The National Cancer Control Programme (NCCP) has published guidelines for healthcare professionals using biosimilar medicines in cancer treatment, following the approval of the first biosimilar for the treatment of cancer, its subsequent availability in Ireland, and the recent opening of a public consultation on biosimilar medicines by the HSE.
Entitled “Guidance on the use of Biosimilar Medicines in Cancer Treatment”, this publication has been welcomed for its provision of a precise background on biosimilars, and the regulatory framework underpinning their approval, as well as for the clarity of its recommendations on their use in cancer in Ireland.
Dr Michal Starnawski, Medical Director, Roche Products (Ireland) Limited commented: “We note and welcome the clear emphasis the NCCP has placed on the central role of the prescribing physician in treatment decisions and the necessity of also involving the patient in these decisions in this guidance”.
The guidance particularly emphasises decision-making by the prescribing physician, in consultation with patients, and highlights the necessity for all for involved in the use of biosimilars, both healthcare professionals and patients, to be fully informed about the treatments and for the implementation of a biosimilar policy to follow a methodical, cross-functional approach.
It recognises the uniqueness of biologics, given that they are different to generic medicines and therefore not currently included in the HPRA list of interchangeable medicines.
It also acknowledges that the current HSE-IPHA Framework Agreement on the Supply and Pricing of Medicines (2016) provides a mechanism for an automatic price reduction for biologics, upon the introduction of a biosimilar to the market.
With effect from August 1st, the price of MabThera IV to HSE hospitals was reduced by 30 per cent from its original price and the price to other purchasers was reduced by 20 per cent.
Roche have estimated that in a full year the new price will result in a total saving of just over €4.6million to the HSE, when compared with what would have been paid just over one year ago.