Despite Lipitor Setback, Future for Switches Remains Bright

While quarterly earnings reports are not often cause for excitement in the consumer health industry, Pfizer’s recent second-quarter conference held the promise of a potentially industry-shifting announcement. Though the buzzing rumours of a new mega-merger had largely died off, it was widely believed the company would announce the results of its Phase 3 trial for over-the-counter (OTC) Lipitor (atorvastatin, 10 mg). A positive outcome could help usher one of the most successful prescription drugs in history into the OTC market. Unfortunately for Pfizer, the study did not demonstrate patient compliance, and the company terminated it after feedback from the US Food and Drug Administration (FDA). Though that potential blockbuster OTC drug may never come to fruition, consumer demands for innovative, efficacious products, advancements in mass health literacy and the desire of insurers and regulators to shift the burden of cost continue to pave the way for future prescription (Rx)-to-OTC switches. Though the sun may have set on OTC Lipitor, the future remains bright for switches.

Regulators increasingly open to switches

As governmental bodies – generally either the ministry of health or national insurance scheme – are heavily involved in the purchase of prescription drugs throughout much of the world, it comes as no surprise that a growing number of countries are exploring new Rx-to-OTC switch opportunities. The combination of growing and/or aging populations and the increasing prevalence of expensive non-communicable chronic diseases like obesity and diabetes provide strong incentive to focus limited resources on high-impact health concerns, while trying to shift spending on basic remedies. In this vein, some national regulators have moved to increase the breadth of drugs available OTC.

In early 2015, Japanese media outlet Nikkei Asian Review reported that the country’s health ministry is considering soliciting input from both consumers and health insurers on prescription drugs that could be switched. It represents a bold departure from the current system, which requires a drug producer to petition the government for a change of status. With the nearly US$19 billion Japanese consumer health market struggling through a decade-long stretch of near zero growth, further OTC switches could provide a much needed spark for the industry. According to Japan’s National Federation of Health Insurance Societies, switching six basic remedies, including digestive remedies like proton pump inhibitors, could shift nearly US$1.3 billion a year to private spending.

Pushback from insurance companies could play an increasingly important role in switches in the future. In major prescription drug markets like the US, large pharmacy benefit managers have become increasingly aggressive in dropping big-name drugs that have lost patent protection. By essentially mandating generic usage (the patients are generally to pay for the entire cost of the medication out-of-pocket, if they want the more expensive, branded version), the changes could potentially magnify the typical threat of generic erosion substantially, thus providing a significant financial incentive to seek OTC status.

However, it is not only the most sophisticated, mature markets that are becoming increasingly friendly to switches. Just across the East China Sea, Taiwan is pushing ahead with evaluations of (in other markets) common OTC molecules for allergies, indigestion and pain, while In Brazil, the national health regulator ANVISA is hoping to bring more competition into the OTC space by requiring companies to switch their eligible products or risk losing registration (Public Consultation 18/2015).

Switches breathe new life into staid categories

Two low-growth consumer health categories were boosted by noteworthy switch-based new product launches in 2014 and 2015. In the United States and across the European Union (through the European Medicines Agency’s centralised switch program), Pfizer launched an OTC version of the proton pump inhibitor (PPI) Nexium (esomeprazole, 20mg). While the European rollout is still underway, the brand made a big splash in the US, ending 2014 as the second-best-selling PPI brand and nearly US$175 million in retail value sales. Also in the US, long-dormant decongestant nasal sprays have been revitalised by recent switches. First pioneered in Norway by the Merck & Co (now Bayer) brand Nasonex (mometasone furoate 50mcg, available OTC since spring 2014), the OTC switch of nasal corticosteroids such as Allegra’s Nasacort (triamcinolone acetonide 55 mcg, 2014), GlaxoSmithKline’s Flonase (fluticasone propionate 50 mcg, 2015) and the impending release of Johnson & Johnson’s Rhinocort (budesonide 32 mcg, expected in 2015) could end up pushing the category past the US$500 million mark by the end of the decade.

Consumer health is aflutter over potential sexual health switches

One area primed for switch-led growth is the burgeoning OTC sexual health market. Sexual health includes products such as oral contraceptives, emergency contraception, and those targeting erectile dysfunction (ED).

Emergency contraception, which was one of the fastest-growing OTC categories from 2009 to 2014, achieved a major breakthrough in the largely untapped Western European market with the November 2014 centralised EU-wide switch of ellaOne (ulipristal acetate, 30mg). Despite some protests from pharmacists, gynaecologist lobbies and conservative political factions in markets like Italy, Poland, and Germany, OTC ellaOne began reaching pharmacy shelves in major European markets in spring 2015. According to Euromonitor’s latest consumer health data, emergency contraceptive retail value sales grew 10% annually from 2009 to 2014, but new availability in large markets like Germany and Italy is expected to further boost the category substantially moving forward.

The necessity for easily accessible family planning measures has also led to growing support for OTC oral contraceptives, including in the US, the world’s largest prescription drug market. In addition to bills encouraging switches introduced by both major political parties (Senate Bills 1438 and 1532), individual states have taken the initiative to increase access. By late 2015, California expects to fully implement Senate Bill 493, which will allow retail pharmacists to “furnish self-administered hormonal contraceptives, which are contraception products that can be self-administered in oral, transdermal, vaginal and depot injection routes.  While oral contraceptives will be restricted to prescription status, if successful, this pharmacy dispensing model could serve as a perfect future case study for the safety of OTC oral contraceptives. Though critics of increased access have pointed to the substantial risks involved with oral contraceptives (most notably venous thromboembolism), medical groups including the American College of Obstetricians and Gynecologists have come out in favour of OTC status, citing women’s ability to self-screen for contraindications and an overall positive risk-benefit profile, though they affirm that OTC oral contraceptives would not obviate the need for women to visit their gynaecologists entirely.

Consumer health producers are also eyeing the potential presented by male sexual health consumers. While expanded access efforts for ED products have been attempted before – most notably Pfizer’s pilot program in the United Kingdom in 2007 – the industry has made little headway in achieving a full-fledged Rx-to-OTC switch. However, recent success may signal a tidal change. Less than six months after Sanofi acquired the global Rx-to-OTC switch rights for Cialis (tadalafil 20mg) from Eli Lilly, New Zealand became the first market to switch sildenafil 100 mg (the molecule used in Pfizer’s Viagra) from prescription to restricted status in late 2014, after Douglas Pharmaceuticals applied for a switch of its brand Silvasta. The drug will be available as a pharmacy-only product with men between the ages of 35 and 70 able to purchase 12 packs (100mg or less per dose) from pharmacists who have completed a special training program. While it remains to be seen how warmly pharmacists will receive the regime, which requires new training and could add to already exacerbated workloads, even with these sorts of moderate sales restrictions, a rollout in larger markets could lead to booming OTC sales.

Global Consumer Health Retail Value by Region 2014-2019 (constant, fixed exchange rates)

Consumer-health

Source: Euromonitor International