As part of the hospital pharmacy sessions the topic of introducing expensive new drugs was presented from the point of view of both a National Health Service trust and a local health authority. The session was chaired by Mr Martin Stephens (chief pharmacist, Southampton general hospital)
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| Ms Sonia Colwill and Mr Peter Sharott discussed the impact of unified
drug budgets and the management of the introduction of expensive new drugs from both a health authority and a trust perspective |
In a joint presentation, Mr Peter Sharott (regional pharmaceutical advisor [secondary care], NHS Executive, London) and Ms Sonia Colwill (head of public health development/principal pharmaceutical adviser, Lambeth, Southwark and Lewisham health authority) gave their individual perspectives on “unified drugs budgets and the introduction of expensive new drugs”.
Controlling drug budgets
Ms Colwill discussed the complex history behind the management of new drugs
within health authorities. In the past, general practitioners’ (GPs) prescribing
budgets had not been limited by cash. The introduction of PACT (prescribing
analyses and cost) and GP fundholding had changed this and had coincided with
the marketing of many new, high-tech drugs.
The development of practice-based formularies had also occurred as a means of
controlling drug budgets. The blacklist, which had been used to control the
introduction of nicotine replacement therapy, had in general been used to “get
rid of old drugs rather than to manage new ones”, said Ms Colwill.
Area prescribing committees had been set up by health authorities which had
looked at the concept of the infamous red/amber list. This had led to guidance
on what was appropriate for prescribing in primary care.
The history of managing new drugs from a trust perspective was less complicated,
said Mr Sharott. Trusts had had to manage drug budgets and cope with the issues
of new drugs for a long time. Historically, new drugs had been managed by hospital
pharmacists and drug and therapeutics (D&T) committees. Such committees
had had a long history and were part of hospital culture. Formularies and control
mechanisms had put rigour and discipline into the system. For many years, the
central drugs budget had been the responsibility of the pharmacy. This had meant
that the drugs budget had sometimes been seen in isolation but in fact it was
just one part of public health. In addition, budgets often did not reflect reality
and at times were very difficult to manage.
Current problems
Commenting on the current problems relating to the management of new drugs facing
health authorities, Ms Colwill said that it felt as if trusts wanted all health
authorities to make the same decisions about new drugs.
In practice, working with more than one clinician resulted in more than one
view about a new drug within a trust, never mind between health authorities.
And, although health authorities were represented on D&T committees, decisions
were made by one trust in isolation of health authority policy.
Ms Colwill added that prescribing should happen in the best place for a particular
patient and now that there was a single budget this should, in theory, happen.
But often GPs did not trust hospital doctors. GPs might also be faced with four
or five different hospital formularies.
Ms Colwill mooted the possibility of having waiting lists for drugs and pointed
out that while it was acceptable to be on a waiting list for a by-pass operation
it was not acceptable to be on a waiting list for a drug. Whether such lists
would be ethical or indeed legal were questions that needed to be answered.
From an NHS trust perspective, Mr Sharott responded by saying that hospital
doctors did not always trust GPs and said that there were arguments about whether
it was possible to have shared care between a GP and a hospital. Another problem
was the development of red, amber and green prescribing lists. It would be helpful
to have amber lists as it was very irritating having to deal with different
red lists from different health authorities.
Another difficulty was that trusts had to develop relationships with a large
number of primary care groups. This meant that there was a risk that separate
policies would have to be developed to meet the needs of each group. “We
have to accept that we’re not going to please everybody all of the time.
We need a consensus,” Mr Sharott told the audience.
Both Ms Colwill and Mr Sharott agreed that drugs were often considered in isolation
of other aspects of treatment and budgeting which caused problems for both the
health authority and trust.
Managed entry of new drugs
There were various levels for managing the introduction of new drugs:
This was not a hierarchical structure and any organisation could choose to
“go its own way”, even at local levels. This was a problem that needed
resolving, said Mr Sharott.
Discussing the NHS plan and what it said about the introduction of new drugs,
Mr Sharott commented that it was significant that the plan talked openly about
the lack of national standards and the resulting “postcode lottery of prescribing
and care”.
The Human Rights Act, which was due to be enforced on October 2, would add an
important dimension to the issues of managing new drugs and patient care. From
an NHS approach it would reinforce the need for good, ethical, moral and legal
practice in the delivery of quality services.
On the issues of setting, delivering and monitoring standards for the introduction
of new drugs, Mr Sharott said that strong financial systems were needed for
dealing with the cost implications. It was also necessary to be more conscious
of the need to audit policies and manage guidance across the interface of primary
and secondary care.
