HTA for Medical Devices. Pascale Brasseur Health Economics & Reimbursement Director, Cardiovascular, Medtronic International Sa

Transcription

1 HTA for Medical Devices Pascale Brasseur Health Economics & Reimbursement Director, Cardiovascular, Medtronic International Sa

2 Agenda A few figures on Medical Devices Frequency of HTAs performed on Medical Devices Key principles for the conduct of HTAs Specificities for HTAs on Medical Devices Results from Eucomed Competitiveness Survey Impact of HTAs Our Perception of HTA Current Environment Implications for Medtronic References

3 European Market of Medical Devices (15%) Source : Eucomed Medtech Brief 2007 Medtronic figure

4 Expenditure on Medical Devices Source : Eucomed Medtech Brief 2007

5 12 Categories as per Global Medical Device Nomenclature Source : Eucomed Medtech Brief 2007

6 Proposed Clustering for Funding & Reimbursement Purposes Category I medical aids standard products which are prescribed and given to an individual patient Category II artificial body parts medical devices which stay at or in the patient (e.g. knee endoprostheses, stents): only one component of a broader service package to implant or adapt the (hardware) product to the individual patient Category III assistance for professionals technical equipment supporting professionals in diagnostics and/or treatment with two-stage financing: IIIa: investment IIIb: refinancing via use (diagnostics/treatment) incontinence pads knee (endo-)prostheses ICD coronary stents implants endoscope (for e.g. gastroscopy) operating room equipment] imaging devices: X-ray, CT, MRI Source : Prof. R. Busse presentation for Med Tech week October 2008

7 Proposed Clustering for Funding & Reimbursement Purposes Category I medical aids standard products which are prescribed and given to an individual patient Little HTA Category II artificial body parts Category III assistance for professionals medical devices which stay at or in the patient (e.g. knee HTA, typically for Service technical equipment endoprostheses, stents): supporting professionals in only indication/ (not product) one component of a is focus diagnostics and/or treatment broader service/product service package to of HTAwith two-stage financing: implant combination or adapt the IIIa: investment (hardware) product to the IIIb: refinancing via use individual patient (diagnostics/treatment) Large emphasis on Limitations to particular patients, products or service providers possible Source : Prof. R. Busse presentation for Med Tech week October 2008

8 HTA for Medical Devices Source : Draborg et al, International comparison of the definition and the practical application of health technology assessment International Journal of Technology Assessment in health Care 21:1; 2005, 89-95

9 HTA for Medical Devices Source : HTA capacity building handbook EUnetHTA WP 8

10 HTA for Medical Devices Source : ISPOR Special Interest Group HTA in evidence-based decisions - May 2008 Congress in Montreal

11 HTA for Medical Devices Source : ISPOR Special Interest Group HTA in evidence-based decisions - May 2008 Congress in Montreal

12 Key principles for the conduct of HTAs

13 Key principles for the conduct of HTAs Structure of HTA programs The goal and scope of the HTA should be explicit and relevant to its use HTA should be an unbiased and transparent exercise HTA should include all relevant technologies A clear systems for setting priorities for HTA should exist Methods of HTA HTA should incorporate appropriate methods for assessing costs and benefits HTAs should consider a wide range of evidence and outcomes A full societal perspective should be considered when undertaking HTAs HTAs should explicitly characterize uncertainty surrounding estimates HTAs should consider and address issues of generalizability and transferability Processes for conduct of HTA Those conducting HTAs should actively engage all key stakeholder groups Those undertaking HTAs should actively seek all available data The implementation of HTA findings needs to be monitored Use of HTAs in Decision Making HTA should be timely HTA findings need to be communicated appropriately to different decision makers The link between HTA findings and decision-making processes needs to be transparent and clearly defined.

14 Key principles for the conduct of HTAs Structure of HTA programs The goal and scope of the HTA should be explicit and relevant to its use HTA should be an unbiased and transparent exercise HTA should include all relevant technologies A clear systems for setting priorities for HTA should exist Methods of HTA HTA should incorporate appropriate methods for assessing costs and benefits HTAs should consider a wide range of evidence and outcomes A full societal perspective should be considered when undertaking HTAs HTAs should explicitly characterize uncertainty surrounding estimates HTAs should consider and address issues of generalizability and transferability Processes for conduct of HTA Those conducting HTAs should actively engage all key stakeholder groups Those undertaking HTAs should actively seek all available data The implementation of HTA findings needs to be monitored Use of HTAs in Decision Making All relevant for Medical Devices HTA should be timely HTA findings need to be communicated appropriately to different decision makers The link between HTA findings and decision-making processes needs to be transparent and clearly defined.

15 Specificities for HTAs on Medical Devices

16 Specificities for HTAs on Medical Devices Diagnostic devices often have multiple applications Drugs also multiple indications, but devices are indivisible, which means that the overall value of one device is some weighted average of its use in multiple applications. On the other hand, being divisible, the value of a drug can be assessed in each indication, and a judgment reached on each separately. RCTs difficult to undertake What do we really compare? Different devices/procedures or different level of expertise? Is blinding ethical if requires a sham procedure? Is randomization possible if patients are aware of a less invasive procedure? Learning curve Prices more likely to change over time

17 Specificities for HTAs on Medical Devices Devices change rapidly Miniaturisation, micro-systems relevance of operator skills, learning curve statistical aspects Digitisation, visualisation, imaging additional benefit of more precise images and details Use of new materials, biomarkers Long term of safety of new materials Information technology, telemetry Impact on organisation of health care services Other sources of evidence such as well designed comparative and non comparative observational studies must be considered

18 A few Considerations - HTA Source : Eucomed Competitiveness Survey 2007

19 A few Considerations - HTA Source : Eucomed Competitiveness Survey 2007

20 A few Considerations - HTA Source : Eucomed Competitiveness Survey 2007

21 Our perception of current HTA Environment More agencies and/or more levels in one system For established agencies, more resources and power Enhanced complexity in evaluations methodological reviews QALY or not QALY relevant data ; indirect or multiple treatment comparisons Cost-effectiveness threshold fir for purposes Increased sophistication in decisions links to value-based pricing, risk-sharing agreements Powerful networks

22 Implications for Medtronic Collate, analyse and inform on HTA information in areas of importance to Medtronic in order to Recommend HTA strategy / policy positions to senior leadership Drive development of relevant evidence Acquire/develop appropriate skills and resources Initiate/strengthen relationships with HTA Agencies Ensure strong presence in key forums HTAi Policy Forum and HTAi Annual Conference ISPOR Medical Device Group, SIG, Annual Conferences Eucomed / Advamed Country Industry Associations Scientific Societies

23 References Busse et al, Best practice in undertaking and reporting Health Techonology Assessments, International Journal of Technology Assessment in Health Care, 18:2 (2002), Drummond et al, Key principles for the improved conduct of health technology assessments for resource allocation decisions, International Journal of Technology Assessment in Health Care, 24:3 (2008), Economic Evaluation for Devices and Drugs Same or Different? Value in Health, December 2008 Editorial by A. Manca Article by M. Drummond et al Article by R. Taylor et al Health Economics of Medical Devices: Opportunities and Challenges, Editorial by Steven Simoens, Journal of Medical Economics 2008; 11:

24 References The OECD Health Project - Health Technology and Decision Making, 2005 Health Technology Assessment and Policy Making in Europe Current Status, Challenges and Potential, WHO Observatory on Health Systems and Policies and EUnetHTA, 2008 EUnetHTA Handbook on HTA Capacity Building, October 2008 Eucomed position paper : ashx

25 Grazie!