By Counterforce Health Team in Koselugo (selumetinib) —

UnitedHealthcare's Coverage Criteria for Koselugo (Selumetinib) in New Jersey: What Counts as "Medically Necessary"?

Answer Box: Getting Koselugo Covered by UnitedHealthcare in New Jersey

UnitedHealthcare requires prior authorization for Koselugo (selumetinib) under both medical and pharmacy benefits, with no step therapy requirements for pediatric NF1 plexiform neurofibromas. Medical necessity requires confirmed NF1 diagnosis with symptomatic, inoperable plexiform neurofibromas, baseline LVEF assessment, and ophthalmologic evaluation. Submit PA through the UHC Provider Portal or OptumRx portal (800-310-6826). If denied, you have 180 days to appeal internally, then can escalate to New Jersey's Independent Health Care Appeals Program (IHCAP) at 1-888-393-1062.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers Koselugo
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity & Frequency Limits
  5. Required Diagnostics & Monitoring
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Documentation
  9. Pediatric Considerations
  10. Quick Reference: Coverage Criteria
  11. Appeals Process in New Jersey
  12. FAQ

Policy Overview: How UnitedHealthcare Covers Koselugo

UnitedHealthcare covers Koselugo (selumetinib) as a specialty medication requiring prior authorization for outpatient administration under both medical and pharmacy benefits. The drug falls under UnitedHealthcare's Specialty Pharmacy Management Program, which routes high-cost medications through contracted specialty pharmacies.

Plan Types Coverage:

  • Commercial plans: Prior authorization required for J-codes (injectable oncology drugs) in outpatient settings
  • Medicare Advantage: Standard PA requirements apply with expedited options for urgent cases
  • Medicaid/Community Plan: Follows New Jersey FamilyCare Preferred Drug List guidelines

Prior authorization is not required for emergency room, inpatient, observation, or urgent care administration.

FDA Indication Requirements

Koselugo received FDA approval on September 10, 2025, expanding coverage to pediatric patients ≥1 year old (previously ≥2 years) with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.

Coverage Requirements:

  • Confirmed NF1 diagnosis with clinical documentation
  • Symptomatic plexiform neurofibromas causing morbidity
  • Tumors deemed inoperable or not fully resectable by surgery
  • Age ≥1 year (capsules and granules formulations available)
Note: Adults with NF1-PN may be directed to mirdametinib (Gomekli), which received FDA approval in 2025 for both adults and children ≥2 years.

Step Therapy & Medical Exceptions

Good news: No explicit step therapy requirements are listed in current UnitedHealthcare policies for Koselugo in pediatric NF1 plexiform neurofibromas. This represents a significant advantage compared to other specialty oncology drugs that often require multiple prior treatment failures.

However, UnitedHealthcare may still require documentation of:

  • Previous surgical consultations and why surgery isn't feasible
  • Conservative management attempts (observation, symptom management)
  • Clinical rationale for starting MEK inhibitor therapy

Medical exceptions can be requested if alternative treatments are contraindicated or have failed.

Quantity & Frequency Limits

Koselugo dosing is based on body surface area at 25 mg/m² twice daily, with quantity limits typically aligned to:

Standard Dispensing:

  • 28-day supply for initial fills
  • 90-day supply for maintenance therapy after stable dosing
  • Dose adjustments allowed for toxicity management

Reauthorization Requirements:

  • Initial approval typically 6-12 months
  • Renewal based on objective response (≥20% volume reduction or symptom improvement)
  • Continued medical necessity documentation required

Required Diagnostics & Monitoring

The FDA label mandates specific baseline assessments that UnitedHealthcare requires for coverage approval:

Baseline Requirements

  • LVEF (Left Ventricular Ejection Fraction): Assess before starting; withhold if <lower limit of normal
  • Ophthalmologic evaluation: Complete exam including visual acuity, slit lamp, fundoscopy, intraocular pressure
  • MRI imaging: Baseline volumetric assessment using STIR and T2-weighted sequences with fat saturation

Ongoing Monitoring

  • Cardiac: LVEF every 3 months; discontinue if confirmed decrease <50% with >20% drop from baseline
  • Ophthalmologic: Every 3 months during treatment
  • Laboratory: CPK levels, vitamin E monitoring for bleeding risk

Specialty Pharmacy Requirements

UnitedHealthcare requires Koselugo to be dispensed through contracted specialty pharmacies in New Jersey, which provide:

  • 24/7 clinical support and patient education
  • Monthly adherence monitoring
  • Direct shipping to patient homes or healthcare settings
  • Coordination with prescribing physicians

No site-of-care restrictions limit Koselugo to specific administration settings, as it's an oral medication for self-administration at home.

