HTA A German perspective Current situation and outlook

HTA – A German perspective Current situation and outlook presentation Prague, march 10 th, 2011

Introduction Health Technology Assessment reflects 5 topics within a systematic evaluation Security Efficacy Effectiveness Ethic, Socials, Psychology Organization, professional HTA survey definition Economy Def. : The systematic evaluation of the properties, effects, and/or other impacts of health technology”* background information Goal Challenges and Problems § Market vs. evaluation timeslot § Integration of ethical and social dimension § Integration of all Stakeholders making situation in a regulatory § Impact Assessment of HTA environment § Transparency of Appraisal § All participants are addressed § Focus: decision makers on macro-level § HTA is base for normative decision- Source: Zerth 2007 ; * International Society of Technology Assessment in Health Care 3

History Milestones** Phase* Germany’s way towards HTA Survey began in 1994 with the founding of ITAS Office at the German Bundestag § 1970 – 1980: first concept to evaluate health technologies § 1980 s: development of national programs § Since ~1985: internationalisation and networking § Since mid 1990: systematic enhancements and standardisation § § § 1994 1995 2000 § 2003 § 2007 founding of ITAS Office at the German Bundestag taskforce at MHH GKV-healthcare law reform (art. 19), DIMDI undertakes the task of evaluating HT for Germany (DAHATA@DIMDI) GKV-Modernisierungsgesetz, since 2004 IQWi. G is responsible for partial aspects of HTA surveys such as comments to health politics or evidencebased guidelines GKV-WSG: § 139 a III nr. 5 SGB V (detection of costs and benefits) Pharmaceutical (AMNOG) Source: * Perleth/ Schwartz; **Econo. Medic AG; ITAS = Institut für Technikfolgenabschätzung und Systemanalyse 4

Process of HTA at DIMDI established a transparent and highly standardized Process following the international accepted methodology DAHTA@DIMDI § § Public collection of issues Feasibility studies in order to prepare and prioritize collected proposals by a Board of Trustees (representatives of G-BA, KV, health insurances etc. ) § Assignment of qualified scientists to create HTA-reports (assessment and quality assurance) Investigations of costs, benefits, risks and effects concerning health care service considering efficacy, effectiveness and efficiency § Publication of completed reports in DAHATA -database and HTA-e. Journal Key figures: § 132 HTA Surveys finished 12 HTA p. a. Public collection of themes PRIORITY LIST HTA Board of Trustees: Selection of Topics HTA REPORT Placing of orders assessment and quality assurance PUBLICATIONS DAHTA-database HTA-e. Journal Updates http: //www. dimdi. de/static/de/hta/basisinfo_de. pdf 5

In terms of HTA, the drug market is ahead of medtech approval Medical products drugs In compliance with minimum requirement § 7 MPG* according to risk classes (§ 37 MPG) need CEcertification Evidence of: • harmlessness • effectiveness • quality • efficiency (GKV-WSG**) Evidence of: • technical harmlessness • medical purpose • required quality Data requirement EN ISO 141553 pharmaceutical testing guidelines referred to in the Arzneimittelgesetz Market structure Huge diversity by suppliers, medium-sized enterprises Small diversity, Huge international operating enterprises Variety of products high low Product life circle 18 -24 month Long (8 -12 years) Mode of action Physical, framework conditions and user skills are of great importance, therapeutic effect often depends on other technologies, embedded in procedure Pharmacological, strongly depends on patients qualities, Often own technologies *Medizinproduktegesetz **Gesetzliche Krankenversicherung-Wettbewerbsstärkungsgesetz 6

Discussion/ critical points Big number of methodical problems during evaluation HTA is steering tool is too slow, to expensive and not goal-oriented Evidence is not equally distributed (Orphan diseases) No standards for HTA-Organizations, Quality of reports varies Ethical/ social/ juristical implications are frequently neglected Unsystematical involvement of assessors … … 7

HTA and Reimbursement influence each other Effects of reimbursement on HTA § § Same origin of HTA and tendency of lumpsum reimbursement (e. g. DRG): scarce resources Thus, increased interest in HTA at micro level This results in methodological implications e. g. concerning the study perspective HTA often designed to help master reimbursement obstacles (therefore less HTA in the outpatient/ ambulatory sector because of higher reimbursement risks) Effects of HTA on reimbursement § § § Two starting points: informal and regulatory supervision Impact-research at the beginning HTA especially influences pricing of drugs/medicinal products (e. g. Australia, Canada) 8

Pharmaceutical vs. Device - HTA is broadly common within European countries but varies significantly Experiences especially in the USA, Canada, GB and Australia Contribution is significantly related to institutional arrangement (responsibility and affiliation, Selection of topics, data requests) 9

Outlook: EU vote on Health Technology Assessment: A step forward - Legal basis for national cooperation now a reality Subject § § § Goal § Press release published on 19 January 2011 by Eucomed European Parliament has voted in favour of the EU Cross-border Healthcare Directive This paves the way for patients to receive medical treatment in any of the EU-27 member states Eucomed’s main focus in the Directive is Article 14 Provides clarity and legal certainty e. g. on important issues such as reimbursement of treatments abroad Also creates a legal basis for HTA cooperation and improved exchange of HTA-related information between member states http: //www. eucomed. org/newsroom/10/19/EU-vote-on-Health-Technology-Assessment-a-step-forward/ http: //www. eucomed. org/uploads/Press%20 Releases/EU%20 Crossborder%20 Healthcare%20 Directive%20%E 2%80%93%20 Compromise%20 text. pdf 10

Contact Chairman: Prof. Dr. h. c. Peter Oberender Executive Board: Dipl. -Kfm. Jan Hacker Dipl. -Kfm. Rainer Schommer Nürnberger Str. 38 95448 Bayreuth Tel. : +49 (921) 150 9114 - 0 Fax: +49 (921) 150 9114 - 29 Ganghofer Str. 31 80339 Munich Tel. : +49 (89) 820 7516 - 0 Fax: +49 (89) 820 7516 - 9 E-Mail: info@economedic. de WWW: http: //www. economedic. de Registered: Local Court Bayreuth, HRB 4267 UST-ID DE 246549731 11

IQWIG receives the order from third parties such as G-BA to undertake action e. g. pharmaceuticals IQWIG § § § Hearing § G-BA or federal ministry of health assigns IQWi. G Creation of a report plan including e. g. the definition of problem, target criteria or criteria for the assessment Within four weeks, statements concerning the report plan are collected Afterwards, procurement of information and scientific evaluation Compilation of the results in a preliminary report statements of steering committee and external consultants, clients etc. Second hearing Final report (can possibly been upgraded in case further unconsidered evidence arises) REPORT PLAN definition of problem and target criteria PRELIMINARY REPORT procurement of information scientific evaluation Hearing § Placing of orders FINAL REPORT Evaluation of statements Updates http: //de. wikipedia. org/wiki/Health_Technology_Assessment 12