GVS advice for cladribine (Mavenclad®) – extension of further conditions
The National Health Care Institute has completed its reassessment whether the further conditions of cladribine (Mavenclad®) could be further extended. Since March 2018, cladribine has been included in List 1A of the Medication Reimbursement System (GVS) for certain patients with highly active relapsing-remitting multiple sclerosis (RRMS). The National Health Care Institute's advice is to extend the List 2 conditions of cladribine to include treatment-naive patients who have had 2 or more relapses in the previous year.
Registered indication
Cladribine has been included in List 1A of the Medication Reimbursement System (GVS) in the 0L01BBCO V cluster since March 2018. The current List 2 condition reads:
- Only for an insured person aged eighteen or older with highly active relapsing-remitting multiple sclerosis (RRMS) who has not responded to treatment with at least one disease-modifying drug (DMD) registered for the treatment of MS.
The National Health Care Institute's advice
On the basis of the considerations mentioned in the report, the National Health Care Institute advises the State Secretary to extend the List 2 conditions of cladribine to include treatment-naive highly active RRMS patients with at least two relapses in the previous year.
The new condition is as follows:
Only for insured patients aged eighteen or older with highly active relapsing-remitting multiple sclerosis (RRMS):
- defined as having had 2 or more relapses in the previous year for treatment-naive patients, or;
- not having responded to treatment with at least one disease-modifying drug (DMD) that is licensed for treating MS.