CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1396 Koselugo Selumetinib_07262024

Defines accepted indications, continuation and exclusion criteria, and approval authority for Koselugo (selumetinib) including FDA-approved and off-label uses supported by recognized compendia or peer-reviewed literature. Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1396 Koselugo Selumetinib_07262024

Policy CodePolicy N/A

Change Typeclarified

Effective DateJul 26, 2024

Next Review Date

Key ActionAll medication requests for Koselugo must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Effective date set to July 26, 2024 with committee approval July 10, 2024; policy reviewed multiple prior dates.

1Covered Indications (specified)

3Explicit Exclusion Conditions

3Committee Review Dates Listed

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines accepted indications, continuation and exclusion criteria, dose and quantity thresholds, and approval authority for Koselugo (selumetinib), applying to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island. Subject: Koselugo (selumetinib). Accepted indication (one line): Koselugo is covered for inoperable plexiform neurofibromas (PN) in patients with a positive NF1 mutation when criteria are met.

Initial Therapy Criteria

Plexiform Neurofibromas (PN) — Initial / single-agent use

Koselugo (selumetinib) may be used as a single agent in members when ALL of the following are met:

Required criteria
- Inoperable PN: Inoperable plexiform neurofibromas (PN)
- Positive NF1 mutation: Positive neurofibromatosis type 1 (NF1) mutation

Exclusions / Not Approvable

"Sufficient evidence" is defined as evidence supported by CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards; detailed criteria include whether the patient and disease characteristics and the administered regimen are adequately represented, reported study outcomes are clinically meaningful (ASCO examples such as HR < 0.80 and survival benefit for OS/PFS of at least 3 months), appropriate experimental design, and that case reports or abstracts without full peer-reviewed articles are generally inadequate.

Provider Actions & Authorization Requirements

Prior Authorization

Medication requests processed by Evolent

All medication requests for Koselugo must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Evidence support requirement

Use of Koselugo must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS standards.

Denial Risk

Exclusions lead to non-approval

Requests will be excluded/denied for disease progression on Koselugo, dosing beyond specified single-dose or monthly capsule limits, or investigational/off-label uses lacking sufficient evidence as defined in the policy.

Billing Rule

Dose and quantity limits

Claims exceeding the single-dose limit or monthly capsule maximums risk denial.

Single-dose limit: 25 mg/m2 (not to exceed 50 mg)
Monthly capsule limit A: 300 capsules per month (10 mg strength)
Monthly capsule limit B: 120 capsules per month (25 mg strength)

Clinical Evidence & References

Evidence and guidance sources referenced include the KOSelugo prescribing information (AstraZeneca 2024), the key study by Gross AM et al., Neuro Oncol 2022, the NCCN 2024 compendium, and CMS-recognized compendia. Requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature that meet the standards of the CMS Medicare Benefit Policy Manual Chapter 15. The policy notes that Evolent processes all medication requests and that Utilization Management Department/Committee have approval authority.

Evidence

Key referencesKoselugo prescribing information (AstraZeneca 2024); Gross AM et al. Neuro Oncol 2022; NCCN 2024; other drug information sources (Clinical Pharmacology, Micromedex, AHFS)

Background & Definitions

This policy establishes the clinical and evidentiary bases for Koselugo (selumetinib) use, emphasizing adherence to FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature per CMS standards. Evolent is responsible for processing all medication requests, with review by the Utilization Management Department and final approval by the Utilization Management Committee.

Definitions

Sufficient evidenceEvidence supported by CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards; detailed criteria listed in exclusion section.

Revision History

July 10, 2024committee_approvalLatest

Utilization Management Committee approval recorded (committee review/approval history through 07/10/24). Changes from this review are non‑material (no explicit clinical policy changes indicated).

July 26, 2024effective_date

Policy effective date set to July 26, 2024.