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Zocor and the high street revolution

Published on 04/01/05 at 10:05am

It's an exciting time for consumer healthcare divisions in the pharma industry. Two years ago, the Department of Health (DH) set out a list of proposals intended to speed up the time it took to switch pharma products from prescription only (POM) status to pharmacy (P) status.

The message from the then health minister Lord Hunt was clear: the government wanted to see more high profile prescription medicines being made available on the shelves of pharmacies as part of a push to make the public more aware of self medication.

Included in the government's list of selected candidates for POM to P reclassification were statins, hypertension treatments, PPIs and erectile dysfunction products. While the political and safety implications of getting some of the industry's biggest and best known prescription medicines out into the consumer market may have ruffled a few feathers within the medical community, the benefits of empowering patients outweighed the disadvantages.

Government opening up OTC opportunities

What was more, some within the industry believed the government was presenting them with an opportunity.

Suddenly, what had been traditionally viewed by many companies as an option limited to just a very small number of drugs in their post-patent product portfolios, had blossomed into a potentially lucrative means of maximising revenues.

Making the switch is no easy task, however. Any pharma marketer will tell you that successful POM to P transition requires a huge amount of groundwork, research, planning, organisation and innovation. Companies not only have to identify the product they want to sell and whether it fits into the completely different consumer market, but also their marketing capabilities and whether they can successfully align with the new and seemingly inhospitable market.

Independent health policy analyst Ray Rowden believes that as many as 70 POM treatments could make the switch to P status within the next few years, because of the Medicines and Healthcare products Regulatory Agency's (MHRA) recommendations. He says that the move towards a more liberal OTC arena is definitely a good thing for patients but is concerned that it has yet to be fully embraced by the industry.

"From talking to different companies, my initial impression is that there's a reluctance on the part of many companies to back the move to increase OTC switches," he reveals. "At the end of the day, the UK industry is still quite conservative and still not comfortable with change it perceives to be too radical."

Pharma industry cautious

This type of reticence is perhaps understandable. After all, regulatory authorities have been known to keep a very keen eye on previous OTC switch applications, as Tom Kass, head of biotech and investment services at EFG Private Bank explains.

Citing Bristol-Myers Squibb's application to the FDA in 2000 for OTC status for its statin Pravachol, he says that the regulator, amid safety concerns about liver failure, eventually turned it down, saying that the target age range of men over 35 and women over 45 for a 10mg dose was too low.

"The committee recommended that BMS further investigate why 27% of Rx lipid-lowering users participating in an actual use study said they would choose to treat themselves with non-prescription statins," he says.

"When you go OTC, suddenly the regulator becomes very concerned about the label and the language used in the marketing."

Zocor launch a test case

Of course, much of the headlines this year have been dominated by the launch of the world's first OTC statin, Johnson & Johnson MSD's Zocor Heart-Pro (simvastatin).

The drug, which was the UK's biggest selling prescription medicine in 2003, went on sale in late July 2004 and is already exceeding sales expectations. The Zocor launch is a test case for the new OTC environment of greater accessibility to medicines that the government is championing.

Despite all the razzmatazz, Rowden insists that companies will remain cautious, for the first couple of years at least.

"I think it will prove to be a 'watch and see' scenario," he says.

"Everyone will be monitoring what happens with Zocor commercially and how the market share is going. One thing that makes me laugh is that while some people will point out the safety concerns of making statins available over-the-counter, they seem to forget that globally, the public is buying erectile dysfunction drugs, minor tranquillisers and anti-anxiety products over the internet by the shedload. Switching to OTC status is a much safer way of accessing healthcare than over the internet."

Perhaps pharma companies are right to be cautious before diving head first into an OTC gold rush. After all, selling consumer healthcare products is an entirely different ball game. Whereas previously, POM products had a relatively small number of tried, tested and identifiable target customers who could more or less be sold to directly, pharmacy products have to be marketed to a much wider and more diverse audience.

Payback period longer

The marketing investment on POM products can usually be recouped after just two years from the initial launch splash - not so for OTC products, where the payback period is significantly longer and therefore requires a much more prolonged and sustained marketing assault.

"For OTC switches, the industry is going to have to start talking to a different set of communities," says Rowden.

"Traditionally, companies have marketed a product, whacked their field force out on the road to talk to GPs and doctors but now it is going to have to become far more subtle at talking to many more audiences, not least nurses and pharmacists, who are going to assume greater prescribing responsibilities over the next five years."

Karen Heather, marketing director at Johnson & Johnson MSD admits that the Zocor Heart-Pro launch has been far from simple. "Essentially the switch is the first in what will probably be a whole new category of switches and until Zocor had become available OTC, it had been impossible to walk into a pharmacist and buy anything to prevent yourself from having a heart attack," she says.

