By Counterforce Health Team in Kesimpta (ofatumumab) —

How to Get Kesimpta (ofatumumab) Covered by Aetna (CVS Health) in North Carolina: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Kesimpta (ofatumumab) Covered by Aetna (CVS Health) in North Carolina

Kesimpta (ofatumumab) requires prior authorization from Aetna (CVS Health) for relapsing multiple sclerosis. Submit via CVS Caremark PA portal with neurologist letter documenting relapsing MS diagnosis (ICD-10: G35), prior DMT failures, and HBV screening. Standard decisions take 30-45 days; expedited within 72 hours. If denied, appeal internally (180 days) then through North Carolina Smart NC external review (120 days from final denial, 45-day decision).

First step today: Call CVS Caremark at 1-800-294-5979 to verify your plan's specific formulary tier and PA requirements.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Letter Requirements
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process for North Carolina
  6. Patient Assistance Programs
  7. When to Contact Smart NC
  8. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Aetna plans CVS Caremark portal or fax CVS Caremark PA Info
Formulary Tier Tier 3-4 specialty drug Plan-specific drug guide Aetna Drug Guides
Diagnosis Required Relapsing MS (ICD-10: G35) Medical records FDA Kesimpta Label
Prescriber Neurologist preferred PA form CVS Caremark verification
Step Therapy May require prior DMT trial Plan policy Verify with CVS Caremark
Quantity Limit 3 pens first month, 1 monthly PA approval Kesimpta Dosing

Step-by-Step: Fastest Path to Approval

1. Verify Coverage Requirements

Who: Patient or clinic staff
Action: Call CVS Caremark at 1-800-294-5979 with member ID
Timeline: Same day
Document: Note formulary tier, PA form needed, and any step therapy requirements

2. Gather Required Documentation

Who: Patient and neurologist
Documents needed:

  • Recent MRI showing relapsing disease activity
  • Prior DMT history with dates, doses, and outcomes
  • HBV screening results (HBsAg, anti-HBc)
  • Current vaccination status
  • Medical necessity letter from neurologist

Timeline: 1-2 weeks to collect

3. Complete Prior Authorization

Who: Prescribing neurologist
Action: Submit via CVS Caremark portal or fax
Required: PA form, medical necessity letter, supporting records
Timeline: 30-45 days for standard decision; 72 hours if expedited

4. Track Decision

Who: Patient or clinic
Action: Monitor portal or call CVS Caremark for status updates
Timeline: Follow up weekly if no response after 30 days

5. If Denied: File Internal Appeal

Who: Patient with neurologist support
Action: Submit appeal within 180 days via Aetna member portal or mail
Timeline: 30 days for standard appeal; 72 hours for expedited

6. If Still Denied: External Review

Who: Patient
Action: File with Smart NC within 120 days
Timeline: 45 days for decision; 72 hours if expedited

7. Coordinate with Novartis Support

Who: Patient
Action: Enroll in Kesimpta Bridge Program for free medication during appeals
Timeline: Process during PA/appeal period

Medical Necessity Letter Requirements

Your neurologist's letter should include these specific elements to meet Aetna's criteria:

Essential Components

  • Diagnosis: Confirm relapsing form of MS (CIS, RRMS, or active SPMS) with ICD-10 code G35
  • Disease Activity: Document recent relapses, new MRI lesions, or disability progression
  • Prior Treatments: List previous DMTs with dates, doses, and reasons for discontinuation
  • Safety Screening: Confirm HBV testing completed and vaccinations up to date
  • Rationale: Explain why Kesimpta is medically necessary over alternatives

Sample Letter Framework

"Patient has relapsing-remitting multiple sclerosis with documented disease activity despite treatment with [prior DMTs]. Recent MRI dated [date] shows [findings]. HBV screening completed on [date] with results [negative/positive with treatment plan]. Kesimpta is medically necessary to reduce relapse rate and prevent disability progression per FDA indication and AAN guidelines."

