Biosimilar ‘uptake drivers’ that encourage prescribing of biosimilars over originator biologics will be applied universally and not just to the brand that makes an application for them, the federal government has confirmed.
The Pharmaceutical Benefits Advisory Committee (PBAC) has set out its position on uptake measures such as lower authority levels in newly-released documents covering the approval of an MSD application to have uptake drivers applied to its infliximab biosimilar Renflexis for use in ulcerative colitis.
The documents show that in November 2017, the PBAC approved a request to relax treatment restrictions on Renflexis, agreeing that doctors can use a “streamlined” authority to prescribe subsequent continuing scripts, providing that patients are responding to treatment. Initial and first continuing scripts will still need a written authority.
The PBAC also “did not have any concerns” about approving a second uptake driver which allows for a note to be included in prescribing software indicating the government prefers doctors prescribe Renflexis for infliximab naïve patients.
In a newly released public summary document, the PBAC says that while MSD had asked for the changes to be applied only to its brand, they would be made universal.
“The advice provided by the PBAC regarding biosimilar uptake drivers will be at the medicine level and not at the brand level,” the document states.
“The decision about applying the lower level of authority for one or more brands of infliximab will be made by the Minister of Departmental delegate following PBAC advice. It is expected that the uptake drivers will be applied to all biosimilar brands for a reference biological medicine following positive advice from the PBAC.”
A spokesperson for the department of health told the limbic it is expected that PBAC advice will be provided at the medicine (active ingredient) level on each occasion.
However “there may be situations where this would not apply, for example medicine level advice may not always be given if there are differences in manner of administration for different forms of the medicine,” they added.
“It is likely that all biosimilars for the same drug will be treated the same under the uptake measures. This is consistent with the policy to increase the uptake of biosimilars, not particular brands. If there are particular reasons why the brands should not be treated the same, the Pharmaceutical Benefits Advisory Committee will advise on those matters.”
Professor Rupert Leong, senior staff specialist gastroenterologist at Concord Hospital in Sydney, said the move will make life easier for busy gastroenterologists, because it will “significantly reduce the amount of time spent on paperwork, especially for the heavy prescribers of biological agents”.
Infliximab is indicated for treatment of refractory Crohn’s Disease, fistulising Crohn’s Disease and ulcerative colitis in adults and children, with the PBS subsidising almost 50,000 treatments for luminal and fistulising CD and acute severe UC between 2007-14, with a fourfold increase in use over that time.
“I would like to see this also extend to the other biological agents including those that do not have biosimilars at present, because it is a considerable barrier and also cost in terms of time and need for pharmacy clerical staff to process the paperwork and man the telephone line for the prescription for this class of medication,” Professor Leong told the limbic.
However, he said he shared safety concerns about multiple switching between brands raised by the Australian Rheumatology Association.
“ We don’t have the data for that at the moment. We just have the data about single switches which does seem to be safe at least in the short term.
“I think this is a good reminder for clinicians when they are writing scripts to use the brand names to make sure that there is no confusion over which brand the patient is supposed to be on,” Professor Leong said.
“With my patients I also remind them they should be receiving the same brand every time.”
Overall, the easing of access was likely to be enough to convince many to prescribe biosimilar medicines, over their biologic originator, he predicted.
“For me personally it’s likely I will be writing the biosimilar initiating that and continuing that.”
Professor Leong sits on the advisory boards for Janssen, Abbvie, Pfizer, MSD and Takeda.