APPROVAL AND FUNDING OF NEW MEDICINES NEEDS FAST TRACKING
The National Association of People with HIV (NAPWHA) welcomes the announcement in the 2017 Federal Budget that the Commonwealth Government will fund all medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).
NAPWHA notes there are a large number of people with serious, life-threatening diseases like HIV who rely on important new medicines becoming available in Australia as early as possible and for the cost of these medicines to be subsidised through the PBS .
“These new medicines can be very expensive and without subsidised access through the PBS the future may be bleak for people living with life-threatening illnesses like HIV,” said Aaron Cogle, Executive Director of NAPWHA, Australia’s peak organisation representing people with HIV.
“Australia’s medicine approval and funding systems need to be proactive in recognising new drugs in the pipeline and their potential benefits to individuals and public health. These new medicines may work more effectively and may also offer big advantages in terms of their tolerability and side-effects.”
NAPWHA notes that the Commonwealth is currently implementing new systems for the Therapeutic Goods Administration (TGA) which will allow for submissions to seek provisional approval for medicines and also provide a capacity for important new medicines to be 'fast-tracked' to help get them to people with serious illnesses as soon as possible”.
“We very much welcome these reforms to the TGA medicines regulatory processes. However, serious delays can still occur at the next key stage, which is all about funding these important medicines and getting them listed on the PBS . Currently, the health system does not have a formal provision for 'fast tracking' of medicines through the PBS . And even if PBAC recommends PBS listing, particular medicines may still need to be approved by Federal Cabinet, which can mean long delays,” Cogle noted.
“Examples in the HIV field where a fast-tracking and provisional approval capacity in the health system is likely to be important over the next few years includes access to long-acting injectable drugs to treat and prevent HIV, as well as having reliable HIV test kits available for purchase to provide HIV self-testing by people who may have issues engaging with mainstream HIV testing services.”
In welcoming the commitments in the 2017 Budget to support timely access to new medicines and medical tests, NAPWHA urges the Government to enhance the capacity of the PBAC to identify and fast track important new medicines. This should also include having a clear timeline if Cabinet approval is required for PBS listing of more expensive medicines recommended by PBAC .
For more details contact: Aaron Cogle: 0468 438 214