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Federal pharmaceutical pricing reform: What do patients think?
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.
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Federal pharmaceutical pricing reform: What do patients think?
- 1. Federal patented medicinesregulations Update on Health Canada’s proposed regulations and patient perspectives January 18, 2017
- 2. What is thePMPRB? • Quasi-judicial federal agency • Regulates medication prices while they are under patent • Reports to the federal health minister • Twofold mandate o Regulatory – Ensures that prices charged by patentees for patented medicines sold in Canada are not “excessive” o Reporting – Tracks pricing trends related to all medicines and the research and development spending of patentees • Classifies medicines based on level of therapeutic improvement • Ex-factory price regulated – not consumer price • PMPRB approval of price not required before sale 2
- 3. Drug Development Health Canada Review PatentedMedicine Prices Review Board Patient Access Late 1980’s: PMPRB was the only organization reviewing drug prices 3
- 4. Drug Development Health Canada Review PatentedMedicine Prices Review Board Health Technology Assessment Hospitals Patient Access Private Drug PlansPublic Drug Plans Today: dozens of organizations review prices 4
- 5. Global market dynamics– reference pricing Source: WHO Workshop on Differential Pricing PMPRB’s question: “Given that it is standard industry practice worldwide to insist that public prices not reflect discounts and rebates, should the PMPRB generally place less weight on international public list prices when determining the non-excessive price ceiling for a drug?” 5
- 6. Pricing regulation –PMPRB Tests International Comparisons (7 comparator countries) FRANCE UK GERMANY ITALY SWEDEN USA SWITZERLAND Level of Clinical Improvement Price Test All Patented Medicines Breakthrough Median International Price Prices of patented medicines can never exceed the International Maximum Price (i.e., the highest price among the PMPRB7 comparator countries Substantial improvement Higher of the Therapeutic Class Comparison (TCC) and the International Median Moderate improvement Midpoint of the Therapeutic Class Comparison and International Median (but not lower than the TCC) No or little improvement Therapeutic Class Comparison or Reasonable Relationship Test 6
- 7. Pricing regulation –monitoring by PMPRB • Price can never be higher than highest international price • Maximum allowable price set at launch • Annual price increases limited to inflation • Regular reporting requirements by manufacturers • Four market segments - retail, distributor, pharmacy and hospital 7
- 8. Pricing Regulation -Enforcement • Investigations • Non-compliance options o Board orders o Voluntary compliance undertakings (VCUs) • Federal court 8
- 9. Key changes indraft regulations • Three new factors are proposed as criteria for price evaluations: - Pharmacoeconomic (P/E) evaluations – with a QALY threshold likely to be included in PMPRB guidelines - Size of market - Gross Domestic Product in Canada • Requirement to report to support new factors • Revised list of comparator countries – closer to OECD median price with proposed changes • Information on discounts/rebates – requirement to report rebates to PMPRB • No active monitoring of patented generics No changes made to the initial proposal introduced by the Health Minister in May 2017, despite over 100 submissions 9
- 10. List of ComparatorCountries Current list: Proposed list (May 2017): FRANCE UK GERMANY ITALY SWEDEN USA SWITZERLAND FRANCE UK GERMANY ITALY SWEDEN AUSTRALIA BELGIUM JAPAN NORWAY S. KOREA NETHERLANDS SPAIN 10
- 11.
