FDA’s approval of the first generic version of Copaxone (glatiramer acetate injection) for treating patients with relapsing forms of multiple sclerosis (MS) has industry insiders contemplating the impact on the generics market as well as payer coverage strategies.
Manufacturer Sandoz with Momenta will market generic glatiramer acetate injection, or Glatopa, in a 20-mg/1-mL daily injection. Currently 45% of Copaxone users are on the same daily dose, while 65% opt for the long-acting 40-mg/mL three times a week injection. There is no long-lasting generic version.
MS is a chronic disease that has no cure. According to the National Multiple Sclerosis Society, more than 2.3 million people worldwide are affected and it is estimated only about half receive treatment, in part because of the high costs of drugs necessary to manage the disease.
“The price of Copaxone has increased...since its launch in 1996 when the cost for a year of treatment was $9,000,” according to Barbara Gilmore, Life Sciences Senior Industry Analyst, Frost & Sullivan. “In 2014, a year of treatment cost $60,000.”
The approval increases the competition in this already competitive space, according to analysts. Generic Glatopa will reduce the annual cost of daily treatment of MS for some patients and may draw back some of the patients who recently switched to the long-acting version of the branded product. Patients have out-of-pocket copays with many drugs, depending on the tier the drug is placed. If the long-acting branded product has a higher out-of-pocket annual cost than the generic, some patients may choose to switch to the generic.
“The expectation is that it will drive down costs for MS treatments, but by how much is yet to be determined,” says Anna Goldbeck, a principal in the National Pharmacy Practice at Buck Consultants at Xerox. “Teva [the manufacturer] was successful [at] converting 65% or more of prescriptions for Copaxone…to the 40-mg/mL version when it became available in January 2014. However, plan sponsors may decide to employ rules that encourage, via financial incentives, or require, participants [to] move utilization back to the 20 mg/mL for coverage to be provided.”
If the two products demonstrate similar comparative effectiveness, the adoption of formulary and utilization management controls for three times per week 40-mg form of Copaxone and the generic version of the daily 20-mg form of Copaxone will boil down to net unit costs for the products, according to Ruth Ann C. Opdycke, PharmD, MS, president, TPG Healthcare Consulting LLC.