Improving Access To Medicines

Young people with Type 1 diabetes are among the many Australians who will benefit from 2008-09 Budget funding of $845.9 million over five years for new medicines and medical devices.

Page last updated: 13 May 2008

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13 May 2008

Young people with type 1 diabetes are among the many Australians who will benefit from funding of $845.9 million over five years for new medicines and medical devices.

Like Medicare, the Pharmaceutical Benefits Scheme (PBS) is an essential component of Australia’s health system. The Government will ensure all Australians have reliable, timely and affordable access to their essential medicines through the PBS.

A number of new listings, costing $815.2 million over five years, are being added to the PBS, including drugs to treat certain patients with cancer, diabetes, urinary incontinence, blindness, hepatitis, kidney disease, attention deficit hyperactivity disorder, rheumatoid arthritis and schizophrenia.

The Government will also provide $25.3 million to fund Naglazyme® (galsulfase) under the Life Saving Drugs Program, to assist patients with a rare, debilitating enzyme deficiency called Maroteaux-Lamy Syndrome.

In addition, some patients with chronic conditions will now only have to see their doctor for a prescription once a year, instead of once every six months.

  • PBS measures
The listing of Sensipar® (cinacalcet) from 1 July 2008 will assist in the treatment of the kidney disease complication known as secondary hyperparathyroidism.

The listing of Tysabri® (natalizumab) from 1 July 2008 will help patients suffering from relapsing remitting multiple sclerosis (RRMS). Natalizumab reduces both relapse rate and worsening disability.

The extended listing of Remicade® (infliximab) from 1 December 2007 will assist patients with the severe skin condition, chronic plaque psoriasis.

The listing of Renagel® (sevelamer) from 1 December 2007 will assist in the management of chronic kidney disease.

The listing of Tykerb® (lapatinib) from 1 May 2008 will assist patients with advanced breast cancer.

The extended listing of Topamax® (topiramate) from 1 December 2007 will help patients with migraine who are unable to take other treatments, including about 24,000 new people in the first full financial year of listing.

The listing of Champix® (varenicline) from 1 January 2008 will help people who want to stop smoking. Varenicline acts by ‘damping down’ the positive effects of smoking and by reducing the severity of withdrawal symptoms. About 194,700 additional people will begin Champix® for smoking cessation in the first full financial year of listing.
  • Insulin pumps – subsidy for young people with type 1 diabetes
The Government will subsidise the cost of insulin pumps for young people with type 1 diabetes from 1 November 2008.

This measure, costing $5.5 million over four years, will provide a means-tested subsidy of up to $2,500 for around 700 people with type 1 diabetes under the age of 18.

An insulin pump is a small computerised device that delivers insulin constantly under the skin through a plastic tube. The pump is programmed to give small background doses of insulin continuously throughout the day and night depending on the individual’s needs.

Insulin pump therapy is regarded as the best treatment for children and young people with type 1 diabetes, particularly for those who are unable to adequately control their diabetes by means of multiple daily injections. An insulin pump significantly improves the health of the user. It also reduces the need for parents to supervise the management of a child’s type 1 diabetes.

Media inquiries only: Sean Kelly – 0417 108 362
For all other inquiries please contact the Minister's office – 02 6277 7220


Life Saving Drugs Program – Funding for Naglazyme® (galsulfase)

Why is this important?
  • The Government will fully fund the cost of Naglazyme®, under the Life Saving Drugs Program, for eligible people for the treatment of Mucopolysaccharidosis Type VI (MPS VI) disease (Maroteaux-Lamy Syndrome).
  • MPS VI is an extremely rare disease that affects multiple organ systems and tissues. It is progressive, debilitating and life-threatening.
  • MPS VI causes deceleration of growth, skeletal deformities, coarse facial features, upper airway obstruction, recurrent airway and ear infections and joint deformities.
  • If left untreated, MPS VI leads to a very poor quality of life and early death.
  • Treatment of MPS VI with Naglazyme® can restore a reasonable quality of life and life span.
Who will benefit?
  • People with MPS VI disease who meet the clinical eligibility criteria.
  • It is expected that 12 people will be eligible for treatment in the first year, with an additional person being eligible in each future year.
What funding is the Government committing to the initiative?
  • Funding for the treatment of people with MPS VI will be ongoing. The initial four years of this initiative is expected to cost $25.3 million.
  • The average cost per patient is expected to be around $480,000 per year.
What is the timeframe for delivery?
  • Government-funded treatment using Naglazyme® will start on 1 September 2008.

