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Pembrolizumab (Keytruda®)

These services may or may not be covered by all CoOportunity Health plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative process

Keytruda requires prior authorization from Pharmacy Administration.

Coverage

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Pembrolizumab (Keytruda) is generally covered when used as follows:

  1. Patient is diagnosed with unresectable or metastatic melanoma; and,
  2. The patient meets one of the following criteria:
    1. BRAF V600 mutation positive with disease progression after treatment with BOTH of the following:
      1. A BRAF inhibitor (e.g., vemurafenib [Zelboraf®], dabrafenib [Tafinlar®]); AND,
      2. Ipilimumab (Yervoy®)
    2. BRAF V600 mutation-negative or unknown status with disease progression after treatment with ipilimumab

Approvals will be for three months. Reauthorizations will be approved every three months with documentation of no disease progression.

Definitions

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Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Codes

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If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Codes

J9999 – Not otherwise classified, antineoplastic drugs

NDC Codes

00006302901 - Keytruda 50 mg solution
00006302902 - Keytruda 50 mg solution

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

References

  1. Keytruda Prescribing Information. Whitehouse Station, NJ: Merck & Co, INC. Sep 2014.
  2. National Cancer Institute: PDQ® Melanoma Treatment. Bethesda, MD: National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/melanoma/HealthProfessional [Accessed Sep 15, 2014]
  3. Updates to the NCCN’s Clinical Practice Guidelines for Melanoma. http://www.cancertreatment.net/lifestyle/cancer-treatment/updates-nccns-clinical-practice-guidelines-melan [Accessed Sep 15, 2014]
  4. Merck & Co’s Keytruda First FDA-approved PDI-1 inhibitor. http://www.pharmatimes.com/article/14-09-04/Merck_Co_s_Keytruda_first_FDA-approved_PD-1_inhibitor.aspx [Accessed Sep. 15, 2014]
  5. FDA News Release: FDA approves Keytruda for advanced melanoma. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm [Accessed Sep 16, 2014]
  6. Hamid O, Robert C, Daud A, et al., Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. NEJM 2013;369:134-44.

This information is for most, but not all, CoOportunity Health plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

CoOportunity Health has contracted with HealthPartners Administrators, Inc. to provide claims processing, medical management and certain other administrative services.