PBS delays need industry and government action

Thursday, November 22, 2012


A new study has revealed that Australians are waiting longer for approved medicines but industry tactics may be as much to blame for the delays as changes to Government policy.

This study is reported in the most recent edition of the Australian Health Review, the peer reviewed journal of the Australian Healthcare and Hospitals Association.

“In February 2011 the Australian Government announced that it would defer the listing of seven medicines on the Pharmaceutical Benefits Scheme (PBS), which lists the medicines to be subsidised by the government. In addition, all future listings would now be considered by Cabinet, which could slow the review process. The Minister for Health characterised these decisions as cost-saving measures to ensure the long-term sustainability of the PBS,” said author Alison Pearce, a PhD candidate at the University of Technology, Sydney.

“This decision raised concerns about the potential for additional delays to affect the accessibility of new, affordable medicines for patients. There has been a decade-long trend in increased delays with research from other sources showing the average time between a positive TGA recommendationand PBS listing has increased steadily from 13.6 monthsin 2000 to 34.2 months in 2009. Delays in the subsidisation of medicines, wherever they occur in theprocess, are important not only because they reduce patient access, but also because they may put pressure on other areas of the health care system to finance suchmedicines.

“This study examined the timelines of PBS applications following approval by the Therapeutic Goods Administration (TGA), allowing the recent Cabinet delays to be considered in the context of the overall medicines approval process.

“We identified all applications for new medicinesor for medicines to be used to treat new conditions approved in 2004 by the TGA and found that only 43% of these products were submitted for PBS listing within 2 years, with an average 17-month delay from TGA approval of a product to consideration by the Pharmaceutical Benefits Advisory Committee (PBAC), who review PBS applications.

“One of the reasons we identified that companies may not apply for PBS listing is the cost of a major submission, particularly for medications with relatively small markets. A major PBS submission requires the collection of rigorous data on effectiveness and cost effectiveness. And although not in place during our study, since 2010 the PBS has charged companies additional cost recovery fees of up to $19,500 per submission.

The time and resources required to prepare a PBAC submission mean companies may choose not to apply for PBS listing and look for alternative ways of selling and marketing products directly to individuals, or through funding available through special access schemes, private insurance companies, hospitals or charitable organisations.

These high submission costs, the availability of alternative sources of funding, and the need to negotiate on price with the Pricing Authority creates fewer incentives for pharmaceutical companies to apply for PBS listing, potentially leaving Australians with limited access to affordable medicines.

“Overall, our study showed that while the recent policy changes requiring Cabinet approval have delayed access to new treatments,there are other delays earlier in the approval process that alsohave a significant PBS delays need industry and government action impact on the overall timeliness of listing. These will all need to be addressed to ensure Australians have timely access to medicines on the PBS,” Ms Pearce said.

For more information and comment: Alison Pearce 0408 117 890