Pharmaceutical Benefits Scheme – Listing of Sensipar® (cinacalcet)

Why is this important?
  • From 1 July 2008, cinacalcet to treat the kidney disease complication known as secondary hyperparathyroidism, will be available under the PBS.
  • Secondary hyperparathyroidism is a progressive and inevitable complication of chronic kidney disease in dialysis patients.
  • Current therapies include phosphate binders (such as calcium carbonate, calcium citrate, calcium acetate or Renagel®) and/or vitamin D preparations (calcitriol or paracalcitol). However these often fail to correct metabolic disturbances in secondary hyperparathyroidism, hence the need for adding cinacalcet therapy.
Who will benefit?
  • Chronic kidney disease affects the lives of around 7 per cent of people over the age of 25. It is a condition that progresses towards the loss of all kidney function and the need for life long dialysis or kidney transplantation.
  • About 2,900 people will begin cinacalcet for the treatment of secondary hyperparathyroidism in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $166.4 million between 2008 09 and 2011 12 for the listing of cinacalcet on the PBS and the Repatriation Pharmaceutical Benefits Scheme.
What is the timeframe for delivery?
  • This is an ongoing initiative that will start on 1 July 2008.

Pharmaceutical Benefits Scheme – Listing of Tysabri® (natalizumab)

Why is this important?
  • The new listing of natalizumab will become available on 1 July 2008 for patients suffering from relapsing remitting multiple sclerosis (RRMS).
  • Natalizumab is a unique immunological therapy, shown to be significantly better than any existing therapy for multiple sclerosis (MS), across a wide range of outcome measures. Most importantly, natalizumab reduces both relapse rate and worsening disability.
Who will benefit?
  • MS is an incurable, degenerative disease of the brain and spinal cord, usually progressive. MS is the most common cause of neurological disability in young adults. It is typically associated with a diverse and unpredictable range of clinical symptomatology, posing a challenge to both clinicians and carers.
  • The most common form of MS is RRMS, occurring in about 85 per cent of patients at diagnosis. The disease is characterised by episodes of nervous system impairment (usually referred to as relapses or exacerbations), alternating with periods of partial or complete remission of symptoms.
  • About 2,300 people will begin natalizumab for the treatment of RRMS in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $370.2 million between 2008 09 and 2011 12 for the listing of natalizumab on the PBS and Repatriation Pharmaceutical Benefits Scheme.
What is the timeframe for delivery?
  • This is an ongoing initiative that will start on 1 July 2008.

Pharmaceutical Benefits Scheme – Listing of Renagel® (sevelamer)

Why is this important?
  • Sevelamer became available on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2007 for the management of chronic kidney disease.
  • Sevelamer lowers the phosphorus concentration in the blood and reduces the risk of high blood calcium levels, compared with using calcium-based phosphate binders.
Who will benefit?
  • Chronic renal failure occurs when functioning kidney tissue is insufficient to meet the demand for excretion of waste products or to regulate blood biochemistry and the other functions normally carried out by the kidney. Once kidney damage has developed beyond a critical point, progressive renal failure slowly develops.
  • Patients with end-stage renal disease retain, and can develop high levels of phosphorus in the bloodstream. Sevelamer lowers the phosphorus concentration in the blood and reduces the risk of high blood calcium levels, compared with using calcium-based phosphate binders.
  • About 3,200 people will commence sevelamer for the management of chronic kidney disease in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $65.1 million between 2007 08 and 2010 11 for the listing of sevelamer on the PBS and Repatriation Pharmaceutical Benefits Scheme. Provision for this funding has already been included in the forward estimates.
What is the timeframe for delivery?
  • This is an ongoing initiative that started on 1 December 2007.

