The Ontario Drug Policy Research Network: Drug Class Reviews

Information Session: July 14th, 2014

www.odprn.ca

Objectives • Provide an introduction of the ODPRN and

our objectives

• Introduce the process and framework of ODPRN Drug Class Reviews

The ODPRN

• Ontario-wide, independent drug policy research group

• Established in 2008 • Funded by grants from the Ontario Ministry of

Health and Long-Term Care Key Objective: Bridge clinical researchers with drug policy decision-makers

to advance evidence-informed decision making

ODPRN Scope of Work: 2008-2012

Observational Research • Focused on large health administrative databases

housed and linked at ICES • Questions driven by either: • Policy Makers • ODPRN Researchers

Basic Pharmacoeconomics • Costing studies based on observational research

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ODPRN Core Principles • Scientific Rigor / Quality

Leading clinical researchers from five medical schools across Ontario

• Timeliness

Ready access to administrative data at ICES Efficient project and REB review and approval processes

• Policy Relevance

Policy-makers involved in generating questions, assessing relevance and prioritizing projects

• Effective Communications Regular communication and feedback with policy-makers Simple, understandable research briefings

ODPRN Funding and Expansion

• 2008-2014: – Drug Innovation Fund (Ontario Public Drug Program) – Focus on observational epidemiology and basic

pharmacoeconomics

• 2013-2015

– Health System Research Fund (Ontario Ministry of Health and Long-Term Care)

– Expansion of focus: evidence-based formulary modernization / drug class reviews

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The ODPRN Structure

Why undertake drug class reviews?

Drug Class Reviews

• Rapidly changing pharmaceutical environment

• Desire for “Formulary Modernization”

• Requests to study multiple drugs from a drug class – need for comprehensive approach to contextualize questions

Objectives of Drug Class Reviews • Pragmatic formulary modernization research to

provide the Ministry of Health and Long-Term Care with recommendations for evidence-informed drug policies.

• Core Principles: – Scientific rigor

– Timeliness

– Policy relevance

Principles of Drug Class Reviews • Conduct reviews that address the needs of patients,

health-care providers and policy-makers

• Provide basis for evidence-informed policies that incorporate societal values and beliefs

• May lead to recommendations regarding: – Expansion of access to drugs on the formulary – Revision or restriction of access to drugs – No change to current listing status – Alternative drug reimbursement models – Education of prescribers regarding appropriate prescribing

Are the recommendations from the Drug Class Reviews binding?

Drug Class Reviews • ODPRN is an independent research

organization with a mandate to provide recommendations to the Ontario Public Drug Program (OPDP) – The recommendations are not binding – Generally, multiple recommendations will be

made, outlining the advantages and disadvantage of each

– The OPDP has internal processes for determining if/how they will adopt a recommendation

What is the framework for the Drug Class Reviews?

Existing DCR Frameworks

• Systematic Reviews Drug Effectiveness Review Project (USA)

• Systematic Reviews •Original research using healthcare administrative databases

Agency for Healthcare Research and Quality (AHRQ)

(USA)

• Systematic Reviews •Economic Analyses •Patient Impact Statements

CADTH Therapeutic Reviews (Canada)

• Systematic Reviews •Economic Analyses • Local and historical contextualizing factors •Environmental Scans •Barriers to Implementation and Health Equity

NHS Centre for Reviews and Dissemination

(UK)

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ODPRN’s Comprehensive

Approach to Drug Class

Reviews

Drug Class Review Framework

Drug Class Review Framework

What is the difference between ODPRN Drug Class Reviews and

CADTH Therapeutic Reviews?

ODPRN Drug Class Review CADTH

Systematic review and network meta-analysis

Qualitative interviews with patients, clinicians

No (obtain patient input)

Real-world, drug utilization trends

No

Ontario – focused

No (Canadian focused)

Reimbursement-based economics

No

Use of Citizen’s Panel

No

Environmental scan

How are topics for drug class reviews determined?

Selection of Drug Classes • Potential drug classes to review may be

suggested by: – Policy-makers/Government:

• OPDP • Committee to Evaluate Drugs

– ODPRN Researchers – Other Stakeholders, including:

• Patients • Healthcare Providers • Industry

» http://www.odprn.ca/submit-and-idea-for-a-dcr/

Selection Criteria • Timeliness

– New medications (and/or dosage forms) that may warrant review – Factors that may make this a higher priority for patients,

clinicians or policy-makers

• Feasibility – Accomplishable within 6-12 months – Sufficient published evidence – Feasibility of pharmaco-epidemiologic and pharmaco-economic

analyses

Selection Criteria • Relevance:

– Policy-makers: • Under- or over-utilization • Burden of disease (including prevalence, mortality, individuals suffering, loss of

productivity) • Costs

– Patients: • Societal impact of disease state and access to therapies • Importance of disease state characteristics on quality and quantity of life

• Potential Impact:

– Clinical impact on patient care and/or clinical decision-making – Economic impact – Quality of life improvements – Policy changes – Education of clinicians, patients, pharmacists, and others

For drugs that are not commercially available in Canada, how will they be

incorporated into the review?

Drugs not available in Canada • In general, limit drug class review to drugs

that are currently available in Canada • If drug is newly available in Canada, may

not be able to incorporate all areas of research (e.g., pharmacoepidemiology since lack of utilization data, qualitative interviews)

How will duplication of topic selection be avoided with other

agencies?

