Colony Stimulating Factors - Leukine® (Sargramostim Injection)

Cigna National Formulary Coverage Policy

Prior Authorization Colony Stimulating Factors - Leukine® (sargramostim injection)

Table of Contents Product Identifer(s)

National Formulary Medical Necessity ...... 1 66005 Conditions Not Covered...... 2 Background ...... 2 References ...... 2 Revision History ...... 3

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

National Formulary Medical Necessity

Cigna covers sargramostim products (Leukine®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence:

Prior Authorization is recommended for prescription benefit coverage of Leukine. All approvals are provided for the duration noted below. In cases where the approval is authorized in months, 1 month is equal to 30 days. Because of the specialized skills required for evaluation and diagnosis of individuals treated with Leukine as well as the monitoring required for adverse events and long-term efficacy, approval requires Leukine to be prescribed by or in consultation with a physician who specializes in the condition being treated.

FDA Indication(s)

1. Acute Myeloid Leukemia. Approve for 6 months if the individual is prescribed by or in consultation with an oncologist or a hematologist.

2. Peripheral Blood Progenitor Cell Collection and Therapy. Approve for up to 14 days if the agent is prescribed by or in consultation with an oncologist, a hematologist, or a physician that specializes in transplantation.

Page 1 of 3 Cigna National Formulary Coverage Policy: PA Colony Stimulating Factors - Leukine 3. Bone Marrow Transplant. Approve for 1 month if prescribed by or in consultation with a hematologist, an oncologist, or a physician who specializes in transplantation.

4. Radiation Syndrome (Hematopoietic Syndrome of Acute Radiation Syndrome). Approve for 1 month if the agent is prescribed by or in consultation with a physician with expertise in treating acute radiation syndrome.

Other Uses with Supportive Evidence

5. Neuroblastoma. Approve for 6 months if the individual meets the following criteria (A, B and C): A) The individual is < 18 years of age; AND B) The individual is receiving Leukine in a regimen with Unituxin® (dinutuximab injection for intravenous use); AND C) The agent is prescribed by or in consultation with an oncologist.

Conditions Not Covered

Sargramostim (Leukine®) is considered experimental, investigational or unproven for ANY other use.

Background

Overview Leukine, a recombinant human granulocyte macrophage colony stimulating factor (GM-CSF), is indicated for the following uses:1 • Acute exposure to myelosuppressive doses of radiation, to increase survival in adult and pediatric individuals from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). • Acute myeloid leukemia following induction chemotherapy, to shorten the time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections in individuals ≥ 55 years of age. • Allogeneic bone marrow transplantation, for acceleration of myeloid reconstitution in adult and pediatric individuals ≥ 2 years of age undergoing allogeneic bone marrow transplantation from human leukocyte antigen-matched related donors. • Allogeneic or autologous bone marrow transplantation: treatment of delayed neutrophil recovery or graft failure, treatment of individuals ≥ 2 years of age who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed. • Autologous peripheral blood progenitor cell (PBPC) and bone marrow transplantation, acceleration of myeloid reconstitution after autologous PBPC or bone marrow transplantation in adult and pediatric individuals 2 years of age and older with non-Hodgkin’s lymphoma, acute lymphoblastic leukemia, and Hodgkin’s lymphoma. • Autologous peripheral blood progenitor cell mobilization and collection, in adult individuals with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

Other Uses with Supportive Evidence Unituxin® (dinutuximab injection for intravenous use) is indicated for use in combination with GM-CSF, interleukin-2, and 13-cis-retinoic acid for the treatment of pediatric individuals with high-risk neuroblastoma who achieve at least a partial response to first-line, multi-agent, multimodality therapy.2

References

1. Leukine® injection for intravenous or subcutaneous use [prescribing information]. Lexington, MA: Partner Therapeutics; May 2018.

Page 2 of 3 Cigna National Formulary Coverage Policy: PA Colony Stimulating Factors - Leukine 2. Unituxin™ injection for intravenous use [prescribing information]. Silver Springs, MD: United Therapeutic Corporation; March 2017.

Revision History

Type of Summary of Changes Approval Date Revision Annual No criteria changes. 08/19/2020 Revision

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Page 3 of 3 Cigna National Formulary Coverage Policy: PA Colony Stimulating Factors - Leukine