This webinar will introduce you to the Patented Medicine Prices Review Board (PMPRB), how they regulate drug pricing in Canada and the proposed changes that will affect cancer patients.
Listeners participated in a live panel session addressing OHIP+, the recently announced expansion of the Ontario drug program to cover young people who are younger than 25 years-old.
The Canadian Cancer Survivor Network is pleased to offer a webinar titled “Health Canada calls for new tools to control drug prices: what will it mean for patients?”. This webinar will summarize the various pharmaceutical pricing reforms recently announced by federal health minister Dr. Jane Philpott and examine their potential effects on patient access to new innovations.
CAPCA wants to make sure that patients have access to innovative and effective cancer treatments, and Heather Logan, ED of CAPCA, will explain how CAPCA is going to do this and answer your questions about the process. This webinar will introduce you to CAPCA and its mandate and to the new pan-Canadian Cancer Drug Funding Sustainability Initiative (DFSI). The goal of DFSI is to ensure that patients continue to have access to innovative and effective cancer treatments, and that the cancer system is achieving maximum value for money invested.
August 19, 2021 from 1-2 pm
CORD’s LAST SUMMER webinar, Part 1 of our series on “How to Get Back to the PMPRB Original Mandate to prevent excessive drug pricing and support pharma R&D investment.” Learn why responding to the most recent (July 15th) proposed guideline changes is very important.
On August 19, 2021 from 1-2 pm, please JOIN:
Listeners participated in a live panel session addressing OHIP+, the recently announced expansion of the Ontario drug program to cover young people who are younger than 25 years-old.
The Canadian Cancer Survivor Network is pleased to offer a webinar titled “Health Canada calls for new tools to control drug prices: what will it mean for patients?”. This webinar will summarize the various pharmaceutical pricing reforms recently announced by federal health minister Dr. Jane Philpott and examine their potential effects on patient access to new innovations.
CAPCA wants to make sure that patients have access to innovative and effective cancer treatments, and Heather Logan, ED of CAPCA, will explain how CAPCA is going to do this and answer your questions about the process. This webinar will introduce you to CAPCA and its mandate and to the new pan-Canadian Cancer Drug Funding Sustainability Initiative (DFSI). The goal of DFSI is to ensure that patients continue to have access to innovative and effective cancer treatments, and that the cancer system is achieving maximum value for money invested.
August 19, 2021 from 1-2 pm
CORD’s LAST SUMMER webinar, Part 1 of our series on “How to Get Back to the PMPRB Original Mandate to prevent excessive drug pricing and support pharma R&D investment.” Learn why responding to the most recent (July 15th) proposed guideline changes is very important.
On August 19, 2021 from 1-2 pm, please JOIN:
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
July 22, 2021 : Aligning on Rare Drug Strategy, PMPRB, and Federal Election
Engage with our Expert Panel in a Townhall style meeting to add your voice on these important issues in preparation for upcoming federal election.
Panelist
Alexandra Chambers (Novartis)
Peter Brenders (BeiGene)
Angela Genge (The Neuro)
Fred Horne (3Sixty Public Affairs)
Leanne Ward (CHEO)
Summer 2020 PMPRB Webinar Series: Webinar 2 (July 16, 2020)
Hearing From Those Who Really Matter. This Webinar will take place after the PMPRB’s promised rescheduled “public forums” and “research webinars.”
Roundtable
Lindy Forte, Principal Consultant, Patient Access Solutions
Dr. Shawn Whatley, family physician, Munk Senior Fellow, Macdonald Laurier Institute and past president of the OMA
Barbara Jaszewski, Advisor Cloud and past global vice president of pricing and market access
Catherine Boivin, SMA Patient
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, CEO, 3Sixty Public Affairs
Webinar 3: (Nov 6 2020). PMPRB: Friend or Foe of Rare Disease Drug Strategy. Webinar 3 in CORD’s Rare Drug Strategy Consultation, a multi-stakeholder panel will consider the potential impact of the PMPRB revised guidelines on entry and access of rare disease therapies, using “real” case examples. Stakeholders will be invited to deliberate on alternatives to the PMPRB guidelines that could better meet the Triple Aim of “timely appropriate patient access”, “optimal, sustainable healthcare expenditure”, and “non-excessive industry compensation that incentivizes launching new therapies and future R&D.”
