GVS advice ofatumumab (Kesimpta®) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS)
The National Health Care Institute has completed its assessment whether the medicinal product ofatumumab (Kesimpta®) can be included in the Medicine Reimbursement System (GVS). Ofatumumab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. The National Health Care Institute advises the Minister to include ofatumumab (Kesimpta®) on List 1B of the GVS. The National Health Care Institute also recommends reimbursement conditions.
Indication for which reimbursement is requested
Ofatumumab (Kesimpta®) is registered for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Ofatumumab is available as a solution for injection in a pre-filled pen. Each pre-filled pen contains 20 mg ofatumumab.
The recommended dose is 20 mg ofatumumab administered by subcutaneous injection with:
- initial doses in weeks 0, 1 and 2, followed by
- monthly maintenance doses from week 4.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to include ofatumumab (Kesimpta®) on List 1B. If the application of ofatumumab (Kesimpta®) is included in the package, the National Health Care Institute recommends the following reimbursement conditions:
Condition ofatumumab (Kesimpta®)
Only for an insured person with active relapsing multiple sclerosis (RMS):
a) with persistent inflammatory disease activity despite adequate treatment with at least one disease-modifying medicinal product that is licensed for treating MS, or
b) Treatment-naive patients with very active disease defined by the presence of two or more disabling relapses in one year and 1 or more gadolinium-stained lesions and/or new T2 lesions and/or significantly increasing T2 lesions (≥ 50 percent increase in maximum diameter).