HN Logo
Prior Authorization Protocol
AFINITORR, AFINITOR DISPERZR (everolimus)

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 adult patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
    • Treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced or metastatic.
    • Treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. The effectiveness is based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume. Improvement in disease-related symptoms and overall survival in patients with SEGA and TSC has not been demonstrated.
    • Treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
    • Treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole (FemaraR) or anastrozole (ArimidexR).
  2. Health Net Approved Indications and Usage Guidelines:
    Advanced or metastatic renal cell carcinoma (RCC)
    • Diagnosis of advanced or metastatic renal cell carcinoma (RCC)
    AND
    • Failure or clinically significant adverse effects to SutentR or NexavarR

    Progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced or metastatic
    • Diagnosis of progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced or metastatic

    Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS)
    • Diagnosis of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS)
    AND
    • Patient is not a candidate for curative surgical resection

    Renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery
    • Diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery

    Hormone receptor positive, human epidermal growth factor receptor-2 (HER-2)negative metastatic breast cancer
    • Diagnosis of hormone receptor positive, human epidermal growth factor receptor-2 negative metastatic breast cancer
    AND
    • Failure or clinically significant adverse effects to a nonsteroidal aromatase inhibitor anastrozole (ArimidexR) or letrozole (Femara R)
    AND
    • In combination with exemestane (AromasinR)
  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:
    • Reimbursement support (AfiniTRACTM program) for healthcare providers and patients is available at 1-888-5AFINITRAC (1-888-523-4648).
    • Advanced renal cell carcinoma includes relapsed disease or Stage IV and medically or surgically unresectable disease.
    • AfinitorR (everolimus) is currently being studied for numerous indications including various cancers and prophylaxis of organ transplant rejection. In April 2010, ZortressR (everolimus) received FDA approval for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.
    • Use in metastatic breast cancer in combination with Aromasin(a steroidal aromatase inactivator) after failure of a nonsteroidal aromatase inhibitor (such as Arimidex or Femara) is a category 2A recommendation per NCCN compendium.
    • The safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumors have not been established.
    • Improvement in disease-related symptoms and overall survival in patients with SEGA and TSC has not been demonstrated.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Sutent (sunitinib)

    Advanced RCC
    50 mg PO QD for 4 weeks followed by 2 weeks off.

    Advanced PNET:
    37.5 mg PO QD

    Dose increase or reduction of 12.5 mg increments is
    recommended based on individual safety and tolerability.

    Advanced RCC
    87.5 mg/day
    Advanced PNET
    62.5 mg/day

    Treatment continues until no longer clinically beneficial or unacceptable toxicity occurs.
    Nexavar (sorafenib)
    Advanced RCC
    400 mg PO BID

    Management of adverse reactions may require temporary interruption and/or dose reduction.
    When dose reduction is necessary, the dose may be decreased to 400 mg PO QD.
    If additional dose reduction is required, the dose may be reduced to 400 mg PO QOD.

    Advanced RCC
    800 mg/day

    Treatment continues until no longer clinically beneficial or unacceptable toxicity occurs.

    ToriselR (temsirolimus)
    Advanced RCC
    25 mg IV infused over 30-60 minutes once a week.
    Advanced RCC
    50 mg/week

    Treatment continues until no longer clinically beneficial or unacceptable toxicity occurs.

    AvastinR (bevacizumab) in combination with Intron AR (interferon alfa-2b)

    Advanced RCC
    10 mg/kg IV infused over 60-90 minutes every 2 weeks (in combination with interferon
    alfa 3 million IU SQ/IM 5 times per week up to 36 million IU SQ/IM 3 times per week)

    Advanced RCC
    15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks (in combination with
    interferon alfa 20 million IU/m2/day IV; 35 million IU/m2/dose SQ/IM)

    ProleukinR (aldesleukin, rIL-2)

    Advanced RCC
    600,000 IU/kg IV Q8 hrs for 14 doses, repeat after a rest period of 9 days

    Advanced RCC
    600,000 IU/kg IV Q8 hrs; 18 million IU/m2/day IV has been used off-label for RCC

    ZanosarR (streptozocin)

    Advanced PNET
    Daily Dose:
    500 mg/m2 IV for five consecutive days every six weeks until maximum benefit or until treatment-limiting toxicity is observed.
    Weekly Dose:
    1000 mg/m2 IV at weekly intervals for the first two courses (weeks).
    In subsequent courses, drug doses may be escalated in patients who have not achieved a therapeutic response and who have not experienced significant toxicity with the previous course of treatment.
    Advanced PNET
    1500 mg/m2 IV in a SINGLE dose

    VotrientR (pazopanib)

    Advanced RCC
    800 mg PO QD
    Advanced RCC
    800 mg/day
    Treatment continues until no longer clinically beneficial or until unacceptable toxicity occurs.
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Afinitor
    Advanced PNET, Advanced RCC, Hormone Receptor Positive Breast Cancer and Renal Angiomyolipoma with TSC:
    10 mg PO QD

    Management of adverse reactions may require temporary treatment interruption and/or dose reduction to 5 mg PO QD.
    For patients with Child-Pugh class B hepatic impairment, reduce dose to 5 mg PO QD.

    If moderate inhibitors of CYP3A4 or P-glycoprotein (PgP) are required, reduce dose to 2.5 mg PO QD. If tolerated, consider increasing to 5 mg PO QD.

    If strong inducers of CYP3A4 are required, increase dose in 5 mg increments to a maximum of 20 mg PO QD.

    SEG:
    4.5 mg/m2 PO QD; adjust dose to attain trough concentrations of 5-15 ng/mL.
    Management of adverse reactions may require temporary treatment interruption and/or dose reduction and/or frequency of dosing reduction to every other day.
    If moderate inhibitors of CYP3A4 or P-glycoprotein (PgP) are required, reduce dose by approximately 50%, or if patient is taking 2.5 mg PO QD, consider alternate day dosing.
    If strong inducers of CYP3A4 are required, double the Afinitor dose.
    Advanced PNET, Advanced RCC, Hormone Receptor Positive Breast Cancer and Renal Angiomyolipoma with TSC:
    Length of Benefit

    SEG
    Initial: 3 months
    Reauthorization: length of benefit
  7. Product Availability:

    Tablet: 2.5 mg, 5 mg, 7.5 mg and 10 mg
    Tablet for oral suspension: 2 mg, 3 mg, 5 mg

  8. References:
    1. Afinitor [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2014.
    2. National Comprehensive Cancer Network. Kidney Cancer Version 3.2014. Available at: http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed July 1, 2014.
    3. National Comprehensive Cancer Network. Neuroendocrine Tumors Version 2.2014. Available at: http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed July 1, 2014.
    4. National Comprehensive Cancer Network. Breast Cancer Version 3.2014. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 1, 2014.
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.