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Novel drugs and adequate clinical decision making: a sometimes conflictive intersection. The case of the recombinant FSH in assisted reproductive technologies.

Larizgoitia I, Estrada D, Garcia-Altes A; International Society of Technology Assessment in Health Care. Meeting.

Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 2000; 16: 209.

Catalan Agency for Health Technology Assessment (CAHTA) Travessera de les Corts 131-159; Pavello Ave Maria, 08028 Barcelona, Spain.

Introduction: Recombinant FSH is a new drug for assisted reproductive techniques (ART), whose introduction highlights, once more, the conflict between consumers', professionals' and community interests in the absence of sufficient data. CAHTA has assessed for the first time the efficacy and efficiency of the recombinant FSH to provide EBM information to the Catalan health authorities regarding ART financing policies. Method: Systematic review of RCTs that compare the efficacy of recombinant FSH in ART with earlier urinary FSH preparations and context analysis (legal, ethical, market issues). Efficacy data was synthesised (sample-size-weighted mean) and efficiency parameters were calculated (cost-effectiveness ratios and incremental cost effectiveness ratios) using as unit-cost the sale price of FSH. Results: Recombinant FSH seems on average 20% more efficacious (5% difference on pregnancy rates) and 40% more expensive than urinary FSH. Cost-effectiveness data shows that recombinant FSH is 40% to 60% less cost-effective than urinary preparations. Estimations using the recombinant FSH incremental cost per pregnancy show that with the same budget slightly more pregnancies could be obtained with urinary FSH. Conclusions: While the efficacy of recombinant FSH seems higher than of urinary preparations, cost-effectiveness data does not support its use for publicly financed programs. Selective payment for certain types of women could be considered, but there is not enough information on most RCTs at subgroup level. However, the decision-making process is hindered by other factors, such as the low external validity of RCTs, ethical issues and commercial practices, by which the low cost urinary preparations are being retired from the market despite cost-effectiveness data. Efficacy and cost-effectiveness arguments are part of a conflictive debate in which individual and community viewpoints, ethical and social arguments, but also powerful commercial interests, are defining the rules for policy decision making. How can we assure the decision will be adequate? For whom?

Publication Types:
  • Meeting Abstracts
Keywords:
  • Cost-Benefit Analysis
  • Costs and Cost Analysis
  • Female
  • Follicle Stimulating Hormone
  • Humans
  • Pharmaceutical Preparations
  • Pregnancy
  • Pregnancy Rate
  • Reproductive Techniques, Assisted
  • economics
  • hsrmtgs
Other ID:
  • GWHSR0000204
UI: 102271878

From Meeting Abstracts




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