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Innovative Agreements for Financing Medicines: a new way of involving stakeholders in paying for real health outcomes WS 5: Establishing multi-stakeholder pain platforms in Europe Jaime Espín, PhD Professor Copenhagen, 30th May 2012 1 Disclosure Statement of Financial Interest I, Jaime Espin DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. 2 Agenda • Pharmaceutical Policies – Some general aspects to remember • New way of financing medicines • The role of different stakeholders in this new way of financing medicines • Some Conclusions (and proposals) 3 DIFFERENT STAKEHOLDERS - INTERESTS Pharmaceutical Sector In Europe GOVERMENTS Control expenditure Accessibility PHARMA INDUSTRY Patents Profits EUROPEAN UNION Free movement of goods Competitiveness 4 Difficult balance for Goverments Industry policy goals Public Health Control Expenditure Innovation Competitiveness Access to affordable medicines 5 Difficult balance for Goverments Public Health Control Expenditure Access to affordable medicines Industry policy goals Innovation Competitiveness 6 7 New way of financing medicines 8 9 Why these new Agreements? 10 Low Level of Innovation 11 Source: Priority Medicines for Europe and the World. WHO. November 2004 12 13 NO CURE, NO PAY 14 New Trend Pharmaceutical Policies based on price regulation Macro New Pharmaceutical Policies based on rational use of resources and cost effectiveness Micro 15 Velcade Risk-Sharing Scheme Individual NHS Trusts Janssen-Cilag Patient initiated on Velcade Provision of stock for first 4 cycles for each patient at cost to NH Respond withim 4 cycles Fail to respond within 4 cycles Continue on Velcade at cost to NHS Discontinue Velcade Trust claims for replacement stock or credit Fuente: PPR Sept 07 Replacement stock or credit at cost to Janssen-Cilag Audit if “unusual” rebate pattern 16 MEDICINE INDICATION A NICE Technology Appraisal Payment of a fixed sum for a patient commencing on a regimen irrespective of actual costs incurred Gefitinib (IressaR) 1st line locally advanced or metastatic non small lung cancer NICE Approved drug B Sunitinib (SutentR) 1st line advanced/metastatic RCC NICE Approved drug Reimbursement of initial phase of treatment C Reimbursement of treatments after an agreed period D Reimbursement for treatments that do not result in anticipated benefits Sunitinib (SutentR) Unresectable or metastatic GIST NICE Approved drug Sorafenib (NexavarR) 1st and 2nd line advanced RCC NICE Rejected drug Sunitinib (SutentR) 2nd line advanced RCC NICE Rejected drug Cetuximab (ErbituxR) Lenalidomide (RevlimidR) Ranibizumab (LucentisR) Trabectedin (YondelisR) Lapatinib (TyverbR) Bortezomib (VelcadeR) Cetuximab (ErbituxR) Sorafenib (NexavarR) Metastatic colorectal cancer NICE Approved drug Relapsed myeloma NICE Approved drug Wet age related macular degeneration NICE Approved drug Treatment of advanced soft tissue sarcoma NICE Approved drug Metastatic breast cancer NICE Rejected drug Relapsed myeloma NICE Approved drug Metastatic colorectal cancer pretreated Hepatocellular carcinoma (advanced and st metastatic) –1 line NICE Rejected drug NICE Approved drug E Discount applied to the total monthly cost F Erlotinib (TarcevaR) Non small cell lung cancer NICE Approved drug Azacitidine (VidazaR) myelodysplastic syndrome, chronic myelomonocytic leukaemia and acute myeloid leukaemia NICE Rejected drug Bevacizumab (AvastinR) Other B+E 1stline treatment of metastatic colorectal cancer –negative ACD Not reviewed by NICE 1st line treatment of metastatic breast cancer in combination with taxane chemotherapy Not reviewed by NICE Degarelix (FirmagonR) advanced hormone dependent prostate cancer NICE Approved drug Everolimus (AfinitorR) 2nd line treatment of advanced and/or metastatic RCC– negative ACD Not reviewed by NICE 17 Incentives under traditional and risk sharing contracts (I) Source: “Risk-Sharing pricing models in the distribution of pharmaceutical”. Staff Working Paper 2003.1. Andrew Lilico. Febrery 2003 Under traditional contracts, the firm’s revenue does not depend on the realisation of the success rate. Once the medicine is accepted on the positive list, the company is guarantue revenue of π* per-unit sold, independently of the actual performance/outcome of the drug 18 Incentives under traditional and risk sharing contracts (II) Under risk sharing scheme, if the succes rate is zero, the firm does not receive any money. But if the actual succes rate is far above expections, the per-unit profit π exceeds the π* level Source: “Risk-Sharing pricing models in the distribution of pharmaceutical”. Staff Working Paper 2003.1. Andrew Lilico. Febrery 2003 19 Incentives under traditional and risk sharing contracts (III) An intermediate solution (dotte line) is the the risk sharing scheme where the firm is guarantee some small fee per unit sold and a “bonus” per every successful treatment. Source: “Risk-Sharing pricing models in the distribution of pharmaceutical”. Staff Working Paper 2003.1. Andrew Lilico. Febrery 2003 20 21 22 Why about implementing these new agreements for pain medicines? 23 Thank you for your attention Jaime Espin [email protected] 24