Proposals for Updating the PMPRB BIA Guidelines-PhD thesis results presentation Aug 8 2019-update

A Proposal for Updating the Canadian
Patented Medicine Prices Review Board
Pharmaceutical Budget Impact Analysis
Guidelines for New Drug Submissions to
Public and Private Payers
A Dissertation Presented in Partial Fulfillment of the Requirements for the Degree
Doctor of Philosophy
Presenter: Naghmeh Foroutan, PhD candidate

Outline
1. Introduction
2. Research method
3. Findings
4. Conclusions (proposals)
5. Important contributions
6. Limitations
7. Future research
5/10/2020 Naghmeh Foroutan- PhD Thesis Defense Presentation 2
Proposal (Chapter #5)
Stakeholder analysis (Chapter #4)
Interviews Online Survey
Systematic literature reviews (Chapters# 2&3)
National and transnational guidelines Canadian guidelines
Introduction (Chapter#1)

Chapter#1: Introduction
Why BIA is important?
𝑩𝑰 = 𝑻𝒓𝒆𝒂𝒕𝒎𝒆𝒏𝒕 𝒄𝒐𝒔𝒕 𝒑𝒆𝒓 𝒑𝒂𝒕𝒊𝒆𝒏𝐭 × 𝑻𝒂𝒓𝒈𝒆𝒕 𝑷𝒐𝒑𝒖𝒍𝒂𝒕𝒊𝒐𝒏 (market size)
• Is a value-based price affordable?
Problem statement
• The PMPRB 2007 BIA Guidelines are outdated and might not have
kept pace with the evolution of BIA guidelines over the past decade.
o Some OECD countries (e.g., Australia, France and the United Kingdom) and transnational organizations (e.g., ISPOR*)
and Canadian Federal, provincial and territorial (F/P/T) drug plans have updated their requirements for BIA reports
since 2007.
*International Society For Pharmacoeconomics Outcomes Research

Introduction (Cont.)
Objective
The main objective of this thesis was to provide a proposal for
updating the Patented Medicine Prices Review Board (PMPRB)
2007 pharmaceutical budget impact analysis (BIA) guidelines in
accordance with the best national and transnational practices in
BIA methodology and Canadian stakeholder feedback.

Introduction (Cont.)
 Research questions
1. What are the national and transnational pharmaceutical BIA
guidelines published since 2007?
2. What Canadian Federal, provincial and territorial (F/P/T) BIA
guidelines have been published/updated since 2007?
3. What are the discordance between the PMPRB 2007 BIA
guidelines recommendations and either Canadian F/P/T or
outside of Canada BIA guidelines?
4. What should be included in a proposal for updating the 2007
PMPRB BIA guidelines based upon Canadian stakeholders’
feedback on an expanded list of recommendations?

Research Method and Design
1. Systematic literature reviews
2. Stakeholder analysis (mixed methods study)

Chapter 2
Publication#1
 Data sources: MEDLINE,
EMBASE, Cochrane, EconLit,
CINAHL, Business Source Premier,
and HealthSTAR and the grey
literature
 Inclusion criteria: BIA guidelines
published since 1998 by different
countries or international
organizations (e.g., ISPOR)
 Data abstraction: BIA key
elements were categorized into
three groups: analytic model
structure, input and data sources,
and the reporting format. In each
category, we defined primary and
secondary elements.
Reference: Foroutan, N., et al., A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new
drug submissions. Clinicoecon Outcomes Res, 2018. 10: p. 821-854.

Chapter 3
Publication#2
 Data sources: websites of the
CADTH, pCPA, Canadian F/P/T
drug plans and private payers
 Inclusion criteria: BIA
guidelines, BIA guidance
documents or (Excel-based)
templates for new drug
submissions
 Data abstraction: an Excel-
based data abstraction form—
which was developed in the
previous systematic review— was
used for data abstraction and
highlighting discordance between
the guidelines.
Reference: Foroutan, N., 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.