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Supporting Documents
Step therapy not met Document prior DMT failures with specific outcomes Pharmacy records, clinic notes showing relapses/side effects
Not medically necessary Provide detailed disease activity evidence Recent MRI, relapse history, EDSS scores
Experimental/investigational Cite FDA approval for relapsing MS FDA label, AAN guidelines
Non-formulary Request formulary exception with alternatives inadequacy Comparative effectiveness data, contraindications to alternatives
Quantity limits exceeded Confirm dosing matches FDA label Kesimpta prescribing information

Appeals Process for North Carolina

Internal Appeals with Aetna

Level 1 Internal Appeal

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard; 72 hours for expedited
  • Submit: Aetna member portal, mail, or fax
  • Include: Denial letter, new medical evidence, updated physician letter

Level 2 Internal Appeal (if available)

  • Timeline: 30 days from Level 1 denial
  • Consider: Peer-to-peer review with Aetna medical director

External Review via Smart NC

If your internal appeals are denied, North Carolina offers external review through Smart NC:

Eligibility

  • State-regulated commercial plan (not self-funded ERISA plans)
  • Exhausted internal appeals
  • Denial based on medical necessity or experimental determination

Process

  • Deadline: 120 days from final internal denial
  • Forms: External Review Request Form
  • Timeline: 45 days for standard decision; 72 hours for expedited
  • Contact: Smart NC at 1-855-408-1212 for assistance

Expedited External Review Available if delay would jeopardize health. Requires physician certification that waiting would seriously harm patient or ability to regain function.

Patient Assistance Programs

While navigating insurance approval, several programs can help reduce costs:

Novartis Support Programs

$0 Access Card

  • Eligibility: Commercial insurance (not government plans)
  • Benefit: Up to $18,000/year copay assistance ($9,000 if copay maximizer applies)
  • Enroll: start.kesimpta.com or 1-855-537-4678

Bridge Program

  • Eligibility: Commercial insurance with PA denial
  • Benefit: Free medication up to 12 months during appeals
  • Process: Prescriber completes Kesimpta Start Form

Novartis Patient Assistance Foundation

  • Eligibility: Uninsured or underinsured patients
  • Benefit: Free medication if approved
  • Apply: pap.novartis.com

Additional Resources

When to Contact Smart NC

Contact Smart NC at 1-855-408-1212 if:

  • Your final internal appeal is denied
  • You need help completing external review forms
  • Aetna fails to respond within required timelines
  • You're unsure if your plan qualifies for North Carolina external review
  • You need assistance gathering medical records for your case

Smart NC provides free advocacy and can help you navigate the external review process, though they cannot guarantee outcomes.

FAQ

How long does Aetna prior authorization take for Kesimpta in North Carolina? Standard PA decisions take 30-45 days. Expedited requests (for urgent medical situations) are decided within 72 hours. You can request expedited review if delay would harm your health.

What if Kesimpta is non-formulary on my Aetna plan? Request a formulary exception by documenting why preferred alternatives are inadequate or contraindicated. Include medical evidence showing why Kesimpta is specifically needed for your condition.

Can I get Kesimpta while my appeal is pending? Yes, through Novartis' Bridge Program. Your doctor can request free medication for up to 12 months while insurance coverage is being resolved. Enroll via the Kesimpta Start Form.

Does step therapy apply if I tried DMTs in another state? Medical records from any state should count toward step therapy requirements. Provide complete documentation of prior treatments, including pharmacy records and physician notes showing outcomes.

What counts as "relapsing MS" for Kesimpta approval? Aetna typically covers Kesimpta for clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). Primary progressive MS usually doesn't qualify.

How do I know if my Aetna plan is regulated by North Carolina? Most individual and small group plans are state-regulated. Large employer plans may be self-funded (ERISA) and follow federal rules. Check with Smart NC at 1-855-408-1212 to confirm eligibility for external review.

From our advocates: We've seen Kesimpta denials successfully overturned when patients provided comprehensive documentation of disease activity and prior treatment failures. The key is often the peer-to-peer review between the prescribing neurologist and Aetna's medical director, where clinical nuances can be discussed directly. Don't give up after the first denial—many approvals come through the appeals process.

When navigating complex insurance approvals like Kesimpta coverage, having expert support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules. The platform pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with all required clinical facts and operational details that payers expect.

This process requires patience and persistence, but with proper documentation and strategic appeals, many North Carolina patients successfully obtain Kesimpta coverage through Aetna. The combination of internal appeals, external review through Smart NC, and manufacturer support programs provides multiple pathways to access this important MS therapy.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurer and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals, consider consulting Counterforce Health or other qualified advocates.

Sources & Further Reading

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