| In a
widely heralded move, on May 12 2004, British Health Secretary
John Reid announced that Merck & Co's statin Zocor
(simvastatin) would be made available over-the-counter in
a 10mg dose. The UK is the first country to approve such a
change in status for a statin.
The
country currently has 1.8 million patients on statins for
cholesterol reduction, and the drugs are thought to save
6-7,000 lives a year. Dr Reid commented, "We have already
seen a 23% fall in premature death rates from heart disease
and stroke over the past five years, on line to meet our
target of a 40% reduction by 2010. This new move will allow
more people to protect themselves from the risk of coronary
heart disease and heart attacks. By extending access to
this drug we are giving people more choice about how they
protect their health."
Top
class CHD
is the UK's biggest killer, causing 110,000 deaths in England
alone each year. It is generally accepted that statins (also
known as HMG-CoA reductase inhibitors) can reduce cardiovascular
events by as much as one-third after three years of treatment.
IMS data suggests that the C10A cholesterol and triglyceride
reducer class is the largest in terms of US dollar sales
in the UK, and saw 37% growth to reach $1.26 billion in
2003.
UK
cholesterol-reducing (C10A) market 2003
($ millions)
Note:
Generic simvastatin from unknown/general manufacturers,
Novartis and Sanofi-Synthelabo. 'Others' includes the fibrates
Lipanthyl from Fournier and Bezalip from Roche.
Source: IMS
World Review 2004
J&J
to partner launch
The
OTC version of Zocor, which will be known as Zocor
Heart Pro, is due for launch in the UK in July 2004.
It will be marketed by Johnson & Johnson: in February
2004, J&J bought out Merck's 50% share in their consumer
pharmaceuticals joint venture, Johnson & Johnson * MSD
Europe; Merck will receive royalties.
Zocor
Heart Pro is expected to be priced at £10-15 for a 28-day
pack; Zocor is currently approximately £18 for 10mg,
while generic 10mg simvastatins cost around £15. A monthly
prescription charge is £6.40, though approximately 80% of
patients are exempt from paying, including those aged 60+.
Many 'at risk' patients would therefore be better off sticking
to prescription treatment, but if large numbers do start
paying for their own simvastatin, the savings to the government
could be significant.
On the
other hand, while the financial success of Zocor Heart
Pro remains to be seen, any increased awareness of CHD
stemming from its launch might prompt more people to visit
their GPs and discuss statin treatment. A number of pharmacists
may also refer patients back to their GPs if they are doubtful
that they would benefit from 10mg simvastatin - so there
is a chance the government's plans to save costs could backfire.
Much
discussion has taken place around the pricing for OTC medicines
indicated for chronic conditions. The retail selling price
of smoking
cessation products and Levonelle (the
'morning after' pill) has smashed the myth that an OTC product
cannot be successful in the UK at a price above £10. An
amazing 20% of pharmacists now believe there is no price
ceiling if the product is right for the market, and a further
20% believe £10+ is more than acceptable (Intr@PharmQ Trade
Switch Study 2003) - significantly higher than a couple
of years ago.
Pharmacists
will check suitability...
Dr Reid
noted: "Pharmacists will ask people a series of questions
and, where appropriate, offer a range of health tests to
ensure that it is safe to issue this drug." Gillian Hawksworth,
President of the Royal Pharmaceutical Society, commented
that the reclassification of simvastatin would, "...provide
a perfect opportunity to discuss other risk factors such
as smoking, obesity and diet with a customer. Most importantly
the public will benefit from access to primary prevention
treatment without compromising on professional expertise
and advice."
Present
UK guidelines suggest that physicians prescribe statins
to patients with a 30% or higher risk of having a heart
attack within the next 10 years. It is believed, however,
that around half of all patients who could benefit from
statin use are not treated, mainly for financial reasons
- though the UK does perform well in the secondary use of
statins. The IMS
Hospital Acute Cardiovascular patient diary study
shows that on average, 65% of acute coronary syndromes patients
across the top five European markets are discharged from
hospital on a statin - but the figure rises to 82% in the
UK.
