Caines, Jake

BACKGROUND: Medication Therapy Management (MTM) is a strategy for developing a variety of non-dispensing clinical pharmacy services to patients which aim to optimize therapeutic outcomes by identifying and resolving drug therapy problems. We conducted a pilot study to see if MTM could serve as a measurable value-add as demonstrated by improved outcomes for IBD injectable biologic patients and reduced disease management burden for clinicians and office staff. METHODS: Adult patients with either UC or CD prescribed new self-injectable biologic agents (adalimumab [ADA], certolizumab pegol [CTZ], golimumab [GOL], or ustekinumab [USTE]) were recruited from outpatient clinics at Mayo Clinic Rochester, Arizona, Florida or Health System. Exclusion criteria included prescriptions that were refills, patients with need for urgent hospitalization, pregnant patients, those without a reliable and confirmed shipping address or reliable telephone access, or patients residing outside of the United States. Patients were randomized to receive standard care or be enrolled in a collaborative, high-touch MTM program administered by Curant Health PharmD's. Patients randomized to MTM were further stratified to either having medications filled by Curant Health or specialty pharmacy as dictated by insurance plan. Patients receiving standard care were managed as per discretion of the treating physician. Patients receiving MTM arms were contacted per a defined protocol with calls at specified time points. The primary outcome of interest was number of unsolicited calls/messages from patients to practice sites during the study time period along with total time spent on the managing of those messages either electronically or via telephone. Secondary outcomes of interest included medication adherence as defined by percent of patients with a score of >6 at week 24 (MMAS-8) and disease activity as measured by relevant disease indices. RESULTS: 20 patients were randomized to MTM and 19 to standard care. There was no difference in median age or sex distribution among groups. The majority of patients were started on ADA, 1 CTZ and 1 USTE. One patient was enrolled twice with different medications to the standard group. Nine MTM patients required additional support to optimize therapy with 1 patient requiring 6 additional calls. The majority of calls involved injection administration, how to treat injection site reaction, pain and misfiring. The number of unsolicited calls overall in the MTM arm were significantly higher than standard care: 3 vs 1 ( P < 0.05). The overall adherence to medication at week 24 was significantly higher with MTM; scores ranged from 7.5–8 vs 5.5–6 in the standard care group ( P < 0.05). The median disease score of the MTM group also improved significantly for both diseases by >50% at week 24 for 13/20 patients compared with 10/19 for standard group. CONCLUSION(S): Patients in the high-touch, collaborative MTM arm received additional engagement as evidenced by the significant increase in unsolicited patient calls. MTM patients also showed improved adherence and improved disease outcomes to injectable therapy. This suggests that MTM services are an effective mechanism to relieve burden of office staff while improving patient care.