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.”
Dr Mona Marabani, co-chair of the Australian Rheumatology Association’s biosimilars working group, said she was concerned the PBAC decision could lead to confusion and multiple switching between biosimilars, which as yet is not proven safe.
Once a patient was eligible for subsequent continuing prescribing, “I assume that if the box is not ticked, the patient can be given either Inflectra or Renflexis each time they present to the chemist with a script after the first demonstration of response,” Dr Marabani told the limbic.
“There is the potential for multiple switches between brands to occur in this scenario, and no systems have been put in place to monitor and detect any problems that may arise, including immunogenicity.”
“How this will affect prescribing is hard to know. More incomplete responders may stay on treatment. Or prescribers may avoid these drugs altogether because of the complexities of prescribing in a market in which a number of alternative therapies are available.”
Dr Marabani said the ARA “continues to support the introduction of biosimilars to the Australian market, but notes that evidence around interchangeability and multiple switches remains sparse and of low quality”.
“We recommend that prescribers choose a drug (originator or biosimilar), prescribe by brand and ‘tick the box’, to always know exactly what medicine the patient is having.”
Dr Marabani declaration of interests covered the companies MSD, Abbvie, Pfizer, Lilly, Janssen, BMS, Novartis and the National Prescribing Service.