Presentation:
Kimberly Robinson, Director, Pricing & Market Access, PDCI
Kim Steele, Director, Government and Community Relations, Cystic Fibrosis Canada
Dr. Leanne Ward, Professor, Medical Director of the CHEO Bone Health Clinic, Scientific Director of the Ottawa Pediatric Bone Health Research Group
Fred Horne, Former Alberta Minister of Health and Senior Advisor to 3Sixty Public Affairs
Marissa Poole, Country Lead, Sanofi Canada and General Manager, Sanofi Genzyme Canada
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
At this webinar, Steve Sampson (Global Public Affairs) discusses how the upcoming federal budget may contain announcements related to the way healthcare is funded in Canada, including changes to the regulation of pharmaceutical prices. Value for taxpayer money should always be the focus for government, but the need for cost-containment needs to be balanced with access to optimal healthcare innovation for patients.
Join Bill Dempster & guests Louise Binder & Martine Elias as they discuss the updates to the federal pharmaceutical price reform proposal, how patient leaders are responding and what steps they are taking to ensure that patients are being heard by decision makers.
Please share this slideshow with anyone who may be interested!
In this webinar:
● What has prompted the recent re-emergence of public calls for national pharmacare?
● What are Canadian health ministers doing to address this issue?
● What are some potential models for national pharmacare that are under discussion?
Contact the presenters:
● Bill Dempster - wdempster@3sixtypublicaffairs.com
● Gerry Jeffcott - gjeffcott@3sixtypublicaffairs.com
View the video: https://youtu.be/Eh3593x4aoI
Webinar 3: Alternative Approaches to Innovative Drug Pricing – 12:00pm on Wednesday, May 13, 2020. The third webinar will review Canada’s approach to managing drug prices with approaches used in other jurisdictions. A panel will discuss experiences with oncology therapies, rare disease drugs, and therapies for pandemics and other urgent situations as points of reference toward evolving alternatives to the proposed PMPRB guidelines.
Panel:
Martina Garau, Director, Office of Health Economics, UK;
Sandra Anderson, Senior VP, Innomar Strategies
PG Forest, Director, School of Public Policy, University of Calgary
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, 3Sixty Public Affairs
Webinar 2: Oct 23, 2020 (12 -1 pm ET). How can we access preventive and risk-reduction therapies: examples from rare blood disorders. What are the benefits of therapies that can prevent or reduce the risk of serious symptomology in rare diseases? What are challenges in approval of these therapies through HTA process? What are the challenges to accessing these preventive therapies through public and private drug plans? Why are these therapies especially relevant in the time of a pandemic?
Cablivi to reduce risk of relapse in acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Reblozyl to reduce frequency of transfusions in beta-Thalassemia
Hemlibra to reduce risk of bleeds in Hemophilia A
Panel Discussion: What are the outcomes that these therapies provide to patients? What are the risks-benefits decisions that patients need to make (in consultation with their clinicians) about taking these therapies? How important are these therapies relative to other options for treating these conditions? Do these serve “unmet” needs?
Presentation:
Durhane Wong-Rieger, CORD Panel Discussion
Dr. Kevin Kuo (University Health Network)
Dr. Katerina Pavenski (St. Michael’s Hospital)
David Page (Canadian Hemophilia Society)
aTTP, Thalassemia, Hemophilia, Patient Panel
Webinar 1 (Oct 9, 2020 at 12 -1 pm ET): Does Canada need an Orphan Drug Policy to incentivize drug development and submissions? What was the rationale for Orphan Drug legislation in other countries? What has been the impact of those legislations? Why did Canada develop and never implement a Canadian Rare Disease Strategy and what has been the aftermath? What is Canada’s Rare Disease Strategy and how has it influenced healthcare?
Key issues:
• Rationale and impact of Orphan Drug legislation around the world (1983 – today)
• Proposed Canadian Orphan Drug Framework and what could have resulted (2014)
• Proposed Canada’s Rare Disease Strategy and what did/did not result (2015 – today)
Given the benefits and challenges that have been raised about Orphan Drug Legislation and the current procedures for reviewing rare disease drugs across Canadian agencies (Health Canada, PMPRB, CADTH/INESSS, pCPA, provincial drug plans), should Canada still pursue a dedicated Orphan Drug Policy and, if so, what should it address? What are the opportunities for stimulating and supporting research and development for rare disease therapies in Canada and what are specific policies needed?
