Build a deeper appreciation and understanding of HTA needs into your wider organization. Stefan Holmstrom

Transcription

1 Build a deeper appreciation and understanding of HTA needs into your wider organization Stefan Holmstrom Executive Director HEOR Medical Affairs, Global Astellas Pharma 1

2 Outline of presentation 1. Changing environment of Pharma 2. The Challenge External Internal 3. Integrating HTA needs into organization and internal alignment 4. Conclusion 2

3 Changes in the healthcare environment A number of factors are having increasing influence on healthcare decision making, resulting in pressure and focus on healthcare budgets. Advances in medical technology Ageing population & resulting increase in chronic illness Increase in public expectation Slower economic growth Pressure on healthcare budgets Cost containment measures by payers Increasing number & types of healthcare professionals 3

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5 Defining the challenges External challenges The HTA and Payers Internal challenges The internal stakeholders and focus points 5

6 We all have different focus External HTA and Payer is focusing on optimizing the use of limited resources/budgets Internal Development organization is focusing on getting NDA and MAA approvals Pricing department is focusing on getting the best possible price = highest possible price? Commercial is focusing on getting the biggest market share Health Economics is focusing on getting an acceptable ICER Market Access is focusing on getting payer acceptance 6

7 Regulators versus HTA bodies Having an approved NDA/MAA, qualifies you to talk to me Dr. Andrew Walker, Sr. Economic Reviewer, SMC 7

8 HTA & Payer relevant endpoints Payer Need Payer performance measures R&D delivery Performance Reduction in symptoms RCT show efficacy improvements (x-y%) Effective Usage Clear stop/start rules Identify responders/diagnostics Value for Money Benefit vs. costs is acceptable Economic Modeling Human Impact Acceptable QoL for patients Demonstrate effect on QoL and family Stakeholders Real-world Level of pressure from key influencers Proof (based on data) that it will deliver real world results Build Constituent need in trial design Phase IV open label, Observational, Chart review 8

9 Our challenges Payers/ HTA Cost Effective Budget Impact Physician and Patient acceptance Quality Safety & Efficacy 9

10 Dialog with regulators, payers & HTA bodies on endpoints and design 10

11 Defining the challenges External challenges The HTA and Payers Internal challenges The internal stakeholders and focus points 11

12 Stakeholder views on the role of a GVD Can a GVD influence submission outcome? UK-LAF: No, it purely depends on the data and if the data is relevant to the market. HQ: Without the GVD you may have submissions prepared by people that don t understand your strategy behind the positioning of the drug.. EU5 vs. non EU5 LAF Yes No HQ and LAF responses 2 HQ (n=7) LAF (n=12) Yes No N/A 4 5 0% 50% 100% EU5 (n=6) 1 Non EU5 (n=6) With permission of Quintiles Advisory Services, Pim Kooreman,

13 Stakeholder views on the content of a GVD Are there any sections in the GVD more important than others? HQ: All sections presented in the GVD are equally important (n=7/7; 100%) LAF: Some sections are more important than others (n=11/12; 92%)» Clinical data (n=8)» Positioning statements (n=5)» Economical data (n=3) HQ: They are all equally important, the GVD is telling a story. Is there information missing from the GVD? HQ (n=6) HQ and LAF responses 5 1 Yes DE-LAF: Not really missing but not as in depth as I need it from a country perspective. No LAF (n=12) 7 5 Ambiguous 0% 20% 40% 60% 80% 100% With permission of Quintiles Advisory Services, Pim Kooreman,

14 Outline of presentation 1. Changing environment of Pharma 2. The Challenge External Internal 3. Integrating HTA needs into organization and internal alignment 4. Conclusion 14

15 HEOR Key activities to maximize product value 10% 20% 30% 40% Drug discovery today 02/2012; 17(11-12):

16 Pyramid of refinement Finding the balance with your intrinsic data & results and the HTA/Payer needs Blue Sky POC Testing your message hypothesis, endpoints, PRO s and models ph2 Delivering final Value Propositions and HE model ph3 RWE and refined Value Launch LCM 16

17 The Global Value Alignment model Early Evidence Generation Data examples Late Phase Evidence Generation/Value Dissemination Data examples Value Arguments Early Value Dossier Value dossier Country dossiers Global Value Team (POC) (Phase II) Phase IIIA Regulatory submission HTA/ Reimbursement submissions, Phase IIIb/IV To LCM 17

18 Global Value Team Chair Region Global Strategic Alignment Region Region 18

19 Integrated focus for optimal Market Access R&D Focus Development focus HTA strategy R&D Commercial Reimbursement strategy Brand support Guidance Competitors and Strategic support Regions/ Affiliates LCM and Regional support RWE 19

20 Integrated focus for optimal Market Access R&D Focus Regulatory Commercial HTA strategy Development focus Reimbursement strategy R&D Commercial Brand support Pre Clinical Market Access Statistics HEOR Guidance Competitors and RWE Governmental Affairs/Policy Strategic support Regions/ Affiliates Clinical KAM LCM and Regional support Medical Multidisciplinary approach 20

21 Global Value Team Chair Region Global Strategic Alignment Region Region 21

22 What does good look like? PRO and QoL guidance Instrument control PRO Expert network Methodology excellence HTA Expert networks Early Scientific Advice PRO s HTA Early Development Global VD Endpoint selection Guidance Focus on development structure Core Team GVD Structural optimization Regional and Affiliate input Focus on Medical Affairs Core Medical Team 22

23 Value chain, working by stage Launch readiness Post approval support Local level engagement Strategic and tactical activities HEOR input into Development studies (Phase 2 / 3 studies) Preparation of Global Value Dossier PRO assessment and input Landscape assessment (e.g. unmet need, disease burden, competitor analysis) HEOR projects: disease registries External database analyses Post hoc analyses Big data analyses Adjust Global Value Dossier to region and country needs Alignment and governance of HEOR activities Engagement with customers (e.g. product presentations) Adjust Global Value Dossier to country needs Global Value team coordination Involvement Global, (with region input) Region, with Global coordination Country execution (with region support) Early decision Approval 23

24 Key recommendations Tailor global market access strategy based on product qualities Breakthrough/first in class vs. me too vs. follower Be pro-active and understand setting-specific requirements and payer mindset engage with key stakeholders early on (regulators, HTAs, patients); not always easy, but necessary Ensure global alignment with development team members (statistics, project lead, medical, regulatory, HEOR, commercial, etc.) as well as continuous regional and policy input 24

25 Key recommendations Ensure Value Dossier is available at NDA/MAA approval Enhance skills and capacity internally to understand client needs: Health systems Pricing, Health economics and outcomes Patient advocacy Regulatory 25

26 CONCLUSION 26

27 Conclusion Planning for evidence generation should begin in early phase and be regarded as a living process that can be updated to account for new internal data and new external pressures throughout the product lifecycle Develop credible evidence Identify unmet information needs Align evidence with product value proposition Build implementation plan Integrated, Holistic Evidence Generation when it is needed for appropriate audiences Health Care Professionals Patients & Caregivers Regulators/Health Authorities Payers P r o d u c t L i f e C y c l e Phase II Phase III Phase IV Loss of Exclusivity (LOE) 27

28 To accomplish great things, we must not only act, but also dream; not only plan, but also believe - Anatole France 28