CurrentCignaPolicy N/A

Reblozyl (luspatercept) prior authorization form

Prior authorization form and clinical questionnaire used by Cigna to request coverage for Reblozyl (luspatercept) across multiple labeled indications (myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, myelofibrosis, transfusion-dependent beta-thalassemia). Captures patient/provider details, indication-specific clinical criteria for initial and continuation therapy, administration site, and documentation/attestation requirements.

Policy Summary

PayerCigna

PolicyReblozyl (luspatercept) prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProviders must complete and submit this Cigna prior authorization form (including all asterisked fields) or submit online via CoverMyMeds or SureScripts to request coverage for Reblozyl.

SourceLink

POLICY UPDATE CHANGES

No material changes

4Indications listed on form

>=1Required documentation items (minimum)

Coverage summary

This payer-specific prior authorization form is for Reblozyl (luspatercept) and covers labeled indications including myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasm (MDS/MPN), myelofibrosis-related anemia, and transfusion-dependent beta-thalassemia (TDT). The form captures patient and provider identifiers (physician name, specialty, DEA/NPI/TIN, contact and patient identifiers), medication requested (dose options/quantity/directions/ICD-10), where the medication will be obtained and administered, and facility/dispensing Tax ID and address for billing.

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Submission and documentation requirements

Prior Authorization

Submit prior authorization using this form

Complete and submit the Cigna Reblozyl prior authorization form (all asterisked fields) or submit online via CoverMyMeds or SureScripts to request coverage.

Documentation Required

Attach supporting medical documentation

Attach patient-specific supporting documentation such as chart notes, lab/test results, claims records, or prescription receipts — especially documentation confirming absence of del(5q) for MDS — or the request may be denied.

Documentation Required

Prescriber specialty requirement

Prescriber must be an oncologist or hematologist or the request must document consultation with one for most indications (required explicitly for MDS, MDS/MPN, myelofibrosis, and TDT initial requests).

Prior Authorization

Urgent review option

Provider may mark the request as Urgent by attesting that standard review time may seriously jeopardize the patient’s life/health/ability to regain function; note Cigna’s standard response time for prescription drug coverage requests is 5 business days (TDT context) and urgent requests should be called to expedite.

Billing Rule

Administration site and billing

Indicate where the drug will be obtained and administered and provide facility/dispensing information including Tax ID; form includes options for hospital outpatient/inpatient, retail pharmacy, ambulatory infusion center, home infusion, physician office stock, and asks for CPT code(s) for billing.

The form requires completion of physician and patient identification fields including physician name, specialty, DEA/NPI/TIN, office contact, office phone/fax/address, and patient name, Cigna ID, date of birth, address, and phone.

The medication request section requires the provider to select the medication requested (Reblozyl 25 mg, Reblozyl 75 mg, or Other), and to provide directions, quantity, and ICD-10 diagnosis code.

The form asks where the medication will be obtained and includes checkboxes for Hospital Outpatient, Hospital Inpatient, Retail Pharmacy, Ambulatory Infusion Center, Home Health/Home Infusion vendor, Physician's office stock and a free-text option; it also provides a field for CPT code(s).

Facility and dispensing information must be provided: facility/doctor name, Tax ID, address (city, state, zip) for billing or dispensing purposes.

The form requires documentation of the administration site (Patient's Home, Physician's Office, Hospital Outpatient, Other) and asks whether the patient is a candidate for redirection to a lower-intensity setting.

Finally, the provider must complete the attestation, sign and date the form; the Urgent box may be checked with an attestation that standard review time may seriously jeopardize life/health.

Myelodysplastic Syndrome (MDS) — Initial therapy criteria

Covered when ALL of the following are met:

ALL of the following

The request is for initial therapy (not continuation) for myelodysplastic syndrome (MDS) as indicated by the prescriber.
The prescriber documents that the patient has very low- to intermediate-risk MDS, as determined by the International Prognostic Scoring System (IPSS).
The prescriber documents the patient has symptomatic anemia attributable to MDS.
Documentation is provided that the patient does NOT have a confirmed deletion 5q [del(5q)] mutation. Medical documentation (e.g., chart notes, laboratory or test results) must be attached to the request.
The requested medication will not be used in combination with an erythropoiesis-stimulating agent (ESA), or if it will be used in combination the prescriber has indicated this and provided rationale.
If combination with an ESA is planned, include clinical justification and supporting documentation.
The medication is prescribed by, or in consultation with, an oncologist or a hematologist.
General submission and medication request requirements are included with the request: completed patient and provider identifiers, medication requested (strength and quantity), ICD-10 diagnosis code, intended site of administration, and supporting clinical documentation.

