This document summarizes a panel discussion on bringing rare disease drugs to Canada. The panel discussed opportunities and challenges, including having the National Pharmacare Council focus on rare disorders, implementing an orphan drug framework, and adopting managed access programs. Panelists represented patients, industry, and government perspectives on issues like national pharmacare and harmonizing provincial formularies. The discussion focused on improving access to treatments for rare diseases in Canada's universal healthcare system.
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
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This document discusses the importance of patient involvement in health technology assessment (HTA). It notes that HTA evaluates new drugs and medical technologies but typically does not incorporate patient perspectives on factors like quality of life. The document advocates that patients should play a role in HTA processes by providing input on treatment outcomes, tolerability, and other real-world considerations to ensure funding decisions align with patient values and needs. It provides examples of how patients could be engaged as representatives, through surveys or public input, and highlights the need for HTA to consider individual patient impacts rather than just average population effects.
Gerry Jeffcott, of 360 Public Affairs, gave a presentation for the CCSN on the drug approval process in Canada on March 27, 2014. He outlines the divide between public and private networks, cost management, as well as the review and approval process for pharmaceuticals in Canada.
The document outlines a discussion on developing a universal pharmacare program in Canada, including reviewing different models proposed, lessons from international programs, and perspectives from mental health advocates. A vision and principles for a potential universal pharmacare plan are proposed that emphasize equitable access to necessary medications for all Canadians through a publicly-funded program. Next steps discussed include finalizing a report and seeking opportunities to promote the proposed approach.
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.
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
Please share this slideshow with anyone who may be interested!
In this webinar:
● Overview of the structure and operation of Canada’s private drug plan marketplace, including the important distinctions and/or overlaps between private (insurance) and public (government) providers
● Explanation of the role and place of medication coverage within the supplemental health benefits plans of life and health insurance companies which provide pharmaceutical coverage
● Identification of the various providers and influencers which contribute to private formulary (lists of drugs which are covered) decision-making and their roles in the system
● Understanding generally what gets covered, by which plans and under what circumstances and which medications are typically subject to restrictions
● Guidance on how to determine which medications are covered
● Exploration of how patients and caregivers can navigate through the complex private plan system including:
● Who should provide answers regarding coverage and
eligibility?
● What you can do if you run into coverage restrictions / rejections?
● How should patients interact with the private payer community generally?
Contact the presenter:
● suzanne@suzannelepage.ca
● www.suzannelepage.ca
● @suzannelepage
View the video on YouTube: https://youtu.be/yKPUT9Ymj3Y
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
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
This document discusses the importance of patient involvement in health technology assessment (HTA). It notes that HTA evaluates new drugs and medical technologies but typically does not incorporate patient perspectives on factors like quality of life. The document advocates that patients should play a role in HTA processes by providing input on treatment outcomes, tolerability, and other real-world considerations to ensure funding decisions align with patient values and needs. It provides examples of how patients could be engaged as representatives, through surveys or public input, and highlights the need for HTA to consider individual patient impacts rather than just average population effects.
Gerry Jeffcott, of 360 Public Affairs, gave a presentation for the CCSN on the drug approval process in Canada on March 27, 2014. He outlines the divide between public and private networks, cost management, as well as the review and approval process for pharmaceuticals in Canada.
The document outlines a discussion on developing a universal pharmacare program in Canada, including reviewing different models proposed, lessons from international programs, and perspectives from mental health advocates. A vision and principles for a potential universal pharmacare plan are proposed that emphasize equitable access to necessary medications for all Canadians through a publicly-funded program. Next steps discussed include finalizing a report and seeking opportunities to promote the proposed approach.
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.
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
Please share this slideshow with anyone who may be interested!
In this webinar:
● Overview of the structure and operation of Canada’s private drug plan marketplace, including the important distinctions and/or overlaps between private (insurance) and public (government) providers
● Explanation of the role and place of medication coverage within the supplemental health benefits plans of life and health insurance companies which provide pharmaceutical coverage
● Identification of the various providers and influencers which contribute to private formulary (lists of drugs which are covered) decision-making and their roles in the system
● Understanding generally what gets covered, by which plans and under what circumstances and which medications are typically subject to restrictions
● Guidance on how to determine which medications are covered
● Exploration of how patients and caregivers can navigate through the complex private plan system including:
● Who should provide answers regarding coverage and
eligibility?
● What you can do if you run into coverage restrictions / rejections?
● How should patients interact with the private payer community generally?
Contact the presenter:
● suzanne@suzannelepage.ca
● www.suzannelepage.ca
● @suzannelepage
View the video on YouTube: https://youtu.be/yKPUT9Ymj3Y
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
The document provides an overview of the Canadian pharmaceutical market, highlighting several key trends that will affect pharmaceutical manufacturers. The Canadian market, while smaller than some other countries, still ranks among the top 10 globally in drug spending. Launching a drug in Canada can be profitable if manufacturers understand the specific nuances of the market, such as Canada's complex reimbursement system with both public and private insurance. Health technology assessments play an important role in reimbursement decisions. Manufacturers must tailor their reimbursement and launch strategies to the target payer market, whether public or private plans. Health economic evidence is also becoming increasingly important for market access, pricing, and contracting in Canada.
SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
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:
● An overview of the court case including the main details, the plaintiffs, and what they were seeking,
● Analysis of the evidence presented during the proceedings,
● What the decision means for patients and producers, and
● Things to come for medical marijuana in Canada
View the video: https://youtu.be/n80-7qGiEnU
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
The document discusses the proposed changes to Canada's Patented Medicine Prices Review Board (PMPRB) regulations and their potential impacts. It begins with concerns over implementing drastic price reductions for new prescription medicines during the COVID-19 pandemic. It then provides an overview of the webinar topics, which include perspectives on alternative drug pricing approaches and implications of the PMPRB changes. The changes would lower Canada's drug prices significantly by changing the comparator countries used to set maximum prices and introducing new factors to unilaterally set maximum rebated prices. There are concerns this could reduce patient access to innovative medicines, especially for rare diseases.
Real-World Data and Real-World Evidence Webinar
Panelists
Tara Cowling, Medlior
Laurie Lambert, CADTH
Craig Campbell, London Health Sciences
Sandra Anderson, Innomar Strategies
Brad Alyward, Canadian Organization for Rare Disorders
Durhane Wong-Rieger, Canadian Organization for Rare Disorders
This document summarizes the challenges faced in gaining government reimbursement for Kuvan, the first drug approved for the treatment of phenylketonuria (PKU) in Canada. It describes PKU as a rare genetic disorder requiring lifelong treatment through a restrictive diet. While Health Canada approved Kuvan in 2010, the Canadian Drug Review recommended against listing it due to a "special note." Provinces have listed Kuvan with strict criteria, denying coverage for all applications to date. The document advocates for less restrictive access criteria and negotiation between provinces and the drug company to improve patient access to this important treatment option.
Oncology Dynamics captures a substantial part of oncological patient treatment journey. It provides real world insights into how standards of care and treatment landscape differ across healthcare systems.
The document summarizes information presented at a rare disease conference panel on preventive and risk-reduction therapies for rare blood disorders. It discusses new therapies for conditions like hemophilia, acquired thrombotic thrombocytopenia purpura, and thalassemia major. Emerging therapies are also mentioned for conditions like fibrodysplasia ossificans progressiva and epidermolysis bullosa. The panel then discusses Canada's capacity for access to orphan and rare disease therapies compared to other countries, noting Canada has a lower reimbursement rate and longer review times on average.
This webinar provides insight into how the drug approval process affects what prescription drugs are available to patients in Canada. The presentation will cover the following topics: Who is responsible for prescription drug approval in Canada? How does the drug approval process impact patient access to medication? How can patients be involved in the drug approval process?
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
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.
Demonstrating Significant Benefit for an OMPMauro Placchi
This article discusses how significant benefit for Orphan Medicinal Products (OMPs) is assessed in the EU and how Health Technology Assessment (HTA) techniques may support demonstrating significant benefit. Significant benefit must be shown at orphan designation and marketing authorization. HTA techniques like cost-utility analysis can estimate cost-effectiveness but may not fully address the unclear definitions of significant benefit in the EU. While HTA preparation should start early, submitting economic data for marketing authorization is inappropriate since pricing is determined separately in each country.
This article discusses using techniques from Health Technology Assessment (HTA) to demonstrate significant benefit for Orphan Medicinal Products (OMPs) in the EU. Significant benefit must be shown at orphan designation and marketing authorization. HTA techniques like cost-utility analysis using Quality-Adjusted Life Years (QALYs) could help compare OMPs to existing treatments. However, QALY analyses for OMPs often find very high incremental cost-effectiveness ratios due to small benefits and high drug costs. The article recommends seeking protocol assistance to ensure appropriate clinical development and establish significant benefit for OMP applications.
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
Canada’s regulatory approach to drugs for rare diseases - Fiona Frappier, Health Canada
The document summarizes a presentation on examining the IBM report on the pan-Canadian Pharmaceutical Alliance (pCPA). The presentation includes an overview of the pCPA, a summary of the key findings and recommendations from the IBM report, and an update on the establishment of a pCPA secretariat as well as impacts on patient access.
In this webinar, our panelists explored ethics, transparency, resources, alignment and conflicts in the important relationships between companies and patient groups.
This webinar presented perspectives from subject matter experts from the innovative medicines industry, governance experts, and patient advocates.
Panelists:
Hugh Scott, Executive Director, Strategic Alliances at Innovative Medicines Canada.
Rosy Sasso, acting Director, Ethics and Compliance at Innovative Medicines Canada.
Brian Huskins, the Senior Fellow of Not-For-Profit Governance at the Institute on Governance.
Martine Elias, Director of Access, Advocacy & Community Relations with Myeloma Canada.
Dr. Durhane Wong-Rieger, PhD, President and CEO of the Canadian Organization for Rare Disorders.
Moderator: Bill Dempster, 3Sixty Public Affairs
The document discusses strategies for successful global drug development. It focuses on navigating FDA accelerated approval programs, new frontiers in personalized medicine, and evolving regulatory paradigms for digital health. The presentation provides an overview of key FDA expedited programs like fast track designation and breakthrough therapy designation. It also examines how regulators are adapting approaches to personalized medicine and digital health technologies.
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
The document provides an overview of the Canadian pharmaceutical market, highlighting several key trends that will affect pharmaceutical manufacturers. The Canadian market, while smaller than some other countries, still ranks among the top 10 globally in drug spending. Launching a drug in Canada can be profitable if manufacturers understand the specific nuances of the market, such as Canada's complex reimbursement system with both public and private insurance. Health technology assessments play an important role in reimbursement decisions. Manufacturers must tailor their reimbursement and launch strategies to the target payer market, whether public or private plans. Health economic evidence is also becoming increasingly important for market access, pricing, and contracting in Canada.
SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
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:
● An overview of the court case including the main details, the plaintiffs, and what they were seeking,
● Analysis of the evidence presented during the proceedings,
● What the decision means for patients and producers, and
● Things to come for medical marijuana in Canada
View the video: https://youtu.be/n80-7qGiEnU
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
The document discusses the proposed changes to Canada's Patented Medicine Prices Review Board (PMPRB) regulations and their potential impacts. It begins with concerns over implementing drastic price reductions for new prescription medicines during the COVID-19 pandemic. It then provides an overview of the webinar topics, which include perspectives on alternative drug pricing approaches and implications of the PMPRB changes. The changes would lower Canada's drug prices significantly by changing the comparator countries used to set maximum prices and introducing new factors to unilaterally set maximum rebated prices. There are concerns this could reduce patient access to innovative medicines, especially for rare diseases.
Real-World Data and Real-World Evidence Webinar
Panelists
Tara Cowling, Medlior
Laurie Lambert, CADTH
Craig Campbell, London Health Sciences
Sandra Anderson, Innomar Strategies
Brad Alyward, Canadian Organization for Rare Disorders
Durhane Wong-Rieger, Canadian Organization for Rare Disorders
This document summarizes the challenges faced in gaining government reimbursement for Kuvan, the first drug approved for the treatment of phenylketonuria (PKU) in Canada. It describes PKU as a rare genetic disorder requiring lifelong treatment through a restrictive diet. While Health Canada approved Kuvan in 2010, the Canadian Drug Review recommended against listing it due to a "special note." Provinces have listed Kuvan with strict criteria, denying coverage for all applications to date. The document advocates for less restrictive access criteria and negotiation between provinces and the drug company to improve patient access to this important treatment option.
Oncology Dynamics captures a substantial part of oncological patient treatment journey. It provides real world insights into how standards of care and treatment landscape differ across healthcare systems.
The document summarizes information presented at a rare disease conference panel on preventive and risk-reduction therapies for rare blood disorders. It discusses new therapies for conditions like hemophilia, acquired thrombotic thrombocytopenia purpura, and thalassemia major. Emerging therapies are also mentioned for conditions like fibrodysplasia ossificans progressiva and epidermolysis bullosa. The panel then discusses Canada's capacity for access to orphan and rare disease therapies compared to other countries, noting Canada has a lower reimbursement rate and longer review times on average.
This webinar provides insight into how the drug approval process affects what prescription drugs are available to patients in Canada. The presentation will cover the following topics: Who is responsible for prescription drug approval in Canada? How does the drug approval process impact patient access to medication? How can patients be involved in the drug approval process?
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
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.
Demonstrating Significant Benefit for an OMPMauro Placchi
This article discusses how significant benefit for Orphan Medicinal Products (OMPs) is assessed in the EU and how Health Technology Assessment (HTA) techniques may support demonstrating significant benefit. Significant benefit must be shown at orphan designation and marketing authorization. HTA techniques like cost-utility analysis can estimate cost-effectiveness but may not fully address the unclear definitions of significant benefit in the EU. While HTA preparation should start early, submitting economic data for marketing authorization is inappropriate since pricing is determined separately in each country.
This article discusses using techniques from Health Technology Assessment (HTA) to demonstrate significant benefit for Orphan Medicinal Products (OMPs) in the EU. Significant benefit must be shown at orphan designation and marketing authorization. HTA techniques like cost-utility analysis using Quality-Adjusted Life Years (QALYs) could help compare OMPs to existing treatments. However, QALY analyses for OMPs often find very high incremental cost-effectiveness ratios due to small benefits and high drug costs. The article recommends seeking protocol assistance to ensure appropriate clinical development and establish significant benefit for OMP applications.
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
Canada’s regulatory approach to drugs for rare diseases - Fiona Frappier, Health Canada
The document summarizes a presentation on examining the IBM report on the pan-Canadian Pharmaceutical Alliance (pCPA). The presentation includes an overview of the pCPA, a summary of the key findings and recommendations from the IBM report, and an update on the establishment of a pCPA secretariat as well as impacts on patient access.
In this webinar, our panelists explored ethics, transparency, resources, alignment and conflicts in the important relationships between companies and patient groups.
This webinar presented perspectives from subject matter experts from the innovative medicines industry, governance experts, and patient advocates.
Panelists:
Hugh Scott, Executive Director, Strategic Alliances at Innovative Medicines Canada.
Rosy Sasso, acting Director, Ethics and Compliance at Innovative Medicines Canada.
Brian Huskins, the Senior Fellow of Not-For-Profit Governance at the Institute on Governance.
Martine Elias, Director of Access, Advocacy & Community Relations with Myeloma Canada.
Dr. Durhane Wong-Rieger, PhD, President and CEO of the Canadian Organization for Rare Disorders.
Moderator: Bill Dempster, 3Sixty Public Affairs
The document discusses strategies for successful global drug development. It focuses on navigating FDA accelerated approval programs, new frontiers in personalized medicine, and evolving regulatory paradigms for digital health. The presentation provides an overview of key FDA expedited programs like fast track designation and breakthrough therapy designation. It also examines how regulators are adapting approaches to personalized medicine and digital health technologies.
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
The document discusses access to drugs for rare diseases in Canada. It notes that Canada currently has no orphan drug policy or definition of rare diseases, unlike the US and EU. As a result, Canadian patients have access to only about half of the orphan drugs approved in the US and EU. A new proposed Canadian orphan drug regulatory framework aims to align with international standards to promote drug development and patient access. It also discusses challenges for drug reimbursement in Canada given the high costs of rare disease drugs and limitations of current review processes. Lifecycle approaches and managed entry programs are proposed to help improve sustainable access.
