Access to Remdesivir for patients in the UK: it won’t be quick or cheap
By saheli.burton, on 9 June 2020
Saheli Datta Burton is a Research Fellow in Geopolitics of Industrial IOT Standards, with an interest in the global governance issues of emerging medical technologies.
Gilead’s drug Remdesivir is increasingly being endorsed by various governments as an aid for improving recovery times in COVID-19 patients. Just last week, the Australian government endorsed Remdesivir as an aid to recovery. A week earlier, the drug was made available in the UK for compassionate use in emergency situations via the Early Access to Medicines Scheme (EAMS) based on a 1-year provisional licensing arrangement between the NHS and Gilead. EAMS allowed doctors in the UK to administer Remdesivir outside the ongoing clinical trials without being penalised for malpractice.
The question is what will happen after the EAMS’ provisional license runs out in a years time? Can patients in UK still receive the drug? The answer depends on the price. Or, more precisely, on Gilead’s ‘rich country’ price mark-up for UK patients. And the higher the price, the longer it will take to become available to patients. Here’s why.
In 2014, when Gilead launched its then newly approved Sovaldi (sofosbuvir) for chronic hepatitis-C, it took almost a year to be approved by the UK’s commissioning body NICE (National Institute for Health and Care Excellence) and then another six months to become available to patients. The sticking point was the cost – a whopping £34,983 for an estimated 12 week treatment. According to a BMJ study, the cost of covering the treatment at that price for the 214,000 hepatitis-C patients in UK then (including the 160,000 in England) was “a pill too hard to swallow for budget planners”. According to the study, this led to the use of “unprecedented delaying tactics” by NHS England to manage budget impact.
Yet the same treatment in India and Egypt with the same Sovaldi cost only US$900 at the time. Gilead even licensed India’s Cipla and Ranbaxy Laboratories (now Sun Pharma) in 2014 to supply cheap generics to 91 other developing countries. While ‘rich’ countries like the UK, US, Germany etc. paid much higher prices. Forbes called it the “Sovaldi Tax’ – “a tax on Americans to defray the cost of treatment for the rest of the world.”
Gilead’s HIV drug Truvada (popularly known as PrEP) also met the same roadblocks before becoming available to patients. The NHS initially refused to fund PrEP in 2016 on grounds of being a ‘preventative’ drug. However, after increasing public pressure, it launched a large 3-year ‘implementation’ trial for PrEP in 2017 allegedly to delay funding the drug until it went off-patent in September 2020 when cheaper generics would become available. All the while, the same PrEP had been available (and found to be highly effective) in Australia for just US$8 per month and around US$100 a month in most other countries.
Nevertheless, NHS’s implementation trial for PrEP did provide free access to 10,000 at-risk patients initially, before expanding access and eventually becoming available to patients this April.
Remdesivir appears to be following the same path. It is currently freely available to UK patients via the EAMS or the clinical trials being conducted by 15 NHS Trusts. However, this access will stop if and when Remdesivir is found to be efficacious and until such time the NHS agrees to fund Gilead’s high price mark-up for the UK.
A study published in the Journal of Virus Eradication estimated the drug’s ingredient cost to be less than a US$1 per dose. While pharmaceuticals in India (Cipla, Glenmark and Dr. Reddys Laboratories) are also readying to supply the drug at a mere US$9 per treatment cost, most likely via a Sovaldi-like licensing agreement with Gilead.
However, the UK NHS is unlikely to get Remdesivir at these cut-price rates. Rather, it is fears of price-gouging that have dominated the pricing discourse among experts in UK and in the US. In a letter to CDC Chief Alex Azar, US senators Doggett and DeLauro sought US government intervention to prevent “pandemic profiteering” from Remdesivir, writing that “an unaffordable drug is completely ineffective. The substantial taxpayer investments in COVID-19 pharmaceutical research must be recognized.” Across the pond, our very own Professor Mahesh Parmar, director of UCL’s MRC clinical trials unit and leading the UK and EU in the 75-centre international Adaptive Covid-19 Treatment Trial (ACTT-EU/UK) trial recently expressed supply concerns.
As to whether Gilead is listening to our concerted fears, only time will tell.