EuroBioForum 2013 2nd Annual Conference 27-28 May 2013 - Hilton Munich City, Munich, Germany http://www.eurobioforum.eu/2013 ======================================= # NATIONAL PERSPECTIVES # Norway: Personalised medicine in Norway Dr Øyvind Melien Senior Advisor at Norwegian Directorate of Health ======================================= http://www.eurobioforum.eu

1. Personalised medicine
in Norway
Øyvind Melien
The Norwegian Directorate of Health
EUROBIOFORUM 2nd Annual Conference
May 27 2013 Munich

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Personalised medicine in Norway
• Information
• Strategy
• Therapy
• Research
• Industry
• Development
• Future Challenges

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Information
Concepts and examples of personalised medicine were
presented in the Norwegian Medicines Handbook from
2007; distributed to health personel in Norway (medical
doctors, pharmacists, students etc).

4. Individualized
treatment
Concomitant
medication
Genetic
factors
Disease
state/phase
Organ
functions
Age
Body weight
Gender
Drug
of choice

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Strategy
The National Strategy for Biotechnology (2011-2020)
provides a national platform for a cross-sectional
development and use of biotechnology within 4 focus
areas including the major category:
Health, health services, health-related industry
• Personalised medicine is examplified in the strategy
National Strategy for Biotechnology
Ministry of Education and Research

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Therapy
Pharmacogenetic tests established for certain
– Drug-metabolising enzymes (CYP enzymes)
– ”Drug targets” (i.e. receptors etc. at which drugs exert
their effect)

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Therapy – when to test?
1. Always for a few (anticancer) drugs
2. Close to routine for a few drugs
– Azathioprine/6-MP, irinotecan, warfarin
3. Most tests available should probably be reserved for
individual «problem patients»:
- Adverse effects/excessive plasma concentration related to dose
- Lack of effect or low plasma concentration
4. For most drugs no tests available at all Prof. Olav Spigset
St. Olav Hospital, Norway

8. Example: targeted therapy in lung cancer
Patient with EGF Receptor mutations
After 1 month with EGFR
inhibitor
After 1 year with EGFR
inhibitor
Before treatment
With permission
Dr. Åslaug Helland
Oslo University Hospital

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Example: targeted treatment in lung cancer
Patient with ALK translocation
With permission
Dr. Åslaug Helland
Oslo University Hospital
Metastases
from lung cancer
After 3 months of targeted therapy
with ALK inhibitor

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Research
A Publicly-initiated programme for Clinical Trials within
the cancer field was established in Norway in 2011
The National Council for Quality and Prioritization in the
Health Services selected «Cancer treatment tailored to
the individual» as focus area in its first call for the
programme subsequent to a broad hearing with experts
and clinical researchers
The programme is organized within the Research Council
of Norway

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Research
Example:
A large scale project
initiated to examine
mutations in eight
types of cancer:
Support from programmes: Including all health regions and Oslo Cancer Cluster
Publicly-initiated Clinical Trials
BIOTEK 2021
 Breast
 Lymphoma
 Leukemia
 Colon
 Malignant melanoma
 Sarcoma
 Multiple myeloma
 Prostate
Norwegian Cancer
Genomics Consortium
Head Ola Myklebost
OUS – Norw. Radium Hospital

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Research
The project aims to establish:
A national research and innovation platform for
personalised cancer medicine
Work Packages include
• WP1. Mutation-based patient stratification
• WP2. Target discovery and preclinical validation
• WP3. Theragnostic interpretation and clinical trials
• WP4. Data sharing and national infrastructure
• WP5. ELSA package

13. CancerGenomics.no
Added values from national
collaboration
• Population-based data
• Standardized genome analysis
• Equal patient access nation-wide
• Standardized treatment choices
• National follow-up of multiple N=1 trials
(compassionate use)
• National evaluation of mutation frequencies and
health-economic consequences
• Over time accumulation of outcome data of
personalized treatments and other therapies
stratified by mutation profiles Prof. Ola Myklebost
OUS – Norw. Radium Hospital

