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Pharmacare Blueprint for Canada
Caveat Emptor: Buyer Beware
June 2, 2016
Webinar Agenda
1. Historical background
2. Some proposed models
3. International comparators
4. Mental health perspective
5. Draft vision
6. Draft values and principles
7. Next steps
2003 First Ministers Health Accord
• National Pharmaceuticals Strategy (NPS)
• F/P/T commitment that:
“No one will be denied access to necessary, very
high cost drugs based on where they live, or
their ability to pay.”
Two Options for Design Proposed
1. Option one:Threshold for the program:
variable percentage of family income from
0%, 3%,6% and 9% after which drugs covered
100%. Below $20,000 income =0% and above
$90,000 = 9%.
2. Option two: 5% fixed income threshold after
which drugs are covered 100%
Kirby and Romanow Reports 2002,
Commission Recommendations
• Both supported catastrophic drug plans.
• Both identified maximum $1500 per annum
threshold for catastrophic drug transfer to federal
plan.
> Kirby added 3% of household income to a
maximum of $1500 per year as threshold for a pan-
Canadian catastrophic drug plan.
Ontario Minister of Health’s Expert
Roundtable June, 2015
Group of academics, provincial government bureaucrats
and politicians, consultants
Issues raised included:
Increasing costs and prices of brand, generic drugs
Poor prescribing practices
HTA recommendations
Limited drug budgets both publicly and privately
Limited R+D from industry
Aging population
Rare diseases and novel drug innovations
Broad areas of consensus
• Too many Canadians without coverage or
insufficient coverage.
• Could spend less on prescription drugs and get the
same or better value.
• Without substantive policy reform the current
situation could get worse.
• We do not want a poor Pharmacare plan e.g. one
that provides “universal coverage” but one where
patients cannot afford to take their medications or
where the costs increase at the rate they have over
the past 15 years.
Broad areas of consensus
• Decisions about publicly funded prescription drugs
should be based on evidence and de-politicized to
the extent possible.
• A good Pharmacare plan would focus not just on
providing coverage to the entire population but
would include improving the quality of prescribing
practices.
• The development of a good pharmaceutical plan
requires ongoing evaluation and refinement.
Broad areas of consensus
• The goals of a pharmaceutical plan should be
a program that produces better health
outcomes at a lower total cost than we
currently spend and provides a good
experience for patients.
• Main Implementation solution identified
– Pharmacare as defined by a common national list of drugs covered by
all jurisdictions
• Federal Minister of Health’s Mandate
– Exploring the need for a national formulary
• Announcement of an F/P/T Working Group to study
Pharmacare.
– Announcement of an F/P/T Working Group to study Pharmacare
• Liberal Party endorsement of Pharmacare
– May 28-29 Convention
Political developments in Pharmacare
Key take-aways from M-A Gagnon
By Marc-André Gagnon*, PhD
Associate Professor, School of Public Policy and Administration
(Carleton University)
Email: ma_gagnon@carleton.ca ; Twitter: @MA_Gagnon
*Research funded by Faculty of Public Affairs (Carleton University), CIHR, Canadian
Federation of Nurses’ Union, Health Canada.
-SG Morgan, MA Gagnon, B
Mintzes and J Lexchin. « A Better
Prescription: Advice for a National
Strategy on Pharmaceutical Policy
in Canada ». Healthcare Policy,
12(1) May 2016.
Reforming Drug Coverage:
Universal, Public, Evidence-
based, Pan-Canadian,
Comprehensive, Integrated
Pharmacare Program with
first dollar coverage for
medically necessary cost-
efficient drugs
Pharmacare for Canada:
1. Eliminate fragmentation: 1 drug plan for all
Canadians, funded through general tax revenues.
2. Improve equity of access (National Formulary).
3. Depoliticized agency managing evidence based
formulary with closed budget (like hospital
formulary committee).
4. Clear mandate to maximize therapeutic value
for money. Systematic use of HTA.
5. Systematic recourse to bulk-purchasing
capacity to contain cost
6. Elimination of co-pays/deductibles based on
official prices.
