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| Journal of the New Zealand Medical Association,
23-June-2006, Vol 119 No 1236
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PHARMAC and EpiPen for anaphylaxis
In response to the
‘Special Series’ article by Dr Penny Fitzharris and colleagues on
the EpiPen® delivery device for anaphylaxis (http://www.nzma.org.nz/journal/119-1233/1965/),
we acknowledge the risks and anxiety related to anaphylaxis.
In essence, EpiPen is a device designed to deliver a cheap
product (adrenaline) and improve compliance; however the evidence to hand
suggests that this is anything but the case. Its cost utility of $650,000 per
quality-adjusted life year gained (when last estimated) reflects this lack of
effectiveness in practice, with health gains being less than 1/30th of medicines
that PHARMAC typically funds.*
Notwithstanding the very high price charged for a relatively
simple device by the supplier, the relatively poor cost-effectiveness is driven
by the inefficient and inappropriate usage of the device.
As the authors acknowledge, empirical data suggest that many
patients do not know how to use the auto-injector device – let alone a
caregiver or bystander unconversant either with the device, the disease process
or the indications for urgent use. Overall, it seems that less than a third of
patients and parents alike have adequate knowledge of the indications and how to
use the device (see endnote†), with similarly infrequent use in practice
in children when needed.‡1 Overseas evidence suggests that patients are
reluctant to self-administer,§ many potential prescribers are unversed in
its use,** and schools may not have adequate first aid measures to safely manage
young children at risk.††
There is also good evidence that patients at significant
risk who have been prescribed this device do not carry it with them—or
carry expired devices—thus negating the point of prescribing
it.‡‡ Although allergy diseases impact on quality of
life,2,3 there is
some evidence too that indicates that EpiPen auto-injectors do not appear to
reduce the anxiety surrounding anaphylaxis.4
PHARMAC is committed to achieving the best population health
outcomes within the funding provided.5 We have a finite health budget and
competing needs, and funding one item can mean not being able to fund something
else. If funded, annual expenditure on EpiPen could reach $1 million by the year
2010. An ampoule of adrenaline costs $5.25, so it is fair to ask why an
auto-injector device costs patients $120 to $190.
Again acknowledged by the authors, it is likely that many
patients will carry this device even though they don’t need it. As well,
there are issues of possible over-use for non-anaphylactic symptoms.§§
Such use is in the context of small but important device-related risks of
adverse events.***
PTAC most recently considered the funding of EpiPen at its
November 2005 meeting, including cost-effectiveness, continuing to recommend
that it be listed with a medium priority. The full PTAC minutes can be found at
http://www.pharmac.govt.nz/pdf/1105.pdf
We agree that simply restricting access to defined
specialists could risk serious inequities for those patients unable to access or
afford them – without necessarily fully addressing other aspects of
effective use. Along with access, any future programmes that funded EpiPen would
need at least to demonstrate appropriate targeting—alongside rigorous
education and anaphylaxis management plans,6–9 etc. including
training.10
Adrenaline ampoules, syringes and needles continue to be
available fully funded for patients. PHARMAC will remain open to the funding of
Epipen devices and examining any further evidence or proposals for a workable
system.
Peter Moodie
Medical Director PHARMAC Scott
Metcalfe
Externally contracted to PHARMAC as Senior Advisor (epidemiology and public health medicine) Sean
Dougherty
Therapeutic Group Manager PHARMAC Endnotes:
* Comparative health gains (measured in
quality-adjusted life years (QALYs)) relate here to the QALYs gained for the
same net spending of DHB funds. Net spending of DHB funds in turn is the
combination pharmaceutical costs and nominal savings to other DHB services (http://www.pharmac.govt.nz/pdf/pfpa.pdf
).
The cost per QALY of pharmaceuticals funded by PHARMAC
within the last five years has generally been less than $20,000, i.e. for every
$1 million net spent at least 50 QALYs would be saved. By contrast, every $1
million spent on EpiPen would save 1½ QALYs (i.e. $650,000 per QALY).
† Overseas studies1,11––13 have
consistently estimated that fewer than half of patients and parents are able to
demonstrate proper use of the device. When parents were asked to indicate the
symptoms of anaphylaxis, ‘the majority reported skin rash and shortness of
breath but few parents reported specific symptoms that may have indicated upper
airway obstruction or hypotension.1
‡ In practice, EpiPen seems to be infrequently
used in children when needed, e.g. in a retrospective survey in Australia, the
device was used in only 29% of recurrent anaphylactic reactions in children
prescribed it.1
§ 23% of adult patients in one series stated that
they would probably not be brave enough to self administer adrenaline—half
would seek medical assistance and the other half would ask another
person.14
** Studies in primary and secondary care settings
overseas have shown that most doctors are themselves uncertain about the correct
method for use of auto-injectors.17
†† Children, especially the very young,
will need to have at least one person at their school able to operate the device
when needed. One paper11 found that 77% of children had a device kept at the
school, but in 19% of these nobody had ensured that the school had adequate
knowledge of both the method of administration and the symptoms of
anaphylaxis.
‡‡ In overseas studies, only 50–75%
of patients had a device at all times,14–17 with lower rates in another
retrospective series (22% at the time of anaphylactic episodes). In another
study,11 while 86% of families claimed to carry a device at all times, only 71%
of this group had one at the time of the clinic-based survey. In addition, 10%
of devices were expired—so only 55% of all patients had an unexpired
device with them at the time.
§§ In one series, for example, 19% of
parents of patients with previous severe anaphylaxis stated they would give
adrenaline with the onset of isolated hives, and 11% stated they would give
adrenaline without the onset of any symptoms.11
*** As patients are often not familiar enough with the
device to select the correct end,11 patients may be at risk of injecting
adrenaline into their thumbs – potentially fraught, both because the
adrenaline has not been correctly administered when it is needed, and because
patients can experience digital ischaemia with consequent sequelae. Although
this is a small risk, it again highlights the importance of patient
education.
References:
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