New approaches to pricing & funding and implications for access: the BeNeLuxA Collaboration

Transcription

1 New approaches to pricing & funding and implications for access: the BeNeLuxA Collaboration Diane Kleinermans Advisor to the Belgian Minister of Healthcare and Social Affairs 9th European Conference on Rare Diseases & Orphan Products Vienna, May 10-12,2018

2 BeNeLuxA initiative

3 Looking back 2014 Rome, IT Presidency: NCAPR debate on collaboration and open invitation to for a coalitio o phar aceutical prici g 2015 Riga, LV EU Presidency: Be-NL sign letter of intent 2015 Luxembourg, LU EU Presidency: Lux joins as partner 2016 Amsterdam, NL EU Presidency: AT joins as partner 8..? 3

4 1 The Initiative Brood hal, Brussels

5 The Initiative Main goal To ensure access to innovative drugs at affordable and sustainable cost by leveling the playing field. Main Focus Political mandate for collaboration Case driven; lean organisational structure Voluntary Consensus based cooperation Price/Reimbursement decisions are national competence 5

6 Thematic approach Collaborative approach to gathering information Mutual recognition; Joint HTA Best practices, registries, policy dilemmas Horizon Scan interpretation; Information exchange; Horizon Scanning HTA Information sharing Specific information sharing Joint negotiations Input for Joint Negotiations 6

7 Benefits of collaboration Better alignment of HTA and P&R across borders Coherent approach of cross-border developments in the pharmaceutical sector: Breaking down silos in the pharmaceutical chain Better Alignment of perspectives on future developments, data and procedures (cli ical data; HTA data; Payer s eeds i ew for s of Market authorisation) 7

8 2 Horizon Scanning Keizersgracht, Amsterdam

9 Horizon Scanning Aim: To identify high impact products at early stage Footer Text 9

10 Horizon Scanning Aim of a joint horizon scanning database: To inform decision makers on emerging and new pharmaceuticals for reimbursement decisions and policy development on issues that are relevant for the managed introduction and monitoring of pharmaceutical products To enhance collaboration between member states by selecting relevant issues for collaboration Footer Text 10

11 Horizon Scanning Current stage: Design and methodology based on Belgian KCE study NL horizon scanning activity as temporary product 11

12 Horizon Scanning June 2017: call for participati on May-Sept 2018: Setup of the legal entity March 2018: Consolidation meeting Nov. 2017: 16 answers Apr- May 2018: Agreement preparatio n (legal, organisatio nal, financial & technical) Sept.-Dec 2018: Tendering Sept. 2018: final procurement preparation Footer Text 2019: launch of the IHSI December 2018: selection of final candidate 12

13 3 Health Technology Assessment Along the Alzette, Luxembourg

14 Joint Health Technology Assessment Structural dialogue between BE, NL, Lux & A HTA bodies Sharing of calenders and age da s of ongoing and future evaluations evaluation pipeli e Mutual recognition of experts that lead to mutually recognized and common scientific evaluation reports Footer Text 14

15 Joint Health Technology Assessment Improvement of collaboration on HTA through: Building on expertise/ experience acquired within EunetHTA and MEDEV (voluntary partnership for HTA and early dialogues) Harmonising formats to facilitate the exchange of work Joint Assessments Exploring new mechanisms of HTA collaboration on pharmaceuticals Footer Text 15

16 Joint Health Technology Assessment Future: To improve collaboration on HTA Sharing expertise within EunetHTA and bilaterally EUnetHTA formats and scientific work as a basis Joint HTA in practice Prevent duplication of existing/new forms of collaboration on HTA! 16

17 4 Information exchange Domkirche St. Stephan zu Wien, Vienna

18 Information exchange Goal: 1. To improve the position of the payer and patient by: Exchanging information on pharmaceutical markets, patient groups, therapy guidelines, industry approach Discussing best practices on policy issues 2. To serve as a platform for exploring cross-border data sharing (registries) 18

19 Information exchange Strategic information: Creation of environment / platform for the exchange of strategic information To prepare joint negotiations/ negotiations for price and reimbursement Feasibility study on specific cross-border registries Footer Text 19

20 5 Pricing & Reimbursement Brood hal, Brussels

21 Pricing & Reimbursement (including joint price negotiations) Process: Selection of candidate product through Horizon Scan Joint HTA as starting point Definition of desired outcomes Joint negotiations Footer Text 21

22 Pricing & Reimbursement (including joint price negotiations) Lessons learnt: Processes have to be aligned first: playbook Legal differences can complicate joint negotiations (language issues, reimbursement obligations etc) Candidates have to be selected carefully (extramural vs. Intramural) Political consensus is essential Footer Text 22

23 6 Lessons learnt Keizersgracht, Amsterdam

24 Lessons learnt - overall Clear political commitment and mandate is important Coalition forming helps align common perspectives in other forums Value of exchange of strategic information has an immediate effect Collaboration dramatically lowers the threshold to exchange ideas/information on other topics (e.g. Medical devices Be<->NL ) 24

25 Lessons learnt day to day collaboration Informal communication on all levels is vital Political willingness and technical possibilities among participants should be clear Alignment of national procedures is necessary Expansion requires careful planning 25

26 Thank you for your attention! Any questions? Footer Text 26

27 Contact: For more information go to: Aldo Golja Overall BeNeLuxA Initiative Coordinator Ministry of Health, Welfare and Sport (NL) //

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29 Expenses related to OD in Belgium Expenditures Orphan Drugs 450,000, ,000, ,000, ,000, ,000, ,000, ,000, ,000, ,000, Public 2013 Hospital #OD

30 Market share of OD in Belgium Part Expenditures Orphan Drugs 20.00% 18.00% 16.00% 14.00% 12.00% 10.00% 8.00% 6.00% 4.00% 2.00% 0.00% Public Hospital 2013 Public + Hospital