Gilotrif - NC Standard

Restricted Product(s)

• Gilotrif® (afatinib)

FDA Approved Use

• For first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. 
• For the treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.

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 metastatic non-small cell lung cancer (NSCLC) that is positive for tumors with epidermal growth factor receptor (EGFR) mutations (medical record documentation required); OR 
5. The patient has been diagnosed with metastatic, squamous non-small cell lung cancer (NSCLC); AND 
   1. The patient has progressed on platinum therapy; 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 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

February 2023: Criteria update: Criteria review and formatting changes. Added duration of approval to the quantity limit exception criteria.
July 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic formulation (if available).
Feb 2018: Expanded indication to include all EGFR mutations in accord with FDA expanded indication
Apr 2017: Original utilization management policy issued