Pembrolizumab (Keytruda) may be considered medically necessary for ANY of the following conditions:
Bladder (Urothelial) Carcinoma
- In combination with enfortumab vedotin, for the treatment of individuals 18 years of age or older with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; or
- Treatment of individuals with locally advance or metastatic Urothelial Carcinoma who:
- Are not eligible for any platinum-containing chemotherapy; or
- Have disease progression during or following platinum-containing chemotherapy; or
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; or
- Treatment of individuals with Bacillus Calmette-Guerin (BCG) unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy; or
Breast Cancer, Triple-Negative (TNBC)
- Treatment of individuals with high-risk early stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; or
- In combination with chemotherapy, for the treatment of individuals with locally recurrent unresectable or metastatic TNBC whose tumor express PD-L1 (CPS greater than or equal to 10); or
Cervical Cancer
- In combination with chemotherapy, with or without bevacizumab, for the treatment of individuals with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to one (1)]; or
- As a single agent for the treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [CPS greater than or equal to one (1)]; or
Cutaneous Squamous Cell Carcinoma (cSCC)
- Treatment of individuals with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation; or
Endometrial Carcinoma
- In combination with lenvatinib, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are not MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or
- As a single agent, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or
Esophageal Cancer
- Treatment of individuals with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter one (1) to five (5) centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- In combination with platinum- and fluoropyrimidine-based chemotherapy; or
- As a single agent after one (1) or more prior lines of systemic therapy for individuals with tumors of squamous cell histology that express PD-L1 (CPS greater than or equal to 10); or
Gastric Cancer
- In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or
Head and Neck Squamous Cell Cancer, HNSCC
- In combination with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
- As a single agent for the first line treatment of individuals with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to one (1); or
- As a single agent for the treatment of individuals with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy; or
Hepatocellular Carcinoma, HCC
- Treatment of individuals with HCC who have been previously treated with sorafenib; or
Kidney (Renal) Cell Carcinoma, RCC
- In combination with axitinib, for first-line treatment of adult individuals with advanced RCC; or
- In combination with lenvatinib, for first-line treatment of adult individuals with advanced RCC; or
- Adjuvant treatment of individuals with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions; or
Lung Cancer, NSCLC
- In combination with pemetrexed and platinum chemotherapy, as first-line treatment of individuals with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
- In combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound), as first-line treatment of individuals with metastatic squamous NSCLC; or
- As a single agent for the first-line treatment of individuals with NSCLC expressing PD-L1 (Tumor Proportion Score (TPS) greater than or equal to one (1) percent), with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III in individuals who are not candidates for surgical resection or definitive chemoradiation; or
- Metastatic; or
- As a single agent for the treatment of individuals with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to one (1) percent) with disease progression on or after platinum-containing chemotherapy. Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab (Keytruda); or
- As a single agent for adjuvant treatment following resection and platinum-based chemotherapy for individuals 18 years of age or older with stage Ib (T2a greater than or equal to 4cm), II, or IIIA NSCLC; or
Lymphoma, Hodgkin, Classic, cHL
- Treatment of individuals 18 years of age or older with relapsed or refractory cHL; or
- Treatment of pediatric individuals with refractory cHL, or cHL that has relapsed after two (2) or more prior lines of therapy; or
Lymphoma, Primary Mediastinal Large B-Cell (PMBCL)
- Treatment of adult and pediatric individuals with:
- Refractory PMBCL; or
- Relapse after two (2) or more prior lines of therapy; or
Limitation of Use: pembrolizumab (Keytruda) is not recommended for treatment of individuals with PMBCL who require urgent cytoreductive therapy.
Melanoma
- Treatment of individuals with unresectable or metastatic disease; or
- Adjuvant treatment of individuals 12 years of age or older with Stage IIB, IIC, or III melanoma following complete resection; or
Merkel Cell Carcinoma, MCC
- Treatment of adult and pediatric individuals with recurrent locally advanced or metastatic MCC; or
Microsatellite Instability-High, MSI-H or Mismatch Repair Deficient Cancer
- Treatment of adult and pediatric individuals with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options; or
- Treatment of individuals with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC); or
Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with MSI-H central nervous system cancers have not been established.
Tumor Mutational Burden-High (TMB-H) Cancer
- Treatment of adult and pediatric individuals with unresectable or metastatic TMB-H [greater than or equal to 10 mutations/megabase (mut/Mb)] solid tumors, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with TMB-H central nervous system cancers have not been established.
The use of pembrolizumab (Keytruda) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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