Synribo® (omacetaxine mepesuccinate) MEDICARE Prior Authorization Form Complete Patient and Physician information (PLEASE PRINT) STEP 1 Member Name: Address: Physician Name: Address: Member ID: Member DOB: Member Phone: Phone #: Fax #: NPI Number: If Applicable: Pharmacy Name: _____________________________________________ Pharmacy Phone: _____________________________________________ Complete the Clinical Assessment: Diagnosis Chronic Myeloid Leukemia Indicate what phase: Chronic phase Accelerated phase Other (please state): _______________________________________________________ Clinical Consideration Patient had resistance and/or intolerance to 2 or more TKIs. [e.g. Gleevec® (imatinib), Sprycel® (dasatinib), Tasigna® (nilotinib), Bosulif® (bosutinib)]. Documentation of failure of 2 therapies is required for approval of Synribo® STEP 2 Physician Specialty Oncologist Other (please state): __________________________________________________ Diagnosis: ICD-9/10 Code #/ Description / J Code (required): Supporting Documentation Please attach all relevant medical records and test results. Please attach a copy of the prescription or provide ALL of the information below: Synribo® (omacetaxine mepesuccinate) Strength ________________________________________________________________ Sig ____________________________________________________________________ Qty ____________________________________________________________________ Refills __________________________________________________________________ We will not process incomplete forms. If we do not receive the completed form and all relevant medical records and test results within 6 calendar days of this request, it will be denied. STEP 3 I certify that the above is correct and accurate to the best of my knowledge and that the form is complete. (Please sign and date) _______________________________________________ Prescriber Signature _________________________ Date STEP Fax completed form to the Rocky Mountain Health Plans Pharmacy Help Desk: 970-248-5034 4 Name of Person filling out form: _________________________________________ Pharmacy Technician initials ______ Date Initiated ____________________ Confidentiality Notice: This facsimile transmission (and/or documents accompanying it) may contain confidential information. This information is intended only for the use of the individual(s) named above. If you have received this transmission in error, or cannot identify the recipient for distribution purposes, please notify us immediately at 970-244-7760. Plans underwritten by Rocky Mountain HMO or Rocky Mountain HealthCare Options. 04/22/14 RMHP Formulary Coverage Policy THIS INFORMATION IS NOT ALL-INCLUSIVE AND IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY Synribo® (omacetaxine mepesuccinate) CLASSIFICATION   Antineoplastic Agent Protein Synthesis Inhibitor DESCRIPTION         Synribo is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs). 95% of CML cases have an abnormal chromosome called the Philadelphia (Ph) chromosome. The Ph chromosome results in the formation of a Bcr-Abl gene which encodes the Bcr-Abl protein, which is a tyrosine kinase that drives abnormal cell proliferation and cancer growth. Synribo is a protein synthesis inhibitor with effect against CML independent of direct Bcr-Abl binding (the exact mechanism has not been fully determined). Synribo showed activity against T315I mutated Bcr-Abl CML. Chronic, accelerated, or blast phases are classified based on the number of immature WBCs in the blood or bone marrow (chronic phase: <10% blasts; accelerated phase (AP): 10% to 19% blasts; blast phase: >20% blasts). Efficacy of Synribo is based on a combined cohort of adult patients with CML from two trials. Patients had received 2 or more approved TKIs and had, at a minimum, documented evidence of resistance or intolerance to dasatinib and/or nilotinib. Additionally, most of these patients had also received prior nonTKI treatments (e.g. hydroxyurea, interferon, and/or cytarabine). Of patients with chronic phase CML (n=76), 47% had failed treatment with imatinib, dasatinib, and nilotinib. The efficacy endpoint was based on major cytogenetic response (MCyR) and occurred in 18.4% (n=14) of patients treated with Synribo. The mean time to MCyR onset in the 14 patients was 3.5 months and the median duration of MCyR for the 14 patients was 12.5 months. Of patients