Transcript Germany
Role of Generics in the German Health Care System Financial Impacts and Implementation Measures “Generic Medicines in the Taiwanese and German Legal Systems” 03 June 2011 in Taipei, Taiwan Silke Baumann Federal Ministry of Health (Germany) Introduction The German Health Care System 1883: 1st act on Statutory Health Insurance (SHI) •pay-as-you-go principle •proportional contributions from insurees and their employers •self-governmental structures to operate the sickness funds and decide about benefit coverage beyond the legally defined scope Otto von Bismarck (1815-1898) Germany‘s Health Care System Today others (3,0 Mio.) private (8,5 Mio.) SHI (70,4 Mio.) approx. 150 Funds SHI Spendings 2009: 170 Billion Euro in-patient treatment 32% sickness allowance 4% remedies 3% transport 2% prevention and reha 1% domestic nursing 2% medical devices 3% pharmaceutical products 18% dental prostheses 2% source: Federal Ministry of Health/KV45 administration 5% out-patient treatment (doctors) 17% dental treatment 5% Share of Drugs in Total SHI-Spendings 17,63% 17,53% 16,69% 16,09% 16,40% 14,67% 12,92% 13,21% 1994 1995 13,65% 13,42% 1996 1997 15,05% 18,07% 18,18% 17,98% 15,56% 13,90% 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 source: Federal Ministry of Health/KJ 1 SHI-spendings on drugs 1994 – 2009 30,70 29,23 27,76 23,45 17,46 16,38 16,81 25,87 2005 2006 24,22 22,33 19,21 25,36 21,81 20,12 17,72 in billion Euro 15,17 1994 1995 1996 1997 1998 source: Federal Ministry of Health/KJ 1 1999 2000 2001 2002 2003 2004 2007 2008 2009 Drug Supply in the Statutory Health Insurance Access to Drugs market authorisation (proof of quality, safety and efficacy) out-patient care: in-patient care: reimbursement by SHI drugs covered by hospitals (DRGs) cost-containing instruments by law no further legal restrictions Drug supply in the out-patient sector market authorisation reimbursement by SHI (price set by producer) limitations of reimbursement => cost containment exclusion by law •life style drugs •OTC G-BA guidelines •exclusion or restriction •reimbursement amounts therapy advice •... co-payment •10 %, min 5 €, max. 10 € •release is possible •individual limits Cost Containment and the Role of Genenics in Germany Share of Generics 2009 (prescriptions) Non Generics 30% Generics 70% Share of Generics (prescriptions) 100,00% 90,00% 80,00% 70,00% 60,00% 50,00% 40,00% 30,00% 20,00% 10,00% 0,00% 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 source: AVR/WIdO of total market of market with generic potential 2004 2005 2006 2007 2008 2009 Average Price per DDD Average Price per DDD in 1991 Average Price per DDD in 2009 Non Generics 1,95 € Total Market 0,55 € Generics 0,44 € Non Generics 0,61 € Total Market 0,84 € Generics 0,41 € Cost Containment Measures Fixed Reimbursement Amounts 2 steps: 1. Clustering of pharmaceutical substances by the Federal Joint Committee same active ingredient (ATC 5) therapeutic equivalence (ATC 4) 2. Establishing reimbursement amounts by Federal Association of Sickness Funds Price-Level: maximum price at lowest third of price range Effects of Reimbursement Amounts most companies lower their prices to the reimbursement amount (or even lower) if not: losing of market share SHI spendings: stable for drugs subject to reimbursement amounts Market Share: with/without Reimbursement Amounts 2009 Spendings 2009 Prescriptions 2009 72% 39% 61% 28% without reimbursement amounts with reimbursement amounts without reimbursement amounts with reimbursement amounts source: Insight Health Individual Rebates/Tendering Sickness funds are allowed to tender for rebates on drugs Producers can contract with sickness funds rebates vs. higher sales quantity share of generics (presciption volume): 96 % (source: ProGenerika) savings in 2010: approx. 1 Bill. Euro Substitution of Drugs prescribtion by INN or by brand name (original or generic) rebate contract NO rebate contract PHARMACY INN pharmacy hands out a rebated product brand name pharmacy hands out one of the 3 cheapest products pharmacy hands out the prescribed product or one of the 3 cheapest ones Release from Co-Payment Patients‘ co-payment: 10 % of the price min. 5 Euro max. 10 Euro Release from co-payment for drugs with price at least 30 % lower than fixed reimbursement amount Price-index January 2005 – May 2007 Cost-containment Instruments fixed reimbursement amounts „aut-idem“ (substitution) individual rebates/tendering release of co-payment prescription controlling no access to physician-related priscibing data for industry no manipulated software for pysicians no free drugs for pharmacies ... Priceindex/DDD 1991 - 2009 350 300 250 200 150 100 50 1991 1992 1993 source: AVR/WIdO 1994 1995 1996 1997 1998 1999 Total Market 2000 2001 Generics 2002 2003 Non Generics 2004 2005 2006 2007 2008 2009 Prescribed DDD 1991 - 2009 40,0 35,0 30,0 Mio. DDD 25,0 20,0 15,0 10,0 5,0 1991 1992 1993 source: AVR/WIdO 1994 1995 1996 1997 1998 1999 Total Market 2000 Generics 2001 2002 Non Generics 2003 2004 2005 2006 2007 2008 2009 Total Spendings 1991 - 2009 30,0 25,0 Bill. Euro 20,0 15,0 10,0 5,0 1991 1992 1993 1994 1995 1996 source: AVR/WIdO 1997 1998 1999 Total Market 2000 2001 2002 2003 Generics Non Generics 2004 2005 2006 2007 2008 2009 Thank you for your attention! Silke Baumann Federal Ministry of Health Germany [email protected]