The first study to examine the impact on real-world outcomes and costs of switching patients with MS from Copaxone to Glatopa revealed few significant differences.
Benjamin Greeberg, MD
The findings of a real-world study demonstrated that treatment with Glatopa (glatiramer acetate; Sandoz) results in similar outcomes and costs to that of Copaxone (glatiramer acetate; Teva Pharmaceuticals), with a trend towards cost savings and lower relapse rates in patients with multiple sclerosis (MS).1
A total of 357 Glatopa-treated and 2291 Copaxone-treated patients qualified for inclusion, with 158 per cohort retained after matching. At baseline, 8% of patients had >1 relapse with mean annualized relapse rates (AAR) of 0.18. At follow-up, relapse rates 8% of Glatopa patients had >1 relapse, compared with 15% of those who were on Copaxone (P = .054). Additionally, AARs were 0.12 versus 0.30 when comparing Glatopa- and Copaxone-treated patients, respectively (P = .05).
The incidence of first MS relapse over the course of a year was numerically lower for patients in the Glatopa group than those in the Copaxone cohort (0.13 vs 0.25, respectively). Additionally, the mean time to the first relapse or the end of follow-up was similar between the 2 groups (Glatopa: 233 days; Copaxone: 221 days; P =.390).
“The improved relapse rates observed in this study may be due to an improvement in patient compliance due to lower patient costs, better patient Accepted Manuscript support during their transition and/or acceptance of the Glatopaject injection device. This hypothesis is supported by the fact that Glatopa patients filled more prescriptions (6.2) than Copaxone patients did (5.5),” first author Benjamin Greenberg,MD, professor of neurology, UT Southwestern Medical Center, and colleagues, concluded.
Mean all-cause medical and pharmacy costs for patients treated with Glatopa were $51,507 (standard deviation [SD], $28,494) versus $55,085 (SD, $37,061; P = .50) for those on Copaxone. Mean MS-related costs were $45,379 (SD, $24,732) and $47,949 (SD, $32,615) for Glatopa and Copaxone, respectively (P =.67). Disease modifying therapy (DMT) costs accounted for $42,926 (SD, $23,196) of the costs for the Glatopa group versus $44,932 (SD, $28,554) for the Copaxone group (P = .59).
At 12 months follow-up, 2% of Glatopa patients (n = 3) used DMTs that included interferon beta 1-a/1-b, mitoxantrone, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, and alemtuzumab compared to 11% of patients in the Copaxone cohort (n = 17; P = .001). The use of medications was similar between the Glatopa and Copaxone cohorts, but the use of narcotics (15% vs 28%, respectively; P = .003), nonsteroidal anti-inflammatory drugs (NSAIDs; 8% vs 16%, respectively; P = .015), and corticosteroids (16% vs 26%, respectively; P = .027) was significantly lower in the Glatopa cohort compared with the Copaxone group.
Greenburg and colleagues pulled data from patients within the HealthCore Integrated Research Database (HIRD) who had put in ≥1 pharmacy claims for Glatopa 20 mg or Copaxone 20 mg during the patient identification period, which was between April 1, 2015, and April 30, 2018, for Glatopa and between January 1, 2013, and April 30, 2018, for Copaxone. The Glatopa cohort contained patients with >1 pharmacy claim for Glatopa during the identification period, as well as patients who switched from Copaxone and new inhibitors.
The study aimed to compare relapse rates and healthcare costs in patients with MS treated with Glatopa 20 mg versus Copaxone 20 mg in a US managed care population. The mean age in the matching cohorts was 49.9 years (SD, 11.0), 75% of patients were female, and a significantly larger proportion of the Glatopa cohort had commercial health plans (Glatopa: 92%; Copaxone: 80%; P <.01). Of the 158 Glatopa-treated patients, 30% (n = 47) switched back to Copaxone 20 mg during follow-up and were censored at that point.
Patients who had previously used Copaxone 40 mg or had <1 continuous health plan enrollment were excluded.
At baseline and follow-up, researchers gathered data on demographic characteristics, percent of patients with >1 fill and number of fills per patient. Additional measures such as all-cause healthcare resource utilization (HCRU), costs, and relapse rates were all assessed at baseline and follow-up. Relapses were defined as either >1 inpatient claim with an MS diagnosis code in the primary position or >1 outpatient claim with an MS diagnosis code in combination with the use of any qualifying corticosteroid or corticotropin on the day of or within 7 days following the outpatient visit.
Follow-up outcomes were reported over the available post-index observation period (the earliest of the end of 12 months post-index, end of health plan enrollment, end of study period, or censoring due to switch to Copaxone 20 mg or 40 mg; days of switching were included in the follow-up period).
Copaxone 20 mg daily was FDA approved in 1996, and was later approved for the 3-times-a-week 40 mg dose in 2014.2 Glatopa, the first generic version of Copaxone, was approved as a 20 mg/mL one-time-daily dose MS therapy in 2015. In 2018, the FDA approved Glatopa 40 mg/mL 3-times-a-week therapy for relapsing forms of MS.3,4
1. Greenburg B, Hall S, Grabner M, et al. Multiple sclerosis relapse rates and healthcare costs of 2 versions of glatiramer acetate. Current Medical Research and Opinion. Published online May 13, 2020. doi: 10.1080/03007995.2020.1760808
2. Here with dosing options for your lifestyle. Copaxone. copaxone.com/about-copaxone/dosage-information. Accessed May 22, 2020.
3. Sandoz recieves FDA approval for Glatopa as the first generic competitor to MS therapy Copaxone 20 mg [news release]. Holzkirchen: Sandoz. Published April 16, 2015. Accesed May 20, 2020. us.sandoz.com/news/media-releases/sandoz-receives-fda-approval-glatopatm-first-generic-competitor-ms-therapy-2
4. Sandoz announced US FDA approval and launch of Glatopa 40 mg/mL 3 times-a-week generic option for relapsing forms of multiple sclerosis [news release]. Holzkirchen: Sandoz. Published February 13, 2018. Accessed May 20, 2020. us.sandoz.com/news/media-releases/sandoz-announces-us-fda-approval-and-launch-glatopar-40-0.