1. Directive EEC - PILs PATIENT ACCESS SCHEMES Christine Gilmour co-chair of NHS Scotland Patient Access Scheme Assessment Group

2. Directive EEC - PILs 1.How are schemes reviewed at National level? 2.What is the impact of multiple schemes on the NHS? 3.How are access schemes costed?

3. Directive EEC - PILs What is a PAS? A pricing scheme proposed by a pharmaceutical company to improve the cost effectiveness of a medicine, thereby facilitating patient access.

4. Directive EEC - PILs Origins of PAS 2009 Pharmaceutical Price Regulation Scheme between DOH and ABPI Pricing is a reserved matter – but it is for the devolved administrations to meet their policy and operational requirements.

5. Directive EEC - PILs Types of PAS Financial schemes = the NHS receives a rebate or free supply based on usage irrespective of response. Performance schemes = the rebate or supply of patient stock is based on patient response to treatment.

6. Directive EEC - PILs PPRS Principles PAS = the exception Priority to schemes that deliver greatest benefit to patients e.g. unmet need Cumulative burden must remain manageable

7. Directive EEC - PILs NHS Scotland Response Transitional PASAG July 09 – March 10 To develop and pilot procedures to –receive, –assess –communicate output to relevant parties. Business Case to Scottish Govt to resource a PAS national service.

8. Directive EEC - PILs Remit of PASAG To deliver a national service for Scotland which will: Assess PAS on a national basis Communicate output to identified stakeholders. Produce guidance notes for NHS Scotland. Monitor uptake and benefits of PAS in Scotland.

9. Directive EEC - PILs PASAG Membership Co-chaired by Director of Pharmacy and Director of Finance Membership ( n = 18) includes : –pharmacy –finance –clinicians –operational and senior NHS management –public health –procurement –information specialists –pharmaceutical industry Observers: SGHD, SMC, NHS QIS, CLO

10. Directive EEC - PILs Key Functions of PASAG Industry Guidance & Application Pack –PAS Industry checklist; PAS template; PAS submission Form; PAS Approval letter Standard T’s & C’s for PAS in Scotland (legal operational framework) Implementation Pack for NHS Boards –PAS submission form (standard template) –PAS approval form (standard template) –Guidance notes : operational flow chart and monitoring template process (specific to each medicine) Maintain a register of PAS submissions

11. Directive EEC - PILs Types of PAS Simple PAS = fits with normal processes e.g. a discount from list price with no patient tracking. Complex PAS = anything else. –Rebate based on patient response –Rebate based number of courses of treatment –Rebate based on patient weight etc –Free of charge stock for initiation of therapy –Free treatment after a preset period

12. Directive EEC - PILs CATEGORISATION of SCHEMES PAS Performance scheme COMPLEX (response dependent) Finance scheme SIMPLE (straight discount) COMPLEX (all other rebates)

13. Directive EEC - PILs Assessment Criteria Patient Confidentiality – meets Data protection and information governance requirements Legally compliant – meets legal framework in Scotland Clinically robust – clinical care and patient numbers fit Operational – is it workable in NHS Scotland health systems Financially viable – running costs in context of proposed rebate

14. Directive EEC - PILs PASAG Meetings National meetings held monthly to enable the output to synchronize with the monthly SMC meetings. 12 meetings per annum equating to an estimated maximum capacity of 36 PAS assessed per annum.

15. Directive EEC - PILs Secretariat – liaison with company Pre-submission = generic advice only Post-submission = clarification of PAS, resolution of show stoppers. Post decision = nominated members of PASAG

16. Directive EEC - PILs Process Flow Submission via SMC secretariat Generic PAS questions to SMC clinical experts PAS questions to NHS operational staff Cost to operate the scheme identified PAS Assessment Proforma completed by Secretariat and submitted to PASAG for decision. SMC informed of decision SMC consider drug with/without PAS as appropriate

17. Directive EEC - PILs Costing a PAS All activities costed, e.g. time to develop data base, time to write SOPs, time to record scripts, time to process claims etc. Costs based on all territorial Boards participating Costs done twice based projected patient numbers Top of pay scale plus on costs – although duties may be delegated

18. Directive EEC - PILs PASAG ‘yes’ & SMC ‘yes’ Pack to support implementation of the PAS by NHS Boards is prepared. Pack includes a PAS Monitoring Template to facilitate development of the PAS Monitoring Database by NHS Boards Pack issued to NHS Boards via SMC. PAS referred to in the SMC Detailed Advice Document

19. Directive EEC - PILs PASAG ‘no’ and SMC ‘no’ Medicine only via individual patient treatment request No national PAS implementation pack The decision on the PAS does not stand alone - it is part of the SMC consideration SMC feedback negative SMC decision PASAG offer same opportunity to feedback on the PAS. Resubmission is via SMC

20. Directive EEC - PILs PASAG ‘yes’ & SMC ‘no’ SMC feedback negative SMC decision Medicine only available via individual patient treatment request No national PAS implementation pack Boards arrange local rebate Resubmission is via SMC

21. Directive EEC - PILs PAS ‘no’ & SMC ‘yes’ Drug may be prescribed without PAS – e.g. Lenalidomide

22. Directive EEC - PILs Individual Board signs up to the PAS Forms sent to company, copied to Finance, details recorded on the PAS Monitoring Database in accordance with SOP. Registration, claim forms etc completed in accordance with SOP Board develops SOP and Monitoring Database Rebate etc recorded on the PAS Monitoring Database. Verification Record is provided to PASAG or the company on reasonable request, as appropriate, excluding any patient identifiable information. Eligible patients registered & assigned PAS patient number

23. Directive EEC - PILs Unique PAS Patient Number PAS Number/Location code/Patient Number Allocated to an approved scheme by PASAG after SMC has reviewed the PAS medicine. Included in guidance notes sent to NHS Boards. Relates to the NHS Board of treatment. Taken from the Location Code Directory maintained by ISD. Assigned by Boards to eligible patients receiving medicine via the PAS.

24. Directive EEC - PILs Verification Record Link to Patient Record (must not be disclosed) Unique PAS Patient Number Dose Date treatment started Date treatment finished Date of claim Date credit received Board of residence where not Board of treatment

25. Directive EEC - PILs Learning to Date Feasible is not the same as acceptable 12 PAS assessed 8 PAS accepted (PAS yes is not an SMC yes) 4 PAS not accepted Most PAS = finance based Most finance schemes = rebate on initial treatment, followed by % discount on list price

26. Directive EEC - PILs Learning contd. Assessment takes 8 weeks Not the exception Unmet need FOI Stakeholder Engagement – NHS Boards / Industry / HTA organisations

27. Directive EEC - PILs Issues Range of schemes - standardisation required Lack of fit with NHS processes –not clinical trials Patient tracking Individual patient stock Cumulative burden Tertiary Centres & repatriation