AMPLE: Comparing Cost-Effectiveness of 2 Biologics for the Treatment of Rheumatoid Arthritis

VBCR - August 2013, Volume 2, No 4 - Health Economics

By Alice Goodman

Madrid, Spain—Abatacept (Orencia) and adalimumab (Humira) were similarly cost-effective for the treatment of adults with rheumatoid arthritis (RA) who had an inadequate response to methotrexate, according to a cost-effectiveness subanalysis of the AMPLE (Abatacept Versus Adalimumab Com­parison in Biologic Naive RA Subjects with Background Methotrexate) trial.

AMPLE is notable as the first randomized, controlled, head-to-head comparison of 2 biologics for the treatment of active RA despite methotrexate treatment. “AMPLE demonstrated the comparable efficacy and safety of subcutaneous abatacept and adalimumab, an anti-TNF [tumor necrosis factor] biologic, on background methotrexate at 12 months,” the investigators stated.

“The cost-effectiveness is comparable, based on measures of clinical efficacy and patient-reported outcomes,” said lead investigator Dinesh Khanna, MD, MS, MBBS, Division of Rheumatology, University of Michigan, Ann Arbor, who presented the poster at the 2013 annual meeting of the European League Against Rheumatism.

AMPLE included adult patients with RA for at least 5 years with moderate-to-high disease activity, defined as a 28-joint Disease Activity Score (DAS28) C-reactive protein of at least 3.2, despite treatment with methotrexate of at least 15 mg weekly. AMPLE is an ongoing trial of 24 months, duration. The primary end point was efficacy at 1 year.

Cost Comparisons
At year 1, the cost-efficacy ratio between the 2 agents for all American College of Rheumatology response rates was comparable for both treatments in US dollars and in Euros.

Other outcomes that were comparable for both treatments at 1 year included:

  • Cost per remission: abatacept, $63,282; adalimumab, $67,947
  • Cost per Health Assessment Questionnaire response: abatacept, $45,366; adalimumab, $49,947
  • Cost per day gained without ac­tivity limitation: abatacept, $323; adalimumab, $380.

 

These costs reflect the cost of the biologic therapy only, excluding any other direct or indirect costs, the investigators note.

Patients in the United States and in Germany were randomly assigned to self-administer subcutaneous abatacept 125 mg weekly (N = 318) or to adalimumab 40 mg biweekly (N = 328) with prefilled syringes. No loading dose was administered to patients in the abatacept arm of the study. During the study, patients also received stable doses of methotrexate, between ≤15 mg and ≥25 mg weekly, except for patients with documented intolerance to methotrexate, who received ≥7.5 mg weekly.

The annual cost of therapy was based on the approved net costs per unit dose of both drugs in the United States and in Germany multiplied by the frequency of administration per dose. The cost of methotrexate was not included in the calculation, based on the assumption that it was the same for both treatments.

The investigators caution that this study did not evaluate safety, which could affect the costs that were factored into the economic analysis.

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