Myelodysplastic Syndrome (MDS) — Continuation therapy criteria

Continuation covered when one of the following is met:

MDS - Continuation therapy criteria

Hemoglobin response: Patient's hemoglobin has increased by >= 1.5 g/dL compared with pretreatment baseline (per prescriber).>= 1.5 g/dL
Response assessed by prescriber.
Transfusion burden response: If hemoglobin response not met, patient has experienced a clinically meaningful decrease in transfusion burden (per prescriber).
Documented by prescriber.

Form capture note: If continuation, prescriber must indicate yes/no for hemoglobin increase and, if no, whether there is a clinically meaningful decrease in transfusion burden.

Myelodysplastic/Myeloproliferative Neoplasm — Initial therapy criteria

Covered when ALL of the following are met for initial requests:

MDS/MPN - Initial therapy criteria

Indication: Myelodysplastic/myeloproliferative neoplasm selected.
IPSS risk: Prescriber determines patient has very low- to intermediate-risk disease using the International Prognostic Scoring System (IPSS).
This is determined by the prescriber using IPSS.
Anemia: Prescriber documents patient has anemia.
Prescriber specialty: Prescribed by or in consultation with an oncologist or a hematologist.

Form fields and administration details (non-criteria capture): Provider and medication request details (physician name, specialty, DEA/NPI/TIN, contact info, patient identifiers, medication selection, quantity, directions, ICD-10, where obtained and administered, facility dispensing info, attestation) must be provided.

Myelodysplastic/Myeloproliferative Neoplasm — Continuation therapy criteria

Continuation covered when one of the following is met:

MDS/MPN - Continuation therapy criteria

Hemoglobin response: Patient's hemoglobin has increased by >= 1.5 g/dL compared with pretreatment baseline (per prescriber).>= 1.5 g/dL
Response assessed by prescriber.
Transfusion burden response: If hemoglobin response not met, patient has experienced a clinically meaningful decrease in transfusion burden (per prescriber).
Documented by prescriber.

Form capture note: If continuation, prescriber must indicate yes/no for hemoglobin increase and, if no, whether there is a clinically meaningful decrease in transfusion burden.

Myelofibrosis — Coverage criteria

Covered when ALL of the following are met:

Myelofibrosis - Coverage criteria

Indication: Myelofibrosis selected.
Prescriber specialty: Requested medication prescribed by or in consultation with an oncologist or a hematologist.
Myelofibrosis-related anemia: Patient has myelofibrosis-related anemia.
Symptoms and JAK inhibitor combination: Provider indicates whether patient has splenomegaly or constitutional symptoms and whether Reblozyl will be used in combination with a JAK inhibitor (e.g., ruxolitinib, fedratinib).
Examples of JAK inhibitors provided on form.
Request type (new start vs continuation) must be indicated.

Transfusion-Dependent Beta-Thalassemia (TDT) — Initial therapy criteria

Covered when ALL of the following are met for initial requests:

TDT - Initial therapy criteria

Indication: Transfusion dependent beta-thalassemia selected.
No prior gene therapy: Patient has not received prior gene therapy for TDT (examples: Zynteglo, Casgevy).
Provider must indicate Yes/No.
Not receiving mitapivat: Patient is not currently receiving Aqvesme (mitapivat).
Provider must indicate Yes/No.
Prescriber specialty: Prescribed by or in consultation with a hematologist.
Transfusion requirement: Prescriber attests patient requires regular red blood cell transfusions defined as at least 6 units packed RBCs within the preceding 24 weeks.>= 6 units in prior 24 weeks
No long transfusion-free period: Prescriber attests the patient has not had any transfusion-free period greater than 35 days within the preceding 24 weeks.No transfusion-free period > 35 days in prior 24 weeks

Transfusion-Dependent Beta-Thalassemia (TDT) — Continuation therapy criteria

Continuation covered when the following is met:

TDT - Continuation therapy criteria: Patient has experienced a clinically meaningful decrease in transfusion burden defined as a decrease of at least 2 units in RBC transfusion burden over the past 6 months compared with pretreatment baseline (prior to initiation of Reblozyl) (per prescriber).Decrease >= 2 units over past 6 months vs pretreatment baseline

Documented by prescriber.

Background

This payer-specific PA form for Reblozyl (luspatercept) is used to evaluate clinical appropriateness across labeled uses (MDS, MDS/MPN, myelofibrosis, TDT).

The form collects information differentiating initial versus continuation requests and documents clinical response thresholds used for decisions: for continuation in MDS/MDS-MPN a hemoglobin increase of >= 1.5 g/dL versus pretreatment baseline or a clinically meaningful reduction in transfusion burden; for TDT continuation a clinically meaningful decrease defined as a reduction of >= 2 units in RBC transfusion burden over the past 6 months versus pretreatment baseline.

The form also requires supporting documentation and prescriber attestation/signature and notes that documentation (e.g., absence of del(5q) for MDS) must be attached or the request may be denied.

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