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Research
The Research Programme on Biotechnology for
Innovation (BIOTEK2021) has provided further funding to
research on personalised medicine in cancer
Programme within the Research Council of Norway

15. Individualized cancer treatment based on tumour gene profiles
• The National Collaboration Group for Health Research (NSG)
recommended that the national Health Service prioritise an
effort on "Individualized cancer treatment based on tumour
gene profiles".
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http://cancergenomics.no/index.php?page=national-priority-of-health-research

16. … the Norwegian approach is wise to take account of
other equally vital considerations such as having
nationally agreed protocols and systems to handle
and process new testing and data, as well as efforts
to underpin health professional and public
education, and provide health economic impact data.
…
UK Public Health Genetics Foundation

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Industry
Pharmaceutical industry emphasizes how personalised
medicine may:
• Identify patients with potential significant effect of
treatment
• Identify patients with minimal or no effect
• Support rational health economy and improve
treatment for the patients
• Influence study designs and the time for development
of new products Monica Kjeken,
The Association of the
Pharmaceutical Industry in
Norway.
In communication

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Relevant processes in development
Personalised medicine
Support to research
Develop clinical research infrastructure
Coordination of Biobanks
Coordination of Health registries
National HTA system
Strategy development

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Development of clinical research infrastructure
Infrastructure and networks for clinical research critical:
• Norwegian Clinical Research Network (NORCRIN)
established as part of the European network (ECRIN)
• Nordic Trial Alliance (NTA) promoted as part of a Nordic
cooperation in Health Care, with reference to
statement by the prime ministers (June 2012)
• Participation in the OECD Global Science Forum
initiative to facilitate international cooperation in non-
commercial clinical trials

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Health registries and biobanks
The combination of health registries and biobanks in
Norway represents a valuable tool for research in
personalised medicine and validation of new tests
Human Biobanks and Health Data (BIOBANK)
A new programme launched by the Research Council of
Norway designed for research on human biological
material in biobanks, by coupling analysis results with
data from health surveys, health registers and the health
services

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Health registries
Norway has a long history of health registries, ex.:
• Cancer registry Established in 1951
Ongoing national project for coordination of health
registries in Norway
• Example: A pre-project evaluates the potential to
coordinate all drug-related registries in a common
overarching registry

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Biobanks
• Biobank Norway: a national biobank infrastructure -
consortium of Norwegian population-based and clinical
biobanks involved in international collaboration
Nine partners National biobanks
• Norwegian Women and Cancer (NOWAC) study
• Janus Serum Bank (Reserved for Cancer research)
HUNT/NTNU
National Institute of Public Health

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Health Technology Assessment
Potential tool for evaluation of personalised medicine
A national system for Health Technology Assessment
(HTA) for the specialist health care is introduced
Treatment strategies for personalised medicine may in
future be systematically evaluated by means of the HTA
methodology with respect to effect, safety, cost-
effectiveness etc. as a basis for potential introduction in
the health care system

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Strategy Development
The Ministry of Health in Norway has initiated an
investigation on personalised medicine which will
include:
• Analysis of the status for personalised medicine at
international and national level
• Development of a strategy for the future
• Proposals for efforts to implement personalised
medicine
• Considerations related to ethical, social, economic and
health implications of implementation
• Recommendations

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Future challenges for personalised medicine
Coordination with treatment guidelines
The challenges and approach for coordination of personalised
medicine and treatment guidelines
Health economy
Economic implications and reimbursement with reference to
complex and dynamic treatment strategies, in many cases
relevant for a limited number of patients
Implementation in clinical practice
Comprehensive approach in the need of several supporting
systems, adaptation of information technologies, education,
monitoring etc.

26. Thanks
• Karianne Solaas, The Research Council of Norway
• Øystein Rønning, The Research Council of Norway
• Ola Myklebost, Oslo University Hospital
• Åslaug Helland, Oslo University Hospital
• Olav Spigset, St Olav Hospital, Trondheim
• Kjetil Taskén, Centre for Molecular Medicine Norway
• Monica Kjeken, The Association of the Pharmaceutical Industry in Norway
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