CurrentUnitedHealthcarePolicy N/A

Koselugo (selumetinib) prior authorization

Prior authorization criteria and coverage rules for Koselugo (selumetinib) for UnitedHealthcare members, including pediatric automatic processing for under-19 and specific oncology indications referenced to NCCN guidance.

Policy Summary

PayerUnitedHealthcare

PolicyKoselugo (selumetinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 16, 2025

Next Review DateN/A

Key ActionFor members under 19, prescriptions automatically process without coverage review and authorization is issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

age <19age <19 auto-process

3indications covered

2020-2025P&T approvals

Coverage Criteria

Initial Authorization — NF1 with plexiform neurofibromas

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Covered when ALL of the following are met for NF1-related plexiform neurofibromas:

NF1 initial authorization: (1) Diagnosis of neurofibromatosis type 1

Initial authorization requires diagnosis of NF1

PN characteristics: (2) Plexiform neurofibromas that are both inoperable and causing significant morbidity (e.g., disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment, bladder/bowel dysfunction)

Both subconditions required

Reauthorization — NF1 with plexiform neurofibromas

Reauthorization for NF1-related plexiform neurofibromas:

NF1 reauthorization: Patient does not show evidence of progressive disease while on Koselugo therapy

Required to continue approval

Initial Authorization — Glioma

Covered when ALL of the following are met for glioma indications:

Glioma molecular criteria: One of: (a) Circumscribed glioma with presence of BRAF fusion or BRAF V600E activating mutation; (b) NF-1 mutated glioma

Either molecular criterion acceptable

Glioma disease status: Disease is recurrent or progressive

Required

Glioma monotherapy: Used as monotherapy

Required

Reauthorization — Glioma

Reauthorization for glioma:

Glioma reauthorization: Patient does not show evidence of progressive disease while on Koselugo therapy

Required to continue approval

Initial Authorization — Langerhans Cell Histiocytosis

Covered when ALL of the following are met for Langerhans cell histiocytosis (LCH):

LCH diagnosis: Diagnosis of Langerhans cell histiocytosis

Required

LCH molecular/testing criteria: One of: (a) Presence of MAP kinase pathway mutation; (b) No detectable mutation; (c) Genetic testing not available

Any one acceptable

LCH monotherapy: Used as monotherapy

Required

Reauthorization — LCH

Reauthorization for LCH:

LCH reauthorization: Patient does not show evidence of progressive disease while on Koselugo therapy

Required to continue approval

NCCN Recommended Regimens

NCCN recognition:

NCCN compendium recognition: Drug recognized in NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Supports coverage for listed oncology indications

Where applicable state law mandates coverage for off‑label medication use or requires reliance on an external compendium, those requirements supersede this policy. Providers should follow any applicable state mandate or compendium reference in place of conflicting policy language when filing coverage requests or appeals.

Initial Therapy Criteria

Initial Authorization — Pediatric NF1 PN

Initial authorization — pediatric NF1 PN

Pediatric automatic processing: Patient is less than 19 years of age

Authorization issued for 12 months; prescription automatically processes without coverage review for members under 19

Initial Authorization — Oncology

Initial authorization — oncology indications

Glioma initial therapy: Meets molecular and disease status criteria and used as monotherapy

See Coverage.criteria_sets for details

LCH initial therapy: Diagnosis of LCH plus molecular/testing criteria and used as monotherapy

See Coverage.criteria_sets for details

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization — General

ALL of the following

Patient does not show evidence of progressive disease while on Koselugo therapy.
Authorization will be issued for 12 months.
State mandates may apply. Any federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. Other policies and utilization management programs may apply.
Operational note

Prior Authorization

Reauthorization requirement — may be denied for progressive disease

Pediatric (<19 years) reauthorizations may be auto-processed when documentation in the medical record supports ongoing benefit and there is no evidence of progressive disease. For non-pediatric members or when documentation is insufficient, submit clinical notes showing disease stability or response.

Auto-processing applies only to members under 19 years of age when criteria are met.
When auto-processing is not applicable, providers must submit recent clinical assessment documenting lack of progression.

Provider Actions and Prior Authorization Workflow

Documentation Required

Document NF1 diagnosis and PN inoperability/morbidity

Initial authorization for NF1-related plexiform neurofibromas requires documentation of a diagnosis of neurofibromatosis type 1 and that plexiform neurofibromas are inoperable and causing significant morbidity (examples: disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment, bladder/bowel dysfunction).

Provide documentation of NF1 diagnosis.
Document PN characteristics showing inoperability and significant morbidity (list specific morbidities).

Documentation Required

Provide molecular testing and disease-status documentation for glioma

For glioma indications, initial authorization requires documentation of either a circumscribed glioma with BRAF fusion or BRAF V600E activating mutation, or an NF‑1 mutated glioma; additionally, disease must be recurrent or progressive and Koselugo must be used as monotherapy.

Submit pathology/genomic testing showing BRAF fusion, BRAF V600E mutation, or NF‑1 mutation.
Document disease status as recurrent or progressive.
Confirm Koselugo will be administered as monotherapy.

Documentation Required

Document LCH diagnosis and MAP kinase pathway testing/status

Initial authorization for Langerhans cell histiocytosis requires documentation of LCH diagnosis and one of: presence of a MAP kinase pathway mutation, no detectable mutation, or that genetic testing is not available; Koselugo must be used as monotherapy.

