Getting Kesimpta (Ofatumumab) Covered by Blue Cross Blue Shield of North Carolina: Complete Prior Authorization and Appeal Guide

Quick Answer: Kesimpta requires prior authorization from Blue Cross Blue Shield of North Carolina and is typically placed in Tier 5 (specialty). Your doctor must document relapsing MS diagnosis, prior treatment failures, and complete HBV screening. If denied, you can appeal internally, then through North Carolina's Smart NC external review within 120 days. Start by calling Blue Cross NC member services to confirm your specific formulary tier and PA requirements.

Table of Contents

  1. What Drives Kesimpta Costs with Blue Cross NC
  2. Prior Authorization Requirements
  3. Investigating Your Benefits
  4. Cost Assistance Options
  5. Appealing Denials in North Carolina
  6. Specialty Pharmacy Requirements
  7. Renewal and Annual Changes
  8. Scripts for Key Conversations
  9. FAQ

What Drives Kesimpta Costs with Blue Cross NC

Blue Cross Blue Shield of North Carolina places Kesimpta (ofatumumab) in their specialty tier (typically Tier 5), which means higher out-of-pocket costs compared to generic medications. Your costs depend on several factors:

Formulary Placement: Kesimpta requires prior authorization and is subject to strict utilization management. While not explicitly listed in all Blue Cross NC formulary excerpts, specialty drugs like Kesimpta typically fall under the highest cost-sharing tier with 30-50% coinsurance rather than fixed copays.

Step Therapy Requirements: Like most Blue Cross plans, Blue Cross NC generally requires patients to try preferred first-line MS therapies before approving newer, more expensive options. This means documenting failure of or contraindications to at least two preferred agents.

Specialty Pharmacy Mandate: Kesimpta must be dispensed through Blue Cross NC's approved specialty pharmacy network, not your local retail pharmacy. This ensures proper cold-chain handling and patient support services.

Coverage at a Glance
Requirement Details Where to Verify
Prior Authorization Yes, required Blue Cross NC Provider Portal
Formulary Tier Tier 5 (Specialty) Your plan's drug formulary
Step Therapy Typically 2+ preferred agents PA criteria documentation
Specialty Pharmacy Required Member services: 1-800-249-6778
Appeal Deadline 180 days internal, 120 days external NC Department of Insurance

Prior Authorization Requirements

Your prescribing physician must submit a prior authorization request demonstrating medical necessity. Based on typical Blue Cross policies for MS medications, the PA will likely require:

Clinical Documentation:

  • Confirmed diagnosis of relapsing multiple sclerosis (CIS, RRMS, or active SPMS)
  • Documentation of disease activity (recent relapses, MRI findings, or disability progression)
  • Complete medical history and current neurological status

Previous Treatment History:

  • Records of at least two prior disease-modifying therapies tried and failed due to lack of efficacy, intolerance, or contraindications
  • Specific reasons for discontinuation of each previous therapy
  • Duration of each treatment trial (typically 3-6 months minimum)

Safety Requirements:

  • Hepatitis B screening results (HBsAg, anti-HBc, anti-HBs)
  • If HBV positive, documentation of antiviral therapy initiation
  • Confirmation of no active infections
  • Immunoglobulin level monitoring plan

Prescriber Attestation:

  • Agreement to monitor for infections and immunoglobulin levels
  • Confirmation that patient is not receiving concurrent live vaccines
  • Documentation that Kesimpta won't be used with other MS DMTs or immunosuppressive therapies
Clinician Corner: Medical Necessity Letter Checklist

Problem Statement: "Patient has relapsing MS with [specific activity/symptoms]" ✓ Prior Treatments: List each DMT tried, duration, and reason for discontinuation ✓ Clinical Rationale: Why Kesimpta is appropriate (efficacy data, patient factors) ✓ Safety Monitoring: HBV screening results and monitoring plan ✓ Guideline Support: Reference FDA prescribing information or MS society guidelines

Investigating Your Benefits

Before your doctor submits the PA, gather key information about your specific coverage:

Call Blue Cross NC Member Services at 1-800-249-6778 with these questions:

  1. "What tier is Kesimpta (ofatumumab) on my formulary?"
  2. "What's my specialty tier coinsurance percentage?"
  3. "Does my plan require step therapy for MS medications?"
  4. "Which specialty pharmacies are in-network for Kesimpta?"
  5. "What's my annual out-of-pocket maximum?"