7. Monitoring prescribing habits/promoting
rational use of medicines
Key take aways from international
comparison
• M-A Gagon
• Neil Palmer
1010
771
736718
668666651
599588574562561
535523514513512498
478473473
454450439
414399
367
321311297295
274
204
70
0
100
200
300
400
500
600
700
800
900
1000
1100
UnitedStates
Canada
Belgium
Japan
Germany
Ireland
France
Greece
Australia
Hungary
Switzerland
Austria
SlovakRepublic
Spain
Italy
Slovenia
Iceland
OECDAVERAGE
Sweden
Portugal
Finland
Korea
Netherlands
CzechRepublic
Norway
Luxembourg
UnitedKingdom
Poland
Estonia
NewZealand
Denmark
Israel
Chile
Mexico
Total expenditure per capita on
pharmaceuticals,
2012 or nearest year
US$, purchasing power parity
Source: CIHI, OECD Health Statistics 2014
Key take aways from international
comparison
• Compared to most European countries:
Canada has the highest growth in
prescription drug cost (2000-2012)
• Kiwis:
– Maximizing therapeutic value for every $ spent
– HTA for all new drugs (positive list)
– “No” Means “No”
– Tendering
– Reference pricing
– PLAs and negotiations
– Clauses to reduce shortages
Key take aways from international
comparison
• UK:
– Universal Pharmacare Integrated with Medicare
– NICE (negative list)
– Low or no co-pays
– 209 clinical commission groups – each with a budget set by NIH
– Innovative reimbursement schemes - Velcade
– Poor performance of cancer drug listings – led to development of Cancer drug fund
• Germany:
– based on price
– Manufacturers still able to freely set a price for a new drug, but it will only apply during the first 12 months of
marketing
– During year 1 manufacturers must prove their drug provides some form of added clinical benefit compared to
existing drugs
• If NO added benefit reference-pricing scheme or pharma walks away
• France:
– Price allocated based on clinical improvement scale
– This system is unique, as both the level of co-payment and the price negotiations depend on
the added value related to effectiveness.
Public Pharmacare should not be an open bar
• Freedom of choice is freedom to pay out-of-pocket for what you
want.
• Public provision of pharmaceuticals must be organized based on a
normative framework focused on clinical evidence at every stage
(approval of drugs, willingness-to-pay, prescribing habits, and
monitoring appropriate use).
• Consulting patients in designing the reimbursement criteria is
central, but societal values of fairness and equity should underpin
design. Every dollar spent should maximize therapeutic gain.
• Mechanics and decisions for reimbursement should be clear and
transparent. Decision-making should be accountable but
depoliticized.
Model Proposed by Canadian Treatment Action
Council (CTAC), 2009
Universal Catastrophic Drug Plan
 Legislated addition to existing public plans
 Multi- stakeholder funded insurance plan
 Available to all Canadian residents i.e. universal, needs based
 For prescription drugs, biologics, medical devices, approved
by HC
 Rare diseases included
 Cosmetic treatments excluded
 Prescribed by a regulated HC professional
 No waiting period from province to province
 For those without any or adequate coverage
CTAC Model
Coverage and Funding
First dollar coverage after cost sharing
Sliding scale cost sharing based on family income and
tax bracket
$0 cost for those in lowest tax bracket
$ TBD for each higher tax bracket
No increased cost to anyone as a result of plan
introduction from last year’s out of pocket expenses
F/P/T governments and employers will also contribute
Mental Health Implications
• Access to a wide range of treatments and
supports has been a long-standing policy priority
for the Schizophrenia Society of Ontario (SSO)
• SSO believes that all treatment types should be
accessible to individuals and families including:
– Community services
– Social supports
– Psychiatric treatment – including medications
Mental Health - Context
• The intersection between mental health and physical
health is dynamic, for example:
– The diagnosis and treatment of cancer has a significant
impact on mental health
– People with schizophrenia who are diagnosed with cancer,
for instance, have poorer outcomes than the general
population
• People with mental illness often use more than one
medication due to the presence of other concurrent
physical and mental health conditions
Intersection - Issues Accessing
Medications
• There are also intersecting challenges with
accessing needed medications, including:
– Affordability
– Gaps in transitions between plans and systems
– Delays in medication listing timelines
– Listing decisions and system sustainability
• Pharmacare as defined by a common national list
of drugs covered by all jurisdictions would not
solve these issues
Key Considerations
• Equal opportunity to access therapies regardless of social
determinants of health
• Values and principles:
– Social justice - uphold equal opportunity for all social
determinants of health
– Protect existing individual access to therapies at their current
level
– Ensure access to medically necessary therapies for uninsured
and underinsured residents of Canada regardless of ability to
pay or place of residency
– Retain pharmaceutical system savings within the Pharmacare
budget in order to provide increased access to therapies
– Ensure recognition and value of real world evidence in
determining therapeutic value
Economic Analysis
• No detailed economic analysis and forecasting
of cost of a universal drug plan has ever been
undertaken
International Comparators
• While other OECD countries have a universal
drug system, “universal” refers to population
inclusion not inclusion of all treatments
• No plan is without some cost to the
participants
Our Vision
• All people residing in Canada have timely,
consistent, equal and equitable access to safe,
appropriate and effective therapies, including
treatments and medications, as well as the
information, diagnostics, care and support that
they need, without conditions.
