BlueCross BlueShield of Tennessee Medical Policy Manual

Pembrolizumab

NDC CODE(S)

00006-3029-XX Keytruda 50 MG SOLR (MERCK SHARP & DOHME)

 

00006-3026-XX Keytruda 100 MG/4ML SOLN (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
NSCLC, SCCHN & Urothelial Carcinoma 200 mg every 21 days for a maximum of 24 months of treatment
cHL & 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

All other indications

2mg/kg every 21 days

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

No controlled studies were found in the published literature that validate the use of pembrolizumab for the treatment of other conditions or diseases.

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. (2017). AHFS DI. Pembrolizumab. Retrieved June 12, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, May). Pembrolizumab. Retrieved June 12, 2017.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Pembrolizumab. Retrieved June 12, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Keytruda® (pembrolizumab) for injection. Retrieved June 12, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/18/2014

MOST RECENT REVIEW DATE:  8/11/2017

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.

Pharmaceutical Decision Support Tree

Pembrolizumab (Keytruda ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #14

  1. Does the individual have a diagnosis of Urothelial Carcinoma with ALL of the following?

If yes, go to question #13

If no, go to question #3

  1. Does the individual have a diagnosis of Bladder cancer/Urothelial Carcinoma for subsequent therapy further diagnosed as ANY ONE of the following?

If yes, go to question #13

If no, go to question #4

  1. Does the individual have a diagnosis of classical Hodgkin lymphoma (cHL) that is relapsed or refractory disease for use as a single agent for ANY ONE of the following?

If yes, go to question #13

If no, go to question #5

  1. Is the individual 18 years of age or older with a diagnosis of melanoma for use as a single agent for disease that is metastatic or unresectable?

If yes, go to question #13

If no, go to question #6

  1. Is the individual 18 years of age or older with a diagnosis of Merkel cell carcinoma for use as a single agent for distant metastatic disease or disseminated recurrence?

If yes, go to question #13

If no, go to question #7

  1. Does the individual have a diagnosis of Microsatellite Instability-High (MSI-H) /mismatch repair deficient (dMMR) Cancer with ALL of the following?

If yes, go to question #8

If no, go to question #9

  1. Is the disease unresectable or metastatic and ANY ONE of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of non-small cell lung cancer that is metastatic or recurrent with a tumor that has high PD-L1 expression (Tumor Proportion Score [TPS] ≥50%) as determined by an FDA-approved test as a single agent for ANY ONE of the following?

If yes, go to question #13

If no, go to question #10

  1. Does the individual have a diagnosis of non-small cell lung cancer with a tumor that has PD-L1 expression (TPS ≥1%) as determined by an FDA-approved test with ALL of the following?

If yes, go to question #13

If no, go to question #11

  1. Does the individual have a diagnosis of non-small cell lung cancer with metastatic disease of nonsquamous histology for first-line therapy used in combination with pemetrexed and carboplatin?

If yes, go to question #13

If no, go to question #12

  1. Is the individual 18 years of age or older with a diagnosis of squamous cell carcinoma of the head and neck (SCCHN) if ALL of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following for an authorization period of 6 months?

INDICATION(S) DOSAGE & ADMINISTRATION
NSCLC, SCCHN & Urothelial Carcinoma 200 mg every 21 days for a maximum of 24 months of treatment
cHL & 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

All other indications

2mg/kg every 21 days

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial to meet the initial approval criteria in questions 2 through 13, including not exceeding the maximum length of treatment for NSCLC, cHL, SCCHN, Urothelial Carcinoma, & MSI-H Cancer (24 months)?

If yes, go to question #15

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the treatment show tumor response as defined by lack of tumor progression, improvement in tumor size and/or improvement in patient symptoms?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 24 months or less for ANY ONE of the following?

If yes, go to question #17

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for renewal of Melanoma treatment?

If yes, go to question #18

If no, go to question #19

  1. Is the request for Melanoma Re-Induction (metastatic or unresectable disease) with ALL of the following?

If yes, go to question #19

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, e.g., lack of hepatic toxicity, grade 2 or greater: pneumonitis, colitis, endocrinopathies and/or nephritis?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.