Medical Policy

Effective Date:04/01/2020 Title:Trastuzumab (biosimilar products and Herceptin)
Revision Date:05/01/2023 Document:BI640:00
CPT Code(s):Q5112, Q5113,Q5114, Q5116, Q5117, J9356, J9355
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)    Trastuzumab preferred biosimilar products (Kanjinti, Ogrivi, and Trazimera) are covered without PA. They are subject to retrospective review to ensure they are used in compliance with the Medical Policy Statement below.

2)    Herceptin, Herceptin Hylecta, Herzuma, and Ontruzant require prior authorization. For new patients, a apreferred biosimilar product must be tried first before Herceptin, Herceptin Hylecta, Herzuma, or Ontruzant would be approved.

3)    Trastuzumab is used to treat breast cancer, gastric cancers, and endometrial carcinoma.

Medical Statement

Trastuzumab preferred biosimilar products (Kanjinti, Ogrivi, and Trazimera)  are covered without PA. They are subject to retrospective review to ensure they are used in compliance with the Medical Policy Statement below.  Herceptin, Herceptin Hylecta, Ontruzant, and Herzuma require prior authorization (PA). For new patients, a preferred biosimilar product must be tried first before these products would be approved.

 

Trastuzumab is considered medically necessary for patients meeting the following criteria and subject to the step therapy noted immediately above.

 

Breast Cancer

1)    Diagnosis of HER2-positive breast cancer AND

2)    Age >18 years old AND

 

Gastric, Esophageal and Esophagogastric Junction Cancer

1)    Diagnosis of HER2-positive metastatic gastric, esophageal, or EGJ adenocarcinoma AND

2)    Age >18 years old AND

3)    Prescribed in combination with a platinum agent (cisplatin or oxaliplatin) and either capecitabine or 5-fluorouracil

 

Endometrial Carcinoma

1)    Diagnosis of HER2-positive endometrial carcinoma with serous histology AND

2)    Age >18 years old AND

3)    Disease is advanced (i.e. stage III/IV) or recurrent AND

4)    Prescribed in combination with carboplatin and paclitaxel

 

Colorectal Cancer (off-label)

1.    Diagnosis of advanced or metastatic colorectal cancer and all of the following (a, b, and c):

a.    Disease is HER2 positive;\

b.    Disease is wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use);

c.    Wild-type BRAF;

2.    Age > 18 years

 

Salivary Gland Tumor (off-label)

1.    Diagnosis of HER2-positive slivary gland tumore:
Age > 18 years;

2.    Prescribed in one of the following manners (a, b, or c):

a.    Single agent;

b.    Combination with docetaxel;

c.    Combination with Perjeta

Initial Approval Duration: 6 months

 

Reauthorization is allowed if patient is responding to therapy and above prescribing guidelines are met for the specific diagnosis.

 Reauthorization Approval Duration: 12 months

 

Codes Used In This BI:

 

Q5112 – Injection, trastuzumab-dttb, biosimilar (Ontruzant), 10mg

Q5113 – Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10mg

Q5114 – Injection, trastuzumab-dkst, biosimilar, (Ogivri), 10mg

Q5116 – Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10mg

Q5117 – Injection, trastuzumab-anns, biosimilar, (kanjinti), 10mg

J9355 – Injection, trastuzumab, excludes biosimilar, 10mg

J9356 – Injection, trastuzumab, 10mg and Hyaluronidase-oysk

Limits
Intentially left empty
Reference

1.     Herceptin Prescribing Information. South San Francisco, CA: Genentech, Inc.; February 2021. Available at https://www.gene.com/download/pdf/herceptin_prescribing.pdf. Accessed February 16, 2022.

2.    Ogivri Prescribing Information. Morgantown, WV: Mylan GmbH.; February 2021. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s004lbl.pdf. Accessed February 16, 2022.

3.    Herzuma Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.; May 2019. https://www.herzuma.com/globalassets/herzuma/herzuma-pi.pdf. Accessed February 16, 2022.

4.    Ontruzant Prescribing Information. Jersey City, NJ: Organon; June 2021. https://www.organon.com/product/usa/pi_circulars/o/ontruzant/Ontruzant-pi.pdf. Accessed February 16, 2022. CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase 

5.    Trazimera Prescribing Information. New York, NY: Pfizer Labs; November 2020. Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12725. Accessed February 16, 2022.

6.    Herceptin Hylecta Prescribing Information. South San Francisco, CA: Genentech, Inc.; February 2019. Available at https://www.gene.com/download/pdf/herceptin_hylecta_prescribing.pdf. Accessed February 16, 2022.

7.    Kanjinti Prescribing Information. Thousand Oaks, CA: Amgen, Inc.; October 2019. Available at https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgencom/kanjinti/kanjinti_pi.ashx. Accessed February 16, 2022.

8.    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed February 16, 2022.

9.    Fahrenbruch R, Kintzel P, Bott AM., et al. Dose rounding of biologic and cytotoxic anticancer agents: a position statement of the hematology/oncology pharmacy association. Journal of Oncology Practice. 2018;14(3)e130-e136.

Addendum:

1)    Effective 05/01/2023: Updated preferred biosimilars; added criteria for off-label uses colorectal cancer and salivary gland tumor.

Resource Document:

 

Resource Document Link

Application to Products
This policy applies to all health plans 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) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, 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.