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Upsher-Smith builds brand-like support around Vigadrone

Getting complex generics to patients can sometimes be as complicated as the drug class name might suggest. As the Food and Drug Administration creates pathways for more complex generics to come to market, some manufacturers are working to ensure that the patients prescribed their products — many of whose disease states can be uncommon — are getting the same level of care they were given when they only had a branded option.

Two years before the July approval of Upsher-Smith Laboratories’ Vigadrone, or vigabatrin, a generic of Lundbeck’s Sabril powder for oral solution, the Maple Grove, Minn.-based company was solidifying plans for supporting families of the patients who would need the treatment for infantile spasms.

As the first generics of the product — a first-line treatment for the spasms that accompany tuberous sclerosis complex that develops in 30% of the roughly 50,000 children born with the illness — hit the market, patients were experiencing difficulty getting the medication in a timely manner.

“When Sabril went generic, there were some physicians’ offices spending hours on the phone trying to get the drug for their patients,” said Kari Rosbeck, president and CEO of the Tuberous Sclerosis Alliance. “Patients were waiting too long to get their drug, in some cases up to three weeks. The whole system went haywire.”

As it readied for the launch of Vigadrone, Upsher-Smith had conversations with Rosbeck to determine the sort of support that patients would need.

“We wanted to make sure that Upsher-Smith was able to at least consider the things that would be extremely important to our TSC community,” Rosbeck said.

Principal among patient concerns was timely delivery of the medication, which often comes from specialty pharmacies. “If there are any delays in deliveries from any specialty pharmacies, the families panic about where they are going to get the next dose of medication for their child,” Rosbeck said, noting that the company incorporated the need for a consistent supply into its support program.

In addition to hearing from advocacy groups, Upsher-Smith senior director of early-stage commercialization, advocacy and professional relations David Stefanoni said the company spoke to doctors and nurses, several of whom were parents of children with infantile spasms.

“We wanted to know what didn’t work, what could be done better, and where families are having difficulties with generics coming into this space,” he said.

After listening, Stefanoni said Upsher-Smith realized the need to build out a support network around Vigadrone. The company developed a hub service that helps patients overcome hurdles to access and assists overnighting the drug to families.

“We wanted to carve out services that would get this patient community back to what they were used to when there was a brand on the market,” he said. “We wanted to make sure we were set up to give them a starter prescription, which is critical. So far, we’ve been able to get the drug to the patient in 24 hours.”

If a parent loses coverage or their insurance coverage changes, and there is a delay in getting covered, Upsher-Smith provides a bridge supply so therapy isn’t interrupted, and it has offered a cash option for those who don’t have insurance.

“We collaborated with the right organizations to proactively plan,” said Jennifer Colvin, Upsher-Smith vice president of marketing, corporate communications and commercial analytics. “We didn’t want the patients to fall through the cracks.”
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