Pricing is a significant factor in Ireland's shortage of hormone replacement therapy (HRT) drugs, according to the head of a generics drug manufacturer, and the recently signed drug pricing and supply agreement has only made things worse.
Most transdermal HRT products for menopausal women have experienced shortages or interruption of supply over the past two years. For a time recently, three of the four available products – two patches and a gel – were struggling with supply.
The medicines regulator, the Health Products Regulatory Authority (HPRA), says it will be mid-July before all are available again.
It's not the only shortage at present. Five different suppliers of paracetamol to the Irish market have also alerted the HPRA to supply interruptions.
Such shortages leave patients, pharmacists and GPs scrambling for alternative treatments. Dr Ciara McCarthy, clinical lead on women’s health at the Irish College of General Practitioners, said it was important for women using HRT to “ensure continuity of treatment”.
“Suddenly stopping HRT is not advised as it may result in a decline in symptom control,” she said.
A dramatic increase in demand has been blamed for the recent shortages but Sandra Gannon, a generics industry veteran, said there was more to the problem.
"Irish demand in and of itself and the growth in it is relatively small [in the context of global pharma companies], very easy to manage, very easy to forecast and a relatively low demand for output of a factory making transdermal patches, " she says, noting that outside Ireland and Britain, there is no evidence of similar shortages in other European countries.
Market gap
Ms Gannon's company, Azure Pharmaceuticals, specifically targets the market gap created when larger pharma companies decide that it is no longer worth supplying common but older, off-patent products in markets, including Ireland.
She noted a lack of competition in the Irish market and said “one thing I would suggest is that price is a factor here”.
Transdermal slow-release medicines were more complex than tablets, she said, and “if you look at the price per patch being reimbursed at the minute, it is €2 a patch – about half the price of a coffee now – that we are paying for this”.
Looking at the experience of drug shortages around Europe, she said a consistent theme was that it always related to the low-cost, low-value segment of the market. "You are not finding the medicines that cost multiples of thousands of euro per box going short," she said. "That never happens."
Pricing agreements
“Consecutive medicines agreements, in trying to drive savings to pay for very expensive new medicines, have had an unintended consequence in the other side of the market where they are pushing price down so low that suppliers are simply leaving the market,” she said.
Under the agreement signed in December, designed to deliver savings of €700 million over four years while funding innovative new drugs coming on to the market, any supplier looking to enter the Irish HRT market would have to price their product at a 60 per cent discount, Ms Gannon said.
The HSE reimbursement price for Estradot, for instance, is €6-€7.65 a pack, according to a document on the current shortage approved by Prof Michael Barry, who is clinical lead on the HSE's Medicines Management Programme.
“We are not looking for them to bring our price above the European pricing,” Ms Gannon said. “We are just saying 60 per cent off prices from last October, it is just too low. No one is going to bring you a HRT product at less than €3 a pack.”
