Collecting data that show the most efficient and effective ways to clinically manage patients is becoming more important than ever in specialty pharmacy.
With specialty drug costs projected to account for 50% of all drug spend by 2020, it is more important than ever that specialty pharmacies document and report positive clinical outcomes for patients. In an effort to identify the most effective therapies and justify the large costs associated with these therapies, specialty pharmacy systems that track patient data around clinical outcomes are now part of our core business model.
When clinically managing patients with complex, chronic disease states such as HIV, multiple sclerosis, and hepatitis C, pharmacies must continually enhance these systems to account for new specialty medications with additional clinical monitoring requirements. Once this information is captured within the specialty pharmacy system, it must then be reported to payers and pharmaceutical manufacturers to fulfill contractual requirements and demonstrate improved clinical outcomes for the drugs and patient lives that they manage. It makes sense, right?
As an employer group, if I’m paying $7000 for a Copaxone prescription, I need to make sure that it’s working. By the same token, if I’m a pharmaceutical manufacturer of an orphan drug, I need to demonstrate continued safety and efficacy for the medication, especially if my initial clinical trial size was limited.
A Study in Specialty Pharmacy Care for MS Patients
It has been proven that specialty pharmacy care significantly improves clinical outcomes for patients. Clinical management of patients’ drug therapy through proactive outreach for renewal prescriptions—as well as prior authorization renewals, consistent patient counseling, clinical monitoring, and refill reminder communication—has been found to improve patient outcomes on both a quantitative and qualitative basis.
To demonstrate this impact, a retrospective cohort study conducted through 2016 followed multiple sclerosis patients for 3 years to track adherence and clinical outcomes when receiving specialty pharmacy care versus traditional community pharmacy care. The study examined the prevalence of MS relapse in a cohort of patients receiving each type of pharmacy care.
The results were clear: The patients with MS receiving specialty pharmacy care had a significantly lower risk of disease relapse than the patients receiving traditional community pharmacy care.
The outcomes reporting from the specialty pharmacies in this study made it possible for these positive clinical results to be demonstrated. In an era in which cost savings are king and new specialty medications are hitting the market with prices more than $40,000 per month, it is essential to continue to show the ways that we, as specialty pharmacies, manage these medications responsibly.
If we can identify the most efficient and effective ways to clinically manage these patients and back up these findings with data, we can ensure mutually beneficial outcomes for our patients and payer partners and gain a competitive advantage in the marketplace.
Outcomes Beyond Clinical Trials for Orphan Drugs
When new specialty medications come to market, especially those with indications for rare diseases with extremely small patient populations, the outcomes data collected by the specialty pharmacies with contractual access to these drugs are required for pharmaceutical companies to prove continued drug safety and efficacy.
In order to ensure positive patient clinical outcomes, we first must insure that our patients are taking their medications correctly. Once the patient starts the medication, we must monitor their adherence and track key clinical indicators associated with the drug over time.
Compiling and reporting these data gives the pharmaceutical manufacturer key insight into the real-world application of their drug as opposed to data compiled in a controlled clinical trial setting. Since many orphan drugs are approved by the FDA based on small clinical trials due to small overall patient populations, these real-world data are necessary to allow patients continued access to the medication.
Typically, there are also specific storage and handling requirements associated with these drugs, so being able to consistently confirm stability data is directly related to the integrity of the drugs and, therefore, patient safety.
Payers and Pharma Rely on Specialty Pharmacy Outcomes Data
Outcomes reporting has really become a core competency of the specialty pharmacy. It is a quintessential part of the specialty pharmacy model and is required for every payer and pharma contract.
Payers depend on specialty pharmacies to demonstrate that they are fluent with cost savings measures while providing excellent care to patients. This care must include attention to clinical details, such as adherence metrics and any additional clinical markers required for the specialty drugs taken by their patients.
Payers must be able to trust that the care provided by the specialty pharmacy will improve their patients’ quality of life and decrease costs associated with hospital admissions and absenteeism. Therefore, the pharmacy must provide patient data back to the payer to prove that their care fits these criteria.
Pharmaceutical manufacturers of specialty medications also depend on specialty pharmacy outcomes data to ensure that their drugs are safe and effective, and that patients can continue to gain access to them.
About the Author
Kimberly Firtz earned her 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. Kimberly has spent the last 5 years working in Specialty Pharmacy, initially as a clinical pharmacist and most recently working on a variety of high profile Specialty Operations Projects. Her current role is working with the Process Innovation team on an effort to transform Specialty Operations and optimize the stakeholder experience.