Financial Protection and Improved Access to Health Care: A Spotlight on Pharm...HFG Project
Presented at “Financial Protection and Improved Access to Health Care: Peer-to-Peer Learning Workshop Finding Solutions to Common Challenges” in Accra, Ghana, February 2016. To learn more, visit: https://www.hfgproject.org/ghana-uhc-workshop
Please share this webinar with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Primer for attendees attending the November 15-16 Drug Pricing Policy Summit
● Broad conceptual blueprint of federal and provincial/territorial public health policy structures across Canada
● Description of legal frameworks, government responsibility centres and their mandates for treatment access, with reference to specific opportunities for patient engagement
View the video: https://youtu.be/X9AB70om-Dw
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
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.
The document summarizes proposed changes to Canada's regulations for pricing patented medicines. It discusses:
- The role of the Patented Medicine Prices Review Board (PMPRB) in regulating drug prices.
- Proposed changes including adding new economic factors, updating comparator countries, and requiring reporting of discounts.
- Potential consequences like reduced drug launches in Canada, delays in drug availability, and price erosion over time.
- Questions around whether the changes will actually lower public drug prices significantly or risk reducing patient access to innovative therapies.
The Conference Board of Canada - Tuesday, April 11, 2017 - Toronto, ON
"Leveraging Change Leadership: Driving Innovation Procurement Forward"
Presentació a càrrec de Antoni Gilabert, director de l'àrea de Farmàcia i del Medicament del CSC
This document discusses managed access programs (MAPs) for rare disease drugs. It provides examples of MAPs from other countries and provinces that use criteria-based access with ongoing monitoring to provide patients with drugs while collecting evidence on effectiveness and budget impact. It recommends that Canada adopt a national MAP approach, with criteria for starting and stopping drugs developed with input from experts, patients, and companies willing to risk-share costs. The goal is to give patients timely access to existing therapies while determining the long-term benefits, costs, and appropriate use.
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 document discusses challenges in accessing rare disease drugs in Canada. It notes that Canada approves only around half of orphan drugs approved in the US and EU. Several provinces have established specialized programs to review rare disease drugs on a case-by-case basis. The document advocates for a "lifecycle approach" where patients are engaged throughout the drug development and review process to improve access and appropriate use. This could include managed access programs combining early approval with ongoing data collection to expand access while managing costs and uncertainties.
This document discusses strategies to improve access to drugs for rare diseases in Canada. It proposes establishing Centres of Expertise across the country to provide coordinated rare disease services. It also recommends creating a national rare disease research network and an accelerated drug access pathway. This would involve concurrent regulatory review and managed access programs to provide early access to drugs while collecting additional evidence. The goal is to deliver on the promise of value-based access to rare disease treatments for Canadians.
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.
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)
This document summarizes a presentation given by David Lin from Novartis Oncology on drug purchasing and pricing from the pharmaceutical industry perspective. The presentation covers:
- The growing demand for healthcare and new treatments putting pressure on pricing and access
- Malaysia's national medicine policy and efforts to improve access to medicines through affordability
- Factors considered in pharmaceutical pricing like production costs, reference pricing to other countries, and balancing access and sustainability
- Efforts by industry like access programs to help patients gain early access to innovative treatments
- The changing treatment landscape with new cellular and personalized therapies requiring new frameworks for evaluation and pricing assessment.
This document summarizes a presentation given by Maureen Smith on patient involvement in drug coverage reviews in Ontario. It outlines how patient groups can submit evidence to be considered by the Committee to Evaluate Drugs, including registering as a patient group, using the submission template, and meeting submission deadlines. It also provides suggestions for making submissions more impactful, such as prioritizing the most important impacts of a disease and treatment outcomes. The goal is to systematically incorporate the patient perspective into drug review and funding decisions in Ontario.
Investigation of the accessibility and affordability of medicines in speciali...Cornelis Jan Diepeveen
The document discusses a study investigating the accessibility and affordability of medicines in specialist medical care in the Netherlands. It provides context on key players in the supply chain and financing of these medicines. The study included interviews, literature reviews, surveys, and data analysis. It examines current expenditures on these medicines, how costs may develop, and ways to better ensure accessibility and affordability. The summary provides high-level information on the purpose, methodology, and focus of the study without copying significant text.
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
Similar to Bringing Rare Disease Drugs to Canada Opportunities, Challenges, and More Challenges (20)
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
About the Webinar: Michelle Colero, Executive Director of Bladder Cancer Canada, will cover the essentials of bladder cancer facts and symptoms while also outlining the support and educational resources provided by Bladder Cancer Canada for those dealing with a diagnosis. Additionally, she’ll share ways individuals can contribute to raising awareness and supporting our community.
About the Webinar: Alcohol is classified as a Group one carcinogen and is estimated to be one of the top three causes of cancer deaths worldwide. Yet, over 40 per cent of people in Canada remain unaware that alcohol consumption increases the risk of developing at least nine cancers. In this presentation, we’ll look at what is and isn’t known about the relationship between alcohol and cancer. We’ll explore what the Canadian Cancer Society is doing to raise awareness of alcohol as a modifiable cancer risk factor, its commitment to funding world-leading research on this subject, and its advocacy for stronger policies that reduce, and increase awareness about the risk of cancer related to, alcohol consumption. Attendees will be invited to seek more information and/or take action on this important topic. We hope you’ll join us in learning more about cancer risk and alcohol — the most commonly used psychoactive substance in Canada.
