A potentially live-saving liver cancer drug that costs €560 per tablet will be made available to more than 100 seriously ill patients six months after doctors treating the disease asked the Government to fund it.
Yesterday Health Minister Leo Varadkar announced that Sovaldi, (sofobuvir), which, when used in combination with other drugs has a cure rate of up to 95%, will be made available to about 120 seriously ill hepatitis C patients with the greatest clinic need.
Mr Varadkar said the patients have been identified by clinical experts as suffering from very serious liver disease and most likely to benefit substantially from this intervention.
The ex-wholesaler cost price of the drug is €563.82 per tablet. Taking the drug for 12 weeks costs €47,361 and taking it for 24 weeks costs €94,722, according to the National Centre for Pharmacoeconomics (NCPE), the body tasked with assessing the cost-effectiveness of medicines.
In fact despite recommending that the drug be funded for “certain subgroups”, the NCPE concludes that the its manufacturer, Gilead Sciences, “has not demonstrated statistically significant superiority of sofosbuvir compared to existing treatments”.
However, a spokesman for Mr Varadkar said the early access programme “would not be happening unless we believed it to be effective”.
The news that the drug will be made available to those most in need was welcomed by the Irish Haemophilia Society.
Chief executive Brian O’Mahony said it would benefit the sickest patients. Because it can be used in combination with drugs other than Interferon — a punitive drug with strong side effects — it will benefit those who cannot medically tolerate Interferon-based treatments due to severe liver damage and increased risk of death.
Early access to the drug follows agreement between the HSE and Gilead Sciences on the pricing of Sovaldi, in combination with other licensed medicines or with the unlicensed Gilead medication, ledipasvir.
The HSE has also reached interim agreements with Janssen and Bristol Myers Squibb in relation to commercial arrangements around two other new hepatitis C medicines: Simeprevir (Brand name Olysio) and Daclatasvir (Brand Name Daklinza).
A spokesman for Mr Varadkar said access to the new drugs would be “pretty much immediate”.
Fianna Fáil TD for Longford-Westmeath Robert Troy, who has criticised the delay in allowing early access, said roll-out needed to be speedy in light of the poor prognosis for affected patients, among them those who contracted the disease through state-supplied infected blood products.
Separately, the Department of Health is chairing an expert advisory group to advise the minister on the optimal management and treatment strategy for patients with hep C. This group will advise on the development of a public health plan that will focus on the treatment and management of people with hep C.
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