Provider Briefing: Kesimpta Access in 2026

Kesimpta (Ofatumumab) has become a cornerstone therapy for relapsing forms of multiple sclerosis since its FDA approval in August 2020. Its combination of high efficacy, self-administered subcutaneous delivery, and favorable safety profile has made it an increasingly popular choice among neurologists. However, patient-reported access difficulties continue to present challenges for clinical workflows.

This briefing provides an evidence-based overview of Kesimpta's current availability status, the structural barriers your patients may encounter, and practical strategies for maintaining treatment continuity.

Timeline: Kesimpta Availability

Kesimpta has not experienced a formal FDA-listed shortage since its 2020 launch. However, the specialty pharmacy distribution model — combined with insurance access barriers — has created persistent patient-level access challenges that can mimic shortage conditions from the patient's perspective.

Key milestones:

• August 2020: FDA approval of Kesimpta for relapsing forms of MS in adults
• 2021–2023: Rapid market uptake as prescribers adopted the at-home anti-CD20 option alongside Ocrevus
• 2024–2025: Continued growth in prescriptions; specialty pharmacy networks expanded capacity
• 2026: No FDA-listed shortage. Supply is adequate at the manufacturer level, but patient access varies by insurance coverage and specialty pharmacy availability

Prescribing Implications

When prescribing Kesimpta, providers should account for the following access considerations:

Prior Authorization Requirements

The majority of commercial and Medicare Part D plans require prior authorization for Kesimpta. Many plans also enforce step therapy protocols, requiring documented failure of at least one first-line DMT (commonly Aubagio, Tecfidera, or a platform injectable) before approving a high-efficacy biologic.

Clinical documentation should include:

• Confirmed diagnosis of relapsing MS (CIS, RRMS, or active SPMS)
• Evidence of disease activity (relapses, new MRI lesions, disability progression)
• Prior treatment history and reasons for failure or intolerance
• Contraindications to alternative therapies, if applicable

Specialty Pharmacy Coordination

Kesimpta is exclusively dispensed through specialty pharmacies due to its cold-chain storage requirements (2°C to 8°C) and biologic handling protocols. Prescriptions sent to retail pharmacies will not be fillable. Ensure your practice's prescription workflows route Kesimpta orders to appropriate specialty pharmacy partners.

Common specialty pharmacy channels include Accredo, BriovaRx, CVS Specialty, Express Scripts Specialty, and Novartis-affiliated distribution partners.

Loading Dose Considerations

Kesimpta's dosing schedule requires loading injections at weeks 0, 1, and 2, followed by monthly maintenance beginning at week 4. Delays in initial access can push back the entire loading sequence. When prescribing Kesimpta for a new patient, initiate the prior authorization and specialty pharmacy enrollment process as early as possible — ideally at the time of the treatment decision, not after the prescription is written.

Current Availability Picture

As of early 2026, Kesimpta availability can be summarized as follows:

• Manufacturer supply: Adequate. Novartis has not reported manufacturing constraints.
• Specialty pharmacy stock: Generally available through major specialty pharmacy networks.
• Patient-level access: Variable. Delays are primarily driven by insurance authorization timelines, step therapy requirements, and patient awareness of specialty pharmacy channels.
• Geographic variation: Minimal. Specialty pharmacies typically ship nationwide, so geographic location is rarely a limiting factor.

Cost and Access Landscape

Kesimpta's wholesale acquisition cost (WAC) is approximately $6,800–$7,500 per 20 mg dose, with an annual treatment cost of approximately $82,000–$90,000.

Insurance Coverage

• Commercial plans: Most cover Kesimpta with prior authorization. Step therapy is common. Specialty tier placement results in higher patient cost-sharing without copay assistance.
• Medicare Part D: Coverage varies by plan. Patients in the coverage gap may face significant out-of-pocket costs. The Kesimpta Access Card is not valid for Medicare beneficiaries.
• Medicaid: Coverage varies by state. Prior authorization is typically required.

Financial Assistance Programs

• Kesimpta Access Card: Up to $18,000/year in copay assistance for commercially insured patients. Per Novartis, 97% of commercially insured patients using the card pay $0 out of pocket. Patients denied coverage may receive free Kesimpta for up to 12 months.
• Novartis Patient Assistance Foundation (NPAF): Provides free Kesimpta to eligible uninsured or underinsured patients who meet income criteria. Contact: 1-800-277-2254 or patient.novartis.com.

Tools and Resources for Providers

The following tools can help streamline Kesimpta access for your patients:

• Medfinder for Providers: Search specialty pharmacy availability and help patients locate Kesimpta in stock.
• Novartis Patient Support (start.kesimpta.com): Centralized enrollment for the Access Card, benefits investigation, and prior authorization support.
• Practice-level workflow optimization: Designate a patient coordinator or nurse to manage specialty pharmacy referrals and prior authorization submissions. Track authorization status and follow up proactively.

Alternative Therapies to Consider

When Kesimpta access is delayed or denied, the following alternatives may be appropriate:

• Ocrevus (Ocrelizumab): Same mechanism (anti-CD20), IV infusion every 6 months. May have different insurance coverage pathways.
• Tysabri (Natalizumab): Highly effective for relapsing MS. Monthly IV infusion or SC injection. Requires JCV antibody monitoring.
• Mavenclad (Cladribine): Oral short-course immunosuppressant. 2-year treatment paradigm.
• Aubagio (Teriflunomide): Daily oral, moderate efficacy. May serve as bridge therapy.

For patient-facing information on alternatives, refer patients to: Alternatives to Kesimpta.

Looking Ahead

The MS biologic market is expected to continue evolving through 2026 and beyond. Key trends to watch:

• Biosimilar pipeline: No Kesimpta biosimilars are currently approved or in late-stage development, but the anti-CD20 space is increasingly competitive.
• Payer landscape: As Kesimpta uptake grows, some payers may tighten formulary restrictions or increase step therapy requirements.
• Patient preference: The at-home subcutaneous injection model continues to drive patient preference for Kesimpta over infusion-based alternatives.

Final Thoughts

Kesimpta remains a highly effective and patient-preferred therapy for relapsing MS. The primary access barriers in 2026 are structural — insurance authorization processes and specialty pharmacy distribution — rather than supply-related. By proactively managing the prior authorization process, leveraging financial assistance programs, and using tools like Medfinder for Providers, you can minimize treatment delays and ensure your patients maintain continuity of care.

For additional provider resources, see our guide on how to help your patients find Kesimpta in stock.