Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and...
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Transcript of Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and...
Professor Adrian TowseDirector of the Office of Health Economics, London
Visiting Professor, London School of Economics
Presentation at ISPOR 19th Annual European CongressNovember 1, 2016
Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability
Putting Theory into Practice
Challenges of introducing differential pricing for drugs in Europe
Putting Theory into Practice • We have a practical problem of
inequitable access in Europe• Variants of differential pricing we could
use • Barriers to use• Are we prisoners of two cults?
• “Law of one price”• “Transparency is always good”
• Options for the way forward
Challenges of introducing differential pricing for drugs in Europe
Belgian Presidency Report 2010
Source: http://www.efpia.eu/topics/industry-economy/access-to-medicines
LARGE VARIATION IN UPTAKE BETWEEN RICHER AND POORER COUNTRIES IN EUROPE EVEN FOR DRUGS THAT HAVE DRAMATICALLY CHANGED OUTCOME (EXAMPLE: CML)
Lower GDP/capita
tier
Mid GDP/
capita tier
Upper GDP/capita
tier
Lower GDP/capita
tier
Mid GDP/
capita tier
Upper GDP/capita
tier2005 2014
0
100
200
300
400
500
600
700
imatinib dasatinib nilotinib
DDD
per c
ase
Source. IMS MiDAS
Reproduced with permission from Jönsson B et al. 2016. Comparator report on patient access to cancer medicines in Europe revisited. IHE Report 2016:4, IHE: Lund
Challenges of introducing differential pricing for drugs in Europe
Putting Theory into Practice • We have a practical problem of
inequitable access in Europe• Variants of differential pricing we
could use • Barriers to use• Are we prisoners of two cults?
• “Law of one price”• “Transparency is always good”
• Options for the way forward
Challenges of introducing differential pricing for drugs in Europe
Theory of Differential PricingFive different pricing rules for pharmaceuticals:1. “Ramsey Prices”: pricing in inverse relation to the demand
elasticity in each country or MS [Ramsey (1927); Jack and Lanjouw (2005)]
2. Value Based Differential Pricing (VBDP): the use of an incremental cost-effectiveness ratio threshold based on populations “willingness-to-pay” for health gains [Danzon, Towse and Mestre-Ferrandiz (2013)]
3. Adaptation of the Peak Load Pricing model [Boiteux (1949); Schweitzer and Comanor (2011)]
4. Two-part pricing structure of consumer co-payment and payer top-up payment. [Garber, Jones and Romer (2006); Jena and Philipson (2008); Lakdawalla and Sood (2013)]
5. Patent buyout, HIF, prizes [Kremer, 1998; Hay, (2005); Banerjee, Hollis, and Pogge (2010); Wilson and Palriwala, (2011)]
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
Challenges of introducing differential pricing for drugs in Europe
Theory of Differential PricingFive different pricing rules for pharmaceuticals:1. “Ramsey Prices”: pricing in inverse relation to the demand
elasticity in each country or MS [Ramsey (1927); Jack and Lanjouw (2005)]
2. Value Based Differential Pricing (VBDP): the use of an incremental cost-effectiveness ratio threshold based on populations “willingness-to-pay” for health gains [Danzon, Towse and Mestre-Ferrandiz (2013)]
3. Adaptation of the Peak Load Pricing model [Boiteux (1949); Schweitzer and Comanor (2011)]
4. Two-part pricing structure of consumer co-payment and payer top-up payment. [Garber, Jones and Romer (2006); Jena and Philipson (2008); Lakdawalla and Sood (2013)]
5. Patent buyout, HIF, prizes [Kremer, 1998; Hay, (2005); Banerjee, Hollis, and Pogge (2010); Wilson and Palriwala, (2011)]
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
Challenges of introducing differential pricing for drugs in Europe
Putting Theory into Practice • We have a practical problem of
inequitable access in Europe• Variants of differential pricing we could
use • Barriers to use• Are we prisoners of two cults?
• “Law of one price”• “Transparency is always good”
• Options for the way forward
Challenges of introducing differential pricing for drugs in Europe
Member State use of IRP
Source: Toumi, Mondher, Cécile Rémuzat, Anne-Lise Vataire, and Duccio Urbinati. 2013. External Reference Pricing of Medicinal Products: Simulation-Based Considerations for Cross-Country Coordination.
