With the aim of controlling health care spending, public authorities
in several countries increasingly are regulating the prescription, use
and reimbursement of drugs. One of the latest examples is therapeutic
substitution policies concerning drug therapies. Although such policies
can reduce some pharmaceutical spending by favouring systematically the
use of cheaper medicines, this involves a bureaucratisation of drug use
that presents risks for the health of the insured and a potential
increase in other health care or patients' costs.
Therapeutic substitution policies have already been implemented in
various forms not only in Europe – in countries such as Germany or the
United Kingdom – but also for example in New Zealand or Canada. Their
principle is simple: facing the high cost of certain products, public
authorities put doctors and patients under pressure to replace them with
cheaper, brand name or generic (but not bio equivalent), therapies.
Accordingly, public authorities put certain drugs together in the same
category because they supposedly treat the same conditions, even if
their chemical composition is different, their effectiveness weaker or
their side effects stronger.
But therapeutic substitution also relies on highly specific coverage
policies that cause patients to change therapy. For instance, the health
insurance system may decide to cover drugs in the same category less if
they are priced higher than another drug chosen as a reference – often
among the least expensive in the category (reference pricing system).
Insured persons who must pay on their own for a more expensive drug – as
is the case in countries including Germany or New Zealand – have a
powerful incentive to change to a less expensive but more broadly
covered therapy.
Health insurance systems, as in British Columbia (Canada), may also
decide to cover only one drug – among the less expensive – in a given
class. The incentive for patients to switch is then even stronger: other
than the drug in question, no drugs at all are covered!
Therapeutic substitution policy may also be implemented by giving
financial incentives to doctors – as in the United Kingdom since 2004 –
to change therapies on a broad scale, abandoning some high-cost therapy
for another different, but less expensive, therapy.
However, this sort of substitution by cheaper drugs, sometimes conducted
on a broad scale for all insured persons, has its own costs and risks,
even if it may create savings in the budgetary item of some specific
pharmaceutical product.
A change in therapy could result in the administration of a less
effective drug with more side effects and different interactions with
other drugs taken by patients. For example, people covered under the
public plan in New Zealand, where this type of policy was instituted in
the late 1990s, were pressured into substituting a less expensive drug
for their anti-cholesterol therapy. The drug in question was judged by
bureaucrats to be perfectly substitutable, but it turned out that those
who switched experienced considerable rises in cholesterol levels and
were thus at higher risk of cardio-vascular incidents.
In the Canadian province of British Columbia, six months after the
establishment of a therapeutic substitution policy for anti-ulcer drugs
in July 2003, nearly 25% of patients who chose the less expensive
referenced drug had to stop taking it because of its ineffectiveness or
major side effects.
Closer to home, there is the example of the United Kingdom. The risks
from the change between two anti-cholesterol drugs were observed in a
study conducted by a cardiology specialist at the North Staffordshire
University Hospital. The drug switching from atorvastatin to simvastatin
was associated with a mortality rate more than three times higher as
well as increased patient readmission rates to hospital following
cardiac events. Another study on switching between the same drugs by the
pharmaceutical company Pfizer and recently presented at the annual
conference of European cardiologists in September 2007 in Vienna also
leads to suspect the existence of similar health risks.
Complications following a change in therapy can end up requiring more
visits to a doctor or a hospital. Even if a public system can reduce
some pharmaceutical spending, bureaucratisation in drug use can thus
also cause an increase in other areas of health care spending as well as
non-monetary but very real costs for patients in terms of lost time or
greater suffering.
Seeking to present some cheaper drugs as substitutable for patients
could indeed be in itself a legitimate strategy for an insurance
provider. However, for such a policy to be truly beneficial to patients
and for its risks to be taken effectively into account, it must be
subject to competition and to the "market test".
Insured persons, acting under their doctors' advice, should have the
option of changing health insurance plans if they feel that therapeutic
substitution is not merely inadequate and lacking in added value in
their eyes but that, on the contrary, it increases the risks to their
health illegitimately. It shouldn't be forgotten that this,
unfortunately, is not the case with our compulsory health insurance
systems.
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