By Counterforce Health Team in Kesimpta (ofatumumab) —

Requirements Checklist to Get Kesimpta (Ofatumumab) Covered by UnitedHealthcare in Washington: Forms, Appeals & Timelines

Quick Answer: Getting Kesimpta Covered by UnitedHealthcare in Washington

Eligibility: Adults with relapsing MS (RRMS, CIS, active SPMS) who need prior authorization through OptumRx. Fastest path: Submit complete PA with documented step therapy failures or contraindications. Start today: Call UnitedHealthcare at the number on your card to verify Kesimpta's formulary status and download the specialty drug PA form. Washington residents have strong appeal rights including external review through an Independent Review Organization (IRO) if initially denied.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Common Denial Reasons & Solutions
  8. Appeals Process in Washington
  9. Cost Savings & Support Programs
  10. Printable Checklist

Who Should Use This Checklist

This guide helps patients and clinicians navigate UnitedHealthcare's prior authorization requirements for Kesimpta (ofatumumab) in Washington state. Use this if you have:

  • A diagnosis of relapsing multiple sclerosis (RRMS, CIS, or active SPMS)
  • UnitedHealthcare coverage through OptumRx pharmacy benefits
  • A neurologist recommending Kesimpta as your disease-modifying therapy

Expected outcome: With complete documentation, initial approvals typically take 72 hours for standard requests and 24 hours for urgent cases when submitted properly through UnitedHealthcare's provider portal.

Member & Plan Basics

✓ Verify Active Coverage

  • Confirm your UnitedHealthcare ID number and group number
  • Check that your plan includes OptumRx pharmacy benefits
  • Verify your plan is active for the requested treatment dates

✓ Understand Plan Type

Washington residents may have:

  • Individual/family plans (Washington Healthplanfinder): Full Washington state appeal rights apply
  • Employer group plans: Most follow Washington rules if fully insured; self-funded ERISA plans follow federal rules
  • Medicare Advantage: Federal appeal timelines, not Washington IRO process

✓ Check Authorization Requirements

Kesimpta requires prior authorization on most UnitedHealthcare formularies and is typically subject to step therapy requirements favoring other MS medications first.

Clinical Criteria Requirements

✓ FDA-Approved Indication

Required: Documented diagnosis of relapsing forms of multiple sclerosis:

  • Clinically Isolated Syndrome (CIS)
  • Relapsing-Remitting MS (RRMS)
  • Active Secondary Progressive MS (SPMS)

✓ Prescriber Requirements

  • Neurologist or MS specialist
  • OR primary care provider in consultation with neurologist (documentation required)

✓ Step Therapy Documentation

Most UnitedHealthcare plans require trial and failure of preferred agents unless contraindicated:

  • Platform therapies: Interferons, glatiramer acetate
  • Oral agents: Dimethyl fumarate, teriflunomide, fingolimod
  • Document specific reasons for discontinuation: lack of efficacy, intolerance, contraindications, or breakthrough disease activity

✓ Safety Screening Complete

Required baseline testing:

  • Hepatitis B surface antigen and core antibody (negative)
  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Quantitative immunoglobulins (if institutional protocol)
  • Updated vaccinations (completed ≥2 weeks before treatment)

Coding & Billing Information

✓ Diagnosis Codes

  • Primary: G35 (Multiple sclerosis)
  • Supporting: G93.40 (Encephalopathy, unspecified) if applicable

✓ Drug Identification

  • Generic name: Ofatumumab
  • Brand name: Kesimpta
  • NDC: 0078-0856-15 (20 mg/0.4 mL prefilled pen)
  • HCPCS: J9302 (for certain billing scenarios - verify with plan)

✓ Dosing Specifications

  • Loading schedule: Week 0, 1, 2 (20 mg subcutaneous each)
  • Maintenance: 20 mg subcutaneous monthly starting at week 4
  • Route: Subcutaneous self-injection

Documentation Packet Essentials

✓ Provider Clinical Note Must Include:

  • MS diagnosis with phenotype (RRMS/CIS/active SPMS)
  • Date of diagnosis and diagnostic criteria met
  • Recent relapse history (past 12-24 months)
  • Current EDSS score or functional status
  • Prior DMT history with start/stop dates and outcomes
  • Recent MRI findings (brain ± spinal cord within 12 months)
  • Physical exam findings supporting active disease