Dr. Rob Rutledge returns for his first webinar of 2024 to discuss the basics behind emotional intelligence. Learn how to develop greater emotional awareness, and learn how to settle fear and frustration. Dr. Rutledge will also share tips on how to live in a more peaceful and connected way as you navigate through your cancer journey.
About the Webinar: Health technology assessment (HTA), the approval process for drugs and healthcare technology, the processes and organizations that support them, such as Canadian Agency for Drugs and Technologies in Health (CADTH), have evolved over the years in response to changing healthcare system priorities and the need to establish their legitimacy. Don Husereau will provide an overview of current processes in Canada, and highlight their perceived (and real) shortcomings and what can be done to overcome these. He will highlight that some perceived weaknesses (such as review times) are not as bad as they appear while perceived strengths (such as stakeholder involvement) need considerable improvement. He will also discuss other opportunities for HTA to innovate and whether there are current plans to address these.
About this Webinar: The time between regulatory approval for new drugs and when drugs became publicly available to patients averaged 736 days (25 months) in 2022. This is double the average time reported in comparable Organisation for Economic Development (OECD) countries. This webinar will highlight variations in drug listing time for new drugs across time, provinces, and type of drugs (oncology vs. non-oncology). It will also present the specific phases involved in moving a drug from approval stage to listing, and the time spent in each. This Conference Board of Canada analysis uses IQVIA’s Market Access Metrics Database (2012 to 2023), which tracks all new products and their indications through the Canadian access journey.
About the Webinar: Learn about pancreatic cancer symptoms, diagnosis, treatment options, statistics, supports and barriers. The presentation will also include some helpful tools that can improve quality of life for those with pancreatic cancer, including the Craig's Cause's PERT (Pancreatic Enzyme Replacement Therapy) calculator and available patient support programs.
As referenced by John Adams in his 2024 CCSN Webinar on the US importing drugs from Canada, this is a slide deck from Health Canada which outlines the timetable and actions taken by the government on this particular issue.
About this Webinar: John Adams takes a dive behind the headlines, news stories and media releases to better understand any real threats to Canadian patients getting the prescription drugs they need.
About this Webinar: We know that methods of eating and diet are a large part of cancer care, but how can you make your diet work for you in your cancer journey? Dr. Rob Rutelege is back to present the latest science around healthy eating and cancer care. In addition, Dr. Rutledge will share the benefits of time-restricted eating, and how you can incorporate it into your daily routine.
Colorectal cancer is the second leading cause of cancer death in Canada, with approximately 24,100 Canadians diagnosed with the disease in 2023. The incidence of colorectal cancer has been declining in Canadians over 50 years of age, largely due to population-based screening programs. Recent evidence has shown, however, that rates have been increasing in adults younger than 50 years. Given that younger adults are typically classified as at low risk for colorectal cancer, this epidemiologic shift is cause for concern.
Individuals under the age of 50 now represent a significant number of colorectal cancer cases. The disease is often being diagnosed at a later stage, and tumour characteristics tend to be more lethal. As for what is accounting for the increasing trend, ongoing research efforts focus on environmental toxicities, lifestyle patterns, and the gut microbiome.
In this webinar, we will present an overview of the current evidence surrounding the rising rates of colorectal cancer in young adults and discuss the unique needs of this patient population, through screening, diagnosis, treatment, and survivorship. A young colorectal cancer patient will share his lived experience in managing this disease and the impact that cancer has had on himself and his family.
About this Talk: This talk will provide a nutritional perspective on the role of diet in cancer focusing on healthy fats known as omega-3 fatty acids. Sources, amounts and types of omega-3 fatty acids will be highlighted. Clinical and experimental evidence in support of a role for omega-3 fatty acids in the prevention and treatment of breast cancer will be presented. Lastly, some practical strategies to support a healthy diet will be shared.
About the Webinar: Genomic testing has already become commonplace in oncology, but exponential growth in more comprehensive genomic tests, other innovative tests and testing approaches in oncology, as well as a number of other therapeutic areas is expected in the coming years. With the emergence of more complex, more expensive, and more promising tests, policymakers and healthcare providers may be challenged to provide these to patients at the pace of innovation. Don Husereau will describe what conditions are necessary for equitable access to advanced innovative testing, how major Canadian provinces are doing, and what more needs to be done in the coming years to benefit all patients.
About this Webinar: This talk will explore breast screening for women 40-49. The benefits and harms for screening will be discussed, as well as what is unique about breast cancer in women in their 40s. In order to understand the controversy around current guidelines recommending against screening women 40-49, we will review the evidence upon which these guidelines are based, and their impact on breast cancer outcomes for these women.
About this Webinar: This presentation will discuss the pathway to pharmaceutical treatments in Canada that involve health technology assessment reviews and decision making. Observations on the current challenges and the importance of patient input to inform decision making will also be discussed. Finally, the key elements that can be critical to successful outcomes will be presented.
About this Webinar: When Canadians turn on the tap for a drink of water or a shower, we take for granted that the water is safe. Few are aware that old asbestos cement water pipes still deliver water to millions of people. As these pipes age and deteriorate, asbestos erodes into the water and poses health concerns, including cancer.
Dr. Meg Sears, Chair of the Board of Prevent Cancer Now, and board member Julian Branch will talk about the history of asbestos in water, the science behind ingested asbestos, and recent developments.
