Cigna Eltrombopag Coverage Update

Coverage and Medical Necessity Criteria

Eltrombopag — Aplastic Anemia (FDA-approved)

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

Aplastic Anemia: initial or continuing: A) Initial Therapy: Approve for 4 months if ALL of i-iv are met: i. Patient has low platelet counts at baseline (pretreatment) [documentation required] (example: < 30 x 10^9/L); ii. Patient meets ONE of the following: (a) patient had tried at least one immunosuppressant therapy [documentation required] (examples: cyclosporine, ATG, mycophenolate mofetil, sirolimus) OR (b) patient will be using eltrombopag in combination with standard immunosuppressive therapy; iii. The medication is prescribed by or in consultation with a hematologist; iv. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 1 year if, according to the prescriber, the patient demonstrates a beneficial clinical response (examples include increases in platelet counts, reduction in red blood cell transfusions, hemoglobin increase, and/or absolute neutrophil count increase).

Eltrombopag — Immune Thrombocytopenia (ITP) (FDA-approved)

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

ITP: initial or continuing: A) Initial Therapy: Approve for 3 months if ALL of i-iv are met: i. Patient meets ONE of the following: (a) platelet count < 30 x 10^9/L (< 30,000/mcL) [documentation required]; OR (b) both: (1) platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required] AND (2) according to the prescriber the patient is at an increased risk for bleeding; ii. Patient meets ONE of the following: (a) patient has tried at least one other therapy [documentation required] (examples: systemic corticosteroids, IVIG, anti‑D, romiplostim, fostamatinib, avatrombopag, rituximab) OR (b) patient has undergone splenectomy [documentation required]; iii. The medication is prescribed by or in consultation with a hematologist; iv. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 1 year if the patient meets BOTH of the following: (i) according to the prescriber, the patient demonstrates a beneficial clinical response (eg, increased or maintained platelet counts or decreased frequency of bleeding episodes); AND (ii) patient remains at risk for bleeding complications.

Eltrombopag — Thrombocytopenia with Chronic Hepatitis C (FDA-approved)

Approve for 1 year if ALL of the following are met:

Hepatitis C-related thrombocytopenia: A) Patient has low platelet counts at baseline (pretreatment) [documentation required] (example: < 75 x 10^9/L); 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, a hepatologist, or an infectious disease specialist; AND D) Preferred product criteria is met for the product(s) as listed in the below table(s).

Eltrombopag — Myelodysplastic Syndrome (Other use with supportive evidence)

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

MDS: initial or continuing: A) Initial Therapy: Approve for 3 months if ALL of i-iv are met: i. Patient has low- to intermediate-risk myelodysplastic syndrome; ii. Patient meets ONE of the following: (a) platelet count < 30 x 10^9/L (< 30,000/mcL) [documentation required]; OR (b) both: (1) platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required] AND (2) according to the prescriber, the patient is at an increased risk for bleeding; iii. The medication is prescribed by or in consultation with a hematologist or an oncologist; iv. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 1 year if the patient meets BOTH of the following: (i) according to the prescriber, the patient demonstrates a beneficial clinical response (eg, increased platelet counts, maintenance of platelet counts, or decreased frequency of bleeding episodes); AND (ii) patient remains at risk for bleeding complications.

Eltrombopag — Post-Allogeneic Transplantation and Checkpoint Inhibitor–Related Thrombocytopenia (Other uses with supportive evidence)

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

Post-allogeneic transplant: initial or continuing: A) Initial Therapy: Approve for 3 months if ALL of i-iv are met: i. According to the prescriber, the patient has poor graft function; ii. Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required]; iii. The medication is prescribed by or in consultation with a hematologist, an oncologist, or a stem cell transplant specialist; iv. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 6 months if, according to the prescriber, the patient demonstrated a beneficial clinical response (examples include increased or maintained platelet counts or decreased bleeding).

Checkpoint inhibitor–related thrombocytopenia: initial or continuing: A) Initial Therapy: Approve for 6 months if ALL of i-iv are met: i. Patient has tried at least one systemic corticosteroid [documentation required] (examples: methylprednisolone, prednisone); ii. Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required]; iii. The medication is prescribed by or in consultation with a hematologist or an oncologist; iv. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve if, according to the prescriber, the patient demonstrated a beneficial clinical response (examples include increased or maintained platelet counts or decreased frequency of bleeding episodes).