• This is part of a broader vision for every person to
have equal opportunity to access therapies
regardless of social determinants of health.
Our Values and Principles
• Respect for people who access the health system and their
support team.
• Meaningful and ethical engagement of people who access
the health system including engagement in health systems
planning, decision making, implementation, knowledge
transfer and exchange, monitoring and evaluation, systems
redesign.
• Universality and equality recognizing diversity and
accommodation.
• Transparency and information sharing in all health systems
processes and health policy decisions.
Our Values and Principles
• Support for health innovations including access to
innovative therapies as required.
• Excellence in health systems and health policy,
including recognition of the importance of
integrating best practices in evidence-based
qualitative and quantitative medicine and the
importance of an accountability framework for all
health systems processes and health policy.
• Capacity building and mentoring.
• Social Justice to uphold equal opportunity for all
social determinants of health.
Our Values and Principles
• Ensure protection of existing individual access to
therapies at their current level.
• Ensure access to medically necessary therapies for
uninsured and underinsured residents of Canada
regardless of ability to pay or place of residency.
• Ensure recognition of the discrete and distinct
needs of people with life threatening and serious
debilitating illnesses that significantly impact
quality of life.
Our Values and Principles
• Ensure recognition and value of real world evidence
in determining therapeutic value.
• Ensure that pharmaceutical system savings are
retained within the Pharmacare budget in order to
provide increased access to therapies.
• Ensure that Pharmacare builds on health care
mechanisms and systems already in place.
• Develop value-based drug pricing contracts,
including systems for data sharing and other
relevant information.
Our Values and Principles
• Analyze the value of a drug for a Pharmacare
system to include savings in other parts of the
health care budget and broader socio-
economic impact.
• Expand health technology assessment
processes to measure the value of all
components of the health care budget.
Next steps
• Finalization of report to be disseminated
broadly for endorsement among patient
organizations.
• Dissemination to all stakeholders, including:
government, policy makers, health care
professionals, academics.
• Request for inclusion on agenda of next F/P/T
Ministers of Health meeting (fall 2016).
• Seek opportunities for public education.
What can you do to help?
• Consider endorsing finalized Vision, Values and
Principles organizationally and individually.
• Disseminate broadly to stakeholders.
• Consider meeting with provincial and federal
representatives.
• Get in touch with us if you want to get more
involved: contact Jackie Manthorne at
jmanthorne@survivornet.ca
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/

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Pharmacare - Caveat Emptor (Let the Buyer Beware)

  • 1. Pharmacare Blueprint for Canada Caveat Emptor: Buyer Beware June 2, 2016
  • 2. Webinar Agenda 1. Historical background 2. Some proposed models 3. International comparators 4. Mental health perspective 5. Draft vision 6. Draft values and principles 7. Next steps
  • 3. 2003 First Ministers Health Accord • National Pharmaceuticals Strategy (NPS) • F/P/T commitment that: “No one will be denied access to necessary, very high cost drugs based on where they live, or their ability to pay.”
  • 4. Two Options for Design Proposed 1. Option one:Threshold for the program: variable percentage of family income from 0%, 3%,6% and 9% after which drugs covered 100%. Below $20,000 income =0% and above $90,000 = 9%. 2. Option two: 5% fixed income threshold after which drugs are covered 100%
  • 5. Kirby and Romanow Reports 2002, Commission Recommendations • Both supported catastrophic drug plans. • Both identified maximum $1500 per annum threshold for catastrophic drug transfer to federal plan. > Kirby added 3% of household income to a maximum of $1500 per year as threshold for a pan- Canadian catastrophic drug plan.
  • 6. Ontario Minister of Health’s Expert Roundtable June, 2015 Group of academics, provincial government bureaucrats and politicians, consultants Issues raised included: Increasing costs and prices of brand, generic drugs Poor prescribing practices HTA recommendations Limited drug budgets both publicly and privately Limited R+D from industry Aging population Rare diseases and novel drug innovations
  • 7. Broad areas of consensus • Too many Canadians without coverage or insufficient coverage. • Could spend less on prescription drugs and get the same or better value. • Without substantive policy reform the current situation could get worse. • We do not want a poor Pharmacare plan e.g. one that provides “universal coverage” but one where patients cannot afford to take their medications or where the costs increase at the rate they have over the past 15 years.