This document summarizes key findings from the EUPROMS study on the impact of prostate cancer treatments on patient-reported outcomes. Some highlights include:
- Radical prostatectomy (RP) and radiation therapy (RT) both significantly reduced sexual function scores compared to active surveillance (AS), with about 1/3 of AS scores. RP also significantly reduced urinary continence scores compared to healthy controls.
- About 30-40% of RP patients and 15-20% of RT patients reported urinary incontinence issues like pad usage. RP also saw greater issues with urinary, bowel and sexual dysfunction compared to RT.
- Shared decision making scores were generally in the moderate range (median 33-
This webinar will serve as an introduction to Cancer and Work, a website that “was designed to address the unique needs of cancer survivors with returning, remaining, changing work or looking for work after a diagnosis of cancer. The website provides newly created information, resources, and interactive tools for cancer survivors, healthcare providers, employers, and highlights helpful information from across the globe.” The talk will include 10 steps to return to work, and job search ideas for cancer survivors
This webinar will have two perspectives.
Jasveen will be presenting about the impact of cancer and treatment on a person’s physical, cognitive & mental health and how an Occupational therapist can work with the person to gradually overcome these challenges to return to work with or without modifications. The presentation will cover some case studies of past success with the opportunity to answer questions at the end.
Then we will hear from Jen who has experienced her own journey with breast cancer and how she advocated for herself and occupational therapy to help her return to full time employment.
Over half of cancer patients surveyed developed COVID-19, with about one in six experiencing long COVID. Nearly half were infected over a year ago. Fatigue, cough, body aches and headaches were common initial symptoms. While most confirmed their infection, nearly half are not receiving help for long COVID symptoms. Two-thirds remain concerned about long COVID due to potential long-term issues and reduced quality of life. Better access to doctors and treatment are needs to help overcome long COVID.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
low birth weight presentation. Low birth weight (LBW) infant is defined as the one whose birth weight is less than 2500g irrespective of their gestational age. Premature birth and low birth weight(LBW) is still a serious problem in newborn. Causing high morbidity and mortality rate worldwide. The nursing care provide to low birth weight babies is crucial in promoting their overall health and development. Through careful assessment, diagnosis,, planning, and evaluation plays a vital role in ensuring these vulnerable infants receive the specialize care they need. In India every third of the infant weight less than 2500g.
Birth period, socioeconomical status, nutritional and intrauterine environment are the factors influencing low birth weight
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
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4. CORD on the Hill yesterday
4
1. Mandate the National Pharmacare
Council to pay special attention to the
2.8 million Canadians with a rare
disorder as it develops national
pharmacare – an opportunity to to fix the
gaps in accessing treatments for rare
disorders and remedy this problem in our
universal healthcare system
2. Implement the federal orphan drug
regulatory framework
3. Adopt a specific drug program or
funding approach – managed access
programs can help bring products through
the system in a sustainable way
5. Panelists
5
John Oliver: Member of Parliament for Oakville;
Member of the House of Commons Standing
Committee on Health (HESA)
Neil Palmer: Founder and Principal at PCDI
Market Access
Sherry O’Quinn: Managing Principal at MORSE
Consulting and formerly Senior Pharmacist with
the Ontario Ministry of Health and Long-Term Care
Durhane Wong-Rieger: President and CEO of
CORD
8. Why National Pharmacare?
1. Universal / comprehensive pharmacare coverage
– Providing coverage for those with no or inadequate coverage
– Ability to pay should not be a barrier
2. Equity / equitable access to prescription drugs across Canada
– National formulary of clinically and cost effective drugs
3. Reducing overall drug expenditures
– Increased bargaining power should result in lower prices
4. Public Only – eliminating private drug insurance
– Consistent with Canada Health Act principles for medically necessary services
March 2018 8
9. But…
1. Universal coverage – we still don’t know the extent of the lack of coverage
– Estimates are based on limited surveys with poor response rate
– True rate of inadequate coverage is unknown
– All jurisdictions have catastrophic coverage (but is it adequate?)
2. Equity / equitable access – pan-Canadian process already in place and evolving
– Provincial formularies are > 90% harmonized already
– CADTH (CDR, pCODR) and pCPA (all public jurisdictions) continue to improve harmonization
– National Formulary may further restrict / limit access to effective drugs
3. Reducing drug expenditures – mechanisms already in place and evolving
– National Pharmacare program is not a prerequisite for lower prices or lowering drug
expenditures
– PMPRB, pCPA , private insurers are actively reforming pricing and funding policies to limit
drug prices and expenditures – how would national pharmacare be any different
4. Public Administration – what will be gained by eliminating private drug insurance?
– Reduced coverage (fewer drugs covered)
– Private drug plans are an employee benefit (like dental, eye care)
– Opportunity Cost (of using scarce health care dollars to cover patients already covered by
private plans)
March 2018 9
10. Recommendations
• Universal Coverage – Yes
– Public plans should expand to cover those with no or inadequate private
coverage but not replace private coverage
– Funding from Feds?
• National Formulary – No
– Provincial Formularies must continue to reflect underlying provincial health
care systems and priorities
– CADTH, pCPA already harmonize >90%
• Physician prescribing
– Physicians (particularly specialists) should have greater latitude to decide
which medications are best for specific patients
March 2018 10
11. Biography
W. Neil Palmer
Founder & 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.
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.
Since 2015, Neil is Adjunct Assistant Professor at the University of Southern California School of Pharmacy graduate program in
Health Care Decision Analysis where he is an occasional lecturer on health technology assessment, pricing and market access
from a global perspective.
