Tofacitinib per il Trattamento dell’Artrite Reumatoide Dopo il Fallimento di Farmaci Antireumatici Disease-Modifying: Una Prospettiva del Gruppo Revisione delle Evidenze di una Valutazione NICE per Singola Tecnologia
Pharmacoeconomics 2018 Sep; 36(9): 1063–72
In this National Institute for Health and Care (NICE) single technology appraisal of tofacitinib (TOF) plus methotrexate (MTX), TOF had similar efficacy and comparable costs to recommended bDMARDs plus MTX in patients with RA. NICE is an independent organisation responsible for providing national guidance on health technologies in England. To be recommended by NICE, the company must provide evidence to prove TOF’s effectiveness, both clinically and costly. This evidence based review, reports the analysis of the evidence review group (ERG) for the single technology appraisal of TOF. In this analysis, the ERG concluded that the clinical effectiveness of TOF was reasonable and generally consistent by the ERG. However, the ERG noted that the safety data was pooled and this was not appropriate to assess the safety of the individual TOF therapies. Regarding the data presented to NICE, the ERG felt that the results should be treated with caution due to the imputation methods used in the trials. In the clinical effectiveness review, TOF + MTX was superior to PBO + cDMARD in the target population. For the cDMARD-IR and bDMARD-IR patients with severe RA, who can tolerate MTX but cannot tolerate rituximab (RTX), TOF + MTX dominated some of its comparators. For patients who can tolerate RTX, RTX + MTX dominated TOF + MTX and for patients who cannot tolerate MTX, TOF monotherapy dominated. TOF was considered cost-effectiveness in majority of populations, however, for TNFi inadequate responders, costs associated with RTX acquisition were significantly lower than TOF with a comparable efficacy, so TOF was not considered to be cost effective when RTX + MTX was an available treatment option for patients. To conclude, TOF monotherapy and combination therapy with MTX have comparable efficacy to that of bDMARDs, for treating severe active RA following inadequate responses to DMARDs, and TOF was considered cost-effective only if RTX could not be given to the patient. In October 2017, NICE approved TOF monotherapy and combination therapy with MTX for patients with severe RA, who had responded inadequately to intensive therapy with cDMARDs and other DMARDs, including ≥1 bDMARD.
