How to Get Kesimpta (Ofatumumab) Covered by Aetna (CVS Health) in Georgia: Complete PA Guide and Appeal Scripts
Quick Answer: Aetna (CVS Health) requires prior authorization for Kesimpta (ofatumumab) with documented relapsing MS diagnosis, neurologist prescription, and evidence of prior DMT failures or contraindications. In Georgia, you have 180 days to appeal internal denials and 60 days for external review through the Georgia Department of Insurance. Start by having your neurologist gather MRI results, prior therapy records, and hepatitis B screening, then submit via the CVS Caremark portal or PA fax form.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Playbook for Georgia Patients
- Peer-to-Peer Review Strategy
- Cost Assistance and Patient Support
- When to Contact Georgia Regulators
- Frequently Asked Questions
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Kesimpta prescriptions | CVS Caremark provider portal | Aetna Clinical Policy |
| Step Therapy | Trial of preferred DMTs (glatiramer, teriflunomide) | Formulary exceptions process | CVS Caremark PA Forms |
| Neurologist Prescription | Must be prescribed by or in consultation with neurologist | Medical necessity letter | Aetna MS Policy |
| Hepatitis B Screening | HBsAg and HBcAb testing required | Lab results within 6 months | FDA Kesimpta Label |
| Quantity Limits | Initial: 3 pens/28 days; Maintenance: 1 pen/28 days | PA form specifications | CVS PA Requirements |
Step-by-Step: Fastest Path to Approval
1. Confirm Your Diagnosis (Patient + Neurologist)
Your neurologist needs to document relapsing MS using the 2017 McDonald criteria. This includes clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS) with ICD-10 code G35.
Timeline: Same day if records are current Documents needed: Recent MRI (within 12 months), EDSS score, relapse history
2. Document Prior Treatment Failures (Neurologist)
Aetna typically requires evidence that you've tried and failed at least one preferred DMT, such as:
- Glatiramer acetate (Copaxone)
- Teriflunomide (Aubagio)
- Dimethyl fumarate (Tecfidera)
Timeline: 1-2 business days to compile records What counts as failure: Disease progression, new relapses, MRI activity, or documented intolerance
3. Complete Safety Screening (Patient + Neurologist)
Before starting Kesimpta, you'll need:
- Hepatitis B surface antigen (HBsAg) and core antibody (HBcAb) tests
- Complete blood count (CBC)
- Comprehensive metabolic panel
- Updated vaccinations (at least 2 weeks before starting)
Timeline: 3-5 days for lab results Submit to: Include with PA packet
4. Submit Prior Authorization (Neurologist's Office)
Your neurologist submits the PA request through:
- CVS Caremark provider portal (preferred)
- PA fax form to CVS Specialty (verify current fax with provider services)
- Phone: 1-866-785-5714 for questions
Timeline: 7-10 business days for standard review; 72 hours for expedited Required attachments: Medical necessity letter, lab results, MRI reports, prior DMT records
5. Follow Up and Track Status (Patient + Office Staff)
Call Aetna member services (number on your ID card) to check PA status after 5 business days for standard requests.
What to ask: "What's the status of my Kesimpta prior authorization? Do you need any additional documentation?"
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "No documented DMT failures" | Submit detailed prior therapy records | Dates of treatment, reasons for discontinuation, clinical notes |
| "Non-neurologist prescription" | Neurologist consultation note | Referral letter or co-signature from MS specialist |
| "Missing hepatitis B screening" | Complete required lab work | HBsAg and HBcAb results within 6 months |
| "Experimental/investigational" | Cite FDA approval for relapsing MS | FDA label, clinical guidelines, peer-reviewed studies |
| "Step therapy not completed" | Request exception with medical justification | Letter explaining why preferred agents are inappropriate |
Appeals Playbook for Georgia Patients
Internal Appeal (First Level)
Deadline: 180 days from denial notice How to file: Aetna member portal, phone, or mail Timeline: 30 days standard; 72 hours if expedited Required: Medical records, prescriber letter, rebuttal to specific denial reasons
Script for requesting expedited review: "My neurologist has determined that a delay in starting Kesimpta will seriously jeopardize my health due to active MS progression. I'm requesting an expedited internal appeal under Georgia law."
External Review (Second Level)
If Aetna upholds the denial, Georgia law provides independent external review through the Department of Insurance.
