While generics benefit from patent cliff, branded drugs turn to innovation
Despite the patent cliff rendering entire therapeutic categories generic-only, numerous opportunities exist, according to a speech delivered in August at the National Association of Chain Drug Stores’ 2012 Pharmacy and Technology Conference in Denver by IMS Health VP industry relations Doug Long.
“Right now, there’s plentiful generic opportunities,” Long, who won the NACDS’ Harold W. Pratt Award at the conclusion of the conference, told DSN Collaborative Care in an interview before the show. “It’s almost a who’s who list of patent expiries.”
Usage of generics has skyrocketed, and they currently account for about 80% of dispensed prescriptions, according to IMS data. Spending on branded drugs increased in 2011 by 2.1%, to $235 billion, while branded generics saw a 2.8% increase and generics experienced a 13.8% increase. “Obviously, generics are doing better than brands and better than branded generics,” Long said. “I think this is a symptom of what I call the commoditization of oral solids.”
Oral solids, meaning capsules and tablets, especially primary care drugs, have seen tremendous erosion in sales due to loss of patent protection, with many classes, such as lipid regulators, set to lose their places among the top-selling drug classes because so many are going generic.
2012 has been a peak year for patent expiries, with $35 billion worth of drugs coming off patent, and 2014 will be an important year as well. Pfizer’s cholesterol drug Lipitor (atorvastatin) is a prime example: The drug lost patent protection in November 2011, and Ranbaxy launched its generic version; after Ranbaxy lost its own exclusivity period in May 2012, atorvastatin became fair game for any generic drug company that can win Food and Drug Administration approval.
“We’re in the teeth of the patent cliff,” Long said, speaking of what he called the “cone of commoditization.” This includes such drug classes as cholesterol medicines, antidepressants and others that have become essentially dominated by generics, compared with classes outside the “cone” that remain relatively safe from generic competition, such as drugs for HIV, hepatitis C and diabetes. The result is that new small molecules ripe for generic competition will gradually dry up. “If they weren’t invented in the first place, then there’s nothing to be genericized,” Long said.
Many drug makers have sought to protect themselves by moving up the value chain, Long said. For generic companies, this has often meant branching out from oral solids and into more complex methods of delivery, such as transdermal patches, injectables and follow-on biologics. While the Patient Protection and Affordable Care Act created an abbreviated approval pathway for follow-on biologics, the regulations are still not in place, prompting some companies looking to make them, such as Teva Pharmaceutical Industries, to seek approval through the same means used by makers of branded biologics.
For branded companies, resisting commoditization means innovation. Long said much of the innovation occurring today is happening in treatments for cancers, autoimmune disorders, orphan diseases and chronic viral infections. “Innovation has picked up in specialty, [but it’s] not quite there in primary care,” Long said.
Biologics have seen higher spending growth than small-molecule drugs, having increased by 6% to $69 billion, while small molecules have increased by 2.9% to $250 billion; spending on traditional drugs increased by 2%, while spending on specialty drugs increased by 8.8%. Overall, $319.4 billion was spent on medicines in 2011, according to IMS Health. Of that, 3.6% of spending growth went through retail channels, while institutional channels accounted for 3.7%.
The growth of specialty drugs and biosimilars opens some opportunities for pharmacy retailers. According to IMS, retailers command only 8.6% of the market for many cancer drugs. But in such areas as HIV and other antivirals, they largely dominate, and Long said there is potential in autoimmune disorders as well. Indeed, many pharmacy retailers, ranging from such national chains as Costco Wholesale, Walgreens and CVS/pharmacy to such regional chains as Hy-Vee, already have branched into specialty pharmacy. “Maybe the focus shouldn’t be on cancer and EPOs and ECGFs — it should be on other classes,” Long said.
Pharmacy retailers also have a role to play in offering primary care services, Long said. “You can play a big role in this as retailers, with your retail clinics and preventive efforts,” Long said, noting opportunities to increase adherence and compliance — especially among elderly patients — and citing a recent medication synchronization study conducted by Thrifty White Pharmacy and Virginia Commonwealth University that tested such efforts as advertising and packaging designed to boost adherence, such as the digital Rx Timer Cap.
Long’s speech followed the presentation of an award presented by Boehringer Ingelheim Pharmaceuticals national accounts director Colin Carr-Hall to Costco Wholesale SVP pharmacy Vic Curtis. Curtis’ award consisted of a plaque and a $10,000 contribution in his name to the NACDS Foundation. Additionally, Matthew Machado, a professor of pharmacy at the Massachusetts College of Pharmacy and manager of patient care services for Walgreens in the Boston area, was awarded the Apotex Preceptor of the Year Award by Apotex director of trade sales and pharmacy relations Sam Boulton.