Presentation:
Durhane Wong-Rieger, CORD Panel Discussion
Rebecca Yu (Takeda Canada)
Nicola Worsfold (Jesse’s Journey Canada)
Sandra Anderson (Innomar Strategies)
Nahya Awada (PhD Candidate Carleton University)
Please share this video with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Background to the role of private drug insurance plans in Canada
● Impact on access of recent developments in private insurance plan programs
● Future directions of private insurance in Canada
View the video: https://youtu.be/rik50CrMffY
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
Webinar 2: Matching Access to Risk
When: May 27, 2021 @ 1:00pm – 2:30pm EST
Toon Digneffe, Head EU Public Affairs & Public Policy, Takeda Slides. Early Access & RWE: building trust and reducing
stakeholder uncertainties – a European perspective
Matching Access to Risk, but Who Pays? Who decides how much risk to accept with a new medicine? How does each stakeholder make that decision? The developer balances availability and ROI. The regulatory makes a population benefit-risk calculation. The clinician compares an unknown drug with known benefits-risks. The payer introduces a third trade-off, cost. And the patient who literally has the most at risk often has the least say.
A panel will deliberate on ways to introduce, manage, and sustain access to medicines that are matched to the types and levels of “risk?” When should managed access programs be used, or not? When do you need bigger, longer, broader clinic trials, and when should we rely on “real-world” data? How can genomic profiling target individuals with highly precise medications? How can blockchain technology and artificial intelligence be used to improve treatment algorithms and cost-effective use?
Webinar 8: Laying A Factual Foundation for Canada’s Rare Drug Program
Feb 12 @ 12 PM ET/ 9 AM PT
Separating Fact from Fiction about rare disease drugs in Canada
Aligning on key issues: Single framework, Innovative access models, and Risk management
Charting the course from Rare Drug Strategy to Rare Drug Program Implementation
Webinar 4: (Nov 20, 2020). Re-imaging Canada’s Rare Drug Strategy. Webinar 4 in CORD’s Rare Drug Strategy Consultation. A multi-stakeholder panel will discuss the many challenges that can “derail” the journey of a rare drug from regulatory approval to patient access. The panel will use two “case examples” to deliberate on the challenges presented by: adequate clinical trials evidence, cost-effectiveness assessment, affordability based on price negotiation, availability based on clinical and other services, and accessibility based on drug plan reimbursement. The panel will consider recommendations to “unblock” barriers that should be built into the operations of “Canada’s Rare Drug Agency 2022.”
Panelists
Fred Little, Canada Lead, Rare Disease, Pfizer Canada
Christopher McMaster, Scientific Director, CIHR Institute of Genetics
Ferg Mills, Director, Strategic Consulting, Innomar Strategies
Blaine Penny, CEO, MitoCanada
This engaging webinar will help you learn more about the Patented Medicine Prices Review Board and the impact of their proposed price review reforms. The webinar was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by a panel of experts.
Former PMPRB staff member Neil Palmer analyzed the government’s perspectives on the proposed reforms. Carole Watson from Janssen presented a case study outlining the effects of the proposals on a pharmaceutical manufacturer’s decision making regarding the launch of a new cancer medicine and Martine Elias, Executive Director of Myeloma Canada, provided input on the proposed reforms from a patient leader perspective.
A moderated Q&A session allowed participants to provide their perspectives and questions on how the proposed pricing reforms might impact the availability of new innovative treatments in this country.
This is the first in a series of eight CCSN webinars on health technology assessment and drug approval. Stay tuned for further webinars.
This webinar was an interactive live webcast from the Canadian Organization for Rare Disorders’ Rare Disease Day event in Ottawa.
The session was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by several Canadian experts in pharmaceutical access, including a former director of the Ontario Public Drug Programs.
This discussion reviewed the current state of public reimbursement for orphan medicines and examined how the emerging discussions about a new national pharmacare program will affect patient access to these medicines.
The session was followed by an interactive question and answer session.
Presenters:
• Bill Dempster, co-founder of 3Sixty Public Affairs Inc., is an in-demand health and pharmaceutical policy expert who works with a range of clients to navigate complex political, policy, regulatory and reimbursement challenges in the Canadian life sciences field
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
July 22, 2021 : Aligning on Rare Drug Strategy, PMPRB, and Federal Election
Engage with our Expert Panel in a Townhall style meeting to add your voice on these important issues in preparation for upcoming federal election.
Panelist
Alexandra Chambers (Novartis)
Peter Brenders (BeiGene)
Angela Genge (The Neuro)
Fred Horne (3Sixty Public Affairs)
Leanne Ward (CHEO)
Summer 2020 PMPRB Webinar Series: Webinar 2 (July 16, 2020)
Hearing From Those Who Really Matter. This Webinar will take place after the PMPRB’s promised rescheduled “public forums” and “research webinars.”
