Specialty Pharmacy: Ignoring What It Is and Making It What We Want

Current definitions attempting to summarize specialty pharmacy fall short.

Act 1

It was 2008 and I was fourth year pharmacy student just 2 years away from graduating. Like most pharmacy students during that time, I was eager to fast forward life and make my mark in the real world. Most of my classmates knew that it was either retail or hospital pharmacy for them, but I knew that neither was for me.

I received an offer for a pharmacy intern position. The employer was a well-known company, but the environment was completely new to me. I had asked around trying to gain an understanding of what I may be in for.

A few had heard of it, but no one could explain it. The mystery of the work environment fueled my curiosity and I ended up accepting the offer.

To sum up my first few weeks and even months in this not so familiar territory, I felt like deer in headlights. It was all new and there was so much to absorb and learn.

Operations consisted of a front-end and back-end. Work was siloed by disease states, the phones did not stop ringing, pharmacists displayed a clinical competence that was both impressive and intimidating. Most importantly though, standing was not required to perform the job function.

For 6 months straight, I pondered whether I made the right decision to accept the job. The more I was exposed to, the more questions I had.

What is a PICC line and how does it work? Why do these medications have special handling requirements? Is there really a need to document everything you do? Why are these medications referred to as large molecules? Last time I checked, 0.2 mLs of fluid is not very large.

Intermission

As you pause for a brief intermission, I feel it necessary to remind you that this was 2008. This particular pharmacy space was still in its infancy. Relatively speaking, it is still an infant almost 10 years later.

The difference is that in 2008, it was crawling; now it is walking briskly. I digress—back to our regularly scheduled program.

Act 2

As any good student would, I tried to incorporate my didactic learnings into my job. This proved to be a very difficult endeavor. Sure, medications such as Humira, Enbrel, and Copaxone were taught during 1 lecture, but it was clearly not enough.

On went my struggles...

At the end of my first year though, it all came together. In this moment of clarity, I realized something and by luck, I found myself at the epicenter of something special.

However, trying to explain my experience to my fellow students was daunting. I didn’t know how to define the type of work I did or the pharmacy environment I was in. Heck, the industry struggled to define it. So, when asked, I went with what I knew.

It was a unique environment in which patients were shipped their medications, instead of picking them up. The medications were complex and costly, some were refrigerated and some were not. They could be administered orally, by injection, or intravenous infusion. Most importantly though, they were life changing.

It was just a special type of pharmacy.

Connecting the past to the present

The irony in my story is that almost 10 years later, we are still searching for the best definition of specialty pharmacy—the gold standard, if you will.

Don’t believe me?

Open your favorite search engine, using your favorite browser. In the search field type, “what is specialty pharmacy?”

My guess is that your results page is filled with variety of different links and some ads. As you are scrolling up and down the page, notice all the different sources? From the likes of pharmacy organizations/associations, payers, pharmacies, and consultants; even Wikipedia got in on the action.

Now, let’s take the next step and click on a link; however, instead of choosing a link randomly, let’s employ some strategy and group all similar entities together. This is where it becomes interesting, in my opinion.

For example, explore the definitions provided by all the pharmacy organizations and associations before moving onto payers and so on. Give it a try for 5 minutes and then come back.

The findings

What I think you will see first, is a lot of commonality. Not only within a particular group, but also across the industry. Here is what I found—high cost, risk evaluation mitigation strategy, and storage and handling. Beyond this, it can vary tremendously and to the point of ad nauseam.

The most consistent point of variation I found was cost. Wait, I just told you it was a common component. How can it also be a point of variation? Hear me out for a moment.

Cost was the number one bullet in findings. The variation occurs with how cost is defined across the different entities. Some define it by month and others per year, some do both. Some definitions include absolute monetary values, while others offer ranges. If cost is going to be a part of the definition, then I needed some clarity.

For example, to whom/what is the high cost being based on? Is it cost to the patient? Is it cost to the plan sponsor? Or is it cost to the pharmacy?

If I am a patient utilizing Humira, I will most likely never exceed $5000 per month out of pocket for it. Now I am a plan sponsor and as I am reviewing my 2016 annual spend, I calculated the per month spend for Metformin ER to be $7000. Being the astute benefits manager that I am, I know Metformin ER is not a specialty medication. Hmm...

The ambiguity of cost and its place as a factor to define specialty pharmacy doesn’t offer much value when you work through the numbers. Don’t forget now, a specialty medication is defined by more than a bullet point. That is genius!

Bullet point number 2: specialty medications are used to treat complex, chronic, and/or rare conditions.

Putting my plan sponsor hat on again, my total spend in 2016 for Metformin ER was $96,000. I know for sure that Metformin ER is not a specialty medication; however, it did cost me more than $5000 per month. Okay, but let’s see if we can rule it out by applying an additional bullet point.

Does Metformin treat a complex, chronic, and/or rare condition? Well, diabetes is not rare, but you cannot argue against it being complex and chronic. I guess I will never know what a specialty medication is.

The current definitions don’t work

Going through this example demonstrates how convoluted the process is to truly define specialty medication. Amazingly enough, the aforementioned example does not even incorporate the other 5 or 6 characteristics that are usually part of most definitions.

Wait, there is even more. How often have you observed the definition of a specialty medication used to explain specialty pharmacy? They are not interchangeable nor are they synonymous, as one is a service and the other is a product.

Defining specialty pharmacy

Specialty pharmacy is not a new concept. As an industry, we have long known about it and its potential. Somehow though, it managed to still surprise us all. Every time that we get close, it reinvents itself and mitigates the progress we made. That said, let me pose a couple of questions for thought.

Is the idea of defining specialty pharmacy that difficult? Or is it perhaps because we are exercising paralysis by analysis and making it more tedious than it is?

In my thinking, it is a little bit of both. So, if you are up to the task, let’s take what we know, add something new, and remove what doesn’t really belong.

So, what is specialty pharmacy?

Specialty pharmacy is the science of preparing and dispensing specialty medications. Specialty medications are inherent to specialty pharmacy. These medications are distinguishable by their highly complex molecular structures.

That is specialty pharmacy defined but I get it though, you want more. Nothing is EVER that simple, especially health care. Well, for those who want to continue the conversation, we will.

The continued pursuit

One pause at this point and understand that as we continue, we aren’t defining specialty pharmacy. We are defining the driver of conversations within specialty pharmacy, which are specialty medications.

These medications are used for the treatment of diseases that are chronic, complex, sometimes rare, and in which traditional medications have demonstrated failure to control the disease. Specialty medications require extensive clinical management because of the risks associated with them.

Yes, all medications carry risk, I get it; however, the differences are that these risks can be lifechanging or life threatening. Specialty medications are also not special if they don’t require special handling and, sometimes, special storage.

This is where the definition ends, at least for me.

If you feel that maybe you have misread something, you didn’t. Cost is not a part of my definition for specialty pharmacy or specialty medications.

It is true, specialty medications are likely pricey. They are driving the industry (crazy), but enough complaining already. The amount of good that specialty pharmacy has brought to the industry far exceeds the costs.

The attention given to costs associated with specialty medications casts a gray cloud over what these medications are. If you personally use a specialty medication or know someone close to you that does, this makes more sense to you. If you don’t, find someone who does and ask to hear about their story.

What you will gain, is a new perspective that sounds something like this.

Specialty pharmacy and the medications encompassing the service are nothing short of lifechanging. They have provided new hope, improved quality of life, and, in some cases, cured diseases. These are pretty remarkable feats and deserve the attention.

About the Author

Joe Thomas earned his Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. He has spent the past several years working across several specialty pharmacies, integrated in both staff- and corporate-experiences.