Justification of Cost: Therapeutic Outcomes in Specialty Pharmacy


Prescribers, pharmacists, and manufacturers must demonstrate that patients are receiving clinical benefits from high-cost specialty drugs.

As the cost of specialty medications continues to rise at a rapid rate and more medications enter the specialty pharmacy space, stakeholders across the health care continuum are looking for ways to accurately quantify value. Patients, who have the most to gain, want to ensure the therapies they are receiving are the best options for their given disease state.

Likewise, prescribers and pharmacists are seeking data to reinforce their clinical product selection, patient counseling, and monitoring parameters. Manufacturers are also extremely engaged in analyzing data and clinical response to therapies that they have developed.

Not only do they want to continue the post marketing surveillance of their products, but they are also looking for ways to improve on existing therapies currently in use. Lastly, third party payers want prescribers, pharmacists, and manufacturers to demonstrate that patients are receiving similar clinical benefits that have previously been documented in the FDA trials which led to the product’s approval.

Perhaps the best way to quantify value of these therapies is through patient outcomes. Several questions arise when discussing outcomes measures.

1. What types of outcomes should be measured?

2. How will outcomes be measured?

3. How much customization is required for a given therapy?

4. How strictly should outcome measures be tied to reimbursement models?

5. Who is responsible for collecting and reporting on outcomes?

6. What constitutes a positive response to therapy?

Most importantly, patient experiences are the fundamental driving force behind reporting outcomes. By demonstrating positive responses through proper medication utilization and therapy management, both pharmacists and manufacturers can demonstrate the value of treatment to payers.

It provides an opportunity to highlight components of care that improve the patient journey. Through the proof of outcomes, pharmacies are able to maintain a line of business with existing and potential business partners, along with meeting contractual obligations.

Clinical responses are often times difficult to quantify. A key measure to show clinical improvement is a proper baseline measurement.

Ideally, this baseline measure will have a quantifiable value. For example, medications that treat congestive heart failure may use a 6-minute walk test.

Therapies that treat HIV would measure viral load, and hepatitis C therapies would examine the sustained virologic response 12 weeks following completion of therapy. Additionally, patient reported outcomes, such as quality of life and improvement in activities of daily living for select treatments may be appropriate to use.

Unfortunately, recording and reporting outcomes data is often difficult. Frequently, baseline data may be incomplete and missing all together.

If patients are started on therapy prior to obtaining proper baselines, demonstrating positive outcomes can become extremely difficult. Specialty pharmacies should work closely with prescribing agents to ensure baseline documentation has been completed before initiation of therapy so that clinical outcomes are associated to therapy.

It has become more common for payers to request clinical outcomes data for patients who are being treated with specialty therapies. These requests for positive response are occurring after completion of therapy for acute conditions, such as C. difficile, and during chronic treatment for disorders, such as Noonan syndrome, that require treatment with growth hormone.

Without proper documentation by the dispensing pharmacy, payers are refusing to provide reimbursement for these products. Moreover, payers may choose to no longer reimburse the pharmacy for products that are not demonstrating a positive clinical response for their plan member.

Unfortunately, defining a positive clinical response can sometimes be difficult, especially for disease states that have less objective quantifiable values. The responsibility for collecting and reporting outcomes lies with all providers involved in the patient’s care.

Effective collaboration between specialty pharmacies and providers will result in the most positive patient outcomes. It is clear that as specialty pharmacy costs continue to rise and there is an increased emphasis on outcomes measures across the health care industry, specialty pharmacies will be called upon to deliver enormous amounts of data to payers, manufacturers, and prescribers.

The importance of specialty pharmacy-reported patient outcomes cannot be understated. The real world use and response to some of the most expensive therapies available will be determined by outcomes in patient populations such as HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, hemophilia, and other rare diseases.

Third party payers will begin to more closely scrutinize the cost and benefit for many specialty therapies. Specialty pharmacies are uniquely positioned to not only report these data to key stakeholders, but also improve clinical outcomes through the enhanced provision of care.

Clinical pharmacists are especially well positioned to offer patient counseling and specialized disease state management services that improve outcomes of medication therapy and patients' overall well-being.

About the Author

Justin Smerker earned his PharmD degree from the University of Pittsburgh in 2009. He is currently a clinical pharmacist for PANTHERx Specialty Pharmacy. He has experience in the implementation and delivery of high-touch patient care services as well as in clinical management, persistency, and adherence programs. Justin also has participated in assisting with the successful launch of newly FDA approved medications. He has served as an adjunct clinical instructor for experiential education at Duquesne University. Prior to working in the specialty pharmacy sector, Justin successfully managed high volume retail pharmacies. He 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.

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