ModifiedCentenePolicy CP.PHAR.180

Eltrombopag (Alvaiz, Promacta) coverage

Clinical coverage and prior authorization criteria for eltrombopag (Promacta, Alvaiz) for Centene lines of business, including FDA‑approved and select NCCN off‑label indications; applies to providers requesting benefit coverage.

Policy Summary

PayerCentene

PolicyEltrombopag (Alvaiz, Promacta) coverage

Policy CodePolicy CP.PHAR.180

Change TypeMaterial updates — added Alvaizadded NCCN compendium indicationsrevised initial approval duration to 12 months for most indications

Effective DateMar 1, 2016

Next Review Date

Key ActionPrior authorization is required; submit office notes and labs showing member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added Alvaiz, a new eltrombopag choline formulation to the policy.

Added NCCN Compendium-supported indications including prolonged thrombocytopenia post-hematopoietic cell transplant, ICAHT, and immunotherapy-related thrombocytopenia.

For all indications other than hepatitis C-associated thrombocytopenia, initial approval duration was revised from 6 to 12 months.

Added exclusion of concurrent thrombopoietin receptor agonist with Promacta for certain indications and exclusion of concurrent spleen tyrosine kinase inhibitor (e.g., Tavalisse) for all FDA-labeled indications.

For post-hematopoietic cell transplant prolonged thrombocytopenia, added requirement that member has poor graft function per NCCN.

12 monthsTypical approval duration for most indications

6 monthsApproval duration for hepatitis C-associated thrombocytopenia

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Coverage includes FDA & NCCN

3FDA-labeled indications listed

Boxed warningHepatotoxicity risk

Coverage Criteria for Eltrombopag (Promacta, Alvaiz)

Initial Approval — Persistent/Chronic Immune Thrombocytopenia (ITP)

Covered when ALL of the following are met

ALL of the following

Diagnosis of persistent or chronic ITP
Prescriber: Prescribed by or in consultation with a hematologist
Age: For eltrombopag (Promacta): ≥ 1 year; For Alvaiz: ≥ 6 years
Severity: Current (within 30 days) platelet count <30,000/µL OR member has an active bleed
Prior therapy: Failure of a systemic corticosteroid unless contraindicated or clinically significant adverse effects are experienced
Product preference: For Promacta and Alvaiz requests, member must use eltrombopag (generic Promacta) unless contraindicated or clinically significant adverse effects are experienced
Concomitant therapy exclusion: Eltrombopag (Promacta) and Alvaiz are not prescribed concurrently with rituximab, another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Nplate), or a spleen tyrosine kinase inhibitor (e.g., Tavalisse)
Quantity limit: Request does not exceed health plan-approved quantity limit, if applicable
Dose limit: Dose does not exceed 1 tablet per day: For Promacta 75 mg/day; For Alvaiz 54 mg/day

Authorization duration: Approval duration: 12 months

Initial Approval — Chronic Hepatitis C‑Associated Thrombocytopenia

Covered when ALL of the following are met

ALL of the following

Diagnosis of chronic hepatitis C-associated thrombocytopenia
Prescriber: Prescribed by or in consultation with a hematologist, hepatologist, gastroenterologist or infectious disease specialist
Age ≥ 18 years
Concomitant therapy: Eltrombopag (Promacta) or Alvaiz will be used concomitantly with interferon-based therapy
Clinical need:

Initial Approval — Severe Aplastic Anemia

Covered when ALL of the following are met

ALL of the following

Diagnosis of severe aplastic anemia
Prescriber: Prescribed by or in consultation with a hematologist
Age: For eltrombopag (Promacta): ≥ 2 years; For Alvaiz: ≥ 18 years
Line of therapy: Either: Promacta only as first-line in combination with immunosuppressive therapy OR refractory/second-line single agent following insufficient response to immunosuppressive therapy

Initial Approval — NCCN Compendium Indications (off‑label)

