Australian Medical Association Questions Government's Approach to Biosimilars

The Australian Medical Association (AMA) has issued a comment to the nation’s government concerning new proposals aimed at increasing biosimilar uptake in Australia.

The AMA maintains that practitioners must retain the independence to make the best treatment recommendations for their patients, and that while the association encourages the use of biosimilars when appropriate, it opposes compulsory prescribing of these agents, highlighting the differences in delivery mechanisms and devices as a potential problem with respect to successful treatment.

The AMA took issue with the prospective way in which biosimilars would be referred to in the nation’s schedule of pharmaceutical benefits; while software is being developed to update doctors’ prescribing systems, the government has proposed to include a prescribing note for practitioners stating that biosimilars are “preferred for” treatment-naïve patients. Such a term, the association suggests, is misleading, as there is no clinical basis for preferring a biosimilar to a reference drug. The AMA calls for the phrase “encouraged for” as replacement, and also indicates that a note should be included that the encouragement takes cost-effectiveness as its basis.

Second, the AMA responded to the government’s proposed action to increase biosimilar uptake by reducing the level of authorization required to prescribe biosimilars. Under the Australian system, some prescriptions covered under the nation’s Pharmaceutical Benefit Scheme (PBS) are “authority-required,” meaning they must be approved on case-by-case basis by the Department of Human Services because they have been deemed to be too costly for wide use. Some medicines may be prescribed under a “streamlined” authority-required benefit; under such a streamlined arrangement, a clinician can prescribe a drug without explicit governmental pre-approval by using a special authority code.

The AMA responded to the government’s proposed action of moving biosimilar etanercept to a streamlined approach while keeping reference etanercept at the highest level of authorization by saying that the approach was “heavy-handed” and unnecessary for increasing uptake of biosimilars. The government’s biosimilar awareness program should be given time to work, the AMA said, and added that biosimilar uptake will proceed naturally as more products enter the market.

Furthermore, the AMA notes that both biosimilar and reference etanercept are listed at the same price on the PBS. Without a substantial cost savings presented by biosimilars, the association says, there is no reason to privilege them: “Unless a biosimilar brand is listed on the PBS for a significantly cheaper price, there appears no justification for applying different restrictions to the same medicine on the basis of brand.”

The AMA voiced concern that the government’s proposals on biosimilar uptake would not serve the public’s interests so much as those of private entities, saying “the AMA cannot support this measure which has nothing to do with safety and quality, and appears mostly to benefit certain pharmaceutical companies.”