Logistic Issues in the Treatment of HCV Patients With the New All-Oral DAA Agents

Abstract

Introduction: To identify logistic challenges in starting and maintaining adherence to an all oral directacting antiviral (DAA) therapy for chronic HCV patients, and to develop strategies to manage these new logistic issues. Methods: Newly approved DAA agents (simeprevir and sofosbuvir) have provided new options for non-IFN-based HCV therapy with improved efficacy and side effect profile. Treating physicians in the past were challenged with management of numerous IFN side effects. However, with these new therapies, physicians and patients are dealing with different challenges related to the logistics of treatment. This observational study describes our experience in managing patients on these new therapies. Results: Total number of subjects were 16 (6 female; 10 male). Prior treatment of the patients was none, IFN/RBV only, IFN/RBV with DAA, and DAA alone in 3, 6, 5, and 2 patients, respectively. Insurance plans included 13 with PPO and 3 with HMO plans. Insurance denied these medications to 10 patients on the first attempt; 5 were approved after 1 appeal letter, and 4 approved after 2 appeal letters. One patient was denied because the medications were not the insurance plan formulary. Average time to receipt of medications was 37±28) days (range: 14-117 days). Most delays were related to the insurance approval process followed by the specialty pharmacies not efficiently using available copay assistance programs. Missed doses occurred in 40% of patients for several reasons: need for repeated prior authorization for second or third month of medication, chronic vomiting during the first month, hospitalization for recurrence of lymphoma, unexpected extension of a business trip, and failure to order refill when patient thought treatment was 1 month. Medication tolerance was very good; however, compliance with designated lab and office visits was poor. Half of the patients followed the plan as given, 3 patients required reminders for each part of the plan, and 4 patients were noncompliant despite reminders. Three patients had other medical conditions that interfered with compliance (encephalopathy in 2 and recurrent lymphoma in 1). Conclusion: Despite of 66% of our patients receiving an initial medication denial, 94% of our patients received eventual approval. Process requires trained, experienced specialty pharmacy personnel and physicians familiar with the data for an appeal letter template. These medications are well tolerated; however, patients still required extensive education to maintain compliance. Despite minimal side effects, office visits were a good tool to monitor compliance and identify the adherence issues. Compliance strategies include working with proactive pharmacies, continuous education of patients, and rapid action for identified issues.