The U.K.'s bullish Rx-to-OTC switch environment can make it an attractive place to try a switch before pursuing the EU-wide centralized procedure, which contains more potential pitfalls, experts say.

But blockbuster switch products are hard to come by in the U.K., some warn.

The nation's pressing need to rein in health care spending has resulted in a push for Rx-to-OTC switches, according to pharma stakeholders.

"In the U.K., we have a very favorable environment for switches," said Helen Darracott, director of legal and regulatory affairs for OTC trade group the Proprietary Association of Great Britain.

"We have an awful lot of high-level political support very keen on expanding access," she said.

Darracott spoke on an industry panel at the Regulatory Affairs Professional Society annual conference in Philadelphia Sept. 16.

Panelists said the U.K. Medicines and Healthcare products Regulatory Agency and Department of Health encourage firms to seek nonprescription indications.

By shifting drugs to behind-the-counter pharmacy access, and then potentially further to general sales list status, the U.K. seeks to make self-care more convenient and relieve some of the cost pressures on its National Health Service, Darracott explained.

She cited smoking-cessation products, which switched in the U.K. in 1995, as an example of a product category that has expanded indications and formats, grown sales and positively impacted public health. She said the products contributed to the greater-than-expected decrease in heart attacks in England since a 2007 public smoking ban went into effect.

Joe McGovern, a consultant with experience in the U.S. and U.K., acknowledged that smoking-cessation switches have had success in the U.K. McGovern, who did not present at the RAPS conference, said in an interview that "there may be an embarrassment factor in going to the doctor" to stop smoking.

For other health issues, however, the British have less incentive to purchase nonprescription drugs out-of-pocket rather than go to the doctor, a free resource, he said. Because U.K. law allows drugs to be both Rx and OTC simultaneously, consumers have access to a vast array of treatments through NHS for minimal co-pay.

"The U.K. makes it easier to switch, but they haven't got it right yet in enabling people to self-treat their conditions," said McGovern, of the Atlantis Group consultancy in Doylestown, Pa.

"In a sense, it's still easier to go to the doctor, even though there's more drugs OTC in the U.K." than in the U.S., he added.

Self-Care As Policy Or Culture

McGovern calls the U.K.'s attempt to solidify self-care as part of health care policy a "work in progress."

A 2005 Department of Health ¹ communication lays out strategies for encouraging self-care and acknowledges they can "be successfully embedded in the care system only if they are integrated in its routine business and have the full backing of care professionals, practitioners and managers."

The Pharmaceutical Services Negotiating Committee and PAGB in 2008 called for a National Minor Ailment Program, to encourage consumers to take self-treatable conditions to pharmacists rather than doctors. Treatment of minor ailments costs NHS 2 billion U.K. pounds ($3.25 billion) annually, the groups said.

In the U.S., the lack of a single-payer health care system, and in turn the higher price of professional care, indirectly has encouraged self-care and demand for OTC drugs, McGovern said. For this reason, he said he expects American consumers would benefit from and understand how to use switched products - such as an OTC statin for lowering cholesterol.

Johnson & Johnson's Zocor Heart-Pro (simvastatin 10 mg) has been less successful than predicted in the U.K. since its switch to pharmacy status in 2004 (² 'The Tan Sheet' March 20, 2006, In Brief).

"The market really just was not ready" for a nonprescription statin, Darracott said, adding that U.K. consumers do not feel comfortable treating themselves for a serious and asymptomatic condition.

Having a pharmacist as a learned intermediary also has not helped Zocor, since neither U.K. pharmacists nor health care professionals support the switched product, she maintained. Many consider the 10-mg dose sub-therapeutic (³ Also see "UK Switch Plan Questioned As European Role Model" - Pink Sheet, 13 June, 2005.).

