By Counterforce Health Team in Kesimpta (ofatumumab) —

How to Get Kesimpta (Ofatumumab) Covered by Blue Cross Blue Shield in Ohio: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Kesimpta Covered in Ohio

Blue Cross Blue Shield (BCBS) in Ohio requires prior authorization for Kesimpta (ofatumumab) with step therapy requirements. Most plans require documented failure or intolerance to at least one preferred disease-modifying therapy before approving Kesimpta for relapsing MS.

Fastest path to approval:

  1. Submit PA form with complete MS diagnosis documentation
  2. Include detailed records of prior DMT failures/intolerances
  3. Provide specialist letter explaining medical necessity

Start today: Contact your neurologist to gather prior treatment records and request they complete the BCBS PA form. If denied, you have 180 days to file for external review through the Ohio Department of Insurance.

Table of Contents

  1. BCBS Ohio Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity Limits & Dosing Rules
  5. Required Diagnostics & Labs
  6. Specialty Pharmacy Requirements
  7. Medical Necessity Evidence
  8. Appeals Process in Ohio
  9. Common Denial Reasons & Solutions
  10. Cost Support Options
  11. Frequently Asked Questions

BCBS Ohio Policy Overview

Blue Cross Blue Shield operates through multiple independent plans in Ohio, with Anthem Blue Cross Blue Shield being the largest. All BCBS plans in Ohio require prior authorization for Kesimpta as a specialty biologic medication.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all BCBS plans BCBS Ohio formulary
Formulary Tier Specialty tier (highest cost-sharing) Member portal or benefits summary
Step Therapy 1+ preferred DMT must fail first PA criteria documents
Quantity Limits 1 pen per 28 days (maintenance) Pharmacy benefit details
Site of Care Designated specialty pharmacy Provider directory
Appeals Deadline 180 days for external review Ohio Department of Insurance
Note: Self-funded employer plans follow federal ERISA rules, not Ohio state regulations. Check with your HR department to confirm your plan type.

FDA Indication Requirements

Kesimpta is FDA-approved for relapsing forms of multiple sclerosis in adults, specifically:

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

The FDA label defines "active SPMS" as secondary progressive disease with clinical relapses and/or MRI evidence of inflammatory activity.

Required Documentation

Your neurologist must document:

  • Confirmed MS diagnosis with phenotype (CIS, RRMS, or active SPMS)
  • ICD-10 codes: G35 (Multiple sclerosis)
  • Evidence of disease activity (relapses, MRI lesions, disability progression)
  • Treatment goals and expected outcomes

Step Therapy & Medical Exceptions

Most BCBS Ohio plans require step therapy before approving Kesimpta. This means you must try and fail at least one preferred disease-modifying therapy first.

Common First-Line Requirements

BCBS typically requires documented failure or intolerance to one or more of these medications:

  • Oral agents: Dimethyl fumarate (Tecfidera), fingolimod (Gilenya), teriflunomide (Aubagio)
  • Injectable agents: Glatiramer acetate (Copaxone), interferon beta preparations
  • Infusion therapies: Ocrelizumab (Ocrevus), natalizumab (Tysabri)

Medical Exception Pathways

You can bypass step therapy if your neurologist documents:

  1. Contraindications to preferred therapies (e.g., cardiac issues with fingolimod)
  2. Severe adverse reactions to required medications
  3. Drug interactions with current medications
  4. Clinical urgency requiring immediate treatment with Kesimpta
Clinician Corner: Include specific details about why preferred therapies are inappropriate. Generic statements like "patient cannot tolerate" are often insufficient. Document specific adverse events, lab abnormalities, or contraindications with dates and severity.

Quantity Limits & Dosing Rules

BCBS Ohio typically restricts Kesimpta to FDA-recommended dosing:

Standard Dosing Schedule

  • Initial dosing: 20 mg subcutaneously at weeks 0, 1, and 2
  • Maintenance: 20 mg every 4 weeks thereafter
  • Quantity limit: 1 pen per 28-day supply for maintenance

Renewal Requirements

Most plans require annual reauthorization with documentation of:

  • Treatment response (stable or improved disease activity)
  • Tolerance (no serious adverse events)
  • Ongoing medical necessity

Required Diagnostics & Labs

Before starting Kesimpta, BCBS requires specific screening tests due to infection and hepatitis B reactivation risks.

Pre-Treatment Requirements

Test Purpose Timing
Hepatitis B panel (HBsAg, anti-HBc, anti-HBs) Screen for HBV infection/reactivation risk Within 3 months of start
Complete blood count Baseline immune function Within 3 months of start
Immunoglobulin levels (IgG, IgA, IgM) Assess immune status Within 3 months of start
Vaccination status review Ensure up-to-date immunizations Before treatment

Ongoing Monitoring

  • Immunoglobulin levels every 6-12 months
  • CBC as clinically indicated
  • Hepatitis B monitoring if at risk for reactivation

Specialty Pharmacy Requirements

Kesimpta must be dispensed through a BCBS-contracted specialty pharmacy. You cannot fill this medication at regular retail pharmacies.

Approved Specialty Pharmacies

Contact BCBS member services to confirm current specialty pharmacy partners. Common options include:

  • IngenioRx (Anthem's specialty pharmacy)
  • Accredo Specialty Pharmacy
  • CVS Specialty

Coordination Steps

  1. Your neurologist sends the prescription to the designated specialty pharmacy
  2. The pharmacy initiates prior authorization on your behalf
  3. Once approved, medication ships directly to your home
  4. Pharmacy provides injection training and ongoing support

Medical Necessity Evidence

When submitting your prior authorization, include evidence supporting Kesimpta's medical necessity over alternatives.

