1 / 22

Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU Nina Zimmermann GÖG/ÖBIG,

Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU Nina Zimmermann GÖG/ÖBIG, PPRI Secretariat Healthcare Forum 2009 Bucharest, 30 September 2009 Out l i n e Introduction: P& R in the EU Overview on pricing practises in the EU

Samuel
Télécharger la présentation

Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU Nina Zimmermann GÖG/ÖBIG,

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU Nina ZimmermannGÖG/ÖBIG, PPRI Secretariat Healthcare Forum 2009Bucharest, 30 September 2009 1

  2. Outline • Introduction: P& R in the EU • Overview on pricing practises in the EU • Overview on reimbursement schemes in the EU • Rational use of pharmaceuticals • Pharmaceutical expenditure &cost-containment measures • European networking initiatives 2

  3. Pharmaceutical P & R in the EU • Market authorisation:regulated at EU level (Directive 2004/27/EC) • Pricing and reimbursement:mainly a competence of the EU Member States • Transparency Directive (Directive 89/105/EEC) 3

  4. Pricing control Definition: Pricing policies where government authorities set the price of a pharmaceutical and/or indirectly influence it (e.g. statutory pricing, price negotiations, public procurement). Contrary to free pricing. Source: PPRI Glossary (http://ppri.goeg.at) Practice in the EU • Price control in 24 of 27 EU-MS (all excl. DK, DE, MT) • In the majority of the EU Member States,price control is limited to reimbursable pharmaceuticals 4

  5. Pricingpolicies at manufacturer level Statutory pricing: Pricing system, where pharmaceutical prices are set on a regulatory basis (e.g. law, enactment, decree). Price negotiations: A form of pricing procedure, where pharmaceutical prices are discussed / negotiated (e.g. between manufacturer and social health insurance / national health service). Public procurement: Buying pharmaceuticals by the state (e.g. public hospitals) on the basis of a tendering procedure, granting the contract to the best tenderer (pharmaceutical company / importer). 5

  6. Pricing policies at manufacturer level • The most common price control policy is statutory pricing (i.e. setting the price on a regulatory, unilateral basis). • e.g. BE, BG, CY, CZ, EL, ES, LT, LU, PT, SE • Price negotiations are used in a few countries (e.g. FR, IT). • Mixture • Statutory pricing after negotiations (EE, LV, PL) • In case of failure of negotiations (e.g. FR) or non-availability of data for comparison (e.g. IE) • Procurement/Negotiations in the hospital sector and/or for public functions 6

  7. Pricing proceduresMethodology to determine a price Pricing procedures • External price referencing • Internal price referencing • Cost-plus • Others (e.g. indirect price control) 7

  8. External Price Referencing Definition: The practice of comparing pharmaceutical prices across countries. There are various methods applied and different country baskets are relevant. Synonym terms: cross-country referencing, international price comparison, international price benchmarking Source: PPRI Glossary, http://ppri.goeg.at Practice in the EU • Increasingly used, currently in 22 EU-MS 8

  9. C. = countries, ref. = reference Note: countries (incl. number of countries) not specified – CZ, IT; respective countries of origin – LU Source:PPRI 2008 External price referencing in the EU MS + NO + TR 9

  10. Pricing policiesat distribution level • 4 of the 27 EU-MS apply no statutory wholesale mark-ups • In these countries (DK, FI, SE, NL) the pharmacy purchasing price is controlled, the ex-factory price is an outcome of negotiations between manufacturer & wholesaler. • All other countries have statutory wholesale mark-ups, either a linear mark-up or a regressive scheme. • Pharmacy margins are regulated in all 27 EU-MS. • Usually, they take the form of a regressive scheme or a linear mark-up. • Pharmacy remuneration - a fixed fee in NL and DE (with a linear mark-up) • SI and UK: fee-for-service remuneration • VAT rates (0-25%) 10

  11. Reimbursement:Positive / negative lists • Positive lists in 23 of the EU Member States (all but DE, ES, EL, UK) • Negative lists are less common (DE, HU, UK; legal basis in EL and FI) • Positive / negative lists have to be seen in consideration with the reimbursement eligibility schemes • Product-specific eligibility (key scheme in 19 EU Member States) • Disease-specific eligibilty (key scheme in the Baltic states) • Population-group-specific eligibility (CY, MT; IE) • Consumption-based-specific eligibility (DK, SE) • Only in a few EU Member States (e.g. AT DE, IT, NL, UK), all pharmaceuticals on the positive list are 100% reimbursed. 11

  12. Reference Price System Definition: The social health insurance / national health service determines a maximum price (= reference price) to be reimbursed for certain pharmaceuticals. On buying a pharmaceutical for which a fixed price / amount ( = reimbursement price) has been determined, the insured person must pay the difference between the fixed price / amount and the actual pharmacy retail price of the pharmaceutical in question, in addition to any fixed co-payment or percentage co-payment rates. Usually the reference price is the samefor all pharmaceuticals in a given ATC 4 and/or ATC 5 level group. Source: PPRI Glossary, http://ppri.goeg.at 12

