ModifiedAmeriHealth Caritas VIP CarePolicy MA08.110e

Luspatercept-aamt (Reblozyl) Coverage

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Medicare Advantage Part B medical-benefit coverage and prior authorization for subcutaneous luspatercept-aamt in adults with transfusion-dependent beta-thalassemia, myelodysplastic syndromes or MDS/MPN, and myelofibrosis-associated anemia. Part D coverage is not addressed.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLuspatercept-aamt (Reblozyl) Coverage

Policy CodePolicy MA08.110e

Change TypeModified

Effective DateJune 18, 2026

Next Review DateN/A

Key ActionObtain prior approval for treatment, and submit a new approval request for any dose, frequency, or regimen change.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmeriHealth Caritas VIP CarePolicy MA08.110e

Luspatercept-aamt (Reblozyl) Coverage

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLuspatercept-aamt (Reblozyl) Coverage

Policy CodePolicy MA08.110e

Change TypeModified

Effective DateJune 18, 2026

Next Review DateN/A

Key ActionObtain prior approval for treatment, and submit a new approval request for any dose, frequency, or regimen change.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were revised for myelodysplastic syndromes based on ring sideroblast percentage, SF3B1 mutation status, prior imetelstat response, and relapse or inadequate response after erythropoiesis-stimulating agents.

The policy history states that ICD-10-CM codes were removed from the policy and that the appropriate diagnosis code should instead be reported to support medical necessity.

The policy history states that lower-risk myelodysplastic syndrome coverage changed from requiring ESA-naive status to allowing coverage with or without prior ESA therapy.

The policy replaced HCPCS code J3590 for unclassified biologics with HCPCS code J0896 for luspatercept-aamt injection.

1 mg/kg q3wkStandard initial dose and frequency

≤11 g/dLBaseline hemoglobin threshold

J0896Current luspatercept-aamt code

J3590Removed unclassified biologics code

Part B onlyBenefit addressed

Coverage Criteria

Initial Therapy for β-thalassemia

Covered when ALL of the following criteria, including dosing and frequency requirements, are met:

ALL of the following

Documented diagnosis of β-thalassemia, hemoglobin E/β-thalassemia, or β-thalassemia combined with α-thalassemia, confirmed by molecular genetic testing revealing pathogenic variation(s) in the HBB gene causing β-thalassemia or by hemoglobin electrophoresis.
Individual has a baseline hemoglobin (Hgb) level of 11 g/dL or less.≤ 11 g/dL
Documentation that the individual is transfusion-dependent and requires regular RBC transfusions, defined as at least six units of RBC in the previous 24 weeks and no transfusion-free period of 35 days or more during that period.
Treatment will not be combined with a gene therapy used to treat β-thalassemia.
Dosing and frequency: 1 mg/kg as a subcutaneous injection every 3 weeks. If a reduction in RBC transfusion burden is not achieved after at least two consecutive doses (6 weeks), coverage is allowed up to a maximum dose of 1.25 mg/kg every 3 weeks.

Continuation Therapy for β-thalassemia

Continuation is covered when the individual has demonstrated a documented reduction in the number of transfusions compared with baseline.

Documented reduction in transfusion burden compared with baseline.

Initial Therapy for MDS and MDS/MPN

Covered when ALL of the following criteria, including dosing and frequency requirements, are met:

ALL of the following

Individual has presence of the long arm of chromosome 5 (i.e., no del [5q]).
Documented diagnosis of ONE of the following
- Lower-risk MDS
  - Lower-risk MDS, defined as International Prognostic Scoring System-Revised (IPSS-R) Very Low, Low, or Intermediate, with or without other cytogenetic abnormalities.
  - ONE of the following disease/treatment features
    ALL of the following
    Ring sideroblasts (RS) 15% or greater, or RS 5% or greater with an SF3B1 mutation.

Continuation Therapy for MDS

Continuation is covered when the individual has demonstrated at least ONE of the following compared with baseline:

At least ONE response criterion

Increase in RBC transfusion independence (transfusion-free period).
Increase in hemoglobin levels.
Reduction in transfusion burden, meaning the amount of units required with each red cell transfusion.

