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| Journal of the New Zealand Medical Association,
25-November-2011, Vol 124 No 1346
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Do pharmaceutical score cards give us the answers we
seek?
(Commentary on Wonder and Milne in the same issue of the
Journal
Wonder M, Milne R. Access to new medicines in New Zealand and Australia. N Z Med J. 2011;124(1346). http://journal.nzma.org.nz/journal/124-1346/4966) Peter Moodie, Scott Metcalfe, Matthew Poynton
Difficulties with international comparisonsThere are many reasons why health costs in general, and
pharmaceutical expenditure in particular, are rising and at a rate where many
countries now recognise they are
unsustainable.1 In terms of managing
pharmaceutical expenditure over the last 18 years, New Zealand’s
Pharmaceutical Management Agency (PHARMAC) has by international comparisons been
successful.2,3 However, that success has not
come without criticisms from both within and outside the country.
It is therefore very important to ensure that the financial
success of PHARMAC has not been at the expense of health gain, and one way to do
this is by way of inter-country comparisons.4,5
An apparent natural comparator for New Zealand is Australia, as both countries
have universal health care systems with roughly similar types of populations.
Both have well-developed pharmaceutical regulatory systems, and funding systems
which appear similar but have fundamental differences.
In particular, New Zealand has a budget which is set
annually by the Minister of Health on the advice of PHARMAC, district health
boards (DHBs) and the Ministry of Health.6
Decisions about such resource allocation are appropriately made by the
Government of the day. By comparison Australia has the ability to seek more
funding when it sees fit—a difference that should not be underestimated.
The two countries also have very different co-payment systems, where in New
Zealand the cost per item is much less than
Australia.7 *
Making comparisons appears simple, but they can come up with
results that appear valid but tell us little. For example, an audit undertaken
by the Karolinska Institute on the use of oncology therapies in various
countries (and sometimes quoted when looking at New Zealand’s
funding8) was quickly discredited for both its
methodological flaws and inappropriate
conclusions.9,10 (See endnote †.)
A new comparison of New Zealand and AustraliaTo make useful comparisons, we need to ask a number of more
detailed questions about the reasons for funding or not funding a particular
medicine, including:
With these sorts of questions in mind,
Michael Wonder and Richard Milne in this issue of the Journal (http://www.nzma.org.nz/journal/124-1346/4966
8) have undertaken a detailed and systematic
analysis comparing the extent and timing of new pharmaceutical funding decisions
between Australia and New Zealand. They make a number of good points,
particularly highlighting the fact that many patients cannot afford to pay for
medicines out of their own pockets and that therefore both countries have
comprehensive and universal pharmaceutical benefits schemes.
Accounting for differences?However, while the lists in the Wonder and Milne
article8 are comprehensive, there are
differences in the way some medicines are funded in the two countries, and other
issues, that have not been addressed.
Different systems—In the first
instance, apart from pharmaceutical cancer treatments (PCTs), therapies in New
Zealand used in a hospital setting are funded at the discretion of the
individual DHB hospital and not PHARMAC. This particularly applies to infusion
therapies. It therefore follows that some of the hospital medicines on the
Australian list will not be found on the NZ Pharmaceutical Schedule, including
bivalirudin for anticoagulation prior to surgery.
Secondly there are some minor errors including levetiracetam
(for refractory epilepsy), which was funded in New Zealand on the Pharmaceutical
Schedule through a Special Access scheme before it came off-patent.
Different time periods, metrics and opportunities to
fund—Any number of comparisons can be done, and some will favour
different views.
For instance, Wonder and Milne have used a long time period
to gather their data. However (and if we suspend issues of validity, see below),
this was also a time of significant fiscal constraint for New Zealand. Had they
reviewed the last 2 years, where the Government has invested significant new
money in pharmaceuticals, the lists would have looked significantly different
with some 59 new medicines funded in New Zealand during that period.
Likewise, New Zealand has fewer restrictions and lists more
treatments overall than Australia.7 (See
endnotes ‡,§.)
There are also differences between the two countries in
opportunities for funding. Pharmaceutical suppliers decide when they will bring
products to market in each country, which means Australia and New Zealand may
not have the opportunity to fund them at the same time.
The effect of a budget cap and cost
effectiveness—Although New Zealand may in some cases be slower to
fund a drug than Australia, the reality of a budgetary cap means that extra care
must be taken to forecast expenditure and ensure that we are getting true value
for money. In fact New Zealand spends half as much per person than Australia
does on medicines in the community, and the direct patient costs are less than a
quarter.7 (See endnote *.)
Talk about PHARMAC declining to list “highly cost
effective pharmaceuticals” because of a pharmaceuticals budget
cap8 needs some thought. This is not so much
because it implies opportunity costs managed by budgeting (which is
true11,12) but that somehow Australia is
funding highly cost-effective medicines that New Zealand is not. The
article’s Table 38 does not state what
these medicines are, particularly when many have NZ-funded alternatives, no
cost-effectiveness information is provided, and some cost over $100,000 per
quality adjusted life year (QALY) in the New Zealand setting.
