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PBAC OKs biosim preference in script software
Posted 6 November 2017
The PBAC has said it has no problem with prescribing software that recommends biosimilars ahead of reference biologicals.
In outcomes released over the weekend, the reimbursement committee responded publicly to an MSD submission considered in August that called for "a change to prescribing software to give preference to Brenzys for patients naive to treament with etanercept".
Brenzys is MSD's etanercept biosimilar. It was PBS listed on 1 April this year against Pfizer's Enbrel.
Despite the successful listing, MSD returned to the PBAC seeking changes to restrictions and a direction from the PBAC that prescribing software be changed to favour its product. It was only partially successful.
The PBAC recommended that all initial treatment restrictions for etanercept, including those for new patients, patients changing treatment and recommencing treatment, remain as Authority Required (in writing) listings.
It said the continuing restrictions for etanercept for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis and severe chronic plaque psoriasis should be split into first continuing and subsequent continuing restrictions, with the first being Authority Required (in writing) and the second being Authority Required (STREAMLINED) restrictions.
It also recommended that continuing restrictions for etanercept retain the requirement for patients to be responding to treatment.
It's response to MSD's call for Brenzys "to give preference to the biosimilar brand of etanercept for patients naive to treatment with etanercept" in both the PBS schedule and in prescribing software, said, "this is a matter for government", however it did not have "any concerns about encouraging prescribing of a biosimilar brand rather than the reference biological agent brand for treatment of naive patients, including through notes in the schedule and prescribing software changes".
At the same time as dealing with the request from MSD, the PBAC also responded to a number of requests for change to reimbursed prescribing of disease-modifying anti-rheumatic drugs (DMARDs) from rheumatologists.
It recommended allowing clinical immunologists with appropriate expertise to prescribe the biological medicines PBS subsidised for ankylosing spondylitis.
It also recommended removing the requirement to re-trial DMARDs for rheumatoid arthritis and juvenile idiopathic arthritis after a treatment break of 24 months and 12 months respectively.
In addition, it agreed to exclude failure to demonstrate a response to treatment with a biological medicine due to the development of a serious adverse reaction from the treatment failure count for such medicines.
However, the committee rejected a request to remove the criteria of allowing patients to fail or cease to achieve a response to three biological medicines, and the requirement of a five year break in biological therapy if a patient fails or ceases to respond to three biological medicines for those indications where these criteria apply.
"The PBAC considered that removal of these criteria may result in continuous cycling of biological medicines, which would in turn likely affect the cost-effectiveness and utilisation of these medicines," it said.
Nick Lush
nick.lush@lushmedia.com.au
Posted 6 November 2017
The PBAC has said it has no problem with prescribing software that recommends biosimilars ahead of reference biologicals.
In outcomes released over the weekend, the reimbursement committee responded publicly to an MSD submission considered in August that called for "a change to prescribing software to give preference to Brenzys for patients naive to treament with etanercept".
Brenzys is MSD's etanercept biosimilar. It was PBS listed on 1 April this year against Pfizer's Enbrel.
Despite the successful listing, MSD returned to the PBAC seeking changes to restrictions and a direction from the PBAC that prescribing software be changed to favour its product. It was only partially successful.
The PBAC recommended that all initial treatment restrictions for etanercept, including those for new patients, patients changing treatment and recommencing treatment, remain as Authority Required (in writing) listings.
It said the continuing restrictions for etanercept for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis and severe chronic plaque psoriasis should be split into first continuing and subsequent continuing restrictions, with the first being Authority Required (in writing) and the second being Authority Required (STREAMLINED) restrictions.
It also recommended that continuing restrictions for etanercept retain the requirement for patients to be responding to treatment.
It's response to MSD's call for Brenzys "to give preference to the biosimilar brand of etanercept for patients naive to treatment with etanercept" in both the PBS schedule and in prescribing software, said, "this is a matter for government", however it did not have "any concerns about encouraging prescribing of a biosimilar brand rather than the reference biological agent brand for treatment of naive patients, including through notes in the schedule and prescribing software changes".
At the same time as dealing with the request from MSD, the PBAC also responded to a number of requests for change to reimbursed prescribing of disease-modifying anti-rheumatic drugs (DMARDs) from rheumatologists.
It recommended allowing clinical immunologists with appropriate expertise to prescribe the biological medicines PBS subsidised for ankylosing spondylitis.
It also recommended removing the requirement to re-trial DMARDs for rheumatoid arthritis and juvenile idiopathic arthritis after a treatment break of 24 months and 12 months respectively.
In addition, it agreed to exclude failure to demonstrate a response to treatment with a biological medicine due to the development of a serious adverse reaction from the treatment failure count for such medicines.
However, the committee rejected a request to remove the criteria of allowing patients to fail or cease to achieve a response to three biological medicines, and the requirement of a five year break in biological therapy if a patient fails or ceases to respond to three biological medicines for those indications where these criteria apply.
"The PBAC considered that removal of these criteria may result in continuous cycling of biological medicines, which would in turn likely affect the cost-effectiveness and utilisation of these medicines," it said.
Nick Lush
nick.lush@lushmedia.com.au
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