ModifiedCignaPolicy N/A

Thrombocytopenia - Eltrombopag Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for eltrombopag products (Alvaiz, Promacta) across FDA-approved indications and selected off-label uses for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyEltrombopag (Promacta, Alvaiz) prior authorization for thrombocytopenia

Policy CodePolicy N/A

Change TypeAdded indications and revised criteria wording

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prior therapies (including trial of at least one systemic corticosteroid for checkpoint inhibitor–related thrombocytopenia) and specialist consultation as required.

SourceLink

POLICY UPDATE CHANGES

Thrombocytopenia in a Patient Post-Allogeneic Transplantation was added to the policy for Promacta and Alvaiz.

Thrombocytopenia in a Patient Due to Immune Checkpoint Inhibitor Therapy was added to the policy for Promacta and Alvaiz.

For initial therapy of checkpoint inhibitor–related thrombocytopenia, the criterion changed from 'has not had a response to at least one systemic corticosteroid' to 'has tried at least one systemic corticosteroid.'

Noted that Promacta (tablets and oral suspension) are available as generics; Alvaiz initial approval duration clarified.

For myelodysplastic syndrome, risk category criterion for Promacta and Alvaiz was changed to include very low, low, or intermediate-risk.

Hematologic Toxicity in a Patient Receiving Immune Effector Cell Therapies was added as a new condition of approval for Promacta and Alvaiz.

7Covered indications

1-12 moApproval durations

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Coverage Criteria for Eltrombopag Products

Aplastic Anemia (FDA-approved)

Approve if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. Patient has low platelet counts at baseline (example: < 30 x 10^9/L [< 30,000/mcL]); AND ii. Patient meets ONE of the following: a) patient had tried at least one immunosuppressant therapy (examples: cyclosporine, ATG, mycophenolate mofetil, sirolimus); OR b) patient will be using eltrombopag in combination with standard immunosuppressive therapy; AND iii. The medication is prescribed by or in consultation with a hematologist. Approve for 4 months.
B) Currently Receiving: Patient is currently receiving eltrombopag. Approve for 1 year if, according to the prescriber, the patient demonstrates a beneficial clinical response (examples: increases in platelet counts, reduction in RBC transfusions, hemoglobin increase, and/or absolute neutrophil count increase).

Immune Thrombocytopenia (ITP) (FDA-approved)

Approve if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. Patient meets ONE of the following: a) platelet count < 30 x 10^9/L (< 30,000/mcL); OR b) BOTH (1) platelet count < 50 x 10^9/L (< 50,000/mcL) AND (2) according to the prescriber the patient is at increased risk for bleeding; AND ii. Patient meets ONE of the following: a) patient has tried at least one other therapy (examples: systemic corticosteroids, IVIG, anti-D, romiplostim, fostamatinib, avatrombopag, rilzabrutinib, rituximab); OR b) patient has undergone splenectomy; AND iii. The medication is prescribed by or in consultation with a hematologist. Approve for 3 months.
B) Currently Receiving: i. According to the prescriber, the patient demonstrates a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes); AND ii. Patient remains at risk for bleeding complications. Approve for 1 year.

Thrombocytopenia with Chronic Hepatitis C (FDA-approved)

Approve for 1 year if ALL of the following are met (A, B, C):

Chronic Hepatitis C criteria: A. Patient has low platelet counts at baseline (example: < 75 x 10^9/L [< 75,000/mcL]); AND B. Patient will be receiving interferon-based therapy for chronic hepatitis C (examples: pegylated interferon, interferon alfa-2b); AND C. The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist.

Hematologic Toxicity after Immune Effector Cell Therapies (supportive evidence)

Approve for 6 months if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. Patient meets ONE of the following: a) according to the prescriber the patient has one or more risk factors for immune effector–cell associated hematotoxicity (examples: bone marrow tumor involvement, high tumor burden, pre-existing cytopenias, inflammatory state, active infection, prior HCT, receipt of bridging therapy, CAR-HEMATOTOX score ≥ 2); OR b) according to the prescriber the patient has cytopenia post infusion; AND ii. The medication is prescribed by or in consultation with a hematologist or oncologist. Approve for 6 months.
B) Currently Receiving: Patient is currently receiving eltrombopag. Approve if, according to the prescriber, the patient demonstrated a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes).

Myelodysplastic Syndrome (MDS) (supportive evidence)

Approve if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. Patient has very low, low, or intermediate‑risk myelodysplastic syndrome; AND ii. Patient meets ONE of the following: a) platelet count < 30 x 10^9/L (< 30,000/mcL); OR b) BOTH (1) platelet count < 50 x 10^9/L (< 50,000/mcL) AND (2) according to the prescriber the patient is at increased risk for bleeding; AND iii. The medication is prescribed by or in consultation with a hematologist or oncologist. Approve for 3 months.
B) Currently Receiving: i. According to the prescriber, the patient demonstrates a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes); AND ii. Patient remains at risk for bleeding complications. Approve for 1 year.

Post-Allogeneic Transplantation Thrombocytopenia (supportive evidence)

Approve if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. According to the prescriber, the patient has poor graft function; AND ii. Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL); AND iii. The medication is prescribed by or in consultation with a hematologist, oncologist, or stem cell transplant specialist. Approve for 3 months.
B) Currently Receiving: Patient is currently receiving eltrombopag. Approve for 6 months if, according to the prescriber, the patient demonstrated a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes).

