New government-funded guidelines promote a more positive approach to initiating biosimilars and switching to them in hospital settings.
The new 2021 guiding principles have been released as part of the Department of Health’s ‘Value in Prescribing’ initiative to promote uptake of biosimilars, updating previous guidance released in 2016.
Currently there are PBS listed biosimilars for several endocrinology-related products including insulin glargine* and teriparatide for osteoporosis.
In contrast to previous versions of guidelines that stressed the need for biosimilars to be used only under protocols drawn up by a by a hospital drug and therapeutics committee (DTC), the new guidance reflects changes that now allow pharmacies to substitute ‘a flagged’ products that have been recognised as equivalent by the TGA.
According to the 2021 guidance, a hospital-wide switch between biologics and biosimilars may be considered as a cost-saving measure with DTCs working in consultations with clinical teams to agree on any switching programs, and a management plan for the switch to occur.
They advise against frequent switching, which may confuse patients and their caregivers and increase the risk of medication errors, and advise that patients should be involved in a shared decision-making process to switch.
The new guidelines have also dropped previous advice that immunogenicity profiles – and individual patient benefits – may differ between a biologic and its biosimilars.
And whereas previous guidelines required a DTC-approved program to monitor disease activity after a switch, the new guidance notes that real world experience has shown that patient responses may be affected by a nocebo effect if patients have a poor perception of biosimilars.
“A reported change in the patient’s condition should be treated cautiously and not be immediately attributed to switching, particularly if the monitoring and reporting is based on subjective measures of disease control,” they state.
“Positive attitudes exhibited by health professionals and patient education providing evidence-based information on the equivalence between the reference and biosimilar brands in terms of quality, safety and efficacy are important factors that mitigate the risk of the nocebo effect,” they add.
In another guiding principle, the new recommendations note that some ‘a flagged’ biologics can be substituted at the pharmacy level and it is not mandatory for them to contact the prescriber where equivalent brands are substituted and the prescriber has not indicated a need to dispense a particular brand.
However they advise that a proposed change of brand “should be discussed with the prescriber in some circumstances, as part of good professional practice, for example when substitution of brands could result in confusion or have a negative impact on adherence.”
“To avoid such confusion and avoid inadvertent or unintended changes in brand, along with ensuring pharmacovigilance and traceability, the DTCs in public hospitals should adopt a whole of health service approach to the management of individual biologics,” they advise.
The guiding principles were developed by the Council of Australian Therapeutic Advisory Groups and had input from an Expert Advisory Group that included clinicians in specialties that may prescribe biosimilars.
Update: The sponsor of one biosimilar brand of insulin glargine, Semglee (Alphapharm), recently announced that the 100 IU/mL, 3 mL solution for injection injector pen will be discontinued as of May 2021.