The Department of Health has released its issues paper on the post-market review of the Life Saving Drugs Program (LSDP) and is now calling for public submissions from stakeholders (individuals and associations) by April 30, 2015.
In its issues paper released last Friday, the expert reference group of the PBS post-market review of the LSDP cited “there remains a need for a funding mechanism for medications for rare conditions that are unlikely to meet the usual cost-effectiveness criteria applied with the Pharmaceutical Benefits Scheme due to the higher than average asking prices of these drugs.”
The paper reiterated that the funding access criteria should remain tight and that “providing the criteria are specified, there appears to be no major practical reason as to why such a funding mechanism needs to be separate to the usual assessment processes of the PBAC.”
The LSDP review commenced August, 2014 with various submissions ranging from the call for a national plan for rare diseases, to significant public concern over the funding assessment criteria for life-saving treatments.
The issues paper identified access being provided to medications mainly before there was clear evidence of whether the treatment was effective in the medium and long-term, resulting in manufacturers being paid for a medication found to be ineffectual, or less efficacious than claimed.
Furthermore, the paper questioned whether the government should demand additional evidence of ongoing benefit through managed entry schemes and pay for performance models when effectiveness is not clear, and the criteria that should be used in deciding upon a fair cost to pay for the treatments.
The reference group also concluded that not one of the life-saving treatments currently funded through the LSDP had demonstrated an ability to cure the disease for which it is subsidised, questioning “Who should decide to continue therapy if the disease and/or the disease symptoms are not stable or improving?”
The reference group outlined the following four options pertaining to the future of the LSDP:
Option 1 – Keeping the LSDP in its current form could prove “unsustainable” cost-wise.
Option 2 – The LSDP to become a PBS S100 program for rare diseases, whereby treatments may be funded through a managed entry scheme with data collected via a registry and an annual report produced for the PBAC.
Option 3 – The LSDP is subsumed into State and Territory public health systems, effectively reducing the administrative cost to the Commonwealth.
Option 4 – Imposing a cap on the LSDP’s budget, with current and new patients managed within that budget.
To ensure the report represents the views of a range of stakeholders, and to inform future discussions about the funding of life-saving treatments, be sure to have your say. Make your public submission here by April 30.