In contrast, meanwhile, the switch of Clamelle (azithromycin), Actavis' oral antibiotic to treat Chlamydia, has had success in pharmacy sales since switching in 2008. Consumers aged 16 years and older can purchase a test for the sexually transmitted disease and subsequently purchase Clamelle without a prescription if the NHS testing service returns a positive result (⁴ 'The Tan Sheet' Aug. 11, 2008, In Brief).

Actavis "really hit at the right moment in time" with the switch, Darracott said, adding Clamelle has been embraced by both teenagers and pharmacists.

Challenge Of Continental Switch

Switching through the European Commission offers sponsors a consolidated approach to bringing a nonprescription drug to 27 markets. However, the EC's centralized switch process remains far from a sure thing, the experts acknowledge.

The European Medicines Agency's Committee for Medicinal Products for Human Use has approved EU-wide nonprescription status for GlaxoSmithKline's weight-loss drug alli (orlistat) and is expected to clear Nycomed's proton pump inhibitor Pantozol Control (pantoprazole) (⁵ Also see "European OTC Industry Prescribes Key Role For Pharmacists" - Pink Sheet, 22 June, 2009.).

Stephen Champion, who had a hand in the alli switch as VP of European regulatory affairs for GSK Consumer Healthcare, said at RAPS the contrast between the U.K. and other EU member states sitting on CHMP is often striking when it comes to switch.

While the U.K. tends toward self-care and public health initiatives, "you've got other countries with a much more social background - Spain, Italy, France - that have a different philosophy to making products available, and yet you have to come to a consensus" on a switch application, he said.

Language can pose another barrier, Champion said. Switch sponsors making a case before CHMP should be prepared with 21 translations of printed materials. Additionally, the drug's brand name should be vetted to ensure it translates benignly in other languages.

"You get this dichotomy between the agency saying I need a name that doesn't have a meaning [and] that doesn't confuse people with different languages. Yet, we want a brand name that actually attracts and brings consumers in," Champion added.

Following a product switch, challenges remain in ensuring that advertising and distribution conform to member state regulations. Once CHMP confers the centralized nonprescription status on a product, "it's up to the individual countries to say, 'What does that actually mean and what can I do?'" Champion said.

McGovern said he advises against trying for centralized switch for all but the most non-controversial drugs. Rather, he recommends taking a country-by-country approach, applying to switch first in more liberal EU members - such as Germany, Ireland and the Netherlands as well as the U.K.

Pfizer's failure to switch Viagra (sildenafil) through CHMP demonstrated the challenge of addressing controversial issues to the satisfaction of all EU member states. Pfizer withdrew its switch application for a 50-mg dose of the erectile dysfunction drug in November 2008 (⁶ Also see "Pfizer Pulls Back On European Viagra Switch As Questions Linger" - Pink Sheet, 24 November, 2008.).

How U.S. Switch Measures Up

If the British once looked to the U.S. for guidance on Rx-to-OTC switch, they now "consider themselves to go down their own road," Champion said. He acknowledged, though, that data from FDA remain helpful, as in the case of alli.

The RAPS presenters noted that generating sufficient data to support a switch in the EU, especially the U.K., is less onerous and costly than in the U.S. For example, while label comprehension and actual use trials in the U.S. involve hundreds of participants at multiple levels of literacy, EU agencies generally accept label comprehension results from 20 subject consumers.

In switching through CHMP, a sponsor is allotted around 30 minutes to present at the committee's packed monthly meeting. In the U.S., the opportunity to argue for a switch before an FDA advisory committee allows for more discussion, but at a steep price.

"The market size opportunity in the U.S. is so much bigger, but the cost of getting there is huge," said another RAPS presenter, Sue James, VP of worldwide regulatory affairs, compliance and quality for GSK Consumer Healthcare.

"When you look at the AUTs, the label comprehension and the cost of running an advisory committee meeting is huge, whereas in Europe, the label comp is 20 people. You may have to do it more than once, but even so," she said.

- Dan Schiff ( ⁷ d.schiff@elsevier.com )

Switch Environment Makes U.K. A Sound Warm-up For Centralized Switch

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