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.