Initial Therapy for Myelofibrosis

Covered when ALL of the following criteria, including dosing and frequency requirements, are met:

ALL of the following

Documentation of ONE of the following myelofibrosis features
- Splenomegaly and constitutional symptoms, such as fever, night sweats, itching, bone pain, and weight loss, are well controlled on a current JAK inhibitor or combination JAK inhibitor.
- Ongoing symptomatic splenomegaly and/or constitutional symptoms, in combination with ruxolitinib.
- No splenomegaly or constitutional symptoms.
Individual has a baseline hemoglobin (Hgb) level of 11 g/dL or less.≤ 11 g/dL

Continuation Therapy for Myelofibrosis

Continuation is covered when the individual has demonstrated at least ONE of the following compared with baseline:

At least ONE response criterion

Increase in RBC transfusion independence (transfusion-free period).
Increase in hemoglobin levels.
Reduction in transfusion burden, meaning the amount of units required with each red cell transfusion.

Subject to the applicable Evidence of Coverage, luspatercept-aamt (Reblozyl) is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria and dosing and frequency requirements in this medical policy are met.

For Medicare Advantage members, luspatercept-aamt (Reblozyl) may be available through either the medical benefit (Part B) or pharmacy benefit (Part D), depending on how it is prescribed, dispensed, or administered. This policy addresses only instances in which luspatercept-aamt (Reblozyl) is covered under the member's medical benefit (Part B); it does not address coverage under the pharmacy benefit (Part D).

Services identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

The safety and effectiveness of luspatercept-aamt (Reblozyl) in pediatric individuals have not been established. Based on findings in juvenile animals, luspatercept-aamt (Reblozyl) is not recommended for use in the pediatric population.

Luspatercept-aamt (Reblozyl) is not indicated as a substitute for RBC transfusions in individuals who require immediate correction of anemia.

The safety and effectiveness of luspatercept-aamt (Reblozyl) in pediatric individuals have not been established; based on findings in juvenile animals, luspatercept-aamt (Reblozyl) is not recommended for use in the pediatric population.

Continuation therapy with luspatercept-aamt (Reblozyl) in individuals with β-thalassemia is considered not medically necessary and not covered when the individual does not experience a decrease in transfusion burden after five doses: two doses at 1 mg/kg and three doses at 1.25 mg/kg. The available published peer-reviewed literature does not support use in this circumstance.

Continuation therapy with luspatercept-aamt (Reblozyl) in individuals with MDS, MDS/MPN, or myelofibrosis is considered not medically necessary and not covered when the individual does not experience a decrease in transfusion burden after at least three consecutive doses of the maximum dosage of 1.75 mg/kg administered at 3-week intervals. The available published peer-reviewed literature does not support use in this circumstance.

When molecular genetic testing reveals established benign variation(s) or a wild-type genotype in the HBB gene, luspatercept-aamt (Reblozyl) is considered not medically necessary and not covered because the available published peer-reviewed literature does not support its use in the treatment of this disease.

Billing and Coding

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10Covered

D46.1	Refractory anemia with ring sideroblasts
D46.9	Myelodysplastic syndrome, unspecified
D56.1	Beta thalassemia
D56.5	Hemoglobin E-beta thalassemia

HCPCS Level II Code Number(s)HCPCSCovered

J0896

Injection, luspatercept-aamt, 0.25 mg

Revenue Code Number(s)Revenue

N/A

Removed HCPCS CodeHCPCSNot Covered

J3590

Unclassified biologics

Replacement HCPCS CodeHCPCSCovered

J0896

Injection, luspatercept-aamt, 0.25 mg

Myelodysplastic Syndromes ICD-10 CodesICD-10Covered

D46.1	Refractory anemia with ring sideroblasts
D46.9	Myelodysplastic syndrome, unspecified

Beta-thalassemia transfusion dependence

RBC transfusionsAt least 6 units in the previous 24 weeks

Transfusion-free periodNo transfusion-free period of 35 days or more during that period

PopulationAdults with transfusion-dependent beta-thalassemia anemia

MDS/MDS-MPN transfusion dependence

RBC transfusionsAt least 2 units every 8 weeks

Provider Requirements and Actions

Prior Authorization

Prior Approval for Treatment and Regimen Changes

The professional provider must obtain prior approval for luspatercept-aamt (Reblozyl) when initiating treatment or changing the member’s dose, frequency, or regimen. Changes may include adjustments based on member weight or incomplete therapeutic response.

Submit treatment and regimen changes to the Company for a new approval as part of utilization management activities.
The Company may conduct postpayment review and audit procedures for submitted claims.