  13. Reimbursement:Reference price systemsin the EU MS 2009 FI: RPS from 4/2009 on • 22 EU Member States with a reference price system Source: PPRI 2008, updated information Source: PPRI, national information sources 13

  14. Rational use of medicines • Prescription guidelines • All EU MS • mostlyindicative • Prescriptionmonitoring • All EU MS • Referringtothereimbursementmarket • Pharmaceuticalbudgetsfordoctors • Quite rare • Budgets are in: DE, CZ, ES in someregions, IE (withincentives), LV (sanctionsagainstdoctors), SE in someregions, UK 14

  15. Pharmaceutical expenditure per inhabitant 2007in € PPPa *** no data of IE, MT, RO, SI ** NO, IT : 2008 SK 2006 BG (only public expenditure), LU, LV: 2005 CY, EE: 2004 TR: 2000 UK: 1997 Source: OECD 2009, Eurostat 2009, PPRI 15

  16. Pricing-related cost-containment measures • Price control (at manufacturer level):in all EU-27 excl. DK, DE, MT • External price referencing:in 22 EU Member States • Price freezes/cuts:- price freezes - observed in DK, HU, IE, NL, UK- a common measure (e.g. CY, FI, FR, IT, NL, PT, SK, UK) • Price control at distribution level:- wholesale margin in 21 of the 27 EU MS (excl. CY, DK, FI, NL, SE)- pharmacy margin in all PPRI countries • Margin cuts:- very common, e.g. EL, FR, FI, HU, LT, PL, SK, UK- either cuts or changes • Statutory discounts:granted to Third Party Payers, e.g. DE, IT (in form of price cuts) 16

  17. Reimbursement-related cost-containment measures • Changes in reimbursement lists:- in nearly all countries • Changes in reference price systems:- e.g. in BE, DE, HU, PL • Systematic reimbursement reviewsof several therapeutic classes or the whole system:- e.g. in BE,FR, LT, SE • Claw-back system- in place in BE, FR, HU, NL and UK 17

  18. Lessons learned • Total pharmaceutical expenditure has increased; however successful cost-containment does not necessarily mean shifting the burden to the patients ( rational use). • Need for information by the Member States • Sharing information at an ad-hoc basis • In-depth and comparable, up-to-date information • Information on the hospital sector is needed • Need for a common understanding language • Need for improvements in data availability and comparability • Need for an active and sustainable network 18

  19. Pharmaceutical Pricing and Reimbursement Information • Framework • Research project • Funded by European Commission, DG SANCO,co-funded by the Austrian Federal Ministry of Health • Project leader: GÖG/ÖBIGAssociated partner: WHO, Regional Office for Europe • April 2005 – October 2007, from 2008 on: the network continues • Objective • improve knowledge and promotes information exchange about the pharmaceutical systems in the enlarged Europe • Deliverables: Glossary, Pharma Profiles, Set of Core Indicators

  20. Pharmaceutical Health Information System (PHIS), http://phis.goeg.at Scope: To monitor and assess up-to-date health information and data for the field of pharmaceuticals in a comprehensive health system approach (i.e. covering the out-patient and in-patient sector) in the EU Member States, and to evaluate these indicators from a public health perspective, and to build a database  to develop a sustainable pharmaceutical health information system Members: All 27 Member States, ALB, CA, NO, IS, CH, TR, South Afrika, plus hospital representatives. More than 60 institutions Leading Institutions: GÖG/ÖBIG (AT, main partner), AIFA (IT), IHHII (BG), SOGETI (LU), SUKL (SK) Establishment: Executive Agency for Health and Consumers (EAHC), Advisory Board: EAHC, DG SANCO, DG ENTR, DG Eurostat, OECD, WHO HQ + Europe Period: September 2008 – April 2011 20

  21. European Medicines Information Network(EMINet), http://www.eminet.eu • Background: Established in December 2008 following a tender of the European Commission, DG Enterprise • Objective: Support P + R decision- and policy-makers on the national and European level • Tasks: Collect, compare and disseminate knowledge on different pricing practices and cost-containment mechanisms in the EU  Analyses to build further knowledge upon need • Project Organisation: Project Management – GÖG, EASP, LSE Health; Evaluation Committee • Time-table: 2009 - 2013 21

  22. Thankyouforyourattention! Nina Zimmermann Researcher at GÖG/ÖBIG Health Economics GÖG / ÖBIG (Austrian Health Institute) / PPRI Secretariat Stubenring 6, 1010 Vienna. AUSTRIA Tel. +43 1 51561/132 e-mail: nina.zimmermann@goeg.at http://www.goeg.at, Health Economicshttp://ppri..at, http://phis.goeg.at

More Related