Medication Comments Perjeta (pertuzumab) N/A

OVERRIDE(S)

Prior Authorization of Benefits

APPROVAL DURATION

1 year

APPROVAL CRITERIA

Requests for Perjeta (pertuzumab) may be approved for treatment of individuals who meet criteria I and either II or III below:

I. The breast tumor is HER2 positive (HER2+) as documented by ONE of the following: a. Immunohistochemistry (IHC) is 3+; or b. In situ hybridization (ISH) positive by any of the following i. Single probe average HER2 copy number greater than or equal to 6.0 signals/cell; OR ii. Dual-probe HER2/CEP17 ratio greater than or equal to 2.0; OR iii. Dual-probe HER2/CEP17 ratio less than 2.0 with an average HER2 copy number greater than or equal to 6.0 signals/cell;

AND II. The individual has metastatic breast cancer and both of the following: a. Perjeta (pertuzumab) will be used in combination with trastuzumab AND either docetaxel or paclitaxel*; AND b. The combination chemotherapy with Perjeta (pertuzumab) will be used as single- line anti-HER2 chemotherapy for metastatic disease until progression.

*Note: If docetaxel or paclitaxel treatment is contraindicated upon initiation or discontinued (for example, related to toxicity), treatment with Perjeta (pertuzumab) and trastuzumab may continue.

OR III. The individual has operable early stage, locally advanced, or inflammatory breast cancer and will undergo neoadjuvant (prior to surgery) therapy and ALL of the following are met: a. Primary tumor is larger than 2 cm in diameter or individual is node positive (clinically evident by palpation or imaging); AND b. ECOG performance status 0-2; AND c. Used in combination therapy with trastuzumab and one of the following: i. Docetaxel with or without carboplatin; OR ii. Paclitaxel; AND d. Complete surgical resection is planned if neoadjuvant therapy results in a sufficient therapeutic response; AND

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e. Not continued post-operatively (adjuvant).

The following are considered investigational and may NOT be approved:  Perjeta (pertuzumab) is considered investigational and may NOT be approved for treatment of individuals who do not meet the criteria listed above.  Perjeta (pertuzumab) is considered investigational and may NOT be approved if it is administered after trastuzumab is discontinued or as part of a regimen without trastuzumab.  Concomitant use of Perjeta (pertuzumab) with other targeted biologic agents not otherwise noted in the criteria above (including, but not limited to erlotinib, cetuximab, panitumumab, bevacizumab, and lapatinib) is considered investigational and may NOT be approved.

PAGE 2 of 2 07/07/2015 Express Scripts, Inc. is a separate company that provides pharmacy services and pharmacy benefit management services on behalf of health plan members.