NICE Seeks More Data From Abbott On Humira In Psoriatic Arthritis

U.K. agency’s preliminary appraisal on cost effectiveness does not call for recommending adalimumab.

The U.K. National Institute for Health and Clinical Excellence is requesting additional information from Abbott on the cost effectiveness of Humira (adalimumab) for psoriatic arthritis compared to Johnson & Johnson's Remicade (infliximab) and Amgen/Wyeth's Enbrel (etanercept) before issuing a final recommendation.

The agency recently released a preliminary recommendation on the cost effectiveness of Humira for psoriatic arthritis, stating that it is "minded not to recommend adalimumab within its licensed indication for the treatment of adults with psoriatic arthritis."

NICE will accept comments on the preliminary appraisal until April 30 and will host a second committee meeting on May 16 to discuss the tumor necrosis factor inhibitor.

Abbott told "The Pink Sheet" DAILY that the NICE appraisal "does not mean that they have given a negative preliminary recommendation."

"Abbott has been, and will continue to be, actively engaged with NICE during this ongoing process," the firm added.

NICE based its preliminary recommendation on an analysis of a cost-utility model from Abbott evaluating the impact of treatment with Humira compared to Remicade, Enbrel or disease-modifying anti-rheumatic drugs on joint and skin outcomes. In that model, the incremental cost-effectiveness ratio for Humira compared to a DMARD was £25,991 per quality-adjusted life year. The results demonstrated that Enbrel was less effective and more costly and that the ICER for Remicade compared to Humira was £209,572 per QALY.

NICE's Evidence Review Group noted that the "strength of the economic model was the evaluation of the impact of the different treatments on both the arthritis and skin components of PsA" and raised concerns about the method, including evidence synthesis, inclusion criteria and key assumptions.

"To explore the validity and robustness of the analysis, the ERG requested more information and revised analysis from the manufacturer around subgroups of people with PsA with and without skin involvement, evidence from trials reported at 12 as well as 24 weeks and exclusion of the open-label portion of the M02-570 study from the evidence synthesis."

The ERG noted that the response rates used in the Abbott model were estimates based on 24-week response rates. "The 12-week response data for etanercept and infliximab were higher than the 24-week results, and therefore the adjustment made in the original manufacturer's submission underestimated the 12-week response rates for the comparators," NICE said.

Following a revised economic analysis, the ICER for adalimumab was £31,458 for QALY for Humira compared to DMARD, and the analysis showed Enbrel and DMARDs were less expensive and more effective than Humira. The ICER for Remicade compared with Enbrel was £114,234 per QALY.

"The committee noted that only one of the studies of adalimumab in PsA included in the manufacturer's submission had been published so far; that the actual 12-week response data for the three anti-TNF-alpha agents had not been used in the indirect comparison; and that absolute response rates were used in the indirect comparison rather than relative response rates, all of which raised concerns about the validity of the indirect comparison," NICE reported.

"The committee therefore concluded the clinical equivalence of adalimumab with etanercept and infliximab had not been proven," the agency added.

The committee is seeking additional clarification from Abbott, including "re-analysis using the actual 12-week response data directly in the economic model, without the constraint that the 12-week response rates are equal to or lower than those reported at 24 weeks" and an analysis using that data of the cost effectiveness of Humira compared to Enbrel and Remicade for people with and without skin involvement, NICE said.

Abbott said it intends to submit the requested information to the agency.

-Jessica Merrill ([email protected])