Glatopa Shows Efficacy Similar to Copaxone, Study in Real-world Use Finds

Glatopa, a generic form of Copaxone, is as effective as the brand-name medication in terms of disease outcomes and has similar healthcare-related costs in real-world use in patients with relapsing multiple sclerosis (MS), a new U.S. study suggests.

Data also suggest a trend toward lower relapse rates with Glatopa compared with Copaxone treatment.

The study, “Multiple sclerosis relapse rates and healthcare costs of two versions of glatiramer acetate,” was published in the journal Current Medical Research and Opinion. Researchers at Sandoz, the Novartis company that manufactures Glatopa, were involved in the work.

Both Copaxone (marketed by Teva Pharmaceutical) and Glatopa are forms of glatiramer acetate injection, a treatment for clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It is believed to work by decreasing the activity of immune cells that cause nervous system damage.

Researchers investigated the health outcomes and cost impact of switching MS patients from the brand to generic glatiramer acetate injection.

They did so by analyzing insurance claim data from the U.S. HealthCore Integrated Research Database, covering 2013 to 2018.

In total, 158 people treated with 20 mg Glatopa once daily were matched, in terms of demographic and clinical characteristics, to 158 people using Copaxone at 20 mg once a day. Most (92%) in the Glatopa group had originally been on Copaxone; the mean age of these people was 49.9, and 75% were female.

The average follow-up time was 251 days (about 8.3 months) in both groups. Of the 158 Glatopa patients, 70 (44%) switched back to Copaxone (20 mg or 40 mg) during follow-up — their data, and the data of their matched individuals in the Copaxone group, were censored at the time of switching, meaning they were no longer part of the analysis.

Reasons for switching were unclear from the insurance data used. The team speculated that reasons could be discomfort with changing medications or negative attitudes toward generic medicines in general.

“Among patients who switched [from Glatopa to Copaxone], no relapses were reported before the date of the switch, suggesting that switchbacks were not the result of such clinical events,” the researchers wrote.

Researchers then compared clinical outcomes, including relapse rates, doctor visits, and hospitalizations, between the two groups. No significant differences were observed for doctor visits or hospitalizations, including emergency department use, between the two.

During follow-up, a lower percentage of people in the Glatopa group had a relapse — 8% vs. 15% in the Copaxone group; and the annual relapse rate for Glatopa was also lower — 0.12 vs. 0.30 relapses/year. These differences, however, were borderline in terms of statistical significance.

The researchers also calculated all-cause medical and pharmacy costs during the follow-up. They found the costs to be lower among the generic patient group — a mean of $51,507 for Glatopa vs. $55,085 for Copaxone. Again, these differences did not reach statistical significance. MS-specific healthcare costs showed the same trend.

Researchers attributed the lack of significance in cost differences to a high amount of individual variation in healthcare costs among people with MS, making it difficult to identify significant differences without larger sample sizes.

“Further research, ideally in even larger samples, will be helpful to paint a better picture of the cost impact of switching to Glatopa,” the researchers wrote.

They also noted that data included in the study were assessed using inflation-adjusted figures from April 2015 to April 2018, during which time the wholesale acquisition cost (WAC) for Glatopa was, on average, about 23% lower than that of Copaxone.

As of September 2019, the WAC of Glatopa was 79% and 74% lower, respectively, than that of Copaxone at 20 mg and 40 mg doses — $1,500 for a one-month supply of Glatopa at either dose level vs. $7,114 for a one-month supply Copaxone at 20 mg and $5,832 for 40 mg — “which suggests potential for cost savings,” the researchers wrote.

“In this real-world study, MS patients treated with Glatopa experienced similar health outcomes and costs compared to those treated with Copaxone, with a trend towards lower relapse rates (borderline statistically significant) and cost savings (not statistically significant),” the team concluded.

Steven B. Hall, executive director and head of differentiated products medical affairs at Sandoz, and a study co-author, said in a press release: “In addition to reinforcing the comparable effectiveness of Glatopa to Copaxone in the real-world, this study highlights the significant US cost reduction (~75%) for glatiramer acetate injection therapy in the five years since the introduction of Glatopa and other generics.”

Glatopa 20 mg was approved for relapsing MS by the U.S. Food and Drug Administration (FDA) in 2015; Copaxone was first approved for RRMS in 1996 and later for all relapsing MS forms.

“For patients who have switched or are considering a switch to Glatopa, the data reinforces that Glatopa has comparable effectiveness to Copaxone in the real-world” Hall told Multiple Sclerosis News Today in an email exchange.

“As of November 2019, Glatopa has the lowest wholesale acquisition cost (WAC) of all glatiramer acetate injection medicines available to people living with MS in the US,” Hall added, suggesting that “another potential benefit of further uptake and use of generic MS disease modifying therapies is that it could lead to additional cost savings for the U.S. healthcare system.”