Pembrolizumab (Keytruda) may be considered medically necessary for ANY of the following conditions:
Bladder (Urothelial) Carcinoma
- Treatment of individuals with locally advance or metastatic Urothelial Carcinoma who:
- Are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (combined Positive Score (CPS) greater than or equal to ten (10); or
- Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; 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
Cervical Cancer
- Treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (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
- Treatment of individuals with advanced endometrial carcinoma that in not MSI-H or dMMR; and
- Individual has disease progression following prior systemic therapy; and
- Individual is not a candidate for curative surgery or radiation; and
- Pembrolizumab (Keytruda) is given in combination with lenvatinib; or
Esophageal Cancer
- Treatment of individuals with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 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 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
- Treatment in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line therapy of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or
- As a single agent for the treatment of individuals with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1], with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; or
Head and Neck Squamous Cell Cancer, HNSCC
- Combination treatment with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
- Single agent, 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 1); or
- Single agent 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
- Combination therapy with axitinib, for first line treatment of individuals with advanced RCC; or
Lung Cancer, NSCLC
- As first-line treatment in combination with pemetrexed and platinum chemotherapy for metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
- As first-line treatment in combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound) for metastatic squamous NSCLC; or
- As first-line, single agent for NSCLC expressing PD-L1 (Tumor Proportion Score (TPS) greater than or equal to 1%), 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 individuals with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) 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
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 relapse 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 with melanoma with involvement of lymph node(s) 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 mismatch repair deficient:
- 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.
The use of pembrolizumab (Keytruda) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication. Scientific evidence does not support the use of any other indication.
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