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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2015 Title: Keytruda (Pembrolizumab)
Revision Date: 11/01/2023 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 when prescribed by or in consultation with an oncologist:

Renal Cell Carcinoma (RCC)

1)    Diagnosis of RCC; AND

2)    Prescribed by or in consultation with an oncologist

3)    Age > 18 years;

4)    Keytruda is prescribed in one of the following ways (a, b, or c):

a.    In combination with Inlyta or Lenvima, and disease is advanced (i.e., relapsed or stage IV);

b.    As single-agent adjuvant treatment, and member is at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection metastatic lesions;

c.    As a single agent for relapsed or stage IV disease with non-clear cell histology (off-label); AND

5)    Request meets one of the following (a or b):*

a.    Dose does not exceed 200mg every 3 weeks or 400mg every 6 weeks for a maximum of 24 months (combination therapy) or 12months (monotherapy);

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regiment must be FDA-approved or recommended by NCCN.

 

Urothelial Carcinoma

1)    Diagnosis of urothelial carcinoma;

2)    Prescribed by or in consultation with an oncologist or urologist;

3)    Age > 18 years;

4)    Keytruda is prescribed in one of the following ways (a, b or c);

a.    In combination with Padcev for locally advanced or metastatic disease, and member is not eligible for cisplatin-containing chemotherapy;

b.    As a single agent for locally advanced or metastatic disease and member is ineligible for or has previously received platinum-containing chemotherapy (e.g., cisplatin, carboplatin);

c.    As a single agent for BCG-unresponssive, high-risk, NMIBC with CIS and member is ineligible for or has elected not to undergo cystectomy.

 

Cervical Cancer

1)    Diagnosis of cervical cancer;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Tumor expresses PD-L1 (CPS ≥ 1);

5)    Prescribed in one of the following ways (a or b):

a.    As a single agent, and (i and ii):

                                      i.    Disease is recurrent or metastatic;

                                    ii.    Disease has progressed on or after ≥ 1 line of systemic therapy;

b. In combination with chemotherapy (e.g., paclitaxel/cisplatin, paclitaxel/carboplatin) with or without bevacizumab, and (i):

i. Disease is persistent, recurrent, or metastatic

 

Cutaneous Squamous Cell Carcinoma

1)    Diagnosis of cSCC;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Member is not a candidate for curative surgery or radiation

5)    Prescribed as a single agent

 

Endometrial Carcinoma

1)    Diagnosis of endometrial carcinoma;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Prescribed in combination with Lenvima* ;

*Prior authorization may be required for Lenvima

5)    Disease is pMMR or not MSI-H

6)    Disease has progressed following prior systemic therapy (e.g., carboplatin/paclitaxel);

7)    Member is not a candidate for curative surgery or radiation

 

Gastric Cancer, Esophageal Cancer, or Gastroesophageal Junction Adenocarcinoma

1)    Diagnosis of gastric cancer, esophageal cancer, or gastroesophageal junction adenocarcinoma;

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    Disease is unresectable, locally advanced, recurrent, or metastatic;

5)    Keytruda is prescribed in one of the following ways (a or b):

a.    In combination with trastuzumab, fluoropyrimdine- and platinum-containing or platinum- and fluoropyrimidine-based chemotherapy;

b.    As a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥ 10);

 

Head and Neck Squamous Cell Carcinoma

1)    Diagnosis of HNSCC (locations include paranasal sinuses, larynx, pharynx, lip, oral cavity, salivary glands; may be occult primary - i.e., primary source unknown);

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Disease is unresectable, recurrent, or metastatic;

5)     Keytruda is prescribed in one of the following ways (a, b, or c):

a.    In combination with platinum-containing chemotherapy and either FU, docetaxel, or gemcitabine;

b.    As a first-line single agent and the tumor expresses PD-L1 with a CPS of ≥ 1;

c.    As a single agent for disease that has progressed on or after platinum-containing chemotherapy (e.g., cisplatin, carboplatin)

6)    Request meets one of the following (a or b):*

a.    Dose does not exceed 200mg every 3 weeks or 400mg every 6 weeks for a maximum of 24 months;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regiment must be FDA-approved or recommended by NCCN.

