CurrentUnitedHealthcarePolicy 2024 P 1083-16

Eltrombopag (Promacta, Alvaiz) prior authorization

Prior authorization and coverage criteria for eltrombopag products (Promacta and Alvaiz) for UnitedHealthcare members, including indications, initial and reauthorization rules, and product exclusions.

Policy Summary

PayerUnitedHealthcare

PolicyEltrombopag (Promacta, Alvaiz) prior authorization

Policy CodePolicy 2024 P 1083-16

Change TypeAdded product and formulation exclusion

Effective Date1/1/2025

Next Review DateN/A

Key ActionObtain prior authorization for eltrombopag (Promacta or Alvaiz) demonstrating diagnosis and indication-specific requirements before therapy.

SourceLink

POLICY UPDATE CHANGES

Alvaiz was added to the program.

Statement that the Promacta tablet formulation is excluded from coverage for the majority of benefits.

Effective date set to 1/1/2025 and multiple P&T approval entries updated through 8/2024.

3Covered indications

12 monthsAuth duration

Promacta tabletExcluded formulation

2024 P 1083-16Program ID

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Coverage Criteria for Eltrombopag Products

Indication-specific authorization criteria

Covered when ALL of the following are met for each indication:

Immune thrombocytopenia (ITP): Diagnosis of chronic immune thrombocytopenia (ITP) AND patient has had an insufficient response to prior treatments (eg, corticosteroids, immunoglobulins, thrombopoietin receptor agonists, or splenectomy)

Authorization issued for 12 months

Chronic hepatitis C-associated thrombocytopenia: Diagnosis of chronic hepatitis C-associated thrombocytopenia AND either planning to initiate and maintain interferon-based treatment OR currently receiving interferon-based treatment

Authorization issued for 12 months

Severe aplastic anemia: Diagnosis of severe aplastic anemia AND (used in combination with standard immunosuppressive therapy OR history of failure, contraindication, or intolerance to at least one course of immunosuppressive therapy)

Authorization issued for 12 months

The Promacta tablet formulation is excluded from coverage for the majority of UnitedHealthcare benefits. Claims submitted for the Promacta tablet may be denied where this exclusion applies. Authorization durations for covered eltrombopag products are 12 months, but federal requirements and member-specific benefit plans may further affect coverage determinations.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required for ITP

Prior authorization required for eltrombopag (Promacta or Alvaiz) for chronic immune thrombocytopenia (ITP). Approval requires all of the following: diagnosis of chronic ITP and documentation that the patient had an insufficient response to prior treatments (for example, corticosteroids, immunoglobulins, thrombopoietin receptor agonists, or splenectomy).

A documented diagnosis of chronic immune thrombocytopenia (ITP).
Evidence of insufficient response to prior therapy (eg, corticosteroids, immunoglobulins, thrombopoietin receptor agonists) or history of splenectomy.

Prior Authorization

Prior Authorization Required for Hepatitis C–Associated Thrombocytopenia

Prior authorization required for eltrombopag (Promacta or Alvaiz) for chronic hepatitis C-associated thrombocytopenia. Approval requires a diagnosis of chronic hepatitis C-associated thrombocytopenia AND either planning to initiate and maintain interferon-based treatment or currently receiving interferon-based treatment. Authorization will be issued for 12 months.

Diagnosis: chronic hepatitis C-associated thrombocytopenia.
Must be planning to start and maintain interferon-based therapy or currently receiving interferon-based therapy.
Authorization term: 12 months.

Prior Authorization

Prior Authorization Required for Severe Aplastic Anemia

Prior authorization required for eltrombopag (Promacta or Alvaiz) for severe aplastic anemia. Approval requires a diagnosis of severe aplastic anemia AND either use in combination with standard immunosuppressive therapy (eg, antithymocyte globulin [equine or rabbit], cyclosporine) or a history of failure, contraindication, or intolerance to at least one course of immunosuppressive therapy. Authorization will be issued for 12 months.

