BlueCross BlueShield of Tennessee Medical Policy Manual

Pembrolizumab

DESCRIPTION

Pembrolizumab is a human programmed death receptor (PD-1)-blocking humanized monoclonal antibody.  It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2 by binding to the PD-1 receptor which is found on T-cells.  This releases PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, which results in decreased tumor growth.

POLICY

• Pembrolizumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)

• • Anal cancer

  • Bone Cancer

  • Bladder Cancer/Urothelial Carcinoma

  • Breast Cancer

  • Central Nervous System Cancers

  • Cervical cancer

  • Cutaneous Squamous Cell Carcinoma (cSCC)

  • Diffuse Large B-Cell Lymphoma (see Primary Mediastinal Large B-Cell Lymphoma [PMBCL])

  • Endometrial Carcinoma (Uterine Cancer)

  • Esophageal Cancer

  • Gastric cancer

  • Gestational Trophoblastic Neoplasia

  • Head and Neck Cancers

  • Hepatocellular Carcinoma (HCC)

  • Hodgkin Lymphoma

  • Melanoma

  • Merkel cell carcinoma

  • Mesothelioma

  • Microsatellite Instability-High (MSI-H)/ Mismatch Repair Deficient (dMMR) Cancers

  • Mycosis Fungoides/Sézary Syndrome

  • Non-small cell lung cancer (NSCLC)

  • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

  • Renal Cell Carcinoma (Kidney Cancer)

  • Small Cell Lung Cancer

  • Soft Tissue Sarcoma

  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)

  • T-Cell Lymphoma/Extranodal NK, nasal type

  • Thymic carcinoma

  • Tumor Mutational Burden-High (TMB-H) Cancer

  • Urothelial Carcinoma (Bladder Cancer)

  • Vulvar Cancer

• Pembrolizumab for the treatment of other conditions/diseases is considered investigational.

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

• Pembrolizumab is considered medically appropriate if ALL of the following: 

• • Individual is 18 years of age or older unless otherwise specified

  • Individual has not received previous therapy with a programmed death (PD-1/PD-L1) -directed therapy (e.g., atezolizumab, avelumab, cemiplimab, durvalumab, nivolumab, etc.) unless otherwise specified

  • Diagnosis of ANY ONE of the following:

  • • Anal Cancer if ALL of the following:

    • • Disease is metastatic squamous cell

      • Used as a single agent for subsequent therapy

    • Breast Cancer if ALL of the following:

    • • Disease is recurrent or stage IV (M1) that is metastatic or unresectable

      • Progressed following prior treatment

      • Individual has no satisfactory alternative treatment options

    • Central Nervous System (CNS) Cancer if ALL of the following:

    • • Used as a single agent

      • Primary tumor is due to melanoma or PD-L1 positive non-small cell lung cancer (NSCLC)

      • Treatment is for ANY ONE of the following:

      • • Small asymptomatic brain metastases as initial treatment

        • Relapsed disease with limited brain metastases and stable systemic disease or reasonable treatment options

        • Recurrent limited brain metastases

        • Recurrent disease with extensive brain metastases and stable disease or reasonable systemic treatment options

    • Cervical Cancer if ALL of the following:

    • • Used as a single agent

      • Individual has recurrent or metastatic disease

      • Tumor expresses PD-L1 (e.g., CPS ≥1, etc.) as determined by an FDA-approved or CLIA-compliant  test***

      • Disease progression on or after chemotherapy

    • Cutaneous Squamous Cell Carcinoma (cSCC) if ALL of the following:

    • • Used as a single agent

      • Disease is recurrent or metastatic and not curable by surgery or radiation

    • Endometrial Carcinoma (Uterine Cancer) if ALL of the following:

    • • Disease is advanced or recurrent

      • Progression following prior systemic therapy

      • Individual is not a candidate for curative surgery or radiation

      • Used in combination with lenvatinib

    • Esophageal Cancer if ALL of the following:

