Main Article Content
Stakeholder analysis, Public drug plans, Private payers, Pharmaceutical industry, PMPRB budget impact analysis guidelines
Introduction: The present study aimed to obtain Canadian stakeholders’ feedback on a list of proposed recommendations for updating the Patented Medicine Prices Review Board (PMPRB)’s 2007 budget impact analysis (BIA) guidelines.
Methods: A mixed-methods study was designed to obtain feedback from two stakeholder perspectives- (public and private) payers and manufacturers- on the proposed BIA recommendations. We obtained policy-makers’ opinions through one-on-one interviews and collected feedback from manufacturers and their consultants using a survey. The interview guide and the survey were developed based on the list of recommendations related to BIA key elements, which were either not discussed or addressed differently in the PMPRB 2007 BIA guidelines. The list was derived from sixteen Canadian or other national and transnational BIA guidelines. A thematic analysis was applied for the analysis of the qualitative (interview) data.
Results: Thirty-five policymakers and manufacturers participated in the study. Stakeholders supported the inclusion 56% of proposed recommendations into the guidelines pertaining to the use of expert opinions, data extrapolated from the payers’ database, scenario analysis, and dynamic population. Inclusion of indirect costs and cost transfers from other jurisdictions were not approved. There was no consensus regarding the inclusion of patients’ adherence/compliance and cost offsets.
Conclusions: The present study has provided sufficient insights to enable the creation of a penultimate version for updating the PMPRB BIA guidelines. This penultimate version will be subject to a broader consultation among stakeholders prior to a final revision and approval. Further Canadian stakeholder feedback is required for reaching consensus on inconclusive recommendations.
2. Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada: Patented Medicine Prices Review Board; 2007 [Available from: http://www.pmprb-cepmb.gc.ca/cmfiles/bia-may0738lvv-5282007-5906.pdf.
3. Marshall DA, Douglas PR, Drummond MF, et al. Guidelines for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada. PharmacoEconomics. 2008;26(6):477-95.
4. Foroutan N, Levine M, Tarride J-E, et al. PP51 Updating Canadian Pharmaceutical Budget Impact Analysis Guidelines. International Journal of Technology Assessment in Health Care. 2019;34(S1):86-.
5. Foroutan N, Tarride JE, Xie F, et al. A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions. ClinicoEconomics and outcomes research : CEOR. 2018;10:821-54.
6. Guidelines for the Economic Evaluation of Health Technologies: Canada: Canadian Agency for Drug and Technology in Health (CADTH); 2017 [Available from: https://www.cadth.ca/sites/default/files/pdf/guidelines_for_the_economic_evaluation_of_health_technologies_canada_4th_ed.pdf.
7. Rubin HJ, Rubin IS. Qualitative interviewing: The art of hearing data: Sage; 2011.
8. Creswell JW. Qualitative inquiry and research design: Choosing among five approaches (ed.). US: Sage. 2007.
9. Foroutan N, Tarride J-E, Xie F, et al. A Comparison of Pharmaceutical Budget Impact Analysis (BIA) Recommendations Amongst the Canadian Patented Medicine Prices Review Board (PMPRB), Public and Private Payers. PharmacoEconomics - Open. 2019.
10. Thorne S. Interpretive description: Routledge; 2016.
11. Elo S, Kyngas H. The qualitative content analysis process. Journal of advanced nursing. 2008;62(1):107-15.
12. Paulden M, O'Mahony J, McCabe C. Determinants of Change in the Cost-effectiveness Threshold. Medical decision making : an international journal of the Society for Medical Decision Making. 2017;37(2):264-76.
13. Guidance on Budget Impact Analysis of Health Technologies in Ireland Dublin: Ireland; 2015 [Available from: https://www.hiqa.ie/system/files/Guidance_on_Budget_Impact_Analysis_of_Health_Technologies_in_Ireland.pdf.
14. Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Comittee 2016 [Available from: https://pbac.pbs.gov.au/.
15. Assessing resource impact process: National Institute for Health and Care Excellence (NICE) 2017 [updated May. Available from: https://www.nice.org.uk/Media/Default/About/what-we-do/Into-practice/assessing-resource-impact-process-manual-ta-hst.pdf.
16. Ferreira-Da-Silva AL, Ribeiro RA, Santos VC, et al. [Guidelines for budget impact analysis of health technologies in Brazil]. Cadernos de saude publica. 2012;28(7):1223-38.
17. Neyt M, Cleemput I, Van De Sande S, et al. Belgian guidelines for budget impact analyses. Acta Clinica Belgica: International Journal of Clinical and Laboratory Medicine. 2015;70(3):175-80.
18. Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis - Principles of good practice: Report of the ISPOR 2012 budget impact analysis good practice II task force. Value in Health. 2014;17(1):5-14.
19. Pearson SD. The ICER Value Framework: Integrating Cost Effectiveness and Affordability in the Assessment of Health Care Value. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2018;21(3):258-65.
20. Ghabri S, Mauskopf J. The use of budget impact analysis in the economic evaluation of new medicines in Australia, England, France and the United States: relationship to cost-effectiveness analysis and methodological challenges. The European Journal of Health Economics. 2017.
21. Budget impact test England: NICE; [Available from: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/budget-impact-test.
22. Ochalek J LJaCK. Assessing health opportunity costs for the Canadian health care systems 2018 [Available from: http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/new_guidelines/Canada_report_2018-03-14_Final.pdf.
23. Faleiros DR, Alvares J, Almeida AM, et al. Budget impact analysis of medicines: updated systematic review and implications. Expert review of pharmacoeconomics & outcomes research. 2016;16(2):257-66.
24. Mauskopf J, Earnshaw S. A Methodological Review of US Budget-Impact Models for New Drugs. PharmacoEconomics. 2016;34(11):1111-31.