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Improving access to generic & biosimilar medicines in Bulgaria and in the EU

Improving access to generic & biosimilar medicines in Bulgaria and in the EU. Sófia, 14 th November 2013. Adrian van den Hoven Director General EGA – European Generic medicines Associations. Executive summary. Patient access to high-quality medicines. The healthcare environment.

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Improving access to generic & biosimilar medicines in Bulgaria and in the EU

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  1. Improving access to generic & biosimilar medicines in Bulgaria and in the EU Sófia, 14th November 2013 Adrian van den Hoven Director General EGA – European Generic medicines Associations

  2. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  3. The European Generic Medicines and Biosimilar Medicines Association (EGA) is at the heart of Europe’s medicine industry and is essential to EU Public Health. 1 Patients 2 Quality 3 Value 4 Sustainability 5 Partnership

  4. Generic medicines account for almost Generic medicines bring savings of 54% 35€ Bn p.a. • in the EU 28 One of the most competitive sectors in Europe • More than1000generic companies directly employing 150,000 European citizens The EU generic medicines industry is highly committed to Europe’s health 21% • volume • value 7%of turnover to R&D exporting to more than 100 countries outside the EU

  5. 7 key therapy areas: 60% price decrease/ 200% increase in number of treatment days Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

  6. Generics provide increased access to affordable medicines Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

  7. Diabetes patients treated in Europe Projection for EU28, 2013 Prevalence: 8.5%, adult population aged above 15 years Total number of treated patients: 36 million Patients treated by generic medicine: 20 million Generic share: 54% ATC classes: A10 drugs used in diabetes Source: International Diabetes Federation (IDF), Diabetes Atlas; European Community Health Indicators (ECHI) Internal estimate based on IMS MIDAS

  8. Hypertension patients treated in Europe Projection for EU28, 2013 Prevalence: total hypertension 40% of population aged above 15 years; 19% - treated hypertension, Total number of treated patients: 82 million Patients treated by generic medicine: 48 million Generic share: 59% ATC classes: C2 antihypertensives Source: Euro Barometer; BMC Public Health - Internal estimate based on IMS MIDAS

  9. Generic Medicines generate savings “(…)policies promoting the use of generic medicines are often at the forefront in the attempt to increase the cost-effectiveness of medicinal products”. EC-FIN “Policies to promote greater use of generic medicines are likely to lower pharmaceutical expenditure and enhance efficiency” –WHO Report Source: European Commission and Mrazek & Frank, 2004 in WHO - Health policy responses to the financial crisis in Europe report).

  10. Lipitor generics help NHS save £1m per day (in the UK), Pharma Times, 15 May • The NHS saved more than £350 million in the first 12 months after the patent expiration of Pfizer’s Lipitor last year. • (…), now costs just £1.89 – the price tag for Lipitor comes in at £13 for the same pack size and dose, according to the British National Formulary.

  11. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  12. In 2010, health spending fell in Europe for the first time since 1975 Avg. EU-27 health exp. Growth rates from 2000 to 2011, public and total Source: OECD, 2013

  13. Health expenditure by function of care, OECD avg., annual growth Pharmaceutical sector cuts Source: OECD, 2013

  14. Disruptive change :unsustainable market environment Governments take short-term cost measures Well-intended EU legislation complexity and cost • External reference pricing • Discounts/rebates, payback and clawback policies • Price freezes and price cuts • Retail tendering National level National +EU level

  15. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  16. Making the Generic medicines market grow Increase savings for the Bulgarian health system

  17. Making the Generic medicines market grow

  18. External Reference PricingNot for generics • Key risks when introducing ERP: • Generic medicines prices below profitability level • Artificial downward price spiral (procurement and tendering) • Price linkage – ERP is applied twice • Inability to launch generics in some markets • Divergences in updating price lists • WHO : ERP not appropriate for generics

  19. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  20. European biosimilar medicines industry needs strong support to develop Cumulative savings for 8 EU countries, 2007-2020: between €11.8 up to 33.4 b€1 Emerging markets for biologic medicines represent $15Bn opportunity Biosimilar medicines as a major opportunity for EU Specialty drugs are forecasted to be 50% of all drug expenditure in 20182 Biosimilar Filgrastim increased patient access by 44% in the UK3 Source: 1. IGES study – 2. Prime Therapeutics & University of Minnesota College of Pharmacy, poster presented at AMCP San Diego April 4 - 3: UK Filgrastim Volume (in Std. Units) increased by 44% between 2009 and 2012

  21. Adoption of biosimilars has increased access and generated savings in the major EU countries Estimates put annual savings in excess of €120 million in these countries Total 10 countries443M $MAT 03/2013 Fast uptake at launch, now mature Consistent uptake Cultural resistance but change undergoing Fast growing due to market trends Biosimilar replaced originator supply Source: IMS MIDAS, MAT 03/2013 Generic medicines and biosimilars generating savings beyond the medicines bill

  22. Future biosimilars offer more saving among newer therapies: anti-TNF and Mabs (It includes old generation insulins which are unlikely to be targeted by biosimilar players) Existing EU approved Source: IMS MIDAS, Mar 2013 Generic medicines and biosimilars generating savings beyond the medicines bill

  23. Biosimilars and the way ahead • Information for doctors : Clear, unbiased information on the scientific concept of biosimilars, approval process, safety and efficacy • Member States: Guidelines to incentivize physicians to prescribe biosimilars; reimbursement rules for biosimilars uptake • Reimbursement: remove hurdles or delays to pricing and reimbursement approval to increase savings and patient access • Advanced Manufacturing Rule: allow European based industry to compete early in emerging markets; Bulgaria 10 % of EU manufacturing

  24. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  25. Europe is the global hub for high-quality generic and biosimilar medicines European countries with generic medicines R&D and manufacturing* European countries with generic medicines manufacturing* European Countries with manufacturing sites of EU approved biosimilars** Source: *EGA Internal survey - **EMA

  26. Industrial PolicyEmerging market opportunities Source: IMS Health 2011 • Emerging markets : 18% to 28% of the global medicines market from 2010- 2015

  27. Market Loss of EU Generic and Biosimilar Medicines Industry Date of international competition 20 year patent + Up to 5 year SPC Period of market loss to EU companies

  28. Executive summary Patient access to high-quality medicines The healthcare environment Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Conclusion

  29. Stronger collaboration is needed to foster industry and to compete at global level Generate savings Increase patient access Jobs and Growth

  30. Conclusion Medicines provide huge value to patients and healthcare systems Stability of pricing for generic and biosimilar medicines is needed Well thought out regulations that achieve patient safety and reduce complexity are key It is time to support the generic and biosimilar medicines industries

  31. благодаря Adrian@egagenerics.com

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