Coverage Policies

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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: 04/01/2020 Title: Trastuzumab (biosimilar products and Herceptin)
Revision Date: 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 biosimilar products (Kanjinti, Ogrivi, Herzuma, Ontruzant, and Trazimera) and Herceptin Hylecta 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 requires prior authorization. For new patients, a biosimilar product or Herceptin Hylecta must be tried first before Herceptin would be approved.

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


Medical Statement

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

2)    Age >18 years old AND

3)    Prescribed in combination with cisplatin 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

 

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

 

 

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


Reference

1)    Herceptin Prescribing Information. South San Francisco, CA: Genentech, Inc.; November 2018.

2)    Ogivri Prescribing Information. Morgantown, WV: Mylan GmbH.; April 2019.

3)    Herzuma Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.; May 2019.

4)    Ontruzant Prescribing Information. Whitehouse Station, NJ: Merck & Co., Inc.; January 2019.

5)    Trazimera Prescribing Information. New York, NY: Pfizer Labs; March 2019.

6)    Herceptin Hylecta Prescribing Information. South San Francisco, CA: Genentech, Inc.; February 2019.

7)    Kanjinti Prescribing Information. Thousand Oaks, CA: Amgen, Inc.; June 2019.

8)    NCCN Drugs & Biologics Compendium. Accessed online January 2020.


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.
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