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DoH blames industry for submission churn
Posted 2 August 2017
Pharma companies are preparing and lodging resubmissions even before their initial submissions have been considered by the PBAC, a spokesperson for the Department of Health has told Pharma in Focus.
In a lengthy response to questions regarding the submissions cap bottleneck that is affecting the November PBAC meeting, the department pointed to the industry's approach to parallel processing submissions being at least partly to blame.
Referring to the newly-minted MA/government strategic agreement, the spokesperson highlighted "clause 10 commitments to work together to streamline medicines listing processes for the PBS, including specific commitments around developing new pathways for PBAC application and assessment, and new cost recovery arrangements".
"This was included in the agreement," she continued, "as both parties recognised that the current arrangements need reform, including because of issues you have raised in your questions, such as submission churn."
'Submission churn' is when submissions for the same drug and indication repeatedly return to the PBAC after deferral, rejection or a 'no result' due to TGA processes being insufficiently complete.
Pharma in Focus asked a series of questions including whether parallel processing could be blamed for submission churn and whether the parallel processing system needed review and/or reform.
"As an example, the PBAC is seeing the phenomenon of resubmissions being prepared and lodged before the first submission has been considered by the PBAC," the department's response said.
"To avoid wasting time and resources, we need to address the cause of this approach," it added.
"If companies are seeking more detailed feedback on aspects of their submissions, clinical evidence or models, there are less resource-intensive ways of doing this, which we will explore with Medicines Australia and our other industry partners.
"Under the existing parallel processing arrangements agreed with Medicines Australia, a submission to the PBAC may be lodged at any time from the date of lodgement of a TGA registration dossier, and sponsors are required to submit the TGA delegate's overview at least one week prior to the PBAC meeting.
"The PBAC is generally not able to make a positive recommendation in the absence of a TGA delegate's overview, as the information and interpretation contained in the TGA delegate's overview is relevant to the PBAC's consideration".
The spokesperson said that when the current parallel processing arrangements were agreed "industry acknowledged the risks in submitting to the PBAC too far in advance of receipt of the TGA delegate's overview".
"The framework also recognised that with faster PBAC consideration processes, there would be the risk that the number of submissions would exceed evaluation capacity."
The framework was quoted as saying: "Should the number of submission exceed the department's evaluation capacity, the department will discuss possible solutions with Medicines Australia, which may include a process and criteria to prioritise submissions."
David Rowley
david.rowley@lushmedia.com.au
Posted 2 August 2017
Pharma companies are preparing and lodging resubmissions even before their initial submissions have been considered by the PBAC, a spokesperson for the Department of Health has told Pharma in Focus.
In a lengthy response to questions regarding the submissions cap bottleneck that is affecting the November PBAC meeting, the department pointed to the industry's approach to parallel processing submissions being at least partly to blame.
Referring to the newly-minted MA/government strategic agreement, the spokesperson highlighted "clause 10 commitments to work together to streamline medicines listing processes for the PBS, including specific commitments around developing new pathways for PBAC application and assessment, and new cost recovery arrangements".
"This was included in the agreement," she continued, "as both parties recognised that the current arrangements need reform, including because of issues you have raised in your questions, such as submission churn."
'Submission churn' is when submissions for the same drug and indication repeatedly return to the PBAC after deferral, rejection or a 'no result' due to TGA processes being insufficiently complete.
Pharma in Focus asked a series of questions including whether parallel processing could be blamed for submission churn and whether the parallel processing system needed review and/or reform.
"As an example, the PBAC is seeing the phenomenon of resubmissions being prepared and lodged before the first submission has been considered by the PBAC," the department's response said.
"To avoid wasting time and resources, we need to address the cause of this approach," it added.
"If companies are seeking more detailed feedback on aspects of their submissions, clinical evidence or models, there are less resource-intensive ways of doing this, which we will explore with Medicines Australia and our other industry partners.
"Under the existing parallel processing arrangements agreed with Medicines Australia, a submission to the PBAC may be lodged at any time from the date of lodgement of a TGA registration dossier, and sponsors are required to submit the TGA delegate's overview at least one week prior to the PBAC meeting.
"The PBAC is generally not able to make a positive recommendation in the absence of a TGA delegate's overview, as the information and interpretation contained in the TGA delegate's overview is relevant to the PBAC's consideration".
The spokesperson said that when the current parallel processing arrangements were agreed "industry acknowledged the risks in submitting to the PBAC too far in advance of receipt of the TGA delegate's overview".
"The framework also recognised that with faster PBAC consideration processes, there would be the risk that the number of submissions would exceed evaluation capacity."
The framework was quoted as saying: "Should the number of submission exceed the department's evaluation capacity, the department will discuss possible solutions with Medicines Australia, which may include a process and criteria to prioritise submissions."
David Rowley
david.rowley@lushmedia.com.au
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