New asthma medicine restrictions will hurt the poorest children the most

Last week, without warning, the federal government significantly restricted the subsidy for an important and safe asthma medicine for children. A short document^[1] explained to prescribers what had changed, but gave no reasons.

The medicine, fluticasone propionate 50mcg, is a metered-dose inhaler^[2], more commonly known by the brand names Flixotide Junior or Axotide Junior. It’s one of the the lowest dose medicines of its type available, and until April 1 the government had subsidised nearly 80,000^[3] of these puffers each year.

However, the new change will make it harder to afford, especially for vulnerable families, who already suffer the greatest burden of asthma.

Read more: What causes asthma? What we know, don't know and suspect^[4]

The importance of asthma prevention

When a child has asthma, inflammation and sensitivity^[5] causes airway narrowing, which makes it hard to breathe.

About one in ten Australian children^[6] has long-term asthma. It can cause frightening breathlessness, poor school participation, and sometimes hospitalisation. Rarely, and tragically, children die from asthma.

Children with persistent or severe asthma symptoms need medicines to reduce airway inflammation. “Inhaled steroids” are the safest and most effective treatments. In fact, the World Health Organisation has included them on its List of Essential Medicines for Children^[7].

These medicines reduce the risk^[8] of severe flares of symptoms, especially^[9] in children with a history of such flares. The aim is to use the lowest effective dose, yet it is the subsidy of low dose fluticasone which the new policy affects.

How medicine subsidy decisions work

To be sold in Australia, all prescription medicines must be registered by the Therapeutic Goods Administration^[11], which assesses the safety and efficacy of the medicine.

The Pharmaceutical Benefits Scheme^[12] (PBS) is a list of medicines our government helps to pay for. This scheme caps the cost of dispensed medicines at about A$30 for most people, and about A$7 for people with concession cards.

To get a drug on the list, the manufacturer needs to convince the Pharmaceutical Benefits Advisory Committee^[13] (PBAC) the medicine is cost-effective.

Having this sort of process – a single major payer, and well-qualified decision-makers – is a good thing. It’s a reason Australia has much more affordable medicines than the United States^[14]. This usually benefits both patients and health authorities.

Read more: Passive smoking, synthetic bedding and gas heating in homes show the strongest links to asthma^[15]

The new rules

Previously, any doctor could prescribe low dose fluticasone for a child with asthma under the PBS. But as of April 1, this is no longer true.

The new PBS rules^[16] are complicated.

First, no one over the age of six will get any government subsidy to help with the cost of this medicine.

Second, the PBS will only subsidise it for children under the age of six if a paediatrician or lung specialist has started the medicine, and if the prescriber has first contacted the PBS for approval.

The PBS has not spelled out why this change was made, either on their website or when pressed by journalists^[17].

Generally, if the Pharmaceutical Benefits Advisory Committee and a manufacturer can’t agree on a medicine’s price, the medicine will stay off the PBS, and will remain unsubsidised. Alternatively, the Pharmaceutical Benefits Advisory Committee may place restrictions on the population for whom the medicine is subsidised.

In this case, given no safety or effectiveness concerns have been raised, and the change coincided with a scheduled price-reduction date^[18], the new restrictions may be simply about money – the Pharmaceutical Benefits Advisory Committee and the manufacturer not agreeing on a price.

What does it mean for families?

In children over the age of six, several alternative medicines can be prescribed.

But in children under five, there are no good alternatives, with no other age-appropriate low-dose steroid inhalers approved by the TGA.

In the under-five age group, GPs now have three options if they think their patient needs inhaled steroids:

1. prescribe fluticasone 50mcg on a private script

2. refer to a child or lung specialist

3. prescribe other medicines “off label” (in a way not approved by the TGA), which will often involve higher-dose steroids.

All of these are problematic.

The use of private scripts will mean families need to pay whatever their local pharmacy charges them. At many pharmacies we expect the price to be around $11^[20] to $28^[21] per inhaler, but there are no guarantees all pharmacies will provide the medication at this cost.

The use of private scripts will certainly hurt families who rely on concessions^[22] or safety nets^[23], including Aboriginal and Torres Strait Islander children^[24] and those from low socioeconomic backgrounds who are disproportionately affected^[25] by asthma.

Requiring referral to a specialist also has many detrimental consequences. There are already bulging waitlists for these services, leading to delays in care. In many parts of Australia there are no bulk-billing specialists, which makes it hard for vulnerable families to access these services.

GPs will feel obliged to refer cases they previously would have been able to manage, which may erode the community’s trust in GPs.

The decision adversely impacts the interests of so many Australian kids, 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 medicines is coming down. But are we helping the right people?^[26]

References

1. ^{^} A short document (www.pbs.gov.au)
2. ^{^} metered-dose inhaler (www.nationalasthma.org.au)
3. ^{^} nearly 80,000 (medicarestatistics.humanservices.gov.au)
4. ^{^} What causes asthma? What we know, don't know and suspect (theconversation.com)
5. ^{^} inflammation and sensitivity (www.nationalasthma.org.au)
6. ^{^} one in ten Australian children (www.aihw.gov.au)
7. ^{^} List of Essential Medicines for Children (www.who.int)
8. ^{^} reduce the risk (www.nejm.org)
9. ^{^} especially (www.ncbi.nlm.nih.gov)
10. ^{^} Shutterstock (www.shutterstock.com)
11. ^{^} Therapeutic Goods Administration (www.tga.gov.au)
12. ^{^} Pharmaceutical Benefits Scheme (www.pbs.gov.au)
13. ^{^} Pharmaceutical Benefits Advisory Committee (www.pbs.gov.au)
14. ^{^} than the United States (www.oecd-ilibrary.org)
15. ^{^} Passive smoking, synthetic bedding and gas heating in homes show the strongest links to asthma (theconversation.com)
16. ^{^} PBS rules (www.pbs.gov.au)
17. ^{^} pressed by journalists (www.ausdoc.com.au)
18. ^{^} price-reduction date (www.pbs.gov.au)
19. ^{^} Shutterstock (www.shutterstock.com)
20. ^{^} $11 (www.chemistwarehouse.com.au)
21. ^{^} $28 (www.pbs.gov.au)
22. ^{^} concessions (www.health.gov.au)
23. ^{^} safety nets (www.servicesaustralia.gov.au)
24. ^{^} Aboriginal and Torres Strait Islander children (www.pbs.gov.au)
25. ^{^} disproportionately affected (www.aihw.gov.au)
26. ^{^} The price of PBS medicines is coming down. But are we helping the right people? (theconversation.com)