CurrentNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Reblozyl

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This policy governs North Carolina Medicaid prior approval for Reblozyl (luspatercept) in eligible beneficiaries with beta thalassemia or specified myelodysplastic syndromes. It establishes initial and continuation criteria, required clinical documentation, approval durations, and dosing-related restrictions.

Policy Summary

PayerNorth Carolina Medicaid

PolicyReblozyl (luspatercept) prior approval coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 12, 2026

Next Review DateN/A

Key ActionSubmit the beneficiary's most recent weight with both initial and renewal prior approval requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum age for initial approval

6–20 RBC unitsInitial beta-thalassemia transfusion requirement

15 weeks / 6 dosesInitial approval

12 monthsRenewal approval

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CurrentNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Reblozyl

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Policy Summary

PayerNorth Carolina Medicaid

PolicyReblozyl (luspatercept) prior approval coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 12, 2026

Next Review DateN/A

Key ActionSubmit the beneficiary's most recent weight with both initial and renewal prior approval requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum age for initial approval

6–20 RBC unitsInitial beta-thalassemia transfusion requirement

15 weeks / 6 dosesInitial approval

12 monthsRenewal approval

Hemoglobin threshold

Coverage Criteria

Initial Therapy

Covered when ALL of the following criteria are met:

ALL of the following

Beneficiary is 18 years of age or older.
ONE of the following diagnoses applies
- Beta thalassemia
  - Diagnosis is confirmed by ONE of the following
    Hemoglobin beta (HBB) sequence gene analysis showing biallelic pathogenic variants.
    Severe microcytic/hypochromic anemia, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis revealing decreased amounts or complete absence of hemoglobin A and increased amounts of hemoglobin F.
  - Beneficiary is RBC transfusion dependent, defined as requiring 6 to 20 RBC units per 24 weeks for initial approval.
- Documented diagnosis of anemia in an ESA-naive beneficiary with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular RBC transfusions.
- Anemia after ESA failure
  - Anemia has failed an erythropoiesis-stimulating agent and requires 2 or more RBC units over 8 weeks.
  - ONE of the following diagnoses applies
    Very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS).
    Myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Beneficiary has not had a deep vein thrombosis or thrombotic stroke requiring medical intervention within 6 months before therapy.
Beneficiary does NOT have major end organ damage, defined as none of the following
- Liver disease with ALT greater than 3 times the upper limit of normal (ULN), or a history of or evidence of cirrhosis.
- Heart disease, heart failure NYHA classification 3 or higher, significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months or requiring treatment.
- Clinically significant lung disease, including pulmonary fibrosis or pulmonary hypertension (for example, grade 3 or higher).
- Creatinine clearance less than 60 mL/min.
Baseline hemoglobin (Hb) is less than 11.5 g/dL.
If Hb is greater than 11.5 g/dL, the dose must be delayed until Hb is less than 11 g/dL.
Other causes of anemia, such as hemolysis, bleeding, recent major surgery, or vitamin deficiency, have been ruled out.
Female beneficiaries of reproductive potential have a negative pregnancy test before starting therapy and will use an effective method of contraception during treatment and for more than 3 months after treatment.

Continuation Therapy

Covered for continuation when ALL of the following criteria are met:

ALL of the following

Beneficiary continues to meet all applicable Initial Therapy criteria.
Beneficiary's hemoglobin (Hb) is less than 11.5 g/dL.
If Hb is greater than 11.5 g/dL, the dose must be delayed until Hb is less than 11 g/dL.
ONE of the following response or dose-adjustment conditions applies
- Beneficiary is experiencing disease response, evidenced by a decrease in the number of RBC transfusions.
- For new starts, beneficiary has not achieved a reduction in RBC transfusion burden after more than 2 consecutive initial doses and requires a dose increase.

Coverage for beta-thalassemia excludes alpha-thalassemia and hemoglobin S/beta-thalassemia variants.

Coverage is excluded when the beneficiary has had a deep vein thrombosis or thrombotic stroke requiring medical intervention within 6 months before therapy.

