1. Making an Exception: PCT Library Services & Individual Funding Requests Richard Wilson Knowledge Services Derbyshire County PCT

2. Resource Based Decisions The NHS allocates finite resources on the basis of clinical need The NHS allocates finite resources on the basis of clinical need PCTs are locally accountable PCTs are locally accountable Given the full support of the Court of Appeal in R v. Cambridgeshire Health Authority ex parte B [1995] 1 WLR 898 Given the full support of the Court of Appeal in R v. Cambridgeshire Health Authority ex parte B [1995] 1 WLR 898 No duty of care owed by PCTs to patients No duty of care owed by PCTs to patients

3. PCT Objectives Increase the healthy lifespan of your client population Increase the healthy lifespan of your client population Reduce inequality in healthy lifespan of your client population Reduce inequality in healthy lifespan of your client population Break even Break even

4. What’s in a Name? OATS Individual funding requests Exceptional cases Non-contract treatments Interventions not normally funded

5. Why Have IFR Panels? To manage those episodes of care that fall outside contracting arrangements with local providers To manage those episodes of care that fall outside contracting arrangements with local providers To address rare events which require a use of resources not covered under existing arrangements To address rare events which require a use of resources not covered under existing arrangements

6. i.e. When it isn’t covered by anything else! When it isn’t covered by anything else!

7. Types of Requests Service developments Service developments Experimental: let’s try it and see Experimental: let’s try it and see Patient initiated requests Patient initiated requests Tertiary care and beyond Tertiary care and beyond Exceptional or individual cases Exceptional or individual cases

8. Exceptionality A rare or unusual event A rare or unusual event Far beyond what is usual in magnitude or degree Far beyond what is usual in magnitude or degree Exceptional likelihood of benefit Exceptional likelihood of benefit Most cases that come before Panel are not in any way, shape or form exceptional Most cases that come before Panel are not in any way, shape or form exceptional

9. Not Exceptional! Social factors Social factors Culpability: it wasn’t the patient’s fault Culpability: it wasn’t the patient’s fault Efficacy: it works for this patient Efficacy: it works for this patient Rule of Rescue: we’ve tried everything else! Rule of Rescue: we’ve tried everything else!

10. Examples of Requests Breast augmentation / reduction (not just for women!) Breast augmentation / reduction (not just for women!) Implanted electrical stimulation for MS Implanted electrical stimulation for MS Botox for jaw dystonia Botox for jaw dystonia Bilateral cochlear implants Bilateral cochlear implants Grass pollen allergen extract for rhinoconjunctivitis Grass pollen allergen extract for rhinoconjunctivitis Deep brain stimulation for Parkinson’s disease Deep brain stimulation for Parkinson’s disease Stereotactic radiosurgery for cerebral mets Stereotactic radiosurgery for cerebral mets Sacral nerve stimulation for urinary incontinence Sacral nerve stimulation for urinary incontinence Aromatherapy for OCD and anxiety disorder Aromatherapy for OCD and anxiety disorder Pulmonary vein ablation for AF Pulmonary vein ablation for AF PDT for central serous chorioretinopathy PDT for central serous chorioretinopathy MR ultrasound embolisation of uterine fibroids MR ultrasound embolisation of uterine fibroids Hair transplantation for female pattern baldness Hair transplantation for female pattern baldness Any high cost drug not yet in the system! Any high cost drug not yet in the system!

11. Numbers of Requests Derbyshire County PCT received about 700 IFR applications last year Derbyshire County PCT received about 700 IFR applications last year About 60% were approved About 60% were approved Annual spend > £3,000,000 Annual spend > £3,000,000 Majority decided out of Panel Majority decided out of Panel

12. IFR Process Receive request Receive request Triage Triage Evidence gathering Evidence gathering Panel meeting Panel meeting Communicating decision Communicating decision Appeal Appeal

13. Triage Is there a policy, existing contract, prior approval process, NICE guideline, etc? Is there a policy, existing contract, prior approval process, NICE guideline, etc? Is it specialised services, e.g. EMSCG? Is it specialised services, e.g. EMSCG? Is it more appropriate for another group – e.g. complex case panel, mental health panel, children’s services? Is it more appropriate for another group – e.g. complex case panel, mental health panel, children’s services?