Immune Checkpoint Inhibitor–Related Thrombocytopenia (supportive evidence)

Approve for 6 months if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy: i. Patient has tried at least one systemic corticosteroid; AND ii. Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL); AND iii. The medication is prescribed by or in consultation with a hematologist or oncologist. Approve for 6 months.
B) Currently Receiving: Patient is currently receiving eltrombopag. Approve if, according to the prescriber, the patient demonstrated a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes).

Updated condition-specific criteria

Policy additions and revisions apply to the following condition-specific approval groups

Added conditions: Thrombocytopenia in a patient post-allogeneic transplantation; thrombocytopenia due to immune checkpoint inhibitor therapy; hematologic toxicity in a patient receiving immune effector cell therapies

These conditions were added to the approval criteria set for Promacta and Alvaiz.

Checkpoint inhibitor–related thrombocytopenia initial therapy: Patient has tried at least one systemic corticosteroid prior to initial approval

Wording changed from 'has not had a response to at least one systemic corticosteroid' to 'has tried at least one systemic corticosteroid'.

Myelodysplastic syndrome risk: Risk category criterion revised to very low, low, or intermediate-risk for Promacta and Alvaiz

Replaces previous 'intermediate-risk' wording.

Eltrombopag products (Alvaiz, Promacta) are not medically necessary for any indications or uses that are not specifically listed in the policy criteria. This includes any off‑label or investigational uses not described in the coverage sections; criteria will be updated if new published data support additional indications.

The excerpted policy does not show the full list of conditions that are excluded or considered not medically necessary. For complete exclusions and condition‑specific details, consult the full policy document; the policy notes that additional not‑covered items appear elsewhere and will be revised as new evidence becomes available.

Any use of eltrombopag that is not explicitly covered by the policy’s listed medical‑necessity criteria is considered not medically necessary. Providers should confirm that the requested indication and supporting documentation correspond to one of the approval groups in the policy before submitting a prior authorization request.

Additional specific conditions that are treated as not medically necessary are referenced elsewhere in the policy history and exclusion sections. The policy history documents additions and revisions (for example, newly added approval groups and wording changes), and the exclusions section states that eltrombopag products are considered not medically necessary for any uses not covered by the criteria; refer to the full policy for the precise list of NMN conditions.

Products and Coding

Platelet count thresholds

Threshold: < 30,000/mcLUsed as an example of a low platelet count for aplastic anemia, ITP, and MDS initial-therapy criteria (listed as < 30 x 10^9/L).

Threshold: < 50,000/mcLUsed in ITP, MDS, and post-allogeneic transplant criteria (listed as < 50 x 10^9/L) and as part of conditional 'and increased bleeding risk' rules.

Threshold: < 75,000/mcLProvided as an example of a low platelet count for chronic hepatitis C criteria (listed as < 75 x 10^9/L).

Provider Actions, Prior Authorization, and Documentation

Denial Risk

Coding / claims denial risk

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of the submission. Review the benefit plan and coding guidance before submission to avoid claim denials.

Claims without covered diagnosis/procedure codes will be denied.

Denial Risk

Denial risk if requested indication is not covered

If the requested indication for eltrombopag is not one of the covered indications listed in this policy (for example, indications added in recent revisions such as thrombocytopenia post‑allogeneic transplant or checkpoint inhibitor–related thrombocytopenia), the request may be denied. Confirm the indication matches the policy criteria before submitting an authorization request.

Denial risk if requested indication is not among newly added or listed conditions.

Line of Therapy Designations

mixed

Line-of-therapy: Policy defines initial therapy approval durations (typically 3–6 months depending on indication) and continuation criteria based on prescriber-documented beneficial response; specific line (first-line vs later) is determined by prior therapy requirements noted in each section.

first-line

Line of therapy applicability: Policy additions apply across relevant lines as indicated in the full policy (not specified in this excerpt).

Full line-of-therapy definitions are in other sections.

Background

Eltrombopag is a thrombopoietin receptor agonist indicated to increase platelet production. It is approved for indications including severe aplastic anemia, immune thrombocytopenia (ITP), and thrombocytopenia related to chronic hepatitis C to allow interferon‑based therapy, and is also used in several hematologic scenarios supported by clinical guidelines and evidence (for example, myelodysplastic syndromes, post‑transplant thrombocytopenia, and hematologic toxicity following immune effector cell therapies). Use should be targeted to patients whose thrombocytopenia places them at increased risk of bleeding or prevents essential therapy.

Definitions and Clinical Terms

Beneficial clinical response

DefinitionPrescriber-reported improvements such as increased platelet counts, maintenance of platelet counts, reduced frequency of bleeding episodes, increased hemoglobin or decreased red blood cell transfusions, and/or increased absolute neutrophil count.

ITP continuation criterion exampleFor patients currently receiving eltrombopag, approval for 1 year requires the prescriber to document a beneficial clinical response (e.g., increased platelet counts, maintenance of counts, or decreased bleeding).

Aplastic anemia continuation exampleFor patients currently receiving eltrombopag for aplastic anemia, approval for 1 year requires prescriber-reported beneficial clinical response such as increased platelet counts or improved other blood counts.

Immune checkpoint inhibitor–related thrombocytopenia (definition)

TermThrombocytopenia occurring as an adverse effect of immune checkpoint inhibitor therapy (immune checkpoint inhibitor–related thrombocytopenia).