    • • Used as a single agent

      • Disease is recurrent, unresectable (or is not a candidate for surgery) locally-advanced, or metastatic

      • Individual with HER2 positive disease must have previously failed on HER2 directed therapy

      • Disease is ANY ONE of the following:

      • • Squamous cell histology (SCC, squamous cell carcinoma) if ALL of the following:

        • • Tumor expresses PD-L1 (CPS ≥ 10) as determined by an FDA-approved or CLIA-compliant test***

          • Disease progression on or after at least one prior systemic treatment

        • Adenocarcinoma histology if ALL of the following:

        • • Tumor expresses PD-L1 (CPS ≥ 1) as determined by an FDA-approved or CLIA-compliant test***

          • Used as third-line or subsequent therapy

    • Gastric Cancer if ALL of the following:

    • • Used as a single agent

      • Diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma

      • Disease is recurrent, unresectable (or not a surgical candidate) or metastatic

      • Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant test***

      • Disease progression on or after minimum of two prior systemic treatments

      • Individual with HER2 positive disease must have previously failed on HER2 directed therapy (e.g., trastuzumab, etc.)

    • Gestational Trophoblastic Neoplasia if used as single agent therapy for multiagent chemotherapy-resistant disease for ANY ONE of the following:

    • • Recurrent or progressive intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) previously treated with a platinum/etoposide-containing regimen

      • Methotrexate-resistant high-risk disease (i.e., FIGO stages II-III and ≥7 Prognostic Score or FIGO stage IV disease)

    • Head and Neck (SCCHN) Cancer if ALL of the following:

    • • Histology is Squamous Cell Carcinoma

      • Disease is unresectable, recurrent, or metastatic

      • Used as ANY ONE of the following:

      • • First-line therapy as ANY ONE of the following:

        • • Single-agent for tumors expressing PD-L1 (CPS ≥1%) as determined by an FDA-approved or CLIA-compliant test***

          • In combination with fluorouracil and a platinum chemotherapy agent

        • Subsequent therapy as ANY ONE of the following:

        • • Single-agent therapy for disease that has progressed on or after platinum-containing chemotherapy

          • In combination with fluorouracil and a platinum chemotherapy agent for non-nasopharyngeal disease and performance status 0-1

    • Hepatocellular Carcinoma (HCC) if ALL of the following:

    • • Used as a single agent

      • Progression on or intolerant to sorafenib

    • Hodgkin lymphoma, diagnosed as Classical Hodgkin lymphoma (cHL) if ALL of the following:

    • • Used as a single agentfor ANY ONE of the following:

      • • Individual is at least 18 years old and has received two or more prior lines of therapy OR in individual more than 60 years old used as palliative therapy if ANY ONE of the following:

        • • Disease has relapsed or progressed after autologous hematopoietic stem cell transplant    HSCT) with or without brentuximab vedotin

          • Relapsed or refractory disease and either transplant-ineligible based on comorbidity or failure of second-line chemotherapy

          • Post-allogeneic transplant

        • Individual is 2 years of age or older and has refractory disease or relapsed after three or more prior lines of therapy

    • Melanoma, Cutaneous, as a single agent used for ANY ONE of the following:

    • • Metastatic or unresectable disease or disease with satellite/in-transit metastases or recurrence used as ANY ONE of the following:

      • • First-line therapy

        • Subsequent therapy

        • Retreatment of disease as re-induction therapy in individual who experienced disease control (i.e., complete response, partial response, or stable disease with no residual toxicity) from prior checkpoint inhibitor therapy, but subsequently had disease progression/relapse > 3 months after treatment discontinuation

      • Adjuvant treatment if individual has ANY ONE of the following:

      • • Lymph node involvement and has undergone complete resection, complete lymph node dissection (CLND), therapeutic lymph node dissection (TLND), or nodal basin ultrasound surveillance

        • Satellite/in-transit metastases or recurrence and has no evidence of disease after complete excision

