DOES PRICE DISCRIMINATION HAVE A PLACE IN PHARMACEUTICAL PRICING IN ASIA? Issues Panel 5: Tues 4pm ISPOR AsiaPacific conference, Taipei, September 2012 MODERATOR: Adèle Weston PhD Executive Vice President/Senior Scientist OptumInsight, Australia Prof Gilberto de Lima Lopes Program Leader for Health Economics and Policy MD, MBA, FAMS Johns Hopkins University School of Medicine, Singapore Prof Michael Drummond PhD Mendel Grobler MBA Professor of Health Economics C t f H lth E Centre for Health Economics, University of York, UK i U i it f Y k UK Director, Patient Access Pfizer, Australia Proprietary and Confidential. Do not distribute. 2 1 Price discrimination DEFINITION: Price discrimination occurs when customers in different markets are charged different prices for the same good or service, for reasons unrelated to the cost a. For example: • Ability to pay • Willingness to pay (eg. difference in demand or priorities) CAVEAT: Price discrimination is effective only if customers can not profit from re-selling the goods or services to customers from a different market (eg, (eg other countries) a Source: OECD Glossary of Statistical Terms:: http://stats.oecd.org/glossary/detail.asp?ID=3283. Proprietary and Confidential. Do not distribute. 3 Ability to pay is highly variable: Source: World Economic Outlook Database-October 2008, International Monetary Fund - Gross domestic product (GDP) based on purchasing-power-parity (PPP) per capita. Data refer to the year 2007. Accessed under free license via: http://commons.wikimedia.org/wiki/File:GDP_PPP_per_capita_2007_IMF.png Proprietary and Confidential. Do not distribute. 4 2 Example • Sweden = $1000 • Indonesia = $100 • Sweden = $100 • Indonesia = $10??? Proprietary and Confidential. Do not distribute. 5 But what is parity? GDP Starbucks Tall Latte Index BigMac PPP Human Development Index Proprietary and Confidential. Do not distribute. 6 3 Status Quo and beyond • • • • International reference pricing Tiered reference pricing Value-based pricing Formalised price discrimination schemes (eg. “Accelerated Access Initiative” for AIDS therapies: UN & 7 pharmaceutical companies) • Other • Advantages, disadvantages, challenges Proprietary and Confidential. Do not distribute. Prof Michael Drummond PhD 7 Professor of Health Economics Centre for Health Economics, University of York, UK Proprietary and Confidential. Do not distribute. 8 4 Value-Based Pricing in Europe An Opportunity for International price Discrimination? Michael Drummond Centre for Health Economics, University of York Outline of Presentation • • • • • Background to value-based pricing in Europe Proposals p for VBP in Germany y and the United Kingdom g Challenges in VBP Opportunities for international price discrimination Conclusions 5 Some Background • International reference pricing is still prevalent in Europe, particularly in the Mediterranean region • Over the past 10-15 years, a growing number of countries have used economic evaluation in their pricing and reimbursement decisions • There is also a growing tendency to negotiate prices based on the estimate of the value-added by products • In Germany and the UK, where previously free pricing was allowed, ‘value-based pricing’ schemes are being introduced Value-Based Pricing Proposal (UK) • Will apply to new branded medicines launched from January 1, 2014 • Recognition that new arrangements may be required for alreadyalready existing medicines • The negotiation would consider: - the ‘basic’ cost-per QALY threshold - the burden of illness and unmet need that the medicine focuses on - the extent of therapeutic innovation - the wider societal benefits (eg impact on carers) 6 Value-Based Pricing Proposal (UK) • A full assessment of these factors will be used to determine the VPB • If the company’s p y p price is higher g than the VBP,, it would be asked to lower its price, or provide extra justification • ‘If the company were not prepared to do either of these, it would be the company’s responsibility to explain to the public why it was not prepared to offer that drug at an appropriate price’ AMNOG Reform in Germany • Value dossiers required for all new drugs, with the exception of orphans • Benefit B fit assessmentt att th the titime off market k t access by b IQWiG • Consideration of incremental clinical benefit, relative to an adequate comparator (on a scale 1-5) • 12 month freedom of pricing whilst the value-based price is negotiated • If a VBP is not agreed, the option exists for IQWiG to conduct a full economic evaluation 7 © Prof. Dr. J.-M. Graf von der Schulenburg Folie 15 Challenges in Value-Based Pricing Defining the dimensions of ‘value’ - health gain only? - other considerations? Determining the local decision rule - explicit cost per QALY threshold? - general rating impacting on price? Dealing with multiple indications - price/volume agreements? - weighted price? Determining the level of transparency - publication of assessments? - publication of negotiated prices? 