Webinar: PMPRB NEW Guidelines and Impact on Rare Diseases
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The document discusses the impact of new PMPRB guidelines on access to rare disease drugs in Canada, highlighting the need for collaboration among stakeholders to establish effective pricing policies. It emphasizes concerns about current regulations leading to uncertainty in the pharmaceutical market and potential delays in drug launches. The PMPRB's focus on low prices contradicts previous court rulings and threatens the availability of innovative treatments for patients in Canada.
![Proposed Guidelines Focus on low prices inconsistent with Court rulings
Federal Court of Appeal (Alexion)
• Over and over again, authorities have stressed that the excessive pricing provisions
in the Patent Act are directed at controlling patent abuse, not reasonable pricing,
price-regulation or consumer protection at large.
• Were the excessive pricing provisions of the federal Patent Act aimed at reasonable
pricing, price-regulation or consumer protection at large, they would be
constitutionally suspect…”
• By obfuscating, the Board has effectively put itself beyond review on this point
[relying on the lowest international price], asking the Court to sign a blank cheque in
its favour. But this Court does not sign blank cheques.
©2022 PDCI Market Access 12](https://image.slidesharecdn.com/pmprbnewguidelinesandimpactonrarediseases18nov2022-221118232722-8b6b728e/85/Webinar-PMPRB-NEW-Guidelines-and-Impact-on-Rare-Diseases-12-320.jpg)
Webinar: PMPRB NEW Guidelines and Impact on Rare Diseases
- 1. PMPRB NEW Guidelines and Impact on Rare Diseases November 18, 2022
- 2. FOR PMPRB • Lives matter. Explore impact of pricing policies on patients’ lives and build polices to support drugs getting to Canadian patients • PMPRB should act less like a punitive body and more like a “public good” agency. Collaborate with patients, clinicians, payers, and other stakeholders to arrive at pricing guidelines that work for all • If goal is 20% reduction toward OECD median, as announced, implement new 11-country comparison; economic factors assessed by CADTH/INESSS as starting point for negotiation; do not set PMPRB maximum $/QALY FOR POLICY MAKERS • This next generation of drugs are revolutionary. Ensure that Canada’s pharmaceutical policies, including pricing policies, will allow Canadians to have access as soon as possible • STOP the PMPRB … until all of the proper consultations and considerations have been conducted • Expand upon COVID-19 Public-Private partnerships between government and pharmaceutical industry. Engage Early in development process; Communicate Continuously; Seek Preferred Partner Pricing Recall where we were TWO YEARS ago 2
- 3. Neil Palmer Principal Consultant Michael Dietrich Executive Director – Policy Laurene Redding Global Head – Strategic Pricing (ex. China) Durhane Wong-Rieger President and CEO Bill Dempster (Moderator) Today’s panel 3
- 4. Canadian pathway for medicines is already uncertain and long Health technology assessments • Comparative clinical and economic reviews pCPA • Long and uncertain process (10 months on average) • $3.4 billion in rebates to public plans PMPRB • Reform has created significant business uncertainty over past 6 years • Damaged Canada’s position in global launch sequencing Provincial listings • Long and variable from one province to another Since mid-2019, of the 140 medicines approved by FDA, less than half have been submitted to Health Canada 4
- 5. 5 Number of annual NAS launches in Canada has declined every year since 2016 and lags behind the global NAS launches 5
- 6. Rare disease drugs face a funnel of uncertainty in Canada ( f u n d i n g fo r o r p h a n d r u g s a p p ro ve d b y E M A f ro m J a n . 2 0 1 5 – M a r. 2 0 2 0 ) Source: Ward et al. Orphanet Journal of Rare Diseases (2022) 17:113: https://doi.org/10.1186/s13023-022-02260-6 63 drugs with EMA approval and orphan designation 44 drugs with Health Canada approval 30 drugs with positive CADTH recommendation (20 INESSS) 24 drugs with completed pCPA negotiation 6
- 7. What is the Patented Medicine Prices Review Board (PMPRB)? • Federal Quasi-Judicial Regulatory Agency • Two functions: regulate patented medicine prices; reports • Regulatory mandate is to ensure that prices for patented medicines are not “excessive” — Determines the maximum prices that can be charged for patented medicines in Canada — Previous guidelines: assed prices based on a treatment’s therapeutic value vs. alternatives; considered prices for same medicine in 7 other countries: GERMANY FRANCE UK ITALY SWEDEN SWITZERLAND USA PMPRB7 7
