Memorandum submitted by the American Pharmaceutical
Group
I am writing on behalf of the American Pharmaceutical
Group to share with you our comments on the NAO's recent Report
on prescribing costs in primary care. I hope that this will be
useful ahead of the Committee's discussion of the Report on 11
June.
The APG welcomes this scrutiny of primary care
prescribing and we strongly support the goal of efficient and
effective prescribing. The Report notes that the average cost
to the NHS of a prescription is £11. However it is also important
to note that a day in an NHS general ward costs up to £400
a day, and £1,200 or more in an intensive care unit. The
Report highlighted that there are areas of under prescribing,
where people are not accessing medicines which could improve their
quality of life and save money by preventing hospital stays. We
welcome this recognition.
We also welcome the Report's recommendations
for an evaluation of medicines use reviews and further research
into medicines wastage. Wastage of drugs and inappropriate use
of medicines costs the NHS money with no benefit to the patient.
The Report gives great emphasis to the potential
of generic medicines to save money, and the APG supports the use
of generics when consistent with the best care for patients. Such
savings can create headroom to fund innovative new medicines.
However it is crucial to understand that replacing a branded medicine
with a different molecule—albeit from the same therapy class—is
not replacing like-for-like and that small differences in medicines
can have significantly different outcomes for different people.
There are strong pharmaco-genomic reasons for needing a number
of different compounds within a therapeutic class. Individuals
metabolise and react to medicines in different ways, and it is
crucial to have a broad spectrum of medicines from which a prescriber
can chose the most suitable.
Decisions to change a medication on which patients
are stabilised must be undertaken with care and in consultation
with the patient, and must be closely monitored to ensure the
best patient outcome. We have provided more detail about this
below.
Another factor to consider when switching medicines
is the effect on patient concordance. Research shows that changing
a patient's medicine often has an adverse affect on concordance
causing more wastage of medicines, but more importantly, negative
consequences for patient care.
The NAO Report goes on to note that GPs benefit
from information support. Our research shows that doctors value
the information provided by the pharmaceutical industry. Central
to this relationship is the strict industry code of practice which
includes limits on the number of times GPs can be contacted, and
with serious sanctions for companies who breach this code. We
would draw your attention to this code of practice, which we firmly
support, and which can be found at: www.abpi.org.uk/links/assoc/PMCPA/pmpca—code2006.pdf.
The Report makes the important point that the
definition of "value for money" in prescribing must
include quality of outcome and not just economy. It is right that
patients have access to more effective, more expensive drugs when
this is clinically appropriate.
Finally, I would like to reiterate our support
for the NAO's aim of improving value for money in primary care
prescribing. We very much support this goal and we would be delighted
to provide further information if that would be helpful to the
Committee.
DETAILED NOTES
The NAO Report suggests an ACE/AIIA target ratio
of 84% / 16%. This is contradictory to the joint British Hypertension
Society/NICE guidance which recommends an 80% / 20% ratio. The
4% differential, if implemented, would deny a significant number
of patients the opportunity to receive the proven clinical benefits
of an AIIA. No consideration is given in the Report to the BHS/NICE
guidance and what this differential means to patient care.
The Report mentions clopidogrel, a treatment
used to prevent patients who have had a heart attack or stroke
from having a further event. The NAO Report implies that the alternative
anti-platelet treatment aspirin can be substituted for clopidogrel.
In fact, aspirin is not a generic equivalent of the patented medicine
clopidogrel (brand name Plavix); the two are entirely different
medicines with different modes of action, and the two treatments
are frequently used in combination with one another. There is
detailed NICE guidance that specifies when clopidogrel should
be used; however national audit data suggests that 40% of patients
who should receive clopidogrel do not in fact get it.
The largest single area of savings the Report
claims to have identified relates to statins. The newer statins
still under patent protection have greater efficacy and different
levels of tolerability (particularly at higher doses) to the older,
generic statins. At the levels of generic prescribing the Report
appears to endorse, a significant number of patients would fail
to reach agreed national clinical targets for cholesterol management,
putting their cardiovascular health at unnecessary risk. Calculations
show that only 68% of patients eligible for statin therapy would
meet the national target of total cholesterol = 5 mmol/l using
40mg simvastatin.
Analyses such as that conducted by the NAO,
which downplay clinical considerations and focus only on spending,
are accelerating the switching of medication patients receive.
As noted above, switching a patient's medication needs to be conducted
with care and be guided by good clinical practice. Unfortunately,
this is not always in evidence: the National Prescribing Centre
(NPC) statin campaign (www.npc.co.uk/statins.htm), published December
2006, implies that a rise in cholesterol of 0.5 mmol/l is of little
clinical consequence. However, a 0.5 mmol/l increase in LDL-cholesterol
can lead to an 11% increase in major vascular events and a 6%
increase in all cause mortality. [Cholesterol Treatment Trialists'
Collaborators (2005) Lancet 366: 1267-78]
The Report also fails to capture many of the
changes to statin prescribing that have taken place since the
significant price differences between generic and on-patent statins
emerged (May 2005):
— 90% of new patients are now initiated
on generic statins.
— Total cash market for statins (£685m)
is down £229m compared with its peak in Dec 04 (£914m).
— At the same time that the budget
has fallen by £229m, the number of patients taking statins
has risen from 3 million to over 4 million—ie the total
statins budget has fallen by 25% as the number of patients has
risen by 35%.
Andrew Hotchkiss
Chair
American Pharmaceutical Group
6 June 2007
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