How to maximize patient access Perspectives from The Netherlands

Transcription

1 Budapest, June 13, 2018 How to maximize patient access Perspectives from The Netherlands Vs18f13 Arnold G. Vulto PharmD PhD FCP Professor Em. of Hospital Pharmacy & Practical Therapeutics Erasmus University Medical Center Rotterdam, The Netherlands Honorary Professor KU Leuven, Belgium

2 Conflict of Interest Statement I declare no personal financial interest in any pharmaceutical business. I entertain friendly relationschips with all innovative and generic / biosimilar companies and I help them all where I can. Companies / Organisations involved are: AbbVie, Amgen, Biogen, EGA (Medicines for Europe), Mundipharma, Pfizer/Hospira, Roche, Novartis/Sandoz I am the co-founder of the Generics & Biosimilars Initiative (GaBi), The Dutch Initiative Group on Biosimilars (IBN) and the KULeuven ErasmusMC MABEL Research Fund 2

3 For background

4 My personal motto as a hospital pharmacist My drive is optimal treatment for all patients at an affordable cost Science gives us the best possible description of the world. It is emotion that is distorting the view. 4

5 The Dutch Landscape Healthcare-coverage in The Netherlands is based on universal solidarity (although 3rd party payers are private companies) General principle is: every patient has access to treatment according to the current scientific insights But: government is concerned about finacial sustainability of health care Continuous pressure on savings The choice of more cost-effective medicines is on every agenda of our Ministry of Health The Dutch Ministry of Health strongly promotes competition in the drug market, both at the top (innovative medicines) as at the bottom (generics, biosimilars). 5

6 2017 approved blockbusters forecast billion dollars extra worldwide cost each year Mullard A. Nat Rev Drug Discov 2018, January

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8 How to maximize access to medicines? Biosimilars are cornerstone in 2 National policies: Hoofdlijnenakkoord between Government and Healthcaresector Cost-increase cost max 1% per year Improve efficiency: strengthen market-powers through biosimilars Dutch Healthcare Institutes (NZI / NZA) carefully monitor both policies and report to Minister / Parliament 8

9 The State of The Netherlands 2016: Medicines in specialistic medical care 9

10 Total spending specialistic medical care (2016): 23 miljard From which expensive medicines: 2 miljard (=8,4%) Annual increase in drug costs: 6,7% (mostly new, expensive medicines) 10

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12 NZA Monitor Expensive Medicines December 2017 Generic name Tradename Spending NL 2016 (M ) Expiration Exclusivity adalimumab Humira 215 October 2018 etanerept Enbrel 142 free Infliximab Remicade 139 free trastuzumab Herceptin 77 free Rituximab MabThera 63 free Bevacizumab Avastin or earlier total

13 Potential effects expiring market exclusivities Imatinib (Glivec, M ): ca. 90% reduction in acquisition costs Biological medicines spending in 2016 total ca. 700 M By competition in the market drop of 40-60% in costs After 2018: ca. 1 million savings EACH DAY! 3 Oncological drugs total in 2016 ca. 200 M Potential savings in due course 100 M of more per year However: savings can be less if volumes expand (see Norway) 13

14 Initiatives in Dutch Healthcare System Biosimilars Toolbox Joint initiative from Dutch Association of Hospital Pharmacists and Federation of Medical Specialists BOM project Initiative from Biosimilars Nederland and Institute of Responsible Medicines Use 3-year project, subsidised by Ministry of Health (800 k E grant) 14

15 Dutch Hospital Pharmacists Association and Dutch Federation of Medical Specialists Toolbox biosimilars (April 2017) A practical guide for succesful implementation Scientific background, definitions and position papers (e.g. MEB) New patients, existing patients Implementation: task force and roadmap Policies for transitioning Information materials, letters MEB, Medicines Evaluation Board

16 Successful biosimilar-policies follow the Rule of Four 1. Multi stake-holder approach Include all that are involved: doctors, pharmacists, nurses, pharmacytechnicians, patient(organisations), hospital management 2. Once voice principle synchronise message from the healthcare-team; avoid nocebo-effects 3. Shared decision making involve patient in decision-making process with positive attitude 4. Gain sharing Create win-win for those who do the work (e.g. the medical department)

17 The confusing definition issue / words to avoid Switching is both: Change from one treatment / molecule to another Change from reference product to biosimilar (also confusingly coined non-medical switching). Better word transitioning: only for biosimilars (FDA, Dörner, 2016) Interchangeability: EMA differs fundamentally from FDA Very confusing: population versus individual level Substitution: Why discuss? We don t do it (with few exceptions). Using these words is framing the discussion (see: Lakoff/YouTube) Weise et al. Nature Biotechnology 29, (2011) Dörner et al Ann Rheum Dis doi: /annrheumdis

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19 BOM: Tailormade Education on Biosimilars in Hospitals National Educational Program for all Hospitals Sponsored by Ministry of Health (3 year, 800 k ) 19

20 BOM-project: on a voluntary basis (at no cost) Objectives Increase knowledge about biosmilars among prescribers, hospital staff and patients Stimulate the prescribing of most cost-effective alternative when prescribing a biological medicine Achieve maximal awareness of the potential offered by biosimilars to reduce healthcare costs and increase access to medicines. 20

21 How the program is executed? Zero-measurement: inventory of todays situation in the hospital Acceptance of biosmilars; are there barriers? Local initiatives already started Efficiency of the drug-procurement process Initiation visit Tailormade educational program for all target-groups Lectures, classes, workshops, e-learning Monitoring developments (2 x per year) What works, what failed 21

22 European Commission Q&A on biosimilars for patients (available in almost all EU-languages) It contains questions and answers on biosimilar medicines and is now available in 23 languages, serving as a reliable source of information for patients. This consensus information on biosimilar medicinal products was drafted by and for patients together with representatives of the European Medicines Agency, the European Commission and concerned stakeholders [the European Patients Forum (EPF), the European Federation of Crohn s & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for BioIndustries (EuropaBio) and Medicines for Europe]. The Q&A was first launched in English in January

23 IAPO biosimilars toolkit (for patients), update 2018 with 8 factsheets

24 IAPO biosimilars toolkit (for patients) update 2018 with 8 factsheets

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26 Thank you very much for your attention. Questions? Contact: 26