  • 8. Broad areas of consensus • Decisions about publicly funded prescription drugs should be based on evidence and de-politicized to the extent possible. • A good Pharmacare plan would focus not just on providing coverage to the entire population but would include improving the quality of prescribing practices. • The development of a good pharmaceutical plan requires ongoing evaluation and refinement.
  • 9. Broad areas of consensus • The goals of a pharmaceutical plan should be a program that produces better health outcomes at a lower total cost than we currently spend and provides a good experience for patients.
  • 10. • Main Implementation solution identified – Pharmacare as defined by a common national list of drugs covered by all jurisdictions • Federal Minister of Health’s Mandate – Exploring the need for a national formulary • Announcement of an F/P/T Working Group to study Pharmacare. – Announcement of an F/P/T Working Group to study Pharmacare • Liberal Party endorsement of Pharmacare – May 28-29 Convention Political developments in Pharmacare
  • 11. Key take-aways from M-A Gagnon By Marc-André Gagnon*, PhD Associate Professor, School of Public Policy and Administration (Carleton University) Email: ma_gagnon@carleton.ca ; Twitter: @MA_Gagnon *Research funded by Faculty of Public Affairs (Carleton University), CIHR, Canadian Federation of Nurses’ Union, Health Canada.
  • 12. -SG Morgan, MA Gagnon, B Mintzes and J Lexchin. « A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada ». Healthcare Policy, 12(1) May 2016.
  • 13. Reforming Drug Coverage: Universal, Public, Evidence- based, Pan-Canadian, Comprehensive, Integrated Pharmacare Program with first dollar coverage for medically necessary cost- efficient drugs
  • 14. Pharmacare for Canada: 1. Eliminate fragmentation: 1 drug plan for all Canadians, funded through general tax revenues. 2. Improve equity of access (National Formulary). 3. Depoliticized agency managing evidence based formulary with closed budget (like hospital formulary committee). 4. Clear mandate to maximize therapeutic value for money. Systematic use of HTA. 5. Systematic recourse to bulk-purchasing capacity to contain cost 6. Elimination of co-pays/deductibles based on official prices. 7. Monitoring prescribing habits/promoting rational use of medicines
  • 15. Key take aways from international comparison • M-A Gagon • Neil Palmer
  • 17. Key take aways from international comparison • Compared to most European countries: Canada has the highest growth in prescription drug cost (2000-2012) • Kiwis: – Maximizing therapeutic value for every $ spent – HTA for all new drugs (positive list) – “No” Means “No” – Tendering – Reference pricing – PLAs and negotiations – Clauses to reduce shortages
  • 18. Key take aways from international comparison • UK: – Universal Pharmacare Integrated with Medicare – NICE (negative list) – Low or no co-pays – 209 clinical commission groups – each with a budget set by NIH – Innovative reimbursement schemes - Velcade – Poor performance of cancer drug listings – led to development of Cancer drug fund • Germany: – based on price – Manufacturers still able to freely set a price for a new drug, but it will only apply during the first 12 months of marketing – During year 1 manufacturers must prove their drug provides some form of added clinical benefit compared to existing drugs • If NO added benefit reference-pricing scheme or pharma walks away • France: – Price allocated based on clinical improvement scale – This system is unique, as both the level of co-payment and the price negotiations depend on the added value related to effectiveness.
  • 19. Public Pharmacare should not be an open bar • Freedom of choice is freedom to pay out-of-pocket for what you want. • Public provision of pharmaceuticals must be organized based on a normative framework focused on clinical evidence at every stage (approval of drugs, willingness-to-pay, prescribing habits, and monitoring appropriate use). • Consulting patients in designing the reimbursement criteria is central, but societal values of fairness and equity should underpin design. Every dollar spent should maximize therapeutic gain. • Mechanics and decisions for reimbursement should be clear and transparent. Decision-making should be accountable but depoliticized.
