Download LEUKINE® (sargramostim)

LEUKINE® (sargramostim)
Criteria for Coverage – Commercial:
Leukine® (sargramostim) is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)
produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic
growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells.
Leukine is indicated:
 Following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) also referred
to as acute non-lymphocytic leukemia (ANLL), to shorten time to neutrophil recovery and to reduce the
incidence of severe and life-threatening infections and infections resulting in death.
 For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
 For acceleration of myeloid recovery in patients with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic
leukemia (ALL) and Hodgkin’s disease undergoing autologous bone marrow transplantation (BMT).
 For acceleration of myeloid recovery in patients undergoing allogenic BMT from HLA-matched related donors.
 For use in patients who have undergone allogenic or autologous bone marrow transplantation (BMT) in whom
engraftment is delayed or has failed.
Criteria for Approval:
 Leukine is being prescribed for prevention of febrile neutropenia following cancer chemotherapy or radiotherapy.
 The patient is 55 years of age or older and has been diagnosed with Acute Myelogenous Leukemia (AML) who is
receiving induction or consolidation chemotherapy.
 The patient is undergoing induction chemotherapy for the treatment of Acute Lymphoblastic Leukemia (ALL)
 Leukine is being prescribed in a patient who has undergone allogenic or autologous bone marrow transplantation.
 Leukine is prescribed to promote mobilization of progenitor cells into peripheral blood for collection by leukphoresis.
 The patient has been diagnosed with a myelodysplastic syndrome and has severe neutropenia (ANC <500), or has
recurrent infections.
 Leukine is prescribed as an adjuvant in a patient diagnosed with febrile neutropenia who is considered to be at high
risk of infection-associated complications due to prolonged duration of neutropenia (greater than 10 days); age
greater than 65; sepsis syndrome (hypotension and multi-organ dysfunction); invasive fungal infections; pneumonia;
or a complicated primary disease process.
Duration of Coverage:
Commercial Enrollees
Initial Authorization: 3 months
Extension of Coverage: Coverage may be extended every 6 months thereafter if documentation of a response to therapy
can be provided. Note: a patient who has not demonstrated an adequate neutrophil response after a 6 week course of
therapy would not be expected to be a candidate for ongoing therapy.
Leukine PA Criteria
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Specialty Medication:
Walgreens Specialty Pharmacy is the preferred provider of Specialty medications for SummaCare. The Authorization
Specialist shall offer the services of Walgreens Specialty to the authorizing prescriber. Upon initial approval or extension
of an approval, the Authorization Specialist should complete the Walgreens Specialty Referral form and fax to 866-6176685. Once received, Walgreens Specialty will contact the prescriber and member to arrange delivery of the
medication.
Note: The use of Walgreens Specialty is mandatory for most SummaCare commercial plans. The use of a specialty
pharmacy service is preferred but not mandatory for all SummaCare Medicare Part D enrollees. Please refer to the BDS
prior to authorizing therapy.
Question and Answer Guide:
1. Does the patient have a diagnosis of one of the following?
Severe chronic neutropenia
Advance HIV
Yes = approve for 3 months at dose requested.
No = continue to 2.
2. Is the medication being used by one of the following?
Patients with Acute Myeloid Leukemia of age 55 years and older receiving chemotherapy
Patients undergoing peripheral blood progenitor cell (PBPC) collection and therapy.
Treatment of myelodysplastic syndromes (MDS).
Drug-induced agranulocytosis or neutropenia
Bone Marrow Transplant patients (Hematopoietic stem cell transplant patients)
Aplastic anemia with neutropenia
Patients with Severe Chronic Neutropenia
Yes = approve for 3 months at dosage requested.
No = continue to 3.
3. Is the medication being used to prevent or treat white blood cell suppression due to chemotherapy?
List chemotherapy drug(s):
Yes = approve for 3 months at the dosage requested.
No = deny. DENIAL TEXT: According to our Pharmacy & Therapeutics Committee approved prior
authorization guidelines for Leukine, approval requires that there should be a documentation that the member
has a diagnosis of severe chronic neutropenia, advanced HIV, acute myeloid leukemia receiving chemotherapy,
undergoing peripheral blood progenitor cell (PBPC) collection and therapy, myelodysplastic syndromes, druginduced agranulocytosis or neutropenia, bone marrow transplant (hematopoietic stem cell transplant patients),
or aplastic anemia with neutropenia.
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Original Approval Date: January 6, 2011
Revised: June 20, 2013
Reviewed: September 5, 2013
References:
1. Leukine [Prescribing Information]. Cambridge MA: Genzyme Corporation. July 2009.
2. Leukine [Prescribing information]. Cambridge MA: Genzyme Corporation. June 2012
3. Leukine, Online Drug Facts and Comparisons. Accessed: June 2013
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