Piqray - NC Standard

Restricted Products:

• Piqray® (alpelisib)

FDA Approved Use:

• Indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced, or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Criteria for Approval of Restricted Product(s):

1. The patient is currently taking the requested medication for a cancer diagnosis; AND
   1. The patient will utilize the generic formulation of this product (if available); OR
2. The patient is 18 years of age or older; AND
3. The patient is being managed by or in consultation with an oncologist; AND
4. The patient has been diagnosed with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced, or metastatic breast cancer. (Medical record documentation required); AND
5. The patient is ONE of the following:
   1. Postmenopausal; OR
   2. Premenopausal with ovarian ablation/suppression; OR
   3. Male; AND
6. The disease has relapsed or progressed during or after endocrine-based therapy (Medical record documentation required); AND
7. The requested agent will be used in combination with fulvestrant; AND
8. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

March 2023: Criteria change: Criteria review and formatting changes. Updated the quantity limitations due to changes in FDA approved dosing and changed quantity to be listed as pack/box due to availability. Updated coverage to include premenopausal with ovarian ablation/suppression per NCCN guidelines.

July 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic. Removed “as detected by an

FDA approved test”.

February 2020: Original utilization management criteria issued.