CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Eltrombopag (Promacta, Alvaiz) drug policy

Defines clinical indications, continuation and exclusion criteria, coding, and utilization management authority for eltrombopag (Promacta and Alvaiz) for members covered by the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEltrombopag (Promacta, Alvaiz) drug policy

Policy CodePolicy N/A

Change TypeAdministrative review — no material clinical changes

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization and support use with FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary FDA/accepted indications

J8499billing code

75 mgPromacta single-dose max

54 mgAlvaiz single-dose max

30/90/90/60Promacta monthly tablet max

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inv-01: Aplastic anemia

Covered when ALL of the following are met for aplastic anemia (Promacta or Alvaiz as specified):

Aplastic anemia coverage: Member meets age criteria and has severe aplastic anemia as defined (ANC <500 /mcL, platelet count <20 x10^9/L, absolute reticulocyte count <60 x10^9/L).ANC <500 /mcL; platelets <20 x10^9/L; absolute reticulocytes <60 x10^9/L

Promacta: may be used as single agent or with immunosuppression in adults and pediatric members >=2 years. Alvaiz: for adult members with insufficient response to immunosuppressive therapy.

inv-02: Chronic immune thrombocytopenic purpura (ITP)

Covered when ALL of the following are met for chronic ITP:

ITP coverage: Diagnosis of relapsed/refractory chronic ITP with insufficient response to previous therapies (including corticosteroids) AND platelet count <30 x10^9/L AND age criteria per product.platelets <30 x10^9/L

Promacta: adults and pediatric >=1 year; Alvaiz: adults and pediatric >=6 years.

inv-03: Thrombocytopenia in chronic hepatitis C infection

Covered when ALL of the following are met for thrombocytopenia in chronic hepatitis C:

HCV-related thrombocytopenia coverage: Thrombocytopenia related to chronic hepatitis C infection AND platelet count <50 x10^9/L.platelets <50 x10^9/L

Promacta: may be used in members; Alvaiz: may be used in adult members.

Requests for eltrombopag will be excluded when there is concurrent use with other thrombopoietin (TPO) receptor agonists such as romiplostim (Nplate) or avatrombopag (Doptelet). Exclusion also applies when dosing exceeds product-specific single-dose limits: Promacta single-dose limits are 75 mg (ITP), 150 mg (aplastic anemia), and 100 mg (HCV-related thrombocytopenia); Alvaiz single-dose limits are 54 mg (ITP), 108 mg (aplastic anemia), and 72 mg (HCV-related thrombocytopenia). Finally, treatment exceeding the monthly tablet maximums for each product will be excluded.

Use of Promacta or Alvaiz for off-label indications that are not supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed evidence is excluded. The policy defines insufficient evidence to include issues such as poor representation of the patient population or therapy regimen in published studies, lack of clinically meaningful outcomes (per ASCO recommendations), inappropriate experimental design, reliance on uncontrolled case reports, or abstracts without full peer‑reviewed articles.

Initial Therapy Requirements

inv-16: Initial therapy

Initial therapy coverage is based on meeting indication-specific clinical thresholds and prior therapy response status.

Initial therapy nodes: Coverage requires meeting the specific indication criteria for aplastic anemia, chronic ITP, or HCV-related thrombocytopenia (see respective criteria groups).

Indication-specific laboratory thresholds and age/prior-therapy requirements apply as specified in each coverage criterion; policy references FDA labeling and guideline/compendia evidence requirements.

Continuation / Renewal Criteria

Continuation requests exemption criteria:

ALL of the following

The requested medication was used within the last year.
The member has not experienced disease progression and/or no intolerance to the requested medication.
Additional medication(s) are not being added to the continuation request.

Prior Authorization

Continuation exemption — operational guidance

If all three continuation criteria are met, the request may be processed as a continuation (exempt) request. If any criterion is not met, full prior authorization documentation and review per policy is required.

Ensure clinical records substantiate prior use within 12 months and absence of disease progression or intolerance.
Do not bundle new medications with the continuation request; submit separate initial-therapy prior authorization for any additions.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Authorization and continuation rules

Prior authorization requests are processed by Utilization Management. Continuation requests may be approved when the three continuation conditions are satisfied (used within the last year; no disease progression or intolerance; no additional medications added). The HCPCS code J8499 is used for Promacta/Alvaiz.

