price: public rationing and implementation of clinical excellence

8/9/2019 PRICE: Public Rationing and Implementation of Clinical Excellence

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Briefing Document Advocating the Establishment of PRICE:

for the Public Rationing and Implementation of Clinical

Excellence. [email protected]

Recently the Health Committee conducted a review into NICE concluding that:

Demand for NHS services will always exceed the ability to meet it. Not every treatment can

be provided to every person. NICE has a vital role to play in the rationing arrangements and,

working with Government, should make clear to the public how and why such decisions are

made. (HC, 2007 p. 69)

Now the NHSs being tasked to reduce costs by as much as 20bn by 2014 (HSJ, 2009) I feel that

technical and allocative efficiency must be dealt with head on, in a very transparent manner.

Since its conception NICE has moved from assessing new technology, to focusing more on value for

money and half of its clinical guidelines are now concerned with long-term chronic conditions. (NICE,

2008) It has thus far operated during an unprecedented period of sustained growth in the overall

NHS budget, 7.3% annually since 2000 and has had a degree of success in this area with several

studies showing its guidelines lead to more cost-effective use of medical devices as well as with

certain drugs for cancer, obesity, and Alzheimer disease. (Pearson & Rawlins, 2005) However this

period has come to an end and the Health Committee believe NICE must now change again:

In the past NICE has changed in response to new challenges, and we are sure it can do so

again. Given the difficult environment, NICE requires the backing of the Government.

Ministers must support NICE, not seek to undermine it. NICE must not be left to fight a lone

battle to support cost and clinical effectiveness in the NHS. (HC, 2007 p. 95)

I believe the report is right in many respects. NICE has indeed overcome many challenges; many

countries look to it as leading the way, and even its critics highlighting the value of its work. (Bryan

et al., 2007; HC, 2007) However with respect to public health there are inherent problems with the

present situation. As NICE (2008 p.9) indicate, statutory instruments and directions do not allow

(them) to take budgetary impact or affordability into account when advising on cost effectiveness.

During the inquiry, doubt was cast on whether NICE alone should continue to determine the level of

the threshold at which technologies are approved. NICE (2008, p.10) also consider the current

situation unworkable within their remit, recommending that:


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A separate body, with representation from NICE, the Department, PCTs and others should set

the level, or range, to be used. NICE's threshold should be closely linked to that used by PCTs.

The threshold should also relate to the size of the NHS budget.

It is my belief that PRICE should be that body.

The current problem.

I feel there are 4 main issues that need to be addressed:

1. Opportunity CostThis pertains to the argument that with a limited budget the decision to fund one course of

treatment is ultimately made at the cost of not funding something else. (Williams, 2005) Birch

&Gafini (2004) provide critique of economic basis of NICE decisions concluding that since theanalytical basis of the NICE guidelines pay no attention to this issue although theymay be useful in

dealing with administrative process but are ultimately unlikely to be well-suited with the effective

use of NHS resources. Also, by approving technologies of marginalcost effectiveness, NICE is

inflating NHS spending with smallhealth gains for the population.Maynard (2008 p.907).

2. Underuse, OveruseMisuse and VariationThe Institute of Medicine (n.d., 1999), identify three main areas where evidence can identify

practices where there is potential to improving care and/or reduce costs.

a. PracticeOveruseE.g. A retrospective study (Bernstein et al., 1993 p.8) showed by UK standards one

half of coronary angiograms were performed for equivocal or inappropriate

reasons.

b. PracticeUnderuseE.g. A US study (RAND, 2004) has shown that Americans receive only about half the

care they need. In the UK, the Government has recognised similar deficits in the

delivery of appropriate primary care.

c. PracticeMisuseE.g. Safety is a big issue in Healthcare as Davies et al., (2004) show of the top 20 risk

factors that account for nearly three quarters of all deaths annually, adverse in-

hospital events come in at number 11 above air pollution, alcohol and drugs,

violence and road traffic injury.


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There is also considerable variation in activity rates in healthcare. For example with respect

consultant surgeons in the English NHS, interquartile variation shows that the top 25% of

consultants have activity rates 60 to 85% higher than the bottom 25%. (Bloor et al., 2004 p.76) As

the Health Committee (2007, p.96) concluded; many treatments currently used are not cost

effective as many studies attest. NICE should adopt a similar standard of cost effectiveness in

assessing such treatments as it uses in its technology appraisals. The organisation must now give

more emphasis to disinvestment.