Step Therapy

ESA Trial or Contraindication Required

For selected lower-risk MDS, coverage requires no response to or relapse after ESA therapy alone despite adequate iron stores, unless the individual has a documented contraindication or intolerance to ESAs.

Applies to lower-risk MDS with ring sideroblasts of 15% or greater, or at least 5% with an SF3B1 mutation, when luspatercept is used following ESA therapy.
The individual must also meet the policy’s other MDS criteria, including applicable risk category and baseline hemoglobin and transfusion-dependence requirements.

Clinical Background

Luspatercept-aamt (Reblozyl) is a subcutaneous erythroid maturation agent and recombinant fusion protein that binds to and inhibits selected transforming growth factor beta superfamily ligands involved in late-stage erythropoiesis, thereby enhancing red blood cell production. The policy addresses its use in adults with anemia associated with transfusion-dependent beta-thalassemia, selected myelodysplastic syndromes (MDS) or MDS/MPN, and myelofibrosis-associated anemia.

Definitions

ESA failure definition

Hemoglobin responseNo rise of at least 1.5 g/dL

Transfusion responseNo decrease in RBC transfusion requirement

Assessment periodBy 6 to 8 weeks of treatment

Lower-risk MDS definition

IPSSLow or intermediate-1 risk

IPSS-RVery low, low, or intermediate risk

WPSSVery low, low, or intermediate risk

Initial Therapy

Beta-Thalassemia Initial Therapy

Covered for adults with transfusion-dependent beta-thalassemia when all requirements are met.

Adult diagnosis: Adult with anemia due to beta-thalassemia, hemoglobin E/beta-thalassemia, or beta-thalassemia combined with alpha-thalassemia, confirmed by pathogenic HBB variation(s) or hemoglobin electrophoresis.

Clinical thresholds: Baseline hemoglobin is 11 g/dL or less; at least 6 RBC units were required in the previous 24 weeks; and there was no transfusion-free period of 35 days or more during that period.Hgb <=11 g/dL; >=6 RBC units/24 weeks; no transfusion-free period >=35 days

Treatment and dosing: Treatment is not combined with beta-thalassemia gene therapy; administer 1 mg/kg subcutaneously every 3 weeks.1 mg/kg SC every 3 weeks

Continuation Therapy

Beta-Thalassemia Continuation

Continuation requires documented improvement compared with baseline.

Required response: Documented reduction in the number of transfusions compared with baseline.

MDS and Myelofibrosis Continuation

Continuation requires at least one documented response compared with baseline.

At least one response criterion

Increase in RBC transfusion independence, meaning an increased transfusion-free period.
Increase in hemoglobin levels.

Sequencing Requirements

Coverage	MDS pathway	Sequencing requirement	Exception
Covered	Lower-risk MDS with ring sideroblasts (RS) <15%, or RS <5% with an SF3B1 mutation; serum erythropoietin (EPO) must be ≤500 mU/mL.	Use luspatercept after no response to or relapse after ESAs alone, despite adequate iron stores.	The ESA sequencing requirement does not apply when an ESA contraindication or intolerance is documented.

Coverage	MDS pathway	Sequencing requirement	Alternative
Covered	Lower-risk MDS with RS ≥15%, or RS ≥5% with an SF3B1 mutation.	Use luspatercept after no response to or relapse after imetelstat.	Luspatercept may instead be used as a single-agent NCCN-preferred regimen.

Site of Care

Billing Rule

Use the most appropriate and cost-effective site of care

The Company may reimburse only the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition, including required monitoring or coincident services.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLuspatercept-aamt (Reblozyl) Coverage

Policy CodePolicy MA08.110e

Change TypeModified

Effective DateJune 18, 2026

Next Review DateN/A

Key ActionObtain prior approval for treatment, and submit a new approval request for any dose, frequency, or regimen change.

SourceLink

On This Page

ONE of the following treatment settings

As a single agent (NCCN-preferred regimen).
Following no response to or relapse after imetelstat (Rytelo) (NCCN-preferred regimen).

RS less than 15%, or RS less than 5% with an SF3B1 mutation, when serum erythropoietin levels are 500 mU/mL or less.

Following no response to or relapse after ESAs alone, despite adequate iron stores, unless contraindications or intolerance to ESAs exist (NCCN-preferred regimen).