Evolent (Utilization Management) processes medication requests
Continuation approval contingent on the three conditions in the continuation exemption
Billing code: J8499 for Promacta (eltrombopag) / Alvaiz (eltrombopag)

Documentation Required

Required supporting evidence

Clinical use must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

FDA-approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Primary exclusion triggers — risk of denial

Requests will be excluded — and are at risk of denial — for specified primary triggers including concurrent use with other TPO receptor agonists, dosing that exceeds single-dose limits, monthly tablet limits for Promacta or Alvaiz, or investigational/off-label indications lacking sufficient evidence.

Concurrent use with other TPO receptor agonists (e.g., romiplostim, avatrombopag)
Promacta single-dose limits exceeded: 75 mg (ITP), 150 mg (aplastic anemia), 100 mg (HCV-related thrombocytopenia)
Promacta monthly tablet limits exceeded: 30 (12.5 mg), 90 (25 mg), 90 (50 mg), 60 (75 mg)
Alvaiz single-dose limits exceeded: 54 mg (ITP), 108 mg (aplastic anemia), 72 mg (HCV-related thrombocytopenia)
Alvaiz monthly tablet limits exceeded: 28 (9 mg), 28 (18 mg), 56 (36 mg), 56 (54 mg)
Investigational or off-label indications without sufficient evidence

Quantity Limits and Dosing Maximums

Promacta (eltrombopag) quantity limits

Promacta (eltrombopag) monthly limits30 tablets (12.5 mg), 90 tablets (25 mg), 90 tablets (50 mg), 60 tablets (75 mg) per month

Promacta single-dose maximums (by indication)75 mg (ITP); 150 mg (aplastic anemia); 100 mg (HCV-related thrombocytopenia)

Exclusion triggerTreatment exceeding the Promacta monthly tablet limits is an exclusion

Alvaiz (eltrombopag) quantity limits

Alvaiz (eltrombopag) monthly limits28 tablets (9 mg), 28 tablets (18 mg), 56 tablets (36 mg), 56 tablets (54 mg) per month

Alvaiz single-dose maximums (by indication)54 mg (ITP); 108 mg (aplastic anemia); 72 mg (HCV-related thrombocytopenia)

Exclusion triggerTreatment exceeding the Alvaiz monthly tablet limits is an exclusion

Quantity and dosing limits are enforced per product and indication. For Promacta, monthly tablet maximums are 30 tablets (12.5 mg), 90 tablets (25 mg), 90 tablets (50 mg), and 60 tablets (75 mg) per month; single-dose maximums by indication are 75 mg, 150 mg, and 100 mg as specified above. For Alvaiz, monthly tablet maximums are 28 tablets (9 mg), 28 tablets (18 mg), 56 tablets (36 mg), and 56 tablets (54 mg) per month; single-dose maximums by indication are 54 mg, 108 mg, and 72 mg. Concurrent use with other TPO receptor agonists is prohibited and will trigger exclusion.

Step	Requirement
1	Document prior therapy failure or insufficiency (e.g., insufficient response to previous therapies including corticosteroids for ITP) before approval.

Definitions and Clinical Criteria

Severe aplastic anemia (per policy)

Severe aplastic anemia definitionANC < 500 /mcL; platelet count < 20 x 10^9 /L; absolute reticulocyte count < 60 x 10^9 /L

Promacta age indicationAdults and pediatric members 2 years of age and older may use Promacta for severe aplastic anemia

Alvaiz use for aplastic anemiaAlvaiz may be used in adult members with insufficient response to immunosuppressive therapy

Relapsed/refractory chronic ITP (per policy)

Relapsed/refractory chronic ITP criteriaDiagnosis of relapsed/refractory chronic ITP with insufficient response to prior therapies including corticosteroids; platelet count < 30 x 10^9 /L

Promacta age criterion for ITPPromacta: adults and pediatric members 1 year of age and older

Alvaiz age criterion for ITPAlvaiz: adults and pediatric members 6 years of age and older

Thrombocytopenia in chronic hepatitis C (per policy)

HCV-related thrombocytopenia criterionThrombocytopenia related to chronic hepatitis C infection with platelet count < 50 x 10^9 /L

Product age language for HCV-related thrombocytopeniaPromacta may be used; Alvaiz may be used in adult members

Indication limitationUse limited to thrombocytopenia related to chronic hepatitis C to permit antiviral therapy per policy

Background

Eltrombopag is an oral thrombopoietin (TPO) receptor agonist indicated to increase platelet counts in specific conditions. The policy covers its use for three primary indications: severe aplastic anemia, relapsed/refractory chronic immune thrombocytopenic purpura (ITP), and thrombocytopenia associated with chronic hepatitis C infection. Dosing and quantity limits differ by product (Promacta or Alvaiz) and by indication, and the policy explicitly prohibits concurrent use with other TPO receptor agonists and use for investigational or unsupported off‑label indications.