We well understand the authors’ frustration at the
lack of available cost-effectiveness information; this is not entirely of
PHARMAC’s making.13 ††
Is the size of the list
important?—Notwithstanding some data inconsistencies in the
article, the more important question relates to the usefulness of the, “my
list is bigger than your list” approach for inter-country comparison
without a lot more supporting information. For instance in New Zealand there is
a reticence to fund “me too” medicines unless there is a financial
or other obvious clinical advantage.**
As an example, rosiglitazone (now withdrawn from the market
due to safety concerns) was funded in Australia but not in New Zealand; however
a similar medicine, pioglitazone, was. Likewise we have two angiotensin II
receptor antagonists on the New Zealand Pharmaceutical Schedule (PS) and we can
see little extra benefit from the other four funded in Australia.
What really matters?From an international perspective, the realities of
burgeoning health expenditure are beginning to sink in. Many affluent countries
are more closely examining ways to not only reduce the growth of expenditure but
also to seek ways to identify the best value for money.
The paper by Wonder and
Milne8 adds to the
debate.14 Ultimately however the question is
about the quality of health care and the quantity of health gain, rather than
numerical item counts and timecourses. We all agree that trans-Tasman
comparisons of health gains from pharmaceutical expenditure invested and forgone
may be valuable.4,5,8,15-19
‡‡
Competing interests: None.
Author
information: Peter Moodie, Medical Director; Scott Metcalfe, Chief
Advisor Population Medicine; Matthew Poynton, Health Economist; Pharmaceutical
Management Agency (PHARMAC), Wellington
Correspondence: Dr Peter Moodie, PHARMAC,
PO Box 10-254, Wellington, New Zealand. Email: peter.moodie@pharmac.govt.nz
Endnotes:
* Standard prescription fees are
higher in Australia (up to A$34.20) compared with NZ$3 here for publicly-funded
patients—so that Australians pay on average 4½ times the prescription
fees of New Zealanders.7 In addition,
proportionately many more prescriptions in Australia will be paid for in full by
the patient as they fall under the cost of A$34.20 (note that charge is per
dispensing so usually this will provide one month’s supply only). Hence
Australia’s actual prescriptions fees will be likely be much higher than
reported.
† Although inter-country
assessments sound straightforward, the analysis is in fact complex and results
must be interpreted carefully. As has been seen in other settings (e.g. the
Karolinska Institute report on the uptake of new cancer drugs and cancer
survival, cited by the authors), such comparisons can be fraught (the devil
being in the detail).
Detailed criticisms of the Karolinska report included
incorrect outcome statistics (using not survival but a medley of prevalence and
incidence data), incorrect drug usage data, incomparable time periods, reporting
bias with mortality, and confounding (e.g. tobacco
use).9,10
In addition, New Zealand’s expenditure on cancer
medicines as recorded by that report was undercounted compared with other
countries, as DHB hospital pharmaceutical cancer spend was poorly captured at
the time.
As was stated by Michel Coleman:
“In short, the new
Karolinska report uses flawed methods to reach flawed conclusions about the link
between cancer drug ‘vintage’ and cancer survival in European
countries. ...It is neither premature nor petulant to criticize a 75-page report
that invents an incorrect method of estimating cancer survival in a single short
sentence, gets the wrong answer, models the incorrect results with drug data for
a period some 10 years after the patients were diagnosed, and then concludes
that low national survival rates are due to poor access to cancer drugs and slow
national drug licensing.”10
‡ The debate about access to
pharmaceuticals often focuses around access to the very newest medicines;
however, for health outcomes, it is more important that the population at large
has access to the entire pharmaceutical armamentarium on affordable and
equitable terms. In this respect, New Zealanders enjoy superior access than our
neighbours. Any number of comparisons can be done, and some will favour
different views. For example New Zealand spends, in total, half as much per
person on pharmaceuticals, has direct patient costs of less than a quarter,
fewer restrictions, and lists more treatments than
Australia.7
§ In the 2 years
2009/1015 and
2010/1117 PHARMAC funded 59 new medicines and
widened access to a further 68, benefitting an average of 180,000 additional
patients each year. This level of investment was aided by government injecting a
further $100 million (over 2008/09 baseline) into community and cancer
pharmaceuticals, with a further $80 million invested in 2011/12 likely to lead
to further increases in the number of medicines funded.
** Often new treatments provide little
or no health gains over existing funded treatments, and are relatively poor
investments compared with other options in the health sector. There are me-toos
of little advantage, and others proposals give relatively little added-value for
their added costs.
†† The authors mention the
availability of cost-effectiveness results for public
scrutiny.8 In fact withholding of such
information has been at the request of the industry
itself.13
‡‡ During 2010/11 PHARMAC
funded 39 new medicines for an estimated 176,000 new patients by the end of 12
months’ funding, and widened access to 43 listed medicines for 264,000
additional patients.17
QALY data are available for 28 of these 82 new and
widened access medicines during that year; in the first year these medicines
were (or will likely be) used by 174,000 patients (i.e. actual or estimates for
12 months' use following implementation). Taken over their remaining treatment
time spans, with consequent probable improvements in quality of life and/or
increased life-expectancy, the new medicines for these patients alone will
likely give approximately 4800 QALYs over remaining treatment time spans more
than from standard current treatments (ranging between 3,800 and 10,700 QALYs,
given uncertainties with the estimates of individuals’ time span gains and
other assumptions). These QALY estimates are discounted at 3.5% per
annum.17
References:
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