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HealthPartners

Coverage criteria policies

Ado-trastuzumab emtansine (Kadcyla®), pertuzumab (Perjeta®), trastuzumab (Herceptin® and Kanjinti™), and trastuzumab and hyaluronidase-oysk (Herceptin Hylecta™)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Ado-trastuzumab (Kadcyla), pertuzumab (Perjeta), trastuzumab (Herceptin), and trastuzumab hyaluronidase-oysk (Herceptin Hylecta) require prior authorization from HealthPartners Pharmacy Administration when request is for a non-covered indication (see below).

For indications and regimens not listed as covered below, HealthPartners may use consultant oncologists indicate that the requested drug and regimen is the most appropriate and most cost-effective therapy option. Consulting oncologists will ensure that acceptable, peer-reviewed literature supports a particular use of an oncology drug. The consulting oncologists are independent, external board-certified medical oncologists and hematologists who work with the health plan and providers to ensure that patients receive the most effective, affordable, and least toxic cancer care possible.

Coverage

Coverage is subject to the indications listed below, and per your plan documents.

Ado-trastuzumab (Kadcyla)

Ado-trastuzumab (Kadcyla) is covered without prior authorization when used for FDA-approved indications, including the following:

  1. HER2-positive metastatic breast cancer, as a single agent; or
  2. HER2-positive metastatic lung cancer.

Ado-trastuzumab (Kadcyla) is not FDA approved and is considered experimental and investigational for all other indications. Prior authorization is required and will be reviewed on a case-by-case basis.

Pertuzumab (Perjeta)

Pertuzumab (Perjeta) is covered without prior authorization when used for FDA-approved indications, including HER2 positive metastatic breast cancer in combination with trastuzumab as first line therapy.

Pertuzumab (Perjeta) is not FDA approved and is considered experimental and investigational for all other indications. Prior authorization is required and will be reviewed on a case-by-case basis.

Trastuzumab (Herceptin & Kanjinti)

Trastuzumab (Herceptin & Kanjinti) is covered without prior authorization when used in FDA-approved indications, including the following:

  1. HER2-positive Breast cancer, or
  2. HER2-positive Esophageal and esophageal-gastric junction adenocarcinomas, or
  3. HER2-positive Metastatic gastric adenocarcinomas, or
  4. HER2-positive Salivary gland tumors.

Trastuzumab (Herceptin) is not FDA approved and is considered experimental and investigational for all other indications. Prior authorization is required and will be reviewed on a case-by-case basis.

Trastuzumab hyaluronidase-oysk (Herceptin Hylecta)

Trastuzumab (Herceptin) is covered without prior authorization when used in FDA-approved indications, including the following:

  1. HER2-positive Breast cancer

Regimens requesting or using doses exceeding the FDA-approved regimen are not covered.

Definitions

Perjeta is a HER2/neu receptor antagonist indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Kadcyla, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.

Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature breast cancer

  • As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • As part of a treatment regimen with docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline based therapy.

Herceptin is indicated:

  • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

KANJINTI is a HER2/neu receptor antagonist indicated for:

    · the treatment of HER2 overexpressing breast cancer,

    · the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, indicated in adults for:

  • The treatment of HER2-overexpressing breast cancer.

HER2-Positive: Over-express the HER2 (human epidermal growth factor receptor 2) protein is defined as level 3+ on an immunohistochemical assay, or where HER2 gene amplification is detected using FISH, a HER2 gene/chromosome 17 ratio greater than 2, or HER2 gene copy number greater than six signals/nucleus.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization, unless submitted with a covered diagnosis below:
HCPCS

Codes

Description

J9306

Injection, pertuzumab, 1 mg (Perjeta)

J9354

Injection, ado-trastuzumab emtansine, 1 mg (Kadcyla)

J9355

Injection, trastuzumab, 10 mg (Herceptin)

J9356

Injection, trastuzumab, 10 mg and Hyaluronidase-oysk (Herceptin Hylecta)

J9999

Injection, trastuzumab-anns, biosimilar (Kanjinti), 10mg

NDC

Codes

Description

50242013201

Herceptin 150 MG SOLR

50242005656

Herceptin 440 MG SOLR

50242013468

Herceptin 440 MG SOLR

50242007701

Herceptin Hylecta 600-10000 MG-UNT/5ML SOLN

50242014501

Perjeta 420 MG/14ML SOLN

50242008701

Kadcyla 160 MG SOLR

50242008801

Kadcyla 100 MG SOLR

55513013201

Kanjinti 420 MG SOLR

The services associated with these diagnosis codes do not require prior authorization:
For Ado-trastuzumab (Kadcyla)
ICD-10-CM

Codes

Description

C34.00 - C34.92

Malignant neoplasm of bronchus and lung [HER2-positive]

C50.011 - C50.929

Malignant neoplasm of breast [HER2-positive]

For Pertuzumab (Perjeta)
ICD-10-CM

Codes

Description

C50.011 - C50.929

Malignant neoplasm of breast [HER2 positive]

For Trastuzumab (Herceptin and Kanjinti)
ICD-10-CM

Codes

Description

C08.0 - C08.9

Malignant neoplasm of other and unspecified major salivary glands [HER2 positive]

C15.3 - C15.9

Malignant neoplasm of esophagus [HER2 positive]

C16.0 - C16.9

Malignant neoplasm of stomach [HER2 positive]

C50.011 - C50.929

Malignant neoplasm of breast [HER2 positive]

For Trastuzumab and Hyaluronidase (Herceptin Hylecta)
ICD-10-CM

Codes

Description

C50.011 – C50.929

Malignant neoplasm of breast [HER2 positive]

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

All other diagnosis codes require prior authorization.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Herceptin prescribing information. Genentech, Inc. A member of the Roche Group. 1 DNA Way, South San Francisco, CA 94080-4990. November 2018.
  2. Herceptin Hylecta prescribing information. Genentech, Inc. A member of the Roche Group. 1 DNA Way, South San Francisco, CA 94080-4990. February 2019.
  3. Kadcyla prescribing information. Genentech, Inc. A member of the Roche Group. 1 DNA Way, South San Francisco, CA 94080-4990. November 2018.
  4. Perjeta prescribing information. Genentech, Inc. A member of the Roche Group. 1 DNA Way, South San Francisco, CA 94080-4990. December 2017.
  5. Kanjinti prescribing information. Amgen, Inc. One Thousand Oaks Drive, Thousand Oaks, CA. 91320-1799. June 2019.

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Policy activity

  • 08/13/2018 - Date of origin
  • 01/01/2019 - Effective date

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