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Kicking the habit on prescription

Published on 14/10/03 at 01:19pm

NRT products have played a leading role in making the UK's smoking cessation services that rare thing - a genuine NHS world-beating success story.

Smoking is responsible for 120,000 deaths in Britain every year - one in five of all mortalities. It is also the principle cause of inequalities in death rates between the rich and poor, and costs the NHS £1.7 billion a year.

In response to these shocking statistics, UK-wide smoking cessation services were set up in 1999/2000 and NRT products have been credited as the biggest factor  other than patient willpower  behind thousands of people quitting and staying off cigarettes through the system.

Department of Health data for April 2001-March 2002 shows that the number of successful quitters at the four-week follow-up (based on self-report) rose from just over 64,000 to nearly 120,000, an increase of 86%. This is a remarkable turnaround for a therapeutic category that had once been on the NHS prescribing blacklist. Up until September 2000, one weeks free supply of NRT was provided to smokers who were entitled to free prescriptions; after this date they were the amount was upped to six weeks supply.

The turning point for patients, the NHS and the companies came in April 2001, when all NRT products were made available on prescription, and smoking cessation services were set a target of helping 50,000 people to quit by the four-week follow-up point. This target was doubled for 2002/3 and the message from the Government is now very clear: the war against tobacco is one of the highest public health and NHS priorities.

Boom time for NRT

Given the green light by the Government, and with PCTs and strategic health authorities working to some of the most demanding performance targets in the NHS, general practitioners have responded with a massive increase in prescribing.

IMS Self Medication data shows 1.73 million NRT prescriptions were written in the year to September 2002, a massive 175% increase in just 12 months, with the products of three companies, GlaxoSmithKline Consumer Health, Novartis and Pharmacia, all competing in a multitude of drug forms.

NHS prescriptions are, though, just one side of the story, since the over-the-counter market for NRT products dates back to the launch of Pharmacia's Nicorette in 1980, and produced annual unit sales of 3.8 million in the year to September.

Nicorette dominates this market, currently commanding a 56.5% sterling sales share, with GSKs NiQuitin CQ in second and Novartis Nicotinell in third place. The market remains unpredictable  a sales slow down in recent months probably concealing the markets underlying dynamic qualities. The one unambiguous indicator is good news for GSK - NiQuitin CQ surged ahead in the period and doubled sales.

A tale of two categories

Despite this dynamic growth, GSK still has a long way to go before its product can challenge Nicorette's number one status in OTC, which is driven by the popularity of its gum. The story in the prescription market is quite different, with NiQuitin representing 54% of all products dispensed (based on MAT Sep 2002), followed by Nicorette (27%) and Nicotinell (19%)

GSK has the vagaries of the NHS prescription blacklist system to thank for its dominance in the market, rather than the strengths of its salesforce. Launched in 1998, NiQuitin was somehow overlooked and never joined Nicorette and Nicotinell on the banned list; instead it found itself in the right place at the right time as the NHS changed its view of NRT products.

"They were seen as lifestyle drugs  the thinking was: 'There was a feeling of why should the Government pay for smokers to quit?' says Claire Conroy, Account Director, IMS Self Medication. "It can now be seen that due to the huge burden placed on resources by smoking-related diseases, funding smoking cessation makes good economic sense in the long term."

A NICE appraisal in April 2002 cemented the health economics case for the NHS, with the Institute stating that GSK's Zyban and all NRT products were among the most cost-effective of any medicines when used as part of a smoking cessation programme. NICE predicted that NHS costs would triple to £9 million following its guidance, but balanced it against its estimate of the £1.5 million spent on treating smoking related diseases every year.

In November, Health Secretary Alan Milburn launched the next phase of its aggressive anti-smoking strategy, with a ban on tobacco advertising to come into force just as a new three-year £15 million TV and radio anti-smoking campaign is launched in collaboration with Cancer Research UK and the British Heart Foundation.