Roundtable
Lindy Forte, Principal Consultant, Patient Access Solutions
Dr. Shawn Whatley, family physician, Munk Senior Fellow, Macdonald Laurier Institute and past president of the OMA
Barbara Jaszewski, Advisor Cloud and past global vice president of pricing and market access
Catherine Boivin, SMA Patient
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, CEO, 3Sixty Public Affairs
Webinar 3: (Nov 6 2020). PMPRB: Friend or Foe of Rare Disease Drug Strategy. Webinar 3 in CORD’s Rare Drug Strategy Consultation, a multi-stakeholder panel will consider the potential impact of the PMPRB revised guidelines on entry and access of rare disease therapies, using “real” case examples. Stakeholders will be invited to deliberate on alternatives to the PMPRB guidelines that could better meet the Triple Aim of “timely appropriate patient access”, “optimal, sustainable healthcare expenditure”, and “non-excessive industry compensation that incentivizes launching new therapies and future R&D.”
Presentation:
Kimberly Robinson, Director, Pricing & Market Access, PDCI
Kim Steele, Director, Government and Community Relations, Cystic Fibrosis Canada
Dr. Leanne Ward, Professor, Medical Director of the CHEO Bone Health Clinic, Scientific Director of the Ottawa Pediatric Bone Health Research Group
Fred Horne, Former Alberta Minister of Health and Senior Advisor to 3Sixty Public Affairs
Marissa Poole, Country Lead, Sanofi Canada and General Manager, Sanofi Genzyme Canada
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
At this webinar, Steve Sampson (Global Public Affairs) discusses how the upcoming federal budget may contain announcements related to the way healthcare is funded in Canada, including changes to the regulation of pharmaceutical prices. Value for taxpayer money should always be the focus for government, but the need for cost-containment needs to be balanced with access to optimal healthcare innovation for patients.
Join Bill Dempster & guests Louise Binder & Martine Elias as they discuss the updates to the federal pharmaceutical price reform proposal, how patient leaders are responding and what steps they are taking to ensure that patients are being heard by decision makers.
Please share this slideshow with anyone who may be interested!
In this webinar:
● What has prompted the recent re-emergence of public calls for national pharmacare?
● What are Canadian health ministers doing to address this issue?
● What are some potential models for national pharmacare that are under discussion?
Contact the presenters:
● Bill Dempster - wdempster@3sixtypublicaffairs.com
● Gerry Jeffcott - gjeffcott@3sixtypublicaffairs.com
View the video: https://youtu.be/Eh3593x4aoI
Webinar 3: Alternative Approaches to Innovative Drug Pricing – 12:00pm on Wednesday, May 13, 2020. The third webinar will review Canada’s approach to managing drug prices with approaches used in other jurisdictions. A panel will discuss experiences with oncology therapies, rare disease drugs, and therapies for pandemics and other urgent situations as points of reference toward evolving alternatives to the proposed PMPRB guidelines.
Panel:
Martina Garau, Director, Office of Health Economics, UK;
Sandra Anderson, Senior VP, Innomar Strategies
PG Forest, Director, School of Public Policy, University of Calgary
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, 3Sixty Public Affairs
Webinar 2: Oct 23, 2020 (12 -1 pm ET). How can we access preventive and risk-reduction therapies: examples from rare blood disorders. What are the benefits of therapies that can prevent or reduce the risk of serious symptomology in rare diseases? What are challenges in approval of these therapies through HTA process? What are the challenges to accessing these preventive therapies through public and private drug plans? Why are these therapies especially relevant in the time of a pandemic?
Cablivi to reduce risk of relapse in acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Reblozyl to reduce frequency of transfusions in beta-Thalassemia
Hemlibra to reduce risk of bleeds in Hemophilia A
Panel Discussion: What are the outcomes that these therapies provide to patients? What are the risks-benefits decisions that patients need to make (in consultation with their clinicians) about taking these therapies? How important are these therapies relative to other options for treating these conditions? Do these serve “unmet” needs?
Presentation:
Durhane Wong-Rieger, CORD Panel Discussion
Dr. Kevin Kuo (University Health Network)
Dr. Katerina Pavenski (St. Michael’s Hospital)
David Page (Canadian Hemophilia Society)
aTTP, Thalassemia, Hemophilia, Patient Panel
Webinar 1 (Oct 9, 2020 at 12 -1 pm ET): Does Canada need an Orphan Drug Policy to incentivize drug development and submissions? What was the rationale for Orphan Drug legislation in other countries? What has been the impact of those legislations? Why did Canada develop and never implement a Canadian Rare Disease Strategy and what has been the aftermath? What is Canada’s Rare Disease Strategy and how has it influenced healthcare?
