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 at: http://www.pmprb-cepmb.gc.ca/cmfiles/bia-may0738lvv-%E2%80%8B5282007-5906.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. https://doi.org/10.2165/%E2%80%8B00019053-200826060-00003
4. Guidelines for the economic evaluation of health technologies: Canada. Canadian Agency for Drug and Technology in Health (CADTH); 2017. Available at: https://www.cadth.ca/sites/default/files/pdf/guidelines_for_the_economic_evaluation_%E2%80%8Bof_health_technologies_canada_4th_ed.pdf
5. Foroutan N, Tarride J-E, Xie F, et al. A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions. ClinicoEcon Outcomes Res 2018;10:821–54. https://doi.org/10.2147/CEOR.S178825
6. Foroutan N. Proposals for updating the Canadian Patented Medicine Prices Review Board pharmaceutical budget impact analysis guidelines for new drug submissions to public and private payers. McMaster University, Hamilton, ON, Canada; 2019.
7. 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 2019;3:437–451. https://doi.org/10.1007/s41669-019-0139-y
8. Foroutan N, Levine M, Tarride J-E, et al. The methodological review of Budget Impact Analysis (BIA) models to update Canada’s pharmaceutical BIAs guidelines for new drug submissions to public and private payers. J Popul Ther Clin Pharmacol 2017;24(3):e51–78.
9. Foroutan N, Levine M, Tarride J-E, et al. Updating Canadian pharmaceutical budget impact analysis guidelines. Health Technology Assessment International (HTAi) annual meeting 2018; Vancouver International Journal of Technology Assessment in Health Care 2018. Available at: https://htai.org/wp-content/uploads/2018/08/AM18_Abstract-Book.pdf
10. Foroutan N, Mills F, editors. Proposed changes to Canada’s PMPRB budget impact analysis guide-lines for new drug submissions to public and private payers. Canadian Agency for Drug and Technologies in Health symposium 2018; Ottawa. Available at: https://www.cadth.ca/symposium2018/proposed-changes-canadas-pmprb-budget-impact-analysis-guidelines-new-drug-submissions
11. Foroutan N, Tarride J-E, Xie F, et al. Penultimate revised version of the Patented Medicine Prices Review Board (PMPRB) pharmaceutical budget impact analysis (BIA) guidelines. The Canadian Association for Population Therapeutics / Association Canadienne pour la Thérapeutique des Populations presents; Toronto: The Journal of Population Therapeutics and Clinical Pharmacology; 2019. p. e23. Available at: https://jptcp.com/index.php/jptcp/article/view/654/568
12. Foroutan N, Levine M, Tarride J-E, et al. Comparative analysis of stakeholder views on proposals for updating the Patented Medicine Prices Review Board (PMPRB) Budget Impact Analysis guidelines. The Canadian Association for Population Therapeutics/Association Canadienne pour la Thérapeutique des Populations presents; Toronto: The Journal of Population Therapeutics and Clinical Pharmacology; 2019. p. e14–34.
13. Rubin HJ, Rubin IS. Qualitative interviewing: the art of hearing data. Thousand Oaks, CA, USA: Sage; 2011.
14. Creswell JW. Qualitative inquiry and research design: choosing among five approaches (ed.). Thousand Oaks, CA, USA: Sage; 2007.
15. Thorne S. Interpretive description. Abingdon-on-Thames, UK: Routledge; 2016.
16. Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs 2008;62(1):107–15. https://doi.org/10.1111/j.1365-2648.2007.04569.x
17. Paulden M, O’Mahony J, McCabe C. Determinants of change in the cost-effectiveness threshold. Med Decis Making 2017;37(2):264–76. https://doi.org/10.1177/0272989X16662242
18. Guidance on budget impact analysis of health technologies in Ireland. Dublin, Ireland; 2015. Available at: https://www.hiqa.ie/system/files/Guidance_on_Budget_Impact_Analysis_of_Health_Technologies_in_Ireland.pdf
19. Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Comittee. 2016. Available at: https://pbac.pbs.gov.au/
20. Assessing resource impact process. National Institute for Health and Care Excellence (NICE); 2017 [updated May]. Available at: https://www.nice.org.uk/Media/Default/About/what-we-do/Into-practice/assessing-resource-impact-process-manual-ta-hst.pdf
21. Ferreira-Da-Silva AL, Ribeiro RA, Santos VC, et al. [Guidelines for budget impact analysis of health technologies in Brazil]. Cad Saude Publica 2012;28(7):1223–38. https://doi.org/10.1590/S0102-311X2012000700002
22. Neyt M, Cleemput I, Van De Sande S, et al. Belgian guidelines for budget impact analyses. Acta Clin Belg 2015;70(3):175–80. https://doi.org/10.1179/2295333714Y.0000000118
23. 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 Health 2014;17(1):5–14. https://doi.org/10.1016/j.jval.%E2%80%8B2013.08.2291
24. Foroutan N, Levine M, Tarride J-E, et al. PP51 updating Canadian pharmaceutical budget impact analysis guidelines. Int J Technol Assess Health Care 2018;34(S1):86. https://doi.org/10.1017/S0266462318002131
25. Pearson SD. The ICER value framework: integrating cost-effectiveness and affordability in the assessment of health care value. Value Health 2018;21(3):258–65. https://doi.org/10.1016/j.jval.%E2%80%8B2017.12.017
26. 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. Eur J Health Econ 2018;19:173–175. https://doi.org/10.1007/s10198-017-0933-3
27. Budget impact test England. NICE. Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/budget-impact-test
28. Ochalek J, Lomas J, Claxton K. Assessing health opportunity costs for the Canadian health care systems. 2018. Available at: http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/new_guidelines/Canada_report_2018-03-14_Final.pdf
29. Faleiros DR, Alvares J, Almeida AM, et al. Budget impact analysis of medicines: updated systematic review and implications. Expert Rev Pharmacoecon Outcomes Res 2016;16(2):257–66. https://doi.org/10.1586/14737167.2016.1159958
30. Mauskopf J, Earnshaw S. A Methodological review of US budget-impact models for new drugs. PharmacoEconomics 2016;34(11): 1111–31. https://doi.org/10.1007/s40273-016-0426-8