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PATIENT ACCESS SCHEMES Christine Gilmour co-chair of NHS Scotland Patient Access Scheme Assessment Group

PATIENT ACCESS SCHEMES Christine Gilmour co-chair of NHS Scotland Patient Access Scheme Assessment Group. How are schemes reviewed at National level? What is the impact of multiple schemes on the NHS? How are access schemes costed?. What is a PAS?.

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PATIENT ACCESS SCHEMES Christine Gilmour co-chair of NHS Scotland Patient Access Scheme Assessment Group

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  1. PATIENT ACCESS SCHEMES Christine Gilmourco-chair of NHS Scotland Patient Access Scheme Assessment Group

  2. How are schemes reviewed at National level? • What is the impact of multiple schemes on the NHS? • How are access schemes costed?

  3. 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. 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. 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. PPRS Principles • PAS = the exception • Priority to schemes that deliver greatest benefit to patients e.g. unmet need • Cumulative burden must remain manageable

  7. 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. 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. 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. 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. 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. CATEGORISATION of SCHEMES

  13. 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. 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. 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. 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. 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. 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. 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. 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. PAS ‘no’ & SMC ‘yes’ • Drug may be prescribed without PAS – e.g. Lenalidomide

  22. Individual Board signs up to the PAS Board develops SOP and Monitoring Database Eligible patients registered & assigned PAS patient number Registration, claim forms etc completed in accordance with SOP Forms sent to company, copied to Finance, details recorded on the PAS Monitoring Database in accordance with SOP. 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.

  23. Unique PAS Patient Number

  24. Verification Record

  25. 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. Learning contd. • Assessment takes 8 weeks • Not the exception • Unmet need • FOI • Stakeholder Engagement – NHS Boards / Industry / HTA organisations

  27. 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

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