Covered when ALL of the following are met

ALL of the following

Indication: Prescribed for one of: MDS; post-hematopoietic cell transplant with prolonged thrombocytopenia; immune effector cell (IEC)-associated hematologic toxicity (ICAHT); or immunotherapy-related thrombocytopenia
Prescriber: Prescribed by or in consultation with an oncologist or hematologist
MDS specifics: For MDS: Member has lower-risk MDS (IPSS-R: Very Low, Low, Intermediate) and one of the specified clinical features (severe or refractory thrombocytopenia, marrow or molecular qualifiers, or symptomatic anemia per NCCN criteria)
Post-HCT specifics:

Covered Indications and Requirements

Covered when meeting FDA-labeled indication-specific dosing and selected NCCN-supported indications with plan requirements

Indications covered: Includes persistent or chronic ITP, chronic hepatitis C-associated thrombocytopenia, severe aplastic anemia, and select NCCN Compendium indications (prolonged thrombocytopenia post-hematopoietic cell transplant with poor graft function, ICAHT, immunotherapy-related thrombocytopenia)

Dosing and age criteria: Follow product-specific dosing and age limits: product dosing differs by indication and age (see dosage table); maintain platelet count ≥50,000/µL when adjusting dosePlatelet ≥50,000/µL

Maximum doses differ by product and indication (e.g., Promacta up to 150 mg/day; Alvaiz up to 108 mg/day)

Response and monitoring: Therapeutic response should be demonstrated by platelet count increases (examples include achieving platelet count ≥50,000/µL or transfusion independence) or other hematologic improvements as applicable; dosing adjusted to maintain targetsPlatelet ≥50,000/µL

Per FDA product labeling, Promacta and Alvaiz are not indicated for the treatment of myelodysplastic syndromes (MDS). This limitation of use is specified in the manufacturers’ prescribing information and therefore MDS is not an FDA‑labeled indication for either product.

When requests involve MDS or other non‑FDA labeled uses, coverage decisions require evaluation against the policy’s off‑label use criteria and any applicable compendia guidance; see off‑label use policies referenced in this document for required supporting evidence.

Non‑FDA approved indications described in this policy are only authorized when supported by sufficient documentation of efficacy and safety in accordance with Centene off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable). Requests for other off‑label uses not covered by this policy require the same documentation and review per those off‑label policies.

For the Health Insurance Marketplace (HIM) line of business, a plan disclaimer applies: Alvaiz is non‑formulary for HIM, and requests for Alvaiz under that line of business are subject to the applicable formulary restrictions noted in the policy change log.

Concurrent therapy with another thrombopoietin receptor agonist is specifically excluded for certain indications. The policy adds an exclusion of concurrent use of another TPO receptor agonist with Promacta for severe aplastic anemia, chronic hepatitis C‑associated thrombocytopenia, and the specified NCCN Compendium indications.

Additionally, the policy excludes concurrent use of a spleen tyrosine kinase inhibitor (for example, Tavalisse™) with Promacta or Alvaiz for all FDA‑labeled indications, as noted in the annual review updates.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the requester provides sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other applicable evidence of coverage documents.

Providers should include the clinical rationale and supporting literature or compendia citations when requesting coverage for off‑label uses so the submission can be evaluated against the plan’s off‑label criteria.

Requests for non‑FDA labeled uses that do not include sufficient documentation per the Centene off‑label use policies referenced in this policy will be considered not medically necessary (NMN) and may be denied.

To avoid a denial, providers must follow the off‑label submission requirements and supply relevant clinical data, peer‑reviewed evidence, or authoritative compendia support as outlined in the referenced policies.

Dosing and Regimens

Regimen requirement	Details
Dose within FDA maximum or supported by NCCN/practice guidelines
Prescriber must submit supporting evidence when dose exceeds FDA maximum for an off-label use or when dosing is justified by practice guidelines/peer‑reviewed literature

Clinical context	Product-specific dosing / maximum
Eltrombopag added to immunosuppressive therapy as first-line in combination or used after insufficient response to immunosuppressive therapy
Promacta (eltrombopag): After insufficient response to immunosuppressive therapy — 50 mg PO QD, adjust to maintain platelet ≥50,000/µL; first-line in combination with immunosuppressive therapy: ≥12 years 150 mg PO QD; 6–11 years 75 mg PO QD; 2–5 years 2.5 mg/kg PO QD. Maximum dose: 150 mg/day. Alvaiz: After insufficient response — 36 mg PO QD, adjust to maintain platelet ≥50,000/µL; Maximum dose: 108 mg/day.

