Stakeholder involvement in expensive drug recommendation decisions: an international perspective.
OBJECTIVE
To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees.


METHODS
We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives.


RESULTS
Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process.


CONCLUSIONS
A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process.
Department of Pediatrics, McMaster University, Canada. zahavars@gmail.com
Zahava R S
ZR
Rosenberg-Yunger
Halla
H
Thorsteinsdóttir
Abdallah S
AS
Daar
Douglas K
DK
Martin
D026683:Advisory Committees; D000911:Antibodies, Monoclonal / Q000191:economics; D001315:Australia; D001549:Benzamides; D002170:Canada; D003256:Community Participation; D003659:Decision Making, Organizational; D016527:Drug Costs; D004345:Drug Industry; D004739:England; D005380:Financing, Government / Q000458:organization & administration*; D043373:Follicle Stimulating Hormone, Human / Q000191:economics; D005962:Glucosylceramidase / Q000191:economics; D006801:Humans; D000068877:Imatinib Mesylate; D000069285:Infliximab; D007527:Isoenzymes / Q000191:economics; D007557:Israel; D010879:Piperazines / Q000191:economics; D055553:Prescription Drugs / Q000191:economics*; D011486:Protein C / Q000191:economics; D011743:Pyrimidines / Q000191:economics; D011994:Recombinant Proteins / Q000191:economics; D012051:Reimbursement Mechanisms / Q000191:economics / Q000458:organization & administration; D014481:United States; D014852:Wales; D000519:alpha-Galactosidase / Q000191:economics
D000911:Antibodies, Monoclonal; D001549:Benzamides; D043373:Follicle Stimulating Hormone, Human; D007527:Isoenzymes; D010879:Piperazines; D055553:Prescription Drugs; D011486:Protein C; D011743:Pyrimidines; D011994:Recombinant Proteins; D000068877:Imatinib Mesylate; D000069285:Infliximab; D000519:alpha-Galactosidase; D005962:Glucosylceramidase; C421124:drotrecogin alfa activated; C090568:imiglucerase; C459420:agalsidase beta