Sir Andrew Dillon, director general del National Institute for Health & Clinical Excellence (NICE) del Regne Unit, va ser l’encarregat d’oferir la conferència central del Fòrum, en la qual va explicar l’experiència de l’entitat que dirigeix —una referència internacional en el seu àmbit— en valorització de la recerca i, sobretot, l’apropament de les necessitats del sistema públic de salut (les necessitats dels pacients i els requeriments tècnics dels professionals) a la indústria farmacèutica i de les tecnologies mèdiques.

1. Working with the life sciences
industries to create value
Biocat
Barcelona, 24 N
B l November 2011
b

2. The purpose of NICE
• H l th h lth service i
Help the health i improve th quality of care
the lit f
• Increase the rate of adoption of effective and cost
effective new technologies by the health system
• Work with companies to help them understand what the
health system needs and how the additional value that
thier products bring to patients is assessed

3. Health technologies
• Pharmaceuticals
Ph ti l
• Biotech
• Diagnostics
Di ti
• Medical devices
• We want to see products which bring additional
diagnostic and th
di ti d therapeutic b
ti benefit f patients and
fit for ti t d
which make good use of health system resources

4. NICE: defining value
Outcomes
for patients
Impact on
Stakeholder health
perspectives system
resources
Scientific
and social
value
judgements

5. NICE:
NICE cost effectiveness analysis
t ff ti l i
1
x
Probability of
rejection
j
Rituximab for x Imatinib for
follicular lymphoma chronic myeloid
leukaemia (blast
phase)
Trastuzumab for
early stage HER-2
positive b
iti breast
t
x cancer
0
16 32 48 64 80
Cost per QALY ($’000)

6. Most new health technologies bring
additional value
Decision
D i i Recommendations
R d i
Yes 276 (63%)
82% of NICE
advice is positive
Optimised 83 (19%)
Only in research 24 (5%)
No 55 (13%)
Breakdown of all decisions contained in published NICE Technology Appraisals
p gy pp
1–236 (January 2000 to October 2011)
Note: 6 withdrawn recommendations and 10 non-submissions are not included

7. Helping innovators understand value
• Early t
E l stage scientific advice
i tifi d i
• Wider definition of value
• Transparent and inclusive evaluative processes
T t di l i l ti
• Clear and detailed guidance
• Targeted research questions

8. Helping innovators understand value
• Early t
E l stage scientific advice
i tifi d i
• Wider definition of value
• Transparent and inclusive evaluative processes
T t di l i l ti
• Clear and detailed guidance
• Targeted research questions

9. Scientific Advice Programme
• I t
Interpretation of NICE t h l
t ti f technology appraisal methods
i l th d
guidance
• Research design (study population duration
population, duration,
comparators, endpoint(s), type of study)
• Economic evaluation design (e g form of evaluation
(e.g.
and approaches to benefit measurement; relevant
trial(s) for economic evaluation; the use of (QALYs)
( ) ( )
• Methods issues (e.g. selection of instruments / research
to derive QALYs; extrapolation of long-term outcomes;
planning for indirect comparisons)
• Insights from existing appraisals

10. Value based pricing
• R
Recent UK G
t Government proposals (to be i t d
t l (t b introduced d
from 2014) designed to extend the definition of value in
UIK drug appraisal and reimbursement decisions
decisions.
• Increased focus on:
– Wider societal benefits
– Products which address areas of unmet need or high
burden of illness
– New products with particularly innovative features
• Seen as an evolution of and not a replacement for the
PPRS and NICE arrangements

11. Conclusion
• I
Innovators and health systems need t work t
t d h lth t d to k together to
th t
create and deliver value for patients
• We need to establish the earliest possible dialogue
between companies and agencies that assess new
technologies
• Health systems – and the agencies that work for them
have a responsibility to support innovation and to work
p y pp
constructively with the companies that deliver it