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Prior Authorization Protocol
ZYDELIGR (idelalisib)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities
    • Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies
    • Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies
    • Limitation of Use: Zydelig is not indicated and is not recommended for first-line treatment of any patient.
  2. Health Net Approved Indications and Usage Guidelines:
    Chronic lymphocytic leukemia (CLL)
    • Diagnosis of CLL
    AND
    • Failure or clinically significant adverse effects to 2 prior chemotherapies
    • Must be used in combination with RituxanR

    Follicular B-cell non-Hodgkin lymphoma (FL), Small lymphocytic lymphoma (SLL)
    • Diagnosis of FL or SLL
    AND
    • Failure or clinically significant adverse effects to 2 prior chemotherapies

    MALT Lymphoma (Gastric and Nongastric), Splenic Marginal Zone Lymphoma
    • Second-line or subsequent therapy for refractory or progressive disease

    Primary Cutaneous Marginal Zone B-Cell Lymphoma
    • Very extensive or refractory generalized T3 cutaneous disease in patients with primary cutaneous marginal zone or follicle center lymphoma
    OR
    • Second-line or subsequent therapy for refractory or progressive generalized extracutaneous disease
  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:
    • According to National Comprehensive Cancer Network (NCCN) guidelines, category 2A recommendations for the treatment of CLL/SLL are as follows: a) first-line therapy: Rituxan + Leukeran, Arzerra + Leukeran, TreandaR + Rituxan, GazyvaTM + Leukeran (category 1), b) relapsed/refractory therapy: Imbruvica (category 1), Rituxan + Leukeran, reduced dose fludarabine /cyclophosphamide /Rituxan (FCR), reduced dose pentostatin/cyclophosphamide/Rituxan (PCR), Treanda + Rituxan, Arzerra, Gazyva,
    • According to NCCN guidelines, category 1 recommendations for the treatment of FL are as follows: a) first-line therapy: Treanda + Rituxan, Rituxan/Cytoxan/doxorubicin/ vincristine/prednisone (R-CHOP), Rituxan/ cyclophosphamide /vincristine/prednisone (R-CVP), b) second-line therapy: Radioimmunotherapy (category 1), Treanda + Rituxan, Rituxan/ cyclophosphamide /doxorubicin/ vincristine/prednisone (R-CHOP), Rituxan/cyclophosphamide /vincristine/prednisone (R-CVP)
    • Recurrence of severe or life-threatening Zydelig-related toxicity upon rechallenge should result in permanent discontinuation of Zydelig.
    • Zydelig was approved with a Risk Evaluation and Mitigation Strategy (REMS) program (which includes a healthcare provider letter and a medication fact sheet) to ensure healthcare providers are aware of the serious risks of hepatotoxicity, severe diarrhea or colitis, pneumonitis, and intestinal perforation.
    • National Comprehensive Cancer Network (NCCN) Drugs and Biologics 2A recommendations include the following lymphomas: MALT (gastric and nongastric), Splenic marginal zone,and Primary Cutaneous marginal zone B-Cell.
    • Zydelig is currently being studied for the treatment of mantle cell lymphoma and Hodgkin lymphoma.
    • Six studies investigating the use of Zydelig as first-line therapy for chronic lymphocytic leukemia and indolent non-Hodgkins lymphoma were discontinued after reports of serious side effects, including multiple deaths, among participants in several of the studies.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    ImbruvicaR (ibrutinib)*

    CLL
    Three 140 mg capsules (420 mg) taken PO QD

    420 mg/day

    LeukeranR (chlorambucil)

    CLL, SLL, FL
    0.1 to 0.2 mg/kg PO daily (4 to 10 mg per day)

    0.2 mg/kg daily

    RituxanR (rituximab)*

    CLL
    375 mg/m2 IV infusion the day prior to the initiation of fludarabine/cyclophosphamide chemotherapy, then 500 mg/m2 on Day 1 of cycles 2-6 (every 28 days)
    FL
    375 mg/m2 IV infusion once weekly for 4 doses (relapsed) or up to 8 doses (untreated)

    500 mg/m2

    GazyvaTM (obinutuzumab) and Leukeran (chlorambucil)

    CLL, SLL

    Varies

    Varies

    FCR
    fludarabine (FludaraR), cyclophosphamide (CytoxanR) and Rituxan (rituximab)*
    CLL, SLL

    Varies

    Varies

    FR
    fludarabine (Fludara) and Rituxan (rituximab)*
    CLL, SLL

    Varies

    Varies

    BR
    Treanda (bendamustine) and Rituxan (rituximab)*
    CLL, SLL, FL

    Varies

    Varies

    PCR
    NipentR (pentostatin), cyclophosphamide (Cytoxan) and Rituxan (rituximab)*
    CLL, SLL

    Varies

    Varies

    R-CHOP
    Rituxan (rituximab)*, cyclophosphamide (Cytoxan), doxorubicin (AdriamycinR), vincristine (Vincasar PFS), and prednisone
    FL

    Varies

    Varies

    R-CVP
    Rituxan (rituximab)*, cyclophosphamide (Cytoxan), vincristine (Vincasar PFS), and prednisone
    FL

    Varies

    Varies

    Arzerra (ofatumumab) and Leukeran (chlorambucil)

    CLL, SLL

    Varies

    Varies

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

    Zydelig

    CLL, SLL,FL, MALT Lymphomas, Splenic Marginal Zone Lymphoma
    150 mg PO BID


    If resuming Zydelig after interruption for other severe or life-threatening toxicities, reduce the dose to 100 mg PO BID.


    Examples of severe or life-threatening toxicities requiring dose modifications are ALT/AST >5-20 times upper limit normal (ULN), bilirubin >3-10 times ULN, severe diarrhea (≥7 stools per day over baseline) or hospitalization,
    absolute neutrophil count (ANC) <0.5 Gi/L (500/mm3), and platelets <25 Gi/L (25,000/mm3).

    Length of Benefit

  7. Product Availability:

    Tablet: 100 mg, 150 mg

  8. References:
    1. Zydelig [Prescribing Information] Foster City, CA :Gilead Sciences, Inc: July 2014.
    2. National Comprehensive Cancer Network. Non-Hodgkin's Lymphomas Version 2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf. Accessed January 2016.
    3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed January 5, 2016.
    4. Zydelig. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 5, 2016.
    5. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 5, 2016.
    6. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed January 5, 2016.
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.