Clinical context

Product-specific dosing / maximum

Eltrombopag added to immunosuppressive therapy as first-line in combination or used after insufficient response to immunosuppressive therapy

Promacta (eltrombopag): After insufficient response to immunosuppressive therapy — 50 mg PO QD, adjust to maintain platelet ≥50,000/µL; first-line in combination with immunosuppressive therapy: ≥12 years 150 mg PO QD; 6–11 years 75 mg PO QD; 2–5 years 2.5 mg/kg PO QD. Maximum dose: 150 mg/day. Alvaiz: After insufficient response — 36 mg PO QD, adjust to maintain platelet ≥50,000/µL; Maximum dose: 108 mg/day.

Platelet count thresholds — key indications

Immune thrombocytopenia (ITP)Current platelet count <30,000/µL OR member has an active bleed (within 30 days).

Chronic hepatitis C‑associated thrombocytopeniaCurrent platelet count <75,000/µL (used to enable interferon‑based therapy).

Severe aplastic anemiaCurrent platelet count <50,000/µL.

ICAHT (immune effector cell‑associated hematologic toxicity)Platelet count <25,000/µL (Grade 4 thrombocytopenia).

Immunotherapy‑related thrombocytopeniaPlatelet count ≤50,000/µL (Grade 3 or 4 thrombocytopenia).

Platelet count target

Product Codes and Availability

NDCNDC

Eltrombopag (Promacta)	Oral tablets: 12.5 mg, 25 mg, 50 mg, 75 mg (all strengths available as generic)
Eltrombopag (Alvaiz)	Oral suspension: 12.5 mg, 25 mg (all strengths available as generic); Oral tablets: 9 mg, 18 mg, 36 mg, 54 mg

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for eltrombopag (Promacta), Alvaiz, and generic eltrombopag. Initial approval durations vary by indication: typically 12 months for most indications; for chronic hepatitis C‑associated thrombocytopenia the duration aligns with the treatment course per criteria. Continuation approvals (including NCCN compendium/off‑label indications meeting criteria) are generally 12 months.

Policy number: CP.PHAR.180; Effective date: 2016-03-01
Initial approval duration: 12 months for most indications; hepatitis C‑associated thrombocytopenia per treatment course
Continuation approval duration: 12 months

Documentation Required

Provider must submit supporting clinical documentation with the prior authorization request. Failure to provide required documentation (office chart notes, lab results, specialist consultation notes, transfusion records, prior therapy history, and any supporting literature for off‑label uses) may result in denial.

Line of Therapy Designations

first-line | second-line | salvage

ANY of the following

First-line for severe aplastic anemia: Promacta only as first-line in combination with immunosuppressive therapy (where applicable)
Second-line/Refractory: Refractory or second-line single agent following insufficient response to immunosuppressive therapy

Administration note: Prescriber must document whether request is for first-line combination therapy or second-line single-agent use; prior authorization may be required for concomitant immunosuppressive agents

salvage

ANY of the following

Definitions and Abbreviations

Eltrombopag — definition and products

Drug class and brandsEltrombopag — a thrombopoietin receptor agonist (Alvaiz, Promacta).

Promacta formulationsPromacta tablets available in strengths (e.g., 12.5, 25, 50, 75 mg) per product availability notes.

Alvaiz formulationsAlvaiz available in tablet strengths (9, 18, 36, 54 mg) and suspensions; dosing differs by indication and age.

ICAHT — definition and context

AcronymICAHT = Immune effector cell‑associated hematologic toxicity.

Context of useReferenced in NCCN Compendium indications for post‑IEC therapy thrombocytopenia and included among covered off‑label indications.