Challenges of introducing differential pricing for drugs in Europe
Barriers for implementation of optimal differential pricing rules
1. International Reference Pricing (IRP): the use of other countries’ prices of a new medicine as reference for setting the local price for that new medicine
2. Parallel Trade (PT): physical arbitrage of medicines from low-priced (low-income) countries to high priced (high-income) ones.
3. Political feasibility and organisational challenges
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
Challenges of introducing differential pricing for drugs in Europe
EU Commission Access to Medicine initiative
• From the countries’ perspective, the main problems cited were: lack of marketing authorisation, shortages of supply, no effective availability, unaffordable prices and marketing delays.
• Economic operators cited the following key factors: low profitability at allowed prices/margins, local language requirements, price spillovers through international reference pricing, and/or risk of parallel trade. (European Commission 2014)
Challenges of introducing differential pricing for drugs in Europe
Putting Theory into Practice • We have a practical problem of
inequitable access in Europe• Variants of differential pricing we could
use • Barriers to use• Are we prisoners of two cults?
• “Law of one price”• “Transparency is always good”
• Options for the way forward
Challenges of introducing differential pricing for drugs in Europe
Cult 1:“The law of one price”,
• The “law of one price” implies that different prices arise from lack of competition, lack of arbitrage, non-trade barriers:• But this doesn’t work for R&D intensive
industries with sunk global costs• The objective is to reward R&D costs
efficiently – by minimising distortions to use
Challenges of introducing differential pricing for drugs in Europe
Cult 2: “Transparency is always good”• Transparency can be a means to an end:
• More efficient use of health care resources• Reduction in the risk of “agency capture”• Reduction in the risk of corruption
• Some people see it as a “good” in its own right• But there are circumstances in which it reduces efficiency
because it links markets together that it is not efficient to link
• We want to be efficient in achieving our equity and health objectives, and we may have transparency as a “good” also in our objectives. But we have to trade
Challenges of introducing differential pricing for drugs in Europe
Why the EU enthusiasm for IRP and PT?• Avoid “special cases” in Treaty change
• Single price convergence is a bigger goal• Competition is a good thing. By implication, parallel trade in
drugs will help achieve a single (low) price for a drug within the EU good for consumers.
• True in the case of off-patent generic medicines. In reality almost all parallel trade is in on-patent products.
• Important to help EU member states at a time of austerity and to support social solidarity
• Visible damage is small (shortages, lack of access)• Don’t believe R&D is under threat from EU pricing • But there is increasing recognition that access in low income EU
member states is being hit
Challenges of introducing differential pricing for drugs in Europe
Putting Theory into Practice • We have a practical problem of
inequitable access in Europe• Variants of differential pricing we could
use • Barriers to use• Are we prisoners of two cults?
• “Law of one price”• “Transparency is always good”
• Options for the way forward
Challenges of introducing differential pricing for drugs in Europe
Implementing differential pricing in Europe
Options for differential pricing in the EU
Degree of centralisation
Europe wide agreement on Ramseypricing, or VBDP
Maximum
Two-tier Europe (a form of peak load pricing)
Medium
Increased confidentiality leading to Ramsey pricing or VBDP
Minimum
Source: Towse, A., Pistollato, M., Mestre-Ferrandiz, J., Khan, Z., Kaura, S. and Garrison, L., 2015. European Union Pharmaceutical Markets: A Case for Differential Pricing? International Journal of the Economics of Business, 22(2), pp.263-275.
Challenges of introducing differential pricing for drugs in Europe
Feasibility of the options (1)
• The maximum centralised option seems unlikely to be implementable. Hard to see how the institutional change required could be agreed.
• The alternative voluntary arrangement to agree a transparent set of prices, cost-effectiveness thresholds, is also likely to be very difficult
• The medium centralisation option of two reference pools of “high” and “low” income countries could be implemented by voluntary agreement, or by a series of unilateral moves creating two de facto pools of countries.
Challenges of introducing differential pricing for drugs in Europe
Feasibility of the options (2)
• The minimum centralisation option is politically feasible
• It would allow price differences to be agreed at member state level which could remain confidential
• This would limit the ability of countries who did not accept the principle of differential pricing to undermine low prices obtained by others.
Challenges of introducing differential pricing for drugs in Europe
Conclusion and policy implications• Low per capita income markets in Europe suffer from
shortages of supply, unaffordable prices and marketing delays
• If current patient access issues in the EU could be addressed, overall welfare would increase, providing returns to R&D were not reduced in the higher income countries.
