Medicines

Biologics shortage fears raised by arthritis patient advocacy group


A charity that advocates for patients with RA and lupus has raised concerns over potential shortage of biologic medicines.

In a submission to the TGA’s consultation on the management and communication of medicines shortages, the patient advocacy group Dragon Claw says the federal government should develop a system to warn consumers about looming shortages of biologic medicines, which have already occurred overseas and “can have major disabling impacts” on patients.

“Two years ago, a biologic medication manufactured by Roche was in short supply in the USA. There was flow on concern in Australia amongst our members, some of whom became very concerned,” the group writes it its submission, a claim that is rejected by Roche (see statement below).

“There was a feeling at the time that supply would be ‘managed’ by the multinational by shifting stock based on profitability irrespective of national need.

“The business case dynamics of the supply industry requires monitoring by well informed TGA staff to avoid a managed shortage scenario. The notification content seems simplistic to us.”

Dragon Claw’s submission makes suggestions for how the government could monitor and report on potential shortages of biologics.

These include expanding the TGA’s searchable database of drug shortages to include medicines for chronic conditions, something the submission says is not currently done. This anomaly means shortages of medications such as “death adder anti venom” are publicly reported whereas the biologics used by RA patients are not.

Dragon Claw founder Mike Gill, a former board member of Health Informatics Society of Australia who has RA, said while the 2016 shortages of the Roche biologic did not hit Australia,  the group wanted to raise the issue because of the anxiety experienced by patients when they heard about shortages of their medication.

“Some of our members in other countries told us that they couldn’t get supply,” Mr Gill told the limbic.

“Some of our members in Australia told us that they may be having difficulty, because their pharmacist had told them they might be having difficulty getting their next month’s supply because of a shortage that seemed to be emerging in the USA.

“We felt duty bound to raise this issue because it impacts our members directly if we can’t get our biologics we are in a hell of a lot of trouble.

“While it’s not a massive issue it could be if things became very negative quickly so this is simply us waving a flag and saying whoops we’ve got a little concern here for people with major chronic conditions.”

Dragon Claw declares funding from two manufacturers of biologic medicines used to treat RA: Pfizer and Janssen. Mr Gill said the Pfizer funding was “unattached” and the Janssen funding was to support a project for rheumatoid arthritis patients in remote Australia project being carried out by Dragon Claw.

The charity had also received support from the Pharmacy Guild of Australia and “as long as the money is not attached in terms of the commercial relationship then we’re quite happy,” he said.

Mr Gill said the submission was not intended to single out the company Roche, but rather to highlight the broader issue.

“No, we are not picking on Roche alone, but that was the example we used….the object of this exercise was not bashing Roche it was about monitoring supply changes,” he told the limbic.

Mr Gill declined to provide Dragon Claw’s membership numbers, but said the organisation was staffed by 28 volunteers and had members in 14 countries including senior rheumatologists.

Dragon Claw was founded in 2014 and subsequently registered as a charity.

A spokesperson for Roche denied there had been a recent shortage of Actemra in the US.

“Roche can confirm that there has been no shortage of Actemra (tocilizumab) over the last two years, and we have received no reports of concern around supply of Actemra from Australian stakeholders,” the spokesperson said.

“In any situation where Roche may temporarily be out of stock of a medicine, we work with health authorities and other relevant stakeholders to carefully manage our supply and minimise disruption, to ensure that patients’ treatment is uninterrupted. “

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