Chapter 4
(Manuscript#3)
 Participants: Policy-makers,
industry experts and CROs
 Data sources: Semi-structured
one-on-one online/phone
interviews and an online survey
 Data collection tools: an
interview guide and a
SurveyMonkey (developed based
on the discordance between the
PMPRB 2007 and other reviewed
BIA guidelines)
 Data analysis: quantitative and
qualitative (deductive thematic)
analysis
References: Foroutan N, Tarride JE, Xie F, et al. Stakeholders' feedback on the proposed recommendations for updating the patented medicine
prices review board (PMPRB) budget impact analysis guidelines. J Popul Ther Clin Pharmacol, 2020. 27(1): p. e1-e24. Available at
https://www.ncbi.nlm.nih.gov/pubmed/31922700

Research Findings
1. Systematic literature reviews
2. Stakeholder analysis (mixed methods study)

Chapters# 2 & 3: Literature Review Findings
National & Transnational
guidelines
Year Organization
Ireland 2018 The Health Information and Quality Authority (the authority)
France 2017 French National Authority for Health (HAS)
United Kingdom (UK) 2017 National Institute for Health and Care Excellence (NICE)
Australia 2016 Pharmaceutical Benefits Advisory Committee (PBAC)
Poland 2016 The Agency for Health Technology Assessment and Tariff System (AOTMiT)
Belgium 2015 Belgian Health Care Knowledge Centre (KCE)
ISPOR 2014 International Society for Pharmacoeconomics and Outcomes Research
Brazil 2012 Ministry of Health (CONITEC)
Canada (PMPRB) 2007 Patented Medicine Prices Review Board (PMPRB)
Canadian F/P/T Guidelines Year Organization
Quebec 2018 Prescription Drug Insurance
Medavie Blue Cross 2018 Private payer
CADTH 2018 pan-Canadian Oncology Drug Review
Alberta 2018 Prescription Drug Programs
Manitoba 2017 Drug Benefits and Interchangeability Formulary
Ontario 2016 Prescription Drug Program
British Columbia 2007 Pharmacare

Chapters# 2 & 3
Literature Review Findings (Cont.)
In total 74 recommendations were initially abstracted from 16
guidelines.
As a result of a comparative analysis between the PMPRB 2007 and
other BIA guidelines, 52% of the pooled recommendations (from 16
guidelines) were not included or discussed differently in the PMPRB
2007 BIA guidelines.
Discordance Table

A snapshot of the Discordance Table between the PMPRB 2007 and rest
of the reviewed BIA guidelines
# BIA secondary elements Canada PMPRB (2007)
Perspective
1
In the case of co-payment, the inclusion of the patient’s perspective is
complementary to the base-case analysis
Not discussed
Technology
2
The technology should be described in sufficient detail to differentiate it from its
comparators and to provide context for the study.
Not discussed
Target population
3 Open (dynamic) population Not discussed
4 Subgroups in the target population assessment are recommended. Not discussed
5
Catch-up effect which applies to the chronic conditions for patients who switch to
the new drug
Not discussed
6 Unit of analysis (per patient or episode) Discussed differently
7
Off-label indications in the target population assessment (base-case analysis) are
recommended.
Discussed and only included in the
sensitivity analysis
8
The degree of implementation of the new intervention (substitution, combination,
and expansion)
Not discussed

Chapter#4
Stakeholder analysis: Qualitative analysis
Eight policymakers participated in the
interviews.
Four themes were identified:
1. BIA usage in drug reimbursement decisions and price
adjustments in Canada,
2. BIA usage in disinvestment decisions,
3. Linking incremental cost-effectiveness ratio (ICER) and BIA
(affordability), and
4. BIA key elements (e.g., time horizon) including additional
recommendations for improving the guidelines.

Chapter#4
Stakeholder analysis: Quantitative data analysis
(n=36)
Obtained from 9 policymakers and 27 industry expert/consultants
We found support for inclusion of 56% of the proposed
recommendations (from the Discordance List) into an updated version
of the PMPRB BIA guidelines.
30% were not supported by stakeholders (e.g., indirect costs).
Some recommendations (14%) will need further input from public and
private payers before being included in the proposal (e.g., inclusion of
cost offsets).
For the items where we were able to obtain common data, there was
general agreement between two groups.

