Tarceva – NC Standard

Restricted Product(s)

Restriction applies to brand and generic

• Tarceva® (erlotinib)

FDA Approved Use

• For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen 
• First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

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. If the request is for brand Tarceva, 
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic erlotinib (medical record documentation required); AND 
5. One of the following:
   1. The patient has been diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) (medical record documentation required); AND
      1. The tumor(s) have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (medical record documentation required); AND 
      2. Treatment is first-line OR 
      3. Treatment is for maintenance OR 
      4. Treatment is second line or greater, and the patient has tried and failed at least one prior chemotherapy regimen OR 
   2. The patient has been diagnosed locally advanced, unresectable or metastatic pancreatic cancer; AND
      1. The patient will be taking Tarceva with gemcitabine; AND
      2. Treatment is first-line; AND
6. Tarceva is not being used in combination with platinum-based chemotherapy; AND 
7. 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 
8. 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

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. Added medical record documentation required for diagnosis.
July 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic formulation (if available).
Jun 2019: Criteria update: Generic erlotinib added to the policy as restricted
Oct 2018: Annual review; No change
Apr 2017: Original utilization management criteria issued.