Reducing POM to P headaches

pharmafile | October 12, 2005 | Feature | Sales and Marketing |   

Following an eight-week period of public consultation, the Committee on Safety of Medicines is to shortly advise health ministers about making the UK's two best-selling prescription-only migraine treatments available over-the-counter.

This is just the latest move in the expansion of POM to P switches that, since new guidelines came into force in 2002, shows no signs of abating.

In its final report in March 2001, The Pharmaceutical Industry Competitiveness Task Force (PICTF) agreed the process for reclassifying prescription-only medicines should be streamlined. The new process was intended to make the whole process quicker and easier for pharma companies and allow them to better plan their switches.

NHS impetus for greater switches

The enthusiasm of the joint industry and ministerial group PICTIF for improving the switch process was also picked up by the NHS, which also thought it a good idea if patient safety could be assured. For the NHS there are obvious financial reasons for encouraging POM to P switches as they lower prescription numbers and thus the health services cost burden. While those of a slightly cynical nature might see some behind the scenes pressure at work to encourage the process for financial reasons, there was nonetheless a genuine feeling that pharmacists were being underutilised.

About 30% of GP consultations tend to be for minor or self-limiting conditions, areas that pharmacists could easily step into. Dr John Blenkinsopp, partner at switching specialists Blenkinsopp Pharma Consultancy says: "There is a body of patients who are quite happy to have many of their medical conditions managed by a non-GP healthcare professional or even themselves. This includes both short-term and long-term conditions."

Prior to PICTIF's reports the government's NHS Plan in 2000 outlined its aim to make more medicines available over-the-counter in order to widen access to medicines and patient choice by 2002. As part of the reclassification project the Royal Pharmaceutical Society of Great Britain was asked to take the lead in identifying potential therapeutic categories suitable for reclassification.

The list contained all the therapeutic categories and product groups the RPSGB identified as worthy of consideration for POM to P reclassification. The Society noted that the list did not necessarily indicate those products most suitable for reclassification and added that the safety profile for each product would need to be considered.

Erring on the side of inclusiveness, the list featured hormone replacement therapy, flu treatments, Viagra and even Cox-IIs like Celebrex and Vioxx, the latter withdrawn last year after serious side-effects emerged. As GlaxoSmithKline Consumer Health's director of innovation Francis Crewdson notes, the list contained "practically everything that's on prescription at the moment and isn't available OTC".

Further momentum was then added when former health secretary John Reid in August 2003's Building on the Best set the MHRA a target of doubling the rate of switches, both POM to P and P to GSL, to ten a year  the first time a target has been set for the number of switches to be approved.

Since then POM to P switches have garnered greater publicity with two landmark switches in 2004. Simvastatin was launched as Johnson & Johnson MSD's Zocor Heart-Pro and the world's first over-the-counter statin drug and GlaxoSmithKline launched Zanprol (omeprazole), formerly marketed by AstraZeneca as its blockbuster Losec. The numbers hover around John Reid's target of ten a year with nine in 2004 and seven so far this year.

Zanprol

AstraZeneca launched omeprazole in 1987 as Losec and it went on to become the biggest-selling drug of all time in the late 1990s. But once a product's molecule comes off patent, anyone can apply to switch it, not just the patent holder. Losec lost patent protection in 2002 and the next year Galpharm applied to switch a 10mg dosage of omeprazole from POM to P status.

But the Anglo-Swedish company chose not to pursue an OTC licence in the UK following Losec's patent expiry in 2002. AstraZeneca UK was understood to have rejected the idea of launching an OTC version of Losec, concerned that it might cannibalise UK prescription sales of its follow-up drug Nexium.

GSK was duly waiting in the wings – as Pharmafocus was the first to reveal back in November 2003 – and launched AstraZeneca's former blockbuster as part of its own OTC Zantac brand range under the name of Zanprol. With Galpharm's record in POM to P switches GSK were able to use it as a stalking horse, as one industry commentator termed it.