✓ Medical Necessity Letter Components:

When Counterforce Health reviews Kesimpta denials, we consistently see approvals when letters include these elements:

  • Clinical justification: Why Kesimpta's anti-CD20 mechanism is appropriate for this patient's disease activity level
  • Prior treatment failures: Specific documentation of inadequate response or intolerance to step therapy agents
  • Safety considerations: Confirmation of appropriate screening and vaccination status
  • Treatment goals: Measurable outcomes expected (relapse reduction, MRI stability, functional preservation)

✓ Required Attachments:

  • Recent neurology consultation notes
  • MRI reports (brain and spinal cord if available)
  • Laboratory results showing HBV screening
  • Vaccination records or provider attestation
  • Prior authorization form specific to your UnitedHealthcare plan

Submission Process

✓ Use Correct Forms

  • Access current PA forms through UnitedHealthcare's provider portal
  • Select "Kesimpta (ofatumumab) - Multiple Sclerosis" from specialty drug list
  • Complete all required fields to avoid automatic rejection

✓ Submit Through Proper Channel

  • Preferred: Electronic submission via provider portal
  • Alternative: Fax to number specified on current PA form (verify with source)
  • Timeline: Submit 7-10 days before needed start date

✓ Common Rejection Reasons to Avoid:

  • Incomplete prescriber information or missing DEA number
  • Missing ICD-10 diagnosis code
  • Inadequate documentation of step therapy trials
  • Missing hepatitis B screening results
  • Unsigned forms or missing patient authorization

Appeals Process in Washington

Note: Washington residents have particularly strong appeal rights, including access to Independent Review Organizations (IROs) that can overturn UnitedHealthcare denials.

✓ Internal Appeal (First Step)

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard review, 72 hours for urgent
  • Submit to: Address/portal specified in denial letter
  • Required: Written appeal explaining medical necessity with supporting documentation

✓ External Review (IRO Process)

If internal appeal fails, Washington residents can request external review:

  • Deadline: 180 days from final internal denial
  • Process: Assigned randomly by Washington Office of Insurance Commissioner
  • Timeline: 15-20 days for standard, 72 hours for expedited
  • Binding: IRO decisions are legally binding on UnitedHealthcare

✓ State Resources

Contact the Washington OIC Consumer Advocacy at 1-800-562-6900 for assistance with appeals or complaints about UnitedHealthcare's handling of your case.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Step therapy not met Document specific failures, intolerances, or contraindications to preferred agents with dates and clinical details
Not medically necessary Submit updated MRI showing active lesions, relapse documentation, or disability progression measurements
Missing safety screening Provide hepatitis B testing, CBC, and vaccination records or provider attestation
Experimental/investigational Cite FDA approval letter and inclusion in major MS treatment guidelines
Quantity limits exceeded Justify loading dose schedule per FDA labeling with treatment timeline

Cost Savings & Support Programs

✓ Manufacturer Support

  • Kesimpta Connect: Patient support program offering benefits verification and copay assistance
  • Copay cards: May reduce out-of-pocket costs for commercially insured patients
  • Bridge therapy: Temporary supply during PA review process

✓ Foundation Assistance

  • National Multiple Sclerosis Society financial assistance programs
  • HealthWell Foundation grants for MS medications
  • Patient Advocate Foundation copay relief programs

Printable Checklist

Before Submitting PA:

  • Verify active UnitedHealthcare/OptumRx coverage
  • Confirm relapsing MS diagnosis with ICD-10 G35
  • Document step therapy trials and failures
  • Complete hepatitis B screening and vaccinations
  • Gather recent MRI and neurology notes
  • Complete current UnitedHealthcare specialty drug PA form
  • Submit via provider portal or verified fax number

If Denied:

  • File internal appeal within 180 days
  • Include point-by-point response to denial reasons
  • Request expedited review if clinically urgent
  • Contact Washington OIC if process concerns arise
  • Prepare for external IRO review if internal appeal fails

From Our Advocates In our experience helping patients navigate UnitedHealthcare appeals in Washington, cases with complete step therapy documentation and clear medical necessity rationale see approval rates above 70% on internal appeal. The key is addressing each specific denial reason with clinical evidence rather than generic form letters.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance representative for personalized guidance.

When traditional appeals processes become overwhelming, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each payer's specific requirements.

Sources & Further Reading

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