1. Hot Topics Pharmaceutical Sales Managers Group January 2007 David Fisher Commercial Director ABPI

2. Hot Topics Office of Fair Trading Market Study Distribution Health Select Committee enquiry into NICE Ministerial Industry Strategy Group

3. Organisation structure Prof Adrian Towse Director Office Health Economics Prof Adrian Towse Director Office Health Economics

4. The ABPIs 7 Objectives Improved access to and of medicines uptake Increased patient engagement The Code and the PMCPA….retain self regulation Pricing and reimbursement ….The PPRS and the OFT MHRA and Better Regulation Improving the technology basein UK Enhance the reputation of the Industry

5. OFT: Does PPRS meet its objectives? –Secure the provision of safe and effective medicines for the NHS at reasonable prices –Promote a strong and profitable pharmaceutical industry capable of such sustained research and development expenditure as should lead to the future availability of new and improved medicines –Encourage the efficient and competitive development and supply of medicines to pharmaceutical markets in this and other countries

6. OFT : ABPI Interactions Series of meetings throughout 2006 Three substantial written submissions OFT briefings on Feb22nd Publication in advance of this date? Outcome?

7. Potential OFT Outcome?? Value based pricing concept Pricing linked to the value of an individual medicine Market entry….pricing linked to HTA? More attention to comparative prices of in-market products? 90 Day public consultation period

8. PS…..National Audit office Typical approach is to highlight potential savings from changes in prescribing patterns Report due April ABPI in dialogue, input to draft report Opportunity….Rx efficiency vs Rx effectiveness

9. Eli Lilly set to shake up UK drugs distribution… Times 14/12/06 AZ plan for delivery of medicines triggers protest…. Times 13/12/06

10. Quarterly reporting of product sales at list and net Disclosure of margin DH concerned about effect on public purse

11. Distribution Changes Opportunities and Threats? A matter for individual companies Unlikely to be one size fits all Direct relationship with purchaser

12. NICE: Health Select Committee Focal point for Industry proposals Multiple stakeholders Probably differing views across Industry Access Strategy Group to coordinate ABPI/Industry Position

13. NICE/HTA: Some major themes Significant negative reaction from patient groups to recent appraisals….patient power! QALY…a precise science? Manufacturers not included in appraisal hearings Variable work output from External Review Groups Appeal Process unsatisfactory No means No……Yes means Maybe!

14. Ministerial Industry Strategy Group Long Term Leadership Strategy Better Regulation Medicines Uptake PartnershipEurope Government support for NHS/Industry partnerships Diagnosis and proposals to address low/variable uptake of new medicines

15. LTLS - Timeframe Progress Report to MISG – 9 February 2006 –Work Programme for 2006 Agreed Progress on Europe and Regulatory Groups – 18 May 2006 Final Report to MISG – 1 November 2006 Publication February 2007

16. Post Code Lottery Inequitable access to medicines/treatments Political and Medical problem Three HTA systems magnifies problem UK lags behind continental Europe in uptake Industry NHS Partnerships offer some solutions

17. Long Term Conditions are a principal driver of healthcare cost Disease AreaNational Prevalence 2005/2006 Asthma5.8 per cent Cancer0.7 per cent Chronic Obstructive Pulmonary Disease1.4 per cent Coronary Heart Disease3.6 per cent Diabetes3.6 per cent Epilepsy0.6 per cent Hypertension12.0 per cent Hypothyroidism2.4 per cent Left Ventricular Dysfunction0.4 per cent Mental Health0.6 per cent Stroke1.6 per cent The Information Centre, NHS Unplanned and expensive inpatient episodes

18. Pharmaceuticals are part of the solution to better long term condition management In all the above areas, pharmaceutical research has resulted in –New treatments for control or reversal –New formulations for easier/faster administration, better compliance –Improved tolerance, fewer complications

19. Implications for salesforces

20. Actual prevalence of disease No contact with system In contact but no related complaint investigated Complaint investigated but not correctly diagnosed Diagnosed but untreated Treated but not optimally Treated optimally 100% Public Health Programmes Find and treat targets incentives Diagnostic tools Therapy decision support More qualified clinicians NICE guidance reinforced Find and Treat Programmes could make a major impact

21. Implications for fieldforces Flexibility in resourcing Collaborate AND Compete Source of knowledge and skill (not just money!) The patient must benefit

22. In Summary Longer Term Industry/Government relationships give room for optimism Short term environment likely to become more negative More pressure to demonstrate value for money of medicines

23. Questions and discussion Pharmaceutical Sales Managers Group January 2007 David Fisher Commercial Director ABPI dfisher@abpi.org.uk