MDS/MPN overlap neoplasm

Myelodysplastic/myeloproliferative neoplasm (MDS/MPN) overlap neoplasm with an SF3B1 mutation and thrombocytosis, defined as platelets 450 × 10^9/L or greater, treated as a single agent.

Individual has a baseline hemoglobin (Hgb) level of 11 g/dL or less.≤ 11 g/dL

Transfusion requirement

Documentation that the individual is transfusion-dependent and requires regular RBC transfusions, defined as at least two units every 8 weeks.
Exception: documentation that the individual cannot receive regular blood transfusions, such as for religious reasons or because of blood shortages.

Dosing and frequency: 1 mg/kg as a subcutaneous injection every 3 weeks. If the individual is not RBC transfusion-free after at least two consecutive doses, an increased dose of 1.33 mg/kg every 3 weeks is covered. If the individual is still not RBC transfusion-free after at least two more consecutive doses, an increased maximum dose of 1.75 mg/kg every 3 weeks is covered.

ESA failure is defined as lack of a ≥1.5 g/dL rise in hemoglobin or lack of a decrease in RBC transfusion requirement by 6 to 8 weeks of treatment, per NCCN.

Regular transfusions may be unavailable because of circumstances such as religious reasons or blood shortages

Applicable conditionsMDS, MDS/MPN, or an MDS/MPN overlap neoplasm

Baseline hemoglobin threshold

Threshold11 g/dL or less

MeasurementBaseline hemoglobin

Applicable conditionsBeta-thalassemia, MDS/MDS-MPN, and myelofibrosis-associated anemia

MDS ring sideroblast and SF3B1 thresholds

Higher ring sideroblast burden15% or greater, or 5% or greater with an SF3B1 mutation

Lower ring sideroblast burdenLess than 15%, or less than 5% with an SF3B1 mutation

Lower-burden pathwaySerum erythropoietin must be 500 mU/mL or less and treatment follows no response to or relapse after ESAs alone, despite adequate iron stores, unless contraindicated or intolerant

MDS/MPN thrombocytosis threshold

Platelet threshold450 × 10^9/L or greater

Mutation criterionSF3B1 mutation

ConditionMDS/MPN overlap neoplasm with thrombocytosis

Dose-safety hemoglobin trigger

Hemoglobin riseGreater than 2 g/dL within 3 weeks

Predose hemoglobin11.5 g/dL or higher

ActionReduce the dose or interrupt treatment when no transfusion occurred before dosing

BELIEVE trial baseline transfusion burden

Baseline burden6 to 20 RBC units in the 24 weeks before randomization

Transfusion-free periodNo transfusion-free period of at least 35 days during that period

TrialBELIEVE

BELIEVE transfusion response endpoint

Reduction from baselineAt least 33%

Additional reductionAt least 2 units from Week 13 to Week 24

EndpointRBC transfusion-burden reduction

Ring sideroblast response predictor

Primary thresholdAt least 15% ring sideroblasts

SF3B1 pathwayAt least 5% ring sideroblasts with an SF3B1 mutation

Clinical usePositive predictor of luspatercept response in lower-risk MDS

Serum EPO treatment-consideration threshold

Serum EPO threshold500 mU/mL or less

Treatment considerationGenerally indicates luspatercept or ESA treatment consideration

Higher levelsGreater serum EPO levels indicate impaired red blood cell production and may indicate immunosuppressants or chemotherapy

MEDALIST transfusion requirement

RBC requirementAt least 2 RBC units per 8 weeks

Assessment periodDuring the 16 weeks before randomization

TrialMEDALIST

MEDALIST bone marrow blast threshold

Bone marrow blastsLess than 5%

Disease settingMDS with ring sideroblasts or MDS/MPN-RS-T

TrialMEDALIST

ESA-naive MDS transfusion requirement

RBC requirement2 to 6 RBC units per 8 weeks

Confirmation periodConfirmed for at least 8 weeks immediately preceding randomization

PopulationESA-naive adults with very low-, low-, or intermediate-risk MDS or MDS/MPN RS-T

