1. SMC Horizon Scanning Anne Lee, Scottish Medicines Consortium Julia Earnshaw, GlaxoSmithKline

2. SMC Horizon Scanning Aims and objectives Outputs Process (industry engagement) Key challenges Industry perspective Priorities for development (workshop)

3. Horizon scanning - aims To facilitate the managed entry of new medicines and new indications for existing medicines into NHS Scotland early consideration allows advanced financial & service planning by Health Boards should lead to improved patient care through timely access to new treatments

4. Audit Scotland 2005

5. Reporting to date Forward Look sent to restricted group (HB CEO, DoF, lead doctor & pharmacist) Focus on high cost impact medicines Point estimate of uptake and costs at yr 1 and yr 5 Forward Look 1 Oct 05 & Interim Update Apr 06 Forward Look 2 Oct 06

6. Process Intelligence Gathering Pharmaceutical Industry Other sources NHS Public Health Finance Prediction NHS Intelligence / Pharm Companies Forward Look Report SMC Forthcoming Submissions SMC Cancer HS Steering Gp Clinical experts MCNs RCAGs SIGs Clinicians

7. Forward Look 2 Context statement (caveats) Focus on medicines expected to become available 07/08 Potential for significant financial impact (+ all orphan medicines) <£500K impact at year 5 – cost impact considered low, generally not included

8. Forward Look 2 Supplementary Information –assumptions / uncertainties Details of medicines considered but not included Update on drugs in Forward Look 1 Financial cost templates

9. Horizon Scanning – FoI No option of blanket refusal to release data All parties acknowledge information provided on CiC basis All acknowledge FoI legislation SMC is committed to maintaining confidentiality Code of Practice and Confidentiality Agreement circulated with Forward Look 2

10. Clinical expertise SMC clinical expert database Cancer – HS steering group Facilitate links and consultation with specialist groups and networks Review draft HS information / report to ensure fit for purpose What if no consensus?

11. Industry engagement Product pipeline intelligence requested 6-monthly Standard documentation developed with UGF Companies alerted to products to be included in report Opportunity to comment on draft information Final copy of information in report

12. Forward Look 2 – industry input Valuable input from 22 of 23 companies Indicative acquisition costs provided for 13 of 22 new medicines / formulations Useful input on estimated uptake Supplementary Information –Assumptions and uncertainties

13. Next steps Develop work on total vs direct drug budget impact (?which medicines) Support HBs in their use of Forward Look Develop relationship with NHSC / other HS organisations

14. Challenges ? How can companies help Engage all appropriate companies Early identification of products with biggest potential impact Improve net budget impact estimates Compare actual vs predicted spend / costs

15. Industry Perspective – SMC Horizon Scanning Julia Earnshaw GSK.

16. Why should industry engage? Opportunity to communicate with decision makers in line with the C of P Ensure information produced accurate and up to date –This will go ahead with or without us! Collaborative working with our ultimate customers Help facilitate market access –Budgets more likely to be available –Prompt guidance to the service

17. Issues for industry Structures within companies – R&D vs LOC Access to accurate information Confidentiality –Rationale for R&D staff Lack of certainty –Disease area –Price –Final indication –Competitor activities –Positioning/uptake –Timing of license Resource Review and approval –Need for consistent company view –Not appropriate to speculate –Market sensitivity Timing of information –What to do if things change

18. How issues could be addressed Collaboration on optimising process Predictability/understanding of process –What is needed –Which products –When and with sufficient time to deliver –Cleary defined written processes and forms Internal processes –Overarching agreed approach –Manager with overall responsibility –Pre-approved materials Use of ranges/estimates