1st WP2 F-t-F training Course for all EUnetHTA stakeholders - EUnetHTA Tools and Methodology. Brussels, 16 Jan. 2014

1. Examples of evidence-supported
decisions
Prof. Marjukka Mäkelä, THL / FINOHTA
16 Jan 2014
Mäkelä – EUnetHTA Training
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2. Evidence is
the best available answer
to a well-formulated question
that experts are able to produce
with good methods
in the time given
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3. Getting evidence
into decisions…
...requires
collaboration
between HTA and
policy makers.
Two examples from
Finland
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4. Case 1:
Hospital policies on liver dialysis
New device to treat liver failure: MARS®
(molecular adsorbents recirculating system)
Life-saving for certain cases of liver failure
Acute toxications (ALF)
Acute-on-chronic liver failure (AoCLF)
Bridging treatment when waiting for transplant
Should all central hospitals provide MARS®?
Merchants marketing actively
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5. The MUMM program
Managed Uptake of Medical Methods
Joint program of all central hospitals in Finland + Finohta
Topics collected & selected twice yearly
Rapid HTAs (3-9 months) from Finohta
Reviewed & published in FMJ
MUMM Board decision on implementing technology
+ agreement on division of labour
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6. Liver dialysis: Effect and cost
HTA (original systematic review)
7 RCTs (n = 230), 20 case series (n = 860)
Survival with conservative treatment 0 - 40%, with
MARS® 16 - 100%
Cost: Machine 18 000 €, filter 3 000 € (1/day)
High expertise required
In Finland 30 - 50 eligible patients per year
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7. MUMM Policy decision on MARS®
National criteria for patient
selection
Close collaboration with
liver transplant unit
necessary
Treatment in one university
hospital (+2 backup)
Patient register & regular
reports of results
↓
A PhD thesis started on the
topic including CEA
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8. Case 2: National policy
21 Jan 2011
Mäkelä CC seminar
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9. Obesity surgery
•
•
•
•
MUMM suggestion in 2007
Important topic, spreading unevenly
Scoping: Major ethical issues
SII also asked for an HTA
→ Full HTA as basis for policies
• Effectiveness, safety, cost, ethical, social,
organisational and legal issues
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11. Policy options
No operations (0-option)
1. Strict criteria: 1500 operations /year
2. International criteria, low demand: 3000/yr
3. International criteria, high demand: 6000/yr
Decision for payers
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12. Each scenario considers
• Effects on health care system
• Effects on health
• Cost impact
• Focal points of
policy discussion
Scenario 2
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13. Scenario 2 items
•
•
•
•
•
•
•
75 000 persons with morbid obesity
Willing and suitable for operation: 13 000
Spread over 5 years: 3000 operations yearly
Personnel need for operations: 105 py
Increased demand for treatment abroad /privately
10-20 operation induced deaths yearly
400 complications, 300 reoperations /yr
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14. Prioritisation by point system
1. Strict criteria
BMI > 45: 50 pts
BMI 40-45: 40 pts
BMI 35-40: 30 pts
BMI points
2. International criteria
BMI > 40: 50 pts
BMI 35-40: 40 pts
Other points
Type 2 diabetes: 20 pts
Any other disease that
Medicated hypertension: 10 pts
obesity aggravates: 10 pts
Sleep apnea w. CPAP: 10 pts
Joint problem needing operation: 10 pts
50 points: Operation indicated
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15. How does this translate to policy?
• Ministry decision on
criteria for elective
operations
• Social insurance
decision on coverage
Same principles for
public and private care
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16. Two successful examples -why?
Policy making structures in place
Clear customers for HTA report
Inclusive process of HTA and decision making
Collaboration and mutual trust between decision
makers, clinicians and methodologists
Sufficiently rapid reply - patience to wait for it
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17. Evidence into
decisions:
Barriers
Policy makers ask wrong
questions
Researchers aim at
perfect answers
They disagree on timing
→ Need to develop a
shared understanding
of HTA use in policy
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18. Policy implementation:
a major challenge
HTA producers provide data, not policies
May participate in policy formation as
experts
Post HTA report implementation: national
seminar, participation in formulating legislation,
national training, producing patient leaflets, web
learning materials, effect assessment...
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19. Values
Decision
Evidence
Resources
JA Muir Gray: Evidence Based Health Policy
Churchill Livingstone, London 2002
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20. Evidence does
not make
decisions.
People do.
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21. Thank you!
21 Jan 2011
Mäkelä CC seminar
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