HIV-prevention drug PrEP is back in stock at key Sydney pharmacies this weekend after the government temporarily approved an overseas version to address a shortage from existing manufacturers.
The Laurus Labs version of PrEP, which is being supplied locally by Phero Pharma, was temporarily approved for importation into the local market by Australia’s medicines regulator, the Therapeutic Goods Administration, on September 3 – the same day Gay Sydney News first reported that pharmacies across the country had begun to run critically low in supply.
Laurus Labs’ PrEP is temporarily approved for sale until January 31, but it remains “unregistered” in Australia, meaning it hasn’t gone through the standard process to prove its safety, efficacy, and quality.
The drug was approved for sale in Australia because there is both a shortage of the existing registered PrEP medicines and because it is needed in the interest of public health.
However, it took some weeks after approval for Phero to receive and then distribute the medication to pharmacies either themselves or via wholesalers or state governments, leading some pharmacists to ration existing stock to just one bottle or blister pack per customer.
While some pharmacies in areas popular with the queer community received limited Laurus PrEP in late September and early October, widespread distribution from Australia’s big four pharmaceutical wholesalers began only this week.
As of Friday, several Sydney pharmacies told customers that PrEP was back in stock. This included Amcal in Kings Cross, Serafim’s Pharmacy in Surry Hills, and Priceline and Blakes Pharmacy in Potts Point.
While some PrEP users have been able to access the medication throughout the shortage from services like local online website prep.health, others say their overseas orders have been held up in customs or delayed.
The race to replenish stock
Roger Darlington, the managing director of Phero Pharma, told Gay Sydney News that when the first shipment of the Laurus Labs product arrived, his Sydney staff resorted to bypassing wholesaler distribution and instead got in their cars and delivered the drug directly to pharmacies to ensure those who needed it most were still able to get it.
“We had a list of pharmacies we did direct ships to, to make sure they had enough,” he said in a telephone interview on Monday.
“And [for] certain high-turnover community pharmacies that work in this space [of supplying PrEP to vulnerable communities], we did multiple deliveries … even by staff putting [the PrEP] in the back of our cars and getting out there, because we wanted to make sure [that] those pharmacies had it.”
Darlington said Phero applied to distribute Laurus Labs’ PrEP in either July or August and was approved on September 3 after informing the Therapeutic Goods Administration he could secure a monthly supply of 10,000 to 15,000 bottles. (Australia currently has 27,000 PrEP users receiving subsidised access to it, according to the federal health minister.)
When he initially applied, he thought he could only secure 500 bottles of PrEP a month.
However, through a US contact who had previously helped Phero supply the Australian market with IV fluids – also facing supply issues – he was introduced to Laurus Labs, who guaranteed Phero they could supply him with a larger continuous supply of PrEP, provided he received approval to sell it locally.
“So I communicated that information back to the TGA, and I think we may have been the only company that perhaps could access in the order of tens of thousands, or, you know, at least five figures’ worth,” he said. “And then we were granted approval based on the fact that we could access that larger number.”
As of Monday, about 8000 bottles of Laurus Labs PrEP had been distributed by the company directly to state governments, he said, some of which then redistributed them to key community pharmacies. An additional 12,000 bottles had been sent to wholesalers, allowing pharmacies to place orders.
Darlington said he had successfully imported about 35,000 PrEP bottles in total since being approved to supply the drug, about 60 per cent of which had been distributed when he spoke to us on Monday. Further orders by wholesalers of 5500 and 8000 were due to be overnight shipped to them this week, he said.
‘Like the old toilet roll situation’
Despite these efforts, he acknowledged that those seeking access to Laurus Labs’ medication may still face delays due to his suspicion that some community pharmacies are ordering “more than they perhaps normally would” out of fear of a longer shortage, thus depriving other pharmacies of stock.
“I suspect in the early days of supplying the market [during this shortage] it may be a little bit like the old toilet roll situation with COVID,” he said.
Darlington said the issue was compounded by the fact that wholesalers couldn’t refuse or limit large orders due to Pharmaceutical Benefits Scheme rules. On September 23, the government added Laurus Labs’ product to the scheme, which subsidises medicines in Australia, capping its cost at $31.60 per prescription, or $7.70 with a concession card – the same price as other versions in short supply.
“So if they see a pharmacy that normally orders 100 [bottles] and now they come in with an order for 400, [they] can’t say no… you can’t restrict on a PBS item,” Darlington said.
The Therapeutic Goods Administration reports tenofovir-based PrEP shortages from Arrotex until November 1, Cipla until November 20, and Sandoz until November 25, with dates subject to change.
Arrotex’s shortage started in June, while Cipla and Sandoz have been affected since August.
At the time of Gay Sydney News‘ first report on the shortage, the Therapeutic Goods Administration cited “commercial changes/commercial viability” and “manufacturing” issues as reasons for the shortages.
Darlington said international suppliers often stop sending stock to Australia when they face shortages, as they can sell it for a higher price elsewhere.
“The Australian marketplace is a bit of a victim of its success in bringing cost-effective medicines to market,” he said.
In a statement, the Therapeutic Goods Administration said it was closely monitoring the situation and was in regular contact with suppliers for all PrEP products in shortage.
“The Department is also working closely with key stakeholders to ensure communication materials are available to health professionals and community organisations,” it said, referring to the Department of Health and Aged Care, which the TGA sits within.
To address shortages, the TGA said it frequently liaised with multiple suppliers to encourage potential applications for the supply of overseas products.
“The TGA has received multiple applications for supplying overseas PrEP products … and is reviewing the need for further approvals to be granted as necessary,” it said.
As of October 19, no further approvals have been published on the TGA’s website.
Federal Health Minister Mark Butler said earlier this month that the government anticipated the supply of tens of thousands of PrEP units would resolve the shortage by early November, “with approximately 4 months’ supply in the country by then, with future planned deliveries meeting normal ongoing demand”.
NSW Health said it is committed to ensuring PrEP is available for those who need it and advised anyone having trouble accessing it to contact the Sexual Health InfoLink at 1800 451 624.
It’s not the first time Australia has faced supply issues with PrEP. In 2021, a recall of drug manufacturer Mylan’s PrEP tablets caused flow-on effects at pharmacies in Sydney and Melbourne.
Correction: We misidentified the Therapeutic Goods Administration as the Therapeutic Goods Association in some instances.
Gay Sydney News editor