        • Undergone TLND and/or complete resection of nodal recurrence

        • Undergone complete resection of distant metastatic disease

    • Melanoma, Uveal, with distant metastatic disease, if used as a single agent

    • Merkel cell carcinoma if ALL of the following:

    • • Individual is 2 years of age or older

      • Used as a single agent if individual has ANY ONE of the following:

      • • Recurrent regional disease and both curative surgery and curative radiation therapy are not feasible

        • Recurrent locally advanced or metastatic disease

    • Mesothelioma, Malignant Pleural if used for subsequent therapy as a single agent

    • Microsatellite Instability-High (MSI-H) Cancer if ALL of the following:

    • • Used as a single agent

      • Individual is 2 years of age or older

      • Disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

      • Pediatric individuals must NOT have a diagnosis of MSI-H central nervous system cancer

      • Disease is ANY ONE of the following:

      • • Bone Cancer (Ewing Sarcoma, Chondrosarcoma [excluding dedifferentiated or mesenchymal subtypes] or Osteosarcoma [excluding high-grade undifferentiated pleomorphic sarcoma]) for ALL of the following:

        • • Unresectable or metastatic disease with progression following prior treatment

          • No satisfactory alternative treatment options

        • Breast Cancer if ALL of the following:

        • • Recurrent, or stage IV disease that is metastatic or unresectable disease

          • Disease progression following prior treatment

          • No satisfactory alternative treatment options

        • Cervical Cancer if ALL of the following:

        • • Histology is adenocarcinoma or squamous cell carcinoma

          • Used as second-line therapy for recurrent or metastatic disease

        • Colorectal Cancer for ANY ONE of the following:

        • • First-line therapy in patients with unresectable or metastatic disease

          • Unresectable advanced or metastatic disease after primary systemic or local therapy

          • Primary treatment for unresectable metastatic disease after previous adjuvant treatment with FOLFOX (fluorouracil, leucovorin and oxaliplatin) or CapeOX (capecitabine-oxaliplatin) in the previous 12 months

          • Unresectable advanced or metastatic disease that has progressed after primary systemic or local therapy

          • Unresectable advanced or metastatic disease that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan

        • Gastric adenocarcinoma, Esophageal/Gastroesophageal Junction Adenocarcinoma or Squamous Cell Carcinoma if ALL of the following:

        • • Used as subsequent therapy

          • Disease is unresectable (or individual is not a candidate for surgery) locally advanced, recurrent or metastatic with performance score of Karnofsky ≥60% or ECOG ≤ 2

        • Hepatobiliary Adenocarcinoma (Gall Bladder Cancer, Intra-/Extra-Hepatic Cholangiocarcinoma) if used for ANY ONE of the following:

        • • Primary Initial therapy for unresectable or metastatic disease

          • Subsequent treatment for unresectable or metastatic disease that has progressed following prior treatment

        • Occult Primary/Cancer of Unknown Primary (CUP) for aggressive disease with ANY ONE of the following:

        • • Axillary involvement in men if clinically indicated

          • Lung nodules or breast marker-negative pleural effusion

          • Resectable liver disease

          • Peritoneal mass or ascites with non-ovarian histology

          • Retroperitoneal mass of non-germ cell histology in selected individuals

          • Unresectable liver disease or disseminated metastases

        • Other Solid Tumor (e.g., Adrenal Gland Tumors, poorly differentiated high-grade Neuroendocrine Tumors [NET], large or small cell NET, etc.) if ALL of the following:

        • • Used for unresectable or metastatic disease progression following prior treatment

          • No satisfactory alternative treatment options

        • Ovarian Cancer, including Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancers, if ALL of the following:

        • • Histology of carcinosarcoma, clear cell, endometrioid, mucinous, oserous

          • Disease is persistent or recurrent

          • Individual is not experiencing an immediate biochemical relapse, e.g., rising CA-125 with no radiographic evidence of disease

