Making an Making an Exception:Exception:PCT Library ServicesPCT Library Services& Individual Funding Requests& Individual Funding Requests

Richard WilsonRichard Wilson

Knowledge ServicesKnowledge Services

Derbyshire County PCTDerbyshire County PCT

Resource Based Resource Based DecisionsDecisions The NHS allocates finite resources on The NHS allocates finite resources on

the basis of clinical needthe basis of clinical need PCTs are locally accountablePCTs are locally accountable Given the full support of the Court of Given the full support of the Court of

Appeal in Appeal in R v. Cambridgeshire Health R v. Cambridgeshire Health Authority ex parte B [1995] 1 WLR 898Authority ex parte B [1995] 1 WLR 898

No duty of care owed by PCTs to No duty of care owed by PCTs to patientspatients

PCT ObjectivesPCT Objectives

Increase the healthy lifespan of Increase the healthy lifespan of your client populationyour client population

Reduce inequality in healthy Reduce inequality in healthy lifespan of your client populationlifespan of your client population

Break evenBreak even

What’s in a Name?What’s in a Name?

OATSOATS

Individual funding Individual funding requestsrequests

Exceptional casesExceptional cases

Non-contract treatmentsNon-contract treatments

Interventions not normally Interventions not normally fundedfunded

Why Have IFR Panels?Why Have IFR Panels?

To manage those episodes of care To manage those episodes of care that fall outside contracting that fall outside contracting arrangements with local providersarrangements with local providers

To address rare events which To address rare events which require a use of resources not require a use of resources not covered under existing covered under existing arrangementsarrangements

i.e.i.e.

When it isn’t covered by anything When it isn’t covered by anything else!else!

Types of RequestsTypes of Requests

Service developmentsService developments Experimental: let’s try it and see Experimental: let’s try it and see Patient initiated requests Patient initiated requests Tertiary care and beyondTertiary care and beyond Exceptional or individual casesExceptional or individual cases

ExceptionalityExceptionality

A rare or unusual eventA rare or unusual event Far beyond what is usual in Far beyond what is usual in

magnitude or degree magnitude or degree Exceptional likelihood of benefitExceptional likelihood of benefit Most cases that come before Most cases that come before

Panel are not in any way, shape Panel are not in any way, shape or form exceptionalor form exceptional

Not Exceptional!Not Exceptional!

Social factorsSocial factors Culpability: it wasn’t the Culpability: it wasn’t the

patient’s faultpatient’s fault Efficacy: it works for this Efficacy: it works for this

patientpatient Rule of Rescue: we’ve tried Rule of Rescue: we’ve tried

everything else! everything else!

Examples of RequestsExamples of Requests

Breast augmentation / Breast augmentation / reduction (not just for reduction (not just for women!)women!)

Implanted electrical Implanted electrical stimulation for MSstimulation for MS

Botox for jaw dystoniaBotox for jaw dystonia Bilateral cochlear Bilateral cochlear

implantsimplants Grass pollen allergen Grass pollen allergen

extract for extract for rhinoconjunctivitisrhinoconjunctivitis

Deep brain stimulation Deep brain stimulation for Parkinson’s diseasefor Parkinson’s disease

Stereotactic radiosurgery Stereotactic radiosurgery for cerebral metsfor cerebral mets

Sacral nerve stimulation Sacral nerve stimulation for urinary incontinencefor urinary incontinence

Aromatherapy for OCD Aromatherapy for OCD and anxiety disorderand anxiety disorder

Pulmonary vein ablation Pulmonary vein ablation for AFfor AF

PDT for central serous PDT for central serous chorioretinopathychorioretinopathy

MR ultrasound MR ultrasound embolisation of uterine embolisation of uterine fibroidsfibroids

Hair transplantation for Hair transplantation for female pattern baldnessfemale pattern baldness

Any high cost drug not Any high cost drug not yet in the system!yet in the system!

Numbers of RequestsNumbers of Requests

Derbyshire County PCT received Derbyshire County PCT received about 700 IFR applications last about 700 IFR applications last yearyear

About 60% were approvedAbout 60% were approved Annual spend > £3,000,000Annual spend > £3,000,000 Majority decided out of PanelMajority decided out of Panel

IFR ProcessIFR Process

Receive requestReceive request TriageTriage Evidence gatheringEvidence gathering Panel meetingPanel meeting Communicating decisionCommunicating decision AppealAppeal

TriageTriage

Is there a policy, existing Is there a policy, existing contract, prior approval process, contract, prior approval process, NICE guideline, etc?NICE guideline, etc?

Is it specialised services, e.g. Is it specialised services, e.g. EMSCG?EMSCG?

Is it more appropriate for another Is it more appropriate for another group – e.g. complex case panel, group – e.g. complex case panel, mental health panel, children’s mental health panel, children’s services?services?