Alvaiz — parallel criteria (FDA-approved indications)

Alvaiz is considered medically necessary when ONE of the following is met (applies to similar indications with specified age limits):

Alvaiz: Aplastic anemia: A) Initial Therapy: Approve for 4 months if ALL of i-v are met: i. Patient is >= 18 years of age; ii. Patient has low platelet counts at baseline (pretreatment) [documentation required] (example: < 30 x 10^9/L); iii. Patient meets ONE of the following: (a) patient had tried at least one immunosuppressant therapy [documentation required] OR (b) patient will be using eltrombopag in combination with standard immunosuppressive therapy; iv. The medication is prescribed by or in consultation with a hematologist; v. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 1 year if, according to the prescriber, the patient demonstrates a beneficial clinical response.

Alvaiz: ITP: A) Initial Therapy: Approve for 3 months if ALL of i-v are met: i. Patient is >= 6 years of age; ii. Patient meets ONE of the following: (a) platelet count < 30 x 10^9/L (< 30,000/mcL) [documentation required] OR (b) both: platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required] AND prescriber states patient is at an increased risk for bleeding; iii. Patient meets ONE of the following: (a) patient has tried at least one other therapy [documentation required] OR (b) patient has undergone splenectomy [documentation required]; iv. The medication is prescribed by or in consultation with a hematologist; v. Preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 1 year if the patient meets BOTH of the following: (i) according to the prescriber, the patient demonstrates a beneficial clinical response; AND (ii) patient remains at risk for bleeding complications.

Thrombocytopenia Post-Allogeneic Transplantation

Thrombocytopenia in a Patient Post-Allogeneic Transplantation — Approve when ONE of the following is met:

Post-allogeneic transplant thrombocytopenia: A) Initial Therapy: Approve for 3 months if ALL of (i)-(iv) are met: (i) according to the prescriber, the patient has poor graft function; AND (ii) platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required]; AND (iii) medication prescribed by or in consultation with a hematologist, an oncologist, or a stem cell transplant specialist; AND (iv) preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve for 6 months if according to the prescriber the patient demonstrated a beneficial clinical response.platelet <50 x 10^9/L

Beneficial response examples listed

Immune Checkpoint Inhibitor–Related Thrombocytopenia

Thrombocytopenia Due to Immune Checkpoint Inhibitor Therapy — Approve for 6 months when ONE of the following is met:

Checkpoint inhibitor-related thrombocytopenia: A) Initial Therapy: Approve for 6 months if ALL of (i)-(iv) are met: (i) patient has tried at least one systemic corticosteroid [documentation required] (examples: methylprednisolone, prednisone); AND (ii) patient has a platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required]; AND (iii) the medication is prescribed by or in consultation with a hematologist or an oncologist; AND (iv) preferred product criteria is met for the product(s) as listed in the below table(s); OR B) Patient is Currently Receiving Eltrombopag: Approve if according to the prescriber the patient demonstrated a beneficial clinical response.platelet <50 x 10^9/L

Corticosteroid examples: methylprednisolone, prednisone; beneficial response examples listed

Continuation Therapy (Patients Currently Receiving Eltrombopag)

General "Patient is Currently Receiving Eltrombopag" approach used across indications:

Currently receiving eltrombopag: Approve for the condition-specific duration if (i) according to the prescriber, the patient demonstrates a beneficial clinical response (examples include increased or maintained platelet counts, reduced transfusion needs, or decreased bleeding) AND (ii) the patient remains at risk for bleeding complications where specified.none

Durations vary by condition (e.g., 1 year for some indications; 6 months for post-transplant or checkpoint inhibitor scenarios).

Reimbursement will not be provided for services billed for conditions or diagnoses that are not covered under this Coverage Policy. Claims submitted without covered diagnosis or procedure codes, or for services billed for non-covered conditions, will be denied as not covered.

Eltrombopag products used for any indication not listed in this policy are considered not medically necessary. Such uses are outside the scope of coverage and may be denied.

Any other uses of eltrombopag products that fall outside the specific indications and criteria enumerated in this policy are considered not medically necessary and are not eligible for benefit coverage.

Formulary and Covered Drug Products

Product	Plan	Preferred/formulary requirement	Trial/generic considerations
Promacta (eltrombopag olamine) tablets
Individual and Family Plans
Covered when criteria met per plan
Patient has tried eltrombopag olamine oral tablet (the bioequivalent generic) AND cannot take it due to a formulation difference in inactive ingredient(s) (eg, dyes, fillers, preservatives) that per prescriber would cause significant allergy or serious adverse reaction

Covered drug products and formulary distinctionsNDC|DrugNameCovered

Alvaiz (eltrombopag choline)	Alvaiz tablets; employer and individual plan preferred product criteria specified (trial of eltrombopag olamine generic or currently receiving Alvaiz).
Promacta (eltrombopag olamine) tablets	Promacta tablets; criteria include trial of bioequivalent generic eltrombopag olamine oral tablet and inability to take generic due to inactive ingredient differences causing significant allergy or serious adverse reaction.
Promacta (eltrombopag olamine) oral suspension	Promacta oral suspension; criteria include trial of bioequivalent generic eltrombopag olamine oral suspension and inability to take generic suspension due to inactive ingredient differences causing significant allergy or serious adverse reaction.

