Development of a specialty medication clinical dashboard to improve tumor necrosis factor-α inhibitor safety and adherence monitoring

Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose To describe the development of a pilot specialty medication clinical dashboard targeting tumor necrosis factor (TNF)-α inhibitor therapy. Summary This was a quality improvement project conducted between August 2019 and April 2020. The dashboard was designed with collaboration between clinical pharmacists and specialty providers in rheumatology, gastroenterology, and dermatology. Data was queried from the Veterans Affairs Corporate Data Warehouse. Patients with an active prescription or intravenous order for a TNF-α inhibitor were included. Dashboard flag criteria focused on TNF-α inhibitor safety and adherence monitoring. Flag results from the dashboard were characterized from data captured at a single time point. For 431 patients on TNF-α inhibitor treatment at the institution, 304 flags corresponding to 223 unique patients (51.7%) were identified on the dashboard: 3% of patients had a new infection, 9% had overdue monitoring laboratory tests, 5% had a critical laboratory result, 2% were on 2 biologic agents, 27% were overdue for a refill, 6% had an emergency department visit, and 2% had an inpatient admission. No patients were flagged for heart failure exacerbation or new malignancy. Seventeen percent of patients were prescribed high-dose etanercept or adalimumab, representing a potential annual cost savings of $302,497 if 50% of these patients had their dose successfully reduced to labeled dosing. Opportunities for pharmacist intervention utilizing the dashboard were identified and characterized through chart review of flagged patients. Conclusion Pharmacists have the opportunity to improve safety and adherence for TNF-α inhibitor therapy through use of a specialty medication clinical dashboard. The dashboard should be used in conjunction with collaborative practice protocols.

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments’ continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients, and shed light on pharmacists’ vital role in patient care. This insightful and real-world experience is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies.

Specialty Pharmaceuticals – Utilization Management

Specialty medications are complicated, treat complicated diseases, and are costly. Yet, even if their cost was to be decreased by 50%, many of the specialty medications would still be too costly either with high copays, or be unaffordable under any circumstance. Hence the use and oversight of Specialty medications is more complex than just cost: effectiveness, risk and cost must be evaluated concurrently. Utilization is actually the great multiplier. No matter the individual cost of a medication, uncontrolled expansion of medication use leads to more drugs, and therefore, higher drug spend. Utilization management of Specialty medications is, thus, a multifactorial process that is as important as cost management. Human Insulin was the first of the so-called “Specialty Medication.” Specialty treatments followed for orphan and previously untreated diseases. Treatments for chronic diseases followed where Specialty medications replaced older small molecules. The major complication was that the cost of these new treatments rivals, and often exceeds, acute care hospital stays. Unfortunately, evidence has not always matched the comparative benefits of Specialty medications over their small molecule counterparts. As a result, the explosion of new Specialty medications has also stimulated the need for strong evidence that these medications are significant improvements over prior therapies. If so, how can they be affordable? Utilization management of Specialty medications shares many of the same elements that have been used for decades to monitor and manage all treatments; namely, prior authorization, drug utilization review, step therapy, and quantity limits. This paper will examine the approach to utilization management of Specialty medications with the goals of providing a template for providers to participate in this management as well as to understand the metrics applied when these medications are submitted for payment.

Development of a specialty medication prior-authorization service at an urban academic medical center

Purpose The project in which a clinical pharmacist enlisted the help of pharmacy students to create a team responsible for prior-authorization (PA) paperwork associated with hepatitis C virus (HCV) infection treatment is described. Summary Many insurance companies require completion of a time-consuming PA process for approval of high-cost specialty medications, such as those used in the treatment of HCV infection. A clinical pharmacist at an urban academic medical center recruited pharmacy students to assist with and streamline the HCV medication PA process. After training, the students developed a protocol to increase the efficiency of completing PA requests, appealing denials, obtaining PA extensions, and documenting progress in the electronic medical record to ensure continuity of care. The PA team collaborated with clinicians to document proof of medical need and worked with insurers, pharmacies, and patients to achieve timely approval and receipt of medications. From June 2014 to March 2015, three students spent 240 hours developing the PA protocol and completing 88 PA requests, with an overall medication approval rate of 87.7%; 18 patients were also referred to medication assistance programs. The PA team’s work allowed the clinical pharmacist to spend more time on clinical activities and scholarship, while the students increased their knowledge of HCV disease and HCV-targeted therapies and improved their skills in written and verbal communication with patients, providers, and insurance companies. Conclusion Pharmacy students successfully implemented a PA team to manage prescription approval for HCV medications with assistance from a clinical pharmacist.