Key issues:
• Rationale and impact of Orphan Drug legislation around the world (1983 – today)
• Proposed Canadian Orphan Drug Framework and what could have resulted (2014)
• Proposed Canada’s Rare Disease Strategy and what did/did not result (2015 – today)
Given the benefits and challenges that have been raised about Orphan Drug Legislation and the current procedures for reviewing rare disease drugs across Canadian agencies (Health Canada, PMPRB, CADTH/INESSS, pCPA, provincial drug plans), should Canada still pursue a dedicated Orphan Drug Policy and, if so, what should it address? What are the opportunities for stimulating and supporting research and development for rare disease therapies in Canada and what are specific policies needed?
Presentation:
Durhane Wong-Rieger, CORD Panel Discussion
Rebecca Yu (Takeda Canada)
Nicola Worsfold (Jesse’s Journey Canada)
Sandra Anderson (Innomar Strategies)
Nahya Awada (PhD Candidate Carleton University)
Please share this video with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Background to the role of private drug insurance plans in Canada
● Impact on access of recent developments in private insurance plan programs
● Future directions of private insurance in Canada
View the video: https://youtu.be/rik50CrMffY
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
Webinar 2: Matching Access to Risk
When: May 27, 2021 @ 1:00pm – 2:30pm EST
Toon Digneffe, Head EU Public Affairs & Public Policy, Takeda Slides. Early Access & RWE: building trust and reducing
stakeholder uncertainties – a European perspective
Matching Access to Risk, but Who Pays? Who decides how much risk to accept with a new medicine? How does each stakeholder make that decision? The developer balances availability and ROI. The regulatory makes a population benefit-risk calculation. The clinician compares an unknown drug with known benefits-risks. The payer introduces a third trade-off, cost. And the patient who literally has the most at risk often has the least say.
A panel will deliberate on ways to introduce, manage, and sustain access to medicines that are matched to the types and levels of “risk?” When should managed access programs be used, or not? When do you need bigger, longer, broader clinic trials, and when should we rely on “real-world” data? How can genomic profiling target individuals with highly precise medications? How can blockchain technology and artificial intelligence be used to improve treatment algorithms and cost-effective use?
Webinar 8: Laying A Factual Foundation for Canada’s Rare Drug Program
Feb 12 @ 12 PM ET/ 9 AM PT
Separating Fact from Fiction about rare disease drugs in Canada
Aligning on key issues: Single framework, Innovative access models, and Risk management
Charting the course from Rare Drug Strategy to Rare Drug Program Implementation
Webinar 4: (Nov 20, 2020). Re-imaging Canada’s Rare Drug Strategy. Webinar 4 in CORD’s Rare Drug Strategy Consultation. A multi-stakeholder panel will discuss the many challenges that can “derail” the journey of a rare drug from regulatory approval to patient access. The panel will use two “case examples” to deliberate on the challenges presented by: adequate clinical trials evidence, cost-effectiveness assessment, affordability based on price negotiation, availability based on clinical and other services, and accessibility based on drug plan reimbursement. The panel will consider recommendations to “unblock” barriers that should be built into the operations of “Canada’s Rare Drug Agency 2022.”
Panelists
Fred Little, Canada Lead, Rare Disease, Pfizer Canada
Christopher McMaster, Scientific Director, CIHR Institute of Genetics
Ferg Mills, Director, Strategic Consulting, Innomar Strategies
Blaine Penny, CEO, MitoCanada
This engaging webinar will help you learn more about the Patented Medicine Prices Review Board and the impact of their proposed price review reforms. The webinar was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by a panel of experts.
Former PMPRB staff member Neil Palmer analyzed the government’s perspectives on the proposed reforms. Carole Watson from Janssen presented a case study outlining the effects of the proposals on a pharmaceutical manufacturer’s decision making regarding the launch of a new cancer medicine and Martine Elias, Executive Director of Myeloma Canada, provided input on the proposed reforms from a patient leader perspective.
A moderated Q&A session allowed participants to provide their perspectives and questions on how the proposed pricing reforms might impact the availability of new innovative treatments in this country.
This is the first in a series of eight CCSN webinars on health technology assessment and drug approval. Stay tuned for further webinars.
This webinar was an interactive live webcast from the Canadian Organization for Rare Disorders’ Rare Disease Day event in Ottawa.
The session was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by several Canadian experts in pharmaceutical access, including a former director of the Ontario Public Drug Programs.