Deadline: 60 days from final internal denial How to file: Georgia DOI online form or call 1-800-656-2298 Timeline: 30 business days standard; 72 hours expedited Cost: Free to patients Binding: Yes - Aetna must comply with favorable decisions
Contact: Georgia DOI Consumer Services
Peer-to-Peer Review Strategy
If your initial PA is denied, request a peer-to-peer consultation where your neurologist speaks directly with an Aetna medical director.
Preparation Checklist for Your Neurologist:
- Review Aetna's Clinical Policy Bulletin 0264 for MS criteria
- Prepare patient timeline: diagnosis date, relapses, MRI progression
- Gather evidence of prior DMT failures with specific dates and outcomes
- Reference published guidelines (AAN, ECTRIMS) supporting Kesimpta use
- Document any contraindications to preferred therapies
Key Points to Emphasize:
- Disease activity: Recent relapses or MRI lesions despite prior treatment
- Treatment failures: Specific reasons why first-line agents didn't work
- Clinical rationale: Why Kesimpta's anti-CD20 mechanism is appropriate
- Patient factors: Injection preference, adherence concerns with oral DMTs
Cost Assistance and Patient Support
While navigating the approval process, several programs can help with costs and access:
Novartis Patient Support Program
- Free drug: Up to 12 months during appeals process
- Copay assistance: Reduces out-of-pocket costs for eligible patients
- Benefits verification: Helps determine coverage requirements
- Enrollment: Kesimpta Patient Support or call 1-844-KESIMPTA
CVS Specialty Pharmacy Services
Once approved, Kesimpta is typically dispensed through CVS Specialty with:
- Home delivery of monthly injections
- Clinical support and injection training
- Refill reminders and adherence monitoring
At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, gathering the right evidence, and crafting targeted rebuttals that speak directly to payer policies. Our platform understands the specific requirements that Aetna and other major insurers use for specialty medications like Kesimpta.
When to Contact Georgia Regulators
Contact the Georgia Department of Insurance if:
- Aetna doesn't respond to appeals within required timeframes
- You need help filing an external review request
- You believe Aetna isn't following Georgia insurance laws
Georgia DOI Consumer Services: 1-800-656-2298 Online complaint form: oci.georgia.gov
From our advocates: We've seen cases where patients initially denied for Kesimpta succeeded on appeal by providing detailed documentation of injection site reactions to glatiramer acetate and MRI evidence of new lesions despite oral DMT therapy. The key was connecting each denial reason to specific clinical evidence and Georgia's step therapy exception provisions.
Frequently Asked Questions
How long does Aetna prior authorization take for Kesimpta in Georgia? Standard PA decisions typically take 7-10 business days. Expedited requests (when delay would jeopardize health) must be decided within 72 hours under Georgia law.
What if Kesimpta is non-formulary on my Aetna plan? You can request a formulary exception by demonstrating medical necessity and providing evidence that formulary alternatives are inappropriate or have failed.
Can I start Kesimpta while my appeal is pending? The Novartis Patient Support Program may provide free drug during appeals. Additionally, your neurologist can request expedited review if delaying treatment poses health risks.
Does Georgia's step therapy law help with Kesimpta appeals? Yes. Georgia Code §33-24-59.25 allows step therapy exceptions when preferred drugs are contraindicated, likely to cause adverse reactions, or medically inappropriate based on clinical guidelines.
What happens if I move to Georgia with existing Kesimpta coverage? Aetna typically provides continuity of care for 30 days while processing new PA requirements. Contact member services immediately after your move to initiate the transition process.
How do I know if my Aetna plan is subject to Georgia external review? Fully insured plans (individual, small group) are subject to Georgia DOI external review. Self-funded employer plans (ERISA) may have different appeal processes - check your Summary Plan Description.
For the most current information about Aetna's Kesimpta coverage policies and Georgia-specific appeal procedures, patients should verify details directly with Aetna member services and the Georgia Department of Insurance.
Sources & Further Reading
- Aetna Clinical Policy Bulletin 0264: Multiple Sclerosis
- Kesimpta Healthcare Provider Coverage Support
- Georgia DOI External Review Process
- CVS Caremark Prior Authorization Forms
- Aetna Provider Appeals Process
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with prior authorizations and appeals, consider working with advocacy services like Counterforce Health that specialize in insurance coverage for specialty medications.
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