- 8. The current situation: the “interim” period • “Economic factors” removed from the regulations by Health Canada (and courts): — pharmacoeconomic value — market size adjustment • New reference countries – basket of 11 rather than 7 • New regulations implemented on July 1, 2022 • Currently an “interim period” – new guidelines are not in effect – no rules for “new” medicines launched since July 1 • So what could go wrong? New list (PMPRB-11) FRANCE UK BELGIUM NORWAY GERMANY ITALY JAPAN SPAIN SWEDEN USA NETHERLANDS AUSTRALIA SWITZERLAND USA & Switzerland removed from original PMPRB-7 Added to original PMPRB-7 8
- 9. How the changes continue to be problematic • What will price reductions be?: Previous analyses suggested 20% price decrease due to basket of countries, however… • No certainty of pricing: Impossible to know what the impact will be – there are no longer any price tests – just criteria that “may” start investigations; process is vague, complicated and untried anywhere else • Reference: Canada’s prices are a direct and indirect reference country for other markets • Pharmacare / rare disease drug program: Not connected to pharmacare programs or any guarantee of funding Source: PMPRB Guidelines, 2022 9
- 10. The PMPRB explored this issue – going back to 1989 Where is the guidance? 10
- 11. Potential Impact of Proposed PMPRB 2022 Guidelines on New Medicines PMPRB-11 Median = 0.86 PMPRB11 Country Annotated by N Palmer / PDCI Reduction to Median International Price Lower of… combinations of MIPC, LIPC, dTCC ©2022 PDCI Market Access 11
- 12. Proposed Guidelines Focus on low prices inconsistent with Court rulings Federal Court of Appeal (Alexion) • Over and over again, authorities have stressed that the excessive pricing provisions in the Patent Act are directed at controlling patent abuse, not reasonable pricing, price-regulation or consumer protection at large. • Were the excessive pricing provisions of the federal Patent Act aimed at reasonable pricing, price-regulation or consumer protection at large, they would be constitutionally suspect…” • By obfuscating, the Board has effectively put itself beyond review on this point [relying on the lowest international price], asking the Court to sign a blank cheque in its favour. But this Court does not sign blank cheques. ©2022 PDCI Market Access 12
- 13. PMPRB 2022 Draft Guidelines –Takeaways • PMPRB “Modernization”: intent is to make Canada a “low” price country • Launch sequencing is an industry best practice (high price countries first) • Innovation (level of therapeutic improvement) ignored – impactful for rare disease drugs • Benefit of patent monopoly (ie price premium) doesn’t apply to pharma / biotech industry • Landmark court decisions ignored by PMPRB • The “Policy Intent” cited by PMPRB is at best “constitutionally suspect” • Impact on price ceilings of latest draft guidelines significantly more severe • Vague guidelines (“investigation criteria”) engenders uncertainty for industry • Overall, PMPRB will be perceived as a barrier to entry to the Canadian market for innovative new drugs ©2022 PDCI Market Access 13
- 14. 14 Why should government and stakeholders pay attention? Life Sciences Strategy Cross purposes to Canadian LS leadership: Will Minister Champagne intervene? PMPRB resolution PMRPB wants to go further than the basket changes. This will prevent all parties from moving forward. Rare Disease Strategy Antithetical to RD strategy success where Gov’t wants a win and we all want progress! ACCESS and investment Foreseeable impacts to new medicines in Canada (where already lags peers)
- 15. 15 Key Challenge:Targets future products, even in some cases where Canadian prices are below international prices Median dTCC (e.g. old generic) List price Mid-point of dTCC and Lowest Lowest Who decides price test? Lack of predictability for companies Launch ? consistent??? “The dTCC is more than 50% lower than the lowest international price, and the list price exceeds the midpoint between the dTTC and lowest international price.”
- 16. 16 Key Challenge: Incentive to delay launch to avoid automatic PMPRB investigation? Launch Order (time) Product automatically under investigation if Canada is the first International launch (i.e. only avail in U.S.) investigation Investigation avoided by delaying launch
- 17. Consultations on guidelines (due Dec 5th!) and resources to learn more and share • Stakeholder input via PMPRB – DUE DECEMBER 5th: https://www.canada.ca/en/patented-medicine-prices- review/services/consultations/2022-proposed-updates-guidelines.html • PDCI early insights on the draft guidelines https://www.pdci.ca/pdcis-early-insights- on-pmprb-draft-guidelines/ • Sharing site for those developing submissions: https://www.pdci.ca/sharing- responses/ 17
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