Health Minister Greg Hunt has given the Department of Health six months to come up with “legislated options” to enable broader and earlier PBS oncology indications for checkpoint inhibitors.
In his response to a PBAC report “Options for listing PD-(L)1 checkpoint inhibitors for multiple cancer indications on the PBS” released on 22 March, the Minister said he wanted rapid action on parts of the report that recommended further work on arrangements for early drug subsidies.
Mr Hunt said he wanted the department to look at options for early subsidy for TGA-approved drugs which “offer a therapeutic advance for conditions where there is a high and unmet clinical need, while the PBAC is considering an application”.
He also instructed his department too look at “conditional funding arrangements” that use the existing Managed Access Program “for reviewing existing funding arrangements for medicines and for managing exit from subsidy”.
While these options would require new legislation, Mr Hunt also urged the health department to work with the PBAC to develop an Appendix to its guidelines “to provide information on possible approaches to multi-indication submissions within the existing legislative framework.”
The advice to the minister provided in the 16-page PBAC report was generally cautious and warned that any new arrangements for cancer drugs must not devalue the PBS listing system by giving preferential treatment to one specific disease area or undermine the role of evidence in the process.
It noted that comparable countries such as the UK and Canada, had no “explicit, stand-alone process for assessing PD-(L)1 checkpoint inhibitors across multiple cancer types”.
It also warned that a fast track system for subsidising checkpoint inhibitors for multiple indications could set a dangerous precedent and was fraught with uncertainty and risk of financial blowouts.
The PBAC report alluded to the “substantially redesigned” UK Cancer Drug Fund as a potential template with its similarity “to the Australian Managed Access Program arrangements, albeit within an overall fixed funding cap and with clearly defined review mechanisms and timeframes for establishing ongoing subsidy arrangements”.
It said there also needed to processes for ceasing subsidy on medicines where longer term evidence didn’t support further funding.
Though the Mr Hunt’s response raises a number of questions, Richard Vines, head of Rare Cancers Australia said he was “delighted” with its contents.
“As we had hoped there was substantially more opportunity for reform than just the initial proposals around lung cancer.
“It is clear that for significant progress to be made Australia urgently needs a workable Managed Access Program and the UK’s redesigned Cancer Drugs Fund may be a useful guide to this end,” said Mr Vines CEO of the industry-sponsored advocacy group.
The revised version of the UK fund, he said, “seems to be seen quite positively”.
Currently only three PD-(L)1 drugs have been PBS-listed – atezolizumab (Tecentriq), pembrolizumab (Keytruda) and nivolumab (Opdivo).