Continuation therapy is excluded when the beneficiary has experienced treatment-restricting adverse effects, including thromboembolic events or severe hypertension.

Clinical Thresholds and Coding Details

Beta-thalassemia transfusion dependence

Transfusion requirement6 to 20 red blood cell (RBC) units

Measurement period24 weeks

ApplicabilityRequired for initial beta-thalassemia approval only; not required for continuation

MDS transfusion requirement after ESA failure

Prior treatment requirementAnemia must have failed an erythropoiesis-stimulating agent (ESA)

Transfusion requirementAt least 2 RBC units

Measurement period

Prior Approval and Submission Requirements

Prior Authorization

Prior Approval Required

Prior approval is required for Reblozyl coverage. Submit the prior approval request with documentation supporting the applicable beneficiary eligibility and clinical criteria.

Prior Authorization

Approval Periods

Approval is limited to the applicable authorization period.

Initial approval: 15 weeks, covering 6 doses.
Renewal approval: 12 months.

Documentation Required

Submit Current Weight

Therapy Background

Reblozyl (luspatercept) is an erythroid maturation agent used to treat anemia associated with transfusion-dependent beta thalassemia and selected lower-risk myelodysplastic syndromes. Coverage is limited to eligible adults who meet the applicable diagnostic, transfusion or treatment-history, hemoglobin, safety, and response requirements.

Policy Definitions

RBC transfusion dependent

DefinitionRequires 6 to 20 red blood cell (RBC) units

Time periodDuring a 24-week period

Approval phaseApplies to initial approval; not required on continuation

Major end organ damage

Liver diseaseALT greater than 3 times the upper limit of normal or a history of or evidence of cirrhosis

Heart diseaseHeart disease, NYHA class 3 or higher heart failure, significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months or requiring treatment

Lung disease

Initial Approval Criteria

Initial approval requires the beneficiary to be at least 18 years old, meet one covered indication, and satisfy all applicable safety, laboratory, anemia-evaluation, and reproductive-safety requirements.

Initial approval

The beneficiary is 18 years of age or older.Age ≥18 years
Covered indication
- Beta thalassemia
  - Diagnostic confirmation
    The diagnosis is confirmed by HBB sequence gene analysis showing biallelic pathogenic variants.

Continuation Approval Criteria

Continuation approval requires all listed criteria.

Continuation approval

The beneficiary continues to meet all initial approval criteria.
The beneficiary's hemoglobin is below 11.5 g/dL.Hb <11.5 g/dL
If hemoglobin is above 11.5 g/dL, delay the dose until hemoglobin is below 11 g/dL. If an RBC transfusion occurred before dosing, use the pretransfusion hemoglobin for dosing purposes.
Response or dose-adjustment pathway
- The beneficiary is experiencing disease response, evidenced by a decrease in the number of RBC transfusions.

Step Therapy Requirements

Step	Requirement	Failure criteria	Duration
1	Prior erythropoiesis-stimulating agent failure is required for qualifying MDS with ring sideroblasts or MDS/MPN with ring sideroblasts and thrombocytosis.	Anemia must have failed an erythropoiesis-stimulating agent and require at least 2 RBC units over 8 weeks.

Quantity and Dose Limits

Reblozyl quantity limit

Quantity limit6 initial doses of Reblozyl

Approval period15 weeks

CourseInitial approval covers the 6 initial doses

Policy Summary

PayerNorth Carolina Medicaid

PolicyReblozyl (luspatercept) prior approval coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 12, 2026

Next Review DateN/A

Key ActionSubmit the beneficiary's most recent weight with both initial and renewal prior approval requests.

SourceLink

On This Page

Beneficiary experienced a response followed by a lack or loss of response, requires a dose increase, and other causative factors (such as a bleeding event) have been ruled out.

Beneficiary will not receive doses less than 21 days apart.

Beneficiary has not experienced any treatment-restricting adverse effects, such as thromboembolic events or severe hypertension.