Background

Eltrombopag is a thrombopoietin receptor agonist approved as Promacta and, more recently added to this policy, the eltrombopag choline formulation Alvaiz. It is used to raise platelet counts in several hematologic conditions, including immune thrombocytopenia (ITP), to enable or maintain interferon‑based therapy for hepatitis C‑associated thrombocytopenia, and as adjunctive therapy in certain cases of severe aplastic anemia.

Policy updates documented in the annual reviews note additions of selected NCCN Compendium off‑label indications (for example, prolonged thrombocytopenia post‑hematopoietic cell transplant, ICAHT, and immunotherapy‑related thrombocytopenia) and the inclusion of Alvaiz as an available eltrombopag formulation; coverage for these uses requires meeting the specific criteria and documentation requirements described in this policy.

Policy Summary

PayerCentene

PolicyEltrombopag (Alvaiz, Promacta) coverage

Policy CodePolicy CP.PHAR.180

Change TypeMaterial updates — added Alvaizadded NCCN compendium indicationsrevised initial approval duration to 12 months for most indications

Effective DateMar 1, 2016

Next Review Date

Key ActionPrior authorization is required; submit office notes and labs showing member meets all approval criteria.

SourceLink

On This Page

Degree of thrombocytopenia has prevented initiation of interferon-based therapy or limited ability to maintain interferon-based therapy

Severity: Current (within 30 days) platelet count <75,000/µL

Product preference: For Promacta and Alvaiz requests, member must use eltrombopag (generic Promacta) unless contraindicated or clinically significant adverse effects are experienced

Concomitant therapy exclusion: Eltrombopag (Promacta) and Alvaiz are not prescribed concurrently with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Nplate) or a spleen tyrosine kinase inhibitor (e.g., Tavalisse)

Quantity and dose limits: Request does not exceed health plan-approved quantity limit, if applicable; Dose does not exceed 2 tablets per day: For Promacta 100 mg/day; For Alvaiz 72 mg/day

Authorization duration: Approval duration: 6 months

Platelet threshold: Current (within 30 days) platelet count <50,000/µL

Product preference: For Promacta and Alvaiz requests, member must use eltrombopag (generic Promacta) unless contraindicated or clinically significant adverse effects are experienced

Quantity and dose limits: Request does not exceed health plan-approved quantity limit, if applicable; Dose does not exceed 2 tablets per day: For Promacta up to 150 mg/day; For Alvaiz up to 108 mg/day

Authorization duration: Approval duration: 12 months

For post-hematopoietic cell transplant with prolonged thrombocytopenia: Member has poor graft function

ICAHT specifics: For ICAHT: Received or is receiving IEC therapy; platelet count <25,000/µL; and either ≥1 risk factor for ICAHT or cytopenias beyond 21 days post-infusion

Immunotherapy-related specifics: For immunotherapy-related thrombocytopenia: Platelet count ≤50,000/µL due to immune checkpoint inhibitor therapy and not responsive to corticosteroids

Product preference and evidence: For Promacta and Alvaiz requests, member must use eltrombopag (generic Promacta) unless contraindicated or clinically significant adverse effects are experienced; prescriber must submit supporting evidence for off-label use

Concomitant therapy exclusion: Eltrombopag (Promacta) and Alvaiz are not prescribed concurrently with another thrombopoietin receptor agonist

Dose limits and evidence: Dose is within FDA maximum for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Authorization duration: Approval duration: 12 months

Examples of acceptable response listed in policy

Authorization and plan requirements: Prior authorization is required; requests must not exceed health plan-approved quantity limits where applicable; initial approval durations typically 12 months (6 months for hepatitis C-associated thrombocytopenia)

Dose adjustment targetMaintain platelet count ≥ 50,000/µL when adjusting dose.

ITP/hepatitis C response examplePlatelet count ≥ 50,000/µL cited as an example of positive response for ITP or hepatitis C‑associated thrombocytopenia.

Aplastic anemia responseFor aplastic anemia, adjust to maintain platelet count ≥ 50,000/µL as a treatment goal.

