There should be a fast, flexible process for immediately reviewing and updating public funding for medications, so patients are not left untreated or out of pocket.
The “rigid” structures of Australia’s current health technology assessment processes, which caused patients needing Shingrix to pay significant out-of-pocket costs, must be made faster and more flexible for the sake of patient outcomes, says the AMA.
In its submission to the Health Technology Assessment Policy and Methods Review, the AMA used Shingrix has an example of the challenges in supporting patients who need medicines not yet approved by the regulatory process.
“While Zostavax was subsidised, Shingrix was not and cost up to $600 per vaccine,” the AMA said.
“Zostavax is contraindicated for immunocompromised people, leaving these patients with no option but to pay significant out-of-pocket costs for Shingrix.
“Shingrix had been approved in 2018 for adults over 50, with an update to make it available to all immunocompromised patients over 18 in March 2022. However, it did not receive a PBS listing until the 2023-24 Federal Budget, more than a year after it was clear there was a genuine need for the subsidy and a solid body of evidence to support it.
“The rigid structures of the current HTA process were a cause for this delay.
“Once there was a much stronger body of international evidence that demonstrated its efficacy and need for a population group, there should have been a process for immediately reviewing and updating for public funding.”
The AMA offered the German model as an exemplar for further investigation.
“Under this model, immediate reimbursement of pharmaceuticals is provided following regulatory approval,” said the submission.
“The formal HTA process and pricing negotiations are conducted simultaneously. This allows immediate access for patients while the more detailed economic considerations are worked through.”
The AMA told the review that the covid pandemic had demonstrated that faster, more efficient processes were possible, despite challenges for the TGA.
Stakeholder submissions for the review have now closed, but expressions of interest for “deep-dive discussions with the committee”, led by Adjunct Professor Debora Picone, are invited until 1 September.
