Low-dose Zoladex to be pulled from shelves

In a ‘distressing’ decision for patients and GPs alike, AstraZeneca will pull low-dose goserelin (sold as Zoladex) from the Australian market on 1 November.
 
The 3.6 mg monthly implant will be removed from the Pharmaceutical Benefits Scheme (PBS) and unavailable via private prescription, manufacturer AstraZeneca has announced.
 
‘The discontinuation of Zoladex monthly implant from the Australian market is a global AstraZeneca decision to change the dose options available in some countries, and not related to the safety or efficacy of Zoladex,’ a spokesperson told newsGP.
 
Dr Magdalena Simonis, a GP with a special interest in women’s health, labelled the decision a ‘backwards step in gender equity’.
 
‘It’s a distressing sign that commercial decisions some pharmaceutical companies make do not take into account the human impact,’ she told newsGP. 
 
‘Uncertainty around medication access for such serious conditions is very distressing and increases anxiety around health conditions deteriorating.
 
‘Whenever we see or hear of a drug company that makes such decisions, we fear there is potential for other similar decisions occurring down the track – this is an unsettling decision and disregards the impact it has on women.’
 
While GPs do not routinely prescribe or insert these implants, as a central part of the multidisciplinary teams managing patients with both endometriosis and breast cancer, the decision could have serious knock-on effects for impacted patients.
 
According to figures relating to the number of PBS and RPBS services processed by Services Australia, the 3.6 mg monthly Zoladex implant has been dispensed 29,680 times this year.
 
AstraZeneca acknowledged it is ‘essential’ to maintain treatment and continuity of care for patients who need access to the monthly Zoladex implant as a treatment option.
 
It confirmed it will be initiating an access program following the discontinuation of the monthly implant from 1 November for six months, for ‘eligible patients without alternative treatment pathways’.
 
‘AstraZeneca will provide free access to the Zoladex monthly implant in Australia following its discontinuation,’ it said.
 
‘The access program will be reviewed every six months to ensure it provides appropriate support for eligible patients.’
 
The decision comes as a 10.8 mg dose of the drug will remain on the PBS for eligible prostate cancer patients.
 
‘AstraZeneca has prepared government regulatory and reimbursement applications to expand availability and access of Zoladex three-monthly implant to include breast cancer patients that are hormone receptor positive as soon as possible,’ the AstraZeneca spokesperson said.
 
However, Dr Simonis said the decision will leave GPs ‘dealing with a lot of the fallout’, which could mean managing patient anxiety and counselling patients around alternative treatment options in collaboration with their non-GP specialist. 
 
‘GPs will need to adapt to the decision as there are few options available to us when drugs become inaccessible,’ she said.
 
‘GPs need to be on the alert for new announcements around the suitability and the affordability of the longer acting Zoladex.
 
‘However, it puts GPs in a precarious position.’
 
AstraZeneca said it is ‘working urgently to provide more information’ about the Zoladex Access Program to clinicians.
 
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