From surgery to pharmacy
pharmafile | October 12, 2006 | Feature | Sales and Marketing |Â Â P, POM, marketing, reclassification, salesÂ
Driven by a change in criteria and the success of major switches such as the launch of the first over-the-counter (OTC) statin, the pharmaceutical switch landscape has opened up in recent years, embracing Rx-to-OTC strategies as a key means of squeezing precious drops of extra value from a products lifecycle. With the increasing importance of switching has come an equivalent acceleration in marketing efforts surrounding switched medicines. Both the promotion of switched products and attempts to raise awareness of status changes have stepped up a gear yet key challenges and unique dilemmas in the marketing of Rx-to-OTC medicines remain
Rx-to-OTC or POM-to-P (prescription only medicine to pharmacy) switching has enjoyed considerable success in recent years, fuelled by empowered consumers taking greater interest in their own health and encouraged by stakeholders and governments actively encouraging self-medication to control and cut costs. In its recent report called Rx-to-OTC Switching Strategies, Business Insights analysed both the current and future global environment for switches, recording a 0.9% growth in OTC product sales in the UK in 2004.
With statins, proton pump inhibitors and triptans having already made their OTC debut, other likely candidates, such as oral contraceptive pills and dermatological treatments, await their curtain call. Other products scheduled for switch in the UK include third-generation proton pump inhibitors like lansoprazole, whose marketing thrust will hinge on careful competitive attack against already-available OTC omeprazole.
To switch or not to switch?
The question 'why switch?' is usually answered with one resounding reason lifecycle extension in the face of looming patent expiration. Cutting Edge Information (CEI) acknowledges that, when implemented correctly, OTC switches can prove a viable generic defence strategy. Timing is critical to success and market share must be shifted to the OTC product before the key patent expires, thus making the market an inhospitable landscape for both branded and generic competitors.
Despite the seemingly simple thinking behind the decision to switch, an Rx-to-OTC transition can also sometimes form part of a more complex strategy, one that additionally involves other company assets. According to Business Insights, the two most important criteria determining switch success are product differentiation and timing. While the fundamental pharmacology of a molecule cannot be changed, its OTC appeal can be increased. This can be achieved through modifications such as dose strength, added ingredients, dosage form, packaging, new or added indications and performance claims.
In some instances, the impetus to switch is exerted from the outside for example, if a key competitor is moving towards OTC status. Equally, in the US, the FDA may force a product or class towards the pharmacy if it decides the public stands to benefit from such a switch.
"But just because a product has superb medical efficacy or heritage does not mean that it will automatically become a successful switch product," warns Paul Jarman, Managing Director of marketing communications company, Ozone Communications.
"The strongest opportunities will demonstrate clear symptomatic relief, uncomplicated use and applications, few contraindications and side effects and, importantly, a big potential consumer audience."
"There are many many classes of drug that are simply not suited for OTC status," adds Greg Bolesh, Research Team Leader at CEI. "Only drugs that treat easily recognized conditions, can be safely administered by untrained individuals and have minimal risk of side-effects are appropriate for OTC status. The complexity of modern drugs means that the majority of brands will live and die as POMs."
Know your customer
Overall, it seems that assessing consumer need is the essential step to take before deciding to take a switch forward. Linda Alstead, Communications Director at TNS Healthcare in the UK, points to a number of recent switches that have proved less successful than envisaged because the brands in question entered an already satisfied and congested market, and the new entrant found it difficult to differentiate itself clearly from the existing products.
Issues are additionally presented by areas where switching could be regarded as inappropriate or undesirable. Despite the listing of conditions such as contraception, asthma and high blood pressure in the MHRA/RPS 2002 suggested switch list, pharma has preferred to stick to its prescription domain in these areas. "Perhaps the slow uptake by the industry demonstrates that, while the theory is sound, in practice there are lots of barriers in place that have made switching difficult for regulatory or commercial reasons," says Alstead, adding that the jury is still out regarding the commercial viability of switching in many of these areas.
When it comes to wielding marketing muscle to promote switches, the key to success appears to lie with employing all the old essential elements, but newly aligned to the nascent consumer audience. The expected commercial value of the brand must also be borne in mind and the old adage of know your customer seems particularly pertinent where switches are concerned. "The product has to satisfy a consumer need either real or perceived," continues Alstead. "It is not enough to assume that a big Rx brand will automatically have consumers beating a path to its door. Do your homework and find out what people need from treatment of this condition. These brands are not in any sense aspirational so there can be no room for trying to deliver a want, it must be a real need."
"Where the promotion of OTC switches are concerned, size isnt everything. Few OTCs warrant the use of large-scale above-the-line campaigns and many of the most profitable consumer brands build up to success slowly by building HCP support, then gradually moving consumers along the confidence chain to feel comfortable with selecting the right brand for themselves."
As always, the opted-for approach will ultimately depend on budgets, market potential and experience. Above all, Paul Jarman believes that the earlier a single-minded focus is adopted, the better on the proposition, the phraseology and the key messages. He says: "PR and opinion leader development, along with training, are key pre-launch and at launch where above the line kicks in. In some particular treatment areas, the development of word of mouth or advocacy programmes can be an exceptionally powerful tool."
