Optimizing maintenance dosing of emicizumab-kxwh as prophylaxis in hemophilia A: Dosing to product labeling while minimizing drug waste.

BACKGROUND: The introduction of the bispecific antibody emicizumab-kxwh has driven a paradigm shift in the management of patients with hemophilia A. Emicizumab-kxwh is gradually replacing factor VIII as the treatment of choice for prophylaxis. The requirement to dose emicizumab-kxwh by weight can drive waste when the appropriate combination of various strengths of single-use vials is not considered, whereas inappropriate rounding to full vials can lead to significantly subtherapeutic or supratherapeutic doses. OBJECTIVE: To quantify waste reduction and impact to savings when a clinical program designed to optimize the emicizumab-kxwh dose, frequency, and vial combination is applied at the dispensing specialty pharmacy level. METHODS: The electronic medical records of 360 patients receiving emicizumab-kxwh as maintenance therapy were retrospectively reviewed. Patients were included in the sample if they were male, were aged 18 to 89 years, were inhibitor negative, and had at least 1 new or renewal maintenance prescription in 2021. Three hundred seventy discrete regimens were identified as evaluated per the Regimen Optimization Algorithm - emicizumab-kxwh and included in the final sample. Data collected for each regimen included patient weight, emicizumab-kxwh dose and interval originally prescribed, every 7-day equivalent regimen (to the hundredth of a milligram), vial combination originally ordered, and resulting waste generated. For those regimens failing the algorithm, additional review of pharmacist follow-up and prescriber engagement was performed. When the prescriber adopted a pharmacist recommendation to adjust dose, frequency of administration and/or vial combination, impact to cost was calculated (Medicare Part B 2022 average sale price). RESULTS: 48% (176/370) of reviewed regimens failed specialty pharmacist review because they drove a potentially subtherapeutic or supratherapeutic dose and/or resulted in the use of partial vials that required that the patient discard all emicizumab-kxwh over the prescribed amount with each dose. 112 (64%) of these failed regimens met full criteria for prescriber engagement to recommend a regimen adjustment to dose, frequency of administration, and/or vial combination. These recommendations were adopted in 43% of cases (48/112), resulting in a cumulative savings of 600 mg per dose while also avoiding significant subtherapeutic or supratherapeutic dosing. When factoring in the frequency of administration at the patient level, cumulative annual savings to payers across these 48 accepted recommendations was $1,793,549.76. CONCLUSIONS: These data illustrate that the application of an evidence-based Regimen Optimization Algorithm at the dispensing specialty pharmacy level can reduce waste and drive payer savings while avoiding significant subtherapeutic or supratherapeutic dosing. DISCLOSURES: Accredo, Inc, a specialty pharmacy dispensing emicizumab-kxwh to patients with hemophilia A, employs the authors. Accredo, Inc, is a subsidiary of EverNorth, which also includes Express Scripts, a PBM that adjudicates a portion of emicizumab-kxwh claims.

Impact of specialty pharmacy on telaprevir-containing 3-drug hepatitis C regimen persistence.

BACKGROUND: Although the recommended treatment of hepatitis C continues to evolve as newer and more effective medications are made available, hepatitis C drug regimens consisting of a 3-drug combination of a protease inhibitor, pegylated interferon, and ribavirin were recommended by the American Association for the Study of Liver Diseases for the HCV genotype I beginning in 2011. Although more effective than the earlier standard of care, these regimens have complex dosing schedules, prolonged duration, and deleterious side effects. It has been shown that patients tend to discontinue these regimens prematurely. Specialty pharmacies offer specialized care management programs to hepatitis C patients, consisting of such services as regularly scheduled patient counseling, assessing regimen appropriateness, monitoring treatment progress, scheduling refill reminders, and coordinating patient care with prescribers. The use of specialty pharmacies by hepatitis C patients may improve persistence on the 3-drug hepatitis C regimens. OBJECTIVE: To examine the association of pharmacy dispensing channel (specialty pharmacy or retail pharmacy) and hepatitis C regimen persistence among patients on a 3-drug hepatitis C regimen containing telaprevir, a widely used hepatitis C protease inhibitor.  METHODS: A retrospective, observational study was conducted using pharmacy claims data from a national pharmacy benefits manager for the period July 2011 to June 2013. Continuously eligible patients who started a new 3-drug regimen containing telaprevir were included in the study and followed for up to 12 months after the index hepatitis C claim. The study outcome was persistence to the 3-drug regimen at treatment week 24 (day 168), representing the completion of an important milestone in the regimen. Patients were defined as persistent if they filled 84 days' supply of telaprevir and 168 days' supply of pegylated interferon and ribavirin each, as required by the regimen protocol. Multivariate logistic regression was used to evaluate the association between dispensing channel and persistence, controlling for differences in demographics, medication burden, out-of-pocket spend per 30-day adjusted hepatitis C prescription, and average days' supply per unadjusted hepatitis C prescription. RESULTS: The final study sample consisted of 1,475 patients-1,182 in the specialty pharmacy group and 293 in the retail pharmacy group. A significantly greater proportion of patients were persistent to the 3-drug hepatitis C regimen containing telaprevir in specialty pharmacy, compared with retail pharmacy (56.0% vs. 39.9%, P less than 0.001). After multivariate adjustment, patients in the specialty pharmacy group had 1.89 times greater odds of being persistent to 3-drug hepatitis C regimens containing telaprevir compared with patients in the retail group (95% CI=1.44-2.48). CONCLUSIONS: Patients who used a specialty pharmacy offering refill reminders, care management, and care coordination with prescribers were significantly more likely to be persistent to 3-drug hepatitis C regimens, compared with patients using a retail pharmacy.