Should Biogen's Spinraza for SMA be delayed amid COVID-19? No, say these parents

Ana Memedovich’s son, Mikhail, started receiving Biogen’s treatment for spinal muscular atrophy (SMA) in the spring of 2017, just months after the product was approved. Over the next few years, Mikhail, now 26, regained much of his mobility and independence. He graduated from the University of Minnesota in 2019 and started working as an account manager at a professional-services firm—achievements his mother attributes largely to Spinraza.

But Mikhail is likely going to miss his next scheduled Spinraza injection on April 1. The problem is an insurance mix-up that under normal circumstances would have been solvable, Memedovich told FiercePharma. But because of COVID-19 shutdowns, she can’t get Mikhail’s pre-approval secured in time, and Biogen is refusing to comp the dose, she said.

What’s worse, she’s worried that even after the payment issue is solved, the outpatient facility near Minneapolis that administers the product will refuse to schedule Mikhail’s Spinraza dose.

“I’m afraid. I’m aware that within our community Spinraza injections are being rescheduled or canceled indefinitely,” said Memedovich, president of SMA United for Treatment Options, a patient advocacy group. “Our children are disabled. We feel a sense of discrimination—as if their lives aren’t important.”

Biogen acknowledged last week that some SMA patients are seeing their Spinraza doses delayed, as hospitals prioritize the treatment of COVID-19 patients.

A spokeswoman for Biogen told FiercePharma the company is aware of Memedovich’s concern and is working with the family to resolve the problem quickly. "We remain hopeful we can work through this together during these difficult circumstances, in time for next week’s planned appointment," she said. As for the Spinraza delays caused by COVID-19, she said, Biogen “continues to work directly with health systems, institutions, physicians, patients and their families to navigate these unique situations as quickly as possible to facilitate access to a critical therapy for people with SMA.”

RELATED: Biogen's COVID-19 woes mount as virus forces Spinraza treatment delays

SMA United’s stance on the Spinraza delays is quite different from that of another group, Cure SMA. It released a statement on its website last week stating that delaying treatment for a few weeks “should not have a huge impact.” A spokeswoman for Cure SMA told FiercePharma that the organization stands by that assessment, but that families should work closely with healthcare providers to reschedule their Spinraza doses “for as soon as reasonably possible.”

SMA is an inherited disease that causes progressive muscle loss and is usually fatal without treatment. Infants who are treated with Spinraza may be able to avoid the disease’s destructive effects altogether and Biogen said that it is receiving “multiple urgent requests” for the drug from around the country. The company was able to provide Spinraza to one infant with less than a day’s notice last week, the spokeswoman said.

Memedovich’s son initially received Spinraza once a month, but is now on a maintenance dose of one injection every four months. Preparing for the injection is a complicated process that involves getting blood tests a week before the treatment—a process the family is avoiding until they receive the approval, she said. Even though everything is done on an outpatient basis that avoids exposure to COVID-19 patients, they don’t want to risk being near people who may have the virus until they’re absolutely sure Mikhail will be able to get his Spinraza treatment, she said.

RELATED: Lilly slashes clinical trial activities in response to COVID-19

For Biogen, dealing with COVID-19 has not been easy. Last week, the company warned investors that the pandemic could impact sales, manufacturing and clinical trials. And the company had to fire an employee who fled to China with symptoms of COVID-19, sparking an uproar both in China and the U.S.

The potential disruption to Biogen’s clinical trials would not be surprising. Earlier this week, Eli Lilly announced that it has delayed starting new trials and paused enrollment in ongoing studies during the pandemic. Several other companies are now reassessing their clinical trial plans. Hospitals are also canceling elective treatments as they struggle to handle the influx of COVID-19 patients.

Memedovich and other members of SMA United are living in fear that health providers will classify Spinraza treatments as elective during the COVID-19 crisis—a mistake, she said. “This should not be disrupting treatments for chronically ill patients,” Memedovich said. “We know the ramifications of delaying Spinraza treatments. We’re going to see losses of motor function gains and other gains our children have made in their lives. We’ll go back to this being a progressive disease.”