The Challenge of Measuring Outcomes in Specialty Pharmacy


There is a growing need to develop standards for measuring outcomes among patients treated with specialty drugs.

The concept of measuring outcomes in pharmacy is nothing new. The industry has been driven to achieve positive outcomes and mitigate negative outcomes since the days of the mortar and pestle. However, in the specialty pharmacy era, it has taken on a whole new meaning.

It is not a secret that specialty medications tend to carry a higher price tag; however, in most cases, they are extremely effective. Their efficacy has led to a nationwide increase in utilization, sometimes warranted and sometimes not.

The notion of being able to determine when use is warranted or not has pushed specialty pharmacies to the forefront of the industry. Specialty pharmacies regularly communicate with patients throughout their journey.

Frequent contact with patients allows for information to be exchanged more often. The information obtained can vary from adverse effects that a patient has experienced to medication/disease updates.

Because of this, specialty pharmacies have become experts at asking the right questions to aid their patients in achieving therapeutic success or positive outcomes. Manufacturers, payers, and physicians rely on specialty pharmacies to share this information with them.

Manufacturers desire to know the outcomes their products have on the intended treatment population. Payers seek to know whether the medication being paid for has produced justifiable results. Physicians want to know whether the prescribed medication is helping their patient achieve the desired outcome.

This is just the tip of the iceberg though.

For a specialty pharmacy, having the tools in place to help improve, measure, and report on outcomes can have even greater implications. A pharmacy that can show how they enabled a patient to achieve a positive outcome, while mitigating risks, will be looked upon favorably by manufacturers.

This is critical for specialty pharmacies to maintain lines of business, especially for those already under contract with manufacturers. Additionally, it may present future opportunities for a specialty pharmacy to grow its business.

Manufacturers of specialty medications are always in search of high quality specialty pharmacy partners. With the vast majority of specialty medications having a limited distribution network, proven specialty pharmacies will be more likely to be rewarded a contract.

Looking at the payer-specialty pharmacy relationship, the same holds true. Payers recognize the value of a specialty pharmacy who is able to assist their member to achieve positive outcome.

Conversely, they also rely on the specialty pharmacies to keep them apprised of a situation in which a member is not achieving the desired outcome. The process of outcomes measuring and reporting seems to be a fluid process, right?

In less than 400 words, I provided you with the framework of outcomes, why it is important, and who is involved. Unfortunately, however, it is much harder than it seems.

The most difficult part is not necessarily the reporting, but instead it is frequently the measurables needed to satisfy one partner to the next.

Aha! You may have just come up with an idea: Why don’t we just use the standards as a benchmark?

I like your idea, but whose standards? Are they subjective, objective, or both? Here lies the gray area in outcomes.

Let’s take a patient who is, receiving a specialty medication to treat mild to moderate Crohn disease. The patient has been on the medication for 6 months and indicates how much better they “feel,” when asked, which is a purely subjective response.

Is this an appropriate criterion to measure the outcome of the medication therapy? Maybe, but there is more. A recent colonoscopy on this same patient shows no improvement from baseline, and in addition, has shown slight disease progression, which is an objective finding.

Now what to do we do? The patient has reported feeling well, but the medical findings contradict this.

If anything, this example demonstrates the need to consider everything when we attempt to measure outcomes. I do not ever foresee a time in which specialty pharmacies measure outcomes in a cut and paste scenario.

Suppose we have 50 patients receiving the same specialty medication. The medication will always be the same. Those 50 patients though, they are all unique. Therefore, while they all might report positive outcomes as a result of the medication, but a gold standard measure might exclude 45 of them.

Therefore, it is important that when measuring outcomes, we consider a few characteristics. First, can outcomes be quantified? Lab values, disease markers, etc.

Next, are there any quantifiable values? Improvements of daily activity, increased quality of life, etc. Finally, how frequently should outcomes be measured? Measuring outcomes in specialty outcomes can be a difficult task. However, with some applied due diligence and consideration of all the information available, we can make the task less distorted.

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.

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