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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: 08/01/2022 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)    Age > 18 years;

3)    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 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

4)    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;

3)    Keytruda is prescribed in one of the following ways (a or b);

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

b.    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

 

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.

 

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

 

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 not MSI-H or dMMR* (i.e., disease is not indicative of MMR gene mutation or loss of expression); *See criteria set I.G. for MSI-H/dMMR endometrial carcinoma

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, b, or c):

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

b.    As a single agent for the treatment of patients whose tumors express PD-L1 (CPS ≥ 1) and disease has progressed on or after ≥ 2 lines of systemic therapy;

c.    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 FU;

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))

 

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 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;

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.

 

Merkel Cell Carcinoma

1)    Diagnosis of MCC;

2)    Prescribed by or in consultation with an oncologist;

3)    Age >2 years

 

Microsatellite Instability-High Solid Tumors or Mismatch Repair Deficient Tumors

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 therepy;

b.    Age > 18 years;

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

a.    As first-line or subsequent therapy for colorectal cancer, gallbladder cancer, intrahepatic/extrahepatic cholangiocarcinoma, occult primary tumor;

b.    As first-line therapy for small bowel adenocarcinoma if oxaliplatin contraindication, otherwise subsequent therapy;

c.    As subsequent therapy for other solid tumors;

 

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)    If disease is positive for an EGFR, ALK, or ROS1 mutation, disease has progressed on or after targeted therapy; AND

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

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

b.    In combination with a chemotherapy regimen;

 

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; D

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 (see Appendix F), 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, and has progressed following prior treatment

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 III mycosis fungoides;

                                        ii.    Stage IV Sezary sundrome;

b.    Keytruda is prescribed as subsequent therapy:

                                          i.    Metastatic anal carcinoma;

                                        ii.    Gestational trophoblastic neoplasia;

                                       iii.    Malignant pleural mesothelioma;

                                       iv.    Extranodal NK/T-celllymphoma, nasal type;

                                        v.    Metastatic or unresctable thymic carcinoma;

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

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.; December 2021. Available at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed December 20, 2021.

2)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at https://www.nccn.org/professionals/drug_compendium/content/. Accessed December 6, 2021.

3)    National Comprehensive Cancer Network Guidelines. Cutaneous Melanoma Version 1.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed December 20, 2021.

4)    National Comprehensive Cancer Network Guidelines. Uveal Melanoma Version 3.2020. Available at https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf. Accessed April 17, 2021.

5)    National Comprehensive Cancer Network Guidelines. Non-Small Cell Lung Cancer Version 4.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed April 17, 2021.

6)    National Comprehensive Cancer Network Guidelines. Head and Neck Cancers Version 2.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/head-andneck.pdf. Accessed April 17, 2021.

7)    National Comprehensive Cancer Network Guidelines. Hodgkin Lymphoma Version 3.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. Accessed April 17, 2021.

8)    National Comprehensive Cancer Network. Pediatric Hodgkin Lymphoma Version 3.2021. https://www.nccn.org/professionals/physician_gls/pdf/ped_hodgkin.pdf. Accessed April 17, 2021.

9)    National Comprehensive Cancer Network. B-Cell Lymphomas Version 3.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed April 17, 2021.

10)  National Comprehensive Cancer Network Guidelines. Bladder Cancer Version 2.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 17, 2021.

11)  National Comprehensive Cancer Network Guidelines. Gastric Cancer Version 2.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. Accessed April 17, 2021.

12)  National Comprehensive Cancer Network. Esophageal and Esophagogastric Junction Cancers Version 2.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. Accessed April 17, 2021.

13)  National Comprehensive Cancer Network. Cervical Cancer Version 1.2021. Available at www.nccn.org. Accessed October 19, 2021.

14)  National Comprehensive Cancer Network. Hepatobiliary Cancers Version 1.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed April 17, 2021.

15)  National Comprehensive Cancer Network Guidelines. Merkel Cell Carcinoma Version 1.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/mcc.pdf. Accessed April 17, 2021.

16)  National Comprehensive Cancer Network. Kidney Cancer Version 3.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed December 1, 2021.

17)  National Comprehensive Cancer Network. Uterine Neoplasms Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed April 17, 2021.

18)  National Comprehensive Cancer Network. Squamous Cell Skin Cancer Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed April 17, 2021.

19)  National Comprehensive Cancer Network. Breast Cancer Version 5.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 28, 2021.

20) 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.


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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