Minister for Health Leo Varadkar has announced that the HSE is putting in place a programme to provide early access to powerful new direct-acting anti-viral drugs for Hepatitis C patients with the greatest clinical need, due to the advanced nature of their condition.
The patients in question have been identified by clinical experts as suffering from very serious liver disease and to be most likely to benefit substantially from this intervention.
“I am very pleased that we can commence the use of these new medicines in Ireland. These drugs have the potential to bring major benefits for patients with serious illness as a result of Hepatitis C. I also want to thank Gilead, Janssen and Bristol Myers Squibb for agreeing to enter into negotiations with the HSE and the Department of Health in the interests of these seriously ill patients,” Minister Varadkar said.
The early access programme will apply to patients deemed to have an urgent need for treatment, and for whom previously licensed drug treatments would not be appropriate. Similar early access programmes are in place in a number of other European countries.
A number of powerful new Direct-Acting Antiviral therapies are being licensed in Europe for people with Hepatitis C. As with other countries, Ireland must ensure that access to high-cost treatments such as these is managed, in order to prioritise access for patients who can benefit most, while ensuring that the financing model is sustainable and affordable. The aim is to provide access for as many patients as possible, within the resources provided by taxpayers.
For that reason, the Department of Health has also set up an advisory group to consider a multi-annual approach to the clinical and public health management of Hepatitis C. This group will report to the Minister in the coming weeks. Its recommendations will inform decisions about extending access to these new drugs to further groups of patients.
Notes to Editors
This early access programme is being put in place pending the completion of a series of pricing and reimbursement assessments for various new direct-acting anti-viral drugs/various combinations of direct-acting anti-viral drugs. These assessment processes are expected to be completed over the next number of months.
In this context, the HSE has reached agreement with Gilead Sciences on the pricing of Sovaldi® (sofosbuvir), 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.)