“Both doses of RPC1063 demonstrated large, significant, and consistent reductions of all MRI measures of MS disease activity,” said Dr. Cohen. “The tolerability and safety results suggest a favorable risk–benefit profile of RPC1063 in the treatment of relapsing-remitting MS. These results support the ongoing phase III portion of the RADIANCE trial of RPC1063 vs interferon beta-1a in relapsing-remitting MS,” he concluded.
—Erik Greb
Improved Adherence to Disease-Modifying Therapy Reduces Health Care Resource Use and Medical Costs
Improved adherence to disease-modifying therapy (DMT) is associated with lower medical and indirect costs, reduced work-loss days, and decreased inpatient stays and emergency visits for patients with multiple sclerosis (MS), investigators reported.
According to published estimates, real-world adherence to DMTs in MS ranges from 41% to 88%, and higher adherence is associated with lower rates of relapse and lower costs. Sander Yermakov, from the Analysis Group in Boston, and researchers from Biogen Idec in Cambridge, Massachusetts, sought to estimate the effect of adherence to DMTs in health care resource use and cost outcomes in patients with MS and to model the impact of improving adherence on these outcomes.
A retrospective analysis was conducted using the OptumHealth Reporting & Insights employer claims database, which contains information on medical and pharmacy claims for more than 18 million beneficiaries in the US, as well as disability claims and salary information in a subset of approximately 4.2 million employees. Employed patients with two or more MS diagnoses (ICD-9-CM 340) initiating DMT from January 2, 2002, through March 31, 2012, were included in the analysis.
Direct medical costs (paid amounts to providers for services or drugs, excluding payments for DMTs), indirect costs (disability payments to employees and work-loss costs to employers), and resource use were analyzed in the six months prior to initiation of any DMT (baseline period) and for three years after initiation (follow-up period). Adherence to any DMT was defined as the proportion of days covered (PDC) and measured using the percentage of days in each follow-up period during which the patient had one or more MS DMT available.
Multivariate regression analyses were used to estimate the effect of PDC on follow-up period outcomes, controlling for baseline characteristics. The estimated model was used to predict the change in use and costs associated with a 10% improvement in PDC.
A total of 1,538 patients met the selection criteria (baseline age, 43.6; 63% female). PDC had a statistically significant effect on direct medical and indirect work productivity costs, work-loss days, and likelihood of an inpatient stay or emergency visit at one-, two-, and three-year follow-up. A 10% improvement in PDC was estimated to reduce direct costs by 4%, indirect costs by 3% to 4%, work-loss days by 3% to 7%, likelihood of an inpatient stay by 13% to 19%, and likelihood of an emergency visit by 8% to 19%, depending on the follow-up period.
The impact on the likelihood of an inpatient stay or emergency visit increased with the length of the follow-up period. In the first year, the decrease in direct costs associated with a 10% improvement in adherence was greater for patients with PDC of 0.8 or higher (10%), men (6%), and patients not on disability in the baseline period.
—Glenn S. Williams
Equivalence Demonstrated by a Generic Version of Glatiramer Acetate
Results of the randomized, double-blind GATE trial indicate that generic glatiramer acetate is equivalent to branded Copaxone in reducing the number of gadolinium-enhancing lesions, a clinically relevant end point in relapsing-remitting multiple sclerosis (RRMS). Other efficacy outcomes, safety, and tolerability also were comparable.
“This is the first generic glatiramer acetate with an efficacy and safety profile demonstrated to be equivalent to the currently marketed product,” said Jeffrey A. Cohen, MD, Director of the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research, on behalf of the GATE Study Group.
“Generic alternatives to the currently approved therapies for RRMS are needed,” Dr. Cohen said. But because glatiramer acetate is a complex polypeptide mixture that precludes pharmacokinetic comparison, a generic version needs to demonstrate equivalence in efficacy and safety. The GATE trial aimed to show that generic glatiramer acetate was equivalent to Copaxone (Teva Pharmaceuticals; North Wales, Pennsylvania), as measured by MRI and clinical end points, safety, and tolerability in RRMS.
Patients with ambulatory RRMS (ages 18 to 55) with one or more relapse in the year prior to screening and one to 15 gadolinium-enhancing brain lesions were randomized in a 4.3:4.3:1 fashion in a multicenter, double-blind, placebo-controlled trial to receive 20 mg of generic glatiramer acetate, 20 mg of Copaxone, or placebo by daily subcutaneous injection for nine months. The primary end point was combined number of gadolinium-enhancing lesions over months seven, eight, and nine. Additional efficacy end points included other MRI parameters, annualized relapse rate, Expanded Disability Status Scale (EDSS) score, and freedom from disease activity. Safety and tolerability were assessed through monitoring of adverse events, injection site reactions, and routine blood laboratory tests.