CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Krazati (adagrasib) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and authorization authority for Krazati (adagrasib) for members of Neighborhood Health Plan of Rhode Island; applies to medication requests processed by Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKrazati (adagrasib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAugust 30, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with documentation of KRAS G12C mutation by an FDA-approved test and supporting evidence per FDA labeling or accepted compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

08/14/24committee approval date

08/30/24effective date

3page count

600 mgsingle dose max

180 tabsmonthly limit

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Coverage Criteria for Krazati (adagrasib)

Covered Indications (Initial and Continuation)

Covered when all applicable indication-specific criteria and continuation criteria are met

Continuation request exemption: For continuation requests to be exempt from the Evolent policy, all of the following must be true: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

Colorectal cancer indication: Krazati (adagrasib) in combination with cetuximab is covered for adult members with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

NSCLC indication: Krazati (adagrasib) as monotherapy is covered for members with KRAS G12C mutation–positive recurrent, advanced, or metastatic non-small cell lung cancer who have received prior platinum-containing therapy, with or without immunotherapy.

Exclusions to coverage for Krazati (adagrasib) include the following: disease progression while receiving Krazati (adagrasib) or another KRAS G12C–targeted therapy (for example, sotorasib); absence of documentation of a KRAS G12C mutation detected by an FDA‑approved test; dosing that exceeds the single‑dose limit of 600 mg or the maximum of 180 (200 mg) tablets per month; and investigational or off‑label use lacking sufficient evidence or broad clinical acceptance.

The policy further defines insufficient evidence as lack of adequate patient and regimen representation in published studies, absence of clinically meaningful outcomes (for example, recommended ASCO thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months), inappropriate experimental design for the question under study, reliance solely on single case reports, or use of abstracts without full peer‑reviewed articles as supporting evidence.

Initial Therapy Criteria

Initial use covered when indication-specific prior therapies and mutation documentation are present.

CRC initial use: Use of Krazati (adagrasib) in combination with cetuximab for KRAS G12C–mutated locally advanced or metastatic colorectal cancer is covered when the member has received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

NSCLC initial use: Use of Krazati (adagrasib) as monotherapy for KRAS G12C–mutated recurrent, advanced, or metastatic non–small cell lung cancer is covered when the member has received prior platinum-containing therapy, with or without immunotherapy.

Continuation Therapy Criteria

Continuation Therapy

Continuation requests may be exempt from policy requirements if all conditions below are met.

Continuation exemption conditions: Member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krazati (adagrasib) requests processed by Evolent. Continuation (renewal) requests may be exempt from prior authorization only when all continuation criteria are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for all new Krazati (adagrasib) requests processed by Evolent.
Continuation requests may be exempt if: member has not progressed on the medication; used within last year with ≤30-day lapse; no new medications added.

Documentation Required

Required Supporting Documentation

Requests must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual, Chapter 15. Lack of documentation of a KRAS G12C mutation detected by an FDA‑approved test will be a basis for denial.

Acceptable supporting documentation: FDA labeling; CMS‑approved compendia; NCCN or ASCO guidelines; peer‑reviewed literature meeting CMS standards.
Must document KRAS G12C mutation detected by an FDA‑approved test.

Step Therapy

Indication-Specific Sequence Requirements

Indication-specific sequencing and use rules:

For KRAS G12C‑mutated colorectal cancer (CRC): Krazati (adagrasib) may be used in combination with cetuximab for adult members with locally advanced or metastatic CRC who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy.
For KRAS G12C‑mutated non‑small cell lung cancer (NSCLC): Krazati (adagrasib) may be used as monotherapy for members with recurrent, advanced, or metastatic NSCLC who have received prior platinum‑containing therapy, with or without immunotherapy.
Dosing limits: single dose should not exceed 600 mg; monthly dosing should not exceed 180 tablets (200 mg strength).

Denial Risk

Triggers for Denial

Triggers that may lead to denial of a Krazati (adagrasib) request include insufficient or missing documentation and clinical exclusion criteria. Examples include disease progression while on adagrasib or another KRAS G12C‑targeted therapy, lack of documentation of KRAS G12C mutation detected by an FDA‑approved test, dosing that exceeds labeled single‑dose or monthly limits, investigational/off‑label uses lacking sufficient evidence (not supported by CMS compendia or acceptable peer‑reviewed literature). The policy defines insufficient evidence as poor applicability of published evidence to the patient population, inadequate representation of the regimen in published studies, absence of clinically meaningful outcomes, or reliance on uncontrolled anecdotal reports (case reports).

Denial risks: disease progression on adagrasib or another KRAS G12C‑targeted therapy (e.g., sotorasib).
Denial risks: missing documentation of KRAS G12C mutation by an FDA‑approved test.
Denial risks: dosing exceeds single‑dose limit (600 mg) or monthly maximum (180 tablets, 200 mg).
Denial risks: investigational/off‑label uses without sufficient evidence per CMS compendia or acceptable peer‑reviewed literature.

Step Therapy / Prior Exposure Requirements

Indication	Required prior therapy
Colorectal cancer (KRAS G12C‑mutated locally advanced or metastatic) — Krazati in combination with cetuximab
Prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Non‑small cell lung cancer (KRAS G12C mutation‑positive recurrent, advanced, or metastatic) — Krazati monotherapy
Prior platinum-containing therapy, with or without immunotherapy

Coding and Limits

Single dose limit — 600 mg

Single dose limit600 mg

Applies toKrazati (adagrasib)

Denial triggerRequests with dosing that exceed this single dose limit may be denied

Maximum tablets per month — 180 (200 mg) tablets/month

Maximum tablets per month180 (200 mg) tablets/month

Applies toKrazati (adagrasib)

Denial triggerRequests exceeding this monthly tablet limit may be denied

Quantity Limits for Krazati (adagrasib)

Krazati (adagrasib) — 180 (200 mg) tablets

DrugKrazati (adagrasib)

Quantity limit (monthly)180 (200 mg) tablets

Related denial criteriaExceeding the 180 (200 mg) tablets/month limit may result in denial

Krazati (adagrasib) — 600 mg

DrugKrazati (adagrasib)

Single dose maximum600 mg

Related denial criteriaDosing that exceeds 600 mg per single dose is listed as an exclusion/denial trigger

Definitions

KRAS G12C-mutated disease — definition

DefinitionTumors (e.g., NSCLC or colorectal cancer) characterized by a specific activating mutation at codon G12C of the KRAS gene, identified by an FDA-approved test.

Examples of tumor typesNon-small cell lung cancer (NSCLC); colorectal cancer (CRC)

Documentation requirementDetection of KRAS G12C mutation must be documented by an FDA-approved test (absence of which is an exclusion).

Background

Adagrasib (Krazati) is a targeted KRAS G12C inhibitor indicated for tumors harboring the KRAS G12C activating mutation. Clinical evidence and the FDA prescribing information support its use in KRAS G12C‑mutated non‑small cell lung cancer (NSCLC) as monotherapy after prior platinum‑containing therapy and in KRAS G12C‑mutated locally advanced or metastatic colorectal cancer in combination with cetuximab after prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy.

When requesting authorization, providers should document the KRAS G12C mutation by an FDA‑approved test and confirm that prior therapy requirements for the specific indication have been met, as described in the covered indications and initial therapy criteria.