Evidence GatheringEvidence Gathering

Searcher Searcher mustmust have full case have full case documentationdocumentation

Evidence sources:Evidence sources:– NICE, SMC, Wales, HTAs, CE/CKSNICE, SMC, Wales, HTAs, CE/CKS– TRIP, Cochrane, Medline, EmbaseTRIP, Cochrane, Medline, Embase– Google ScholarGoogle Scholar– NeLM, DTB, EMEA, MeReC, conferencesNeLM, DTB, EMEA, MeReC, conferences

Levels of evidenceLevels of evidence Presentation of resultsPresentation of results

Author, date and country

Patient group

Study type (level of evidence)

Outcomes Key results Study Weaknesses

Brookes et al1993Australia

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 al1993Australia

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 al1994UK

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

Panel MeetingPanel Meeting

Composition of PanelComposition of Panel Decision making forms, backed Decision making forms, backed

by detailed minutesby detailed minutes Is the proposed treatment:Is the proposed treatment:

– Clinically effective?Clinically effective?– Cost-effective?Cost-effective?– Affordable?Affordable?

Clinical EffectivenessClinical Effectiveness

NICE guidanceNICE guidance Evidence searchEvidence search Additional information from Additional information from

requesting clinicianrequesting clinician Clinical knowledge of Panel Clinical knowledge of Panel

membersmembers Specialist clinical expertise within Specialist clinical expertise within

PCTPCT

Cost-EffectivenessCost-Effectiveness

NICE thresholds:NICE thresholds:– £30,000 per QALY gained for curative £30,000 per QALY gained for curative

interventionintervention– £20,000 per QALY gained for palliative £20,000 per QALY gained for palliative

interventionintervention Actual primary care spends (BMJ, 2007):Actual primary care spends (BMJ, 2007):

– £12,000 per QALY gained in circulatory £12,000 per QALY gained in circulatory diseasedisease

– £19,000 per QALY gained in cancer£19,000 per QALY gained in cancer

AffordabilityAffordability

Richards report (Nov 2008)Richards report (Nov 2008)– ““Many stakeholders believe that the value Many stakeholders believe that the value

society places on supporting people nearing society places on supporting people nearing the end of their life is not adequately reflected the end of their life is not adequately reflected when the cost-effectiveness of drugs is when the cost-effectiveness of drugs is appraised.”appraised.”

– ““Recommendation 5: The Department of Recommendation 5: The Department of Health should work with NICE to assess Health should work with NICE to assess urgently what urgently what affordableaffordable measures could be measures could be taken to make available drugs used near the taken to make available drugs used near the end of life that do not meet the end of life that do not meet the cost‑effectiveness criteria currently applied to cost‑effectiveness criteria currently applied to all drugs.”all drugs.”

AffordabilityAffordability

NICE end-of-life treatments advice (Jan NICE end-of-life treatments advice (Jan 2009)2009)– “…“…there will be circumstances in which it there will be circumstances in which it

may be appropriate to recommend the use may be appropriate to recommend the use of treatments with high reference case of treatments with high reference case incremental cost effectiveness ratios” incremental cost effectiveness ratios” IFIF

– Short life expectancy (<24 months) Short life expectancy (<24 months) ANDAND– Life extension (>3 months) Life extension (>3 months) ANDAND– Nothing of comparable effectiveness Nothing of comparable effectiveness

available from NHS available from NHS ANDAND– Small patient population (<7000 p.a.)Small patient population (<7000 p.a.)

i.e.i.e.

Your life really is worth more than Your life really is worth more than other people’sother people’s

……If you’re about to die from If you’re about to die from cancercancer

……But only if it’s a rare oneBut only if it’s a rare one

The Price of LifeThe Price of Life

BBC2 documentary (June 2009)BBC2 documentary (June 2009) NICE reverses its decision on Revlimid NICE reverses its decision on Revlimid

(lenalidomide) for multiple myeloma(lenalidomide) for multiple myeloma NICE estimates:NICE estimates:

– a non-recurrent cost of treating a backlog a non-recurrent cost of treating a backlog of patients of £221,000 per 100,000 of patients of £221,000 per 100,000 population in the first year, andpopulation in the first year, and

– a recurrent cost of £107,000 per 100,000 a recurrent cost of £107,000 per 100,000 population per yearpopulation per year

SunitinibSunitinib

Following appeal, NICE reverses its Following appeal, NICE reverses its decision on sunitinib (Mar 2009)decision on sunitinib (Mar 2009)

At an estimated cost per QALY At an estimated cost per QALY gained of (compared to IFN-alpha):gained of (compared to IFN-alpha):

£105,000£105,000 Patients already started on IFN-alpha Patients already started on IFN-alpha

may get sunitinib in 2may get sunitinib in 2ndnd line line

Rule of RescueRule of Rescue

Cookson et al (2008)Cookson et al (2008) In a humane society:In a humane society:

– Allow exceptional departures from a cost Allow exceptional departures from a cost effectiveness norm in clinical decisions effectiveness norm in clinical decisions about identified individualsabout identified individuals

– Do not exempt any one group of Do not exempt any one group of unidentified individuals from the rules of unidentified individuals from the rules of opportunity cost at the expense of all opportunity cost at the expense of all othersothers

NICE now incorporates the Rule of NICE now incorporates the Rule of Rescue in its decision makingRescue in its decision making

……But PCTs will pick up the bill But PCTs will pick up the bill

Be Afraid…Be Afraid…