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Policy challenges in HTA in Europe: the impact on patient access Andrea Rappagliosi Vice President European Government Affairs & Head of Brussels Office.

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Presentation on theme: "Policy challenges in HTA in Europe: the impact on patient access Andrea Rappagliosi Vice President European Government Affairs & Head of Brussels Office."— Presentation transcript:

1 Policy challenges in HTA in Europe: the impact on patient access Andrea Rappagliosi Vice President European Government Affairs & Head of Brussels Office An Industry perspective The European Patients Forum Health Technology Assessment Seminar – May 18 th, 2010

2 A disclaimer…

3 European co-operation in HTA: Four significant programmes launched in 2009… Centralised Value Assessment: 1. EUnetHTA Network 2010/12: Core HTA dossier, Capacity building for MSs, RE for Pharmaceuticals. (MSs & DG Sanco). 2. EMA Initiative – Getting new medicines faster to patients, anticipate payers input in the regulatory process, scientific capability,“new paradigm” (EMEA, Regulatory Bodies & DG Enterprise). 3. Swedish Presidency initiative: Assessing drug effectiveness in real life setting (post MA); Pilot projects in Orphans, Cancer, Biologics (November ’09). 4. EURORDIS / CAVOD: facilitate informed decision, MSs commitment to common assessment report, use review of scientific data at time of MA Timing: 1. EUnetHTA Network 2010/12: EU Commission invited Stakeholders on November 6 th, 2009 – 2010: EMA engagement EPAR+ and RE; Governance? Work Packages? Pilots? 2. EMA Initiative : EuropaBio meeting on September 11 th ; EFPIA meeting on October 6 th – Row data transparency, need for a post MA value assessment; 2010 launched Road Map to 2015 - RE; 3. Swedish Presidency initiative: Pilot projects in discussion with individual companies – November13th, 09: Brussels follow-up meeting in April 2010; Pilots? Governance? Funding? 4. EURORDIS / CAVOD: Facilitate MSs decisions, based on existing clinical data, holistic value assessment.

4 HTA initiatives: common denominators… Exchange of information Integrated assessment (clinical, economical, social, ethical…) Avoid duplications Pilot projects (“willingness to deliver”) MSs Collaboration (MSs shaping EU healthcare agenda) No extra hurdles Stakeholders involvement

5 Centralised Value Assessment: 1. EUnetHTA Network 2010/12: Core HTA dossier, Capacity building for MSs, RE for Pharmaceuticals. (MSs & DG Sanco). 2. EMA Initiative – Getting new medicines faster to patients, anticipate payers input in the regulatory process, scientific capability,“new paradigm” (EMA, Regulatory Bodies & DG Enterprise). 3. Swedish Presidency initiative: Assessing drug effectiveness in real life setting (post MA); Pilot projects in Orphans, Cancer, Biologics (November ’09). 4. EURORDIS / CAVOD: facilitate informed decision, MSs commitment to common assessment report, use review of scientific data at time of MA Fragmentation of Payers: 1. Consolidated procurement: e.g. AP-HP (Paris) and the Marseille Hospital-Buying Group, France; 2. Contracting/discounting on branded products required for formulary placement: e.g. Germany; 3. Regional level formulary management and tendering: e.g. Italy; 4. Application of regional technology assessment which result in specific localised data requirement: e.g. Catalunia, Spain… Linking patient access to sustainability: the Public Health new challenge…

6 October 2 nd, 2008 – 27 Ministers of Health agreed on: EU Commission High Level Pharma Forum: the agreed framework Core Principle on Relative Effectiveness 1.Process transparency to all parties and evidence-based 2.Stakeholders be able to contribute 3.Process separate from MA 4.Process time-framed 5.Source of evidence discussed with stakeholders 6.Comparison with most appropriate healthcare interventions 7.Outcomes communicated in a clear and timely manner 8.Assessment should be eligible for subsequent revision and updating (evidence development) Guiding Principles for good practices in Pricing & Reimbursement policy 1.Ensure timely access to valuable innovation 2.Provide affordable medicines 3.Ensure equal availability of medicines 4.Limit price control to where it is needed to contain public budget 5.Set-up a consistent package of supply and demand-side measures 6.Create the right environment for price competition 7.Set expectations 8.Recognise innovation / Be consistent when giving reward