Quantitative analysis: survey results (n=36)
-100% -80% -60% -40% -20% 0% 20% 40% 60% 80% 100%
In the case of co-payment, inclusion of a patient’s perspective is recommended
The time horizon (TH) may vary from 2 to 6 years. The Canadian BIA guidelines have adopt 3 years
Open or dynamic populations should be used in the target population assessment
Subpopulation analysis should be conducted
Off-label indications should be included in the base-case analysis
Training or introduction cost should be included in the BIA
Transportation, productivity and caregiver related costs should be included in the BIA
Opportunity cost estimation in BIAs should be provided by the manufacturers
An appropriate rate of tax (e.g. HST) should be applied to the applicable costs
Cost transfer from other jurisdictions should be included in the BIA
The total and incremental impact on the budget should be included in the BIA
Least Cost Alternative (LCA) price for relevant drug comparators should be used in the BIA
The effects of inflation should NOT be included in the BIA
Discounting should NOT be included in the BIA
Aggregated and disaggregated budget impact results should be reported for each year
There should be reporting of the gross and net impact on the budget
Outcomes should be presented separately for different payers
Outcomes should be presented in natural units (e.g. number of unpaid working days)
Outcomes should be presented in monetary units
There should be a schematic representation of the uncertainty analysis
The impact of uncertainty (quantifying the precision of the results) should be presented in the BIA
Data from manufacturer can be considered as a reliable source of data
Expert opinions can be considered as a reliable source of data
Extrapolating data from similar drug experience can be considered as a reliable source of data
A BIA should use scenario analysis for dealing with uncertainty
A BIA should use deterministic sensitivity analysis for dealing with uncertainty
A BIA should use probabilistic sensitivity analysis for dealing with uncertainty
A BIA should include a proposed risk sharing agreement for dealing with uncertainty
A longer introduction phase should be used with early BIAs to address issues of uncertainty
Do you agree with including the treatment switch in BIAs?
Do you agree with including patient adherence in BIAs?
Do you agree to capture changes in the rate of mortality and disease progression?
Do you agree with including cost of adverse events, clinical outcomes and disease complications?
Do you agree with the fact that a BIA guidelines should provide a list of acceptable databases?
Do you agree with considering a cap or threshold for budget impact?
Do you agree to build in a reassessment process of BIAs in a future real-world?
-52% 41%
Note: Gold refers to” policy-makers” and “Blue bars” represent Manufactures/consultants
25% 25%

A Proposal for Recommendations to be
Included in an Updated PMPRB BIA
guideline
Chapter 5: Conclusions

Chapter 5: Proposal
The proposal consists of 72 recommendations:
• 49% (n=35) are identical with the PMPRB 2007 BIA guidelines
oe.g., inclusion of off-label indications in the sensitivity analysis,
considering market/clinical data from other jurisdictions and expert
opinions as acceptable sources of data and not including cost offsets and
indirect costs
• 36% (n=26) are new
oe.g., catch-up effect, dynamic population, scenario analysis and reporting
gross and net impact
• 15% (n=11) are modified
oe.g., time horizon, health care resource utilization and modelling

NEW Recommendations (n=26)
NEW recommendations in the proposal
Recommended
by Stakeholders
o The technology should be described in sufficient detail to differentiate it from its comparators and to
provide context for the study
n/a
o Open or dynamic populations should be used in the target population assessment Yes
o Rate of mortality and disease progression should be considered in BIA Yes
o Subpopulation analyses are to be included with the base-case analysis Yes
o The degree of implementation is essential in market size estimation n/a
o Treatment switch should be considered in BIAs (catch-up effect) Yes
o Patient adherence/compliance may be included in BIAs Maybe
o In the situation where a drug’s indications are evolving, this issue has to be addressed in the BIA Yes
o “Treatment mix” rather than “strategy-based treatment” should be the terminology for defining
concomitant medications of comparators
n/a
o Least Cost Alternative (LCA) price for relevant drug comparators should be used in the BIA Yes
o Drugs which require reconstitution or dose preparation, the method of dose preparation, stability and
specifics around potential drug wastage should be mentioned.
n/a
o Cost of supplies to the manufacturer and the payer and any cost of companion diagnostic test or medical
device should be reported
n/a
o Markov models are not recommended; however, it is advised that the disease condition should be
modeled as much as possible to capture the long-term consequence
Yes