 

Hepatocellular Carcinoma

1)    Diagnosis of hepatocellular carcinoma (HCC);

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    Disease is classified as Child-Pugh Class A and has progressed on or after therapy with Nexavar® or Lenvima®;

*Prior authorization may be required for Nexavar and Lenvima

5)    Member has not previously been treated with immune checkpoint inhibitor therapy (PD-L1/PD-1, e.g., Tecentriq (atezolizumab), Opdivo (nivolumab))

6)    Prescribed as a single agent.

 

Classical Hodgkin’s Lymphoma

1)    Diagnosis of cHL;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Age ≥ 2 years;

4)    Keytruda is prescribed as single-agent therapy (adults or pediatrics) or in combination with GVD (gemcitabine, vinorelbine, liposomal doxorubicin) (adults only) in one of the following ways (a, b, c, or d):

a.    After hematopoietic stem cell transplant;

b.    For disease that is refractory to ≥ 1 line of systemic therapy

c.    Age ≥ 18 years: for disease that has relapsed after ≥ 1 line of systemic therapy;

d.    Age ≥ 2 years to < 18 years: for disease that has relapsed after ≥ 2 lines of systemic therapy;

 

Melanoma

1)    Diagnosis of melanoma AND

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 12 years;

4)    Disease is Stage IIB, IIC, III, recurrent, unresectable, or metastatic.

5)    Prescribed as a single agent or in combination with Lenvima or Yervoy.

 

Merkel Cell Carcinoma

1)    Diagnosis of MCC;

2)    Prescribed by or in consultation with an oncologist;

3)    Age >2 years

4)    Disease is recurrent, locally advanced, or metastatic.

 

Microsatellite Instability-High/Mismatch Repair Deficient Cancer

1)    Diagnosis of a solid tumor classified as MSI-H or dMMR (indicative of MMR gene mutation or loss of expression);

2)    Prescribed by or in consultation with an oncologist;

3)    Member meets one of the following (a or b):

a.    Age > 2 years to < 18 years and request is not for first-line therapy;

b.    Age > 18 years;

4)     Keytruda is prescribed in one of the following ways (a or b):

a.    As first-line or subsequent therapy for ampullary adenocarcinoma, colorectal cancer, gallbladder cancer, intrahepatic/extrahepatic cholangiocarcinoma, non-nasopharyngeal head and neck cancer, occult primary tumor, pancreatic adenocarcinoma, or small bowel adenocarcinoma;;

 

b.    As subsequent therapy for other solid tumors;

5) Prescribed as a single agent

 

Non-Small Cell Lung Cancer (NSCLC)

1)    Diagnosis of NSCLC;

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    Disease is recurrent, advanced, or metastatic; AND

5)    Request meets one of the following:

a.    Disease mutation status is negative for actionable biomarkers (EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 [HER2]);

b.    Disease mutation status is positive for EGFR S768I, L861Q, and/or G719X, and member has received prior afatinib, osimertinib, erlotinib, gefitinib, or decomitinib;

c.    Disease mutation is positive for EGFR exon 19 deletion or L858R, and member has received prior erlotinib + (ramucirumab or bevacizumab), afatinib, gefitinib, osimertinib, or dacomitinib;

d.    Disease mutation status is positive for ROS1 rearrangement, and member has received prior crizotinib, entrectinib, or ceritinib;

e.    Disease mutation status is positive for ALK rearrangement, and member has received prior crizotinib, ceritnib, alectinib, brigatinib, or lorlatinib;

f.     Disease mutation status is positive for EGFR exon 20, KRAS G12C, NRTK1/2/3, BRAF V600E, MET exon 14 skipping, or RET  rearrangement;

6)    Keytruda is prescribed in one of the following ways (a, b, c, or d)):

a.    For PD-L1 positive disease (TPS>1%);

b.    In combination with a chemotherapy regimen;

c.    As single-agent continuation maintenance therapy if previously given first line as part of a chemotherapy regimen;

d.    As single-agent adjuvant treatment following resection and platinum-based chemotherapy (e.g., cisplatin, carboplatin) for adult patients with stage IB (T2a > 4cm), II, or IIIA disease;

7) Member does not have contraindications to PD-1/PD-L1 inhibitor therapy (e.g. Opdivo, Yervoy, Tecentriq, Imfinzi);

 

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

1)    Diagnosis of PMBCL;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Age > 2 years;

4)    Disease is refractory to or has relapsed after > 1 line of systemic therapy;