A new profit control mechanism for NRT?

The Government has also announced a groundbreaking cashback agreement with the pharmaceutical companies involved, giving a rebate on smoking cessation products sold above a certain threshold. Senior executives at the companies are still thrashing out the details of the Government-proposed scheme, but have had to accept the scheme as inevitable as prescription of the products continues to grow.

Indeed, on a first glance, the scheme appears to be a mini-version of the larger profit control agreement, the Pharmaceutical Price Regulation Scheme; it allows free pricing and, perhaps most importantly, does not seek to restrict prescribing.

Pharmacia Spokesman Roy Sutherwood said: "We have had a long and fruitful relationship with the DoH in making smoking cessation services effective, so we welcome this initiative as a win-win-win for patients, the NHS and the industry. Exactly how the scheme will work is currently being discussed with the relevant civil servants, so watch this space. But the plan is to get the scheme up and running by April so we can achieve that higher number of quitters."

The companies will now be trying to calculate how their bottom lines will be affected, but should allow for continued growth. Claire Conroy says: "It was expected that the cost impact on PCTs would have to be limited in some way so this is by no means a surprise. At the end of the day it is going to be in each companys interest to get as many people through as they can, even if they are going to be slightly subsidising it."

The cashback scheme is one further factor for the marketers to consider in an already unpredictable market. The industry has only had 18 months of the post-blacklist prescription market to see how it affected the picture in OTC sales, but the trends have defied expectation so far.

"The prescription market does not appear to have taken away from the OTC market," says Claire. "Patches retail at up to £20, so you might think consumers would avoid this cost by getting the product on prescription and paying the £6.20 charge or, in fact, no charge, as most patients are exempt from prescription charges. The continued strength of the OTC market suggests this hasn't happened."

Market watchers hypothesise that this pattern might be because OTC consumers and prescription patients are quite distinct users of NRT products  in 2001/2, OTC sales peaked around the time of New Years resolutions, whereas prescriptions were much more consistent, peaking around No Smoking Day in March.

One of the key elements of the market is the constant need for innovation in producing new form types  from patches and gum to inhalators, microtabs and, most recently, lozenges. The trend stems from the consumer driven OTC market, where well-intentioned quitters try one formulation, fail, and move onto another form for their next attempt.

GSK's recent campaign to promote its new lozenge range was an example of the power of a good media PR campaign. Claire says: "We have seen successes where form types have been second to market, such as the NiQuitin CQ lozenge, but have still been characterised by significant success, perhaps driven by the level of media coverage gained."

The company has also suffered at the hands of the media, however, with UK prescriptions of Zyban badly hit by reports of serious and sometimes fatal side-effects linked to its use. Reassurances from the MCA of its safety when administered correctly to appropriate patients have not lifted its fortunes considerably, and NRT is still seen as the safest and most convenient option.

All of the competing products share an identical active ingredient  nicotine  and so in that sense fall into the category of branded generics. Thus, if a company sales rep can persuade a GP to write a brand name instead of simply nicotine gum 2mg, their product is guaranteed to be dispensed by the pharmacist.

Growth in prescriptions written generically was double that for any branded product in the year to September, and so the companies must also try to persuade pharmacists in receipt of these generic prescriptions to dispense their product.

But the immaturity of the prescription market, and the changing dynamic in relation to its OTC twin makes the field an unexplored territory. "The only certainty in the NRT market is that it will continue to change," says Claire.

The companies are still sussing it out and they have to keep their options open. What's going to be exciting is when a company takes a product and looks at it as one brand  its the same pack, unlike most prescription/OTC products.

The planned Pfizer/Pharmacia merger could also create a new marketing force to be reckoned with. "It will be interesting to see the impact Pfizer could make on Nicorette given the level of promotional resource they could leverage," says Claire.

However the market develops in the future, NRT marketers, like those promoting coronary heart disease products, know their products will play an intrinsic role in delivering the NHS's top health improvement targets.

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