March 2018 11
12. Man i & O ’Qu in n Reimb u rsement S trateg y E xp erts
( MO RS E )
Public Reimbursement of Drugs for Rare Diseases
(DRDs) in Canada
Canadian Organization for Rare Disorders (CORD)
Rare Disease Day 2018 Conference: March 21, 2018
Presented by: Sherry O’Quinn
Managing Principal
Note: Analysis results are preliminary and require additional internal validation
13. Objective
13
To provide an analysis of drugs for rare diseases
(DRDs) which have made their way through the
Canadian reimbursement pathway in order to
better understand the specific challenges for
DRDs versus other drugs.
14. Health Canada
CADTH: CDR
CADTH:
pCODR
INESSS
pCPA
Public Payer Private Payer
Regulatory
HTA HTAHTA
Reimbursement
Reimbursement Reimbursement
How do drugs become a part of the
pharmaceutical market and achieve
funding in Canada?
PMPRB
Pricing
THE REIMBURSEMENT PATHWAY
LEGEND
PMPRB – Patented
Medicine Prices Review
Board
HTA – Health Technology
Assessment
INESSS – Institut National
d’Excellence en Santé et en
Services Sociaux
CADTH – Canadian Agengy
for Drugs & Technologies in
Health
pCODR- pan-Canadian
Oncology Drug Review
CDR – Common Drug
Review
pCPA – pan-Canadian
Pharmaceutical Alliance
The reimbursement process is complex with little customization for DRDs specifically.
15. MORSEAnalysis:
Objectives &
Assumptions
15
MORSE conducted a preliminary analysis* of DRDs for this presentation
Objective: to develop an understanding of how DRDs are considered in the
Canadian reimbursement landscape with a focus on CADTH recommendations
and pCPA negotiations
Methodology & Assumptions:
• Drugs for rare diseases were based on a list provided by CORD.
• All drugs reviewed by CADTH are based on MORSE’s internal database
• The relevant pCPA files for the list of DRDs were identified as were the
applicable HTA reviews in order to assess the reimbursement
recommendation, pCPA status and timelines associated with market access.
• Data from INESSS was not included
*Preliminary analysis with results still to be validated
16. CDRRecommendations:
AlldrugscomparedtoDRDs
16
3%
33%
2%
62%
Reimburse
Do Not Reimburse
Do not list at submitted
price
Reimburse with
conditions
14 (3%) recommend to reimburse
274 (62%) recommend to reimburse with criteria
and/or conditions
144 (33%) do not recommend to reimburse
11 (2%) do not reimburse at submitted price
CDR Recommendations for
all drugs*
n=443
CDR Recommendations for
Drugs for Rare Diseases**
n=52
Key Take-Away:
**only includes drugs for rare diseases which have been referred to the pCPA as identified by CORD
* Approximation based on MORSE data (as of March 2018)
2%
38%
2%
58%
1 (2%) recommend to reimburse
30 (58%) recommend to reimburse with criteria
and/or conditions
20 (38%) do not recommend to reimburse
1 (2%) do not reimburse at submitted price
Within the non-oncology space, there is a relatively small difference between the “positive”
reimbursement recommendations for DRDs when compared to all CDR recommendations as a whole.
17. pCODRRecommendations:
AlldrugscomparedtoDRDs
• Since its initiation in 2010 through to June 2017, pCODR has released 88 “Notifications to
Implement”
• Source: CADTH Drug Portfolio Slides – October 3, 2017
10%
68%
22%
Positive
Recommendation
Conditional
Recommmendation
Negative
Recommendation
9 (10%) recommend to reimburse
59 (68%) recommend to reimburse with clinical criteria
and/or conditions
19 (22%) do not recommend to reimburse
All pCODR Recommendations
As of June 2017
pCODR Recommendations for
Drugs for Rare Diseases*
68 (78%) received a recommendation recognizing clinical
benefit, with the majority noting a need for a price reduction to
improve cost-effectiveness
*only includes drugs for rare diseases which have been referred to the pCPA as identified by CORD
7 (10%) recommend to reimburse
47 (69%) recommend to reimburse with clinical criteria
and/or conditions
14 (21%) do not recommend to reimburse
10%
21%
69%
For oncology drugs, the recommendations for DRDs are very consistent with all drugs.
18. pCPANegotiationStatus:
DRDscomparedtoalldrugs
18
Drugs for Rare Diseases All Other Files
Individual
P/T Level
3
Referred to pCPA
115 Files
No
Negotiation
25
Negotiate
87
Currently
Underway
20
No Deal
6
Signed Letter
of Intent
61
70%
3%22%
7%
Referred to pCPA
190 Files
No
Negotiation
32
Individual
P/T Level
10
Negotiate
148
Currently
Underway
15
No Deal
15
Signed Letter
of Intent
118
17% 5%
80%
10%
DRDs have had a slightly lower percentage of files negotiated and completed, however, they have a
lower rate of failed negotiations. It is also noteworthy that more DRDs are currently being negotiated.
23%
75% 78%
10%
19. pCPANegotiationStatus:
ByCADTHReviewProcess
19
0
20
40
60
80
100
120
140
Declined Negotiation Completed Negotiation
(LOI)
Closed Negotiation (No LOI) Individual Negotiation Active
NumberofFiles
pCPA Status
pCPA Status of Drugs for Rare Diseases
By CADTH Review Process
CDR pCODR No HTA Review
The pCPA has successfully completed negotiations for more oncology than non-oncology DRDs. In
addition, there are a large number of DRDs under active negotiation right now.
