2012 off to 'soft start' as patent cliff continues


DENVER — While the growth in healthcare costs remains a threat in the United States, the growth in drug expenditures is moderating, but numerous opportunities exist for retail, according to a speech delivered Tuesday morning at the National Association of Chain Drug Stores' 2012 Pharmacy and Technology Conference in Denver by Doug Long, VP industry relations of healthcare industry research firm IMS Health.

The moderation is due to a number of factors, such as the economic downturn, more introductions of new generic drugs, an innovation drought in the drug industry, concerns over the safety of certain drugs, over-the-counter switches and increased cost sharing. Real per capita spending growth in 2011 was 0.5%, Long said, saying that 2012 was off to a “soft start.” In particular, usage of generics has skyrocketed, and they currently account for about 80% of dispensed prescriptions, according to IMS data, while a recent report by the company and the Generic Pharmaceutical Association found that usage of generics has saved the country more than $1 trillion over the last 10 years. 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.

Meanwhile, 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 and 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. Of that, 3.6% of spending went through retail channels, while institutional channels accounted for 3.7%.

While generic drug makers have benefited tremendously from patent expiries on blockbuster drugs, the period when that pool of expiring patents begins to dry up, commonly known as the patent cliff, has continued. 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. But the party only lasts for the 180 days during which the first generic drug maker to successfully file for Food and Drug Administration approval has the exclusive right to compete against the branded drug, after which the drug becomes commoditized. 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 FDA 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 FDA 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.

The growth of specialty drugs and biosimilars opens some opportunities for pharmacy retailers too. 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 national chains, inclduing Costco Wholesale, Walgreens and CVS/pharmacy, to regional chains like 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.

But despite 2012's soft start, a number of notable things have happened already this year, Long said. These included the completion of the merger between Express Scripts and Medco Health Solutions and the merger between pharmacy benefit managers SXC and Catalyst; the announced merger between Walgreens and USA Drug; the Supreme Court's affirmation of the healthcare-reform law; free oral contraceptives; generic drugs reaching 80% market share and generic drug company mergers, such as Watson's acquisition of Actavis and Sandoz's acquisition of Fougera; the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act reauthorization; drug shortages; the Drug Enforcement Administration's stepped up enforcement of laws; Walgreens' acquisition of Alliance Boots and the resolution of its dispute with Express Scripts, among other events.

Long originally had been scheduled to speak on Monday morning, but switched places with former Centers for Medicare and Medicaid Services and FDA chief Mark McClellan. 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.

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