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C h a i n D r u g s t o r e D a i l y 1 1 M o n d a y, A p r i l 2 7 , 2 0 1 5 NAVIGATING FINANCIAL COMPLEXITIES OF SPECIALTY PHARMACY POSSIBLE By Jeff Pepperworth, President, Inmar Healthcare Network If the current challenges of the evolving healthcare landscape aren't difficult enough, specialty pharmacy has its own hurdles to overcome. Retail pharmacy economics have been difficult in recent years as profits have eroded in the face of increases in discount and free generic programs, aggressive MAC pricing and the recent upward trend in generic drug pricing. Historically, developments such as expiring patents of big-selling brand drugs would have been great news for retailers, as generic drugs have long driv- en profits, but as these new programs have increased, profitability has declined. Are specialty drugs the answer? According to an April 2014 report from the UnitedHealth Center for Health Reform & Modernization, spending on specialty drugs in 2012 in the United States was about $87 billion dollars. Estimates from the "Current Trends and Future Opportunities" report indicate that it could quadruple by 2020, reaching about $400 billion dollars. The growth of specialty pharmaceu- ticals brings with it significant challenges in navigating the complexities associated with this case of expensive treatments as they manifest in distribution models, multiple payer and payment assistance possibilities and new accountabilities for pharmacies. While specialty pharmacy represents revenue opportunities, it also requires a more complex environment with heightened expectations of vigi- lance to realize those gains. Specialty pharmacy presents oppor- tunities for business diversification for retailers and manufacturers, as evidenced in the number of companies tap- ping the specialty market. However, it also presents chal- lenges for traditional retailers and manufacturers, as many new drugs are released in limited drug distribution networks, and many health plans and other payers have created limited specialty pharmacy net- works to help control specialty drug spend. Benefit coverage of specialty drugs is evolving with its own complexities. While some specialty drugs are moving under pharmacy coverage, they remain under medical coverage on some plans, presenting a number of tracking and reimbursement challenges for pharma- cies. This diversity of coverage can result in investigations regarding benefits, spawning new exception and reconcilia- tion challenges. Benefit design and new specialty tiers come with a much higher patient co-pay or co-insurance, adding patient-assistance programs to the mix. The complexity of the disease state, intense risk evaluation strategies pro- grams, unique drug administration requirements, complex therapy regimens and drug toxicities have led phar- macy providers to implement com- plicated patient-support programs. These programs require extensive reporting back to the payer, the manufacturer and potentially FDA. Managing the complexities of specialty drug business means hav- ing the agility to identify and track exceptions, reconcile payments and min- imize sales outstanding. Inmar's soft- ware-based solutions provide the ability to search and sort exceptions and other unpaid transactions by multiple cate- gories, generating accounts receivable aging reports that aid in the effort to max- imize payment within specified timelines that meet specified objectives. Inmar's solutions allow better focus on managing the fundamentals of busi- ness by keeping forward business momentum while effectively addressing the challenges and costs and new com- plexities that come with growth into this exciting new territory. Visit Inmar at booth #430. For more information, go to www.inmar.com or call 866.440.6917. METHYLPHENIDATE HCI CHEWABLE TABLETS, CII When it comes to Methylphenidate, some options are simply easier since some chil- dren have trouble swallowing tablets. GAVIS Pharmaceuticals announced the launch of Methylphenidate HCl Chewable tablets, CII. Not only is it available in generic, it is AB-rated to Methylin and offers convenient, precise dosing to improve compliance. This chewable tablet offers an alter- native for children who have difficulty swallowing tablets – and is now available as a generic. It's just one more example of how GAVIS Pharmaceuticals is listen- ing – and delivering – what patients, physicians and pharmacists want: a choice. Its dosage forms come in 2.5 mg, 5 mg, and 10 mg Chewable Tablets in great-tasting grape flavor. About GAVIS Pharmaceuticals GAVIS Pharmaceuticals is a leading company in the formulation, develop- ment, manufacturing, packaging, sales, marketing and distribution of first- class generic pharmaceuticals. Founded in 2008 by industry veteran, Dr. Veerappan Subramanian, GAVIS Pharmaceuticals develops, markets and, in conjunction