Zocor Heart-Pro

The launch of Zocor Heart-Pro in July 2004 made it the world's first over-the-counter statin and perhaps the highest profile POM to P switch to date. This is almost certainly the case if press headlines are anything to go by. Zocor was the biggest-selling prescription drug in the UK in 2003 but, unlike AstraZeneca with Losec, Zocor's manufacturer Merck Sharpe & Dohme did want to take it OTC themselves and teamed up with Johnson & Johnson to switch the product, which hit UK pharmacy shelves in July last year.

Johnson & Johnson MSD – the company formed to handle the switch – has been renamed McNeil Limited. Product manager Nicola Sunshine said: "The launch of Zocor Heart-Pro was a major step forward for both pharmacy and the provision of self-care. Our research shows that many pharmacists are really embracing the challenge. What is clear is that those taking the initiative and being proactive are seeing greater success."

McNeil's communications strategy for the cholesterol-lowering Zocor Heart-Pro centred on how to beat and treat heart disease. There are about eight million people in the UK who are classed as having a moderate risk of heart attack, but the challenge for pharmacists and pharma companies alike is that those at risk are currently walking around feeling perfectly well. McNeil's message for the new product was that it was the most effective thing people at risk could take to reduce cholesterol.

Paul Jarman, managing director of Ozone, who worked with McNeil on Zocor Heart-Pros launch, says: "We spent a lot of time focusing on the pharmacy sector as the product was becoming available, to get them used to it and how it would have to be recommended and sold and the benefits of this to pharmacy."

McNeil spent a huge amount of time and effort preparing the marketing and then detailing the product post-launch. The product gave pharmacists a new role in their interaction with customers and as such McNeil and Ozone developed materials such as certified Continuing Professional Development programmes through the pharmacy press.

Given the ground-breaking nature of the switch, there was ample national and trade press coverage so consumer media niches were targeted and a CRM programme developed. The Healthy Heart programme was an educational vehicle with its own website with national newspaper ads to encourage people to join up. It was intended to educate the consumer about the benefits of lowering their cholesterol and thus lowering their risk of heart attack.

Further consumer involvement was sought through Boots the chemist's nationwide Kick Cholesterol campaign, which was headed up by England rugby star Jonny Wilkinson and offered free cholesterol testing in stores. This in turn influenced sales predictions for what was still, from a consumer point of view, a very new sort of product.

Despite the amount of coverage, McNeil was realistic from the outset about how much change could be achieved in the short-term. "We believe that the expectations for this new category have been influenced by the vast amount of media attention given to the launch of Zocor Heart-Pro. Our expectations have always been more realistic as experience has shown that innovative POM to P switches take time to establish themselves," she said. She adds that sales of Zocor Heart-Pro have been in line with other POM-P switches in recent years.  

Switching triptans

The most recent switch concerns migraine treatments. The manufacturers of the UK's two best-selling prescription-only treatments have, coincidentally or otherwise, both applied for approval to the MHRA to switch their products at the same time.

The regulator has received applications from GlaxoSmithKline Consumer Health for Imigran (sumatriptan) 50mg tablets and AstraZeneca for Zomig (zolmitriptan) 2.5mg to reclassify their prescription status.

Imigran and Zomig have been available on prescription in the UK since 1991 and 1997 respectively and have well-established safety profiles, vital given that patient safety is the MHRA's primary consideration for switches.

Migraine affects approximately 10-15% of adults and can last from several hours up to three or more days. It is best to treat them as early as possible, hence the rationale for making the two triptans available through a pharmacy for quicker patient access.

Both products will be limited to a pack size of two tablets and no more than four OTC packs can be dispensed in a single month in order to reduce the risk of overdose. Patients requiring more than four packs will be referred to a doctor.

If it goes ahead, the switch will require pharmacists to undertake additional training on the characteristics and management of migraine and in the use of triptans.

"But you have to realise that pharmacists have been diagnosing migraine for ages because there are existing products out there that claim to be migraine specific, although they are just analgesics," comments GSK's Crewdson.

