Lumakras – NC Standard

Restricted Product(s):

• LumakrasTM (sotorasib)

FDA Approved Use:

• For the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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 locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) (medical record documentation required); AND
5. The patient has had disease progression after receiving at least one prior systemic 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 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. f 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

November 2024: Criteria update: Added new Lumakras (sotorasib) 240 mg tablet to the policy’s quantity limit chart.

March 2023: Criteria update: Added new Lumakras (sotorasib) 320 mg tablet to the policy.

December 2022: Criteria update: Criteria review and formatting changes

June 2021: Original utilization management criteria issued.