Australia's most trusted source of pharma news
Resubmission isn't 'churn' says PBAC chief
Posted 25 September 2017
A second submission to the PBAC shouldn't be interpreted as "churn" but rather the system of evaluation at work, PBAC chair Professor Andrew Wilson has told Pharma in Focus.
"People talk about churn. What is churn? Is it the same document going backwards and forwards, backwards and forwards? No, it's not."
He said the process of a sponsor making a submission to the PBAC was "a value-added", allowing the company to comment on that evaluation.
"Both those things are then considered by our two principal sub-committees - the economic sub-committee and DUSC - and the company then gets a chance to comment on," he said.
Combined with submissions from both clinical and patient groups, all of which are part of the advice, there were a number of reasons why the PBAC might accept or reject a submission, ranging from concerns about comparative effectiveness and safety, to cost-effectiveness, how the sponsor "positions" the drug and economic modeling.
"Most of these submissions, other than for drugs which have relatively short effects," he said, "will have some sort of economic model to estimate the cost-effectiveness" but, he added, "models are always tricky and always open to some discussion".
"So there are elements when that submission comes to the PBAC and there is a legitimate issue from our perspective where we say 'we don't think the application is up to scratch, and you need to go away and do some more work on it'."
"They get detailed minutes from our meeting and they get a chance to talk to me. The minutes map out the PBAC's concerns and they also get an opportunity, if it's a major submission, to then meet with me and the department to discuss their concerns.
"If they get rejected that first time round, it's simply because we don't agree with what's in there. I don't think that's 'churn'. I think that's the nature of the beast." And, he added, the first time around most submissions "almost always" require modifications to meet the needs of the PBAC.
"I do not count a second submission as churn because I don't believe there is a way of getting around that. The PBAC is not able to give its comprehensive advice about the submission until it's seen it at least once."
But, after a second submission the omnipresent issue of price was often the sticking point.
"There's no doubt part of the problem is a lot of these drugs have very high prices relative to modest benefits; we don't necessarily get the best price first time around and the current process for dealing with that is that companies have to re-apply."
"And much as I'd like to think there are ways of reducing that, I don't believe companies will ever be in a position to offer their best price first time around and, second, we're not in a position to offer our advice about their model and its strengths and weaknesses the first time around".
Although he says beyond that second round, the discussions is often around price, that is not always the case.
"Sometimes it's unbelievable what companies don't respond to in terms of the advice that's given to them," he said. "They may be told that what we believe to be the comparator in Australia but they will respond using their original comparator. To be fair, it doesn't happen a lot but there are some times when we scratch our heads and think "Why are they doing this?"
Wilson is upbeat when talking about the huge wave of a reputed 42 major submissions put forward for consideration at the November PBAC meeting - which some have ascribed to misuse of the parallel processing system creating the so-called "submission churn".
The solution was 36 major submissions on the PBAC November meeting agenda and the overflow from that - believed to be six major submissions in all - to be considered in December in place of the committee's usually scheduled supplementary meeting - the details of which will be published on October 4.
Wilson sees that spike as probably a 'one-off' and freely admits the large number of submissions caught the system off-guard and it didn't have the flexibility to quickly manage the increased load.
"We've had an exceptional number of submissions this time around - more than 40 - and that just went over the capacity of the system to handle," he said.
But, he added, "I don't expect that to be an ongoing problem - or if it is an ongoing problem, then I'm happy to have it and we'll just expand the capacity.
"If there are more submissions coming in, it means there are new drugs becoming available for patient care and we want to see that. That's not a bad thing. I would expect the department to respond appropriately and expand capacity to manage what submissions come forward," he said.
David Rowley
david.rowley@lushmedia.com.au
Posted 25 September 2017
A second submission to the PBAC shouldn't be interpreted as "churn" but rather the system of evaluation at work, PBAC chair Professor Andrew Wilson has told Pharma in Focus.
"People talk about churn. What is churn? Is it the same document going backwards and forwards, backwards and forwards? No, it's not."
He said the process of a sponsor making a submission to the PBAC was "a value-added", allowing the company to comment on that evaluation.
"Both those things are then considered by our two principal sub-committees - the economic sub-committee and DUSC - and the company then gets a chance to comment on," he said.
Combined with submissions from both clinical and patient groups, all of which are part of the advice, there were a number of reasons why the PBAC might accept or reject a submission, ranging from concerns about comparative effectiveness and safety, to cost-effectiveness, how the sponsor "positions" the drug and economic modeling.
"Most of these submissions, other than for drugs which have relatively short effects," he said, "will have some sort of economic model to estimate the cost-effectiveness" but, he added, "models are always tricky and always open to some discussion".
"So there are elements when that submission comes to the PBAC and there is a legitimate issue from our perspective where we say 'we don't think the application is up to scratch, and you need to go away and do some more work on it'."
"They get detailed minutes from our meeting and they get a chance to talk to me. The minutes map out the PBAC's concerns and they also get an opportunity, if it's a major submission, to then meet with me and the department to discuss their concerns.
"If they get rejected that first time round, it's simply because we don't agree with what's in there. I don't think that's 'churn'. I think that's the nature of the beast." And, he added, the first time around most submissions "almost always" require modifications to meet the needs of the PBAC.
"I do not count a second submission as churn because I don't believe there is a way of getting around that. The PBAC is not able to give its comprehensive advice about the submission until it's seen it at least once."
But, after a second submission the omnipresent issue of price was often the sticking point.
"There's no doubt part of the problem is a lot of these drugs have very high prices relative to modest benefits; we don't necessarily get the best price first time around and the current process for dealing with that is that companies have to re-apply."
"And much as I'd like to think there are ways of reducing that, I don't believe companies will ever be in a position to offer their best price first time around and, second, we're not in a position to offer our advice about their model and its strengths and weaknesses the first time around".
Although he says beyond that second round, the discussions is often around price, that is not always the case.
"Sometimes it's unbelievable what companies don't respond to in terms of the advice that's given to them," he said. "They may be told that what we believe to be the comparator in Australia but they will respond using their original comparator. To be fair, it doesn't happen a lot but there are some times when we scratch our heads and think "Why are they doing this?"
Wilson is upbeat when talking about the huge wave of a reputed 42 major submissions put forward for consideration at the November PBAC meeting - which some have ascribed to misuse of the parallel processing system creating the so-called "submission churn".
The solution was 36 major submissions on the PBAC November meeting agenda and the overflow from that - believed to be six major submissions in all - to be considered in December in place of the committee's usually scheduled supplementary meeting - the details of which will be published on October 4.
Wilson sees that spike as probably a 'one-off' and freely admits the large number of submissions caught the system off-guard and it didn't have the flexibility to quickly manage the increased load.
"We've had an exceptional number of submissions this time around - more than 40 - and that just went over the capacity of the system to handle," he said.
But, he added, "I don't expect that to be an ongoing problem - or if it is an ongoing problem, then I'm happy to have it and we'll just expand the capacity.
"If there are more submissions coming in, it means there are new drugs becoming available for patient care and we want to see that. That's not a bad thing. I would expect the department to respond appropriately and expand capacity to manage what submissions come forward," he said.
David Rowley
david.rowley@lushmedia.com.au
Drought, fire and now virus cut chance of PBS relief.
Don't do it for the accolades; do it for your kids.
New forms of rotavirus vaccine Rotarix.