CurrentCignaPolicy N/A

Oncology (Oral - Kirsten RAt Sarcoma Virus Inhibitor) - Lumakras PA Policy

Prior authorization policy for outpatient prescription coverage of Lumakras (sotorasib tablets) for FDA-approved and select guideline-supported indications (NSCLC, colorectal, ampullary, pancreatic, small bowel adenocarcinomas) with specific clinical criteria and approval durations.

Policy Summary

PayerCigna

PolicyOncology (Oral - Kirsten RAt Sarcoma Virus Inhibitor) - Lumakras PA Policy

Policy CodePolicy N/A

Change TypeAnnual and selected revisions (added indications; moved colon/rectal to FDA-approved)

Effective Date

Next Review DateMay 14, 2025

Key ActionPrior authorization is recommended/required for Lumakras; document KRAS G12C mutation status and prior systemic therapy as applicable.

POLICY UPDATE CHANGES

Pancreatic Adenocarcinoma added as a condition of approval with criteria based on guideline recommendations.

Small Bowel Adenocarcinoma added as a condition of approval with criteria.

Colon or Rectal Cancer moved from 'Other Uses with Supportive Evidence' to 'FDA-Approved Indication' and criteria clarified regarding combination regimens.

Policy name updated to include broader oncology class and drug name formatting.

5Covered Indications (listed)

1 yearStandard approval duration

KRAS G12CRequired biomarker

Coverage Summary

Prior authorization policy for outpatient prescription coverage of Lumakras (sotorasib tablets) for FDA-approved and select guideline-supported indications including NSCLC, colorectal, ampullary, pancreatic, and small bowel adenocarcinomas, with specific clinical criteria and an approval duration of 1 year when criteria are met.

Policy attributes

Covered indications count5

Standard approval duration1 year

Required biomarkerKRAS G12C

Policy statusCURRENT

Last review date2025-05-14

Initial Therapy Criteria

FDA-Approved Indications - NSCLC

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an approved test
Patient has been previously treated with at least one systemic regimen
Examples of systemic regimens include agents such as pemetrexed, pembrolizumab, nivolumab, atezolizumab, albumin-bound paclitaxel, bevacizumab, cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel, vinorelbine

ref": "b1_0

title": "FDA-Approved Indications - NSCLC"

Provider Actions

Prior Authorization

Prior authorization required for Lumakras

Prior authorization is recommended/required for prescription benefit coverage of Lumakras. Approvals are provided for the indicated duration (1 year) when criteria are met.

Documentation Required

Document KRAS G12C mutation status

Provider must document KRAS G12C mutation-positive status as determined by an FDA-approved/approved test for all indications requiring mutation confirmation.

Applicable Codes

Drug productNDCCovered

No codes listed

Clinical Evidence & Guidance

Evidence sources include: Lumakras™ tablets prescribing information, Amgen; January 2025 (FDA prescribing information); and multiple NCCN guideline versions cited for 2024–2025 covering NSCLC, colon, rectal, pancreatic, ampullary, and small bowel adenocarcinomas.

Background

Lumakras (sotorasib) is a KRAS G12C inhibitor. The FDA indications include treatment of KRAS G12C–mutated locally advanced or metastatic NSCLC in adults who have received at least one prior systemic therapy, and, in combination with panitumumab (Vectibix), for KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Guideline-supported additional uses include ampullary, pancreatic, and small bowel adenocarcinomas. The NSCLC indication was approved under accelerated approval based on overall response rate and duration of response, with continued approval contingent on verification in confirmatory trials.

Definitions:

• Subsequent therapy / subsequent therapy (used as): Therapy used after prior lines of treatment; policy uses term to indicate later-line treatment.

• Approved test: An FDA-approved test to determine KRAS G12C mutation status.

Revision History

05/14/2025addedLatest

Small Bowel Adenocarcinoma added under 'Other Uses with Supportive Evidence' with criteria for approval as subsequent therapy (approve for 1 year; adults with advanced/metastatic KRAS G12C-positive disease to be used as subsequent therapy).

05/14/2025addedLatest

Pancreatic Adenocarcinoma added under 'Other Uses with Supportive Evidence' as a condition of approval with criteria based on guideline recommendations (approve for 1 year; adults with KRAS G12C-mutated locally advanced or metastatic disease who have prior systemic therapy or recurrent disease after resection).

FDA-Approved Indications - Colon or Rectal Cancer

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has advanced or metastatic colon or rectal cancer
Patient has KRAS G12C mutation-positive disease, as determined by an approved test
ONE of
- The medication is used in combination with Erbitux (cetuximab intravenous infusion) or Vectibix (panitumumab intravenous infusion)
- Per the prescriber, the patient is unable to tolerate combination therapy
Patient has previously received a chemotherapy regimen for colon or rectal cancer
Examples of chemotherapy regimens include a fluoropyrimidine such as 5-fluorouracil (5-FU), capecitabine; oxaliplatin, irinotecan, or an adjunctive chemotherapy regimen such as FOLFOX (5-FU, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin).

ref": "b1_1

title": "FDA-Approved Indications - Colon or Rectal Cancer"

ref": "b1_1

title":