NICE OKs dabigatran after cost-effectiveness data review

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The U.K. National Institute for Health and Clinical Excellence (NICE) has recommended dabigatran (Pradaxa, Boehringer Ingelheim) for approval for the indication of preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The approval comes after the institute reviewed cost-effectiveness data of the drug.

Previously, NICE had asked Boehringer to provide further materials and clarification on dabigatran’s cost-effectiveness. The new cost-effectiveness data compared costs and outcomes of dabigatran with other treatments including warfarin, aspirin and dual-antiplatelet therapy (aspirin plus clopidogrel).

The company presented two models: a single-dose model (patients received either 110 mg twice daily or 150 mg twice daily) and a sequential regimen model (patient cohort was divided by age and modeled separately). These models included patients younger than 80 years who began dabigatran 150 mg twice daily treatment and were switched to dabigatran 110 mg twice daily when the age of 80 was reached.

Within the analysis, Boehringer said that INR costs were £241.54 (U.S. $386.76). The incremental cost-effectiveness ratios (ICERs) were reported to be £14,518 (U.S. $23,253) per quality-adjusted life year (QALY) gained for the dabigatran sequential regimen in people starting treatment when younger than 80 years and £18,269 (U.S. $29,260) per QALY gained for the sequential regimen in people starting treatment at 80 years and older compared with warfarin.

NICE also asked the company to provide results that more closely depicted the AF patient population in the U.K. When the company included more data, ICERs increased to £17,373 (U.S. $27,818) and £19,680 (U.S. $31,512) per QALY gained for the dabigatran sequential regimen in people starting treatment when younger than 80 years and at 80 years and older respectively, compared with warfarin.

The institute concluded that the “most plausible” ICERs for the entire patient population eligible for dabigatran “were within the range normally considered a cost-effective use of NHS [National Health Service] resources, being less than £20,000 (U.S. $32,023) per QALY gained.

“The committee concluded that evidence for stratifying by INR control was insufficient to exclude the minority of people with very good control from the recommendation of dabigatran as a potential treatment option, and that the ICER for the whole population should be the basis of the recommendation.”

Based on the results of the RE-LY trial, FDA approved dabigatran 150 mg and 75 mg doses for use in the U.S.