Clinical Thresholds and Coding Notes

Platelet count thresholds

Common thresholdsExamples of platelet-count thresholds used across indications: < 30 x 10^9/L (< 30,000/mcL); < 50 x 10^9/L (< 50,000/mcL); < 75 x 10^9/L (< 75,000/mcL).

Aplastic anemia examplePolicy notes an example low platelet count of < 30 x 10^9/L (< 30,000/mcL) for aplastic anemia initial-therapy criteria.

ITP and MDS example< 30 x 10^9/L and < 50 x 10^9/L are used in ITP and MDS initial-therapy criteria (with < 50 x 10^9/L often requiring prescriber statement of increased bleeding risk).

Chronic hepatitis C exampleAn example threshold for chronic hepatitis C–related thrombocytopenia is < 75 x 10^9/L (< 75,000/mcL).

Platelet count threshold (< 50 x 10^9/L)

Primary threshold

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of eltrombopag products. All approvals are provided for the duration noted in the policy; prescribing may be required by or in consultation with a specialist for the treated condition.

Approvals are provided for the duration noted in the policy (months counted as 30 days).
May require prescription by or consultation with a physician who specializes in the condition being treated.

Prior Authorization

Prior authorization and preferred product requirements

Prior authorization is required and plan-specific preferred product rules apply. Employer and Individual & Family Plans require trial of the bioequivalent eltrombopag olamine (generic Promacta) before Alvaiz, or current receipt of Alvaiz; branded Promacta products require trial of the bioequivalent generic oral tablet or suspension unless there is a prescriber-documented inability to tolerate due to inactive ingredient differences.

Employer Plans: Alvaiz requires prior trial of eltrombopag olamine (generic Promacta) or current receipt of Alvaiz; Promacta brand products require trial of the bioequivalent generic or documentation of intolerance to inactive ingredients.

Salvage and Line-of-Therapy Notes

salvage

MDS/Other supportive uses: Use considered in patients with refractory or severe thrombocytopenia per supportive evidence; initial therapy approvals are time-limited and require specialist consultation and documentation of low platelet counts or bleeding risk.

salvage

Checkpoint inhibitor-related initial therapy: Patient has tried at least one systemic corticosteroid and meets platelet threshold and prescriber specialty requirements for initial therapy; approvals are time-limited as specified in the policy.platelet <50 x 10^9/L

Initial therapy conditions

Definitions and Clinical Terms

Low platelet count (policy examples)

Definition examplesLow platelet count examples provided in the policy include < 30 x 10^9/L (< 30,000/mcL) and < 50 x 10^9/L (< 50,000/mcL).

Contextual useThese thresholds are applied across indications (e.g., aplastic anemia, ITP, and MDS) to define 'low platelet counts' for initial-therapy criteria.

Documentation noteThe policy specifies that baseline low platelet counts must be documented when used to meet approval criteria.

Examples of checkpoint inhibitors

Checkpoint inhibitor examplesExamples of immune checkpoint inhibitors listed in the policy: pembrolizumab (Keytruda), nivolumab (Opdivo), ipilimumab (Yervoy), atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi), and cemiplimab (Libtayo).

Therapy context

Background

Eltrombopag is an oral thrombopoietin receptor agonist indicated for a variety of thrombocytopenic conditions, including aplastic anemia, immune thrombocytopenia (ITP), and thrombocytopenia associated with chronic hepatitis C where interferon-based therapy is planned. The agent stimulates platelet production via the thrombopoietin receptor and is used both as initial therapy under specified criteria and as continuation therapy when a prescriber documents a beneficial clinical response (for example, increased or maintained platelet counts or reduced bleeding). Clinical guideline sources such as BSH, ASH, and NCCN reference eltrombopag for aplastic anemia, ITP, myelodysplastic syndromes (MDS), post-allogeneic transplant thrombocytopenia, and checkpoint inhibitor–related thrombocytopenia in selected scenarios.

OpenPayer

Eltrombopag Products (Promacta and Alvaiz) — Coverage Criteria

Coverage and Medical Necessity Criteria

Formulary and Covered Drug Products

Clinical Thresholds and Coding Notes

Prior Authorization, Documentation, and Step Therapy Requirements

Salvage and Line-of-Therapy Notes

Definitions and Clinical Terms

Background