How to Get Kesimpta (Ofatumumab) Covered by Blue Cross Blue Shield in California: Prior Authorization, Appeals & Cost Savings
Answer Box: Getting Kesimpta Covered by Blue Shield of California
Kesimpta (ofatumumab) requires prior authorization from Blue Shield of California for relapsing multiple sclerosis. The fastest path to approval: 1) Submit PA request with MS diagnosis (ICD-10: G35) and documentation of failed/contraindicated alternatives like Betaseron or Copaxone, 2) Obtain through network specialty pharmacy only (not retail), 3) If denied, file internal appeal then California DMHC Independent Medical Review (IMR) with 68.6% success rate for Anthem Blue Cross denials. Start with Blue Shield's provider portal or call 800-535-9481 for PA forms.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Understanding Your Costs and Assistance Options
- Specialty Pharmacy Requirements
- Common Denial Reasons & How to Fix Them
- Appeals Process: Internal to IMR
- Scripts for Insurance and Pharmacy Calls
- FAQ: Your Most Common Questions
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Mandatory clinical review before dispensing | Blue Shield provider portal | PA Policy |
| Formulary Status | Specialty drug on all Blue Shield plans | Plan-specific drug lists | Specialty Drug Lists |
| Diagnosis Required | Relapsing MS (CIS, RRMS, active SPMS) | ICD-10: G35 | PA Policy |
| No Concurrent DMTs | Must discontinue other MS therapies | Clinical documentation | PA Policy |
| Specialty Pharmacy Only | Network specialty pharmacy required | Member services | Specialty Drug Policy |
| Dosing Coverage | 20mg SC weeks 0,1,2,4 then monthly | FDA-approved schedule | PA Policy |
Step-by-Step: Fastest Path to Approval
1. Confirm Your Blue Shield Plan Coverage
Who: Patient or caregiver
What to do: Call member services at the number on your insurance card to verify Kesimpta is on your plan's specialty drug formulary
Timeline: 5-10 minutes
Source: Blue Shield Member Portal
2. Gather Required Documentation
Who: Your neurologist's office
Documents needed:
- MS diagnosis with ICD-10 code G35
- Documentation of prior DMT failures or contraindications (Betaseron, Copaxone, Extavia, Gilenya, etc.)
- Current clinical notes showing relapsing disease activity
- Lab results confirming no active hepatitis B Timeline: 1-2 business days
3. Submit Prior Authorization Request
Who: Prescribing physician
How: Blue Shield provider portal or fax PA form
Required elements: Clinical rationale, prior therapy documentation, self-administration plan
Timeline: Blue Shield has 72 hours to respond (24 hours for urgent requests)
Source: PA Requirements
4. Coordinate Specialty Pharmacy Fulfillment
Who: Patient with pharmacy coordination
What: Contact Blue Shield's designated specialty pharmacy network
Note: Kesimpta cannot be dispensed through regular retail pharmacies
Timeline: 3-5 business days after PA approval
5. Enroll in Copay Assistance (If Commercially Insured)
Who: Patient
Program: Alongside Kesimpta $0 Access Card
Savings: Up to $18,000 annually
Enroll: start.kesimpta.com or 1-855-KESIMPTA
Source: Novartis Copay Program
Understanding Your Costs and Assistance Options
What Drives Kesimpta Costs
Kesimpta is classified as a specialty biologic, placing it on higher formulary tiers with significant cost-sharing. Your out-of-pocket costs depend on:
- Formulary tier: Specialty tier with higher copays/coinsurance
- Deductible status: Whether you've met your annual deductible
- Plan design: HMO vs. PPO benefit structures
- Pharmacy network: Specialty pharmacy requirements
Manufacturer Assistance Programs
Alongside Kesimpta $0 Access Card offers substantial savings for commercially insured patients:
- Eligibility: US residents with commercial insurance (excludes Medicare, Medicaid, TRICARE)
- Annual savings: Up to $18,000 per calendar year
- Enrollment: start.kesimpta.com or call 1-855-537-4678
- California residents: No state-specific restrictions apply
Tip: Enroll in copay assistance before your first fill. The program can reduce your copay to $0 in many cases, but you're responsible for costs once the annual cap is reached.
Foundation and State Programs
If you don't qualify for manufacturer assistance:
- Novartis Patient Assistance Foundation: Income-based free medication for uninsured/underinsured patients
- California state programs: Medi-Cal expansion may cover Kesimpta through managed care plans
- Bridge programs: Up to 12 months of free maintenance doses for commercial patients with PA denials
Specialty Pharmacy Requirements
Blue Shield of California requires Kesimpta to be dispensed exclusively through their network specialty pharmacies. This means:
What You Need to Know
- No retail pickup: Your local CVS or Walgreens cannot fill Kesimpta
- Mail delivery: Most specialty pharmacies ship directly to your home
- Coordination required: Your doctor's office must coordinate with the specialty pharmacy
- Cold chain: Kesimpta requires refrigerated shipping and storage
Working with Your Specialty Pharmacy
- Initial setup: The pharmacy will contact you to verify insurance and delivery preferences
- Injection training: Most offer free training on self-administration techniques
- Refill reminders: Automated systems track your monthly schedule
- Clinical support: Pharmacists available for side effect questions
Note: If Blue Shield's network specialty pharmacy cannot fulfill your prescription, alternative arrangements may be possible per your plan documents. Contact member services for options.