NEW recommendations in the proposal
Recommended
by Stakeholders
o Model validity has to be checked and documented. n/a
o Describe the direction and magnitude of the impact of uncertainty on the overall estimates. Yes
o Scenario analyses should be undertaken by changing selected input parameter values and structural
assumptions to produce plausible alternative scenarios.
Yes
o A reassessment process of BIAs in a future real-world should be considered Yes
o Extrapolating data from similar drug experience can be considered as a reliable source of data Yes
o BIA guidelines may provide a list of acceptable databases Maybe
o Original cost survey, obtaining primary data, by sampling, involving interviews with health professionals
under study could be an option for obtaining required data.
n/a
o Cost outcomes should be presented separately for different payers Yes
o Cost outcomes should be presented in monetary units Yes
o The total and incremental impact on the budget may be included in the BIA Maybe
o Aggregated and disaggregated budget impact results should be reported for each year Yes
o There should be reporting of the gross and net impact on the budget Yes
o A cap or threshold for budget impact should be considered Yes
NEW Recommendations (n=26) (Cont.)

Modified Recommendations (n=11)
Modified recommendations in the proposal
Recommended by
stakeholders
o A 3-year time horizon with some degree of flexibility is recommended Maybe
o Either a top-down (epidemiological) or a bottom-up (market-share or claims-based analyses) approach is
recommended
n/a
o The choice of comparators in BIA should be an accurate reflection of the existing therapeutic options for the
condition(s) of interest and preferably be consistent with the health economic evaluation
n/a
o The BIA should identify all medicines likely to be affected by the new drug (treatment mix) n/a
o Cost offsets should be excluded unless there are substantial costs related to the resource utilization and are directly
required by drug plans
Maybe
o In the case of medications where recommended duration of use is less than 30 days (e.g., antibiotics), this should be
specified and the cost calculated accordingly.
n/a
o The BIA should clearly state which unit of analysis is adopted in measuring the outcomes (e.g., per patient or
episode of care, therapeutic equivalences)
n/a
o Robust methods for sensitivity analysis are required to adequately address the issue of uncertainty. n/a
o Provide deterministic sensitivity analysis (DSA) (i.e., one-way, multi-way and analysis of extremes) to inform
decision-makers of the sensitivity of the model to specific assumptions
n/a
o There should be a schematic representation of the uncertainty analysis Yes
o BIA calculations and formula n/a

Limitations
There was a limited sample size for
interviews providing the qualitative data.
•In order to make any meaningful comparison
between the opinions of public and private payers’
(subgroup analysis) we would have required
substantially larger numbers.
Only 6 out of 15 organizations have
published their BIA requirements for
drug submissions on their websites.
For private payers, very limited
information was available online.
In the literature review we only included
BIA guidelines from jurisdictions which
had adapted the guidelines.

Important Contribution
The first systematic review of national and transnational BIA guidelines which can be
of use to any country interested in building or updating their BIA guideline.
A Canadian perspective of BIA guidelines, acknowledging
differences across provinces as well as the private payers.
The final contribution from this thesis is the presentation of a proposal
for updating the PMPRB BIA guidelines.

Future Research
Further Canadian stakeholder
feedback is required for
reaching consensus on
inconclusive recommendations
Develop a list of reliable and
available databases for
decreasing data uncertainty
We suggest further research for
a review of the terminology
used in the BIA literature
internationally

Thank You!
Q & A

Multiple-criteria decision-making (MCDM)
Multiple-criteria decision-making (MCDM) or multiple-
criteria decision analysis (MCDA) is a sub-discipline of
operations research that explicitly evaluates multiple
conflicting criteria in decision making (both in daily life
and in settings such as business, government and
medicine).
MCDA methods are widely used in other sectors, and
recently there has been an increase in health care
applications. In 2014, ISPOR established an MCDA
Emerging Good Practices Task Force.

References for MCDA
1. Thokala, P., et al., Multiple Criteria Decision Analysis for Health Care
Decision Making--An Introduction: Report 1 of the ISPOR MCDA Emerging
Good Practices Task Force. Value Health, 2016. 19(1): p. 1-13.
2. Marsh, K., et al., Multiple Criteria Decision Analysis for Health Care Decision
Making--Emerging Good Practices: Report 2 of the ISPOR MCDA Emerging
Good Practices Task Force. Value Health, 2016. 19(2): p. 125-37.
3. Angelis, A. and P. Kanavos, Multiple Criteria Decision Analysis (MCDA) for
evaluating new medicines in Health Technology Assessment and beyond:
The Advance Value Framework. Soc Sci Med, 2017. 188: p. 137-156.

