Australia Allows Pharmacy-Level Substitution of Biologics

June 24, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

The decision makes Australia the first and only nation to permit automatic substitution of biosimilars.

Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) of Australia recently announced that Australia will not require physician notification when substitution of a biologic medicine occurs at the pharmacy level, giving pharmacists the autonomy to automatically substitute one medication for another.

On June 19, 2015, Minister Ley’s office released a statement regarding substitution of biosimilars. “The PBAC has made a world-first recommendation to allow clinicians and pharmacists to give patients the option of substituting expensive biologic medicines at the chemist if there is a cheaper replacement or ‘biosimilar’ available that has been determined by experts to be a safe, equally-effective treatment.” The release states that there are already biosimilar versions of medicines listed on the Pharmaceutical Benefits Scheme (PBS) that are being safely prescribed to patients.

There is no interchangeability requirement associated with the switching of medicines through the PBS. Unlike much of the proposed state-level legislation in the US, the recommendation does not appear to require that pharmacists notify physicians or patients of a substitution, nor does it specify that pharmacists must keep a log of the substitution. Although Minister Ley said physicians would “still have a say” on whether substitution would be appropriate, patients “would still have the ultimate choice regarding whether they receive the biologic medicine or the biosimilar at the chemist when they fill their script.”

Some opponents of Ley’s decision say the move has the potential to reduce the standards of safe use of biosimilars and could put patients at risk. “Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia,” said Stephen Murby, former chair of the Consumers Health Forum and an ASBM Advisory Board member, in an ASBM press release. “There are good reasons that no country in the world currently uses automatic substitution-chief among them that treatment decisions involving these complex and sensitive medicines should be made by the physician and patient, not a third party.”

Mona Marabani, MD, president of the Australian Rheumatology Association (ARA), said that the safety with switching from biologics to biosimilars has not been proven. “Scant evidence exists regarding switching to a biosimilar in people with autoimmune arthritis who are stable or in remission on the original biologic," she toldTheAustralian Journal of Pharmacy. "Switching to a biosimilar could undo years of clinical stabilization.” She also added that numerous countries-including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland-have banned pharmacy-level substitution of biosimilars.

In a separate release earlier in June, the Abbott Government proposed improvements to the pricing of drugs, including a $1 copayment discount to patients, changes to generic medicine calculations, and reductions in the price of patent-protected medicines. The measures are part of PBS' larger Access and Sustainability Reform Package initiative. The Abbott Government also announced in June that it will invest $372 million to ensure Australians “continue to have timely access to life-saving chemotherapy drugs.”