Document 6428074

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
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Antineoplastic Agent
Protein Synthesis Inhibitor
DESCRIPTION
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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
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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
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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
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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.