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Working with the life sciences
industries to create value
Biocat
Barcelona, 24 N
B    l        November 2011
                   b
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
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
NICE: defining value

                Outcomes
               for patients
                              Impact on
Stakeholder                     health
perspectives                    system
                              resources

                 Scientific
                and social
                  value
               judgements
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)
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
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
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
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
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
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

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Working with the life sciences industries to create value / Sir Andrew Dillon, chief executive of the National Institute for Clinical Excellence (NICE)

  • 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