High Expectations Accompany Specialty Drug Therapies

Clinical outcomes have different meanings among specialty pharmacy stakeholders.

Why are specialty pharmacies and pharmaceutical manufacturers so profitable?

This question seems to be the primary topic of many conversations surrounding health care and politics. The revenue and net profit associated with specialty therapies has shifted the focus of the entire pharmaceutical industry.

Every stakeholder, including pharmaceutical manufacturers, providers, health plans, and the general public, seem to be fascinated with the expense of the therapies. What expectations do the stakeholders have due to the high expenses? The answer is very apparent: they demand improved clinical outcomes.

Clinical outcomes have a different definition to each stakeholder in the specialty pharmacy industry. Each stakeholder has a different measurement of efficacy.

Providers often reference lab values and clinical response, while patients are more concerned about their quality of life. Providers and patients need to weigh these factors when justifying the cost.

Why measure the clinical outcomes of these therapies at all? All therapies, excluding their cost, must be able to demonstrate some positive clinical response; however, specialty therapies have higher expectations due to their expense.

In the age of evidence-based medicine, a provider must have a concrete rationale for placing a patient on specialty therapies. More often than not, providers must justify their logic before any health plans cover the therapies. This process is a simple verification by the health plans to ensure their dollars are spent appropriately. They must ensure that they will receive a return on investment.

How does the industry measure clinical outcomes? The industry must look at clinical outcomes through a different lens. Most stakeholders agree with the fact that the main measure of any therapy is a positive clinical response, be it a cure or extending a patient's life by a few months.

If clinical responses are being met, then is the cost justified? What if they're not?

The increased number of specialty pharmacies is a testament to the income that can be made from these therapies. This leads to another question: how do manufacturers and health plans pick specialty pharmacies to be partners in their network?

Each specialty pharmacy must be able to prove why utilizing their services will increase their patient's clinical outcomes.

Specialty pharmacies come in a variety of different sizes, and can focus in different therapeutic areas. Some specialize in a particular disease state, while others cover a broad spectrum of diseases.

Despite their size, every specialty pharmacy is tied to the outcomes of their patients. Medication adherence is a primary focus of many health plans and providers.

Proportion of Days Covered (PDC) rates are rapidly becoming the industry standard, and can be a benchmark used to compare specialty pharmacies. The percentages can range from the mid-80s to the mid-90s, and often vary for each disease state.

Health plans often require much more than compliance numbers, and this is evident by the intricate provider agreements that are negotiated. Care management services include prior-to-therapy counseling, in which a specialty pharmacy must document a patient's ability to understand the purpose of the medication, dosage, schedule, side effects, and a therapy action plan.

Once therapy is started, specialty pharmacies must have periodic assessments to re-evaluate the appropriateness of therapy. Overall, each stakeholder is looking to take a patient from baseline, add one intervention, or several that leads to positive results.

The layering of interventions often can have a compounded effect, and is the reason why many accrediting bodies require multiple standards to be met for each patient.

Specialty outcome data goes way beyond just mere drug adherence. How a specialty pharmacy detects and documents dispensing errors is also a common metric.

Mistakes made with specialty therapies have a compounded effect due to their cost. Not only must new medication be dispensed to the patient, but they must find if the error led to more medical interventions and cost.

How is overall patient satisfaction measured with each specialty pharmacy? Is this an important metric? Specialty pharmacies have an obligation to ensure their patients are cared for in a way that makes their therapies as effortless as possible.

Phone metrics, for example, are a common requirement for accrediting bodies and health plans. Each stakeholder deserves to have their needs met in as real time as possible. Patient surveys are often used to measure the quality of life and overall satisfaction.

Specialty pharmacies are at the epicenter of the health care debate over specialty medications and their cost. Each specialty pharmacy must be able to demonstrate increased clinical outcomes with their interventions.

Clinical outcomes can justify the extreme costs associated with therapy and must be well documented and followed. As the industry moves down the specialty path, it will be imperative that each health care dollar is being used effectively.

About the Author

Anthony Mazzarese is a graduate of The University of Pittsburgh School of Pharmacy, 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 is the Pharmacist-In-Charge at Giant Eagle Specialty Pharmacy. His practice is focused on improving medication compliance and overall wellbeing in the areas of HIV, auto-immune disorders, oncology, and organ transplantation.