This discussion reviewed the current state of public reimbursement for orphan medicines and examined how the emerging discussions about a new national pharmacare program will affect patient access to these medicines.
The session was followed by an interactive question and answer session.
Presenters:
• Bill Dempster, co-founder of 3Sixty Public Affairs Inc., is an in-demand health and pharmaceutical policy expert who works with a range of clients to navigate complex political, policy, regulatory and reimbursement challenges in the Canadian life sciences field
Don’t miss our upcoming webinars: Subscribe today!
In this webinar:
Join our presenters, Wayne Critchley from Global Public Affairs and Ryan Clarke from Advocacy Solutions, and CCSN to learn more about changes to the Patented Medicine Prices Review Board (PMPRB) and receive guidance about how to support the cancer community’s engagement at this stage of regulatory reform.
View the video:
https://youtu.be/4IsiptCD0Tw
To learn more about CCSN, visit us at survivornet.ca
Follow CCSN on social media:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Instagram: https://www.instagram.com/survivornet_ca/
Pinterest - https://www.pinterest.com/survivornetwork
December 12, 2017
The Sixth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/sixth-annual-health-law-year-in-p-review
On this webinar, we’ll hear from experts on the issue and invite an open conversation with stakeholders. We need discussion, shared questions and answers and a review of case studies, which is why we are hosting this session.
Panelist:
Neil Palmer, Principal Consultant, WN Palmer & Co. and former PMPRB staff
Michael Dietrich, Executive Director, Policy, Innovative Medicines Canada
Laurene Redding, Global Head, Strategic Pricing (ex-China), BeiGene
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, CEO, 3Sixty Public Affairs
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● A discussion on the Canadian public and private drug access environment
● A moderated panel on the broader access and innovation context, featuring an update on international access to innovative therapies, patient support programs, and innovative pathways for access to treatments
View the video:
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
How High Will They Go? Managing Rising Drug Prices in a Changing Healthcare E...CompleteRx
In 2016, spending on prescription drugs is expected to reach $500 billion. So, how high will they really go? That is a common question asked with drug prices as recent headlines have exploited drug pricing schemes and how the pharmaceutical industry is handling rising prices. This webinar discusses how hospitals and health systems can prepare for and manage rising drug costs, ensure patient care and positively impact the bottom line.
Global HTA and pricing mechanisms
What can we learn about national medicines pricing and procurement?
Led by Janssen UK
Day One, Pop-up University 3, 16.00
The Regulatory Policy Institute, based in Oxford, holds an annual conference on competition and regulation. At this year’s conference, OHE’s Jon Sussex described how the prescription medicines market in England is regulated for innovation.
The regulatory problem for the pharmaceutical market is different from that for utilities markets, transport, financial services and indeed markets for all other types of goods and services. The source of the regulatory problem for prescription medicines in the NHS is that the consumer (patient) neither decides which medicine is prescribed nor is responsible for paying for it. For other goods and services, the consumer decides and pays, as well as consumes. In the pharmaceutical market under the NHS, it is the payer who effectively decides the value of an innovation, not the patient.
The cost and risk in drug development are high. To determine how best to target its R&D efforts, the pharmaceutical industry needs clear signals about what innovation the health care payer, the NHS, values. The recent history of such signalling has been dominated in England by the actions of the National Institute for Health and Care Excellence (NICE), whose assessments also have considerable influence internationally. Moreover, although England represents only 2% of the world pharmaceutical market, its prices are use as a reference for pricing in other markets.
How NICE expresses the value of medicines can be viewed as a mean of regulating innovation. NICE always has based its decisions about value on the incremental cost to the tax-funded health and social care services of the additional quality-adjusted life years a new medicine offers to patients. During the last year, NICE has been consulting on ways to broaden its assessment of value, particularly on whether to take account of the burden of disease and wider societal impacts beyond QALYs. The decisions have not yet been made and the signal to potential pharmaceutical innovators remains fuzzy.