Key Supporting Documentation

Clinical Guidelines:

  • FDA prescribing information for approved indications
  • American Academy of Neurology MS treatment guidelines
  • National MS Society treatment recommendations

Clinical Evidence:

  • ASCLEPIOS I & II trial data showing superior efficacy vs. teriflunomide
  • Real-world evidence studies demonstrating effectiveness
  • Safety profile compared to other CD20-targeting therapies

Individualized Factors:

  • Patient's relapse history and MRI progression
  • Response to previous therapies
  • Contraindications to alternatives
  • Quality of life considerations (self-injection vs. infusion)
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with each plan's specific criteria.

Appeals Process in Ohio

If your initial prior authorization is denied, Ohio provides a structured appeals process with specific timelines and rights.

Step-by-Step Appeals Process

1. Internal Appeal (First Level)

  • Deadline: File within 180 days of denial notice
  • Timeline: BCBS has 30 days to decide (72 hours for urgent appeals)
  • How to file: Submit written appeal with additional documentation
  • Required: Copy of denial letter, medical records, physician letter

2. Internal Appeal (Second Level)

  • When: If first appeal is denied
  • Process: Same timeline and requirements as first level
  • Tip: Request peer-to-peer review with BCBS medical director

3. External Review

  • Deadline: Within 180 days of final internal denial
  • Timeline: Independent Review Organization (IRO) has 30 days to decide
  • Cost: Free to patients
  • Authority: Ohio Department of Insurance

Appeals Success Strategies

Strengthen Your Case:

  • Address each specific denial reason point-by-point
  • Include peer-reviewed literature supporting Kesimpta use
  • Provide detailed treatment history with dates and outcomes
  • Request expedited review if treatment delay poses health risks

Get Help:

  • Contact ODI consumer hotline: 800-686-1526
  • Consider working with Counterforce Health for expert appeal assistance
  • Consult patient advocacy organizations like the National MS Society

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Step therapy not completed" Document failed trials with specific medications, doses, durations, and adverse events
"Not medically necessary" Provide neurologist letter explaining why Kesimpta is clinically superior for this patient
"Experimental/investigational" Include FDA approval letter and prescribing information showing approved indication
"Incomplete documentation" Resubmit with all required forms, labs, and clinical notes
"Non-formulary medication" Request formulary exception with medical necessity justification

Sample Medical Necessity Language

"Patient has relapsing-remitting MS with breakthrough disease activity on dimethyl fumarate, evidenced by two clinical relapses and new T2 lesions on MRI over the past 12 months. Kesimpta is medically necessary as a more effective CD20-targeting therapy that can be self-administered, improving adherence compared to infusion alternatives."

Cost Support Options

Even with insurance coverage, Kesimpta can be expensive. Several programs can help reduce your out-of-pocket costs.

Manufacturer Support

  • Kesimpta Connect: Novartis patient support program
  • Copay assistance: May reduce monthly costs to $10-$25
  • Bridge program: Free medication during appeals process
  • Contact: KesimptaConnect.com or 1-833-KESIMPTA

Foundation Assistance

  • National MS Society: Emergency financial assistance
  • Patient Advocate Foundation: Copay relief programs
  • HealthWell Foundation: Specialty medication assistance

State Programs

Ohio residents may qualify for additional support through state pharmaceutical assistance programs. Contact the Ohio Department of Medicaid for eligibility information.

Frequently Asked Questions

Q: How long does BCBS prior authorization take in Ohio? A: Standard PA requests typically take 15-30 business days. Urgent requests must be processed within 72 hours if certified by your physician.

Q: What if Kesimpta isn't on my BCBS formulary? A: You can request a formulary exception with medical necessity documentation. This process follows the same timeline as standard prior authorization.

Q: Can I get an expedited appeal if my MS is worsening? A: Yes, if your neurologist certifies that delays in treatment would seriously jeopardize your health or functional ability, you can request expedited review at all levels.

Q: Do I need to restart step therapy if I switch BCBS plans? A: Generally no, if you can provide documentation of previous step therapy completion. However, each plan may have different requirements.

Q: What happens if the external review upholds the denial? A: The IRO decision is binding, but you may still have legal remedies or can reapply with additional evidence if your clinical situation changes.

Q: Does BCBS cover Kesimpta for progressive MS without relapses? A: No, Kesimpta is only FDA-approved for relapsing forms of MS, including active secondary progressive MS with evidence of inflammatory activity.

From Our Advocates: We've seen many Kesimpta appeals succeed when patients provide comprehensive documentation of their treatment journey. One effective approach is creating a timeline showing each medication tried, duration of use, and specific reasons for discontinuation. This helps insurance reviewers understand why Kesimpta is the logical next step rather than just another expensive option.

When to Get Professional Help

Consider working with coverage specialists like Counterforce Health if you encounter repeated denials or complex medical situations. Professional advocates can analyze your specific denial reasons and craft targeted appeals that address each insurer concern with appropriate clinical evidence and policy citations.

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact the Ohio Department of Insurance or qualified legal counsel for specific appeals guidance.

Sources & Further Reading

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