5)    Prescribed as a single agent;

Triple Negative Breast Cancer (TNBC)

1)    Diagnosis of TNBC (i.e., estrogen receptor/progesterone receptor [ER/PR] negative and human epidermal growth factor receptor 2 [HER2]-negative);

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    One of the following (a or b):

a.    Disease is high-risk early-stage , and:

                                          i.    Prescribed in combination with chemotherapy (e.g., carboplatin, paclitaxel, doxorubicin, cyclophosphamide) as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery;

b.    Disease is locally recurrent unresectable or metastatic, and both of the following (i and ii):

                                          i.    Tumor expresses PD-L1 (CPS ≥ 10);

                                        ii.    Prescribed in combination with chemotherapy (e.g., paclitaxel, paclitaxel protein-bound, gemcitabine and carboplatin)

Tumor Mutational Burden-High Cancer

1)    Diagnosis of a solid tumor classified as TMB-H (i.e., ≥ 10 mutations/megabase [mut/Mb]);

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 2 years;

4)    Disease is unresectable or metastatic;

5)    One of the following (a or b):

a.    Disease has progressed following prior treatment;

b.    Prescribed as first-line therapy for ampullary adenocarcinoma or pancreatic adenocarcinoma

6) Prescribed as a single agent;

 

NCCN Recommended Uses (off-label) (must meet all)

1)    Diagnosis of one of the following (a or b):

a.    Keytruda is prescribed as first-line or subsequent therapy:

                                          i.    Stage IIIb or III mycosis fungoides;

                                        ii.    Stage IV Sezary sundrome;

                                       iii.    Unresectable or metastatic adrenocortical carcinoma;

                                       iv.    Alveolar soft part sarcoma;

                                        v.    Metastatic or unresectable thymic carcinoma, and prescribed as a single agent.

b.    Keytruda is prescribed as single-agent subsequent therapy:

                                          i.    Metastatic anal carcinoma and member has not previously received Keytruda or Opdivo;

                                        ii.    Gestational trophoblastic neoplasia;

                                       iii.    Extranodal NK/T-cell lymphoma;

                                       iv.    Advanced, recurrent, or metastatic PD-L1-positive (CPS> 1) vulvar carcinoma;

                                        v.    Relapsed or refractory cutaneous anaplastic large cell lymphoma;

                                       vi.    Relapsed or primary progressive small cell lung cancer

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer=reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Codes Used In This BI:

J9271  Injection, Pembrolizumab, 1mg (Keytruda)


Reference

1. Keytruda Prescribing Information. Whitehouse Station, NJ: Merck and Co.; April 2023. Available at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed April 26, 2023.

2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at https://www.nccn.org/professionals/drug_compendium/content/. Accessed May 11, 2023.

3. Salem ME, Puccini A, Grothey A, et al. Landscape of tumor mutation load, mismatch repair deficiency, and PD-L1 expression in a large patient cohort of gastrointestinal cancers. Molecular cancer research : MCR. 2018;16(5):805-812. https://pubmed.ncbi.nlm.nih.gov/29523759/

 

Addendum:

1)    Effective 05/01/2017: Updated criteria regarding melanoma and non-small cell lung cancer. Added approved diagnoses of head and neck cancer, colon or rectal cancer, Hodgkin’s lymphoma, and Merkel Cell carcinoma.

2)    Effective 07/01/2017. Update criteria to include bladder cancer as covered diagnosis

3)    Effective 11/01/2017: Update criteria to include gastric cancer as covered diagnosis.

4)    Effective 04/01/2018: Updated criteria regarding NSCLC and added additional covered diagnoses (bone cancer, hepatobiliary, pancreatic adenocarcinoma, and penile cancer).

5)    Effective 03/01/2019: Updated criteria for Merkel cell carcinoma.

6)    Effective 06/01/2019: Updated criteria for advanced renal cell cancer and expanded indications for NSCLC.

7)    Effective 05/01/2022: Updated criteria for several indications and added criteria for newly approved indications.

8)    Effective 08/01/2022: Updated multiple criteria sets, including adding approved diagnoses.

9)    Effective 01/01/2023: Updated multiple criteria sets.

10) Effective 08/01/2023: Updated multiple criteria sets.

11) Effective 11/01/2023: Updated NSCLC and tumor mutational burden-high cancer criteria.


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.
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