ESA-naive MDS efficacy endpoint

Transfusion criterionNo RBC transfusion during a consecutive 12-week period

Hemoglobin criterionConcurrent mean hemoglobin improvement of at least 1.5 g/dL

Assessment windowAny consecutive 12-week period during Weeks 1 to 24

Ring sideroblast percentage criterion

Standard thresholdAt least 15% ring sideroblasts

SF3B1 thresholdAt least 5% ring sideroblasts with an SF3B1 mutation

Clinical settingLower-risk MDS treatment recommendation

ESA hemoglobin response definition

Hemoglobin responseAt least a 1.5 g/dL rise

Response windowWithin 6 to 8 weeks

TherapyErythropoiesis-stimulating agent treatment

ESA transfusion response definition

Transfusion responseA decrease in red blood cell transfusion requirement

Response windowWithin 6 to 8 weeks of treatment

TherapyErythropoiesis-stimulating agent treatment

Step Therapy

Imetelstat Sequencing Requirement

For selected lower-risk MDS with ring sideroblasts, luspatercept may be covered following no response to or relapse after imetelstat (Rytelo), consistent with the NCCN-preferred regimen.

Applies to lower-risk MDS with ring sideroblasts of 15% or greater, or at least 5% with an SF3B1 mutation.
The individual must also meet the policy’s other MDS criteria.

Documentation Required

Medical Records and Test Reports Required

The medical record must reflect the medical necessity for luspatercept-aamt (Reblozyl). Records and test reports must be available to the Company upon request for review or audit.

Supporting documentation may include records from professional provider offices, hospitals, nursing homes, home health agencies, therapy providers, and test reports.
Failure to produce requested documentation may result in denial of the service.
The Company may review or audit services regardless of the provider’s participation status.

Documentation Required

Documentation for Nonstandard Dosing

When coverage is requested outside the policy’s dosing and frequency requirements, the prescribing professional provider must submit supporting documentation, including published peer-reviewed literature, that supports the nonstandard dose or frequency.

Documentation must support the requested use under the Company’s recognized pharmacology compendia or applicable off-label coverage policy.

Prior Authorization

Submit Updated Dose and Regimen Information

Accurate member information is required to approve the requested luspatercept dose and frequency. The provider must submit updated dose, frequency, or regimen information whenever treatment changes.

Updates may be required because of changes in member weight or incomplete therapeutic response.
A new approval is required for the changed treatment information.

Denial Risk

β-Thalassemia: No Response After Five Doses

Continuation therapy for β-thalassemia is not medically necessary and is not covered when the individual does not experience a decrease in transfusion burden after five doses.

The five-dose trial consists of two doses at 1 mg/kg and three doses at 1.25 mg/kg.

Denial Risk

No Response at Maximum Dose

Continuation therapy for MDS, MDS/MPN, or myelofibrosis is not medically necessary and is not covered when the individual does not experience a decrease in transfusion burden after at least three consecutive doses at the maximum dosage.

Maximum dosage is 1.75 mg/kg administered at three-week intervals.

Denial Risk

Benign or Wild-Type HBB Result

Luspatercept-aamt (Reblozyl) is not medically necessary and is not covered when molecular genetic testing reveals established benign variation(s) or a wild-type genotype in the HBB gene.

The policy does not support use in this circumstance based on the available published peer-reviewed literature.

Denial Risk

Experimental or Investigational Uses Not Covered

All other uses of luspatercept-aamt (Reblozyl) are experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company’s policy for off-label coverage for prescription drugs and biologics.

Hemoglobin S/β-thalassemia or α-thalassemia.
Non-transfusion-dependent β-thalassemia.
Use as a substitute for RBC transfusions when immediate correction of anemia is required.

Denial Risk

Likely Pathogenic or Uncertain HBB Variant

When molecular genetic testing reveals a likely pathogenic HBB variant or a variant of unknown significance (VUS), use of luspatercept-aamt (Reblozyl) is experimental/investigational and is not covered.

Coverage is excluded because the safety and/or effectiveness of the service cannot be established from the available published peer-reviewed literature.

Denial Risk

Noncovered Experimental or Not Medically Necessary Services

Services identified in the policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

Coverage is subject to the applicable Evidence of Coverage and requires that the policy’s medical-necessity criteria and dosing and frequency requirements be met.
This section applies to luspatercept-aamt (Reblozyl) covered under the Medicare Advantage medical benefit (Part B); pharmacy benefit (Part D) coverage is not addressed by this policy.

