Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study.

BACKGROUND: Despite the availability of new direct-acting antiviral (DAA) regimens, changes in DAA reimbursement criteria, and a public health focus on hepatitis C virus (HCV) elimination, it remains unclear if public and private insurers have increased access to these therapies over time. We evaluated changes in the incidence of absolute denial of DAA therapy over time and by insurance type. METHODS: We conducted a prospective cohort study among patients who had a DAA prescription submitted from January 2016 to April 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services across the United States. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. We calculated the incidence of absolute denial, overall and by insurance type (Medicaid, Medicare, commercial), for the 16-month study period and each quarter. RESULTS: Among 9025 patients from 45 states prescribed a DAA regimen (4702 covered by Medicaid, 1821 Medicare, 2502 commercial insurance), 3200 (35.5%; 95% confidence interval, 34.5%-36.5%) were absolutely denied treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than Medicaid (34.5%, P < .001) or Medicare (14.7%, P < .001). The incidence of absolute denial increased across each quarter of the study period, overall (27.7% in first quarter to 43.8% in last quarter; test for trend, P < .001) and for each insurance type (test for trend, P < .001 for each type). CONCLUSIONS: Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.

Adherence to hydroxyurea medication by children with sickle cell disease (SCD) using an electronic device: a feasibility study.

Adherence to hydroxyurea (HU) is a significant modifying factor in sickle cell vaso-occlusive pain. We conducted a study using an electronic medication container-monitor-reminder device (GlowCap™) to track adherence and determine whether use of this device affected rates of HU adherence. Subjects were regular attendees to our clinic. They were given a 37-item questionnaire and were asked to use a GlowCap containing HU. When the device cap is opened, it makes a remote "medication taken" record. The device also provides usage reminder in the form of lights and alarm sounds if the cap opening is delayed. Nineteen subjects participated in the survey, and 17 in the intervention phase. Of the 17, 12 had reliable adherence data. Seventeen caregivers of patients and two patients completed the survey. Two most common barriers to adherence identified were lack of reminders and absence of medicine home delivery. The intervention component of this study, which used both the electronic (GlowCap) method and medication possession ratio showed that the median adherence rate for the 12 patients evaluated was 85 %. The GlowCap device accurately kept a record of adherence rates. This device may be an effective tool for increasing HU medication adherence.

A retrospective study of direct cost to patients associated with the use of oral oncology medications for the treatment of multiple myeloma.

OBJECTIVE: To examine direct cost to patients associated with oral oncolytics for the management of multiple myeloma (MM) both before and after financial assistance, and assess the effect on adherence. METHODS: In this retrospective study, pharmacy claims were analyzed for those patients with a diagnosis of MM who received thalidomide, lenalidomide, or pomalidomide from a large specialty pharmacy in the US between January 1, 2011, and December 31, 2013. Average direct cost to patients, per prescription, was analyzed both before and after financial assistance. Adherence was assessed through an analysis of medication possession ratio (MPR) for those patients who filled a prescription ≥2 times throughout the 3-year time period. RESULTS: A total of 77,821 prescriptions for thalidomide, lenalidomide, and pomalidomide were filled by 6731 unique patients between January 1, 2011, and, December 31, 2013. The average direct cost to patients, per prescription, for any of these three agents was $227.23 prior to financial assistance and $80.11 after financial assistance, representing an average patient savings of $147.14 per prescription. Prior to financial assistance, the average direct cost to patients was ≤$50 for 57.6% of all prescriptions. After financial assistance, 86.2% of patients had a direct cost of ≤$50 per prescription. Adherence, as assessed by MPR, did not vary significantly based on direct cost to the patient. LIMITATIONS: This study included patients receiving therapy from a single specialty pharmacy for a single indication. There may be patients included in the analysis who received prescriptions from other pharmacies prior to or after the prescriptions available for analysis. Most of the prescriptions included in the analysis were for lenalidomide. CONCLUSIONS: This retrospective study demonstrated that the specialty pharmacy helped patients significantly reduce their direct cost expenditures by securing funding and co-pay assistance.