Memorandum submitted by Sanofi-Aventis
& Bristol-Myers Squibb Pharmaceuticals Ltd
INTRODUCTION
The National Audit Office recently published
a Report, Prescribing Costs in Primary Care. The PAC is
due to take evidence from David Nicholson, Chief Executive of
the NHS, on 11 June in relation to the Report's findings. We thought
it important to point out to the Committee that we have a number
of significant concerns about the report with regard to its analysis
and findings relating to our product clopidogrel. We have set
out these concerns in detail in a letter to Sir John Bourn, the
Comptroller and Auditor General, requesting that the mistakes
in the report be rectified. This letter can be shared with PAC
Members on request. Our specific comments on the Report follow
below.
COMMENTS ON
THE NAO REPORT
1. The NAO Report claims that the NHS could
achieve more efficient prescribing by ensuring that 75% of Primary
Care Trusts reduce the volume of their clopidogrel prescribing.
This methodology for determining efficiency is overly simplistic,
utilising low prescribing as a proxy for efficient prescribing
and taking no account of the clinical need of the population.
Encouraging PCTs to reduce prescribing to meet this flawed definition
of efficiency could have a negative impact on patient safety and
clinical benefit.
2. Many of the PCTs that the NAO deem to be
inefficient prescribers have successfully reduced the incidence
of heart attacks and strokes through implementation of effective
prescribing policies based on national guidelines. If they were
to be encouraged to reduce their prescribing, this success could
be jeopardised.
3. The report suggests that population-based
medicines reviews can be used to reduce prescribing. In light
of the complexity and severity of the diseases that patients receiving
clopidogrel are suffering from, any approach to medication review
should be based on a clinician reviewing the patient in an individual
face-to-face consultation.
4. The Report suggests that all patients receiving
clopidogrel should have their treatment stopped after 12 months.
This is inconsistent with the clinical trial evidence supporting
the use of clopidogrel and national guidance issued by NICE. Clopidogrel
is indicated to treat patients with a range of cardiovascular
related conditions—principally unstable angina, heart attack,
stroke and peripheral arterial disease. There are two separate
pieces of NICE guidance that apply to these indications, one of
which recommends a treatment duration of 12 months (TA80 on Acute
Coronary Syndromes) and one which makes no specific recommendation
on treatment duration (TA90 on Occlusive Vascular Events). Stopping
clopidogrel therapy for all patients at 12 months may jeopardise
the safety of patients who require longer-term treatment.
5. The NAO considers only the potential to stop
therapy and does not address the significant issue currently facing
the NHS that patients who, according to NICE guidance, could benefit
from treatment with clopidogrel but are not receiving it. National
audit data suggest that 40% of patients with ACS do not receive
clopidogrel. The potential £39 million saving claimed by
the NAO's report fails to take into account the additional spending
that would be required to treat these patients according to national
guidelines.
In putting these points, we wish to make clear
that we agree with the NAO that clopidogrel should be prescribed
appropriately so as to maximise the cost-effective use of resources
as well as the benefit to patients. NICE is charged with issuing
guidance that ensures efficiency and cost-effectiveness in prescribing
practice and it has been very clear as to where and when clopidogrel
should be used. We support NHS activity aimed at achieving the
full and equitable implementation of the guidance—a policy
that would ensure that money spent by the NHS on clopidogrel is
spent effectively and efficiently.
Our concern is that the shortcomings in the
report could lead the Department of Health to pursue policies
that have a negative impact on patient safety and care. Anecdotal
evidence suggests that many PCTs are already carrying out population-base
reviews of clopidogrel usage, and in some instances stopping therapy
for patients against the clinical judgement of the treating GP.
It is critical that the Department does not encourage this financially
driven approach to patient care.
The right way to for the Department to pursue
efficient spending on clopidogrel is to promote robust, clinically-driven
audit processes that seek to ensure the right patients are treated
with clopidogrel—initiating therapy for patients who are
not currently treated as well as stopping therapy for those who
no longer require it. We remain open to dialogue with the Department
to support the development of tools and processes that can help
achieve this objective.
4 June 2007
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