Pharmacogenomics: The Future is Now!

Welcome to the second edition of Specialty Pharmacy Times. This month’s SPT features articles from several of the leaders from specialty pharmacy—from a pharmacist/owner in independent practice to one of the largest PBM-owned specialty pharmacies to related best of breed support organizations. Our SPT authors have taken note of key trends that will greatly affect the future of specialty pharmacy. You’ll be informed about pharmacogenomics, REMS, patient care, new regulations, reimbursement, excellence in staffing, what it takes to prepare your business for a potential sale, and more— all by industry experts.

In fact, this issue serves as a great reminder of our mission: Specialty Pharmacy Times is THE journal fully committed to setting the publication standard through peer-written and peer-reviewed articles which are focused on the “real world” of specialty pharmacy practice.

An emerging area that will greatly affect specialty pharmacy is molecular diagnostics and pharmacogenomic testing. Genomic testing predicts how effective therapies will be for specific patients and their diseases, allowing health care professionals to target the right drug for the circumstances. Product targeting optimizes the patient’s therapy, which in turn can drive treatment decisions. An excellent example is oncology patients, such as those treated for breast cancer with targeted products, who are screened for their HER-2 status. Pharmacogenomics testing assures that the right patient receives the right drug at the right time in the right dose, thereby improving patient outcomes while managing overall health care costs.

Other future disease states that can benefit from pharmacogenemomics include rheumatoid arthritis, multiple sclerosis, oral contraceptives, depression, and osteoporosis. Isn’t this much of what specialty pharmacy is all about?

Pharmacogenomics is here and now and is driving trends resulting in changes to our specialty pharmacy practice and businesses. The health care system can ill afford a one size fits all product selection model when the ability to personalize therapy exists. There will be challenges to overcome, among them, that the pharmaceutical industry is reluctant to potentially limit the use of its products, reimbursement for tests is still in flux, regulators and ethicists debate what the appropriate standards should be for testing, physicians are not certain what to do as clinical standards have yet to be determined, insurers have yet to see a strong ROI on the technology, and patients have not come together to demand access.

But new business models are emerging where specialty pharmacists are inserting themselves into a gatekeeper role in pharmacogenomics and product access. We invite our SPT readers to understand where these trends have placed us: at a dynamic crossroads from an ethics and standard of care perspective. Where does your business see pharmacogenomics working in your operation?

About the Editor-in-Chief, Specialty Pharmacy Times: Dan Steiber is a Principal of D2 Pharma Consulting LLC (www.d2rx. com) and is responsible for commercial operations, trade-supply chain strategy development including 3PL selection, regulatory oversight, and “operationalizing” organizations. Dan has served in several senior positions in pharmacy, distribution, and industry over the course of his 35-year career. He is a licensed pharmacist in California, Pennsylvania, Texas, and Washington. He is also affiliated with several professional associations and publications and is a frequent speaker on behalf of many professional organizations. He graduated from Washington State University College of Pharmacy and participated in a variety of postgraduate programs in law and business development/marketing at Harvard University and Northwestern University. Dan currently resides in Plano, Texas, with his wife and 2 sons.