20. pCPAProcessTimelinesfor
CompletedNegotiations:
DRDscomparedtoalldrugs
• It is assumed that pCPA Initiation/closure dates occur mid-month
20
The median calendar days for initiation and a successful negotiation for DRDs were similar compared to
all drugs, however, there were certain non-oncology DRD files that skewed the total duration.
0
50
100
150
200
250
300
350
400
450
CDR
n=67
pCODR
n=37
Median Calendar Days in pCPA
process for All Completed Files (LOI)
from 2015 – 2017*
Time to Initiation
Duration of Negotiation
Total Time from Recommendation to pCPA Completion
* Excludes pCPA initiated files
• n includes all files, however if initiation date was unavailable then that file was not included in the median
time to initiation or duration calculation
0
50
100
150
200
250
300
350
400
450
CDR
n=13
pCODR
n=43
No HTA Review
n=3
MedianCalendarDays
Median Calendar Days in pCPA Process
Completed (LOI) Negotiations
from 2010 – Jan. 2018*
Drugs for Rare Diseases
Time to Initiation
Duration of Negotiation
Total Time from Recommendation to pCPA Completion
21. pCPAProcessTimelinesfor
ClosedNegotiations:
DRDscomparedtoalldrugs
• It is assumed that pCPA Initiation/closure dates occur mid-month
21
For negotiations that are eventually closed with no LOI, DRDs from CDR have negotiations that are
started sooner but are negotiated over a longer time period than all drugs.
0
100
200
300
400
500
600
CDR
n=6
pCODR
n=1
Median Calendar Days in pCPA Process
Closed (No LOI) Negotiations from 2010 to Jan. 2018
for Drugs for Rare Diseases
Time to Initiation
Duration of Negotiation
Total Time from Recommendation to pCPA Closure of Negotiation
0
100
200
300
400
500
600
CDR
n=16
pCODR
n=1
Median Calendar Days in pCPA process for All Closed
Files (LOI) from 2015 – 2017*
Time to Initiation
Duration of Negotiation
Total Time from Recommendation to pCPA Closure of Negotiation
* Excludes pCPA initiated files
• n includes all files, however if initiation date was unavailable then that file was not included in the median
time to initiation or duration calculation
22. Considerations
• This analysis does not show:
o Time to listing across public plans
o Challenges with implementation or restrictive criteria
o Impact of stakeholder input
o Changes within process
o Potential changes in metrics over time
• Surprising findings with less “difference” between HTA review
outcomes and pCPA metrics for DRDs vs. all drugs
• A large number of DRDs are within the oncology space where
there seems to be almost no difference
• More analysis can help shed further light on these issues.
22
23. Panelists
23
John Oliver: Member of Parliament for Oakville;
Member of the House of Commons Standing
Committee on Health (HESA)
Neil Palmer: Founder and Principal at PCDI
Market Access
Sherry O’Quinn: Managing Principal at MORSE
Consulting and formerly Senior Pharmacist with
the Ontario Ministry of Health and Long-Term Care
Durhane Wong-Rieger: President and CEO of
CORD
24.
25. 25
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
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/
Editor's Notes
Regulatory Modernization
CADTH / HTA
National Procurement
Health Accord / Health System Renwal
Bolster support for key short term J&J and individual sector opportunities:
Intellectual property / CETA
Reprocessed devices
Regulatory Modernization
CADTH / HTA
National Procurement
Health Accord / Health System Renwal
Bolster support for key short term J&J and individual sector opportunities:
Intellectual property / CETA
Reprocessed devices
Regulatory Modernization
CADTH / HTA
National Procurement
Health Accord / Health System Renwal
Bolster support for key short term J&J and individual sector opportunities:
Intellectual property / CETA
Reprocessed devices
Includes all CDR recs since beginning initially – based on MORSE database
All recommendations chart is from CADTH presentation deck.
Purple: # completed/# negotiate
No Review includes Tobi, Jadenu and Cerezyme
DRDs INCLUDE pCPA initiated files hence the long total time from recommendation to pCPA completion (I.e. drugs with recommendations in 2004/2005)
2015/16 that is driving it downward.
DRDs INCLUDE pCPA initiated files hence the long total time from recommendation to pCPA closure
The illustration shows how a biomarker test is performed.
The clinician will discuss the test and the purpose of the test with his patient.
A tissue sample (biopsy) of the tumor will then be taken, and the clinician orders the biomarker test. If a patient has already had a biopsy, he or she may not have to get another one. The clinician may be able to see if the tumors are positive for certain biomarkers by testing a previous sample with a biomarker test.
The biopsy is sent to a lab and is analyzed.
The clinician will get the results and discuss treatment options with the patient based on these results.
Patients can aim to learn more and engage with their health care team and/or patient group to better understand how biomarker tests can help shape their treatment. Key questions to consider include:
What biomarker tests are recommended and why?
How are the tests performed?
How often do I need the tests?
What do the results of the tests mean?
How will the results affect my treatment options?
In this regard, I want to mention that the Canadian Cancer Survivor Network will be hosting a webinar on biomarkers on November 29th.
Patients and patients groups can also get involved in personalized medicine policy and advocacy:
work with health technology assessment agencies and payers to ensure that value assessments are patient-centered and that biomarker tests are reimbursed and included as part of patient care
work with payers to ensure that emerging paying models are aligned with personalized medicine and that they recognize the improved health outcomes from personalized medicine
In particular, patients and patient groups will get the chance to provide input on the new evaluation process for companion diagnostics that CADTH is developing in the coming months.