Mark Spedding, director of the strategic research consultancy, Insight Research Group, agrees that the tone of communication to the public is a key issue. When promoting switched medicines, it is important not to negate the role of doctors and always ensure that consumers remain fully informed and health aware. Greg Bolesh agrees, adding: "Consumer advertising may come into play if the product has a high enough profile or is otherwise suited to mass marketing. In these cases, you may see magazine ads and television spots, coupon campaigns and even websites set up to drive consumer loyalty."
Pharmacy friendly
As obvious as it seems, when marketing POM-to-P products, pharma can ill afford to overlook the primary power players pharmacists. Says Mark Speeding: "Most prescription pharma companies are aware of the need for advertising a switched product to the public, but they may be less attuned to whats needed in the pharmacy itself."
"For example, what they need to communicate to pharmacists and shop staff, when they need to do it, what training and support might be needed, setting a price that will incentivise use and thinking about materials to promote the brand within the shop, such as display stands, shelf-enders, table-toppers and other point-of-sale materials."
The view is echoed by Alstead: "Early investment is best spent at the pharmacy. Ensure pharmacists are happy and comfortable recommending, then move on to consumer campaigns later."
Overall, it makes sense for a company to continue to target all those specialists responsible for making patients aware of OTC treatment options, as Bolesh points out: "Dentists are prime targets in the marketing of OTC dental products."
According to Alstead, pricing is also a sensitive issue for OTCs. "The optimal approach requires a fine balance between establishing an OTC price that doesn't undermine the prescription brand, while not alienating the consumer through overly high pricing."
The main challenges associated with marketing a switch product fall into two broad categories those related to the pharmacy and those stemming from consumer considerations. In Jarman's opinion, the key pharmacy challenge lies with gaining the vital acceptance and support that will follow through into sales. Where consumers are concerned, high hurdles to be overcome include the motivation and mobilisation of early adopters or advocacy groups, methods to enhance understanding of the product and its properties, and attempts to make the medicine relevant within a general culture of wellness.
Promoting switched products to the pharmacist fraternity poses its own particular problems due to the unique part played by this HCP group. Spedding describes the challenge as "understanding that pharmacists have very specific needs which only partially overlap with GPs and which can seem contradictory for example, tension between the provision of care and maximisation of profits."
Counting the cost
As always, cost is an issue, as Alstead points out: "The single most important challenge is how to find ways of promoting an OTC launch without causing profitability problems for the brand in its early life. Blanket consumer advertising is often prohibitively expensive and has become more fragmented in terms of audience, so clever, cost-efficient ways of hitting consumers with clear messages that will motivate a trip to the pharmacy are vital. But, of course, these are not easy to engineer."
Even before marketing comes into play, awareness, or rather lack of it, has the potential to cripple a POM-to-P products chances of success. Bolesh says: "The main problem is awareness among both physicians and consumers, so the company launches a two-pronged communications campaign. Theyll use mass market techniques such as radio, print and TV ads and may also use more targeted approaches, such as doctor detailing, with reps repeatedly discussing the pending switch, and work with patient advocacy groups who will help spread the word."
The name game
Where naming switched medicines is concerned, for many products, the decision to stick with tried and tested brand identity is a non-starter. As Tufts states in its Outlook 2005 report, pharmaceutical firms see voluntary switches as a lucrative way to extend brand name viability.
According to Alstead, most switch-related brand dilemmas are resolved through compromise, with switched products carrying a derived name based on the Rx brand, but with an additional component to distinguish it from its prescribed form. Indeed, this is more or less mandatory across Europe due to the complex legislation surrounding the promotion of medications to consumers. Alstead describes how, in most European countries, brands promoted directly to consumers through advertising cannot be reimbursed via the state health system, hence it is not commercially viable to use exactly the same name because this would, in effect, either prevent promotion of the OTC or kill the prescription sales of the brand.
Yet there are some exceptions to these naming nuances. In the UK, Gaviscon carries the same name in both its Rx and OTC incarnations, and the OTC product can be advertised. Now, however, the UKs regulatory authorities are demanding that all switch applications bear a derivative name for new POM-to-P product transitions.
Aside from the legislative wrangles over names, the importance of branding is equally true for a switched product as for its Rx cousin. Jarman says: "Switch products are no longer medicines in the marketing sense, but consumer products that have to attract the attention off the shelf and in advertising and other communications. Clear, strong branding that resonates with consumers is key, and research and refinement with consumer groups is essential".
When it comes to OTC branding, Spedding believes the best bet is to start afresh. "Uptake of switched brands is driven by consumers whose response to promotion is entirely different from healthcare professionals. Promotion may have to be less self-important and more downmarket. Zantac is a good example of this. You dont even have to keep the same brand name everyone knows Nurofen but who remembers Brufen?"
Alstead admits that, although the use of an Rx name wont necessarily be of any benefit in the consumer market, it is a brave marketer who decides to move completely away from the prescription branding that is, unless the company boasts the benefits conferred on it by a pre-existing consumer brand umbrella under which the switched molecule could fit.
Overall, it seems unlikely that the current enthusiasm for switching will be dampened any time soon. When it comes to making the most of these switch opportunities, pharma is dependent on a rich mix of savvy, strategy and, ultimately, cold hard cash.
"If theres enough marketing muscle i.e. money behind the switch, its not such an uphill slog," concludes Bolesh.
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