• Two feasible solutions:• Establishment of a two-tier Europe, a block of lower per capita
income countries with parallel trade and IRP only allowed within and not between blocks (equivalent to a form of peak load pricing with “peak” and “off peak” users).
• Confidential discounts applied by the Member States, perhaps linked to the use of voluntary contractual agreements. Such an arrangement could be used to implement Ramsey pricing or VBDP
Challenges of introducing differential pricing for drugs in Europe
References (1) • Banerjee A, Hollis A, Pogge T. 2010. The health impact fund: incentives for improving access to
medicines. Lancet 375:166–169
• Boiteux, Marcel P. 1949. “La tarification des demandes en pointe: Application de la theorie
• Danzon, Patricia M., Adrian K. Towse, and Jorge Mestre-Ferrandiz. 2013. “Value-Based Differential Pricing: Efficient Prices for Drugs in a Global Context.” Health Economics
• Garber, Alan M, Charles I. Jones, and Paul Michael Romer. 2006. “Insurance and Incentives for Medical Innovation.” Forum for Health Economics & Policy 9 (2): 1–27. http://econpapers.repec.org/article/bpjfhecpo/v_3abiomedical_5fresearch_3ay_3a2006_3an_3a4.htm.
• Hay Joel W. 2005.“Application of Cost Effectiveness and Cost Benefit Analysis to Pharmaceuticals.” Chapter 14 in Santoro M, Gorrie T, eds. The Grand Bargain: Ethics and the Pharmaceutical Industry In the 21st Century. Cambridge University Press, New York NY, 2005:225-248
• Jack, William, and Jean O. Lanjouw. 2005. “Financing Pharmaceutical Innovation: How Much Should Poor Countries Contribute?” The World Bank Economic Review 19 (1): 45–67. http://wber.oxfordjournals.org/content/19/1/45.short.
• Jena, Anupam B., and Tomas J. Philipson. 2008. “Cost-Effectiveness Analysis and Innovation.” Journal of Health Economics 27 (5): 1224–36. doi:10.1016/j.jhealeco.2008.05.010.
• Jönsson B, Hofmarcher T, Lindgren P and Wilking N. 2016. Comparator report on patient access to cancer medicines in Europe revisited. IHE Report 2016:4, IHE: Lund
• Kaló, Zoltán. 2014. “Differential Pricing Across Europe - Addressing Central-Eastern European Country Needs.” presented at the ISPOR 17th Annual European Congress, Amsterdam, November 10.
Challenges of introducing differential pricing for drugs in Europe
References (2)• Kaló, Zoltán, Lieven Annemans, and Louis P Garrison. 2013. “Differential Pricing of New Pharmaceuticals
in Lower Income European Countries.” Expert Review of Pharmacoeconomics & Outcomes Research 13 (6): 735–41. doi:10.1586/14737167.2013.847367.
• Kremer M, “Patent Buyouts: A Mechanism for Encouraging Innovation.” Quarterly Journal of Economics, 1998, November: 1137–7
• Lakdawalla, Darius, and Neeraj Sood. 2013. “Health Insurance as a Two-Part Pricing Contract.” Journal of Public Economics 102 (C): 1–12. https://ideas.repec.org/a/eee/pubeco/v102y2013icp1-12.html.
• Ramsey, F.P. 1927. “A Contribution to the Theory of Taxation.” The Economic Journal 37 (145): 47–60. http://darp.lse.ac.uk/papersdb/Ramsey_(EJ_27).pdf.
• Schweitzer, Stuart O., and William S. Comanor. 2011. “Prices of Pharmaceuticals in Poor Countries Are Much Lower than in Wealthy Countries.” Health Affairs (Project Hope) 30 (8): 1553–61. doi:10.1377/hlthaff.2009.0923.
• Toumi, Mondher, Cécile Rémuzat, Anne-Lise Vataire, and Duccio Urbinati. 2013. External Reference Pricing of Medicinal Products: Simulation-Based Considerations for Cross-Country Coordination.
• Towse, A., Pistollato, M., Mestre-Ferrandiz, J., Khan, Z., Kaura, S. and Garrison, L., 2015. European Union Pharmaceutical Markets: A Case for Differential Pricing? International Journal of the Economics of Business, 22(2), pp.263-275.
• Wilson Paul and Amrita Palriwala. 2011. Prizes for Global Health Technologies. The Results for Development Institute (R4D). http://resultsfordevelopment.org/sites/resultsfordevelopment.org/files/resources/R4D-PrizesReport.pdf