Innovate or die

1
Innovate or die
David Fisher ABPI, Commercial Director
7th February 2008
2
Agenda

• Introduction opportunity for policy changes
• Sir David Cooksey
• Lord Darzi
• Current situation in the UK
• Myths and realities
• Conclusions policy changes required

3
Cooksey recommendations to streamline the process

• Goal bring new medicines faster to patients
• Shortening the RD process
• Overcoming two points of dislocation in
  process translational research and uptake of
  innovation
• Recognised issues to be tackled
• Translational medicine - from bench to bedside,
  and from trials to use
• Connecting for Health identifying patients for
  trials, better pharmacovigilance
• Earlier dialogue with NICE, which is currently
  being piloted
• Option for earlier restricted release,
  conditional licensing

4
Lord Darzis Interim Report

• Our vision should be an NHS that is
• Fair equally available to all, taking full
  account of personal circumstances and diversity
• Personalised tailored to the needs and wants of
  each individual, especially the most vulnerable
  and those in greatest need, providing access to
  services at the time and place of their choice
• Effective focused on delivering outcomes for
  patients that are among the best in the world
• Safe as safe as it possibly can be, giving
  patients and the public the confidence they need
  in the care they receive.

NHS NEXT STAGE REVIEW Interim report Summary,
October 2007
5
Immediate steps highlighted by Lord Darzi

• To help make care fairer the Secretary of State
  has announced a comprehensive strategy for
  reducing health inequalities, challenging the
  NHS, as a key player, to live up to its founding
  and enduring values.
• To support the delivery of more effective care,
  we should establish a Health Innovation Council
  to be the guardians of innovation, from discovery
  to adoption.

NHS NEXT STAGE REVIEW Interim report Summary,
October 2007
6
Fairness within the UK?
http//www.telegraph.co.uk/news/main.jhtml?xml/ne
ws/2007/11/26/nhealth126.xml
7
Cancer illustrates the issues of NICE blight
sales of ATC L1 cancer drugs in 2006
attributable to products launched in previous 5
years
Source IMS
8
Fairness compared to other countries?
5-YEAR SURVIVAL RATES FOR ALL CANCERS
Countries grouped then ordered by total national
expenditure on health
9
Myths and realities

• Myth Patients will only benefit if drugs are
  cheaper?
• Reality it costs 500m to bring a new medicine
  on the market. If no returns is achieved, RD
  activities will be at risk.
• There will always be a need for new medicines
  unmet needs, patients building resistance to
  existing drugs and disease evolution.

10
Discovery development takes 10-12 years and
gt500m
Marketing approval product launch
Final patent application
Investigational new drug application
Marketing application
Regulations
10-12 years
2004
1998
1995
2006
Discovery research
Development research
Time (years)
Regulatory review
Post-mktng devel
Phase IV
Phase III
Phase I
Phase II
Synthesis Biological testing pharmacological
screening
Basic research
Phases of drug development
50-100 subjects
200-400 patients
3000 patients
Clinical phases
Toxicology and pharmacokinetic studies
Attrition rates
550m
0
Cost
Source CMR International

11
Treatment needs to evolve with the disease, e.g.
HIV

• Identification of the HIV virus
• AZT (monotherapy)
• Protease inhibitors. Used in a "cocktail" with
  existing AIDS therapies, protease inhibitors will
  help reduce AIDS deaths by 65 in the next three
  years.
• Non-nucleoside reverse transcriptase inhibitors
• Nucleoside analogue reverse transcriptase
  inhibitors
• Drug combination HAART
• Fusion inhibitors (new hope for people who have
  developed resistance to other HIV medicines)
  Fuzeon
• Chemokine receptor antagonist Maraviroc
• First-in-Class Oral HIV-1 Integrase Inhibitor
  Isentress

1981
1986
1995
1996
2001
2003
2007
12

• Myth Industry research does not fit the NHS
  priorities?

NHS priorities reflected in new medicines
approved by the FDA in 2007
Isentress HIV Ixempra Breast cancer Tasigna Chro
nic merlogenous leukemia Kuvan HPA Bystolic H
igh blood pressure Soliris Paroxysmal nocturnal
hemoglobinuria Mircera Anaemia Ceprotin Prot
ein C deficiency Evithrom Control of
bleeding ACAM2000 Smallpox vaccine Afluria Influe
nza virus vaccine
Tekturna Hypertension Tykerb Breast
cancer Altabax Impetigo (infection) Vyvanse Atten
tion Deficit Hyperactivity Disorder Neupro Par
kinson's disease Torisel Renal cell
carcinoma Letairis Pulmonary arterial
hypertension Selzentry HIV Ammonia N13 PET
imaging of CAD Somalupine depot
Acromegaly Doribax Complicated infections
Red NHS priorities
13
Myth We cannot afford to spend more on drugs?
Average cost of prescription item
Net Ingredient cost / Number of prescription items
9.78
14
The UK has a lower prescribing cost per head than
most European countries
Medicines expenditure per head of population, 2006
Source ABPI calculations based on IMS World
Review, 2006
15
Resources should be invested in funding
cost-effective innovation The UK can afford to
spend more in this area
Pharmaceutical expenditure as per cent of GDP in
selected OECD countries, 2005
16
An ideal system
17
Our proposals to Lord Darzis NHS Review on
innovation

• NICE guidance should be made mandatory and
  implemented consistently at a local level.
• QOF, PbR, commissioning and league tables and
  other levers should be used to incentivise uptake
  and reward prescribers for following NICE
  guidance
• Prescribing indicators within Better Care, Better
  Value should encourage the uptake of, and
  benchmark the use of, cost-effective innovation.
• A range of options should be provided for
  accelerated market access including conditional
  licensing.
• Systemic barriers should be removed through
  better joint planning and pump-priming funding,
  to stimulate uptake.

18
Our proposals to Lord Darzis NHS Review on
innovation

• Patients should be provided with better
  understanding of their condition and options that
  exist for their treatment. Patients should be
  able to compare NHS providers on their clinical
  outcome-based performance which will reflect use
  of optimum technologies.
• The medicines bill should feature as a
  proportion of clinical areas expenditure
  allowing the analysis on returns on investments
  and the efficiency of patient management over the
  longer term.
• SHAs should have access to funds of their own to
  support patients with very rare diseases
  (ultra-orphans) and, by regionalising the
  problem, take the pressure off individual PCTs.
• The Clinical Excellence Awards Scheme should
  recognize the performance of innovators who
  participate actively in research.

19
Conclusions

• Patients will benefit from
• Increased NHS expenditure on cost-effective
  treatments
• Incentives and rewards for health professionals
  taking part in research and treating their
  patients cost-effectively (using PbR, QOF and
  other levers)
• Better Health Technology Assessment using cost
  per QALY not as a rule, but a tool
• Consistent use of NICE guidance to tackle
  inequalities
• Continuous activities in RD