CurrentAvMedPolicy N/A

Koselugo (selumetinib) prior authorization for Neurofibromatosis Type 1 with plexiform neurofibromas

Form and criteria governing prior authorization and step-edit requests for selumetinib (Koselugo) for pediatric patients with NF1 and plexiform neurofibromas; applies to providers prescribing through AvMed and specialty pharmacy processes.

Policy Summary

PayerAvMed

PolicyKoselugo (selumetinib) prior authorization for NF1 with plexiform neurofibromas

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribing physician must sign and print name on the PA request; form must be complete with contact information and faxed to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

2-18 yrsApproved patient age

≤100 mgMax daily dose

≥0.55 m2Minimum BSA

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Provider specialty: Provider is an oncologist, a neurologist, or specialized in treating Neurofibromatosis Type 1

Initial authorization criterion

Age: Patient is between 2 and 18 years of age at start of therapy2-18 years

Initial authorization criterion

NF1 diagnosis: Patient has a confirmed diagnosis of Neurofibromatosis Type 1 (NF1) by meeting two or more specified diagnostic findings OR by a positive genetic test for NF1

Specific diagnostic findings listed on form (e.g., café au lait macules, neurofibromas, freckling, optic glioma, Lisch nodules, osseous lesion, affected first-degree relative)

Policy Summary

PayerAvMed

PolicyKoselugo (selumetinib) prior authorization for NF1 with plexiform neurofibromas

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribing physician must sign and print name on the PA request; form must be complete with contact information and faxed to 1-305-671-0200.

SourceLink

On This Page

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Plexiform neurofibromas: Patient has confirmed measurable plexiform neurofibromas and resection/operation is not feasible without substantial risk or morbidity

Must submit MRI data documenting measurable PN and infeasibility of resection

Baseline MRI: Baseline tumor volumetric MRI assessment completed and submitted with the request

Required for initial request; submit MRI data and results

Body surface area and dosing: Body surface area (BSA) ≥ 0.55 m2; dosing will follow the provided BSA-based table and will not exceed 100 mg (4 capsules) per day>= 0.55 m2; <=100 mg/day

Enter calculated BSA and prescribed dose on form; follow BSA dosing table

Baseline safety monitoring: The following safety monitoring parameters have been obtained prior to initiating therapy and documentation submitted: liver function tests, creatine phosphokinase (CPK), ejection fraction, and R or PTT if receiving vitamin-K antagonists or antiplatelet agents

Submit current laboratory/clinical documentation with the request

Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Tumor stability/response: MRI volumetric assessment shows no progression of plexiform neurofibromas compared to pretreatment

Submit MRI comparison data and results

Safety monitoring: Patient is being monitored for and is not experiencing signs or symptoms of increased bleeding, cardiotoxicity, liver injury, or ocular toxicity

Ongoing monitoring required; submit current clinical/lab documentation

Dose limit: Dose does not exceed 100 mg (4 capsules) per day<=100 mg/day

Reauthorization criterion

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Prior medication exposure will be verified through pharmacy paid claims or submitted chart notes; samples alone are not sufficient to meet step-therapy or prior authorization requirements.

Coding and Clinical Thresholds

Diagnosis code entryICD-10

ICD Code, if applicable (space provided on form)

Body Surface Area

Minimum BSABody Surface area ≥ 0.55 m2

Where to recordEnter calculated BSA on the PA form (line provided)

Relation to dosingDosing follows table and must not exceed 100 mg (4 capsules) per day

Provider Actions and Requirements

Prior Authorization

Form submission requirement

The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps are not valid). All required contact fields (office contact name, phone, fax, DEA or NPI) must be complete and legible. Fax the completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information may delay processing or result in denial.

Fax: 1-305-671-0200
Ensure prescriber signature and printed name (stamps not valid)
Provide office contact name, phone, and fax
Include DEA or NPI

Prior Authorization

Authorization durations

Initial approvals are issued for 6 months; reauthorizations may be approved for 12 months when required monitoring and documentation are provided and criteria are met.

Initial authorization: 6 months
Reauthorization: 12 months (requires documentation of monitoring and continued benefit)

Step Therapy

Step-edit / sample rule

Use of samples to start therapy does not satisfy step-edit or preauthorization requirements. The pharmacy will verify prior therapies via paid claims or submitted chart notes.

Samples do not meet step-therapy/preauth criteria
Prior therapies verified via pharmacy claims or chart notes

Documentation Required

Required documentation

Submit supporting clinical documentation with the request. For initial requests include baseline tumor volumetric MRI assessment and BSA calculation/dose; for reauthorization include MRI volumetric comparison showing no progression and current laboratory/clinical monitoring results. All checked clinical criteria require accompanying documentation or the request may be denied.

