Medical Policy

Effective Date:01/01/2015 Title:Keytruda (Pembrolizumab)
Revision Date:03/01/2019 Document:BI469:00
CPT Code(s):C9027, J9271
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Keytruda (Pembrolizumab) requires prior authorization.

2)    Keytruda is used to treat a number of different types of cancer.

3)    Keytruda is considered a specialty drug and is covered under the medical benefit.

Medical Statement

Keytruda is considered medically necessary for patients meeting the following criteria:

Advanced Renal Cell Cancer

1)    Diagnosis of advanced renal cell cancer, AND

2)    Used in combination with Inlyta (axitinib) as first line therapy.

Bladder Cancer

1)    As a single agent for clinical stage T4b or T2-4a, N1-3 disease, OR

2)    For recurrence post-cystectomy, OR

3)    For metastatic disease as subsequent systemic therapy.

Bone Cancer – Osteosarcoma

1)    Diagnosis of osteosarcoma, OR

2)    Diagnosis of Ewing sarcoma.

Colon or Rectal Cancer

1)    Diagnosis of unresectable advanced or metastatic disease as single agent initial therapy, OR

2)    Subsequent therapy as a single agent (if Opdivo or Keytruda has not been previously used) for unresectable advanced or metastatic disease, OR

3)    Primary treatment as a single agent for unresectable metachronous metastases and previous adjuvant FOLFOX treatment within the past 12 months.

Gastric Cancer

1)    Diagnosis of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, AND

2)    Tumors express PD-L 1 [Combined Positive Score (CPS) >1] as determined by an FDA approved test, AND

3)    Disease progression on or following 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

Head and Neck Cancer

1)    Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), AND

2)    Disease progression after platinum-containing chemotherapy.

Hepatobiliary Cancers

1)    Diagnosis of intrahepatic cholangiocarcinoma that is unresectable or metastatic disease that is microsatellite instability-high (MSI-H)

Hodgkin’s Lymphoma

1)    Diagnosis of Hodgkin lymphoma (classical Hodgkin lymphoma) for patients >18 years of age as additional therapy as a single agent for refractory disease, OR

2)    For palliative therapy as a single agent for relapsed or refractory disease in older adults (> 60).

Melanoma

1)    First line therapy with a diagnosis of unresectable or metastatic melanoma, OR

2)    Second-line or subsequent therapy for disease progression for patients with performance status of 0-2 and no previous use of anti PD-1 monotherapy (e.g. Opdivo), AND

3)    If BRAF V600 positive with performance status of 0-2, must also have previously been treated with a BRAF inhibitor (e.g. Tafinlar or Zelboraf), OR

4)    Re-induction therapy for patients with performance status of 0-2 who experience disease control and have no residual toxicity, but subsequently experience disease progression/relapse > 3 months after treatment discontinuation.

Merkel Cell Carcinoma

1)    Diagnosis of recurrent locally advanced or metastatic Merkel cell carcinoma for adult and pediatric patients

Microsatellite Instability-High Solid Tumors or Mismatch Repair Deficient Tumors

1)    Diagnosis of unresectable or metastatic instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment with no satisfactory treatment alternatives, OR

2)    Diagnosis of unresectable or metastatic instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluorpyrimidine, oxaliplatin, and irinotecan.

Non-Small Cell Lung Cancer (NSCLC)

1)    Diagnosis of metastatic non-small cell lung cancer, AND

2)    As first line therapy for tumors that are EGFR, ALK, and ROS-1 negative or unknown, OR

3)    If EGFR genomic tumor aberrations present, should have disease progression on therapy for this aberration  (e.g. Tarceva, Gilotrif, Iressa, or Tagrisso) prior to receiving Pembrolizuma, OR

4)    If ALK genomic tumor aberrations present, should have disease progression on therapy for this aberration (e.g. Xalkori, Zykadia, or Alecensa), OR

5)    If ROS-1 genomic tumor aberrations present, should have disease progression on therapy for this aberration (e.g. Xalkori) OR

6)    If stage 3 and not candidate for surgical resection or definitive chemoradiation OR

7)    If stage 3 with a PD-L 1 expression level of 1% or more and do not harbor EGFR or ALD aberrations.

Pancreatic Adenocarcinoma

1)    Diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma, AND

2)    Has progressed following prior treatment.

Penile Cancer

1)    Diagnosis of unresectable or metastatic, microsatellite instability-high (MSI-H) penile cancer, AND

2)    Has progressed following prior treatment.

Codes Used In This BI:

J9271  Injection, Pembrolizumab, 1mg (Keytruda)

Limits
Intentially left empty
Reference

1)    Keytruda Package Insert.  Merck.  April 2019.

2)    Clinical Pharmacology.  Accessed online May 14, 2019.

3)    NCCN Drugs & Biologic Compendium.  Accessed online May 14, 2019.

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.