with accelerated phase CML (n= 35), 63% had failed treatment with imatinib, dasatinib, and nilotinib. The efficacy endpoint was assessed based on MCyR and MaHR. MaHR is defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR is defined as absolute neutrophil count of 1.5 x 10(9)/L, platelet count of 100 x 10(9)/L, no blood blasts, bone marrow blasts less than 5%, no extramedullary disease. NEL is defined as less than 5% bone marrow blasts. No patient with AP-CML achieved a major cytogenetic response (coprimary outcome). A major hematologic response was achieved by 14.3% of patients (95% CI: 4.5% to 30.3%) and a complete hematologic response was achieved in 11.4% (n=4). No evidence of leukemia was achieved in 2.9% (n=1). Median time to response onset was 2.3 months and the median duration was 4.7 months. FORMULARY COVERAGE Prior authorization: Yes Good Health Formulary: Tier 6 Commercial Formulary: Tier 6 Medicare Part D coverage: Tier 5 COVERAGE CRITERIA Synribo® (omacetazine mepesuccinate) meets the definition of medical necessity for all FDA approved indications, not otherwise excluded from Part D, including the following:  Documented diagnosis of chronic phase or accelerated phase chronic myelogenous leukemia (CML) with resistance and/or intolerance to 2 or more TKIs. [e.g. Gleevec® (imatinib), Sprycel® (dasatinib), Tasigna® (nilotinib), Bosulif® (bosutinib)].  Documentation of prior therapies is required for approval of Synribo. Synribo® (omacetazine mepesuccinate) is considered experimental for the following:  Any condition or diagnosis not FDA approved or Compendia supported Required Provider Specialty:  Approval is limited to Oncologist DOSAGE/ADMINISTRATION Adult Dosing (safety and efficacy has not been determined for pediatric patients less than 18 years):  Chronic or accelerated phase chronic myelogenous leukemia (CML) with resistance or intolerance to two prior TKI therapies: o Induction: 1.25 mg/m2 SUBQ BID for 14 consecutive days every 28 days until a hematologic response is achieved. o Maintenance: 1.25 mg/m2 SUBQ BID for 7 consecutive days every 28 days as long as a clinical benefit is maintained.  See full prescribing information for dose adjustments and modifications.  See full prescribing information for preparation and administration precautions.  Synribo is administered by a healthcare professional. PRECAUTIONS          Grade 3 or 4 anemia, including fatalities, has been reported; monitoring recommended. Delaying treatment or reducing the number of days of therapy may be required. Avoid use if poorly controlled diabetes mellitus. Elderly patients age 65 years of age or older have an increased risk for hematologic toxicity. Cerebral hemorrhage (some fatal) and gastrointestinal (severe but non-fatal), have been reported. The risk is increased with severe thrombocytopenia. Monitoring is recommended. Grade 3 or 4 hyperglycemia has been reported. Monitoring recommended, particularly in patients with diabetes or risk factors. Grade 3 or 4 neutropenia, including fatalities, has been reported. This increases the risk for infection, therefore monitoring is recommended. Delaying treatment or reducing the number of days of therapy may be required. Platelet count < 50,000/microliter; avoid concomitant anticoagulants, aspirin, and NSAIDs due to increased bleeding risk. Pregnancy should be avoided. Grade 3 or 4 thrombocytopenia, including fatalities, has been reported; Monitoring is recommended due to increased risk for hemorrhage. Delaying treatment or reducing the number of days of therapy may be required. Billing/Coding information HCPCS Coding: C9399 Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY) J9999 Not otherwise classified, antineoplastic drugs COST  AWP (January 2013): o Synribo subcutaneous injection (3.5mg vial): $1,002 o During induction, if 1 vial per day (14 vials): $14,028/28 day cycle. o During maintenance, if 1 vial per day (7 vials): $7,014/28 day cycle COMMITTEE APPROVAL January 2013 GUIDELINE UPDATE INFORMATION January 2013 Prior Authorization and Coverage Policy created REFERENCES    DRUGDEX®, accessed 1/14/2013 Product Information: Synribo® (omacetaxine mepesuccinate) for injection, for subcutaneous use. Teva Pharmaceuticals USA, Inc., North Wales, PA. October 2012. National Comprehensive Cancer Network, Inc. 2012. Chronic Myelogenous Leukemia. Version 3.2013. Accessed 1/14/2013.