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    Keytruda

    Drug - Keytruda® (pembrolizumab) [Merck & Co., Inc.]

    January 2018

    Therapeutic area - Oncology

    Initial approval criteria

    Melanoma

    • Patient must be at least 18 years of age AND
    • Patient must have a diagnosis of unresectable or metastatic melanoma AND
    • If BRAFV600 mutation positive, patient has had prior treatment with vemurafenib or dabrafenib

    Non-Small Cell Lung Cancer (NSCLC)

    • Patient must be at least 18 years of age AND
    • Patient must have a diagnosis of NSCLC whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC OR
    • Patient must have a diagnosis of metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab OR
    • Patient must have a diagnosis of metastatic nonsquamous NSCLC; AND be prescribed pembrolizumab in combination with pemetrexed and carboplatin

    Head and Neck Squamous Cell Cancer (HNSCC)

    • Patient must be at least 18 years of age AND
    • Patient must have a diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy

    Classical Hodgkin Lymphoma (cHL)

    Patient must have a diagnosis of refractory cHL; OR cHLpatient who has relapsed after 3 or more prior lines of therapy.

    Urothelial Carcinoma

    • Patient must be at least 18 years of age AND
    • Patient must have a diagnosis of locally advanced or metastatic urothelial carcinoma and is not eligible for cisplatin-containing chemotherapy OR
    • Patient must have a diagnosis of locally advanced or metastatic urothelial carcinoma and have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

    Microsatellite Instability-High (MSI-H) Cancer

    • Patient must have a diagnosis of unresectable or metastatic MSI-H or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment AND have no satisfactory alternative treatment option OR
    • Patient must have a diagnosis of unresectable or metastatic MSI-H or mismatch repair deficient (dMMR) colorectal cancer that have progressed following prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan
    • Prior authorization requests for pediatric patients with MSI-H central nervous system cancers will not be approved

    Renewal approval criteria

    Documentation must be supplied at time of request showing patient has no disease progression AND
    Absence of any one of the following unacceptable toxicities from the drug:

    • Pneumonitis (recurrent grade 2 or grade 3-4)
    • Colitis (grade 4)
    • Nephritis (grade 3-4)
    • AST/ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
    • For patients with liver metastasis who begin treatment with grade 2 AST/ALT, if AST/ALT increases by ≥ 50% relative to baseline and lasts for at least 1 week
      • Infusion-related reactions (grade 3-4)
      • Inability to reduce corticosteroid dose to 10mg or less of prednisone or equivalent per day within 12 weeks
      • Persistent Grade 2 or 3 adverse reactions that do not recover to Grade 0-1 within 12 weeks after last dose of pembrolizumab
      • Any severe or grade 3 treatment-related adverse reaction that recurs

    Quantity limits

    • Melanoma: 200 mg every 3 weeks
    • NSCLC: 200 mg every 3 weeks
    • HNSCC: 200 mg every 3 weeks
    • cHL: 200 mg every 3 weeks for adults; 2mg/kg (up to 20 mg) every 3 weeks for children, patient’s weight must be provided at time of request
    • Urothelial Carcinoma: 200 mg every 3 weeks
    • MSI-H Cancer: 200 mg every 3 weeks for adults; 2mg/kg (up to 20 mg) every 3 weeks for children, patient’s weight must be provided at time of request

    Billing

    Keytruda should be billed using J code J9271.

    Background information

    • Keytruda’s indication for first line treatment of patients with metastatic nonsquamous NSCLC in combination with pemetrexed and carboplatin is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
    • Keytruda’s indication for HNSCC is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
    • Keytruda’s indication for cHL is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
    • Keytruda’s indication for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy is approved based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
    • Keytruda’s indication for MSI-H cancer is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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