Value framework: model-building process using MCDA
(Example)
Systematic literature
review
Stakeholder analysis
28
Source: Angelis, A. and P. Kanavos, Multiple Criteria Decision
Analysis (MCDA) for evaluating new medicines in Health Technology
Assessment and beyond: The Advance Value Framework. Soc Sci
Med, 2017. 188: p. 137-156.
5/10/2020 Naghmeh Foroutan- PhD Thesis Defense Presentation

PMPRB BIA 2007 Excel-based software

Deductive vs. Inductive qualitative
analysis
The process may be based on prior categories (Pre-
figured or ‘objective’), or on categories that become
clear to the researcher only as the analysis proceeds
(Emergent or intuitive). The later is more highlighted in
the grounded theory.
Grounded theory is a research methodology which
operates inductively, in contrast to the hypothetico-
deductive approach. A study using grounded theory is
likely to begin with a question, or even just with the
collection of qualitative data.
Reference: Vaismoradi, M. , Turunen, H. and Bondas, T. (2013), Qualitative descriptive study.
Nurs Health Sci, 15: 398-405. doi:10.1111/nhs.12048

Recommendations were not supported by stakeholders
(n=11)
 In the case of co-payment, inclusion of a patient’s perspective is recommended
 Off-label indications should be included in the base-case analysis
 Training or introduction cost should be included in the BIA
 Transportation, productivity and caregiver related costs should be included in the BIA
 Opportunity cost estimation in BIAs should be provided by the manufacturers
 An appropriate rate of tax (e.g. HST) should be applied to the applicable costs
 Cost transfer from other jurisdictions are acceptable in the BIA
 Outcomes should be presented in natural units (e.g. number of unpaid working days)
 A BIA should use probabilistic sensitivity analysis for dealing with uncertainty
 A BIA should include a proposed risk sharing agreement for dealing with uncertainty
 A longer introduction phase should be used with early BIAs to address issues of
uncertainty

Interview guide-ver. 1 (part 1): Open-Ended Questions
# Question
1 In general, how useful are the BIA reports for new drug reimbursement decisions and price adjustments?
2 Do you think BIA can help in disinvestment decisions? How?
3 Do you think it would be more helpful for decision-making to link CEA and BIA together than keeping BIA separately? Why?
4 Do you think BIA should take into account the complexity of the disease/ condition under study or of the treatment (e.g., acute plus
chronic treatments)? Do you prefer to do it through more complex modeling techniques (e.g., Markov models) or sensitivity analysis?
5 What is your opinion about increasing the time horizon to more than 3 years (e.g., 6 years)?
6 Do you think one could require the pharmaceutical company to calculate the opportunity cost of paying for new technology in your
province? How practical it is?
7 If applies on you, could you briefly explain the generic versus brand drug pricing or price negotiation process in your province? What
happens after PCPA negotiation?
8 If applicable, do you use Least Cost Alternative (LCA) price for relevant drug comparators in your province?
9 Have you ever used or reviewed PMPRB BIA guidelines? Do you believe that there is a need for an update to the PMPRB BIA guidelines?
10 In your view, what are the most important methodological gaps and challenges in the provincial BIA reports for new drug submissions?

Interview guide (part 2): Closed Questions (survey)
We used Likert-type ordinal scales to rate the responses ranging from
1 to 5 (were: 1 = “strongly disagree,” and 5 = “strongly agree”) with a
middle neutral category (3 = “neither agree nor disagree”).
14 questions were included in the survey (pg. 163)
Strongly
disagree
Disagree Neither agree
nor disagree
Agree Strongly
agree
1 2 3 4 5