Information to Record:

  • Your member ID and group number
  • Plan year dates (coverage can change annually)
  • Specialty pharmacy contact information
  • Prior authorization submission process (online portal vs. fax)

For the most current formulary information, check your plan documents or visit the Blue Cross NC member portal. Drug coverage can vary between Blue Cross NC's different plan types (ACA marketplace, employer-sponsored, etc.).

Cost Assistance Options

Novartis Kesimpta Copay Program

If you have commercial insurance (not Medicare, Medicaid, or other government coverage), you may qualify for significant savings:

Eligibility Requirements:

  • Must have commercial insurance that covers some portion of Kesimpta
  • Not eligible if you have Medicare, Medicaid, TRICARE, or VA coverage
  • Not available if your plan pays 100% of Kesimpta costs or doesn't cover it at all

Savings Details:

  • Up to $18,000 per calendar year in copay assistance
  • If your plan uses a copay maximizer program, assistance may be limited to $9,000 annually
  • You're responsible for costs beyond the annual program limit

How to Apply: Contact the Alongside Kesimpta coordinator program for enrollment and ongoing support.

Additional Financial Resources

Patient Assistance Foundation: For uninsured patients or those with government insurance, the Novartis Patient Assistance Foundation may provide free medication based on income eligibility.

State Programs: North Carolina residents may qualify for additional assistance through state pharmaceutical assistance programs. Contact Smart NC at 1-855-408-1212 for guidance.

Appealing Denials in North Carolina

If Blue Cross NC denies your Kesimpta request, North Carolina offers robust appeal rights through a two-level process:

Internal Appeals (Blue Cross NC)

First Level Appeal:

  • Deadline: 180 days from denial notice
  • Submit via: Blue Cross NC member portal or written request
  • Timeline: 30 days for standard review, 72 hours for urgent requests
  • Include: Updated clinical documentation, specialist letters, treatment history

Second Level Appeal:

  • Available if first appeal is denied
  • Same timeline and submission process
  • Consider requesting peer-to-peer review with a neurologist

External Review (Smart NC)

If Blue Cross NC upholds the denial after internal appeals, you can request an independent external review:

Eligibility:

  • Must exhaust internal appeals first (unless urgent)
  • Plan must be state-regulated (not self-funded employer plans)
  • Denial must be based on medical necessity, experimental treatment, or similar coverage issues

Process:

  • Deadline: 120 days from final internal denial
  • Contact: Smart NC at 1-855-408-1212
  • Timeline: 45 days for standard review, 72 hours for urgent cases
  • Cost: Free to patients

Required Documentation:

  • Final denial letter from Blue Cross NC
  • All medical records supporting Kesimpta necessity
  • Completed external review request form
  • Specialist letter explaining why Kesimpta is medically necessary
From Our Advocates: We've seen MS patients successfully overturn denials by providing comprehensive documentation of previous treatment failures and current disease activity. The key is showing that standard first-line therapies either didn't work or caused intolerable side effects, making Kesimpta the most appropriate next step. External review decisions are binding on insurers.

Success Strategy: Include peer-reviewed studies supporting Kesimpta's efficacy, FDA prescribing information highlighting its benefits for relapsing MS, and detailed neurologist notes explaining why other options aren't suitable.

Counterforce Health helps patients navigate complex prior authorization and appeal processes by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed appeals that address payers' own requirements. Our platform streamlines the appeals process by pulling relevant clinical guidelines and weaving them into targeted rebuttals.