  • 20. Model Proposed by Canadian Treatment Action Council (CTAC), 2009 Universal Catastrophic Drug Plan  Legislated addition to existing public plans  Multi- stakeholder funded insurance plan  Available to all Canadian residents i.e. universal, needs based  For prescription drugs, biologics, medical devices, approved by HC  Rare diseases included  Cosmetic treatments excluded  Prescribed by a regulated HC professional  No waiting period from province to province  For those without any or adequate coverage
  • 21. CTAC Model Coverage and Funding First dollar coverage after cost sharing Sliding scale cost sharing based on family income and tax bracket $0 cost for those in lowest tax bracket $ TBD for each higher tax bracket No increased cost to anyone as a result of plan introduction from last year’s out of pocket expenses F/P/T governments and employers will also contribute
  • 22. Mental Health Implications • Access to a wide range of treatments and supports has been a long-standing policy priority for the Schizophrenia Society of Ontario (SSO) • SSO believes that all treatment types should be accessible to individuals and families including: – Community services – Social supports – Psychiatric treatment – including medications
  • 23. Mental Health - Context • The intersection between mental health and physical health is dynamic, for example: – The diagnosis and treatment of cancer has a significant impact on mental health – People with schizophrenia who are diagnosed with cancer, for instance, have poorer outcomes than the general population • People with mental illness often use more than one medication due to the presence of other concurrent physical and mental health conditions
  • 24. Intersection - Issues Accessing Medications • There are also intersecting challenges with accessing needed medications, including: – Affordability – Gaps in transitions between plans and systems – Delays in medication listing timelines – Listing decisions and system sustainability • Pharmacare as defined by a common national list of drugs covered by all jurisdictions would not solve these issues
  • 25. Key Considerations • Equal opportunity to access therapies regardless of social determinants of health • Values and principles: – Social justice - uphold equal opportunity for all social determinants of health – Protect existing individual access to therapies at their current level – Ensure access to medically necessary therapies for uninsured and underinsured residents of Canada regardless of ability to pay or place of residency – Retain pharmaceutical system savings within the Pharmacare budget in order to provide increased access to therapies – Ensure recognition and value of real world evidence in determining therapeutic value
  • 26. Economic Analysis • No detailed economic analysis and forecasting of cost of a universal drug plan has ever been undertaken
  • 27. International Comparators • While other OECD countries have a universal drug system, “universal” refers to population inclusion not inclusion of all treatments • No plan is without some cost to the participants
  • 28. Our Vision • All people residing in Canada have timely, consistent, equal and equitable access to safe, appropriate and effective therapies, including treatments and medications, as well as the information, diagnostics, care and support that they need, without conditions. • This is part of a broader vision for every person to have equal opportunity to access therapies regardless of social determinants of health.
  • 29. Our Values and Principles • Respect for people who access the health system and their support team. • Meaningful and ethical engagement of people who access the health system including engagement in health systems planning, decision making, implementation, knowledge transfer and exchange, monitoring and evaluation, systems redesign. • Universality and equality recognizing diversity and accommodation. • Transparency and information sharing in all health systems processes and health policy decisions.
  • 30. Our Values and Principles • Support for health innovations including access to innovative therapies as required. • Excellence in health systems and health policy, including recognition of the importance of integrating best practices in evidence-based qualitative and quantitative medicine and the importance of an accountability framework for all health systems processes and health policy. • Capacity building and mentoring. • Social Justice to uphold equal opportunity for all social determinants of health.
  • 31. Our Values and Principles • Ensure protection of existing individual access to therapies at their current level. • Ensure access to medically necessary therapies for uninsured and underinsured residents of Canada regardless of ability to pay or place of residency. • Ensure recognition of the discrete and distinct needs of people with life threatening and serious debilitating illnesses that significantly impact quality of life.
  • 32. Our Values and Principles • Ensure recognition and value of real world evidence in determining therapeutic value. • Ensure that pharmaceutical system savings are retained within the Pharmacare budget in order to provide increased access to therapies. • Ensure that Pharmacare builds on health care mechanisms and systems already in place. • Develop value-based drug pricing contracts, including systems for data sharing and other relevant information.
  • 33. Our Values and Principles • Analyze the value of a drug for a Pharmacare system to include savings in other parts of the health care budget and broader socio- economic impact. • Expand health technology assessment processes to measure the value of all components of the health care budget.
  • 34. Next steps • Finalization of report to be disseminated broadly for endorsement among patient organizations. • Dissemination to all stakeholders, including: government, policy makers, health care professionals, academics. • Request for inclusion on agenda of next F/P/T Ministers of Health meeting (fall 2016). • Seek opportunities for public education.
  • 35. What can you do to help? • Consider endorsing finalized Vision, Values and Principles organizationally and individually. • Disseminate broadly to stakeholders. • Consider meeting with provincial and federal representatives. • Get in touch with us if you want to get more involved: contact Jackie Manthorne at jmanthorne@survivornet.ca
  • 36. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Blog: http://jackiemanthornescancerblog.blogspot.com/ Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/