RXMP-16 Trastuzumab Form

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AlohaCare Medical Policy Trastuzumab

Policy Number:
RXMP-16 Current Effective Date:
4/2/2025 Original Effective Date:
5/1/2019 Next Review/Revision Date:
10/20/2025 Plans AlohaCare Medicaid & Medicare

PRODUCTS: Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera

HCPCS Code HCPCS Description Drug Name J9355 Injection, trastuzumab, excludes biosimilar, 10 mg Herceptin 150mg, 420mg vial Q5112 Injection, trastuzumab-dttb, biosimilar, (ontruzant), 10 mg Ontruzant 150mg, 420mg vial Q5113 Injection, trastuzumab-pkrb, biosimilar, (herzuma), 10 mg Herzuma 150mg, 420mg vial Q5114 Injection, trastuzumab-dkst, biosimilar, (ogivri), 10 mg Ogivri 150mg, 420mg vial Q5116 Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg Trazimera 150mg, 420mg vial Q5117 Injection, trastuzumab-anns, biosimilar, (kanjinti), 10 mg Kanjinti 150mg, 420mg vial Bolded drugs indicates preferred agents. Medicare preferred: Herzuma, Trazimera; QUEST preferred: Kanjinti, Trazimera *QMC Infusion Center formulary as of 8/27/2020: Kanjinti (new starts), Herceptin (COC).

Formulary Status: Medical Benefit: Authorization Required
Pharmacy Benefit: Excluded, process under the Medical Benefit Duration of Approval: Initial Request: 6 months COC/Reauthorization: 12 months Dosing Limit: See dosing information

MEDICARE CMS CRITERIA: • Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 6/8/2023. • For new starts, step therapy criteria must be met in addition to clinical criteria before a request may be approved.

MEDICARE PART B STEP THERAPY CRITERIA: Herceptin, Kanjinti, Ogivri, and Ontruzant (new starts): The member has an inadequate response to, intolerable adverse event to, or has a contraindication to Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp).

CONTINUATION CRITERIA FOR APPROVAL FOR MEDICARE/MEDICAID: ➢ Pharmacy staff: For QUEST & non-ABD members with cancer, send ADRC referral with chart notes.

➢ MEDICARE PART B 90-DAY TRANSITION PERIOD:
For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-

Page 2 of 4 network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. For All Indications

1. Member does not show evidence of disease progression while on therapy AND
2. Left ventricular ejection fraction (LVEF) is assessed within the last 3 months and results of LVEF include one of the following:
   a. Within normal limits, but no more than an absolute decrease of 16% from pre-treatment baseline b. Below normal limits, but no more than an absolute decrease of 10% from pre-treatment baseline

3. For Medicaid: Herceptin, Herzuma, Ogivri, Ontruzant: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Kanjinti (trastuzumab-anns) or Trazimera (trastuzumab-qyyp).

   INITIAL CRITERIA FOR APPROVAL FOR MEDICARE/MEDICAID: ➢ Pharmacy staff: For QUEST & non-ABD members with cancer, send ADRC referral with chart notes.

   Adjuvant Breast Cancer

4. Diagnosis of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer AND
5. Used for one of the following:
   a. As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel b. As part of a treatment regimen with docetaxel and carboplatin c. As a single agent following multi-modality anthracycline based therapy AND
6. Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy AND
7. Prescribed by or in consultation with an oncologist AND For Medicaid: Request for Herceptin, Herzuma, Ogivri, Ontruzant: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Kanjinti (trastuzumab-anns) or Trazimera (trastuzumab-qyyp) OR

8. For Medicare: Herceptin, Kanjinti, Ogivri, and Ontruzant are not covered for new starts, unless the member has an inadequate response to, intolerable adverse event to, or has a contraindication for Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp).

   Metastatic Breast Cancer

9. Diagnosis of HER2 overexpressing metastatic breast cancer AND
10. Used for one of the following:
    a. In combination with paclitaxel for first-line treatment b. As a single agent in patients who have received one or more chemotherapy regiments for metastatic disease AND
11. Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy AND
12. Prescribed by or in consultation with an oncologist AND
13. For Medicaid: Request for Herceptin, Herzuma, Ogivri, Ontruzant: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Kanjinti (trastuzumab-anns) or Trazimera (trastuzumab-qyyp). OR
14. For Medicare: Herceptin, Kanjinti, Ogivri, and Ontruzant are not covered for new starts, unless the member has an inadequate response to, intolerable adverse event to, or has a contraindication for Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp).

Page 3 of 4 Metastatic Gastric Cancer

1. Diagnosis of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma AND
2. Used in combination with cisplatin and capecitabine or 5-fluorouracil for first-line metastatic treatment AND
3. Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy AND
4. Prescribed by or in consultation with an oncologist AND
5. For Medicaid: Request for Herceptin, Herzuma, Ogivri, Ontruzant: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Kanjinti (trastuzumab-anns) or Trazimera (trastuzumab-qyyp) OR

6. For Medicare: Herceptin, Kanjinti, Ogivri, and Ontruzant are not covered for new starts, unless the member has an inadequate response to, intolerable adverse event to, or has a contraindication for Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp).

   All Other Indications

7. Diagnosis is supported by compendia (e.g. NCCN, DRUGDex, AHFS-DI) or peer-reviewed published literature AND
8. Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy AND
9. For Medicaid: R equest for Herceptin, Herzuma, Ogivri, Ontruzant: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Kanjinti (trastuzumab-anns) or Trazimera (trastuzumab-qyyp) OR

10. For Medicare: Herceptin, Kanjinti, Ogivri, and Ontruzant are not covered for new starts, unless the member has an inadequate response to, intolerable adverse event to, or has a contraindication for Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp).

    EXCLUSION: Concurrent use with another trastuzumab or trastuzumab-based product (e.g. Kadcyla, Enhertu, Herceptin Hylecta, or Phesgo).

    FDA INDICATIONS, DOSING & ADMINISTRATION: Indication(s) Usual Dosing Herceptin Kanjinti Ogivri Trazimera Herzuma Ontruzant HER2(+) Breast Cancer (Adjuvant) 8mg/kg (loading), then 6mg/kg (maintenance) IV Q3Weeks x12 months [alternate initial dosing if starting with chemo] X X X X X X Metastatic HER2(+) Breast Cancer 8mg/kg (loading), then 6mg/kg (maintenance) IV Q3Weeks [alternate initial dosing if starting with chemo] X X X X X X Metastatic HER2(+) Gastric Cancer 8mg/kg (loading), then 6mg/kg (maintenance) IV Q3Weeks X X X X

    X

    REFERENCES:

11. OptumRx, PA criteria, accessed June 2023.
12. CodeSource, accessed June 2023.

13. Herceptin Prescribing Information, accessed June 2023.

    Change History:

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1. Antineoplastic Monoclonal Antibodies, retired June 2023, HB.
2. Trastuzumab, new as of 6/7/2023, PH.
3. 4/2/2025 AP: Added Continuity of Care requirement