Required documentation examples: office chart notes, recent laboratory results (including platelet counts within specified windows), documentation of prior therapies and responses, specialist consultation notes
If off‑label/NCCN-supported use is requested, prescriber must submit supporting evidence (e.g., NCCN recommendation, peer‑reviewed literature) per off‑label use policies

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications will be considered only when sufficient documentation of efficacy and safety is provided per applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents. Insufficient documentation may lead to denial.

Off‑label requests must include supporting evidence (NCCN compendium listing, peer‑reviewed studies, practice guidelines) and rationale for use
Refer to plan-specific off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)

Documentation Required

Required Clinical Documentation

Providers must include specific clinical information to demonstrate the member meets the relevant approval criteria: diagnosis, specialist involvement, age, recent platelet counts (with dates), evidence of bleeding when applicable, prior therapies tried and reasons for failure or contraindication (including corticosteroid trials), concurrent medications that are not allowed, and dosing information.

Diagnosis and date (e.g., persistent/chronic ITP, severe aplastic anemia, hepatitis C‑associated thrombocytopenia, or NCCN‑supported indication)
Specialist prescribing or consultation note (hematologist, hepatologist, gastroenterologist, infectious disease specialist as applicable)
Age of member and indication‑specific age requirements
Recent platelet count with date (within 30 days for initial criteria; within 90 days for continuation)
Documentation of prior systemic corticosteroid trial and outcome, or documentation of contraindication/adverse effects
Medication history documenting absence of concurrent prohibited agents (other TPO‑RAs, rituximab when applicable, spleen tyrosine kinase inhibitors)

Documentation Required

Response Documentation

Objective evidence of response to therapy is required for continuation/renewal. Examples of acceptable response measures vary by indication and should be provided in the request.

For ITP or hepatitis C‑associated thrombocytopenia: increase in platelet count from baseline; platelet count ≥ 50,000/µL; reduction in clinically important bleeding events
For severe aplastic anemia: platelet count ≥ 50,000/µL; platelet increase ≥ 20,000/µL above baseline or stable platelets with transfusion independence for ≥ 8 weeks; hemoglobin increase > 1.5 g/dL or reduction of ≥ 4 units RBC transfusions for 8 consecutive weeks; ANC increase of 100% or > 500/µL
For NCCN/off‑label indications: objective measures per the supporting guideline/literature and prescriber's documentation of clinical benefit

Salvage/NCCN-supported indications: Includes prolonged thrombocytopenia post-hematopoietic cell transplant (requires poor graft function per NCCN), ICAHT, and immunotherapy-related thrombocytopenia

Evidence requirement: Prescriber must document NCCN support and submit clinical rationale and supporting evidence for salvage/off-label use

EHA‑EBMT definition linkICAHT defined per EHA‑EBMT criteria (see Appendix D) for grade 4 thrombocytopenia specifics.

ITP duration of 3–12 months (Persistent ITP)

DefinitionITP duration of 3–12 months = Persistent ITP.

Source guidelinePer 2019 American Society of Hematology guideline definition listed in Appendix D.

UsageUsed to classify patients in initial approval criteria for persistent vs chronic ITP.

ITP duration > 12 months (Chronic ITP)

DefinitionITP duration of > 12 months = Chronic ITP.

Source guidelinePer 2019 American Society of Hematology guideline definition listed in Appendix D.

UsageUsed to classify patients in initial approval criteria for persistent vs chronic ITP.

ICAHT — EHA‑EBMT grade 4 thrombocytopenia definition

EHA‑EBMT ICAHT criterionGrade 4 thrombocytopenia (platelets <25,000/µL) persistent >7 days or requiring transfusion/growth factor dependence per EHA‑EBMT consensus criteria.

Policy useThis EHA‑EBMT definition is cited in Appendix D and used to qualify ICAHT in NCCN Compendium off‑label indications.

Associated requirementsICAHT coverage requires received/receiving IEC therapy and either ≥1 risk factor for ICAHT or cytopenias beyond 21 days post‑infusion.