There are just over 2 weeks to go before 1 July and the official start of the new Cancer Drugs Fund (CDF) operating model. A period of transition began on 1 April 2016, to allow for the operational detail of the new model to be developed which is due to be published by the end of June.
We already know the main features of the new model with further details relating to interim funding processes, managed access agreements, data collection, commercial access agreements and financial control mechanisms (rebates?) filtering through following a number of meetings and workshops the National Institute for Health and Care Excellence (NICE) have held with the Pharmaceutical Industry and other stakeholders.
In addition, the recent publication of the appraisal consultation document for ibrutinib, NICE has invited the company to submit a proposal for inclusion in the CDF for adults with chronic lymphocytic leukaemia who have a form of cancer with genetic changes (known as 17p deletion or TP53 mutation). In the draft guidance the committee set out what the case for CDF consideration would need to look like. This includes details of data collection that would address uncertainties about the clinical benefits of ibrutinib and any necessary commercial access agreements to reduce the overall cost to the NHS.
So as these new processes are starting to come into play, the big question remains. Will these changes improve patient access to cancer drugs in England and Wales? NICE believe so, with Sir Andrew Dillon stating “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before. In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their licence, with funding from NHS England available if approved. No other country in Europe does this.”
Other stakeholders do not seem so certain. The main concern continually raised is that there is no change to the current NICE methodology (this apparently needs to be requested by the Department of Health). It is feared that without reform of NICE methodology and processes, there will likely be a decrease in the number of medicines entering routine commissioning, resulting in patients receiving access to even fewer innovative cancer medicines in the future.
What do you think? If you are interested in hearing more on access to new drugs following the reformed CDF, please join us at Conversations in Oncology II on Tuesday 28 June, 2016. The event will feature a faculty of top oncology experts (Prof Ian Smith, Prof Martin Gore and Prof David Cunningham, all from the Royal Marsden Hospital; and Prof Adrian Newland, from Barts and the Royal London, and a member of the Chemotherapy Clinical Reference Group).
Please register here for your place at this unmissable event.
1. National Institute for Health and Care Excellence. Leukaemia (chronic lymphocytic) - ibrutinib [ID749]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-tag492/documents (last accessed June 2016).
2. National Institute for Health and Care Excellence. Cancer Drugs Fund. Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/cancer-drugs-fund (last accessed June 2016).