        • Pancreatic Adenocarcinoma for ANY ONE of the following:

        • • Second-line therapy for locally advanced or metastatic disease after progression

          • Recurrent disease (after resection)

          • First-line therapy for metastatic disease with poor performance status  (i.e., ECOG ≥ 2)

        • Penile Cancer if ALL of the following:

        • • Subsequent treatment of unresectable or metastatic disease that has progressed following prior treatment

          • No satisfactory alternative treatment options

        • Small Bowel Adenocarcinoma for ANY ONE of the following:

        • • Initial therapy for advanced or metastatic disease with prior oxaliplatin therapy in the adjuvant setting (or contraindication)

          • Subsequent therapy for advanced or metastatic disease

        • Testicular Cancer as third-line therapy

        • Uterine Cancer (Endometrial Carcinoma) if ALL of the following:

        • • Individual has recurrent, metastatic or high risk disease

          • Disease progressed following prior treatment

        • Vulvar Squamous Cell Carcinoma used for ALL of the following:

        • • Advanced, recurrent or metastatic disease

          • Second-line therapy

    • Mycosis Fungoides/Sézary Syndrome as systemic therapy used for ANY ONE of the following:

    • • Primary treatment OR relapsed or persistent disease of ANY ONE of the following:

      • • Stage III Mycosis Fungoides (MF)

        • Stage IV Sézary Syndrome (SS)

      • Stage III Mycosis Fungoides that is refractory to multiple previous therapies

    • Non-Small Cell Lung Cancer (NSCLC) used for ANY ONE of the following:

    • • Stage III disease if ALL of the following:

      • • First-line therapy as a single-agent

        • Individual is not a candidate for surgical resection or definitive chemoradiation

        • Tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved or CLIA compliant test***

        • Tumors have no EGFR or ALK genomic tumor aberrations

      • Recurrent, advanced or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy as ANY ONE of the following:

      • • First-line therapy for ANY ONE of the following:

        • • Used for PD-L1 expression-positive (≥1%) tumors that are EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET rearrangement negative* and performance status (PS) 0-2 as ANY ONE of the following:

          • • Single agent therapy

            • In combination with pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology for tumor

            • In combination with carboplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology

          • Individual with PS 0-1 and tumors negative* for EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET rearrangement and PD-L1 expression <1% (TPS <1%) OR with tumor positive for BRAF V600E mutation, NTRK gene fusion, MET exon 14 skipping mutation or RET rearrangements for used as ANY ONE of the following:

          • • In combination with carboplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology

            • In combination with pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology

        • Subsequent therapy for ANY ONE of the following:

        • • With PS 0-1 with EGFR, ALK, or ROS1 positive tumors and prior targeted therapy OR tumor is positive for BRAF V600E mutation,  NTRK gene fusion, MET exon 14 skipping mutation or RET rearrangements in combination with ANY ONE of the following:

          • • Carboplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology

            • Pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology

          • PS 0-2 with tumors expressing PD-L1 (TPS ≥1%) as determined by an FDA-approved or CLIA compliant test as a single agent

        • Continuation maintenance therapy with a PS 0-2 with tumor response or stable disease following initial therapy for ANY ONE of the following:

        • • In combination with pemetrexed following a first-line pembrolizumab/pemetrexed/ (carboplatin or cisplatin) regimen for disease of non-squamous cell histology

          • As a single agent following a first-line pembrolizumab/carboplatin/(paclitaxel or nab-paclitaxel) regimen for disease of squamous cell histology

          • As a single agent following a first-line pembrolizumab monotherapy regimen

    • Primary Mediastinal Large B-Cell Lymphoma (PMBCL) if ALL of the following:

    • • Individual is 2 years of age or older

      • Disease is relapsed or refractory

      • Used as a single agent

      • Individual does not require urgent cytoreductive therapy

    • Renal Cell Carcinoma (RCC) (Kidney Cancer) if ALL of the following:

    • • Disease is advanced, relapsed or metastatic

      • Histology is clear cell

      • Used in combination with axitinib

    • Small Cell Lung Cancer (SCLC) if ALL of the following

    • • Used as subsequent single-agent therapy

      • Disease is ANY ONE of the following:

      • • Metastatic with progression on or after platinum-based treatment and at least one other line of therapy

        • Relapse within 6 months following a complete or partial response or after stable disease with initial treatment but NOT while on maintenance atezolizumab or durvalumab at time of relapse

        • Primary progressive disease

    • Soft Tissue Sarcoma if used as a single agent for ANY ONE of the following:

    • • Alveolar soft part sarcoma (ASPS)

      • Metastatic undifferentiated pleomorphic sarcoma (UPS)

    • T-Cell Lymphoma/Extranodal NK, nasal type if ALL of the following:

    • • Disease is relapsed or refractory

      • Disease progressed following additional treatment with an alternative asparaginase-based chemotherapy regimen not previously used

      • Participation in a clinical trial is unavailable

    • Thymic Carcinoma as second-line therapy as a single agent for ANY ONE of the following:

    • • Unresectable disease following first-line chemotherapy for ANY ONE of the following

      • • Potentially resectable locally advanced disease

        • Solitary metastasis

        • Ipsilateral pleural metastasis

      • Extra-thoracic metastatic disease

    • Tumor Mutational Burden-High (TMB-H) Cancer if ALL of the following:

    • • Individual is 2 years of age or older with solid tumors that are tumor mutational burden-high (TMB-H) (≥ 10 mutations/megabase [mut/Mb]) as determined by an FDA-approved or CLIA-compliant test***

      • Disease is unresectable or metastatic that progressed following prior treatment

      • Used as a single agent

      • No satisfactory alternative treatment options

      • Pediatric individuals do NOT have a diagnosis of TMB-H central nervous system cancer

    • Urothelial Carcinoma (Bladder Cancer) if ALL of the following:

    • • Used as a single agent

      • Further diagnosed as ANY ONE of the following:

      • • Bacillus Calmette-Guerin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) (defined as persistent disease despite adequate BCG therapy, recurrence after an initial tumor free state following an adequate BCG course of therapy [i.e., administration of at least five of six doses of an initial induction course AND at least two of three doses of maintenance therapy or at least two of six doses of a second induction course] OR T1 disease following a single induction course of BCG) if ALL of the following:

        • • Diagnosis of carcinoma in situ (CIS)

          • Disease is high-risk with or without papillary tumors

          • Individual is ineligible for or has elected not to undergo cystectomy

        • Primary Carcinoma of the Urethra as ANY ONE of the following:

        • • Recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease

          • Used for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal lymph nodes for first-line therapy only

        • Locally advanced or metastatic Urothelial Carcinoma

        • Local bladder cancer recurrence or persistent disease in a preserved bladder

        • Local or metastatic bladder cancer recurrence post-cystectomy

        • Metastatic Upper genitourinary (GU) Tract Tumors

        • Metastatic Urothelial Carcinoma of the Prostate

      • Used as ANY ONE of the following:

      • • First-line therapy in cisplatin-ineligible** patients if ANY ONE of the following:

        • • Individual is carboplatin-ineligible**

          •  Individual has a PD-L1 Combined Positive Score (CPS) of ≥10 as determined by an FDA-approved or CLIA-compliant test***

        • Subsequent therapy after previous platinum treatment**

    • Vulvar Squamous Cell Carcinoma if ALL of the following:

    • • Second line therapy as a single agent

      • Disease is advanced, recurrent or metastatic after progression on or after chemotherapy

      • Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant test***

*Note: If there is insufficient issue to allow testing for all of the EGFR, ALK, ROS1, and BRAF, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes

**If platinum treatment occurred greater than 12 months ago, the individual should be re-treated with platinum-based therapy if still eligible. (See below for cisplatin- or carboplatin-ineligible comorbidities).