Diagnosis: severe aplastic anemia.
Used in combination with standard immunosuppressive therapy (eg, Atgam, Thymoglobulin, cyclosporine) OR history of failure/contraindication/intolerance to ≥1 course of immunosuppressive therapy.
Authorization term: 12 months.

Step Therapy

Step Requirement for ITP

Requirement that the patient had an insufficient response to prior treatments before approval for ITP. Examples include inadequate response to corticosteroids, immunoglobulins, thrombopoietin receptor agonists, or prior splenectomy.

Insufficient response to prior therapies (eg, corticosteroids, immunoglobulins, thrombopoietin receptor agonists).
Prior splenectomy can be considered as part of treatment history documentation.

Documentation Required

Automated Approval and Excluded Formulation Denial Risk

UnitedHealthcare may approve initial authorization and reauthorization based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Automated approval and re‑approval processes vary by program and therapeutic class. Note that federal regulatory requirements and the member-specific benefit plan may also impact coverage. Additionally, Promacta tablet formulations may be excluded from coverage for the majority of benefits and could lead to denial if billed in excluded form.

Automated approvals may use prior claims, medication history, and ICD-10 diagnosis coding.
Coverage may be affected by federal requirements and member-specific benefit plan.
Promacta tablet formulation exclusions may result in claim denial.

Initial Therapy Authorization Rules

Initial therapy rules

Initial authorization requirements vary by indication and require diagnosis plus indication-specific conditions.

ITP initial: Diagnosis of chronic immune thrombocytopenia (ITP) AND patient has had an insufficient response to prior therapies (eg, corticosteroids, immunoglobulins, thrombopoietin receptor agonists; e.g., splenectomy)

Hepatitis C-associated thrombocytopenia initial: Diagnosis of chronic hepatitis C-associated thrombocytopenia AND (planning to initiate and maintain interferon-based treatment OR currently receiving interferon-based treatment)

Severe aplastic anemia initial: Diagnosis of severe aplastic anemia AND (used in combination with standard immunosuppressive therapy OR history of failure, contraindication, or intolerance to at least one course of immunosuppressive therapy)

Reauthorization / Continuation Rules

Reauthorization rules

Reauthorization requires documentation of positive clinical response.

General reauthorization - ITP: Documentation of positive clinical response to Promacta or Alvaiz therapy

Authorization will be issued for 12 months

General reauthorization - Hepatitis C: Documentation of positive clinical response to Promacta or Alvaiz therapy AND patient is on interferon-based therapy when applicable

Authorization will be issued for 12 months

General reauthorization - Severe aplastic anemia: Documentation of positive clinical response to Promacta or Alvaiz therapy

Authorization will be issued for 12 months

Step	Requirement
1	Patient must have tried and had an insufficient response to prior therapies (e.g., corticosteroids, immunoglobulins, thrombopoietin receptor agonists, or splenectomy) before approval for ITP.

Definitions

Immune thrombocytopenia (ITP) — definition and clinical context

DefinitionChronic immune thrombocytopenia (ITP): an immune-mediated disorder causing thrombocytopenia with increased bleeding risk; treated when patients have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Clinical significanceUse of eltrombopag (Promacta or Alvaiz) is reserved for patients whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

Age indicationsPromacta: approved for patients 1 year and older; Alvaiz: approved for patients 6 years and older (for ITP and related indications).

Treatment contextEltrombopag is indicated for chronic ITP after insufficient response to first-line therapies (corticosteroids, immunoglobulins, or splenectomy).

Related indicationsAlso indicated for thrombocytopenia in chronic hepatitis C to allow initiation/maintenance of interferon-based therapy and for severe aplastic anemia after insufficient response to immunosuppressive therapy.

OpenPayer

Eltrombopag (Promacta, Alvaiz) prior authorization

Coverage Criteria for Eltrombopag Products

Provider Actions and Prior Authorization Requirements

Initial Therapy Authorization Rules

Reauthorization / Continuation Rules

Step Therapy Requirements

Background on Eltrombopag

Definitions