as indicated on the form.

form asks Yes/No

Transfusion burden for beta thalassemia: Either: (a) patient required at least 6 red blood cell units in the previous 24 weeks (form queries this), or (b) patient has regular red blood cell transfusions defined as greater than or equal to 2 units per 8 weeks.>=6 units/24 weeks or >=2 units/8 weeks

form captures both metrics

Continuation Therapy

Continuation covered when ALL of the following are met:

Transfusion reduction response: Patient has achieved or maintained a reduction in red blood cell transfusion burden while on therapy (form asks Yes/No).

required for continuation requests

Tolerability: Patient has not experienced unacceptable toxicity while taking the medication (form asks Yes/No).

required for continuation requests

The precertification form does not include an explicit list of exclusions. Instead, coverage is conditioned on completion of required diagnostic and clinical fields on the two‑page Reblozyl request form. For initiation requests the form requires diagnostic confirmation of beta thalassemia or hemoglobin E/beta‑thalassemia by hemoglobin electrophoresis, high‑performance liquid chromatography (HPLC), or molecular genetic testing, documentation of symptomatic anemia prior to treatment, recording of pretreatment or pretransfusion hemoglobin, and documentation of transfusion history including whether the patient required at least 6 red blood cell units in the previous 24 weeks.

Although the form does not print a formal noncoverage statement, it implies requests may be denied or deemed not medically necessary when required items are missing or thresholds are not met. Examples include absence of diagnostic confirmation by electrophoresis/HPLC/molecular testing, failure to indicate the patient has symptomatic anemia prior to treatment, lack of a recorded pretreatment/pretransfusion hemoglobin, or failure to document the queried transfusion burden such as fewer than 6 RBC units in the prior 24 weeks for the beta thalassemia transfusion‑burden criterion.

Coding: Administration and Diagnosis Codes

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be provided on the form

Diagnosis codes (ICD-10)ICD-10

Primary ICD Code	Primary diagnosis ICD code to be provided
Secondary ICD Code	Secondary diagnosis ICD code to be provided
Other ICD Code	Other applicable ICD codes

inv-07: Transfused units in prior 24 weeks

Transfused units in prior 24 weeks>= 6 red blood cell units

TimeframePrevious 24 weeks

PurposeUsed to establish transfusion burden for initiation eligibility

inv-08: Regular transfusion definition

Regular transfusion definition>= 2 units per 8 weeks

Measurement period8-week intervals

Application

Provider Actions and Requirements

Prior Authorization

Precertification required

Precertification (prior authorization) is required for Reblozyl. Submit the completed two-page Reblozyl precertification request form; use the Aetna Precertification Notification phone or fax shown on the form for submission and questions.

Aetna Precertification Notification Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
For Medicare Advantage Part B: use the Medicare Request Form

Step Therapy

Record prior transfusion burden and response

Document the patient's transfusion history and response on the form: indicate whether the patient required at least 6 RBC units in the previous 24 weeks and whether the patient has been receiving regular RBC transfusions defined as ≥2 units per 8 weeks.

Did the patient require at least 6 red blood cell units in the previous 24 weeks? (Yes/No)

Background

Reblozyl (luspatercept‑aamt) is indicated on the form for treatment of certain anemias, including beta thalassemia (including hemoglobin E/beta‑thalassemia) and anemia associated with myelodysplastic syndromes such as myelodysplastic syndrome with ring sideroblasts or related MDS/MPN entities (for example, MDS/MPN‑RS‑T). The form requests confirmation of diagnosis by laboratory or genetic testing and captures baseline hemoglobin and transfusion history to determine eligibility.

Definitions

inv-14: regular red blood cell transfusions

DefinitionRegular red blood cell transfusions: greater than or equal to 2 units per 8 weeks

ContextForm queries regular transfusions when assessing transfusion-dependence for initiation and continuation requests

Related threshold>= 6 RBC units in previous 24 weeks is an alternate transfusion-burden metric on the form