1. 1. • Cisplatin-ineligible comorbidities may include the following: GFR < 60 mL/min, PS ≥ 2, hearing loss of ≥ 25 decibels (dB) at two contiguous frequencies, or grades ≥ 2 peripheral neuropathy. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.

      • Carboplatin-ineligible comorbidities may include the following: GFR < 30 mL/min, PS ≥ 3, grade ≥ 3 peripheral neuropathy, or NYHA class ≥ 3, etc.

***As confirmed using an immunotherapy assay @ http://www.fda.gov/companiondiagnostics

RENEWAL CRITERIA

• Pembrolizumab is considered medically appropriate for renewal if ALL of the following criteria are met:

• • Individual continues to meet initial approval criteria (not including prerequisite therapy)

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

  • Absence of unacceptable toxicity from the agent, e.g., severe infusion reactions, immune-mediated adverse reactions such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, skin reactions, hepatoxicity when used in combination with axitinib, etc.

  • For a diagnosis of ANY ONE of the following, the individual has not exceeded a maximum of twenty-four (24) months of therapy:

  • • Anal Cancer

    • Cervical Cancer

    • Classical Hodgkin Lymphoma (cHL)

    • Cutaneous Squamous Cell Carcinoma (cSCC)

    • Endometrial Carcinoma

    • Esophageal Cancer

    • Gastric/GEJ Adenocarcinoma

    • Hepatocellular Carcinoma (HCC)

    • Malignant Pleural Mesothelioma (MPM)

    • Merkel Cell Carcinoma (MCC)

    • MSI-H Cancer (including the following cancers: colorectal, pancreatic, bone,  gastric/gastroesophageal, ovarian, uterine, penile, testicular, hepatobiliary and other solid tumors)

    • Mycosis Fungoides/Sézary Syndrome

    • Non-small cell lung cancer (NSCLC)

    • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

    • Renal Cell Carcinoma (Kidney Cancer) (RCC)

    • Squamous Cell Carcinoma of the Head and Neck (SCCHN)

    • Small Cell Lung Cancer (SCLC)

    • Thymic Carcinoma

    • Tumor Mutational Burden-High Cancer

    • Urothelial Carcinoma/Bladder Cancer

    • Uveal Melanoma

    • Vulvar Squamous Cell Carcinoma

  • For use as adjuvant treatment in melanoma, patient has not exceeded a maximum of twelve (12) months of therapy

  • Melanoma (metastatic or unresectable disease) – Refer to initial criteria

  • Non-small cell lung cancer (NSCLC) for continuation maintenance therapy must meet initial criteria

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed, unless otherwise specified.

SCCHN, cHL, NSCLC, SCLC, HCC, Bladder Cancer/Urothelial Carcinoma, MPM, MSI-H/dMMR, PMBCL, Cervical, Anal, Vulvar, MCC, Mycosis Fungoides/Sézary Syndrome, RCC, Thymic, Esophageal, Gastric Cancers and Endometrial Carcinoma can be authorized up to a maximum of 24 months of therapy.

Adjuvant therapy in melanoma can be authorized up to a maximum of 12 months of therapy.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES 

Eastern Cooperative Oncology Group. (2015, May) ECOG Performance Status. Retrieved May 1, 2015 from http://ecog-acrin.org/resources/ecog-performance-status.

Lexicomp Online. (2020). AHFS DI. Pembrolizumab. Retrieved August 19, 2020 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, July). Pembrolizumab. Retrieved August 19, 2020.

National Comprehensive Cancer Network. (2020). NCCN Drugs & Biologics Compendium®. Pembrolizumab. Retrieved August 19, 2020 from the National Comprehensive Cancer Network.

ORIGINAL EFFECTIVE DATE:  9/18/2014

MOST RECENT REVIEW DATE:   12/31/2020

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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