Higher-risk MDS definition

IPSSIntermediate-2 or high risk

IPSS-RHigh or very high risk

WPSSHigh or very high risk

Hemoglobin dose-safety trigger definition

Hemoglobin rise triggerGreater than 2 g/dL within 3 weeks when no transfusion occurred before dosing

Predose triggerHemoglobin 11.5 g/dL or higher

Required responseDose reduction or treatment interruption

Luspatercept-aamt definition and mechanism

DrugLuspatercept-aamt (Reblozyl)

StructureRecombinant fusion protein

MechanismBinds to and inhibits several endogenous TGFβ superfamily ligands involved in late-stage erythropoiesis, diminishing abnormally elevated Smad2/3 signaling and enhancing RBC production

Ring sideroblasts definition

Cell typeErythroid precursors

CharacteristicIron-laden mitochondria forming a perinuclear ring

Clinical significanceThe mitochondrial iron retention prevents iron from incorporating into heme, leading to low RBC production

Erythropoietin definition

TypeGlycoprotein hormone

SourcePeritubular cells of the kidney

FunctionStimulates red blood cell production

MDS-RS or MDS/MPN-RS-T definition

MDS-RSMyelodysplastic syndromes with ring sideroblasts

MDS/MPN-RS-TMyelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis

Clinical contextAssociated anemia treated in the MEDALIST study

ESA failure definition and 6-to-8-week response window

Hemoglobin criterionNo rise of at least 1.5 g/dL

Transfusion criterionNo decrease in red blood cell transfusion requirement

Response windowAfter 6 to 8 weeks of treatment

Ring sideroblast criterion definition

Primary criterionAt least 15% ring sideroblasts

SF3B1 criterionAt least 5% ring sideroblasts when an SF3B1 mutation is present

UseDefines ring sideroblast status for treatment consideration

If transfusion burden does not decrease after at least two consecutive doses, coverage may continue up to 1.25 mg/kg every 3 weeks.

MDS and MDS/MPN Initial Therapy

Covered for adults with qualifying MDS or MDS/MPN when all requirements are met.

Disease and laboratory requirements: Adult with MDS, MDS/MPN, or an MDS/MPN overlap neoplasm; presence of the long arm of chromosome 5 with no del(5q); and baseline hemoglobin of 11 g/dL or less.Hgb <=11 g/dL; no del(5q)

Qualifying disease pathway

Lower-risk MDS with ring sideroblasts of at least 15%, or at least 5% with an SF3B1 mutation, treated as a single agent or after no response to or relapse after imetelstat.
Lower-risk MDS with ring sideroblasts below those thresholds, serum erythropoietin of 500 mU/mL or less, and no response to or relapse after ESAs alone despite adequate iron stores, unless an ESA contraindication or intolerance exists.RS <15% or <5% with SF3B1; EPO <=500 mU/mL
MDS/MPN overlap neoplasm with an SF3B1 mutation and thrombocytosis, treated as a single agent.Platelets >=450 x 10^9/L

Transfusion requirement: Regular RBC transfusions of at least 2 units every 8 weeks, or documented inability to receive regular transfusions because of religious reasons, blood shortages, or similar circumstances.>=2 RBC units every 8 weeks, or documented exception

Dosing and escalation: Administer 1 mg/kg subcutaneously every 3 weeks; escalate to 1.33 mg/kg after at least two consecutive doses without being RBC transfusion-free and to the maximum 1.75 mg/kg after at least two additional consecutive doses without being RBC transfusion-free.1 mg/kg, then 1.33 mg/kg, maximum 1.75 mg/kg SC every 3 weeks

Myelofibrosis Initial Therapy

Covered for adults with myelofibrosis-associated anemia when all requirements are met.

Qualifying clinical-feature pathway

Splenomegaly and constitutional symptoms are well controlled on a current or combination JAK inhibitor.
Ongoing symptomatic splenomegaly and/or constitutional symptoms are present in combination with ruxolitinib.
No splenomegaly or constitutional symptoms.

Hemoglobin and dosing requirements: Baseline hemoglobin is 11 g/dL or less; administer 1 mg/kg subcutaneously every 3 weeks; escalate to 1.33 mg/kg after at least two consecutive doses without being RBC transfusion-free and to the maximum 1.75 mg/kg after at least two additional consecutive doses without being RBC transfusion-free.Hgb <=11 g/dL; 1 mg/kg, then 1.33 mg/kg, maximum 1.75 mg/kg SC every 3 weeks

Reduction in transfusion burden, meaning a reduction in the number of units required with each red cell transfusion.