Hemoglobin thresholds

Hemoglobin requirementHemoglobin must be below 11.5 g/dL

Dose-delay triggerIf hemoglobin is above 11.5 g/dL, delay the dose

Dose-resumption thresholdAdminister the delayed dose when hemoglobin is below 11 g/dL

Liver disease threshold

Laboratory measureAlanine aminotransferase (ALT)

ThresholdALT greater than 3 times the upper limit of normal (ULN)

Clinical significanceQualifies as major end organ damage

Renal function threshold

Laboratory measureCreatinine clearance

ThresholdBelow 60 mL/min

Clinical significanceQualifies as major end organ damage

Minimum dose interval

Minimum interval21 days between doses

RestrictionDoses must not be administered fewer than 21 days apart

ApplicationApplies to continuation dosing

Submit the beneficiary’s most recent weight with every initial and renewal prior approval request.

Current weight is required for both initial and renewal requests.

Documentation Required

Clinical Eligibility Documentation

Document the clinical eligibility criteria supporting the request, including the applicable diagnosis, clinical evidence, transfusion history, and ESA history.

Beneficiary must be 18 years of age or older.
Eligible indications include documented beta thalassemia; ESA-naive anemia with very low- to intermediate-risk MDS that may require regular RBC transfusions; or anemia after ESA failure requiring at least 2 RBC units over 8 weeks in MDS-RS or MDS/MPN-RS-T.
For beta thalassemia, document qualifying HBB genetic findings or the specified severe microcytic/hypochromic anemia, smear, and hemoglobin-analysis findings. Alpha-thalassemia and hemoglobin S/beta-thalassemia variants are excluded.
For initial beta-thalassemia approval, document RBC transfusion dependence requiring 6–20 RBC units per 24 weeks.

Documentation Required

Required Weight Documentation

The beneficiary’s weight must be documented in the prior approval submission for both initial and renewal requests.

Include the most recent measured weight with each request.

Documentation Required

Continuation and Dosing Documentation

For continuation requests, document ongoing eligibility, treatment response or lack/loss of response, the need for any dose increase, and administration details.

Hb must remain <11.5 g/dL; if Hb is >11.5 g/dL, delay the dose until Hb is <11 g/dL.
Document decreased RBC transfusions, or for new starts, no reduction after more than 2 consecutive initial doses with a dose increase required.
If response was followed by lack or loss of response, document the dose increase and that other causes, such as a bleeding event, were ruled out.
Doses must not be administered less than 21 days apart.
Document that no treatment-restricting adverse effects, such as thromboembolic events or severe hypertension, occurred.
For dosing, use the pretransfusion Hb when an RBC transfusion occurred before dosing; obtain laboratory values within 7 days of administration.

Prior Authorization

EPSDT and Prior Approval

For beneficiaries under 21, follow EPSDT requirements. If the service, product, or procedure requires prior approval, being under 21 does not eliminate the prior approval requirement.

Consult the NCTracks Provider Claims and Billing Assistance Guide and the EPSDT provider page for additional EPSDT and prior approval information.

Denial Risk

Age, Diagnosis, or Indication Criteria Not Met

The request may be denied when age, diagnosis, or covered indication criteria are not met.

Beneficiary is under 18 years of age.
Diagnosis or required diagnostic evidence is not documented.
The indication is not a covered beta-thalassemia, ESA-naive MDS, MDS-RS, or MDS/MPN-RS-T anemia indication.
Beta-thalassemia criteria are not met, including required transfusion history for initial approval.

Denial Risk

Clinical Safety or Hemoglobin Exclusion

The request may be denied when clinical safety or hemoglobin exclusion criteria are present.

Deep vein thrombosis or thrombotic stroke requiring medical intervention within 6 months before therapy.
Major end-organ damage, including qualifying liver, heart, lung, or renal disease: ALT >3 times the ULN or cirrhosis; specified serious heart disease or recent myocardial infarction; clinically significant lung disease such as grade 3 or higher pulmonary fibrosis or pulmonary hypertension; or creatinine clearance <60 mL/min.
Baseline Hb is not <11.5 g/dL. If Hb is >11.5 g/dL, dosing must be delayed until Hb is <11 g/dL.