with its sister com- pany Novel Laboratories of Somerset, N.J., manufactures niche, specialty and difficult-to-make products across a range of therapeutic classes and dosage forms. With a trusted team of experienced professionals that have 300+ years of generic pharmaceutical experience, GAVIS is ded- icated to bringing niche products to market first. GAVIS delivers value to its retail pharmacy part- ners by identifying the needs of patients, pre- scribers and pharmacies, and delivering products that offer ther- apeutic, economic or continuity bene- fits to everyone involved. Often, these are products for which no generic ver- sion is available. GAVIS is focused on product safety and conducts compre- hensive safety monitoring and evalua- tion throughout all stages of its product lifecycle. It is also committed to the safe and efficacious use of its prod- ucts. Its development portfolio focuses on products for gastrointestinal, women's health and controlled drug substances across a range of dosage forms that include modified-release tablets and capsules, orally-disinte- grated tablets, chewable tablets, immediate-release tablets and capsules, non-sterile liquids and suspensions, sachets, powders, semi-solids, topical solutions, rectal gels and rectal supposito- ries. GAVIS launched its first three prod- ucts in May 2009 and distributes its prod- ucts from a state-of-the-art, 150,000- square-foot warehouse facility in Somerset, N.J. Since its debut, GAVIS has built – and will continue to expand – a robust pipeline of specialty pharmaceu- ticals with limited competition. GAVIS Pharmaceuticals remains committed to delivering valuable products to the mar- ket that make a difference in people's lives. For more information, visit www .gavilyte.com or www.gavispharma.com. DAVID BIERNBAUM & ASSOCIATES HAS POWERED OVER 200 SUCCESSFUL OTC/HBC BRANDS David Biernbaum is President and Senior Consultant at David Biernbaum & Associates LLC and is one of the consumer goods and retail industry's foremost business development con- sultants. A national sales specialist in the field of health and beauty, OTC and personal care, Biernbaum and his teams have had a major impact on more than 200 brands since 1977. As a consultant as well as a nationwide "master broker," he continues to have the magical touch. The latest and greatest examples: Australian Dream Arthritis Cream, Australian Dream Back Pain Cream and TriCalm Hydrogel. Biernbaum passionately explained: "Australian Dream is a 4-ounce jar of pain relief that retails for an average of $30 in drug stores like Walgreens, CVS and many of the regional drug chains and supermarkets. At one of the drug chains, we're selling nearly 4,000 pieces per week at $30 per unit even when not on promotion!" Australian Dream is also sold as a 2-ounce at Walmart, Target and a number of super- markets, too. The brand has responded extremely well over these past two years to TV and radio advertising. Biernbaum added, "We advertise every day of the year and we never stop." Biernbaum cautions that he does- n't take on all new clients, saying, "After 35 years in this business, I am very particular and have strict criteria for the clients and brands I take on. I take on only products that offer the retailer points of differenti- ation, innovation, high produc- tivity on the shelf and an hon- est spend." Biernbaum explained further, "And I take on only clients that give me the room and the mandate to go to market the right way, with no under- mining, and they must allow me to sur- round them with other champions that I know, trust and have worked with for years." David Biernbaum is extremely well connected. In 2009, he started up the Consumer Goods & Retail Professionals networking group on LinkedIn that now has more than 55,000 members and contributes every morning as a "BrainTrust panel mem- ber" on the popular Retailwire.com blog as well as holding a number of committee positions at NACDS and in other trade associations. Biernbaum is passionate about the CPG retail industry and enjoys his long history bringing success and profits not only to his own clients and brands, but also to his retail partners. "Retail category managers and executives are thrilled with the profits being made on destination- items like Australian Dream and TriCalm. My clients' brands not only are making big profits but are the ones making the disruptive difference in the aisle while bringing in the most coveted premium customer that spends the most money in the store." Of the numerous products that have benefited from his approach, a few older brands that David and his teams have guided or helped influence include ZarBee's children's cough syrups, Zooth licensed toothbrushes, Aquafresh, Oral-B, Selsun Blue, Gillette Sensor, Germ-X, Sonicare and TheraBreath. For more information, visit www.con- sultdavidb.com, call 314.434.6008 or email david@biernbaum.com.