3. Insufficient Legislation and ResearchThe HC report (2007, p.12) also highlights that NICEs public health recommendations are currently

advisory and not mandatory,although in 2003 it became a legal requirement that funding for all

positive advice arising from technology appraisals should be made available within three months ofpublication in order to improve consistency in patients access to treatment. This is has lead the

somewhat absurd situation where new NICE guidance is mandatory, andPCT are obliged to fund its

decisions; yet without any budget restraint this can lead inflationandbias when setting priorities.As

a result of this there can be pressure on PCTs to fund new technologies with arguably marginal

benefit at the expense of increasing funding to other cost effective areas. (Maynard, 2005(a)) To

date this issue has largely been avoided by claiming there to be plenty of money to go around but

now funding has been cut, or at the very least is not expected to increase in the immediate future, I

believe the issue can no longer be avoided. In addition there is a lack of research into the level ofimplementation of current guidelines (HC, 2007) and limitations as to the evidence base for

managerial implementation. (Rousseau, 2005;Rousseau &Mccarthy 2007; Walshe&Rundalls 2001) In

other words, even where we do know what we should be doing we dont know the best way to

achieve it.

4. Political and Public PressureHealthcare is a very politically emotive subject, an example the Health committee report (2007)

chose to pick up on was when the Rt. Hon. Patricia Hewitt MP publicly voiced concerns over the

refusal of a PCT to prescribe trastuzumab (Herceptin, a then unlicensed indication un-assessed by

NICE), to a patient with breast cancer. Making it almost impossible for NICE not to approve the drug,

once licensed, regardless of cost. (HC, 2007 p.9) When questioned by the committee the then

Minister of State, the Rt. Hon Dawn Primarolo MP, stated I would absolutely stress that it is not the

role for ministers to contradict, override or directly seek to influence a process where NICE are


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already engaged inconsideration.(HC, 2007, p.25) adding that NICEs final guidance will be final

(HC, 2007 p.25). The HC note that it is not the role for Ministers to directly or indirectly seek to

influence the NICE decision-making process.(2007, p.25)

Public opinion voiced by the media plays an imported role here as one media consultant states

"patients are a powerful force and can highlight the clinical, societal and quality of life benefits of a

treatment far more passionately than any press release ever could."(Spinks as cited in Ferner&

McDowell, 2006 p.1269) A Cochrane Study (Grilli et al., (2002 p.1) into this subject concluded mass

media information on health-related issues may induce changes in health services utilisation, both

through planned campaigns and unplanned coverage. Recommending further research be

conducted on whether and how media messages have a different impact on members of the public

and health professionals; and more information be collected on whether mass media coverage

brings about appropriate use of services in those patients who will benefit most. In addition the

Pharmaceutical Industry plays a big role; as Ferner& McDowell (2006) highlight, a study found 76%

of patient groups received support from drug companies in the EU, (though how much was unclear),

and groups campaigning for NICE to approve specific drugs have often declared corporate relations.

Where PRICE would operate

In its founding I envisage PRICE be mandated to address the legal issues discussed above. Like with

the approval of new technologies its guidance should be a statutory requirement. The bulk of its

work would be to firstly assess and secondly enforce rationing thereby addressing opportunity cost

as well as overuse, underuse misuse and variation in resource utilisation. It would work closely with

the DH, the NHS, Parliament, the Public and Press as well as independent bodies such as NICE and

Monitor. In addition to this it should help to signal what new products are desired by the NHS;

helping to steer research as consequence.

Addressing Opportunity Cost

As Smith highlights (HC, 2007 p.61), this is a delicate balancing act; if we adopts too high a threshold

technologies might be implemented that drive out more cost-effective treatments. If we adopt to

low a threshold it may limit development and adoption of newer more cost-effective treatments.

Bryan et al. (2007 p.189) have produced an interesting paper following interviews with many people

at NICE finding The line put forward by many interviewees on the threshold subject was that there

was not a precise value to the threshold but that when the ICER exceeded 30 000 per QALY this

began to signal that the technology was unlikely to be cost-effective. This is backed up by Devlin


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&Parkin (2004) who find support for a threshold based on a range determined by calculations of

probability as opposed a single value;their analysis suggesting it is higher than NICE identify

publically.

PRICE would ultimately have to set threshold ranges per QALY related to NHS budgets, but decisions

should not be, (or seem to be), based purely on the maths. The case of Oregon of shows how

mathematical based rationing was ultimately discarded as patient and government pressure forced

managers to move services up and down the list by hand. Whilst results could be said to be modest;

(US OTA n.d., 1992) it did, however, still manage to reduce the amount of people in the state

without health cover from 18% to 11%. (Oberlander, 2001) Also, a more recent Oregon review by

Wilson (2008) discusses at a potential for organisational learning and thus for further improvements,

with time.

Like NICEs decisions, mathematical models would be very important in guiding decisions but PRICEwould also have to take into account issues such as continuing to pay for orphan drugs for rare

conditions and deciding which future treatment look like producing the best results in the future.