Initial: baseline tumor volumetric MRI data and results
Initial: calculated Body Surface Area and prescribed dose (BSA ≥ 0.55 m2; dosing per table; max 100 mg/day)
Initial and reauthorization: current Liver Function Tests
Initial and reauthorization: Creatine Phosphokinase level
Initial and reauthorization: Ejection Fraction
If on anticoagulants/antiplatelets: R or PTT results
Reauthorization: MRI volumetric comparison demonstrating no progression

Denial Risk

Denial triggers

Incomplete, incorrect, or illegible information on the request form or missing supporting documentation for any checked clinical criteria may delay processing or result in denial.

Missing prescriber signature or contact information may lead to denial
Absent MRI, lab results, or dose/BSA documentation may lead to denial

Background

Selumetinib (Koselugo) is indicated for pediatric patients with Neurofibromatosis Type 1 (NF1)liver function tests, creatine phosphokinase, ejection fraction, and coagulation testing (R or PTT) when patients receive vitamin-K antagonists or antiplatelet agents. Reauthorization requires documentation of tumor stability by MRI volumetric comparison, ongoing safety monitoring without concerning signs or symptoms (bleeding, cardiotoxicity, liver injury, or ocular toxicity), and confirmation that the dose does not exceed 100 mg (4 capsules) per day.

Definitions

NF1 diagnostic criteria

Diagnostic ruleNF1 diagnosis confirmed by meeting TWO or more NIH diagnostic findings listed (e.g., ≥6 café au lait macules, ≥2 neurofibromas or 1 plexiform neurofibroma, axillary/inguinal freckling, optic glioma, ≥2 Lisch nodules, distinctive osseous lesion, or a first‑degree relative meeting criteria)

Alternative confirmationDiagnosis can be confirmed with a positive genetic test for NF1

Specific lesion criterionOne plexiform neurofibroma (PN) counts toward diagnostic findings

Initial Therapy Criteria

Initial Therapy — Initial therapy criteria

Initial therapy criteria

Specialist prescriber: Provider is an oncologist, a neurologist, or specialized in treating NF1

Age: Patient age 2-18 years at therapy start2-18 years

Confirmed NF1: NF1 confirmed by meeting two or more diagnostic findings (e.g., CALMs, neurofibromas/plexiform neurofibroma, axillary/inguinal freckling, optic glioma, Lisch nodules, osseous lesion, or affected first‑degree relative) OR by positive genetic test

Specific diagnostic findings listed on form

Measurable PN and unresectable: Confirmed measurable plexiform neurofibromas where resection is not feasible or would carry substantial risk/morbidity

Must document extent (e.g., interdigitation into vital structures, risk of nerve injury/hemorrhage)

Baseline MRI: Baseline tumor volumetric MRI assessment completed and submitted

Please submit MRI data and results with initial request

BSA and dosing limits: Body surface area ≥ 0.55 m2; dosing per BSA table and will not exceed 100 mg/day>= 0.55 m2; <=100 mg/day

Enter calculated BSA and prescribed dose on form; follow recommended BSA-based dosing table

Baseline monitoring: Obtain and submit liver function tests, creatine phosphokinase, ejection fraction, and R or PTT if on vitamin‑K antagonists or antiplatelet agents prior to starting therapy

Submit current laboratory/clinical documentation

Continuation / Reauthorization Criteria

Continuation Therapy — Reauthorization criteria for continuation of therapy

Reauthorization criteria for continuation of therapy

MRI assessment: MRI volumetric assessment shows no progression compared to pretreatment

Submit MRI data and results for reauthorization

Safety: No signs or symptoms of increased bleeding, cardiotoxicity, liver injury, or ocular toxicity

Ongoing monitoring required and documentation must be submitted

Step Therapy / Sample Rules

Step	Requirement / Note
1	Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Quantity Limits

Koselugo (selumetinib) — quantity limit / max daily dose (capsules)

Maximum daily doseDo not exceed 100 mg (4 capsules) per day

Quantity limit (per day)100 mg/day

Dispensing noteDosing should follow the BSA-based recommendation table and the prescribed dose must be entered on the PA form

Site of Care / Dispensing

Note

Dispense via specialty pharmacy (PropriumRx)

Medication must be provided by the specialty pharmacy listed on the form (PropriumRx) per the form instructions.

Ensure specialty pharmacy coordination with PropriumRx per form