7 What Do Different Stakeholders Value in a Health Technology? Results of a Small Group Analysis Devidas Menon (Canada), Marjukka Makela (Finland), and members of the HTAi Policy Forum Value Group* Background: In HTA, the “value” of a health technology is most often measured by means of an economic evaluation (1) or through determining financial implications (2). At the same time it is becoming recognized that the perceived value of a new technology will depend on whether one is a payer, a patient, a family caregiver, or a health professional providing care to a patient, i.e. it is perspective-dependent. Therefore, there has been considerable debate recently on this notion of “value”, particularly as it might influence price-setting, and decisions made by governments on new health technologies, and therefore, access to them. It has been a topic of specific interest to HTAi’s Policy Forum, whose members include government decision-makers, senior industry executives, health professionals, academics and HTAi Board members. In the February 2006 meeting of the Policy Forum, the Value Group met to consider the different perspectives on “value”. Objectives: To identify technology attributes which are deemed to be of value to individuals in various sectors, and their relative importance to these sectors. Methods: The Value Group* comprises 13 individuals from a number of different sectors. This group met to identify the relevant stakeholder groups who would have an interest in health technologies, their introduction and use. Eight stakeholder groups were identified (see Table). The Value Group also discussed the potentially important attributes of new health technologies, and agreed on 14 such attributes. These were then rated by consensus on a three point scale (3: very valuable; 2: somewhat valuable; 1: not valuable) based on what the Value Group thought would be “value” to each stakeholder group. Agreements between stakeholder groups on specific attributes were examined, as well as those for which there were major differences. The kappa statistic was used to assess the differences between pairs of stakeholder groups. Results: The table shows the results of this exercise.  “Lack of alternatives” was seen to be a very important value of new technologies to all stakeholder groups. All groups also rated “safety” and “effectiveness” similarly.  The groups differed in their view of financial aspects (“cost of intervention” and “budget impact”), with patients, professionals and employers considering these to be not important aspects of value. Clearly, managers and payers thought differently about these aspects.  Statistical analysis of the data, using the kappa coefficient, showed that there was “very good” overall agreement between payers and government (k=0.88), good agreement between managers and payers (k=0.63) and moderate agreement between managers and government (k=0.51). This seems to be driven (as indicated in the previous point) by cost and expenditure considerations. There was at best poor agreement between any other pairs of groups.  Patients and professionals agreed substantially on their judgments of value; the exceptions were “convenience of use” which initially was thought would be important to patients, professionals and industry, but seems not to be so to professionals, and “feasibility” (the feasibility of providing the technology in existing surroundings, i.e., training, space, etc. needs), which was important to professionals but not to patients.  “Newness” was of high value to all except payers, employers and government. Conclusions: In conventional HTA, the value of a technology is usually based on a clinical, economic or humanistic outcome of its use. This was a preliminary study to ascertain what different stakeholders value in new technologies. The “data source” for this study was the Value Group itself. Its members were from academia, industry, payer organizations and HTA producers; however, the members had to try and make a judgment of value for other sectors, such as managers. Clearly, this limits the findings, and this study will need validation by the primary stakeholder groups. However two conclusions can be drawn despite this limitation. “Value” is clearly in the eyes of the beholder. Reimbursement decisions that are made from the perspective of payers or governments would likely ignore attributes of technologies that patients or professionals consider to be of value. Innovativeness of a new technology (based on the response to “newness”) does not seem to be inherently valued by payers. The current interest in innovation would need to involve a broader spectrum, including patients and professionals. References: (1)Pearson SD and Rawlins MD (2005). Quality, Innovation, and Value for Money, JAMA,294:2618-2622. (2) OECD (2005). Health Technologies and Decision-making, pp 47-69. *Nick Bruce (UK), Frances Charlesworth (UK), Americo Cicchetti (Italy), Jens Grueger (Switzerland), Marjukka Makela (Finland), David Matchar (USA), Aaron McCracken (Canada), Devidas Menon (Canada), Steven Pearson (USA), Andrea Rappagliosi (Switzerland), Michael Rawlins (UK), Milena Richter (Belgium), Mike Wallace (UK).

8 A new paradigm for the industry perspective?... 1. Policy-makers face tremendous challenges when making recommendations for the adoption of new therapies to address unmet medical need. 2. The perceived value of a therapy may differ depending on whether one is a payer, a patient, a family member, or a physician involved in the healthcare of a patient. 3. Where healthcare allocation decisions are judgemental and values driven, the fullest possible transparency and stakeholder involvement are basic and necessary components.

9 Policy challenges in market access in Europe: four questions to be addressed… 1. Have common standards at European level in the Relative Effectiveness assessment the potential to better meet the needs of Europe’s payers? 2. Will the separation between EU Relative Effectiveness (clinical) and the National appraisals (economical) improve patients access performances? 3. To what extent can pan-EU RE assessment be undertaken and acceptable to MSs? 4. Will a full stakeholders involvement in the assessment and appraisals of medicines be implemented in order to reduce controversies?


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