- 12. May 2017 CONSULTATION DOCUMENT released – 6weeks stakeholder input (Over 100 stakeholder submissions) Dec. 11, 2017 Scoping document on new PMPRB guidelines 75-day consultation Dec. 2, 2017 DRAFT REGULATIONS pre- published in Canada Gazette Part-1 along with regulatory impact analysis statement Timeline for regulation development Aug. 2017 New Health Minister Feb. 14, 2018 Deadline for stakeholder input on draft regs Oct. 2017 PMPRB’s 2016 Annual Report is released Consultations on PMPRB scoping document and guidelines Dec. 2017 Fall 2018 Spring 2018 (TBC) Release of new PMPRB guidelines Spring 2018 Final PMPRB regs to be published in Canada Gazette Part-2 Jan 1, 2019 Implementation 12
- 13. Patent Act RegulationChanges Why should Patients Care ? 13
- 14. Context • Health carejurisdiction in Canada is divided between the federal government and the provinces/territories 14
- 15. Federal jurisdiction Funding Canada HealthAct • Transfers funds to the provinces/territories to ensure for basic hospital and doctor coverage • Drugs provided in hospital from the hospital list of medications covered are free 15
- 16. Federal jurisdiction (cont’d ) Approvals Food and Drugs Act • Health Canada approves clinical trials, approves drugs, biologics and medical devices for sale in Canada and monitors them post market Patent Act • Patented Medicine Prices Review Board determines if the price a manufacturer wants to sell a product for is “excessive” 16
- 17. Provincial jurisdiction Coverage andReimbursement • Each province/ territory determines whether drugs/biologics have a value in the treatment armamentarium that makes them worth spending taxpayers dollars from public drug budgets to provide them to eligible residents in the province • In some cases provinces also have reimbursement plans for eligible drugs (e.g., Trillium in Ontario) 17
- 18. Provincial jurisdiction (cont’d) Mechanismfor Determination of Value for Public Plans • Canadian Agency for Drugs and Technologies in Health (CADTH) uses health technology assessment processes to advise governments about value and therefore reimbursement • The CDIAC of CAPCA makes recommendations to the provinces/territories regarding cancer drug coverage • pan-Canadian Pharmaceutical Alliance (pCPA) negotiates prices for the provinces 18
- 19. Private insurers • Individualand group insurance are available through private insurers • The price they pay for the drugs/biologics they cover are either the PMPRB price or a negotiated price with the manufacturer 19
- 20. Individual payers • Somepeople have neither eligibility for public coverage nor private coverage • Others have inadequate coverage • They pay for drugs/biologics out of pocket • They pay the PMPRB price + mark ups for added costs 20
- 21. Coverage split • Publicplans cover approximately <41 % of Canadians • Private plans cover < 34% of Canadians • It is estimated that < 23 % of Canadians are paying out of pocket for all or some of their drug coverage 21
- 22. Price, cost andvalue • Non-excessive ex-factory price monitoring is the jurisdiction of PMPRB • Cost refers to the additional amount added to the manufacturer’s price to get a drug to market e.g. distribution costs, dispensing fees, administration costs. • This is the jurisdiction of the provinces/territories • Value refers to the determination of whether to cover and fund a drug from public drug budgets rather than spending on other drugs for the same or a different disease or condition . • This is the jurisdiction of the provinces/territories 22
- 23. So why thePatent Regulation changes ? Assumptions 1) The federal government has determined that 2) drug spending is increasing as a total health expenditure from 10% to 16%, the second highest expenditure in the total health budget 3) innovative drug therapies including biologics and genetic therapies are higher priced and costlier than previously and used more prevalently than in the past 4) Canada pays higher drug prices than most other developed 5) limited public drug budgets mean less overall access to drugs for Canadians 23
- 24. Assumptions (cont’d) 6) Thereis a growing discrepancy exists between public list prices and lower actual market prices due to the increased use of confidential rebates and discounts 7) There has been no corresponding increase in R&D spending in Canada 8) F/P/T Minsters of Health need to work together to improve affordability, accessibility and appropriate use of drugs 24
- 25. How does theFederal Government Plan to do This ? 1) Add a new economics-based price regulation factor that will ensure prices reflect Canada’s willingness and ability to pay for drugs that provide demonstrably better health outcomes 2) Update the list of countries used by Canada for comparison so that it aligns with PMPRB’s consumer protection mandate and median OECD country prices 3) Move to a complaints based system for patented generic drug products that are lower risk of excessive pricing 4) Require patentees to provide information about third party rebates and discounts 25