14. Evidence Gathering Searcher must have full case documentation Searcher must have full case documentation Evidence sources: Evidence sources: –NICE, SMC, Wales, HTAs, CE/CKS –TRIP, Cochrane, Medline, Embase –Google Scholar –NeLM, DTB, EMEA, MeReC, conferences Levels of evidence Levels of evidence Presentation of results Presentation of results

15. Author, date and country Patient groupStudy type (level of evidence) OutcomesKey resultsStudy Weaknesses Brookes et al 1993 Australia 272 fractures over 6.5 years, 124 isolated fractures, 93% from RTA's Retrospective review Accident details, fracture grade, cardiac sequelae Isolated fracture minimal complications, arrythmias seen with age>65, IHD or digoxin Possible missed fractures, retrospective design Hills et al 1993 Australia 172 fractures over 6.5 years, 89% from RTA's Prospective cohort study Associated injuries No clear association with intrathoracic injury. Slight increase in thoracic spine injury Data collection uncertain, no uniform cardiac screen Bu'Lock et al 1994 UK 63 patients with central chest trauma, 45 seat belt related Prospective cohort study ECG findings and cardiac enzymes, echocardiography None of these needed treatment and no adverse effects seen. ECG and enzymes correlated poorly with these findings. 25% of isolated seat belt injuries had pericardial effusion Small numbers, not all had fractures

16. Panel Meeting Composition of Panel Composition of Panel Decision making forms, backed by detailed minutes Decision making forms, backed by detailed minutes Is the proposed treatment: Is the proposed treatment: –Clinically effective? –Cost-effective? –Affordable?

17. Clinical Effectiveness NICE guidance NICE guidance Evidence search Evidence search Additional information from requesting clinician Additional information from requesting clinician Clinical knowledge of Panel members Clinical knowledge of Panel members Specialist clinical expertise within PCT Specialist clinical expertise within PCT

18. Cost-Effectiveness NICE thresholds: NICE thresholds: –£30,000 per QALY gained for curative intervention –£20,000 per QALY gained for palliative intervention Actual primary care spends (BMJ, 2007): Actual primary care spends (BMJ, 2007): –£12,000 per QALY gained in circulatory disease –£19,000 per QALY gained in cancer

19. Affordability Richards report (Nov 2008) Richards report (Nov 2008) –“Many stakeholders believe that the value society places on supporting people nearing the end of their life is not adequately reflected when the cost-effectiveness of drugs is appraised.” –“Recommendation 5: The Department of Health should work with NICE to assess urgently what affordable measures could be taken to make available drugs used near the end of life that do not meet the cost ‑ effectiveness criteria currently applied to all drugs.”

20. Affordability NICE end-of-life treatments advice (Jan 2009) NICE end-of-life treatments advice (Jan 2009) –“…there will be circumstances in which it may be appropriate to recommend the use of treatments with high reference case incremental cost effectiveness ratios” IF –Short life expectancy (<24 months) AND –Life extension (>3 months) AND –Nothing of comparable effectiveness available from NHS AND –Small patient population (<7000 p.a.)

21. i.e. Your life really is worth more than other people’s Your life really is worth more than other people’s …If you’re about to die from cancer …If you’re about to die from cancer …But only if it’s a rare one …But only if it’s a rare one

22. The Price of Life BBC2 documentary (June 2009) BBC2 documentary (June 2009) NICE reverses its decision on Revlimid (lenalidomide) for multiple myeloma NICE reverses its decision on Revlimid (lenalidomide) for multiple myeloma NICE estimates: NICE estimates: –a non-recurrent cost of treating a backlog of patients of £221,000 per 100,000 population in the first year, and –a recurrent cost of £107,000 per 100,000 population per year

23. Sunitinib Following appeal, NICE reverses its decision on sunitinib (Mar 2009) Following appeal, NICE reverses its decision on sunitinib (Mar 2009) At an estimated cost per QALY gained of (compared to IFN-alpha): At an estimated cost per QALY gained of (compared to IFN-alpha): £105,000 £105,000 Patients already started on IFN-alpha may get sunitinib in 2 nd line Patients already started on IFN-alpha may get sunitinib in 2 nd line

24. Rule of Rescue Cookson et al (2008) Cookson et al (2008) In a humane society: In a humane society: –Allow exceptional departures from a cost effectiveness norm in clinical decisions about identified individuals –Do not exempt any one group of unidentified individuals from the rules of opportunity cost at the expense of all others NICE now incorporates the Rule of Rescue in its decision making NICE now incorporates the Rule of Rescue in its decision making …But PCTs will pick up the bill …But PCTs will pick up the bill

25. Be Afraid…