The
UK's track record for primary prevention, however, is less
impressive, and the country has the poorest record for CHD
mortality in Western Europe. One reason is that CHD is often
not diagnosed until after a first acute coronary event,
so preventative self-medication could reduce a number of
associated healthcare costs. But diagnosis is a key issue:
unlike, for example, hayfever or heartburn, CHD has no obvious
symptoms. One concern is that wealthier, health-focused
patients (say, women in their 40s who already exercise and
use cholesterol-lowering 'nutraceuticals' like J&J's
Benecol range) are more likely to self-medicate with
statins than those at greater actual risk, such as 50-something,
overweight men who smoke.
...
but medics query motives
Some
doctors believe the government has acted for financial reasons
rather than out of any concern for improved health. Influential
medical journal The Lancet said UK citizens were
being used as "guinea pigs", and that there was insufficient
clinical data to justify self-medication with statins. It
may also be difficult to get across to patients that statins
have to be taken on a long-term basis to provide any real
benefit.
Moreover,
doctors have worries about the lack of monitoring of patients
for possible side-effects, such as rhabdomyolysis (muscle
pains) and liver disease, and expressed doubts that the
low 10mg dose will be clinically effective. IMS prescription
data suggests that the 10mg dose accounts for just under
30% of simvastatin prescriptions in the UK, with 20mg being
the most commonly used dosage. While the highest 80mg dose
is rarely prescribed, more than 25% of simvastatin patients
take 40mg.
Dosage
for UK prescribing of statins
Source: IMS
MIDAS Prescribing Insights
European
Society of Cardiology President Jean-Pierre Bassand said
it was important that other risk factors for heart disease,
such as diet and exercise, were considered: "Whilst statins
are extremely effective in reducing the risk of heart disease,
it is crucial that a global approach is taken and efforts
are made to reduce risk factors on all levels. Patients
must be adequately encouraged to improve their lifestyles...
and not misperceive the taking of a statin as a stand-alone
risk reduction option."
Will
other countries follow suit?
The
performance of OTC Zocor, which may also soon arrive
in New Zealand, will be monitored closely by other countries
- particularly the US. In 2000, the FDA rejected applications
from Merck and Bristol-Myers Squibb to market Mevacor
(lovastatin) and Pravachol (pravastatin) OTC, citing
safety concerns. Mevacor was Merck's first statin,
and lost US patent exclusivity in 2001, while Pravachol
was developed by Sankyo.
In November
2003, it was reported that Merck was planning to ask the
FDA to review Mevacor again for OTC status, this
time in a 20mg dose: an advisory committee had questioned
the efficacy of a 10mg version. In the US, OTC Mevacor
would be marketed by the J&J-Merck Consumer Pharmaceuticals
joint venture, which was unaffected by J&J's buyout
of the European partnership.
Zocor
itself loses US patent protection in 2006 - likely to be
a difficult year for Merck. Following on from Rx-to-OTC
switches for ulcer drug Prilosec (omeprazole) and
non-sedating
antihistamine Claritin
(loratadine), plus the ongoing debate about healthcare costs
in the US, it must be optimistic that the FDA will at least
grant OTC status for Mevacor.
In 2003,
the US cholesterol market was worth $15 billion - and most
of the 18 million Americans deemed at moderate risk (10-20%
risk of cardiovascular problems within a decade) are not
treated at all. It is this group that J&J-Merck would
target with OTC Mevacor: the companies plan to seek
FDA approval for the switch by the end of 2004.
This
article was written by Selena Class, Deputy Executive Editor
of IMS
Company Profiles. For more information on
IMS' Intr@pharm community pharmacy network service, please
contact Claire
Conroy or call +44 208 723 3448.
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