Making an Exception:PCT Library Services& Individual Funding Requests Richard Wilson Knowledge Services Derbyshire County PCT
Resource Based Decisions • The NHS allocates finite resources on the basis of clinical need • PCTs are locally accountable • Given the full support of the Court of Appeal in R v. Cambridgeshire Health Authority ex parte B  1 WLR 898 • No duty of care owed by PCTs to patients
PCT Objectives • Increase the healthy lifespan of your client population • Reduce inequality in healthy lifespan of your client population • Break even
What’s in a Name? OATS Exceptional cases Interventions not normally funded Non-contract treatments Individual funding requests
Why Have IFR Panels? • 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
i.e. • When it isn’t covered by anything else!
Types of Requests • Service developments • Experimental: let’s try it and see • Patient initiated requests • Tertiary care and beyond • Exceptional or individual cases
Exceptionality • A rare or unusual event • Far beyond what is usual in magnitude or degree • Exceptional likelihood of benefit • Most cases that come before Panel are not in any way, shape or form exceptional
Not Exceptional! • Social factors • Culpability: it wasn’t the patient’s fault • Efficacy: it works for this patient • Rule of Rescue: we’ve tried everything else!
Breast augmentation / reduction (not just for women!) Implanted electrical stimulation for MS Botox for jaw dystonia Bilateral cochlear implants Grass pollen allergen extract for rhinoconjunctivitis Deep brain stimulation for Parkinson’s disease Stereotactic radiosurgery for cerebral mets Sacral nerve stimulation for urinary incontinence Aromatherapy for OCD and anxiety disorder Pulmonary vein ablation for AF PDT for central serous chorioretinopathy MR ultrasound embolisation of uterine fibroids Hair transplantation for female pattern baldness Any high cost drug not yet in the system! Examples of Requests
Numbers of Requests • Derbyshire County PCT received about 700 IFR applications last year • About 60% were approved • Annual spend > £3,000,000 • Majority decided out of Panel
IFR Process • Receive request • Triage • Evidence gathering • Panel meeting • Communicating decision • Appeal
Triage • Is there a policy, existing contract, prior approval process, NICE guideline, etc? • 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?
Evidence Gathering • Searcher must have full case documentation • Evidence sources: • NICE, SMC, Wales, HTAs, CE/CKS • TRIP, Cochrane, Medline, Embase • Google Scholar • NeLM, DTB, EMEA, MeReC, conferences • Levels of evidence • Presentation of results
Panel Meeting • Composition of Panel • Decision making forms, backed by detailed minutes • Is the proposed treatment: • Clinically effective? • Cost-effective? • Affordable?
Clinical Effectiveness • NICE guidance • Evidence search • Additional information from requesting clinician • Clinical knowledge of Panel members • Specialist clinical expertise within PCT
Cost-Effectiveness • NICE thresholds: • £30,000 per QALY gained for curative intervention • £20,000 per QALY gained for palliative intervention • Actual primary care spends (BMJ, 2007): • £12,000 per QALY gained in circulatory disease • £19,000 per QALY gained in cancer
Affordability • 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.”
Affordability • 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.)
i.e. • Your life really is worth more than other people’s • …If you’re about to die from cancer • …But only if it’s a rare one
The Price of Life • BBC2 documentary (June 2009) • NICE reverses its decision on Revlimid (lenalidomide) for multiple myeloma • 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
Sunitinib • Following appeal, NICE reverses its decision on sunitinib (Mar 2009) • At an estimated cost per QALY gained of (compared to IFN-alpha): • £105,000 • Patients already started on IFN-alpha may get sunitinib in 2nd line
Rule of Rescue • Cookson et al (2008) • 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 • …But PCTs will pick up the bill