Why is access to medicines for palliative care an issue?

Many people who want to receive palliative care at home are unable to afford the medicines they need. To address this, a key area of the National Palliative Care Program is to improve access to affordable medicines, through the Pharmaceutical Benefits Scheme (PBS).

To achieve listing under the Scheme, medicines first need to be approved and registered by the Therapeutics Goods Administration (TGA). This involves reviewing the evidence to demonstrate that the medicine is safe and effective for the proposed use (indications).

How does a medicine gain listing on the PBS?

Getting a medicine on to the Pharmaceutical Benefits Scheme is a complex process, as illustrated below.

The PBS process cannot be started unless there is a TGA approval for the required formulation or route of administration. Only the organisation that sponsored the original medicine can apply for approval for a new indication or to change the indication on the Australian Register of Therapeutic Goods. Therefore each medicine considered for palliative care use needs to be assessed against the requirements of the TGA and PBS, and work done to meet those requirements.

 

The Australian Government has demonstrated its commitment to providing affordable access for palliative care medicines by including palliative care medicines recommended for subsidy by the Pharmaceutical Benefits Advisory Committee in a new section in the PBS Schedule.

It is important to note that this new section of the Schedule is intended to complement and be used together with the many palliative medicines already in the general listings section.

How to use the Palliative Care Section of the PBS?

For the purpose of prescribing under the Palliative Care Section of the PBS, a patient receiving palliative care is defined as: A patient with an active, progressive, far-advanced disease for whom the prognosis is limited and the focus of care is the quality of life. This makes these medicines available for any person with a life-limiting condition, regardless of the disease they suffer.

All palliative care listings are “Authority Required”. All prescribers can request an initial authority to provide a maximum of 4 months therapy for palliative care patients. Where a subsequent authority is requested for continuing treatment, the provision of repeats is subject to confirmation by the prescriber that a palliative care physician or palliative care service has been consulted regarding the care of the patient.

What now?

The Palliative Care Clinical Studies Collaborative (PaCCSC) has been established to gather the evidence required to support further PBS listings.

PaCCSC is a group of palliative care units across Australia, which will gain the scientific evidence needed for TGA approval of many of the medicines currently only available freely in public hospitals to treat symptoms of palliative care. These studies may support the registration of a number of medicines used in palliative care on the Australian Register of Therapeutic Goods and subsequently support their listing on the PBS.

For further information go to www.health.gov.au and for updates to the PBS schedule, go to www.pbs.gov.au.