- 26. New Economic-Based PriceFactor What is it ? • An economic-based drug assessment identifies, measures and compares the cost and benefits of a given drug to the patients and the payers, particularly the public healthcare system • CADTH does this through a health technology assessment process based on measuring the Quality of Adjusted Life Years • Patients are not necessarily satisfied that even this approach captures value as determined through patient reported outcome measures • In any case this is not the same as saying the price is fair, reasonable or non-excessive • It is saying that at this price public or private payers do or do not want to invest taxpayers or plan sponsor dollars in this way 26
- 27. Will a neweconomics-based price factor lower actual public drug prices ? • This is the millions of dollars question • CADTH is already doing a value-based economic price assessment- Why the duplication ? Is it even within PMPRB’s jurisdiction to determine “value” ? • Price and value are not the same • Even a “non-excessive” price does not guarantee that public plans consider a drug good value for a limited drug budget • The drug should still be available to those who wish to purchase it 27
- 28. Will a neweconomics-based price factor lower actual public drug prices ? • PMPRB’s hypothesis is that if the entry level price is lower, then the pCPA negotiated price for public plans will end up lower. Will it ? • PMPRB argues that it has a duty of consumer protection. It has said that the real problem in this regard is with new innovative drugs where there are no comparators in the same class. This is only about 10% of the drugs that PMPRB reviews. Why not focus on a process for solving that problem ? • Economic-based factors are about relative value for money, not price. If neither public or private payers consider a drug of value they will not purchase it. 28
- 29. Proposed List ofcountries in the NEW PMPRB12 Europe France UK Germany Belgium Italy Netherlands Spain Sweden Norway Asia Pacific Japan Korea Australia 29
- 30.
- 31. Potential Consequences • Reducinglist prices by the expected 20% or so by adopting the median price of the proposed 12 comparator countries may have profound and unwanted consequences for Canadians. – Companies not launching products in Canada – Delay in drug being submitted to HC – Wait for all of the 12 countries to have a price – Negative impact on Health Outcomes • There will be winners and losers – Private and public payers • Med-low priority category – price erosion of further entries… why bother 31
- 32. Health Canada offersa reassurance • Health Canada has issued Q&As to the proposed Amendments to the Patented Medicines Regulations and to the question: Would Companies still bring their medicines to Canada if prices were lower? • Its answer is: Prices are currently significantly lower in several countries economically comparable to Canada. Companies still bring medicines at rates that are equal or better than the rates that Canada enjoys. … Canada would remain a sizable market for patented medicines. 32
- 33. Summary of Conclusions •PMPRB is responsible to determine if a proposed price is excessive, It is up to the provinces to negotiate a price together through pCPA, with the advice of CADTH and CAPCA, that will determine if the purchase of the drug will be a good value proposition for the payer • CADTH has the jurisdiction for recommendations to the provinces/territories regarding value, not PMPRB • The big winners in these changes are private insurers. Will the savings to them result in savings to plan sponsors eg employers, unions, individual plan holders ? If not, where will the new big savings come • Lower entry level prices may lower the negotiated price but by how much ? 33
- 34. Summary of Conclusions •Patients need access to innovative life –saving and life enhancing therapies. This new approach does not guarantee enhanced access or even the level of access presently available. • If the problem is with the 10% of drugs that do not have comparators why not find a solution to that problem e,g, a dispute resolution mechanism. 34
- 35. What can youdo to ensure accountability ? 1) Respond to the consultation, either individually or collectively 2) Meet with your MP, federal Health Canada bureaucrats and politicians, PMO 3) Write to the bureaucrats and politicians 4) Raise this issue with provincial politicians For further information: louise.binder@rogers.com Martine? 35
- 36. Themes for discussionand Qs and As • Process and consultations • Substance of the proposed regulations • Expected and potential impacts • Alternative approaches • What patients are expecting from their governments and other stakeholders • What can patients and other stakeholders do? 36
- 37.