BlueCross BlueShield of Tennessee Medical Policy Manual

Pembrolizumab

NDC CODE(S)

00006-3026-XX KEYTRUDA 100 MG/4ML Solution (MERCK SHARP & DOHME)

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

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Defined as ANY ONE of the following:

**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)

Sensitizing EGFR mutation-positive tumors

Erlotinib

Afatinib

Gefitinib

Osimertinib

Dacomitinib

ALK rearrangement-positive tumors

Crizotinib

Ceritinib

Brigatinib

Alectinib

Lorlatinib

ROS1 rearrangement-positive tumors

Crizotinib

Ceritinib

Entrectinib

BRAF V600E-mutation positive tumors

Dabrafenib/Trametinib

NTRK Gene Fusion positive tumors

Larotrectinib

PD-L1 expression-positive tumors (≥1%)

Pembrolizumab

Atezolizumab

 

 

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

NSCLC, SCLC, HCC, RCC, SCCHN, Esophageal Gastric/GEJ Carcinoma, Anal, Cervical, Vulvar, Urothelial, Thymic, Endometrial Carcinoma

200 mg every 21 days 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

Melanoma

200 mg every 21 days (adjuvant therapy for up to one year)

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.

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. (2019, December). AHFS DI. Pembrolizumab. Retrieved February 26, 2020 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, January). Pembrolizumab. Retrieved February 26, 2020.

National Comprehensive Cancer Network. (2020). NCCN Drugs & Biologics Compendium®. Pembrolizumab. Retrieved February 26, 2020 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2020, January). Center for Drug Evaluation and Research. Keytruda® (pembrolizumab) for injection, for intravenous use. Retrieved March 3, 2020 from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287.   

ORIGINAL EFFECTIVE DATE:  9/18/2014

MOST RECENT REVIEW DATE:   6/30/2020

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

DIAGNOSIS

MAXIMUM UNITS

SCCHN, cHL, NSCLC, SCLC, Melanoma, Bladder/Urothelial, Gastric, Esophageal, CNS

metastases, PMBCL, Anal, Cervical, Vulvar, MSI-H/dMMR, MCC, RCC, Thymic, HCC, &

Endometrial Carcinoma

200 billable units every 21 days

MPM & Uterine Cancer

1150 billable units every 14 days

NK/T-Cell Lymphoma, MF/SS & Gestational Trophoblastic Tumor

250 billable units every 21 days