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Bringing Rare Disease Drugs to Canada Opportunities, Challenges, and More Challenges

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This webinar was an interactive live webcast from the Canadian Organization for Rare Disorders’ Rare Disease Day event in Ottawa.

The session was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by several Canadian experts in pharmaceutical access, including a former director of the Ontario Public Drug Programs.
This discussion reviewed the current state of public reimbursement for orphan medicines and examined how the emerging discussions about a new national pharmacare program will affect patient access to these medicines.

The session was followed by an interactive question and answer session.

Presenters:
• Bill Dempster, co-founder of 3Sixty Public Affairs Inc., is an in-demand health and pharmaceutical policy expert who works with a range of clients to navigate complex political, policy, regulatory and reimbursement challenges in the Canadian life sciences field

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Bringing Rare Disease Drugs to Canada Opportunities, Challenges, and More Challenges

  1. 1. Bringing Rare Disease Drugs to Canada: Opportunities, Challenges, and More Challenges National Pharmacare and Rare Disorders March 21, 2017
  2. 2. Federal context 2
  3. 3. Provinces / Federal-Provincial-Territorial Context 3
  4. 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. 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
  6. 6. 6
  7. 7. National Pharmacare: Where should the focus be? W. Neil Palmer Ottawa, March 2018
  8. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 24. 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/

This webinar was an interactive live webcast from the Canadian Organization for Rare Disorders’ Rare Disease Day event in Ottawa. The session was moderated by 3Sixty Public Affairs’ Bill Dempster, who was joined by several Canadian experts in pharmaceutical access, including a former director of the Ontario Public Drug Programs. This discussion reviewed the current state of public reimbursement for orphan medicines and examined how the emerging discussions about a new national pharmacare program will affect patient access to these medicines. The session was followed by an interactive question and answer session. Presenters: • Bill Dempster, co-founder of 3Sixty Public Affairs Inc., is an in-demand health and pharmaceutical policy expert who works with a range of clients to navigate complex political, policy, regulatory and reimbursement challenges in the Canadian life sciences field

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