Pembrolizumab
NDC CODE(S) |
00006-3026-XX KEYTRUDA 100 MG/4ML Solution (MERCK SHARP & DOHME) |
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).
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
Genomic Aberration Targeted Therapies (not all inclusive, refer to guidelines for appropriate use) |
Sensitizing EGFR mutation-positive tumors Afatinib Dacomitinib Erlotinib Gefitinib Osimertinib |
ALK rearrangement-positive tumors Alectinib Brigatinib Ceritinib Crizotinib Lorlatinib |
ROS1 rearrangement-positive tumors Ceritinib Crizotinib Entrectinib |
BRAF V600E-mutation positive tumors Dabrafenib±Trametinib Vemurafenib |
NTRK Gene Fusion positive tumors Entrectinib Larotrectinib |
PD-L1 expression-positive tumors (≥1%) Atezolizumab Entrectinib Pembrolizumab |
MET Exon-14 skipping mutations Capmatinib Crizotinib |
RET rearrangement-positive tumors Cabozantinib Selpercatinib Vandetanib |
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
INDICATION(S) |
DOSAGE & ADMINISTRATION |
NSCLC, SCLC, HCC, RCC, SCCHN, Esophageal Gastric/GEJ Carcinoma, Anal, Cervical, Vulvar Carcinoma, Bladder Cancer/Urothelial Carcinoma, Thymic, Endometrial Carcinoma |
200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or up to a maximum of 24 months without disease progression |
cHL, PMBCL, MCC & MSI-H/dMMR Cancer |
Adults: 200 mg every 21 days Pediatrics: 2 mg/kg (up to 200 mg) every 21 days Up To a maximum of 24 months in patients without disease progression or unacceptable toxicity |
Melanoma |
200 mg every 21 days (adjuvant therapy for up to one year of treatment) |
CNS metastases |
200 mg every 21 days |
Gestational Trophoblastic Tumor |
2 mg/kg every 21 days or 200 mg every 21 days |
MPM & Uterine Cancer |
10 mg/kg every 2 weeks for up to 24 months or until confirmed progression or unacceptable toxicity |
NK/T-Cell Lymphoma & MF/SS |
2 mg/kg every 21 days |
Gestational Trophoblastic Tumor |
3 mg/kg every 21 days |
Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following: • Standard dose 200 mg IV every 3 weeks for patients > 50 kg • Use 100 mg IV every 3 weeks for patients ≤ 50 kg Note: This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account. |
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).
GRADE |
ECOG PERFORMANCE STATUS |
0 |
Fully active, able to carry on all pre-disease performance without restriction |
1 |
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work |
2 |
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours |
3 |
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours |
4 |
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair |
5 |
Dead |
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.
U. S. Food and Drug Administration. (2020, June). Center for Drug Evaluation and Research. Keytruda® (pembrolizumab) for injection, for intravenous use. Retrieved August 19, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s084lbl.pdf.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.
This document has been classified as public information
DOSAGE LIMITS Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg
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