New roadside health solutions help at-risk drivers keep on truckin’
Out of all U.S. industries, the drivers shuttling statins and beta-blockers from the distribution centers to the pharmacies are perhaps most in need of healthcare counseling.
Professional drivers sport the highest obesity rate, with nearly 4-in-10 transportation workers considered obese, according to a recent Gallup-Healthways Well-Being Index. And according to statistics published by the Heavy Duty Trucking trade journal, as many as half of all long-haul drivers smoke tobacco; 28% suffer from hypertension (compared to 17% of manufacturing workers); 25% had high cholesterol (compared to 16%); 10% had diabetes mellitus (compared to 5%); and almost 15% had sleep apnea. Only 58% are covered by health insurance. The life expectancy of a commercial driver is 16 years shorter than the norm, the journal reported, referencing data from the Centers for Disease Control
A proclivity toward unhealthy behaviors on the job site, in this case behind the wheel of a 80,000-lb. semi, can have pretty severe consequences. According to a study published in the October issue of Population Health Management, employees with an unhealthy diet were 66% more likely to report having experienced a loss in productivity than those who regularly ate whole grains, fruits and vegetables. Employees who exercised only occasionally were 50% more likely to report having lower levels of productivity than employees who were regular exercisers. Smokers were 28% more likely to report suffering from a drop in productivity
There are several organizations helping those drivers to keep health and wellness in the center lane; one of the more prominent being Rolling Strong. Rolling Strong has teamed with several national healthcare-focused companies — Kroger pharmacy is the preferred provider for on-site health screenings, for example. Kroger pharmacists provide on-site biometric readings for drivers at Rolling Strong’s trucking clients and also on the road through trucker-friendly Kroger stores.
Rolling Strong most recently launched health-check stations that are being placed in truck terminals, and with that, the organization is tapping into Kroger’s network of healthcare kiosks located in front of the pharmacy counter. Drivers can sit down at one of these healthcare kiosks and with a swipe of their membership card have their weight, BMI, heart rate, blood pressure and vision measurements all uploaded to their healthcare profile. “That information is automatically populated into their web portal, so the driver can … track it,” Bob Perry, Rolling Strong president, told DSN Collaborative Care. “They can get a live screening [at Kroger] as well.”
And the health-and-wellness program provider has partnered with Bayer Healthcare on providing diabetes education and meters.
In addition to partnering with Kroger and Bayer, Rolling Strong has relationships with Snap Fitness, a 24-hour fitness center franchise with more than 1,200 locations nationwide. Rolling Strong recently launched its first 24-hour facility within a Pilot Flying J travel center in Dallas. “The membership is really growing nicely — individual drivers are joining on their own because they recognize the value,” Perry said. In addition to the Dallas hub, Rolling Strong has identified five additional locations. Perry noted that Rolling Strong is working toward opening 80 such fitness centers over the next two years.
Rolling Strong is also expanding its partnership with Healthy Vending Management Co. and placing vending machines stocked with healthier choices across many of the driver hubs of those trucking companies that have signed Rolling Strong as their corporate health-and-wellness driver.
The vending machines are stocked with Rolling Strong-
branded foods like fresh salads and healthy sandwiches. Rolling Strong is currently providing health-and-wellness initiatives across six major distribution operators.
GSK Consumer Healthcare introduces Abreva Conceal
PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare recently introduced Abreva Conceal, a clear nonmedicated patch that covers cold sores.
Abreva Conceal uses MicroAir technology, which allows air in while keeping contaminants out. Once the cold sore blister has appeared, Abreva Conceal can be placed over it, creating a covered, protected environment for up to eight hours and provides a smooth surface so that makeup can be applied on top of the patch. GSK said the product delivers true product innovation and will drive significant growth in the cold sore category.
According to GSK’s recent "Undercover Cold Sore Survey" of more than 1,000 women, found that cold sore sufferers go to extreme lengths to cover their cold sores. For example, 9-out-of-10 respondents noted a cold sore is an ugly surprise and are bothered that there is no way to prepare for one. Additionally, more than one-third of respondents said they have stayed home because of a cold sore, and 1-in-4 women have lied about what a cold sore is.
"About 80 million Americans suffer from cold sores in the United States, which can be unsightly and sometimes painful. Our research illustrates the social and emotional impact cold sores can have and the need for products like Abreva Conceal," said Vidhu Bansal, director of medical affairs of GSK Consumer Healthcare. "GSK wanted to provide cold sore sufferers with an option to conceal their cold sores so they don’t have to hide from the world. Abreva Conceal helps sufferers face the day with confidence, even with a cold sore."
Suggested retail price for Abreva Conceal is $9.99 for a 6-pack and $13.99 for a 12-pack (pricing may vary by location).
To check out a video "how-to" hosted by Carmindy, a professional makeup artist from TLC’s TV show "What Not to Wear," click here.