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How to maximize patient access

Perspectives from The Netherlands

Budapest, June 13, 2018

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

a.vulto@gmail.com

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

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For background

▪ www.gabionline.net

▪ www.gabi-journal.net

▪ www.biosimilars-nederland.nl

▪ www.pharm.kuleuven.be/clinpharmacotherapy/mabel

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My personal motto as a hospital pharmacist

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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.

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).

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2017 approved blockbusters forecast 2023

40 billion dollars extra worldwide cost each year

Mullard A. Nat Rev Drug Discov 2018, January

How to maximize access to medicines?

▪ Biosimilars are cornerstone in 2 National policies:

▪Hoofdlijnenakkoord between Government and Healthcare-

sector

▪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

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The State of The

Netherlands 2016:

Medicines in

specialistic

medical care

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▪ 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)

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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 58 2022 or earlier

total 69512

Potential effects expiring market exclusivities

▪ Imatinib (Glivec®, 2016 37 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)

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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)

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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

Successful biosimilar-policies follow the Rule of Four

1. Multi stake-holder approach

Include all that are involved: doctors, pharmacists, nurses, pharmacy-

technicians, 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)

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, 690–693 (2011)

Dörner et al Ann Rheum Dis doi:10.1136/annrheumdis-2016-209166

BOM: Tailormade Education on

Biosimilars in Hospitals

National Educational Program for all

Hospitals

Sponsored by Ministry of Health (3 year,

800 k€)

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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.

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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 failed21

European Commission Q&A on biosimilars for patients

(available in almost all EU-languages)

http://ec.europa.eu/DocsRoom/documents/2664

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▪ 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 2017.

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

https://www.iapo.org.uk/biosimilars-toolkit

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

https://www.iapo.org.uk/biosimilars-toolkit

▪Thank you very much for your attention.

▪Questions?

▪Contact: a.vulto@gmail.com

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