"That has set up a variety of issues on the consumer side. For example, despite the fact that there are over a million people in the UK currently taking statins, the awareness of this class of drug was zero, as it was for the name 'Zocor'. Even the awareness of cholesterol was mixed, with many members of the public questioning why they needed to take a drug to lower their levels. Others drew no direct link between cholesterol and heart attack."

New target market for Zocor

Another huge launch issue was the fact that Johnson & Johnson MSD was targeting a completely new group of perfectly healthy people as opposed to the prescription Zocor users, who naturally all had health problems.

"People are not walking into their local chemist saying they think they are going to have a heart attack in the next year and asking the pharmacist what they would recommend," says Heather.

"From the other side, pharmacists are not engaging in what is potentially a 'hard sell' discussion either. There's a huge balance in educating the target groups, but not to the point where people have so much information that it scares them and they run to the doctor. The doctor is not going to prescribe anything as they are not in the higher risk group."

The overt government backing of the Zocor launch has raised more than a few eyebrows. In fact, it would be fair to say that earlier this year when Health Secretary John Reid was talking to the press, one could be forgiven for thinking that it was the government putting the product on pharmacy shelves rather than a pharma company.

Rowden says the government's motive behind its backing of the campaign is essentially about easy access to medicines.

"According to the traditional route, a patient's only way into any kind of disease management was via the GP and to put it bluntly you don't need a medical degree to do a lot of his work in terms of long-term management. The government's backing is about broadening possibilities and making medicines access better for patients."

He also points to the backlog of evidence that suggests non-doctor prescribers, such as pharmacists, are actually very cautious and careful prescribers. "When nurse prescribing came in under John Major, everybody said the bills would go through the roof," he says. "As a matter of fact, they did not, and in many cases, they actually went down."

Government backing

Heather is philosophical about how much credit the government should take for backing the Zocor launch. "Obviously the government got behind the launch and there was a certain amount of noise generated by John Reid quite early on in the process," she says.

"But at the end of the day, whether the switch went ahead or not was not down to the government but instead to the switch file that was submitted to the MHRA. The Committee on Safety of Medicines (CSM) had to decide whether the protocols we were suggesting were appropriate, whether the drug was safe to use and whether it was the right target group to go for. Our switch got through on the merits of the actual application that went in and we're very comfortable with the way that the MHRA worked closely with us to enable that."

For any POM to P switch, a training document with a product-specific outline of the areas and topics that need to be covered in training materials for pharmacists and support staff, has to be submitted to the MHRA.

Fawz Farhan, pharmacist and co-director of Mediapharm, explains: "Education and training is a fundamental part of POM to P switches. In essence, a switch cannot happen unless there is clear guidance on the training that will be produced to support the product launch."

Farhan says that a robust training document is one of the key criteria for successful submission to the MHRA and POM to P approval.

Compliance problems

Of course, safety issues do not go away once a medicine has been approved for OTC status. One of the major concerns of any OTC switch is compliance: without the presence of GPs to monitor the situation, patients have to be trusted to stick to their treatment and the correct dose by themselves. Kass believes that the government's desire to subtly nudge more POM to P switches could end up backfiring on them one day.

"The big question is: 'How do you control compliance?'" he says. "Virtually all drugs have side-effects and companies have got to make sure that people within the advising community, like pharmacists, are well detailed and repped. Companies are going to need a big post-marketing risk assessment on their OTC switches and to be able to show the regulators that they are monitoring the situation as closely as they can."

Heather says Johnson & Johnson MSD takes the issue of compliance very seriously. "Compliance is an issue in the Rx arena and we would be naive to think that it wouldn't be the same in the OTC arena," she says. "Certainly the people who are going to be taking Zocor OTC will be given a lot more information."

The company has also set up an information website (www.heartpro.co.uk) which provides OTC users with information that would not usually be given to prescription users such as exercise and smoking cessation programmes.

Heather suggests that there is also good reason to hope that the OTC user is likely to be more compliant than POM users.

"OTC users are generally more motivated as they have bought the product with their own money. With the extra backup support we're providing, we would hope the compliance would be even higher," she says.

OTC gold rush?

But with the successful launch of Zocor, will we see a flood of future OTC products breaking down the doors, making chronic disease management a process patients take care of from the privacy of their homes, without bothering overburdened GPs?

"One thing that could slow down future OTC switches is the fact that products will never get the go-ahead unless they have been well tried and tested out in the prescription only market," says Rowden. "So in that sense, I don't see any 'new' products making it."

Heather believes there will be follow-up switches but where they come from is anybody's guess. "A lot of the drugs that have been identified are generic products. It will be interesting to see whether generic companies will be prepared to switch. I don't think that many will as switching is one thing; whether you can make an ongoing commercial success of the product is another."

Rowden states that, in the broader scheme of things, a more liberal OTC market in the future is connected to the whole question of dear old direct-to-consumer and how much companies operating in the UK will be allowed to talk directly to patients.

"I do see a time in the not too distant future when it will come," he says. "We live in a consumer age and there's no putting the genie back in the bottle now."

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