The PBAC has recommended the PBS listing of the infliximab biosimilar Inflectra™ for the same indications that apply to its comparator drug Remicade™.
It has also recommended Inflectra™ for ‘a’ flagging, meaning pharmacists can substitute biosimilars for brand name original biologics.
However as reported by the limbic last month the ‘a’ flagging of biosimilars has been met with concern from several professional bodies and patient advocacy groups including the ARA and Arthritis Australia.
Following a consumer hearing on biosimilars President of the ARA Mona Marabani told the limbic that the issue they were most concerned about was the potential for patients to be switched between brands multiple times.
But in its July meeting outcomes notes published this week the PBAC said that based on three randomised trials it considered that Inflectra™ had “equivalent effectiveness and safety” compared to Remicade™ to allow “a-flagging” at the point of dispensing.
There appeared to be a public misunderstanding about how substitution occurs, it said.
“For any individual prescription, a prescriber may choose to not permit brand substitution. If substitution has been permitted by the prescriber, the patient may choose which brand they wish to receive from the pharmacist.”
With regards to concerns about traceability, Medicare routinely collects information on the brand of drug that is dispensed for a patient.
The potential for multiple switches of brands to occur was unlikely to occur in practice because infliximab was administered via an infusion, it noted.
The decision to recommend Inflectra™ for ‘a’ flagging has been met with disappointment by the ARA.
“It is the first step of a process that concerns us. Should other large molecule biosimilars, particularly those delivered by the patients themselves via subcutaneous injection, be ‘a’ flagged in future, multiple substitutions at the retail pharmacy level could occur on a month-to-month basis,” ARA President Mona Marabani told the limbic.
“There is a dearth of evidence as to the outcome of this approach”.
“The government must immediately commence an intensive monitoring programme to ensure patients are protected. Careful and meticulous pharmacovigilance is vital,” she said.
The PBAC has recommended that the Department develop an implementation strategy for infliximab before an “a” flag can be included against the Inflectra™ and Remicade™ brands on the Schedule.
“This implementation strategy should include an education campaign designed to support and promote the use of biosimilars, improving awareness and confidence by both health professionals and consumers to choose these products,” it advised.
This week the PBS published fact sheets on biosimilars for both consumers and healthcare professionals addressing issues such as what are the differences between biosimilars and generics, how they are evaluated by PBAC and the TGA, and what “a-flagging” means for patients and prescribers.