Last week, without warning, the federal government significantly cut funding for an important and safe childhood asthma drug. A short document explained to prescribers what had changed, but gave no reasons.
The drug, fluticasone propionate 50mcg, is a metered dose inhaler, better known by the brand names Flixotide Junior or Axotide Junior. It is one of the lowest dose drugs of its kind available, and until April 1, the government had subsidized nearly 80,000 of these puffers per year.
However, the new change will make it more difficult to afford, especially for vulnerable families, who already suffer the most from asthma.
Read more: What Causes Asthma? What we know, don’t know and suspect
The importance of asthma prevention
If a child has asthma, inflammation and sensitivity causes narrowing of the airways, making breathing difficult.
About one in ten Australian children has long-term asthma. It can cause terrifying shortness of breath, poor school attendance, and sometimes hospitalization. Rarely, and tragically, do children die from asthma.
Children with persistent or severe asthma symptoms need medication to reduce airway inflammation. “Inhaled steroids” are the safest and most effective treatments. In fact, the World Health Organization has included them in her List of essential medicines for children.
These drugs reduce the risk of severe outbreaks of symptoms, special in children with a history of such flares. The aim is to use the lowest effective dose, but it is the subsidy of the low dose of fluticasone that the new policy affects.
How drug subsidy decisions work
To be sold in Australia, all prescription drugs must be registered by the Therapeutic Goods Administrationthat assesses the safety and efficacy of the medicine.
The Medicines regulation (PBS) is a list of medicines that our government co-pays. This scheme limits the cost of dispensed medicines to about A$30 for most people and about A$7 for those with concession cards.
To get a drug on the list, the manufacturer must convince the manufacturer Pharmaceutical Benefits Advisory Committee (PBAC) the drug is cost effective.
Having these kinds of processes – a single major payer and well-qualified decision-makers – is a good thing. It’s one reason why Australia has much cheaper drugs than the United States. This usually benefits both patients and health authorities.
Read more: Passive smoking, synthetic bedding and gas heating in homes show the strongest associations with asthma
The new rules
Previously, under the PBS, any physician could prescribe low-dose fluticasone to a child with asthma. But from April 1, that is no longer the case.
The new PBS Rules are complicated.
First, no one over the age of six receives a government subsidy to cover the cost of this drug.
Second, the PBS will only subsidize it for children under six if a pediatrician or pulmonologist started the drug and if the prescriber first contacted the PBS for approval.
The PBS has not made it clear why this change was made, either on their website or when pressured by journalists.
In general, if the Advisory Committee on Pharmaceutical Benefits and a manufacturer cannot agree on the price of a drug, the drug remains with the PBS and is not subsidized. Alternatively, the Pharmaceutical Benefits Advisory Committee may impose restrictions on the population for which the drug is subsidized.
In this case, no safety or effectiveness concerns were raised and the change coincided with a planned change price reduction datecould the new restrictions simply be about money – the Pharmaceutical Benefits Advisory Committee and the manufacturer disagree on a price.
What does it mean for families?
Various alternative medicines may be prescribed for children over the age of six.
But in children under the age of five there are no good alternatives because no other age-appropriate low-dose steroid inhalers have been approved by the TGA.
In the under five age group, GPs now have three options if they think their patient may need inhaled steroids:
prescribing fluticasone 50mcg on a private script
refer to a pediatrician or pulmonologist
prescribing other drugs “off-label” (in a way not approved by the TGA), often requiring higher doses of steroids.
These are all problematic.
Using private scripts means families have to pay what their local pharmacy charges them. We expect the price to be around at many pharmacies $11 Unpleasant $28 per inhaler, but there are no guarantees that all pharmacies will dispense the medication at this price.
Using private scripts will certainly harm families who rely on them concessions or safety netsincluded Aboriginal and Torres Strait Islander children and those from low socioeconomic backgrounds who are disproportionately affected by asthma.
Mandatory referral to a specialist also has many adverse consequences. There are already bulging waiting lists for these services, leading to delays in care. There are no bulk billing specialists in many parts of Australia, making it difficult for vulnerable families to access these services.
GPs will feel obliged to refer cases they could have previously treated, which could erode community trust in GPs.
The decision negatively affects the interests of so many Australian children, especially those from our most vulnerable populations who already suffer disproportionately from asthma. The Pharmaceutical Benefits Advisory Committee and the manufacturer should work together to reconsider it.
Read more: The price of PBS drugs is falling. But are we helping the right people?