PHARMACY

Past patent cliff, biosimilars to be focus

BY Alaric DeArment

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years. But according to IMS’ latest figures, it was not the start of a trend.

The company’s latest report, released last month, shows that spending on drugs in the United States will once again rise in 2014. The drop in 2012 was the result of patent expiries on such drugs as Pfizer’s cholesterol medication Lipitor (atorvastatin calcium) and Sanofi’s blood-thinning drug Plavix (clopidogrel bisulfate), but the wave of patent expiries known as the patent cliff has mostly passed.

With many primary-care therapeutic categories now available as generics, drug companies have been investing heavily in the development of specialty drugs for such difficult-to-treat conditions as cancers, autoimmune disorders and chronic viral infections. According to IMS’ latest report, new drug launches will be “dominated” by specialty, especially cancer drugs. Specialty spending also is expected to increase rapidly, from $148 billion last year to $193 billion in 2017.

Concurrently, follow-on versions of biotech specialty drugs are expected to become a bigger part of the market as well. According to a report last month by Dallas-based research company MarketsandMarkets, the global market for biosimilars will hit $2 billion before the end of the decade. IMS estimates they will remain a relatively small share of the overall market for biologics for many years to come. With an expected biologic market value of $221 billion in 2017, biosimilars and non-original biologics — follow-on biologics that are approved through the same pathway as branded biotech drugs rather than through an abbreviated regulatory approval pathway — will account for 2% to 5% of that market. But that’s still much bigger than the 1.4% share of the $169 billion biologic market they had in 2012. By contrast, in 2011, generic pharmaceutical drugs accounted for 27% of total drug spending, according to the Generic Pharmaceutical Association.

Though the Patient Protection and Affordable Care Act of 2010 contained a provision for an abbreviated regulatory approval pathway for biosimilars, the Food and Drug Administration has yet to finalize regulations. Companies looking to market biosimilars must get them approved through the same pathway as branded biologics. For example, last year Teva received FDA approval for tbo-filgrastim, a biosimilar version of Amgen’s Neupogen for neutropenia, a condition that affects chemotherapy patients.

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Embrace change at NACDS Regional

BY Antoinette Alexander

NAPLES, Fla. — Change is not coming. Change is here. Are you prepared?

That’s the question regional chain pharmacies should be asking themselves as the healthcare landscape rapidly evolves and performance-based outcomes grow increasingly vital. That is why the 2014 NACDS Regional Chain Conference is perhaps more important than ever.

Coming to The Ritz-Carlton here in Naples, Fla., from Feb. 2 to Feb. 4, the Regional Chain Conference is an invaluable and unique educational and networking opportunity for senior executives who operate up to 250 retail pharmacy locations.

From one-on-one business meetings to educational sessions to interactive idea exchanges to get those creative juices flowing, this powerful event is not one to miss.

It is no secret that consolidation has significantly reshaped the regional landscape in recent years, and the evolving role of community pharmacy continues to fuel change throughout the industry. But what is certain is that, in many ways, regional players have been — and continue to be — leaders in evolution.

“Part of that comes from the simple reason that they are in many ways more nimble and efficient than some of the larger chains … That being said, if you take a look at some of the issues that have been out there through the Regional Chain Conference over time, whether it be a front-end issue, a pharmacy issue, a federal legislative issue or a state legislative issue, some of the regionals have been the ones to see it and bring it to the forefront of NACDS first,” said Jim Whitman, SVP of member programs and services at NACDS.

Sharing his insights and perspectives on the industry will be regional executive Bob Narveson, president and CEO of Thrifty White Pharmacy. He will be delivering the “State of the Industry” update as part of his role as NACDS chairman.

“We have Bob Narveson, who is the NACDS chairman of the board, and is he a regional chain. He will be speaking at the conference, and a lot of people are looking forward to it. He is a very dynamic leader and chairman of NACDS,” Whitman said. “We are certainly looking forward to hearing Bob’s take on some of the challenges and opportunities in the industry.”

As noted earlier, the robust agenda includes, among other things, interactive idea exchanges, which are one-hour sessions featuring leading experts on topics related to pharmacy care and retail market trends.

“The program always gives us a good snapshot of the industry. It is appreciated and informative but, in addition, this year the idea exchanges are very important, and we need to understand the issues facing our membership and discuss solutions,” Narveson said. “Personally, I have always felt the idea exchanges help guide our decision-making process and are an essential part of the meeting.”

So what are some ways in which regional players can gear up and prepare for a successful meeting?

“For the retailers, we want you to take a look at the sessions and share with your other executives in your companies. … We encourage everyone to do their homework. These companies are coming prepared with programs and solutions to help the regionals, so be prepared to ask for the help,” Whitman said. “For the supplier members, know the regionals. Know what is on their mind, and know the kinds of issues they are facing.”

