Abstract (#32) is accessible at http://www.jptcp.com/articles/patient-engagement-and-outcomestaking-it-to-the-next-level--abstracts.pdf CAPT 2017- poster presentation- Toronto-Canada

1. 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
Naghmeh Foroutan 1,2, Jean-Eric Tarride 1, 2, Feng Xie1, 2, Mitchell Levine 1,2
1Programs for Assessment of Technology in Health, Research Institute of St. Joe’s Hamilton, Hamilton, ON; 2Department of Health Research Methods, Evidence and Impact,
McMaster University, Hamilton, ON
BAC KG RO U N D
Budget or resource impact analyses (BIAs) estimate the financial
consequences of adoption and diffusion of a new health intervention or
implementing evidence-based guidelines within a specific healthcare setting
or system context in the short to medium term.
 Objectives: The present study aims to systematically review BIA guidance
documents, comparing the model structure and data input key elements of
recently updated guidelines with the present PMPRB guidelines, to provide
a list of international recommendations which are missing in the current
guidelines and likely to be applicable in Canada.
M E T H O D S
A systematic search of literature was undertaken to identify guidance
documents published from 1947 to 14th of August 2017. The following
bibliographic databases were searched through the Ovid interface: Medline,
EMBASE, Cochrane, EconLit, CINAHL, Business source, Ovid Healthstar and
the grey literature.
 Inclusion criteria: The titles and abstracts identified to find articles
reporting practical and methodological frameworks, models, or tools for
conducting BIAs for adding new drugs to the formularies or reimbursement
decisions, in the English language.
Updated BIAs guidelines from 2007 to 2017 [1-11]
R E S U LT S ( C O N T ’ D )
A sample of items included in international and provincial recommendations
Search results: PRISMA flowchart
Records identified through database
searching (n =4,928)
Records after duplicates removed
(n = 2,888)
Records excluded not meeting
inclusion criteria (n =2,833)
Articles passed full-text screening
eligibility (n = 55)
Full-text articles excluded, with
reasons (n = 44)
Articles included in the final review
(n =11)
Records passed title & abstract
screening (n = 55)
Records identified from the grey
literature (n =22)
2007 2009 2011 2013 2015 2017 2019
Canada`s updated guideline
Canada PMPRB guidelines
ISPOR
Alberta
Belgium
Ireland
Australia
Poland
Ontario
Manitoba
United Kingdom (UK)
Quebec
2018
2008
2014
2014
2015
2015
2016
2016
2016
2016
2017
2017
R E S U LT S ( C O N T ’ D )
Australia UK Belgium Ireland Poland ISPOR Ontario Alberta Manitoba Quebec
Co-payment yes yes
Population Size and Characteristics
Degree of implementation (full replacement
or partial substitution of existing technologies
or shifts in target population, market growth
or expansion)
yes yes yes yes yes yes Yes yes yes
Open population yes yes yes yes
Subgroups yes yes yes yes
Off-label yes yes
Costs and outcomes
Show actual costs and savings yes yes yes
Show tangible savings in actual practice if
applicable
yes yes yes
Training or introduction cost if applicable yes yes yes yes
Direct non-healthcare related costs (e.g.
transport) or indirect non-healthcare related
costs (e.g. productivity costs or costs for
unpaid caregivers)
yes maybe
Transfers of budgets between different
governments (Federal/territorial/provincial)
yes maybe
Opportunity Cost yes yes
Scope of cost (Capital cost, labor cost,
technology cost)
yes yes yes
Time horizon (years) 6 5 3 5 2 1- 5 3 4 5 3
Presenting results
Total and incremental impact on the budget yes yes yes yes yes yes yes
Consumption of resources and the outlays yes yes yes
Aggregated and disaggregated Results in each
year of the time horizon
Yes yes yes yes
Estimated financial implications for other
health sectors
yes
Impact of uncertainty (quantify how precise
are the results)
yes yes yes
Post marketing surveillance study yes
Resource impact statements yes
Quality assurance and publication yes
Other important change proposals Australia UK Belgium Ireland Poland ISPOR Ontario Alberta Manitoba Quebec
Budget impact threshold (Cap) yes
Rare disease yes
Technology appraisal fast rack yes
Handling Data input uncertainty
Scenario analysis yes yes yes
Risk sharing yes
D I S C U S S I O N A N D C O N C LU S I O N
 The present literature review is the initial step of updating Canada`s PMPRB
budget impact analysis (BIA) guidelines published in 2007- 2008.
 Eleven guidelines (including Canada`s provincial templates) were reviewed in
detail and new recommendations for BIA analytic framework, data input and
handling uncertainty key elements were abstracted. In total, almost 80
recommendations were recognised.
 The next step is a qualitative study with a questionnaire regarding new
proposed recommendations and open-ended questions asking stakeholders
about current challenges and gaps in using and conducting BIA reports in
Canada.
R E S U LT S