Memorandum by Dr Daphne Austin (COM 115)
COMMISSIONING SUPPORT APPRAISAL SERVICE (CSAS)
SCOPE OF
BRIEFING
The Commissioning Support Appraisals Service
(CSAS) was commissioned from Solutions for Public Health (SPH)
in Oxford by NHS Birmingham East and North, on behalf of the 153 English
Primary Care Trusts. It was established to facilitate PCT engagement
with NICE during the development of Technology Appraisal Guidance
(TAG). The newly established CSAS has stimulated a great deal
of press interest, but much of it has been based on either poor
information or misinformation. This briefing is intended to provide
a full background about why CSAS has been established and the
functions that it will deliver.
BACKGROUND
The National Institute for Health and Clinical
Excellence (NICE) has a number of work programmes. One of these,
the Centre for Health Technology Evaluation generates Technology
Appraisal Guidance (TAG), which reviews the cost effectiveness
of new drugs and other health care technologies. If approved for
introduction, NHS organisations are required by statute to make
funding available for implementation. Primary Care Trusts are
the NHS bodies which receive a cash-limited annual allocation
to deliver health improvement and ensure access to cradle to grave
health care for all of their registered population.
The process for the development of each TAG
is unique in that for each appraisal there is a specific list
of designated consultees which are separate from the more general
consultation process. Consultees are selected by NICE and
invited by the organisation to engage in the appraisal process.
Consultees have special status in that:
— They are given additional opportunities,
and at an earlier stage, to comment on the guidance. This includes
having opportunities to give evidence directly to the appraisal
committee.
— They have a right of Appeal.
The list of named consultees routinely includes
professional bodies, patient groups, manufacturers and NHS PCTs.
They number up to about 30 organisations. In addition to
the NHS commissioners, of which in each case there will be two
PCTs (picked at random) who are invited to contribute on behalf
of colleagues, one or two Specialised Commissioning Groups might
also be invited for relevant technology appraisals.
There are three problems with PCT engagement
in the NICE process:
1. The first is that PCTs are not engaging at
all. Of the first 176 TAGs published by NICE, NICE reported
that none received any input from PCTs at either the scoping stage
(where the research question is defined) or the evidence review
stage. Seven of the named PCT consultees did appeal against NICE
guidance but without having contributed views or evidence to the
guidance whilst it was still being developed and considered. Such
appeals have proven to be expensive, unpopular (due to perceived
delay) and may have been avoided had the PCT consultee played
its part more actively during the early development of the TAG.
There are a number of reasons why engagement has been poor. These
include: communication (PCTs were unaware that they had been selected
to be a consultee or in some instances NICE had contacted PCTs
that no longer existed), training (PCTs were unaware of why they
should be a consultee and how to participate), capability (individual
PCTs may be asked to contribute to a complex and technical appraisal
of a relatively esoteric subject) and competing local commitments.
2. The second was that participating formally
in a NICE appraisal requires a major resource commitment, usually
from one individual in the PCT. The most likely contributor would
be a senior public health specialist with commissioning experience.
Many PCTs have only one individual in this role and this contribution
is often part time at that. Furthermore, this individual may need
to access other expertise such as clinical, economic and legal
advice. Based on my experience I calculated that the resource
cost to a PCT to participating in a straightforward consultation
was approximately £2000-4000 and could go as high as
£15,000 for more complex consultations and appeals.
3. Finally a number of public health practitioner
who had considerable other contact with NICE were aware that NICE
were finding it difficult to engage commissioners.
PCT ENGAGEMENT IN
TECHNOLOGY APPRAISAL
GUIDANCE
There are three reasons why PCT engagement in
the development of NICE Technology Appraisal Guidance may be considered
important:
1. Budget. PCTs are the legal guardians of the
budget and tasked with the duty to oversee healthcare provision
for their whole local populations. When another body, which has
no budgetary responsibility commits the resources of the PCT—it
has a legitimate interest in the decision of that body. Indeed
I would go as far as to say it is a major stakeholder in the work
of NICE. Not to engage in the consultation process, when invited
to do so could be seen as a neglect of its function. Worse, given
that only two PCTs are offered this opportunity at a time and
that there is no current mechanism for PCTs to work on each other's
behalf—failure of both PCTs to engage means NICE guidance
is developed without evidence or information from PCTs which may
be relevant and important.
2. Other patient groups. There are important
ethical arguments for ensuring PCTs participate in their role
as consultee. Less than 5% of committee members actually represent
the population view. Out of the nominated consultees only the
PCTs represent the whole population perspective, as opposed to
the specialist interest of a particular patient group or disease.
When making choices in a resource constrained system, it is vital
that any decision maker or decision making body understands the
full consequence of the decisions they take. Although the committees
of NICE can never truly appreciate opportunity costs it is important,
nevertheless, that they are made aware of competing patient groups
and these other patients groups are represented when NICE makes
its decisions. If the NHS budget holder is not present then other
patients have no voice and the only views that will be heard are
those with a special interest in that subject—the patient
groups, clinicians with a special interest and industry. NICE
has expressed a desire to better understand the opportunity costs
of their decision and only PCTs can provide this information.
3. Implementation. There are practical reasons
why PCT should provide input at all stages of the process. They
have expertise and experience which others cannot provide—particularly
around policy making with a view to implementation. NICE committees
do sometimes deliver decisions which the NHS has found difficult
to either interpret or implement. It is therefore important to
have access to have PCT input before the final policy is written.
