PCSK9s: A Shot in the Arm for Specialty Pharmacy?

PCSK9 inhibitors are about to make their debut, and specialty pharmacy is poised to play a key role in their management.

Successful specialty pharmacies work hard at prospecting opportunities for business, and that often means seeking to be included in the distribution of newly approved products. Most new specialty products being launched today are highly niched, developed for the treatment of orphan disease states or specific tumor types in oncology. Rarely do we see the more “mainstream” products come across our counters. One exception was the recent introduction of several oral hepatitis C products that have very large patient populations.

On the very near horizon are the pending approvals of 2 compounds that treat patient populations that far exceed any others in specialty. On July 24, 2015, the FDA approved one of these drugs, and it is expected that approval of the second will follow shortly. The European Medicines Agency has shown very favorable signs these products will be approved in the next year. We strongly suggest that our specialty pharmacy readers pay close attention to these products and learn what your potential role can be in order to gain access, because there are no other products on the horizon that have nearly the same potential to be game changers for specialty pharmacy.

PCSK9 INHIBITORS

The 2 new drugs being developed by 2 different manufactures are part of a new class of medication to manage high cholesterol: proprotein convertase subtilisin/kexin 9 (PCSK9) enzyme inhibitors. The potential population of patients for these drugs will be huge, possibly in the millions.

These new medications will be injected once or twice a month. Evidence from randomized controlled trials suggests that they are well-tolerated and highly effective in reducing low-density lipoprotein (LDL) cholesterol. These products will be used in addition to a patient’s current therapy and to further reduce LDL levels. PCSK9 inhibitors will be costly and will therefore be considered specialty medications. Speculation was that these drugs would cost in the range of $10,000 per year; however, one manufacturer has already flashed a price of nearly $15,000 per year. One company may eventually have a lower-dose alternative in the sub-$5000-per-month range, according to a recent quote in Fierce Biotech.

Unlike the hepatitis C products, the PCSK9 inhibitors will not be a cure; they will used long-term, potentially over decades, at a significant cost for patients and payers. The math is pretty simple: at the theoretical annual price of $15,000, every 1 million patients could cost $15 billion per year. Wow! According to the National Center for Health Statistics, 1 in 4 US adults 45 years and older is on some form of statin drug.

As with hepatitis C products, it is likely that there will be conditions in place before PCSK9s will be covered. Requirements may include lab results, consideration of prior therapies, and other key factors, in addition to cost-sharing strategies to limit access.

Since there are currently 2 manufacturers going through the approval process for PCSK9s, it seems reasonable to expect that discounts and the use of strict formularies will come into play as the manufacturers compete to contract with payers, just as they did in the hepatitis C category.

This is where specialty pharmacy comes in. Who better to manage the appropriate use of high-cost complex therapies? Specialty pharmacy is best positioned to help drive compliance around clinical guidelines, patient compliance, and education and cost management. The statin category continues to be the standard of care for cholesterol management. It is fair to say that the PCSK9 products have the potential to redefine specialty pharmacy. In my view, the scale of the potential patient population will require these products be offered to a much broader group of pharmacies than the typical limited-distribution products currently in the market. Although final labeling is not in place, a review of the FDA.gov website shows a positive safety profile for these products. Do not miss the boat for this category: learn about these drugs. Build your value proposition and know what differentiates your business from others, what sets you apart in your market, and how can you convince these manufacturers to include you in any limited-distribution programs they may choose to introduce. Get plugged in NOW. The ship is already sailing—trust your editor-in-chief on that!

SPECIALTY IN THE EUROPEAN UNION

Here in the United States, the practice of pharmacy has evolved greatly in comparison with other countries, including those of our European Union (EU) counterparts, over the last 20 to 30 years. We have come a long way, and specialty pharmacy is driving many of those changes. Earlier this summer, I had the privilege of presenting to a group of 300-plus pharmacists in Athens, Greece, on the practice and business of specialty pharmacy. I also spent some time with many of their European counterparts; it was fascinating to learn of the differences in acceptable and legal practice in the EU compared with the United States. The EU is still very much a physician-driven patient relationship market. In many countries, pharmacists have the training to counsel patients on their medications, but not the authority. The good news is that our European counterparts use their knowledge and put their patients first. Our counterparts were amazed to hear now much we have evolved; how pharmacists, under the Omnibus Reconciliation Act of 1990, must offer consultation; and how we have leveraged our education.

With specialty products in particular, specialty pharmacy has taken our training to an even higher level. In the EU, where most products that we would define as specialty are only available on a direct basis through state-owned hospital pharmacies, specialty pharmacy is largely locked out. I am pleased to share with our readers that Specialty Pharmacy Times is well read in the EU and that we are changing the paradigm across the pond. We’ll have many international attendees at the upcoming National Association of Specialty Pharmacy conference, and they are coming to learn from their US counterparts. I look forward to seeing you in Washington, DC: www.naspnet.org/#!attend2015/cj46. SPT

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Dan Steiber, RPh, is a founder 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. He has served in several senior positions in pharmacy, distribution, and industry over the course of his 40-year career. Mr. Steiber is a licensed pharmacist in Texas, Washington, California, and Pennsylvania. He is 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 has participated in a variety of postgraduate programs in law and business development/marketing at Harvard University and Northwestern University. Dan currently resides in Highland Village, Texas.