(NICE, 2008) Its remit should involve dealing with some very emotive and difficult concepts such as

the fair innings argument (Farrant, 2009), which argues against spending increasing sums on

expanding life beyond a normal span of years, possibly at the expenses of care to the young which

society might value more. (Nord, 1992)

As Williams (2005) reminds us, maximising public health is ultimately incompatible with reducing

equalities as are concepts of choice. Here the perfect would be the enemy of the good and a body

devoted to perusing evidence based rationing would be a big step forward in addressing the many

issues surrounding opportunity cost.

Addressing Overuse, Underuse andMisuse

PRICE would also be tasked with helping ensure allocative efficiency and reduce variation by

implementing the guidance NICE gives and which it deems cost-effective. As the HC (2007, p.80)

identified, better measurement of guidance implementation is also needed. Self-assessment is not

enough. We recommend that the Healthcare Commission conduct more in-depth inspections of this

element of practice.Cooksey (2006) would term this second gap in translation, (see Chart 1 p.8),

and PRICE would need legal powers to enforce decisions here.


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Chart 1: Pathway for Translation of Health Research into Healthcare Improvement

from the Cooksey Review (2006, p.99 )

It is obviously difficult to put a number as to the potential savings here and even if we could quantify

potential it would be difficult to realise; however a number of studies indicate it could be very

substantial. For example, Maynard (2005(b), p.294), citing the work of Fisher, who found that

Medicare expenditure per capita in 2000 varied from $10550 perenrollee in Manhattan to 4823 in

Portland, Oregon.The differential being due to volume effects, independent of differences in the

population studied, which was adjusted for illness rates, service price and socioeconomic status.

Along with how there were potential savings for Medicare of 30% of the budget with no adverse

effects on patient health if high spending areas the reduced expenditure and provided safe practices

of conservative low spending areas.

As the Cooksey Review believed:

To enhance the evidence base informing decisions on the effectiveness and cost-effectiveness

of technologies in the NHS, the Review therefore recommends an expansion of the NHS HTA

programme to fund these developments, which, for a relatively modest investment, could

deliver large improvements in the quality and efficiency of healthcare(Cooksey, 2006 p.102)

Bottom up implementation should not be viewed as the only, or even the best way of realising this

potential. As Berwick (2003) for example highlights, modern theories which utilize the imagination

and participation of the workforce to improve healthcare processes from the bottom up will be

much more effective than older theories which look more to control and standardise from the top

down. Directives such as PRICE are limited in this respect but will strongly signal intent.PRICE would

have to work closely with bodies such as the HTA, Monitor and the CRD, determining which practices

are considered best, disseminate evidence and help guide change from within.


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Helping inform theMedia and Public

Since 2004 NICE has stood for the National Institute for Health and Clinical Excellence; reflecting the

increased need to account for Public Health as part of its remit. (HC, 2007) I was unable to find any

research indicating whether the public at large are aware of this fact, though opinion polls do

suggest that public confidence in NICE is satisfactorily high. (IMC Omnibus Poll 2004 -2007, as cited

in Minhas& Patel, 2008)There is also support from prominent UK medical journals such as the BMJ

and the Lancet have both endorsed the rigour of NICEs methodology and called for the government

to lead a public debate around rationing. (Minhas&Patel, 2008)

PRICE would also be tasked with helping bring this issue further into the public arena. Like with NICE,

government the public and industry should be involved with decisions, press releases be issued

regularly and decisions, with reasoning, be freely available online. A study by Wilson et al., (2008,

p.130) concluded: newspaper coverage of trastuzumab(Herceptin)has been characterized by

uncritical reporting. Believing Journalists (and consumers) should be more questioning when

confronted with information about new drugs and of the motives of those who seek to set the news

agenda.As they discuss the media play an important role in shaping societies understanding about

which decisions are taken regarding cost effectiveness in our NHS. Health resources are not infinite,

more balanced debate here should be encouraged.

Conclusions

Ultimately if the current flat of the curve paradigm continues; with new health technologies

producing marginal benefit at considerable cost, I dont really see any alternative to a body such as

PRICEs creation in the immediate future. As NICE, the HC, the BMJ, the Lancet and numerous

academics highlight, evidence based rationing is the next logical step the NHS needs to take. Whilst

NICE has generally done a good and difficult job to date, in having no remit to tackle rationing it is

now outgrowing its intended purpose. A new body needs to be created to deal with these issues,

with power to enforce decisions legally mandated. I believe it makes sense both politically and

socially for government to be distanced from these decisions to an extent. The sooner it is

implemented the sooner society we will begin to reap the benefits.


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