RXMP-26 Pertuzumab (Perjeta) Form

Page 1 of 2

AlohaCare Medical Policy pertuzumab (Perjeta)

Policy Number:
RXMP-26 Original Effective Date:
10/1/2023 (Medicaid), 1/1/2024 (Medicare) Review Date:
10/20/2025 Plans AlohaCare Medicaid & Medicare

PRODUCT(S): Perjeta (pertuzumab)

HCPCS Code HCPCS Description How Supplied J9306 Injection pertuzumab 1 mg Perjeta 420mg/14mL SDV

Formulary Status: Medical Benefit: Authorization Required
Pharmacy Benefit: Excluded to Medical Benefit
Duration of Approval: Initial Request: 3 months COC/Reauthorization: 12 months
Quantity Limit: See dosing information

MEDICARE PART B COVERAGE 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 10/20/2025. Review using General Coverage Criteria below.

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- 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.

MEDICARE PART B STEP THERAPY CRITERIA: • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

GENERAL COVERAGE CRITERIA:  Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

Member has HER2-positive (HER2+) breast cancer AND one of the following:

1. Member has early stage, locally advanced, or inflammatory breast cancer with an ECOG performance status of 0-2 AND all of the following: a. Member will use in one of the following ways: 1) Neoadjuvant (prior to surgery) therapy AND the primary tumor is larger than 2 cm in diameter or member is lymph node positive (clinically evident by palpation or imaging) 2) Adjuvant systemic therapy AND the cancer is at high risk of recurrence. b. Member is using in combination with trastuzumab and either paclitaxel (J9267) or docetaxel (J9171) +/-carboplatin (J9045)
   c. Member is using pertuzumab for a maximum of 18 cycles (12-month course)

2. Member has metastatic breast cancer; AND

Page 2 of 2 a. Member is using in combination with trastuzumab and either docetaxel (J9171) or paclitaxel (J9267); b. This combination will be used as the only chemotherapy until metastatic disease progression; c. Treatment with pertuzumab and trastuzumab may continue if docetaxel or paclitaxel has to be stopped due to toxicity or other side effects.

3. Member is requesting pertuzumab in combination with trastuzumab for 12 months after completing 6 cycles (18 weeks) of TCHP (docetaxel, carboplatin (J9045), trastuzumab, pertuzumab for early stage, locally advance, or inflammatory breast cancer.
4. Member has metastatic breast cancer with brain metastases AND all of the following: a. Member has a primary diagnosis of HER2+ breast cancer and is used in one of the following ways: 1) In those with asymptomatic brain metastases as primary or initial therapy 2) In those with recurrent or stable disease b. Member is using in combination with trastuzumab

5. Member is requesting for colorectal cancer, including appendiceal and anal adenocarcinoma AND all of the following: a. Member has HER2-amplified and RAS and BRAF wild type disease b. Member has not been previously treated with HER2 inhibitor in combination with trastuzumab; c. Member is not a candidate for intensive therapy or pertuzumab is being used as subsequent therapy for progression of advanced or metastatic disease.

   EXCLUSIONS:

6. If pertuzumab is administered after trastuzumab is discontinued or as part of a regimen without trastuzumab.

7. Concomitant use of pertuzumab with other targeted biologic agents not otherwise noted in the criteria above [including, but not limited to erlotinib, cetuximab (J9055), panitumumab (J9303), bevacizumab (J9035/Q5107/Q5118), lapatinib, and ziv-aflibercept (J9400)].

   FDA INDICATIONS, DOSING & ADMINISTRATION: Drug Name Indication Dosing/Administration J9306, Injection pertuzumab 1 mg [Perjeta] HER2-positive Breast Cancer • 840 mg initial dose followed by 420 mg every 3 weeks

   REFERENCES:

8. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: September 19, 2023.
9. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology, Plymouth Meeting, PA: NCCN. http://www.nccn.org/index.asp. a. Breast Cancer. V4.2023. Revised March 23, 2023. b. Central Nervous System Cancers. V1.2023. Revised March 24, 2023. c. Colon Cancer. V3.2023. Revised September 21,2023. d. Biliary Tract Cancers. V2.2023. Revised May 10, 2023. e. Head And Neck Cancer. V2.2023. Revised May 15,2023. f. Rectal Cancer. V5.2023. Revised September 21, 2023. CHANGE HISTORY: 9/19/23 DS/PH: New