Specialty Pharmacy Requirements

Kesimpta cannot be filled at your local retail pharmacy. Blue Cross NC requires specialty pharmacy dispensing for several reasons:

Why Specialty Pharmacy is Required:

  • Cold-chain storage and shipping requirements
  • Patient education and injection training
  • Ongoing monitoring and support services
  • Insurance coordination and prior authorization management

Blue Cross NC Specialty Pharmacy Network: Contact Blue Cross NC member services to confirm which specialty pharmacies are in-network. Common options include:

  • Accredo Specialty Pharmacy
  • CVS Specialty Pharmacy
  • Express Scripts Specialty Pharmacy

Ordering Process:

  1. Your doctor sends the prescription to the specialty pharmacy
  2. Pharmacy contacts you to verify insurance and shipping address
  3. Medication is shipped directly to your home with temperature monitoring
  4. Pharmacy provides injection training and ongoing support

Coordination Tips:

  • Ensure your doctor sends prescriptions to an in-network specialty pharmacy
  • Confirm shipping address and someone will be available to receive the medication
  • Schedule delivery to avoid weekends or holidays when you won't be home

Renewal and Annual Changes

Prior Authorization Renewal:

  • Most PA approvals last 12-24 months
  • Your doctor will need to submit renewal documentation before expiration
  • Include updated disease status, current treatment response, and continued medical necessity

Annual Plan Changes:

  • Formulary placement can change each plan year
  • Copay amounts and coinsurance percentages may be adjusted
  • Specialty pharmacy networks might change

Budgeting Reminders:

  • Track your annual out-of-pocket spending toward your deductible and maximum
  • Manufacturer copay assistance resets each calendar year
  • Consider timing of prescription refills around plan year changes

Conversation Scripts

Calling Blue Cross NC Member Services

"Hi, I'm calling about prior authorization requirements for Kesimpta, which is ofatumumab, for multiple sclerosis. My member ID is [number]. Can you tell me:

  • What tier Kesimpta is on my formulary?
  • What my specialty tier cost-sharing is?
  • Which specialty pharmacies are in-network?
  • How to check the status of a prior authorization request?"

Peer-to-Peer Request Script (for clinic staff)

"I'm calling to request a peer-to-peer review for [patient name], member ID [number], for Kesimpta prior authorization. The patient has relapsing MS and has failed [list specific medications] due to [specific reasons]. Our neurologist would like to speak with your medical director about why Kesimpta is medically necessary. When can we schedule this call?"

Specialty Pharmacy Coordination

"I'm calling about my Kesimpta prescription. I need to:

  • Confirm you received the prescription from Dr. [name]
  • Verify my insurance information is current
  • Schedule delivery for [preferred day/time]
  • Arrange for injection training if this is my first fill"

FAQ

How long does Blue Cross NC prior authorization take? Standard PA reviews typically take 14-30 days. Urgent requests (when delay could jeopardize health) must be reviewed within 72 hours. Your doctor can request expedited review if clinically appropriate.

What if Kesimpta is non-formulary on my plan? You can request a formulary exception by providing documentation that preferred alternatives are inappropriate due to contraindications, previous failures, or other clinical factors. This requires detailed justification from your neurologist.

Can I request an expedited appeal? Yes, if delaying Kesimpta treatment would seriously jeopardize your health or ability to function. Both Blue Cross NC and Smart NC external review offer expedited processes for urgent situations.

Does step therapy apply if I tried medications outside North Carolina? Yes, documented treatment failures from other states should count toward step therapy requirements. Ensure your new neurologist has complete records from your previous providers.

What happens if Smart NC external review overturns the denial? The decision is binding on Blue Cross NC. They must provide coverage within 3 business days of the favorable decision. If they don't comply, contact Smart NC immediately.

How much will Kesimpta cost with Blue Cross NC? Costs vary by specific plan, but specialty tier medications typically have 30-50% coinsurance. With Novartis copay assistance (up to $18,000 annually), many patients pay significantly less.

Can I appeal if I'm denied due to missing hepatitis B screening? This type of denial is usually administrative rather than medical necessity. Work with your doctor to complete the required screening and resubmit the PA rather than filing an appeal.

What if my employer plan is self-funded? Self-funded plans aren't subject to North Carolina external review requirements. However, they typically have their own appeal processes, and you may still be able to access Smart NC's advocacy services for guidance.


This guide provides educational information and should not replace professional medical or legal advice. For personalized guidance on your specific situation, consult with your healthcare provider and insurance plan directly.

Need help with a complex denial or appeal? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals that address specific coverage criteria.

Sources & Further Reading

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