Roche prices enfuvirtide (T-20) at €18,980 a year – making it the most expensive HIV drug yet
1 April 2003. Related: Antiretrovirals.
Graham McKerrow HIV i-Base
Roche has priced its new HIV drug enfuvirtide (T-20, Fuzeon) at €52 a day, or €18,980 (£12,951) a year, which makes it the most expense anti-HIV drug to date. The price has fuelled controversy about the cost of HIV treatments, although the company says it has impressive cost effectiveness data that it will publish soon.
Roche blamed the high price on the complexity of the manufacturing process which involves more than 100 production steps, compared to eight to ten steps for most drugs. Making enfuvirtide involves threading 36 amino acids one by one onto three separate molecular fragments, which are then assembled to create a fragile chain. It requires 45kg of raw materials to make 1kg of the drug.
The price of the twice daily injections was greeted with criticism from American activist groups. The AIDS Treatment Activists Coalition said enfuvirtide would be “at least four to five times higher” than other HIV drugs which could prove prohibitive for people on Medicaid and AIDS Drug Assistance Programmes. The price is not expected to be an issue in the UK, where the National Health Service is thought willing to meet the costs.
Enfuvirtide is already available to some patients through an Early Access Programme and the new price is for a special pre-licence sales programme. The European Medicines Evaluation Agency is expected to licence the drug later this year. Marketing authorisations are also being sought in Australia, Canada, and Switzerland. A licence was granted in the USA in March. Roche will then announce its price in different markets, although the company said those prices would be close to €52 a day.
Enfuvirtide is particularly useful for people who have multi-drug resistant HIV or who are intolerant of other drugs. It can act against resistant virus because it is the first of a new class of drugs, fusion inhibitors, that tackles HIV in a different way. Other drugs work inside the cell to stop replication, but enfuvirtide is designed to block HIV from entering healthy T-cells.
David Reddy, head of Roche’s HIV business, said the cost of bringing enfuvirtide to market was $600 million, not including marketing expenses. He added: “It’s something new and something that can bring hope to some patients. And if you consider this in the balance, I think pricing will not be a big issue.”
While some observers are critical of the high costs, others say the company has to recoup a considerable investment and pay for a complicated production process and it has to do so from a small patient population, because enfuvirtide is only suitable for a minority of people with HIV, and it has to recoup its costs before competitor drugs are launched in perhaps two years. Enfuvirtide is an inconvenient drug, which can cause discomfort when administered.
Links:
Roche Press Release: European price announced for AIDS drug Fuzeon
http://www.roche.com/med-corp-detail-2003?id=939&media-language=e
AIDS Treatment Activist Network: Papers and community discussions about US pricing
http://www.atac-usa.org/Roche.html
FDA Approves First Drug in New Class of HIV Treatments
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00879.html
New England Journal of Medicine
http://content.nejm.org/cgi/content/abstract/NEJMoa035026v1
Project Inform Press Release:
http://www.projectinform.org/news/03_03fuzeonpr.html
ACT UP Creates “Fuzeon Graveyard” at Roche HQ
http://www.ultinet.net/~kfo/roche.html
Comment
The emmergency access programme (EAP) for T-20 is due to finish at the end of March 2003. A few unfilled places may remain available for a short time until T-20 is licensed.
Any HIV centre in England, Wales and Northern Ireland can apply for EAP access for any patient meeting the criteria (vL >10,000 and CD4 count <100, currently on treatment). Having a viable background i.e. 1-2 active drugs to combine with T-20 is very important.Contact Dr Leroy Benons, Medical Advisor HIV, Roche. Tel: +44 (0) 1707 367515. Mobile: + 44 (0) 7769 935741. Email: leroy.benons@roche.com
As HTB went to press, FDA approval was granted in the USA and the EMEA expressed a positive opinion indicated European approva within the next 1-3 months.