Denial Risk

Alternative Anemia Cause or Reproductive Safety Requirement

The request may be denied when alternative causes of anemia have not been ruled out or reproductive safety requirements are not documented.

Rule out other causes of anemia, including hemolysis, bleeding, recent major surgery, and vitamin deficiency.
For female beneficiaries of reproductive potential, document a negative pregnancy test before therapy and use of effective contraception during treatment and for more than 3 months after treatment.

Denial Risk

Continuation or Dosing Criteria Not Met

Continuation or dosing criteria must be met for renewal and ongoing therapy. Requests may be denied when the beneficiary no longer meets the initial criteria or required continuation criteria are not documented.

Hb must meet the dosing threshold.
Required response, lack or loss of response with dose-increase criteria, and relevant causative-factor assessment must be documented.
Doses must be at least 21 days apart.
Treatment-restricting adverse effects must not be present.

Clinically significant lung disease, including pulmonary fibrosis or pulmonary hypertension, such as grade 3 or higher

Renal diseaseCreatinine clearance below 60 mL/min

Dosing laboratory timing

Laboratory timingObtain laboratory values within 7 days before the date of administration

Pretransfusion measurementUse the pretransfusion hemoglobin for dosing purposes when an RBC transfusion occurred before dosing

Hemoglobin requirementHemoglobin must be below 11.5 g/dL for dosing; if above 11.5 g/dL, delay dosing until below 11 g/dL

The beneficiary has severe microcytic or hypochromic anemia, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis showing decreased or absent hemoglobin A with increased hemoglobin F.

The beneficiary is RBC transfusion dependent, requiring 6 to 20 RBC units over 24 weeks for initial approval.6–20 RBC units per 24 weeks

Alpha-thalassemia and hemoglobin S/beta-thalassemia variants are excluded; transfusion dependence is not required on continuation.

ESA-naive MDS

The beneficiary has anemia without previous erythropoiesis-stimulating agent use and very low- to intermediate-risk myelodysplastic syndromes that may require regular RBC transfusions.

ESA-failure MDS or MDS/MPN

The beneficiary has anemia failing an erythropoiesis-stimulating agent and requiring 2 or more RBC units over 8 weeks in very low- to intermediate-risk MDS with ring sideroblasts or MDS/MPN with ring sideroblasts and thrombocytosis.≥2 RBC units over 8 weeks

Safety criteria

The beneficiary has not had a deep vein thrombosis or thrombotic stroke requiring medical intervention within 6 months before therapy.
The beneficiary does not have major end organ damage, including liver disease with ALT greater than 3 times the upper limit of normal or cirrhosis; heart disease, NYHA class 3 or higher heart failure, significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months or requiring treatment; clinically significant lung disease; or creatinine clearance below 60 mL/min.
The baseline hemoglobin is below 11.5 g/dL.Hb <11.5 g/dL
If hemoglobin is above 11.5 g/dL, delay the dose until hemoglobin is below 11 g/dL.
Other causes of anemia, including hemolysis, bleeding, recent major surgery, or vitamin deficiency, have been ruled out.

Reproductive safety

Female beneficiaries of reproductive potential have a negative pregnancy test before starting therapy and will use effective contraception during treatment and for more than 3 months after treatment.

For a new start, the beneficiary has not achieved a reduction in RBC transfusion burden after more than 2 consecutive initial doses and requires a dose increase.>2 consecutive initial doses

The beneficiary previously experienced a response followed by a lack or loss of response, requires a dose increase, and other causative factors, such as a bleeding event, have been ruled out.

Doses will not be administered less than 21 days apart.≥21 days between doses

Laboratory values should be obtained within 7 days before administration.

The beneficiary has not experienced treatment-restricting adverse effects, including thromboembolic events or severe hypertension.