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Prior Authorization Protocol
POMALYSTR(pomalidomide)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment of patients with multiple myeloma in combination with dexamethasone who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of multiple myeloma
    AND
    • Failure or clinically significant adverse effects to at least 2 prior chemotherapies including RevlimidR and VelcadeR unless contraindicated
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • FDA approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
    • According to National Comprehensive Cancer Network guideline, category 1 recommendation for the treatment of multiple myeloma is listed as follows: a) maintenance therapy when in remission: Revlimid, ThalomidR, and b) salvage therapy: Velcade, Velcade/liposomal doxorubicin, Revlimid/dexamethasone. Salvage therapy is used in patients who have relapse following allogeneic or autologous stem cell transplant or in patients with primary progressive disease following allogeneic or autologous stem cell transplant. Salvage therapy can also be used in patients who are ineligible for stem cell transplant with progressive or relapsing disease after initial induction therapy.
    • Because of the embryo-fetal risk, Pomalyst has a Risk Evaluation and Mitigation Strategy (REMS) program that consists of a Medication Guide and a Dear Healthcare Professional Letter. Patient and physician enrollment in the manufacturer's REMS program is required.
    • Pomalyst is currently being studied for the treatment of myelofibrosis.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Revlimid (lenalidomide)*

    Multiple myeloma
    25 mg PO QD on Days 1-21 of repeated 28-day cycles.

    Recommended dose of dexamethasone is 40 mg PO QD on Days 1-4, 9-12, and
    17-20 of each 28-day cycle for the first 4 cycles of therapy and then
    40 mg/day PO on Days 1-4 every 28 days

    40 mg/day

    Thalomid (thalidomide)*

    Multiple myeloma
    200 mg PO QD.
    Recommended dose of dexamethasone is 40 mg/day
    on days 1-4, 9-12, and 17-20 every 28 days

    200 mg/day

    Velcade (bortezomib)

    Multiple myeloma (untreated)
    1.3 mg/m2/dose in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles.
    In Cycles 1-4, Velcade is administered SC or IV BIW (days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9,
    Velcade is administered SC or IV QWk (days 1, 8, 22 and 29).
    At least 72 hours should elapse between consecutive doses of Velcade
    Multiple myeloma (relapsed)
    1.3 mg/m2/dose SC or IV BIW for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21).
    For extended therapy of more than 8 cycles, Velcade may be administered on the standard schedule or on a
    maintenance schedule of once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35).
    At least 72 hours should elapse between consecutive doses of Velcade.

    1.3 mg/m2/dose

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Pomalyst

    Recommended Starting Dose
    4 mg PO QD on days 1-21 of repeated 28-day cycles until disease progression.
    Pomalyst should be given in combination with dexamethasone

    Avoid Pomalyst in patients with a serum creatinine greater than 3.0 mg/dL
    Length of Benefit
  7. Product Availability:
    Capsule: 1 mg, 2 mg, 3 mg, and 4 mg
  8. References:
    1. Pomalyst [package insert]. Summit, NJ: Celgene Corporation; April 2015.
    2. National Comprehensive Cancer Network. Multiple Melanoma Version 2.2014. Available at: http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed July 1, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.