The move to next generation ‘low carbon’ salbutamol inhalers will end up costing taxpayers billions if they are used by industry as a monopoly ploy to keep generics off the market, experts are warning.
They say there are lessons to be learned from the successful drug company lobbying efforts in the 1990s that resulted in the ban of first-gen beta agonist inhalers – removing competition from generics as new products were coming to market.
Initially approved in 1981, the first salbutamol inhalers such as Ventolin have been off-patent for more than 30 years, with multiple low-price generics available since the mid-1990s.
However, these devices were prohibited in the late 2000s in countries like the US and Australia as they contained ozone-depleting chlorofluorocarbons (CFCs). This was despite a loophole under the global Montreal Protocol for lifesaving products.
Health economists led by Dr Olivier Wouters (PhD) say the ban followed an intensive lobbying campaign by pharmaceutical companies, which developed inhalers with hydrofluoroalkane (HFA) rather than CFC propellants and sought to shift patients to these newer products.
Despite still using a decades-old salbutamol molecule, these were protected by new patents and generally cost much more than generic CFC inhalers – netting approximately USD $14 billion in US sales between 2007 and 2018, they reported in the New England Journal of Medicine (link here).
Annual revenue from sales of brand-name salbutamol inhalers was on the decline in the 1990s and it had dipped below USD $200 million by the early 2000s, they noted.
But with the increased uptake of HFA inhalers in the years leading up to and following the 2009 CFC ban, sales rebounded to almost USD $1 billion by 2010. Annual sales figures then remained around that figure for the entire decade until the first generic alternative was approved in 2020.
“Had the FDA delayed the CFC ban by several years, until generic HFA inhalers were closer to becoming available, payers and patients would probably have saved billions of dollars,” the authors said.
Beyond that, FDA estimates suggested that inhalers accounted for just 0.1% of CFC global emissions before being pulled from the market, they pointed out.
The development of even ‘greener’ inhalers by companies like AstraZeneca and GSK raised the question of whether the pattern was likely to be repeated, the authors added.
“The history of [salbutamol] over the past 40 years offers a cautionary tale for regulators and policymakers seeking to ensure access to prescription drugs while still meeting other goals such as environmental protection,” they wrote.
“Unless policymakers work to minimize the extent to which any new patents on these products delay the approval of generic equivalents, the United States may end up spending billions more in the coming decades on a product whose active ingredient was first approved in 1981.”
It also raised the question of whether the same thing could happen for other medications currently delivered by HFA-based metered-dose inhalers.
Australia’s situation
Nevertheless, the PBS had price matching rules which offered some protection to local taxpayers, said Jarrod McMaugh, manager of the Pharmaceutical Society of Australia’s Victorian branch.
“The rules mean that drug companies would have to show that the HFA inhalers currently on the market are so dangerous, or so bad, that you must switch immediately,” he told the limbic.
“Only then would they be able to negotiate a higher price.”
Mr McMaugh said a downside to the system was that Australia could be a low-profit country for the pharmaceutical industry, which meant local patients were often back of the queue in times of drug shortages.
A pharmacist in Melbourne, he added that from an environmental perspective, the biggest concern with HFA inhalers was the disposal of the inhalers themselves rather than the propellants.
“That definitely wasn’t the case with CFC inhalers, but today the major issue is the metal canisters, particularly if they aren’t getting recycled,” he said.