Evidence to Support Medical Necessity

When submitting prior authorization requests, include evidence from these authoritative sources:

Clinical Guidelines

  • FDA prescribing information for dosing and safety requirements
  • SPRINT Stratum 1 trial data showing 66% of pediatric patients achieved ≥20% volume reduction
  • Neurofibromatosis clinical care guidelines for plexiform neurofibroma management

Required Documentation

  • Confirmed NF1 diagnosis (genetic testing or clinical criteria)
  • MRI demonstrating symptomatic plexiform neurofibromas
  • Surgical consultation documenting inoperability
  • Baseline cardiac and ophthalmologic assessments

Sample Medical Necessity Documentation

Template paragraph structure for prior authorization letters:

"This [age]-year-old patient with confirmed neurofibromatosis type 1 (NF1) presents with symptomatic, inoperable plexiform neurofibromas documented by MRI on [date]. The tumors cause significant morbidity including [specific symptoms: pain, functional impairment, cosmetic concerns]. Surgical consultation on [date] confirmed the lesions are not amenable to complete resection due to [location/complexity]. Baseline LVEF is [value]% and ophthalmologic examination is normal. Koselugo (selumetinib) 25 mg/m² twice daily is requested as the FDA-approved first-line therapy for this indication, with monitoring per prescribing information."

Clinician Corner: Include ICD-10 code Q85.01 (neurofibromatosis type 1) and specific symptoms (e.g., G89.3 for chronic pain) to strengthen medical necessity documentation.

Pediatric Considerations

Special considerations for pediatric patients in New Jersey:

Age-Specific Requirements

  • 1-2 years: Granules formulation available since 2025 FDA approval expansion
  • ≥2 years: Both capsules and granules available
  • Dosing: BSA-based calculations require regular height/weight monitoring

Family Support

  • Patient assistance programs through AstraZeneca
  • New Jersey Department of Human Services resources for families
  • Coordination with pediatric specialty care networks

Quick Reference: Coverage Criteria

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all outpatient use Complete PA form with clinical justification UHC Provider Portal
NF1 Diagnosis Confirmed neurofibromatosis type 1 Genetic testing or clinical criteria documentation FDA Label
Symptomatic PN Plexiform neurofibromas causing morbidity MRI imaging, symptom documentation Imaging Guidelines
Inoperable Status Not amenable to complete surgical resection Surgical consultation notes FDA Label
Baseline Assessments LVEF and eye exam required Cardiology and ophthalmology reports FDA Label
Age Eligibility ≥1 year old Birth certificate or medical records FDA Label
Specialty Pharmacy Must use contracted network Provider Vendor Assistance List UHC NJ Community Plan

Appeals Process in New Jersey

If your Koselugo prior authorization is denied, New Jersey offers robust appeal options:

Internal Appeals (UnitedHealthcare)

  1. File within 180 days of denial notice
  2. Submit through: UHC Provider Portal, fax, or mail
  3. Timeline: 30 days for pre-service, 60 days for post-service
  4. Expedited option: 72 hours for urgent medical needs

External Review (IHCAP)

If internal appeals fail, escalate to New Jersey's Independent Health Care Appeals Program:

  • Contact: 1-888-393-1062
  • Timeline: File within 4 months of final internal denial
  • Process: Independent physician reviewers with specialty expertise
  • Decision: Binding on UnitedHealthcare if overturned
  • Cost: Free to patients

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned to the insurer's own rules, pulling appropriate FDA labeling, peer-reviewed studies, and clinical guidelines to support medical necessity arguments.

FAQ

How long does UnitedHealthcare prior authorization take for Koselugo in New Jersey? Standard PA decisions take 3-5 business days. Expedited requests for urgent medical needs are processed within 72 hours.

What if Koselugo is non-formulary on my plan? Even non-formulary drugs can be covered with prior authorization demonstrating medical necessity. Focus on FDA approval and lack of therapeutic alternatives.

Can I request an expedited appeal if my child needs treatment urgently? Yes, urgent cases qualify for expedited review (72 hours internally, expedited external review if needed). Document why delays would cause serious harm.

Does step therapy apply if we tried treatments outside New Jersey? Prior treatment history from other states should be accepted. Include complete medical records documenting previous therapies and outcomes.

What's the difference between medical and pharmacy benefit coverage? Koselugo may be covered under either benefit. Pharmacy benefit goes through OptumRx (800-310-6826), while medical benefit uses standard UHC prior authorization processes.

How often does UnitedHealthcare approve Koselugo for pediatric NF1? While specific approval rates aren't published, rare disease drugs with strong FDA approval and clear medical necessity typically have high approval rates when properly documented.

When navigating insurance coverage challenges, Counterforce Health provides specialized support for prescription drug appeals, helping families access the medications their children need through targeted, evidence-based advocacy.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies may vary by specific plan. Always verify current requirements with UnitedHealthcare and consult healthcare providers for medical decisions.

Sources & Further Reading:

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