Biosimilars reference group stalls

Specialists’ calls for a new electronic database and prescribing system to access subsidised biologics appear to have hit a bureaucratic roadblock.

The revelation comes following the release of communiques from the first two meetings of the  Biosimilar Awareness Initiative Reference Group, which was set up to “give guidance on the activities of the Biosimilar Awareness Initiative and ensure key messages are clearly articulated and appropriately targeted.”

Members of the Reference Group consists of stakeholders from the pharmaceutical industry, consumers, pharmacists and relevant medical authorities. It is understood they are banned from talking to the media about matters discussed by the group.

Outspoken senior gastroenterologist Professor Jane Andrews, Chair of the Australian Inflammatory Bowel Disease Association, head of Inflammatory Bowel Disease Services at the Royal Adelaide Hospital’s Centre for Digestive Diseases, said there was a general feeling that the views of clinicians were not being considered.

“The government does not seem to be listening to our concerns,” said Dr Andrews who is not a member of the reference group.

She said there appeared to be little movement from the government on the two major area of concern raised by clinicians – the need for pharmacovigilance through a new electronic system to replace the current paper system, and also reconsideration of ‘a’ flagging of biosimilars following the PBAC’s recommendation to ‘a’ flag the Inflectra and Remicade brands of infliximab on the PBS.

“We are not against the use of biosimilars, we are only worried about the care of our patients,” Professor Andrews said.

She said peak health bodies had well-developed patient registries which could be integrated into a new electronic system.

Prescribing data would be invaluable from a research perspective as it could be studied and used to maximise patient care and help better predict government expenditure on subsidies as well as save money, she said.

The ‘a’ flagging of biosimilars also needed to be reconsidered by the government, especially as more were coming on to the market, including subcutaneous self-injectables.

“We are very concerned about this issue,” she said.

The Biosimilar Awareness Initiative Reference Group meets again in July.

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