scholarly journals Can Standard Health Technology Assessment Approaches Help Guide the Price of Orphan Drugs in Canada? A Review of Submissions to the Canadian Agency for Drugs and Technologies in Health Common Drug Review

2020 ◽  
Vol Volume 12 ◽  
pp. 445-457
Author(s):  
Chakrapani Balijepalli ◽  
Lakshmi Gullapalli ◽  
Eric Druyts ◽  
Kevin Yan ◽  
Kamal Desai ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Orphan Drugs ◽  
Common Drug Review ◽  
Common Drug ◽  
Drug Review

What does meaningful look like? A qualitative study of patient engagement at the Pan-Canadian Oncology Drug Review: perspectives of reviewers and payers

2018 ◽  
Vol 23 (2) ◽  
pp. 72-79 ◽  
Author(s):  
Linda Rozmovits ◽  
Helen Mai ◽  
Alexandra Chambers ◽  
Kelvin Chan
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Patient Advocacy ◽  
Health Technology ◽  
Assessment Process ◽  
Advocacy Groups ◽  
Oncology Drug ◽  
Patient Advocacy Groups ◽  
Drug Review

Objectives While there is wide support for patient engagement in health technology assessment, determining what constitutes meaningful (as opposed to tokenistic) engagement is complex. This paper explores reviewer and payer perceptions of what constitutes meaningful patient engagement in the Pan-Canadian Oncology Drug Review process. Methods Qualitative interview study comprising 24 semi-structured telephone interviews. A qualitative descriptive approach, employing the technique of constant comparison, was used to produce a thematic analysis. Results Submissions from patient advocacy groups were seen as meaningful when they provided information unavailable from other sources. This included information not collected in clinical trials, information relevant to clinical trade-offs and information about aspects of lived experience such as geographic differences and patient and carer priorities. In contrast, patient submissions that relied on emotional appeals or lacked transparency about their own methods were seen as detracting from the meaningfulness of patient engagement by conflating health technology assessment with other functions of patient advocacy groups such as fundraising or public awareness campaigns, and by failing to provide credible information relevant to deliberations. Conclusions This study suggests that misalignment of stakeholder expectations remains an issue even for a well-regarded health technology assessment process that has promoted patient engagement since its inception. Support for the technical capacity of patient groups to participate in health technology assessment is necessary but not sufficient to address this issue fully. There is a fundamental tension between the evidence-based nature of health technology assessment and the experientially oriented culture of patient advocacy. Divergent notions of what constitutes evidence and how it should be used must also be addressed.

scholarly journals SCIENTIFIC AND SOCIAL VALUE JUDGMENTS FOR ORPHAN DRUGS IN HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (4) ◽  
pp. 218-232 ◽  
Author(s):  
Elena Nicod ◽  
Panos Kanavos
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Orphan Drugs ◽  
Social Value ◽  
European Medicines Agency ◽  
Final Decision ◽  
Value Judgments ◽  
Accountability For Reasonableness ◽  
The Impact

Objectives: We explore how broader aspects of a treatment's value and the impact of the condition on patients not captured by routine health technology assessment (HTA) methods using clinical and economic evidence, defined as “other considerations,” may influence HTA processes in different settings.Methods: Countries included were England, Scotland, Sweden, and France. Data sources were the publicly available reports on HTA recommendations. Ten drugs with European Medicines Agency orphan designation and appraised in England were selected. Qualitative thematic analysis was used to systematically identify and code all “other considerations” based on a previously developed methodological framework, which also coded whether it was provided by stakeholders, and how it influenced the decision.Results: A classification framework of scientific and social value judgments was developed and used throughout the study. A total of 125 “other considerations” were identified and grouped into ten subcategories based on the information provided. Eighteen to 100 percent of these, depending on the agency, were put forward as one of the main reasons for the final decision potentially contributing to accepting a higher incremental cost-effectiveness ratio or uncertain evidence. Some of these were nonquantified or nonelicited and pertained to the assessor's judgment. A taxonomy of these value judgments was created to be used in future cases. Results also contributed to better defining the determinants of social value and improving accountability for reasonableness.Conclusions: The systematic identification of the scientific and social value judgments enables to better understanding the dimensions of value, which can be used to improve their transparency and consistent use across decisions and settings.

INTEGRATING HEALTH TECHNOLOGY ASSESSMENT PRINCIPLES IN FORMULARY MANAGEMENT

2016 ◽  
Vol 32 (1-2) ◽  
pp. 81-87 ◽  
Author(s):  
Monica Teng ◽  
Ai Leng Khoo ◽  
Ying Jiao Zhao ◽  
Liang Lin ◽  
Boon Peng Lim
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Pharmacoeconomic Evaluation ◽  
Management Program ◽  
Project Team ◽  
Public Healthcare ◽  
Formulary Management ◽  
Drug Review

Objectives: Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore.Methods: A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary.Results: Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists’ proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management.Conclusions: Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

scholarly journals ACTIVITIES OF THE PAN-CANADIAN PHARMACEUTICAL ALLIANCE: AN OBSERVATIONAL ANALYSIS

2018 ◽  
Vol 25 (2) ◽  
pp. e12-e22
Author(s):  
Angela Rocchi ◽  
Fergal Mills
Keyword(s):  
Health Technology ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Effectiveness Ratio ◽  
Common Drug Review ◽  
Common Drug ◽  
The Common ◽  
Time Required ◽  
Drug Review ◽  
Public Drug

Background The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada’s centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. Objective To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization. Methods The analysis was based on the archive of drugs handled through the pCPA, as posted on its website. The period of observation was from inception to August 31, 2017. HTA recommendations were sourced from the websites of the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review. Descriptive and statistical analyses were conducted. Results The dataset contained 206 drug-indication pairings. There was close but imperfect alignment between HTA agency recommendations and the pCPA’s decisions to negotiate; deviations occurred only with CDR-reviewed drugs. The median incremental cost-effectiveness ratio of negotiated drugs was $168K/QALY for oncology drugs, but $70K/QALY for non-oncology drugs. The time to initiate negotiations was dramatically shorter for oncology versus non-oncology drugs (mean 54 versus 263 days) and also differed between therapeutic areas at CDR. The time required for PCPA activity was surprisingly similar for drugs recommended without a price condition and for those conditional on a price reduction.

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