Helen Kroger (Victoria, Liberal Party) Share this | Hansard source

I write today to place on the public record the critical need for publicly funded nitric oxide therapy to treat critical care infants. This therapy is used to treat hypoxic respiratory failure, HRF, which affects about 500 newborn babies each year. I would like to note that Senator Connie Fierravanti-Wells raised the issue of nitric oxide therapy in estimates only last week, and, disappointingly, the witnesses knew nothing about it. Nitric oxide therapy is available and could provide much-needed help, but it is not listed on the PBS. It is a safe, proven and effective treatment that has a clear role in the management of critical respiratory failure in newborns.

Exactly a month ago, I wrote to the Minister for Health and Ageing, Ms Roxon, about my concerns. As of today I have not received a response from the minister or her department. In my letter I urged the minister to investigate the situation and consider how this therapy could help newborn babies with respiratory failure. My office has been contacted by two key stakeholders in this area. The Australian and New Zealand Neonatal Network wrote to me, seeking assistance for critically ill babies and young children, which their members care for. Associate Professor Dr Kei Lui, director of newborn care at the Royal Hospital for Women in Sydney, wrote to me as the spokesperson for the group in August, and expressed the critical need for appropriate funding for HRF. In correspondence with my office, she recently said:

I strongly believe that critical care babies who need this Inhaled Nitric Oxide (INO) treatment should have access to it under a federal funding scheme. Withholding or rationing a life saving treatment due to local budgetary constraints is unacceptable to health care providers and the families of babies who need it. Access to a life saving treatment should not be a lottery.

Earlier this month I met with Lorna Meldrum, the general manager of IKARIA—and Lorna and her colleagues are here in the gallery this evening; I note their attendance, and thank them for coming. IKARIA is the Australian provider of the drug INOmax, which is nitric oxide for inhalation. Lorna advised me that the drug is currently used around Australian in over 20 hospital neonatal units. She expressed her concern that, due to the hourly cost of nitric oxide treatment, it is potentially being rationed within the hospital system. IKARIA has been advised that the drug cannot be subsidised through the PBS and MBS because it is classified as a designated ‘orphan drug’ and should be funded through the hospital budget.

In Australia, orphan drugs are defined as drugs which treat diseases or conditions affecting no more than 2,000 individuals at a time. Whilst other orphan drugs are eligible for public subsidy consideration under the PBS, MBS or the Life Saving Drugs Program, IKARIA has been advised that INOmax does not meet the criteria as INOmax treatment is only administered in a public hospital setting and requires technology to deliver it. INOmax is only ever used within a hospital, and therefore should fall under the hospital budget.

Hypoxic respiratory failure is a serious condition that occurs when the cells in a baby’s body are unable to receive enough oxygen. Nitric oxide has been used by Australian specialists to treat HRF for a number of years prior to its approval by the TGA. Prior to the introduction of nitric oxide, there was no other pharmaceutical product available, and the only alternative form of treatment was heart-lung bypass surgery. Mortality rates reported in the pivotal nitric oxide registration trials indicate that 11 per cent to 17 per cent of newborns receiving conventional treatment died before discharge from hospital. This equates to 65 to 85 babies dying each year. It is important to note, however, that management of hypoxic respiratory failure has improved since these trials were conducted which is likely to have an effect on the mortality rates.

In the pivotal nitric oxide registration study, referred to as the NINOS study, the incidence of primary outcome, defined as death or the requirement of a heart-lung bypass, was reduced by almost one-third in babies who were treated with nitric oxide. Treatment duration varies, depending on the baby’s response and needs. This therapy allows medical professionals to determine if it will be effective in opening up the blood vessels in the lungs within the first four hours. If no response is seen in the first four hours of treatment, it can be stopped, capping the cost at a mere $300.

The truth is that at such a dramatic time for newborns and parents, especially mothers who have only just given birth, the cost of life-saving therapies should not be a consideration they are burdened with. The benefits and risks of nitric oxide have been extensively analysed in clinical trials. Nitric oxide has received both TGA and FDA approval for the treatment of full-term and near-term babies with HRF associated with pulmonary hypertension. Nitric oxide therapy causes few side effects. During treatment with nitric oxide all babies remain under constant supervision and are monitored within the neonatal intensive care unit to minimise the risk of side effects. A recent published detailed analysis by the prestigious Cochrane Collaboration concluded with the following summary:

Inhaled nitric oxide is safe and can help some full-term babies suffering respiratory failure who have not responded to the usual methods of support. Trials have shown that inhaled nitric oxide can increase the level of oxygen in babies’ blood and reduce the need for extracorporeal membrane oxygenation, a highly technical and invasive therapy. Unfortunately, these benefits of inhaled nitric oxide care are not seen in babies whose respiratory failure is due to a diaphragmatic hernia. Inhaled nitric oxide has not shown any short- or longer-term adverse effects.

Dr Lui estimates that the average cost of this treatment per case is around $10,000. However, treatment duration varies depending on a baby’s responses and needs. There seems to be a simple solution to this circumstance: if INOmax cannot be funded through the PBS then it should be funded through the hospital system. But, of course, politics gets in the way of the good, made even more difficult by the recent deal between the Prime Minister and the Independents. Let me just recap on one recent example of the confusion and outrage this deal has caused. Reports just after the deal was struck said that the government had freed up almost $2 billion of its health and hospitals funding in a new round of spending for regional Australia. One of the most publicised examples was Blacktown Hospital in Western Sydney, where a $150 million, 100-bed upgrade, including new renal and cancer units, was put on hold so that federal funding could be redirected—all in the name of politics, I might add. The Daily Telegraph reported:

WESTERN Sydney's most urgent hospital upgrade has been dumped from a funding priority list because of the political deal between the NSW independents and the Gillard Government to divert health money ...

I thought it important to conclude with two brief examples of how this therapy can literally save a life. Baby Nagirrah was born by caesarean after doctors discovered major complications. He was struggling to breathe properly and needed treatment immediately. His parents feared the worst but he was put on life support and successfully treated. Within a week he was be able to be taken off ventilation and go home with his parents. His mother reflected afterwards: ‘I was worried sick that my baby boy would pull through but his improvement was so dramatic he was taken off the ventilator in less than a week.’

This is potentially a life-and-death decision and Minister Roxon should immediately act to fix the problem and fund this life-saving treatment.