Codebook
Parent Node Child Node/
Grand-Child Node(s)/ Great-Grand-Child Node(s)
Node Description
Perceptions on
the usage of BIA
in policy-making
Refers to descriptions and reflections by the research participant that speaks to the usage of BIAs in drug pricing and reimbursement decisions
Yes, BIA could be useful in drug reimbursement decisions
and price adjustments
Participant describes that BIA can be useful in policy-making, drug coverage, price
negotiation, and drug budget prioritization.
NO, I do not find it very helpful in real-world drug pricing
and reimbursement decisions
Participant describes that BIAs are not useful in drug pricing and reimbursement
decisions
Maybe… I’m not sure/I do not have a strong idea about it Participant describes that she/he does not use BIA at their organization on a regular basis
so that he/she does not have a strong idea about it
Refers to descriptions and reflections by the research participant that explains the usage of BIA in disinvestment decisions and estimation of the opportunity cost for
the payer
Yes, BIA could be useful in disinvestment decisions Participant describes that BIA can be useful in disinvestment (delisting) decisions
Theoretically, yes, but… Participant describes that BIAs are theoretically useful for disinvestment decisions, but
describes apprehension or concerns
No, BIA is not useful/necessary for disinvestment decisions Participant describes that BIA is not relevant to disinvestment decisions
Yes, opportunity cost could/should be calculated in BIAs Participant describes that it is realistic to ask manufacturers to calculate opportunity cost
in BIAs.
Theoretically, yes, but… Participant describes that the calculation of opportunity cost is theoretically useful for
BIA, but describes apprehension or concerns or is unsure how it would work
No, opportunity cost cannot be estimated by
manufacturers
Participant describes that opportunity cost in BIAs is not relevant to manufacturers.
Refers to descriptions and reflections by the research participant that speaks about linking cost-effectiveness analysis (CEA) results and BIA
Yes, could be helpful Participant believes that linking cost-effectiveness analysis (CEA) and BIA together would
be more helpful
No, the current (separate) system is ok Participant believes that there is no value in linking cost-effectiveness analysis (CEA) and
BIA together for decision-making and keeping them separate (as it is) is fine
Why? Participant explains their reasons for recommending linking (or not linking) the CEA and
BIA results in decision-making

Coding process

BIA schematic: Epidemiologic or Top-down approach

BIA schematic: Claim-based or Bottom-up approach

Canadian F/P/T organizations for new drug submissions
# Federal, Provincial and Territorial Public drug
benefit programs
Review BIA for
new drug
submissions*
Template or guidelines
1 Alberta (Prescription Drug Programs) Yes Budget Impact Assessment for the Alberta Drug Benefit List (Version 9,
updated: May 2018) [11]
2 British Columbia (Pharmacare) Yes PMPRB BIA Guidelines (2007) [7]
3 Manitoba (Drug Benefits and Interchangeability
Formulary)
Yes Budget Impact Analysis for the Manitoba Health, Seniors and Active Living
(Updated: April 2017) [10]
4 New Brunswick (Prescription Drug Program) Yes No information
5 Newfoundland (Pharmaceutical Services) Yes No information
6 Northwest Territories No information No information
7 Nova Scotia (Pharmacare) Yes No information
8 Nunavut No information No information
9 Ontario (Drug Benefit Program) Yes ODB financial impact estimates (2016) [9]
10 Prince Edward Island (Drug Cost Assistance
Programs)
Yes No information
11 Quebec (Prescription Drug Insurance) Yes Guidance document for submitting a request to INESSS (Updated: 2018) [12]
12 Saskatchewan (Drug Plan) No information No information
13 Yukon No information No information
14 Non-Insured Health Benefits Program (Federal
Public Drug Benefit Programs)
Yes No information
15 CADTH Yes† pan-Canadian Oncology Drug Review Submission guidelines [22]

List of Canadian private payers included
in the review
# Private payers Review BIA for new
drug submissions*
Template or guidelines
1 Green Shield Yes AMCP‡ document (USA)[23]
2 Great-West Life No information No information
3 Express Scripts Canada No information No information
4 Medavie Blue Cross Yes BIA checklist for new drug submissions*
5 TELUS Health Benefits and Payment
Solutions (Pharmacy Benefit Manager)
Yes AMCP document (USA)[23]

Literature Review Findings (Cont.)
0
1
2
3
4
5
6
Australia UK Ireland Belgium France Canada Poland ISPOR Brazil
Time horizon
Minimum Maximum

Proposals for Updating the PMPRB BIA Guidelines-PhD thesis results presentation Aug 8 2019-update

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