Pemazyre – NC Standard

Restricted Products:

• Pemazyre (pemigatinib)

FDA Approved Use:

• For treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
• For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

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 unresectable locally advanced or metastatic cholangiocarcinoma; AND
   1. The patient has progressed while on or following at least one prior therapy; AND
   2. The patient has had an FGFR2 gene fusion or non-fusion rearrangement (medical record documentation required); OR
5. The patient has been diagnosed with relapsed or refractory myeloid/lymphoid neoplasms (MLNs); AND
   1. The patient has fibroblast growth factor receptor 1 (FGFR1) gene rearrangement (medical record documentation required); AND
6. 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
7. 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).

References:

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

Policy Implementation/Update Information:

September 2022: Criteria change: Added new indication of relapsed or refractory myeloid/lymphoid neoplasms (MLNs)

July 2020: Criteria update: Updated duration of approval to 1 year (previously not specified).

April 2020: Original utilization management criteria issued.