Regulatory Restrictions on Biologic Rheumatoid Arthritis Drugs

How does the patient population that is eligible for reimbursed treatment compare to the patient population that was approved in a marketing authorization?

A drug’s market share is dependent on several external factors, one of which is the drug’s health technology assessment (HTA). HTA agencies frequently grant reimbursement to only a subset of the patient population for whom the drug has been approved. The HTA decision can be compared to the regulatory label to determine whether the HTA agency restricts the population that is eligible for reimbursed treatment. 

We analyzed HTA decisions from NICE, HAS, IQWiG, HIS, and SMC for rheumatoid arthritis (RA) drugs, specifically examining the subpopulations established by the HTA agencies through restrictions against the European label, and noting whether these restrictions changed over time.

See our analysis and conclusions in the full research brief.


Original research presented at HTAi 2015 in Oslo.

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