Even if the overall decision is the same the technology appraisal
may be a better document for PCT input. Similarly, in for example
developing the scope of an appraisal, the technology appraisal
teams can benefit by obtaining a strategic and population perspective
in terms of areas to focus on.
There are therefore important reasons why PCTs
should take up their invitation by NICE to participate in the
appraisal process.
Why the Commissioning Support Appraisal Service
model?
Any potential solution to improving engagement
with NICE and providing NICE with information that they have been
requesting from PCTs for many years needed to overcome a number
of problems:
1. Many PCTs have insufficient capacity to release
staff with appropriate skills, knowledge and expertise to take
part.
2. PCTs are likely to be invited to participate
only once every two or more years. There is a substantial learning
curve with demanding timescales in understanding the NICE TAG
process and how to contribute. The solution needs to support PCT
consultees to fulfil the information requirements by NICE in a
timely and effective way.
3. PCT consultee selection is currently a random
process. It is therefore possible that the most appropriate PCT
is not selected and therefore cannot contribute as a consultee.
The service model needs to be able to access information from
PCTs who have an interest in the healthcare intervention. Since
the establishment of CSAS and the PCT Steering group, dialogue
with NICE has indicated that they are interested in working together
with PCTs/CSAS to consider alternative ways of selecting PCT consultees—with
the aim of achieving high quality PCT engagement.
4. Prior to the establishment of CSAS, if the
two PCT consultees were unable to participate there was no fallback
position This resulted in guidance being developed without PCT
evidence eg alternative treatments, the place of the intervention
in the care pathway, the realistic likely cost impact and the
opportunity cost for the rest of the population (many of whom
have health needs which will never be considered by TAG). .
It was therefore proposed that the best way
to proceed would be for PCTs to collaborate through the commissioning
of a central service to provide administrative and technical support
and training as required. The support needed will vary from consultee
to consultee and in each case this will be agreed between the
two participating PCTs and the Unit. The Unit will also provide
single point assessments for PCTs to aid them in their decision
making in the period before NICE makes its decision. This avoids
individual PCTs making assessments on treatments in this pre-NICE
period which is more efficient and is likely to lead to more consistent
decision making.
The proposal was put before the Primary Care
Network of the NHS Confederation to develop a central service.
The proposal was accepted in principle and Sophia Christie and
myself were tasked with developing more detailed proposals and
costs and consulting with all PCTs on the proposal and securing
support from all PCTs This was done and as a consequence Birmingham
East and North PCT was delegated the task of commissioning the
service.
The proposal was also discussed with NICE in
the very early stages. In March 2008, Andrew Dillon wrote to me
following a meeting I had with him and Dr Gillian Leng:
Thank you for giving us time to talk about
how NICE can better work with PCTs. I look forward to hearing
how the NHS Confederation initiative to resource a co-ordinating
centre proceeds.
The draft service specification for the unit
was shared with Peter Littlejohns in advance of the tendering
process.
The Health Select Committee was also made aware
of these proposals from both the oral evidence made by Professor
Rawlings to the Health Select Committee in one of its Inquiries
into NICE and these was reiterated in NICE's formal response to
the Health Committee in National Institute for Health and Clinical
Excellence: NICE Response to the Committee's First Report of Session
2007-08:
20. A number of steps were proposed by
witnesses to alleviate the situation. To improve coordination
between NICE and PCTs, we support the wider use of implementation
consultants, who would provide information both from NICE to the
PCTs and from the PCTs to NICE. (Paragraph 242)
We welcome the Committee's support for our six
implementation consultants who work across England. Although they
have only been operating for 18 months they have shown that
they can provide a valuable service to PCTs and local government.
We have recently submitted a proposal to the Welsh Assembly Government
for the appointment of a comparable post in Wales and we would
like to do the same in Northern Ireland. We are also working with
the NHS Confederation on a scheme to improve the engagement which
NHS organisations have with NICE as it develops its guidance.
The initiative was discussed again in early
2009 at a workshop held by NICE which in part looked at the
relationship between PCTs and NICE. Dr Doug Naysmith, MP, was
at that meeting.
NICE have formally welcomed the establishment
of CSAS. At their recent annual conference in December, Dr Carole
Longson, Director, Centre for Health Technology Evaluation, invited
Claire Cheong-Leen, Director, CSAS to talk about service as part
of the conference programme citing CSAS as an "important
development". Additionally, there is frequent communication
between NICE and CSAS to facilitate PCT engagement and contribution
to the development of TAG.
The Unit is an exemplar of collaborative commissioning
to enable PCTs to participate in an important process in the most
efficient and effective way. Such collaborative working is even
more important given the current economic climate and likely staffing
reductions within PCTs. PCTs are therefore disappointed that this
initiative has been portrayed as a lobbying organisation and not
about securing best quality evidence and information to support
best health outcomes to inform the development of NICE TAGs or
about improving PCT engagement and communications between two
key decision makers.
In terms of the procurement details, the lead
commissioner for the service is NHS Birmingham East and North.
This PCT undertook a European tendering process via OJEU (as legally
required) in January 2009 on behalf of all English PCTs.
In May 2009, Solutions for Public Health were selected as the
preferred provider. Based in Oxford, SPH is part of Milton Keynes
PCT and has over 12 years experience in providing central
public health support and expertise to PCTs in a number of areas.
NHS BEN has contracted SPH to provide the CSAS for an initial
period of three years. The cost of the service to each PCT is
£2,000 per annum.
Dr Daphne Austin
Consultant in Public Health
West Midlands Specialised Commissioning Team
January 2010
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