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PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007

PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007. http://www.pdig.org.uk/. Pharma produce innovative products Patients can’t access them!! Is this true?. Professor Liz Kay, Clinical Director Medicines Management and Pharmacy Services Leeds Teaching Hospitals NHS Trust.

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PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007

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  1. PROCUREMENT & DISTRIBUTION INTEREST GROUPAutumn Symposium 2007 http://www.pdig.org.uk/

  2. Pharma produce innovative products Patients can’t access them!!Is this true? Professor Liz Kay, Clinical Director Medicines Management and Pharmacy Services Leeds Teaching Hospitals NHS Trust

  3. Overview • Key stages in transition from trial to licence • Compassionate use – what is this? • Access to new medicines • National systems delays • Risk sharing • What next?

  4. Transition from trial to licence • Key issue – separate ‘clinical trial’ and ‘unlicensed use’ • What is a clinical trial? Research study, human volunteers, specific health question to answer Phase I 20 to 80 people Phase II 100 to 300 people Phase III 100 to 1000s of people Phase IV post licence

  5. Clinical trials and LTH • LTH Clinical trial policy • REC – protect participants • R+D check process • Medicines Management and Pharmacy • ‘Authorisation to proceed’ step = letter from Chief Pharmacist. • All medicines managed by Pharmacy

  6. LTH MMPS Authorisation stepWhat is this? • Documentation in place • Local risk assessment and procedures • Operationally feasible • Products manufactured in accordance GMP • Written agreement about responsibilities with investigator • Payment

  7. New Product Review Product Request Clinical Trial R&D Process Risk Assessment DTC Outside Trial Licensed PbR Patient? Unlicensed Unlicensed Risk Assessment DTC PbR Patient?

  8. JANE 'LET DOWN OVER CANCER DRUG' 05/10/2007 14:17 (Daily Express +0) Mike Tomlinson, from Leeds, hit out after revealing that his wife had to travel to Nottingham to receive the cancer drug Lapatinib. • Mr Tomlinson detailed how she battled to get access to Lapatinib. He said her medical team in Leeds decided the drug was her best option. However, Leeds Teaching Hospitals NHS Trust had taken the decision not to participate in a GlaxoSmithKline-sponsored access study of the treatment.

  9. Medicines without marketing authorisation • LTH Trust policy • Management of policy via DTC • Assessment of risk • Patient consent • Code of business conduct • Involvement of commissioners

  10. Unlicensed medicines policy

  11. Unlicensed medicines policy risk matrix

  12. See handout 1 Unlicensed medicines policy

  13. EAPs Discourage use of investigational agents outside clinical trials ISSUES Management of clinical risk ‘Unlicensed medicine’ Lose potentially valuable data Management of costs and financial risks Substantial charges (‘admin and supply’!!) Equity of access for patients Pharma ‘bypass of process’ for managing entry of new drugs

  14. National approval systems • NICE and SMC • Different terms of reference – timelines, Political issues?????????? • LTH approach • Medicines Finance Committee and use of Health Economist • Commissioning Group for Medicines, Yorkshire & The Humber (North)

  15. What effect the PbR tariff? • LTH £ 32+million spend (50%) non tariff • Non tariff NICE approved – PCT pay to agreed volumes • Non Tariff Non NICE (NTNN), individual patient PCT approval – postcode lottery, LTH 440+ in 2007

  16. DoH view on Risk Sharing Schemes • Not against such schemes in principle • Any schemes should be operationally workable for the NHS (not lead to disproportionate costs or bureaucracy). • Velcade - content on this point and for NICE to appraise the scheme. • Responder schemes - important that response can be measured and in the case of Velcade, NICE agreed with the company's method for measuring response. • Cash/credit or free stock – no strong view but vital that scheme is not too burdensome on the NHS.

  17. NICE guidance on Bortezomib

  18. Velcade Response Scheme Janssen Cilag: Drug costs removed for ‘non responders’ NICE: Response based on serum M protein after 4 cycles Rebate: ‘Patients responded less than partially’ ICER of £20,700 per QALY Additional cost to NHS to administer – not funded. Process for rebate: Form to Fax Replace stock, credit note, cash

  19. Myeloma matters – impact on NHS • Bortezomib licence  NICE approval  planned use • Lenalidomide (better than thalidomide) Licensed June 2007 No NICE approval Planned use Cost £50K pa NTNN – postcode lottery Doesn’t reflect use More responders than planned Less rebates than DoH expected

  20. Issues for industry • Ready to use product – minimise waste (infliximab) • Appropriate vial size – minimise waste (infliximab) • Packed with risk management in consideration • Realistic costs – global pricing • Free stock or BOGOF – pharmacy computer schemes • No more rebate schemes

  21. Where next? • Clarity about medicines used without or outside marketing authorisation and peer support for their use outside clinical trials • Systems to ‘fast track’ to marketing authorisation for major advances • Systems for ‘national approval’ faster than NICE • Commissioning on wide geographical scale to ensure equity of access for patients

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