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "Not relapsing MS phenotype" | Submit neurologist letter confirming CIS, RRMS, or active SPMS diagnosis | Clinical notes with ICD-10 G35, MRI reports showing active lesions |
| "Missing baseline labs" | Complete hepatitis B screening and vaccination status | Lab results for HBsAg, anti-HBc, anti-HBs; vaccination records |
| "Concurrent DMT use" | Document discontinuation of other MS therapies | Medication list showing stopped therapies, washout period if required |
| "Quantity limits exceeded" | Confirm dosing follows FDA schedule | Prescription for 20mg SC at weeks 0,1,2,4 then monthly |
| "Not medically necessary" | Provide clinical rationale with guideline support | Treatment history, disease activity measures, peer-reviewed evidence |
Strengthening Your Medical Necessity Case
When appealing a "not medically necessary" denial, include:
- Disease activity: Recent relapses, new MRI lesions, disability progression
- Prior treatment failures: Specific reasons other DMTs were discontinued (efficacy, tolerability, contraindications)
- Guideline support: Reference AAN, ECTRIMS, or other recognized MS treatment guidelines
- Specialist input: Letter from MS specialist or neurologist familiar with your case
Appeals Process: Internal to IMR
California offers robust appeal rights with high success rates for specialty drug denials.
Level 1: Internal Appeal with Blue Shield
Timeline: File within 180 days of denial
Process: Submit appeal with supporting documentation
Response time: Blue Shield has 30 days to respond (or expedited timeframes for urgent cases)
Success strategy: Focus on medical necessity with peer-reviewed evidence
Level 2: DMHC Independent Medical Review (IMR)
When to file: After internal appeal denial or if Blue Shield doesn't respond within 30 days
Cost: Free to patients
Timeline: 30-45 days for standard review, 72 hours for expedited
Success rates: 68.6% of medical necessity denials overturned for Anthem Blue Cross in 2023
How to file: DMHC online portal or call 888-466-2219
From our advocates: We've seen strong IMR success when patients include a detailed timeline of their MS progression, specific reasons why alternative treatments failed, and current clinical evidence supporting Kesimpta's effectiveness for their disease phenotype. The key is connecting your individual medical story to the broader evidence base.
Required Documents for Appeals
- Original denial letter
- Complete medical records related to MS diagnosis and treatment
- Prescriber's medical necessity letter
- Peer-reviewed studies supporting Kesimpta use
- Documentation of failed prior therapies
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals that align with payer requirements, pulling the right clinical evidence and citations to strengthen your case. Learn more about our appeal assistance.
Scripts for Insurance and Pharmacy Calls
Calling Blue Shield Member Services
"Hi, I'm calling to verify coverage for Kesimpta, spelled K-E-S-I-M-P-T-A, for multiple sclerosis. Can you confirm: 1) Is this on my plan's formulary? 2) What tier is it on? 3) Do I need prior authorization? 4) Which specialty pharmacy should I use? 5) What's my estimated copay after my copay card?"
Requesting Expedited Review
"My doctor prescribed Kesimpta for my multiple sclerosis, and I need to request an expedited prior authorization review. I'm currently experiencing active disease symptoms, and any delay in treatment could worsen my condition. What documentation do you need for an urgent review?"
Specialty Pharmacy Coordination
"I'm calling to set up delivery for my Kesimpta prescription. I'll need: 1) Confirmation of my insurance coverage, 2) Training on the injection technique, 3) A delivery schedule that works with my monthly dosing, and 4) Information about storing the medication properly."
FAQ: Your Most Common Questions
Q: How long does Blue Shield prior authorization take in California?
A: Blue Shield must respond within 72 hours for standard requests and 24 hours for urgent cases. If they don't respond within these timeframes, your PA request is automatically approved under California law.
Q: What if Kesimpta isn't on my specific Blue Shield plan's formulary?
A: You can request a formulary exception by demonstrating medical necessity. Include documentation that preferred alternatives are contraindicated or have failed. The DMHC IMR process offers strong appeal rights if initially denied.
Q: Can I get expedited appeals for urgent MS treatment?
A: Yes. If you're experiencing active MS symptoms or disease progression, you can request expedited internal appeals and expedited DMHC IMR (decided within 72 hours). Your neurologist must document the urgent medical need.
Q: Does step therapy apply if I've tried other DMTs outside California?
A: Yes, prior treatment history from other states counts toward meeting step therapy requirements. Ensure your medical records clearly document previous DMT trials, outcomes, and reasons for discontinuation.
Q: How do I coordinate between Blue Shield and the specialty pharmacy?
A: Your prescriber's office typically initiates the coordination, but you can call Blue Shield member services to identify your designated specialty pharmacy network and ensure smooth handoffs.
Q: What happens if my appeal is denied at every level?
A: After exhausting DMHC IMR, you may have additional options through state regulatory complaints or working with organizations like Counterforce Health that specialize in complex insurance appeals for specialty medications.
Q: Can I switch to a different Blue Shield plan during open enrollment to get better Kesimpta coverage?
A: Yes, but coverage requirements are generally consistent across Blue Shield plans. Focus on factors like copay amounts, deductibles, and specialty pharmacy networks when comparing options.
Q: What if I move to another state while on Kesimpta?
A: You'll need to transition to that state's Blue Cross Blue Shield affiliate, which may have different PA requirements and specialty pharmacy networks. Start the transition process 60-90 days before your move.
Sources & Further Reading
- Blue Shield of California Kesimpta Prior Authorization Policy
- Blue Shield Specialty Drug Lists by Plan
- California DMHC Independent Medical Review
- Novartis Kesimpta Copay Assistance Program
- Blue Shield Provider Authorization Portal
- DMHC Help Center: 888-466-2219
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage policies and requirements may change. Always verify current information with Blue Shield of California and consult your healthcare provider for medical decisions. For additional support with insurance appeals and prior authorizations, consider consulting with coverage advocacy services.
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