According to Blenkinsopp, training must be targeted towards both pharmacists and their counter staff and it is vital to get the tone and content right. He suggests pharma companies use advisory boards as a way of testing this out.

"Pharmaceutical companies are getting better at identifying and providing the training requirements needed for switches, which fits in nicely with the MHRA's desire to see more and better pharmacist training put in place.

"According to my community pharmacy contacts the recent chloramphenicol switch is off to a flying start. Which proves that we are learning how to do this better as we progress towards more complex switches," he says.

AstraZeneca appears to be taking a more forward thinking approach to its switch, given the difference in their patent life expectancies. In contrast, the older Imigran looks to be pursuing a traditional product lifecycle approach where a switch is the last stage of the  lifecycle before patent expiry.

Although reluctant to reveal commercially sensitive information about her company's switching strategy for Imigran, GSK's Crewdson says: "We would be quite silly not to use the Imigran name, considering it's the market leader in prescription sales and is dispensed by pharmacists all the time, so there's a lot of heritage behind the brand."

Given that the rules and regulations surrounding switches forbid a switched product from keeping the exact same name it had as a prescription product, a similar name is allowable. As Zocor changed to Zocor Heart-Pro, so Imigran or Zomig might be branded as Imigran Migraine or Zomig Plus.

Switch approaches

According to Ozone's Paul Jarman, the approach a pharma company takes to switching a product depends on the type of product involved, but he says beyond this there is one fundamental to remember.

"The first thing to bear in mind is that you have to prepare a completely new environment for the drug coming from a GP-referred environment into one where there are more stakeholders involved," he says.

Within the industry different types of companies have taken different approaches to product switching. Big pharma for example has generally tended to view POM to P switches predominantly in terms of the final stage of a long-term lifecycle management strategy, which is why AstraZeneca's approach with Zomig stands out, although it could be argued that GSK's intentions with Imigran forced its hand in the matter.

Smaller pharma companies tend to take a more strategic point of view, perhaps looking for off-patent opportunities as with Galpharm and its application to switch omeprazole. Generics companies have recently joined the fray.

"Generics companies, such as Alpharma, who have applied for trimethoprim to be switched for uncomplicated female cystitis, have started to spot switch possibilities in their catalogue of POM licences. The generic companies take a different view of the process than big pharma who often see switches only in terms of being a problem with reduced margins," says Blenkinsopp. "Generics companies on the other hand can generally see more of a benefit to their bottom line by switching a product from POM to P than big pharma sometimes can."

Waiting for the avalanche

The predicted avalanche of products switching from POM to P in the wake of simvastatin may not have yet materialised, but steady progress continues to be made in improving patient access to medicines.

Ozone's Jarman says the switch of Zocor was a great opportunity. "But, as with any switch there are people who have other agendas and are opposed to it. On the one hand you have the huge public health benefit and support from ministers, the Department of Health and the Royal Pharmacy Colleges and then there are other organisations that have a different perspective."

One of the organisations with a different perspective was the Consumers Association. In its written evidence to the Health Select Committee last year the CA said: "The medicines reclassification process illustrates the conflicts of interest, lack of transparency and lack of accountability prevalent in the regulatory system. Reclassification is driven by industry demands and produces clear benefits for the industry. The benefits to the public are often less certain. We are concerned that insufficient regard is paid to the public interest and that the efficacy and long-term safety of reclassified drugs is not sufficiently evaluated."

Where will the next big name switches come from? It was suggested that asthma and hypertension could be next in line, but the pharma companies who were looking at these therapy areas seem to have been were frightened off by the coverage generated by the switch of simvastatin. Generics companies have taken their place and switches in these areas are still ongoing.

There is plenty of room for new opportunities. Crewdson says GSK is looking at a number of future areas, all in the RPSGB's 2002 list. "Everybody would be looking at those opportunities in terms of possible switch opportunities. Obviously we'd look to do stuff where we have expertise too," she said.