Are bDMARDs, tsDMARDs and biosimilar DMARDs cost effective? Save

Treatment advances with new biologic disease-modifying antirheumatic drugs (bDMARDs), targeted synthetic DMARDs (tsDMARDs) and biosimilar DMARDs (bsDMARDs) have proven efficacy and safety; but does their increased cost yield commensurate benefits in patients with rheumatoid arthritis (RA) and high disease activity?

The use of methotrextate with either bDMARDs, tsDMARDs or bsDMARDs was not shown to be cost effective, even though reduced disease activity and improved patient quality of life. 

This study used data from the Thai Health population and evaluated the cost-effectiveness of 11 alternative treatment strategies for RA patients with high disease activity despite treatment with three conventional synthetic DMARDs (csDMARDs); namely methotrexate (MTX) + sulfasalazine (SSZ) + leflunomide (LEF).  A Markov model was constructed to estimate relevant costs and health outcomes in terms of quality-adjusted life years (QALYs) for a lifetime horizon (100 years), using a 3% annual discount. Direct and non-medical care costs were estimated abd lifetime cost, QALYs and an incremental cost-effectiveness ratio were calculated and compared to the cost-effectiveness threshold of 160,000 THB per QALY gained (US $4,634, where 1 USD = 34.53 THB in 2022). 

The 11 alternative treatment strategies including five bDMARDs, two tsDMARDs, and four bsDMARDs in combination with methotrexate (MTX) were compared with the standard of care (SoC), i.e., cyclosporine and azathioprine. The alternative treatments could be divided into 4 groups: 1) anti-TNF-α, i.e., etanercept, infliximab, and golimumab; 2) anti-IL6, i.e., tocilizumab; 3) anti-CD20, i.e., rituximab; and 4) JAK inhibitor, i.e., tofacitinib and baricitinib or 5) biosimilars (TNFi: infliximab/Remsima or Ixifi, and adalimumab/Amgevita; or to rituximab/Truxima).

The bDMARDs, tsDMARDs or bsDMARDs combined with MTX provided 0.09 to 0.33 QALYs gained with additional costs of $15,957 to $60,722 USD compared to the SoC. The Incremental Cost-Effectiveness Ratio (ICER) ranged from $65,935 to $234,996 USD compared to the SoC.

None of these combinations was cost-effective in the context of Thai (or US) healthcare costs.

Cost efficacy analyses can be useful in price negotiation process for these treatments as they are introduced and as cheaper biosimilars are being developed.

Are bDMARDs, tsDMARDs and biosimilar DMARDs cost effective?  The answer is no, but.... under what circumstances could they be, or how should they be competitively priced in the future?