Narveson added, “Review with your team what their biggest issues are and potential solutions so we can discuss them at the show, such as medication therapy management, patient access and specialty pharmacy. … Come prepared looking for opportunities to expand your menu of services. Ask yourself questions such as, ‘What are you doing today for your patients that you could be looking to do better or adding to the services you provide to your patients?’ This kind of preparation can help ensure a successful conference experience.”

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Bioprinting on horizon for 3-D printing

BY Alaric DeArment

In the late 1980s, “Star Trek: The Next Generation” introduced viewers to the replicator, which could make food, beverages and other items materialize out of thin air.

The idea of Captain Picard instantaneously getting his favorite brew by telling a machine “Tea, Earl Grey, hot” won’t happen any time soon. But with the advent of 3-D printing, it’s a lot closer to reality than one might think.

Three-dimensional printing at retail is an idea still in its infancy. At the National Association of Chain Drug Stores’ Total Store Expo in August, the show floor featured an Innovation Zone with a 3-D printer that created sample products like sculptures and bracelets. But its potential applications go far beyond a few knick-knacks.

The market itself is still relatively small, but it’s growing rapidly. According to IBIS-World, 3-D printer manufacturers’ 2012 sales were $2 billion, with 10.2% growth from 2008, while 3-D printing services hit $800 million as of March 2013, growing at 10.3%. It’s in those services where retailers might find the most opportunity.

Cincinnati-based 3DLT, which launched last year, maintains a library of designs across multiple categories that can be purchased and printed at home or in a store. In an interview with Drug Store News, co-founder and chief marketing officer John Hauer explained why the company recently pulled out of a planned deal with an online retailer. “We got to the finishing line and felt there was a missing ingredient, and brick-and-mortar was that missing ingredient,” Hauer said. Currently, the company is in talks with eight major retailers, Hauer said.

Hauer sees 3-D printing as a way to give brick-and-mortar a competitive edge against online by allowing stores to have entire libraries of designs they could print on demand. “Our idea is that you could flip Amazon’s model and drive cost out of your equation,” he said. Hauer envisions retailers storing tens of thousands of SKUs digitally for printing in store, with 3-D printing departments resembling full-service photo departments. Such libraries — as opposed to simply having customers come in with designs of their own, as UPS did earlier this year in a pilot program at several of its retail stores — also would solve some potential intellectual property issues, he said.

Most 3-D printable products fit in the general merchandise category, such as toys, decorations and housewares, as well as personal care products like combs and brushes. Further on the horizon, researchers already are experimenting with 3-D “bioprinting” of organs and implants using patients’ own DNA. Still, Isaac Katz, a Mexico City-based artist and designer who in September spoke at Mediabistro’s Inside 3-D Printing Conference and Expo in San Jose, Calif., sees the technology as still in a phase more suitable for prototypes and aiding in design rather than for large-scale manufacturing. “It still has to trickle down,” Katz told DSN. But he also compares its present phase to that of personal computers in the 1980s and the Internet in the 1990s.

But retail pharmacies could still find some potential uses much sooner than later. Hauer cited customizable shoe inserts as one example. Another is customized durable medical equipment. In the 2012 Paralympics in London, some members of the U.K. basketball team used wheelchairs with 3-D printed seats specially tailored to their bodies and disabilities. The main problem with that kind of work is it’s really expensive and requires 3-D scanning of the user’s bodies and movements. But smaller, simpler applications may be more feasible for now. Recently, Enabled By Design, a U.K.-based organization that promotes functionally designed products for people with disabilities, sponsored a design contest that included 3-D printed products for the disabled like a fork that’s easier to grip for people with dexterity problems and a set of thimble-like pronged “finger cactuses” for picking up food.

In terms of more complex healthcare products, Katz said 3-D printed versions of durable medical equipment — such as canes, crutches, walkers and manually powered wheelchairs — may take a while to reach the market due to economic limitations. In addition to scanning technology, printers that use metal and high-durability plastics can be prohibitively expensive, costing tens of thousands each. But that could soon change, as researchers at Michigan Technological University recently unveiled a design for a metal-based 3-D printer that can be built for about $1,500.

At the same time, such DME products might be easily made from a regulatory standpoint because they’re usually exempt from the Food and Drug Administration’s 510k clearance requirements — certainly easier than a 3-D printed artificial jaw made from titanium. Three-dimensional scanning technology also is becoming more advanced; Hauer noted that Microsoft has experimented with 3-D scanners on mobile phones.

Three-dimensional printing is, as Katz suggested, following a trajectory not unlike computers in the 1980s, jumping from the realm of hobbyists and hardcore enthusiasts to mainstream industry and retail. And with the race to get products in the hands of consumers faster and faster, it could be a boon for brick-and-mortar retailers — including pharmacy retailers.

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