Opportunities or Challenges: Need for Transparent Consultation and Reality-Based Thinking on Canadian Drug Pricing and Access to Innovation; How to Make PMPRB Guidelines, HTA, and National Pharmacare Work for Patients
Neil Palmer, PDCI Market Access Inc
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State crafting: Changes and challenges for managing the public finances
How Changes to the PMPRB Could Affect Patients' Access to Drugs
1. 1
How Proposed Changes to the
Patented Medicine Prices Review Board
Could Affect Patients’ Access to Drugs
September 28, 2017
2. 2
Today’s participants
Bill Dempster
CEO – 3Sixty Public Affairs
Moderator
Panelist
Neil Palmer
Founder & Principal Consultant –
PDCI Market Access
Panelist
Wayne Critchley
Senior Associate –
Global Public Affairs
Panelist
John-Peter Bradford
CEO – Life Saving Therapies Network
3. 3
1. Introduction to
PMPRB / proposed
changes
2. Panellists’
perspectives
3. Discussion
What we’ll discuss
4. What is the PMPRB?
• Quasi-judicial federal agency
• Reports to the federal health minister
• Twofold mandate:
regulates prices and reports on trends
• Regulates prices of patented drugs based on:
o independent assessment of treatment’s therapeutic value vs.
alternatives
o prices for same medications in other countries, which currently
include France, Germany, Italy, Sweden, Switzerland, the United
Kingdom and the United States (i.e., the basket of reference
countries or PMRB7)
4
5. Proposed changes to the PMPRB
• Patented Medicines Regulations key
changes:
o Addition of economic factors for PMPRB
excessive price determinations:
- Pharmacoeconomic analysis
- Size of market
- Canadian GDP
o Updating the list of comparator countries
- Remove U.S. and Switzerland
- Add Australia, Belgium, Norway, Japan,
Netherlands, South Korea & Spain
o Requirements to report rebates to the
PMPRB
5
Source: PMPRB’s strategic plan
6. Evolution and key dates
May 16, 2017
Consultation
document released
– opportunity to
provide written
input until
Jun. 28, 2017
Fall 2017
Draft regulations
will be published in
Canada Gazette I
along with
regulatory impact
analysis statement
(RIAS)
2018
Review of
comments/input on
draft regulations
and development of
final regulations to
be published in
Canada Gazette II
75-day
consultation period
End of 2018
Health Canada
aiming to conclude
the regulatory
amendment process
by this time
Strategic Plan
Dec. 2015
PMPRB
Guidelines
Jun. 2016
Nov-Dec 2017
GUIDELINES
discussions
and consultations
to occur at the
same time
NEW
Health
Minister
Ginette
Petitpas Taylor
6
8. 8
Minister of Health: Prime Minister’s Mandate Letter
“…Improve access to necessary prescription
medications”
• “joining with provincial and territorial
governments to buy drugs in bulk”
• “reducing the cost Canadian governments
pay for these drugs”
• “making them more affordable for
Canadians”
• “exploring the need for a national formulary”
9. 9
Health minister vows to
save Canadians
'billions' on drug prices
January, 2017
… will bring prices in
“line to what we are
seeing in countries like
New Zealand”
10. 10
PMPRB Reform –
Statements from Former Minister Philpott
PMRPB reform is a precursor to any potential
Pharmacare plan: we don’t want to “lock in extremely
high-price medications” – April 13, 2016
May 16, 2017 Speech:
• Announced proposed PMPRB reforms and
consultation process
• Canada has the 3rd highest drug prices & the 2nd
highest per capita pharmaceutical spending in the
OECD
• Proposed changes would lower prices in range of
25%
• Would bring annual savings of $3.5 billion
Other announcements in May 16 speech:
• Work with provinces on a “National Formulary”
• System alignment – Health Canada and CADTH
• Promised announcement on pCPA
11. 11
Government's Regulatory Proposals –
Some Potential Impacts
• Duplication of HTA reviews
• 25% reduction in overall list
prices
• Impact on pCPA and
PLAs????
• Lower prices for private
insurers
• Impact on government
innovation policies and
biopharmaceutical investment
• Delayed launch of innovative
drugs in Canada
12. 12
SOME KEY ISSUES
CONSULTATIONS
• No multi-
stakeholder
consultations
• Written
submissions only
• Limited meetings
LIMITED LINK TO
PUBLIC PAYERS
• PMPRB has no
engagement in
HC/CADTH/pCPA
processes
• Potential for
conflict between
agencies
SPECIAL ISSUES
FOR PATIENT
GROUPS
• Potential delays in
access
• New barriers for
drugs for rare
diseases
• PMPRB has no
patient input
mechanisms
13. 13
Contact:
Wayne Critchley
Senior Associate, HLS
Tel: 613-783-3449
wcritchley@globalpublic.com
Global Public Affairs: Contact Information
Ottawa
50 O’Connor Street, Suite 901
Ottawa, ON K1P 6L2
Telephone: 1 (613) 782-2336
Toronto
595 Bay Street, Suite 401
Toronto, ON M5G 2C2
Telephone: 1 (416) 597-3485
Edmonton
10060 Jasper Avenue, Suite
2020
Edmonton, AB T5J 3R8
Telephone: 1 (780) 665-4946
Calgary
633-6th Avenue SW, Suite
1000
Calgary, AB T2P 2Y5
Telephone: 1 (403) 264-3800
Vancouver
355 Burrard Street, Suite
570
Vancouver, BC V6C 2G8
Telephone: 1 (604) 362-2522
16. PMPRB: Less Reliance on International Prices?
• PMPRB: “Given that it is standard industry
practice worldwide to insist that public prices
not reflect discounts and rebates, should the
PMPRB generally place less weight on
international public list prices when
determining the non-excessive price ceiling
for a drug?”
• International price referencing began in
Canada in 1987 (PMPRB C-22 amendments
to Patent Act)
• Listing agreements and patient access
schemes make international price
comparisons challenging
– but these exist because of international price
referencing
– transparent pricing would result in a
downward spiral of prices
– even if prices are identical at launch, prices
will inevitably move apart because of
exchange rates
16September 2017
17. Health Canada: Criteria for selecting proposed reference countries
Three main criteria have been used to select the countries:
1. Consumer protection: whether the country has national pricing containment measures in place to protect
consumers from high drug prices;
2. Economic Standing: whether the country has a similar economic standing to Canada, as measured by GDP
per capita; and
3. Pharmaceutical market characteristics: whether the country has similar market characteristics to Canada,
such as population, consumption, revenues and market entry of new products.
17September 2017
Proposed Countries
Source: Health Canada “Protecting Canadians from Excessive Drug Prices: Consulting on Proposed Amendments to the Patented Medicines Regulations”, Ottawa May 2017
18. What is the impact of International Reference Pricing?
• Is there evidence that lower prices delay product
introduction in “low price” countries?
18September 2017
19. Health Canada / PMPRB: Lower prices have no effect on Access to Medicines
19September 2017
20. But for New Medicines…
Foreign Prices are similar or higher than Canada
20September 2017
New med prices the same or higher in most
other countries including Sweden & UK
23. Reservation Prices – At what point will products not be available?
• Reservation (or reserve) price is a term referring to a limit on the price of
a good or a service.
– On the demand side, it is the highest price that a buyer is willing to pay;
– On the supply side, it is the lowest price at which a seller is willing to sell a
good or service.
23September 2017
24. International (External) Reference Pricing
24September 2017
Pharmaceutical Reference Pricing in the U.S. Delusion or a soon-to-be Reality? April 2016 Ilkka Anhava Ling Chen Huiyan
Jin Emil Nedev David Spellberg.
25. Biography
25September 2017
W. Neil Palmer
President & Principal Consultant
PDCI Market Access Inc
Neil.Palmer@pdci.ca
www.pdci.ca
Neil Palmer President and Principal Consultant of PDCI Market Access Inc. (PDCI) a leading pricing and
reimbursement consultancy founded in 1996. He leads a senior team of market access professionals with
pricing & reimbursement engagements covering Canada, Europe, and the United States.
Prior to PDCI, Neil worked with the Canadian Patented Medicine Prices Review Board (PMPRB) where his
responsibilities included policy development, overseeing the price review of patented medicines and
conducting economic research. Prior to the PMPRB, he worked with the Health Division of Statistics Canada
where he was responsible for economic and statistical analysis of health care costs and utilization. Neil also
worked with RTI Health Solutions (Research Triangle Park, North Carolina) where he served as global vice
president for pricing and reimbursement. After completing his studies at the University of Western
Ontario, Neil began his career in Montreal with the research group of the Kellogg Centre for Advanced
Studies in Primary Care. He has written extensively on pharmaceutical pricing and reimbursement issues
and is a frequent speaker at conferences in North America and Europe.
In January 2015, Neil was appointed Adjunct Assistant Professor at the University of Southern California
School of Pharmacy graduate program in Health Care Decision Analysis where he lectures on health
technology assessment, pricing and market access from a global perspective.
26. 26
Discussion
CONSULTATIONS
• No multi-
stakeholder
consultations
• Written
submissions only
• Limited meetings
LIMITED LINK TO
PUBLIC PAYERS
• PMPRB has no
engagement in
HC/CADTH/pCPA
processes
• Potential for
conflict between
agencies
SPECIAL ISSUES FOR
PATIENT GROUPS
• Potential delays in
access
• New barriers for
drugs for rare
diseases
• PMPRB has no
patient input
mechanisms
27. 27
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone: 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Website www.survivornet.ca
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/