CurrentBlue Cross Blue Shield - IowaPolicy 05.01.73

DRUG POLICY

Defines Wellmark Blue Cross and Blue Shield coverage, prior authorization criteria, duration limits, quantity limits, prescriber specialties, exclusions, documentation requirements, and non-formulary exception criteria for eltrombopag products (Promacta brand, Alvaiz, generic).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyDRUG POLICY

Policy CodePolicy 05.01.73

Change TypeAdministrative revision (non-material)

Effective DateMay 17, 2023

Next Review Date

Key ActionPrior authorization required; submit required documentation (pretreatment platelet count for initial ITP, current platelet count for continuation ITP, current platelet count for aplastic anemia continuation) and medical records to support exception requests or intolerance to preferred products.

SourceLink

POLICY UPDATE CHANGES

Policy history notes Reviewed: October 2025; Revised: October 2025; Current Effective Date: January 1, 2026

6Covered Indications (listed)

3Compendial Uses listed

MultipleProduct strengths with quantity limits

Coverage Summary

Coverage stance: covered_with_criteria per policy 05.01.73 and scope: Defines Wellmark Blue Cross and Blue Shield coverage, prior authorization criteria, duration limits, quantity limits, prescriber specialties, exclusions, documentation requirements, and non-formulary exception criteria for eltrombopag products (Promacta brand, Alvaiz, generic). The policy covers FDA-approved indications for eltrombopag (Promacta, Alvaiz, generic) including immune thrombocytopenia (ITP), thrombocytopenia in chronic hepatitis C to allow interferon-based therapy, and aplastic anemia when criteria are met. Compendial uses listed as covered (with criteria) include MYH9-related thrombocytopenia, myelodysplastic syndromes (MDS), and chemotherapy-induced thrombocytopenia (CIT)/post-hematopoietic cell transplant thrombocytopenia.

Initial Therapy Criteria

Initial Approval - Chronic or Persistent Immune Thrombocytopenia (ITP)

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Inadequate response or intolerance to prior therapy with corticosteroids, immunoglobulins, or splenectomy
Untransfused platelet count at any point prior to initiation is < 30 x 10^9/L OR 30 x 10^9/L to 50 x 10^9/L with symptomatic bleeding or risk factors for bleeding< 30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding or bleeding risk factors
Examples of symptomatic bleeding: significant mucous membrane bleeding, gastrointestinal bleeding or trauma; see Appendix for bleeding risk factors

Initial Approval - Thrombocytopenia associated with Chronic Hepatitis C

Authorization of 6 months may be granted when:

ALL of the following

Member is prescribed the requested drug for initiation and maintenance of interferon-based therapy for thrombocytopenia associated with chronic hepatitis C

Initial Approval - Aplastic Anemia

Authorization of 6 months may be granted when ANY of the following specific to product:

ANY of the following

Promacta - first-line severe aplastic anemia
- Requested drug will be used in combination with standard immunosuppressive therapy (e.g., horse antithymocyte globulin (h-ATG) and cyclosporine)
Promacta - after insufficient response
- Treatment of aplastic anemia in members who have had an insufficient response to immunosuppressive therapy
Alvaiz - after insufficient response
- Treatment of severe aplastic anemia in members who have had an insufficient response to immunosuppressive therapy

Initial Approval - MYH9-related disease with thrombocytopenia

Authorization of 12 months may be granted when:

ALL of the following

Member has thrombocytopenia associated with MYH9-related disease

Initial Approval - Myelodysplastic Syndromes (MDS)

Authorization of 12 months may be granted when:

ALL of the following

Member is being treated for myelodysplastic syndromes (MDS)

Initial Approval - Chemotherapy-Induced Thrombocytopenia (CIT)

Authorization of 6 months may be granted when:

ALL of the following

Member is post-allogeneic transplant, has poor graft function, and has prolonged thrombocytopenia

Preferred Drug Plan Design - Promacta (brand) override criteria

Promacta (brand only) initial approval when ONE of the following is met:

ANY of the following

Member had documented intolerable adverse event with preferred products (Alvaiz or generic eltrombopag olamine) and AE was not an expected adverse event attributed to the active ingredient as described in prescribing information
Member is currently receiving treatment with the requested product through insurance (not samples or manufacturer PAP) and experiencing a positive therapeutic outcome

Prescriber Specialty Requirements

Medication must be prescribed by or in consultation with appropriate specialist depending on indication:

ALL of the following

For persistent/chronic thrombocytopenia, aplastic anemia, MYH9-related disease, MDS, and CIT: prescribed by or in consultation with a hematologist or oncologist
For thrombocytopenia with hepatitis C: prescribed by or in consultation with an infectious disease, gastroenterology, hematology, hepatology, or transplant specialist

Documentation Required for Prior Authorization

Submission of the following is necessary to initiate prior authorization review:

ALL of the following

For initial requests for chronic/persistent ITP: pretreatment platelet count
For continuation requests for chronic/persistent ITP: current platelet count
For aplastic anemia continuation: current platelet count

Non-Formulary Exception Criteria

A non-formulary medication may be covered when ALL of the following are met in addition to Criteria for Approval:

ALL of the following

Requested drug is used for an FDA-approved indication or an indication supported in compendia of current literature; diagnostic testing/lab results required when applicable
Prescribed dose/quantity falls within FDA-approved labeling or dosing guidelines in compendia
All covered formulary alternative drugs on any tier will be ineffective, have been ineffective, would not be as effective, or would have adverse effects; documentation required including chart notes indicating prior treatment failure, severity of AE, dosage and duration, or contraindication

Continuation / Reauthorization Criteria

Continuation / Reauthorization Criteria - Chronic or Persistent ITP

Authorizations based on current platelet count and clinical response:

ANY of the following

Authorization of 3 months: current platelet count < 50 x 10^9/L, platelet count not sufficient to prevent clinically important bleeding, and member has not received a maximal dose for at least 4 weekscurrent platelet count <50 x10^9/L
member has not received maximal dose for at least 4 weeks
Authorization of 12 months: current platelet count < 50 x 10^9/L and platelet count is sufficient to prevent clinically important bleedingcurrent platelet count <50 x10^9/L
sufficient to prevent clinically important bleeding
Authorization of 12 months: current platelet count 50 x 10^9/L to 200 x 10^9/L50–200 x10^9/L
Authorization of 12 months: current platelet count > 200 x 10^9/L to ≤ 400 x 10^9/L when dosing will be adjusted to achieve platelet count sufficient to avoid clinically important bleeding>200 to ≤400 x10^9/L
dosing will be adjusted to achieve appropriate platelet count

Continuation / Reauthorization Criteria - Thrombocytopenia with Chronic Hepatitis C

Authorization of 6 months may be granted when:

ALL of the following

Member is continuing to receive interferon-based therapy

Continuation / Reauthorization Criteria - Aplastic Anemia

Authorizations based on current platelet count and prior therapy:

ANY of the following

Authorization up to 16 weeks total: current platelet count < 50 x 10^9/L and member has not received appropriately titrated therapy with the requested drug for at least 16 weekscurrent platelet count <50 x10^9/L
not received appropriately titrated therapy for at least 16 weeks (up to 16 weeks total authorization)
Authorization up to 16 weeks total: current platelet count < 50 x 10^9/L and member is transfusion-independentcurrent platelet count <50 x10^9/L
member is transfusion-independent
Authorization of 12 months: current platelet count 50 x 10^9/L to 200 x 10^9/L50–200 x10^9/L

Continuation - MYH9-related disease with thrombocytopenia

Continuation requires meeting initial authorization criteria:

ALL of the following

All members requesting continuation (including new members) must meet all initial authorization criteria

Continuation - MDS and CIT

Authorization of 12 months may be granted when benefiting from therapy:

ALL of the following

Member experiences benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced need for platelet transfusions)

Exclusions and Concomitant Use

Exclusions

Not covered when concomitant with certain agents:

ALL of the following

Concomitant use of the requested drug with other thrombopoietin receptor agonists (e.g., Nplate, Doptelet, Mulpleta) is excluded
Concomitant use with spleen tyrosine kinase inhibitors (e.g., Tavalisse) is excluded
Concomitant use with Bruton's tyrosine kinase inhibitors (e.g., Wayrilz) is excluded

Claims will be denied if eltrombopag is used concomitantly with excluded agents; specifically, the policy excludes concomitant use with other thrombopoietin receptor agonists (e.g., Nplate, Doptelet, Mulpleta), spleen tyrosine kinase inhibitors (e.g., Tavalisse), and Bruton's tyrosine kinase inhibitors (e.g., Wayrilz), and prior authorization and documentation requirements apply.

