Bold Moves in the Specialty Landscape

Is it time to take sides or stay on the sidelines? With major happenings in specialty pharmacy, specialty pharmacists will want to take note as the profession moves on.

In the last few weeks, we’ve had a few changes in the landscape and now have interesting choices for those of us in the specialty pharmacy arena: Specialty Pharmacy Association of America (SPAARx), an organization formed by Armada, and the National Association of Specialty Pharmacy (NASP), an organization formed by the publishers of an electronic pharmacy journal. These are 2 very diverse entities with different roots and interests. NASP has aligned itself with the Academy of Managed Care Pharmacy (AMCP).

Time will tell which of these organizations emerges or if it will be some other entity that is in the works. I’ve always found it very interesting and a bit disappointing that our profession focuses on our differences rather than the similarities within our organizations.

Does pharmacy need another professional organization for specialty? Our SPT readers need to decide which organization, if any, best serves their needs and in my view the answer lies in this question: what are the “motives” behind their founding? I’ll leave that up to our readers to decide, and time will likely reveal the answer. Both organizations have an interest in creating credentialing of specialty pharmacists also, but don’t we already have organizations focused on pharmacist credentialing? Are we risking another set of confusing choices for specialty pharmacy stakeholders?

Where is the leadership of the American Pharmacists Association in putting forward a stance on professional credentialing for specialty or, for that matter, developing an academy for specialty as they do for other areas of specialization in the profession? Well, for my 2 cents, I’m going to wait and see which of all of these players emerge as a true advancement for specialty. Motives have a way of revealing themselves over time.

In a second bold move, with the latest Format for Formulary Submissions, version 3.1, the AMCP strives to define specialty pharmaceuticals and pharmacy as: “Requiring a difficult or unusual process of delivery to the patient (preparation, handling, storage, inventory, distribution, Risk Evaluation and Mitigation Strategy [REMS] programs, data collection, or administration) or, patient management prior to or following administration (monitoring, disease or therapeutic support systems).”

In addition, the AMCP continues by stating “High cost is not enough to define a product as a specialty pharmaceutical, as this definition alone would potentially capture an expensive branded drug with no other special needs for delivery or patient management.”

They also state, “Specialty pharmacies are distinct from traditional pharmacies in coordinating many aspects of patient care and disease management. They are designed to efficiently deliver medications with special handling, storage, and distribution requirements with standardized processes that permit economies of scale. Specialty pharmacies are also designed to improve clinical and economic outcomes for patients with complex, often chronic and rare conditions, with close contact and management by clinicians. Health care professionals employed by specialty pharmacies provide patient education, help ensure appropriate medication use, promote adherence, and attempt to avoid unnecessary costs. Other support systems coordinate sharing of information among clinicians treating patients and help patients locate resources to provide financial assistance with out-of-pocket expenditures.”

Frankly, both of these definitions are overdue—albeit, we have credentialing bodies that have tackled the second. We all agree that specialty products generally require a great deal of more professional intervention than “lick, stick, and pour.” I feel we have not gone far enough, however, and it is way past the time when one or more of the pricing compendia step up to the plate and create designations in their systems as to what is specialty or not. This won’t be an easy task; however, having aligned definitions improves the opportunities for specialty pharmacies dispensing specialty products to receive adequate compensation for their services. We need some leadership here, and likely this will take a P and T committee type flavor to pull off a fair and datadriven process of categorization. So, how about it, Medi-Span, FDB, and Gold Standard? Who is bold enough to lead?

There are a couple of solid specialty pharmacy events coming up the next few weeks—hope to see you there and get your feedback on these “bold moves.”

About the Author

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