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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

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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

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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

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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)

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pricing control
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

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pric i ng policies at manufacturer level
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).

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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

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Pricing proceduresMethodology to determine a price

Pricing procedures

  • External price referencing
  • Internal price referencing
  • Cost-plus
  • Others (e.g. indirect price control)

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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

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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

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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%)

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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.

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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

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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

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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

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pharmaceutical expenditure per inhabitant 2007 in pppa
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

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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)

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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

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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

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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
pharmaceutical health information system phis http phis goeg at
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

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european medicines information network eminet http www eminet eu
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

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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