Alecensa - NC Standard

• Alecensa® (alectinib) 

• For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 
• For adjuvant treatment following tumor resection in adults with anaplastic lymphoma kinase (ALK)-positive (as detected by an approved test), non–small cell lung cancer (NSCLC) (tumors ≥4 cm or node positive)

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); AND
5. The tumors are anaplastic lymphoma kinase (ALK)-positive (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 apply to brand and associated generic products. 

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)

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

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

May 2024: Criteria update: Updated indication section to include adjuvant treatment following tumor resection in adults with anaplastic lymphoma kinase (ALK)-positive (as detected by an approved test), non–small cell lung cancer (NSCLC) (tumors ≥4 cm or node positive). Updated P&T review section.

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 taking generic (if available).

March 2018: Updated to add duration of approval.

January 2018: Original utilization management criteria issued.