8 Opportunites for International Price Discrimination • Individual jurisdictions would negotiate prices based on their own assessments of value • Assessments of value will depend on: – local attitudes towards health and healthcare – existing service configuration – wealth of the country (ie GDP per capita) • Negotiated VBPs could remain confidential, limiting the opportunities for international reference pricing Conclusions • Value-based pricing is not without its challenges • In p principle, p , it is a superior p approach pp to international reference pricing • The critical issue (for international price discrimination) is whether negotiated prices can remain confidential or not • A loss in transparency could be justified if this led to increased access to pharmaceuticals in middle and low income countries 9 Mendel Grobler MBA Director, Patient Access Pfizer, Australia Proprietary and Confidential. Do not distribute. Price discrimination: i di i i i Reconciling payer and supplier needs Mendel Grobler 19 Australia 10 Overview The issues Formal price discrimination: GDP as an exchange rate • How much of GDP? One size or all? • Supply side effects g g the debate progressing Summation and p Issues that need to be addressed Affordability Value of life Whi h nation(s) ti ( ) set(s) t( ) th h k Which the b benchmark Precision and validity of QALY Dynamic versus static efficiency GDP as the ‘exchange rate’ between countries The much buy?? Th standard t d d good: d how h h life lif tto b Controlled versus market dynamics Supply side impact 11 GDP as the exchange rate Level of development and health needs • Less developed: generally different spectrum of health need e g sanitation, sanitation infection, infection injury, injury etc e.g. • • Patents usually expired for the most needed or urgent medicines: more health can be bought for less • • • No need to provide universal access to specialised treatment until that level of development reached e.g. targeted biologics for rare diseases p g g HIV ( hence AAI)) Exception urgent need e.g. The general conclusion, “spend to size”: spend is relative and linear e.g. (k x GDP) per unit of health Caveat: assumes relative health needs match relative GDP GDP plus? Level of health and development needs • • • • Poor health is a brake on economic development • i bilit tto b i ll active ti compromises ability be economically • consumes family or society resources • Bigger impact in less developed nations (health wealth cycle) Health and health spend can be a factor in multinational competitiveness The general conclusion, spend relatively more i.e. higher multiplier of GDP per unit of health e e.g. g (k x GDP) + (catch up factor) if you are a less developed nation Caveat: spending on something else could have a bigger return e.g. roads, electricity. 12 How much health? Top down approach: what multiple of GDP to use? • Concept of using GDP as basis for relative affordability has appeal i.e. i e pay within means appeal, • But if (k x GDP), what is the right ‘k’ • Broad guidance available, but national sovereignty is important • • ‘k’ could be determined nation by nation based on development needs Critical pre-condition (the consequences are lasting): • that the correct multiple is chosen (1x (1x, 2x 3x GDP) and delivers the strategy • Must address development need - not purchasing power • lower investment = slower development How much health to buy Bottom up: maximise welfare 1. 2. 3. 4. Determine how much health is needed in a year i.e. how many QALYs must be bought Allocate a budget and set the cut off price per QALY or set a desired QALY and then find the budget Reconcile allocative and technical efficiency. Alternatively scour the literature for the right QALY cut-off 13 How much health to buy Bottom up: maximise welfare 1. 2. 3. 4. Determine how much health is needed in a year i.e. how many QALYs must be bought Allocate a budget and set the cut off price per QALY or set a desired QALY and then find the budget Reconcile allocative and technical efficiency. Alternatively scour the literature for the right QALY cut-off • Much opinion opinion, many methods methods, many answers ----→ Top down... How does the system respond? Supply side effects.... 14 Suppliers: flow on consequences Investment decisions in a therapeutic area generally influenced by unmet clinical need, i other h d l expertise, developments, etc • Investment decisions in a therapeutic area are subject to commercial rules • • E.g. CAPM i.e. investing capital must generate equal or greater return than alternatives • Therefore price Th f i is i a kkey variable i bl iinfluencing fl i where h to invest • QALY threshold sets the price Medical innovation over time Economic growth arises from use of new goods and services → Basic research builds a g foundation of knowledge → From this, potential treatments are developed → Experience with new treatments informs next stage of basic research →Process is a path to progress →Cost is correlated Drug Development Drug Development Clinical Experience Basic research Clinical Experience Basic research 15 Markets, prices and innovation Supply and demand curves Price • Perfect markets balance supply and demand and set th ideal id l price i ((efficient ffi i t the price). • Perfect markets, through reacting to change, price innovation • Imperfect markets invite government intervention • An HTA market is a market – but the demand curve that informs price is replaced Equilibrium price Supply Demand Quantity Markets, prices and innovation • The supply pp y curve still exists • The QALY thresholds chosen determine the price • Setting the price at a point has a consequence on supply including R&D investment and future supply Price Supply and demand curves Supply Quantity 16 R&D investment: key challenges now Diminishing returns in major therapeutic areas • Incremental efficacy gains getting smaller in some areas • Top of curve in some, gap in science in others (see below) More targeted complex molecules • Treat a smaller fraction of the population development costs and increased cost of manufacture • Same Global shift to centralised technology assessment and cost reduction • • HTA markets interconnected One country’s actions can affect an industry over time In summary and what next? General principle of GDP as a guide is logical But setting fixed rules may be counterproductive • Sovereignty still rules • Supply side issues becoming a shared responsibility • • Cross-border spillover • Trade issues may arise over time • E.g. Between countries that host clusters of suppliers in a technology and others • Solvable with care e.g. international treaty 17 QUESTION TIME 18
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