Applicable Codes

Drugs / NDCs referenced (product-level)NDC

Promacta (eltrombopag)	Brand eltrombopag (packets and tablets) - multiple strengths (12.5 mg, 25 mg, 50 mg, 75 mg) referenced in quantity limits
Alvaiz (eltrombopag choline)	Alvaiz tablets (9 mg, 18 mg, 36 mg, 54 mg) referenced in quantity limits
eltrombopag olamine (generic Promacta)	Generic eltrombopag olamine referenced as preferred

Billing/Procedure codes (general guidance)mixed

CPT	Use appropriate CPT codes to report provider services
HCPCS (alpha-numeric)	Use appropriate HCPCS level II codes where applicable
Revenue	Use appropriate revenue codes where applicable
ICD-10	Use appropriate ICD diagnostic codes

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Submit the required documentation: pretreatment platelet count for initial chronic/persistent ITP requests; current platelet count for continuation ITP requests; and current platelet count for aplastic anemia continuation requests. Also submit medical records/chart notes to support any non-formulary exception requests or documentation of intolerance to preferred products.

Documentation Required

Documentation of prior therapy failures/intolerance

Provide chart notes documenting prior therapy failures or intolerance for ITP: prior corticosteroid, immunoglobulin, or splenectomy failure or intolerance. For non‑formulary exception requests, include documentation of prior treatment failures or contraindications with details on dosage, duration, and severity of adverse events.

Denial Risk

Exclusion for concomitant use

Claims will be denied/excluded if the requested eltrombopag product is used concomitantly with other thrombopoietin receptor agonists, spleen tyrosine kinase inhibitors, or Bruton's tyrosine kinase inhibitors.

Other thrombopoietin receptor agonists (e.g., Nplate, Doptelet, Mulpleta)
Spleen tyrosine kinase inhibitors (e.g., Tavalisse)
Bruton's tyrosine kinase inhibitors (e.g., Wayrilz)

Prior Authorization

Preferred product exception for Promacta (brand)

Promacta (brand) will only be approved as a non‑preferred product when the member has either: documented an intolerable adverse event with preferred products (Alvaiz or generic eltrombopag olamine) that was not an expected active‑ingredient adverse event per prescribing information, or is currently receiving Promacta through insurance (not samples or manufacturer assistance) with a demonstrated positive therapeutic outcome.

Billing Rule

Quantity limits enforceable

Approvals may be subject to product‑specific quantity limits per 30 days and must adhere to FDA labeling and accepted compendia dosing.

Product-specific quantity limits (examples listed per 30 days for Alvaiz and Promacta formulations)

Step Therapy

Preferred product requirement

Alvaiz (eltrombopag choline) and generic eltrombopag olamine are the preferred products. Promacta (brand) is non‑preferred and requires meeting the override criteria described for approval.

Preferred: Alvaiz and generic eltrombopag olamine
Promacta (brand) requires meeting preferred‑product exception criteria

Clinical Evidence & References

Evidence summary: Primary sources cited include the Promacta package insert (March 2023) and the Alvaiz package insert (November 2023). The policy also references multiple peer-reviewed studies and guideline sources such as NCCN and ASH guidance documents supporting compendial uses and clinical recommendations.

Background and Definitions

Eltrombopag is a thrombopoietin receptor agonist with FDA-approved indications for treatment of thrombocytopenia in persistent or chronic immune thrombocytopenia (ITP), to allow initiation and maintenance of interferon-based therapy in chronic hepatitis C, and for aplastic anemia (including first-line in combination with immunosuppressive therapy and for patients with insufficient response). Compendial uses include MYH9-related thrombocytopenia, myelodysplastic syndromes (MDS), and chemotherapy-induced thrombocytopenia/post-transplant thrombocytopenia.

Untransfused platelet count: Platelet count measured at any point prior to initiation without recent platelet transfusion.

Preferred products: Alvaiz (eltrombopag choline) and eltrombopag olamine (generic Promacta).

Revision History

Reviewed: October 2025policy_review

Policy was reviewed (administrative).

Revised: October 2025policy_revision

Revision history indicates changes were made but policy statements show no explicit clinical changes; treated as non-material administrative update.

Current Effective Date: January 1, 2026effective_dateLatest

Policy effective date updated to January 1, 2026 (non-material administrative update).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyDRUG POLICY

Policy CodePolicy 05.01.73

Change TypeAdministrative revision (non-material)

Effective DateMay 17, 2023

Next Review Date

SourceLink

On This Page

Authorization of 12 months: current platelet count > 200 x 10^9/L to ≤ 400 x 10^9/L when dosing will be adjusted to achieve and maintain appropriate target platelet count>200 to ≤400 x10^9/L

dosing will be adjusted to achieve and maintain target platelet count