More than 160,000 Australians per year will benefit from the Australian Government's decision to provide subsidised access to 48 medicines, including treatments for serious heart conditions including heart failure in infants and children, rare but serious infections like tuberculosis, and cancer.
These listings include drugs that were deferred in February and new drugs recently considered and approved for listing by Cabinet.
When some listings on the Pharmaceutical Benefits Scheme (PBS) were deferred in February, the Government said it would reconsider these drugs when fiscal circumstances allowed.
Budget savings created by price reductions arising from more competitively priced medicines, as well as a number of recent Pharmaceutical Benefits Advisory Committee (PBAC) recommendations, mean that it is now possible to list these medicines.
These PBS listings come as the Government also agreed with consumer and industry groups to improve the certainty around the PBS listing process.
As part of our commitment with the Consumers Health Forum, Generic Medicines Industry Association and Medicines Australia:
* The Government, industry and consumer groups agreed to work together to discuss ways to manage deferrals into the future.
* They also agreed to work together on further savings for the 2012-13 Budget and other savings following the expiry of the memorandum of understanding between industry and Government.
* The Government committed to not defer any drugs that cost under $10 million a year for the coming year, while it works with all parties to achieve longer-term PBS sustainability.
* Industry has also agreed to legislative amendments to complete price disclosure reforms, which will help to end anomalies in the current pricing system.
This builds on the Gillard Government's strong track record of working productively with industry and consumer groups to deliver a sustainable PBS that provides Australians with access to affordable medicines.
New listings on the PBS and price changes
Most listings will take effect from 1 December 2011, subject to final listing arrangements being met by the suppliers of these medicines and will include:
* paliperadone palmitate (Invega Sustenna®) - for the treatment of schizophrenia
* oxycodone/naloxone (Targin®) - for the treatment of severe cancer pain
* budesonide with eformoterol (Symbicort®) - for the treatment of lung disease
* botulinum toxin type A (Botox®) extension - for the treatment of severe axillary hyperhidrosis
* dalteparin sodium (Fragmin®) - for the treatment of blood clots in patients with cancer
* nafarelin (Synarel®) - for the treatment of patients undergoing in-vitro fertilisation
* alendronate (Fosamax®) - for the treatment of osteoporosis
* asenapine (Saphris®)- for the treatment of bipolar 1 disorder and schizophrenia
* bortezomib (Velcade®)- for the treatment of multiple myeloma in patients with severe acute renal failure
* capecitabine (Xeloda®)- for the treatment of patients with advanced bowel cancer
* darunavir (Prezista®)- for the treatment of HIV infection
* denosumab (Xgeva®)- for the treatment of bone metastases from breast cancer and hormone-resistant prostate cancer
* losartan (Cozavan®) - for the treatment of hypertension
* magnesium aspartate (Mag-Sup®) - for the treatment of hypomagnesaemia and chronic renal disease in Aboriginal and Torres Strait Islander persons
* rituximab (Mabthera®)- a high cost medicine for the treatment of a specific form of chronic lymphocytic leukaemia.
The Government has also agreed to increase the price of 23 medicines currently listed on the PBS including:
* digoxin oral solution (Lanoxin®) - for the treatment of serious heart conditions including heart failure in infants and children
* dothiepin (Dothep®) - for the treatment of depression
* oxprenolol (Corbeton®) - for the treatment of high blood pressure, particularly in pregnancy
* rifampicin (Rimycin®) - for the treatment of rare but serious infections including tuberculosis and as a prophylaxis for close contacts of patients with meningococcal disease
* ritonavir (Norvir®) - for the treatment of HIV infection
* erythromycin lactobionate (Erythrocin-IV®) and erythromycin ethyl succinate (E-Mycin 200®, E.E.S. 200®, E-Mycin 400® and E.E.S. Granules®) - for the treatment of bacterial infections
* acarbose (Glucobay®) - for the treatment of diabetes
* Glucose indicator - urine (Diastix®) - used by diabetes patients
* Hexamine hippurate (Hiprex®) - for the treatment of bacterial infections
* Pancreatic extract (Creon 10,000®, Creon 25,000® and Creon 40,000®) - for the treatment of enzyme deficiency in children and adults
* Sucralfate (Ulcyte® and Carafate®) - for the treatment of peptic ulcers.
Pradaxa
The Government has also considered the advice of the PBAC of March 2011 with respect to the medicine dabigatran (Pradaxa®), which will cost the budget up to$1 billion over the forward estimates. PBAC advised that, based on the results of the pivotal clinical trial, Pradaxa represents a safe, efficacious and cost effective therapy for some ‘at risk' stroke patients.
However, PBAC also raised some important questions about listing Pradaxa on the PBS that require further consideration. Importantly, PBAC advised the Government that the benefit of Pradaxa® observed in a clinical trial context may or may not be reflected wholly in the Australian population which may lead to this medicine being over prescribed without an adequate education campaign for doctors, pharmacists and patients.
Following this advice, the Government will commission Emeritus Professor Lloyd Sansom AO, the former Chair of PBAC, to inform the Government on options for improving the health outcomes of patients treated with anticoagulation therapies, including optimising the use of currently available treatments in Australia as well as the future role of newer therapies for the treatment of atrial fibrillation, such as Pradaxa®.
The terms of the commitment made between the Australian Government, the Consumers Health Forum, Generic Medicines Industry Association and Medicines Australia is available from www.health.gov.au.
For media inquires about specific drugs listed on the PBS, please call: (02) 6289 7400