London New Drugs Group
Describing the London New Drugs Group (LNDG) which had been established in September,
1997, Mr Sharott said that it had been instigated because of concern that “it
was not helpful for each health authority to do its own thing”. The intention
behind the group was to avoid duplication of effort at health authority level
and to reduce policy differences across boundaries. The group, which had preceded
the setting-up of the NICE, set out to provide firm prescribing guidance based
on current evidence and a consensus of regional clinical expertise.
A problem faced by the LNDG was the issue of the timeliness of its guidance.
Organising expert working groups was time consuming but health authorities wanted
guidance quickly and would do the work themselves if they were forced to wait.
There was also the problem of fitting in with the NICE programme to ensure avoidance
of duplication of effort.
In response to these problems, the LNDG had recently decided to abandon the
working group approach in favour of using a panel of health care professionals
in primary and secondary care. Draft documents were to be prepared by a “new
drugs pharmacist” and circulated to the clinical panel and LNDG members
for comment. The aim of this approach was to publish final guidance prior to
the launch of a drug or within one month of its launch.
LNGD’s “work in progress” included classes of drugs not on the
NICE timetable. This showed that there was still a role for regional groups
to complement the NICE’s work, said Mr Sharott.
Prescribing policies
Health authorities had to juggle their responsibilities with the limited resources
available, said Ms Colwill. Increasingly, cash limited prescribing budgets were
being seen in primary care with the associated development of prescribing policies.
Most health authorities had an area prescribing committee to bring in local
expertise. This included representation from both trusts and primary care which
helped to encourage a joint agenda. Expert working groups reported to the area
prescribing committee which in turn reported to the health board. Funding requirements
were identified and then funding was given to trusts to manage. Sometimes, a
limited budget for a particular drug was given to a clinician to manage but
this was controversial and often difficult, said Ms Colwill.
The introduction of beta interferon for use in multiple sclerosis (MS) in Ms
Colwill’s health authority had been managed in this way. The working group
had included local neurologists, and public health and patient representatives.
Interestingly, the patients had wanted improved services for MS sufferers rather
than funding for beta interferon, she said.
Following a presentation of the working group’s findings to the health
board, funding had been agreed for the drug as well as for additional services
for MS patients.
A unified drug budget was “uncharted territory”, said Ms Colwill.
Its aim was to delegate responsibility for managing drugs to primary care groups/trusts,
which was as close to the patient as possible. The real impact of unified budgets
was that the whole prescribing budget was cash limited. Previously, the overspend
had been funded by the Treasury, then it had come out of the next year’s
NHS drugs budget. Now the limits were set explicitly at a local level and prioritisation
would be inevitable.
It was important to make use of the flexibility afforded by unified budgets
and to move money around to make the best use of it. “Activity should take
place in the most efficient and effective part of the system,” she said.
In hospitals, drug expenditure was increasing at a rate of 11-12 per cent, said
Mr Sharott. This was probably due to the introduction of new drugs but without
a system similar to PACT it was difficult to collect information. The managed
entry of new drugs within trusts was mostly the responsibility of trust D&T
committees with some trusts having separate new drugs committees. There was
an average of 25-30 requests for new drugs each year with over 70 per cent of
the requests being approved.
The trust decision making process also involved representation from local health
authorities and/or primary care groups/ trusts. Decisions were based on clinical
considerations but final decisions had to take into account financial considerations
in both primary and secondary care.
Antiretroviral agents, which were expensive but effective, had been a major
component of the total HIV drug expenditure. Prescribing had been patient focused
and had relied on trial and error, said Mr Sharott. In terms of outcomes, the
introduction of the new antiretrovirals had been effective but there had been
no control over their introduction.
It was increasingly difficulty to obtain funding for new drugs so there was
a need to ensure best practice across all trusts. To do this, networks for dealing
with HIV drugs needed to be developed.
The impact of the introduction of atypical antipsychotic drugs was seen clearly
in terms of spending, said Mr Sharott. Their use had been uncontrolled. Across
a large London mental health trust, considerable prescribing differences had
been seen across the six main sites within the trust. The challenge now was
to bring clinicians together to get them to work to locally agreed policies.
Sharing information
The relationships between prescribing committees and the NICE were crucial to
the successful management of expensive new drugs. The NICE was going to influence
how committees operated and its guidance would be adapted to meet local needs
and priorities. Regional new drugs groups would also have a role in this integrated
approach. By sharing information on the decisions taken by area prescribing
committees and trust D&T committees, duplication of effort could be reduced.
Mr Sharott concluded that there was no alternative to collaborative working
and the development of joint formularies. The NHS plan and NSFs required closer
collaboration with the pharmaceutical industry but it was important that the
industry understood what was achievable. Unified budgets were bound to have
an influence on the development of new drug strategies but their impact was
hard to predict.
Ms Colwill added that there was a need to harness a huge amount of energy to
manage the entry of new drugs. It was also important to recognise that the NICE
would not necessarily provide all the answers.