Avoidance of duplication • Direct communication with CADTH • PROSPERO (registration of systematic

reviews) (http://www.crd.york.ac.uk/NIHR_PROSPERO/)

Who are members of the Research Team?

Members of the Research Team • ODPRN Principal Investigators

– David Juurlink (Sunnybrook) – Muhammad Mamdani (St. Michael’s) – Tara Gomes (St. Michael’s/ICES)

• Formulary Modernization Unit – Paul Oh (UHN) – Sandra Knowles (St. Michael’s)

• Clinical Experts (typically 2-3) • Representative from OPDP • Patient Representative • CED Representative

Members of Research Team • Systematic review:

– George Wells (University of Ottawa) and team OR – Sharon Straus (St. Michael’s Hospital) and team

• Pharmacoeconomics – Doug Coyle (University of Ottawa) and team – Karen Lee (CADTH)

• Qualitative Research Team (Knowledge Translation Program) – Julia Moore (St. Michael’s) and team

• Pharmacoepidemiology – Tara Gomes (ICES, St. Michael’s) and team

What timelines have been established for the Drug Class

Reviews?

ODPRN Reviews: Timelines and Process

ODPRN Reviews: Timelines and Process

ODPRN Reviews: Timelines and Process

How can stakeholders become involved in the Drug Class

Reviews?

Who are our stakeholders? • Stakeholders are defined as individuals or

organizations who have a personal or professional interest in the topic.

Stakeholders include: • Patients and caregivers

• Individual patients and patient groups • Public • Clinicians, including pharmacists and physicians

• Individual clinicians and professional organizations • Industry • Policymakers

Stakeholder Engagement

1. Communication 2. Consultation 3. Participation

How are stakeholders involved? • Idea submission for drug class review Topic Generation

• One-on-one interviews • Committee membership Topic Development

• Review of Research Plan • Evidence Submission Package Topic Refinement

• Review of draft review/recommendations Research Review

• Dissemination of key findings and recommendations Dissemination

Idea submission for Drug Class Review

• Identify potential drug class reviews Purpose

• Online submission Type of

engagement

• Throughout the review process Timeline

• All stakeholders (e.g., patients, public, healthcare providers, industry) Stakeholders

One-on-one interviews

• Elicit the specific perceptions and opinions of the ‘end users’ of the drug therapies (i.e. clinicians and patients) Purpose

• One-on-one interviews conducted by the Qualitative Team

Type of engagement

• During Topic Development Timeline

• Patients, healthcare providers Stakeholders

Committee Membership

• To provide ongoing comment/feedback during entire drug class review

Purpose

• In person or via teleconference Type of

engagement

• During entire drug class review (5 meetings) Timeline

• Patients, healthcare providers, policy makers Stakeholders

Evidence Submission Packages

• To ensure that all relevant research is available for inclusion in the final report Purpose

• Electronic submission Type of

engagement

• 6 week period during topic refinement Timeline

• All stakeholders (e.g., patients, public, healthcare providers, industry) invited to submit package Stakeholders

What should be submitted as part of the Evidence Submission

Package?

Evidence Submission Package • Full citation for all published studies

(including clinical trials, follow-up studies, evidence from disease registries) for the drug and specific indication under review

• Full text of any unpublished work – NOTE: contents of all submissions will be

made available to public upon request

Privacy Policy • Materials communicated as confidential to

ODPRN cannot be used in the report. • Exception: ODPRN will consider scientific

materials in confidence if awaiting academic publication

What type of input is needed on Comprehensive Research Plans

and Draft Reports and Recommendations?

Input on Comprehensive Research Plans

•To ensure that the Comprehensive Research Plans address problems found in real-life situations Purpose

•Comments can be submitted online, electronically (via email) or via mail

•Workshop

Type of engagement

•2 week period during topic refinement •Workshop held during this 2 week period Timeline

•All stakeholders (e.g., patients, public, healthcare providers, industry) invited to submit comments

•Workshop: industry, patient groups Stakeholders

Input on Draft Report/ Recommendations

•To ensure that the report and recommendations reflect the most important questions that patients, healthcare providers and policymakers have regarding a specific drug class

Purpose

•Comments can be submitted online, electronically (via email) or via mail

•Workshop • Social acceptability survey (led by the Qualitative Team)

Type of engagement

•4 week period during research review •Workshop held during this 4 week period Timeline

•All stakeholders (e.g., patients, public, healthcare providers, industry) invited to submit comments

•Workshop: industry, patient groups Stakeholders

Stakeholder input • Outlining any areas that are unclear,

concerns with analyses, gaps etc. • Should be limited to 5 pages or less

ODPRN Stakeholder Engagement Type of engagement Stakeholders participating Review Stage

Patient/ Caregiver/ Advocacy

group

Public Healthcare provider

Industry Policy- makers

Qualitative Research (1-on-1 interviews)

Planning

Committee membership

All

Evidence Submission Package

Planning

Targeted Online Feedback

#1. Planning #2. Stakeholder review

Stakeholder Group Workshop

#1. Planning #2. Stakeholder Review

Societal Values Workshop

Stakeholder Review

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Discussion

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