Pharmaceutical Benefits Scheme – Listing of Tykerb® (lapatinib)

Why is this important?
  • The new listing of lapatinib was made available on 1 May 2008 for people with advanced HER 2 positive breast cancer.
Who will benefit?
  • Advanced HER-2 positive breast cancer refers to disease that has spread to distant parts of the body (metastasised) or which cannot be removed with surgery. HER-2 positive breast cancer is a particular type which produces an increased amount of a protein molecule called human epidermal growth factor receptor 2 (HER-2). The HER-2 protein is associated with more aggressive disease.
  • Breast cancer is the most common cancer in women and affects 14,000 Australians per year. In 2004, more than 2,600 people died from the disease in Australia. About 2,000 Australians are diagnosed with HER-2 positive breast cancer each year.
  • Lapatinib is a new treatment for metastatic or advanced breast cancer which can only be used after the disease has progressed despite treatment with the other drug used specifically for HER-2 positive breast cancer, trastuzumab (Herceptin®). Unlike trastuzumab, which must be administered intravenously, lapatinib is an oral medicine which can be taken at home, in combination with another anti-cancer drug, capecitabine.
  • About 800 eligible patients will begin lapatinib for advanced HER 2 positive breast cancer in the first full year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $83.5 million between 2007 08 to 2011 12 for the listing of lapatinib on the PBS and the Repatriation Pharmaceutical Benefits Scheme. This is partially offset by a saving of around $63.5 million between 2007 08 and 2011-12 to the Herceptin® Program (non PBS subsidised) for advanced breast cancer.
What is the timeframe for?
  • This is an ongoing initiative that commenced on 1 May 2008.

Pharmaceutical Benefits Scheme – Extension to the Listing of Topamax® (topiramate)

Why is this important?
  • The listing of topiramate on the Pharmaceutical Benefits Scheme (PBS) was extended from 1 December 2007 to allow access for patients with migraine who are unable to take other treatments.
  • The goals of migraine prevention are to reduce attack frequency, severity and duration, improve responsiveness to treatment of acute attacks and improve function and reduce disability.
Who will benefit?
  • Migraine is a disabling disorder that affects individuals, their families, and society. The World Health Organization ranks migraine among the world’s most disabling illnesses.
  • In addition to impairment of an individual’s ability to function during an episode of migraine, sufferers show a reduction in quality of life immediately after and between episodes. One half of migraine sufferers are reported to discontinue normal activities during episodes and nearly one third require bed rest.
  • About 24,000 additional people are expected to commence topiramate for the prevention of migraine in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $39.1 million between 2007 08 to 2010 11 to extend the listing of topiramate on the PBS and Repatriation Pharmaceutical Benefits Scheme. Provision for this funding has already been included in the forward estimates.
What is the timeframe for delivery?
  • This is an ongoing initiative that started on 1 December 2007.

Pharmaceutical Benefits Scheme – Listing of Champix® (varenicline)

Why is this important?
  • Varenicline became available on the Pharmaceutical Benefits Scheme (PBS) from 1 January 2008 and is a new and effective treatment to help people who want to stop smoking.
  • Varenicline acts by ‘damping down’ the positive effects of smoking and by reducing the severity of withdrawal symptoms.
Who will benefit?
  • It is estimated that 50 per cent of smokers will die of disease caused by tobacco use. The most common causes of smoking related mortality are chronic obstructive pulmonary disease, cardiovascular disease and cancers, especially of the mouth, throat and lung. Lung cancer is a particularly intractable malignancy and the majority of sufferers will succumb to the disease. Ceasing smoking greatly reduces a person’s risk of dying from these illnesses and the reduction in risk is detectable after two years of abstinence.
  • Smoking and nicotine addiction are strongly interrelated and it is therefore important to deal with both when attempting to reduce smoking prevalence.
  • About 194,700 additional people will commence Champix® for smoking cessation in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $97.1 million between 2007 08 to 2011 12 for listing of varenicline on the PBS and Repatriation Pharmaceutical Benefits Scheme.
What is the timeframe for delivery?
  • This is an ongoing initiative that started on 1 January 2008.

Pharmaceutical Benefits Scheme – Extending the Listing of Remicade® (infliximab)

Why is this important?
  • The listing of infliximab on the Pharmaceutical Benefits Scheme (PBS) was extended from 1 December 2007 to allow access for patients suffering from chronic plaque psoriasis.
  • This will give patients an alternative therapy for psoriasis.
Who will benefit?
  • Psoriasis is an inflammatory skin disease characterised by a red, scaly rash which can be itchy. It is a disabling and disfiguring condition that has a major impact on patients’ quality of life, social relationships and participation in daily life.
  • About 430 additional people will commence infliximab for the treatment of psoriasis in the first full financial year of listing.
What funding is the Government committing to the initiative?
  • The Government will provide $25.5 million between 2007 08 to 2010 11 to extend the listing of infliximab on the PBS and the Repatriation Pharmaceutical Benefits Scheme. Provision for this funding has already been included in the forward estimates.
What is the timeframe for delivery?