How Pfizer Achieved 'Switch Success' With Viagra and Nexium
Executive Summary
Pfizer secured two of the biggest prescription-to-OTC switches in recent years with the reclassification of Viagra and Nexium. Michelle Riddalls, Pfizer's director of regulatory affairs in Europe, offers her advice to firms looking to emulate this 'switch success'.
Market readiness, company capabilities and selecting a product with the right attributes are the three most important factors for securing a successful prescription-to-OTC switch, says Pfizer Inc.’s director of regulatory affairs for its Northern European cluster, Michelle Riddalls.
At the recent 13th Annual Ceuta International Alliance Conference in London, Riddalls told delegates that Pfizer had enjoyed “switch success” with the reclassification of Viagra Connect in the UK last year and Nexium Control EU-wide through the centralized procedure in 2013, by concentrating its efforts on these three factors.
Firms looking to achieve similar success to Pfizer, Riddalls suggested, had to make sure they had selected the right candidate to switch; had identified the appropriate market for the application; and, importantly, had the internal know-how and commitment to see the process through.
Meet Unmet Need
Beginning with product attributes, Riddalls said firms had to make sure their switch candidate met “an unmet consumer need”.
“There needs be a gap in the market in the OTC world which isn’t being fulfilled,” she advised. “Generally, the medicine has to be simple to use, you don’t want a very intricate posology or indication that complicates things and makes it hard for a consumer to understand.”
Furthermore, the substance had to be delivered in an appropriate dosage form, “as injectable medicines can’t usually be pharmacy medicines,” Riddalls pointed out, and needed to have an “acceptable safety profile and positive benefit risk assessment”.
A switch candidate that already had brand recognition as a prescription medicine – as was the case with both Viagra Connect and Nexium Control – gave it a better chance of commercial success, she noted.
To maximise the investment made behind the switch application it was also important to have a potential pipeline to expand the brand, Riddalls said, highlighting as an example Pfizer’s Nexium Control Mini-Capsules line extension launched last year.
Once a company was certain it had a promising switch candidate, it was vital to have in-house a “really good medical and safety department, on both the prescription side and the consumer side”, Riddalls said.
“The prescription side will hold all of the knowledge of the product,” she noted, “but you need the consumer side to translate that information and work out what’s going to work from an OTC perspective to make sure it’s a viable proposition in the market. And that can mean narrowing down a really wide indication, or changing the population involved.”
Supporting regulatory specialists, it was imperative to have a good government and corporate affairs team, Riddalls explained, to interact with key opinion leaders and professional bodies, as well as “specialized” marketing and sales teams to take the product to market once switched.
“It’s no good just having a prescription sales team who are used to detailing doctors, you need people that are used to retail, trade, and talking to pharmacists,” she insisted. “It’s always helpful if the product is in the company core capabilities – so it’s a product that you know about and you’ve got experience with.”
"If the market isn’t ready, you’re not going to be able to switch the product." -- Michelle Riddalls, Pfizer's Northern Europe regulatory affairs director
With the right candidate selected and a strong team in place, the next piece of the jigsaw, Riddalls said, was identifying the most appropriate market or markets for the switch. “You can have the greatest product and your company can be ready to go, but if the market isn’t ready, you’re not going to be able to switch the product,” she insisted. “And that can happen in a number of different ways, there can be many barriers to switch.”
One of the biggest potential barriers, Riddalls pointed out, were the medicines regulators themselves. “If the regulators don't believe that a product is viable in the self-care arena for a particular condition, then it’s unlikely you’ll be able to persuade them that it’s a positive move and to get the switch approved,” she observed. “You can provide data but sometimes there are set beliefs held by some of the authorities.”
For firms looking to switch, it was “really important” to ensure that the regulator in the selected market accepted that the substance addressed a condition that could be treated in a self-care environment, Riddalls noted.
Pharmacist Training Key
But gaining regulatory approval was not the final hurdle, Riddalls warned. “The regulators may have said yes [to the reclassification] but if the pharmacist doesn’t feel confident in supplying that product, you’re not going to achieve switch success.”
Training was key, Riddalls believed, to getting pharmacists to support a switch. “Pfizer has put a big emphasis on training pharmacists adequately to make sure they understand the product and have confidence in supplying it to consumers in a safe way,” she revealed.
From Pfizer’s point-of-view, securing successful switches could not only help to extend the life of a brand, Riddalls noted, but also offered a “very good public health benefit”, reducing healthcare costs and enabling consumers to “take control of their own conditions”.