Provide pathology confirming LCH.
Provide molecular testing results or statement that testing is unavailable.
Confirm Koselugo will be used as monotherapy.

Note

Automatic processing for patients <19 years; 12‑month authorization

Prescriptions for members under 19 years of age will automatically process without coverage review; an authorization will be issued for 12 months.

Step Therapy

Monotherapy required for glioma and LCH indications

When covered under the glioma or LCH criteria, Koselugo must be used as monotherapy; authorization requires confirmation that no concurrent anti‑cancer systemic therapies will be administered with Koselugo.

Attest that Koselugo will be the sole systemic anti‑cancer therapy for the indication.

Billing Rule

Administrative approvals may use prior claims, ICD‑10, and claim logic

UnitedHealthcare may approve initial or reauthorization requests based on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; automated approval and re‑approval processes and supply limits may vary by program.

Ensure relevant prior claims and ICD‑10 codes are present in the record to support automated approval where applicable.

Step Therapy / Treatment Sequence

Requirement	Details
Monotherapy requirement	Koselugo must be used as a single‑agent (no concurrent anti‑cancer systemic therapies) for the glioma and Langerhans cell histiocytosis indications when those criteria apply.
Supporting glioma language	Initial authorization for glioma requires that disease is recurrent or progressive and the tumor meets one molecular criterion (circumscribed glioma with BRAF fusion or BRAF V600E mutation, or NF‑1 mutated glioma) and is used as monotherapy.
Supporting LCH language	Initial authorization for Langerhans cell histiocytosis requires diagnosis of LCH, one of: presence of MAP kinase pathway mutation, no detectable mutation, or genetic testing not available, and use as monotherapy.

Quantity Limits

Koselugo (selumetinib) — supply limits

Quantity limit statusSupply limits may be in place for Koselugo (selumetinib).

Approval basis may varyUnitedHealthcare may use previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic for approval decisions which can affect supply handling.

Program variabilityUse of automated approval and re-approval processes varies by program and/or therapeutic class, which may influence supply or dispensing limits.

Site of Care

Note

No explicit site‑of‑care restrictions; check supply limits and program rules

Policy does not state any explicit site‑of‑care restrictions; however, supply limits may apply and automated approval processes vary by program.

Verify program‑specific supply limits and whether automated approval applies for the member.

Definitions

Plexiform neurofibromas (PN) — definition & impact

Definition of PNPlexiform neurofibromas (PN) are complex nerve-sheath tumors associated with neurofibromatosis type 1 that can be symptomatic and inoperable, causing significant morbidity (e.g., disfigurement, motor dysfunction, pain, airway or visual impairment, or bowel/bladder dysfunction).

Clinical significancePN can produce substantial functional impairment and cosmetic deformity, making medical therapy like selumetinib an indicated option in pediatric NF1 when PN are inoperable and symptomatic.

Related guideline recognitionNCCN recognizes selumetinib for related oncology indications (see compendium recognition), supporting its use in specific tumor contexts.

Monotherapy — policy definition

Policy definitionMonotherapy: use of Koselugo (selumetinib) as a single‑agent treatment without concurrent anti‑cancer systemic therapies, as required for certain covered indications (glioma and LCH).

Where requiredThe policy requires monotherapy for recurrent or progressive glioma indications (NF‑1 mutated glioma or circumscribed glioma with BRAF fusion or V600E mutation) and for Langerhans cell histiocytosis when covered.

Guideline basisNCCN recommends selumetinib as a single‑agent therapy for specific recurrent/progressive gliomas and for LCH with MAP kinase pathway involvement or when testing is unavailable.

Background

Koselugo (selumetinib) is a MAP kinase pathway–targeted kinase inhibitor with an FDA indication for pediatric patients aged 2 years and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. NCCN also recognizes selumetinib for certain oncology uses, including select gliomas with NF1 or BRAF alterations and Langerhans cell histiocytosis with MAP kinase pathway involvement or when genetic testing is unavailable.

When authorized for pediatric NF1‑related plexiform neurofibromas, the policy provides automatic processing for members under 19 years of age (the prescription will automatically process without a coverage review) and authorizations are issued for 12 months.

Coding

Covered CPT CodesCPTCovered

No codes listed

Revision History

2025-11-16effective_dateLatest

Policy effective date established for this program version.

2025-09P&T_approval

Annual review with no changes to coverage criteria; references updated in prior authorization program.

2024-09P&T_approval

Annual review; no changes to clinical criteria and references updated.

2023-09P&T_approval

Annual review; removed prior pilocytic astrocytoma criteria and added criteria for glioma; references updated.

2022-08P&T_approval

Annual review; added coverage criteria for Langerhans cell histiocytosis per NCCN and updated background, references, and added state mandate footnote.

2021-08P&T_approval

Annual review; added coverage criteria for pilocytic astrocytoma per NCCN and updated background and references.

2020-08P&T_approval

Program created; prior authorization/notification established for Koselugo (selumetinib).

Policy Summary

PayerUnitedHealthcare

PolicyKoselugo (selumetinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 16, 2025

Next Review DateN/A

Key ActionFor members under 19, prescriptions automatically process without coverage review and authorization is issued for 12 months.

SourceLink

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