India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Cancer Drugs Fund: To be or not to be?
Recently, the National Audit Office published a report on England's Cancer Drugs Fund, concluding that the CDF is "unsustainable". The conclusions of the report can hardly be called surprising - discussions over the sustainability of CDF have gathered a certain momentum in the past few months. In March, IHS Life Sciences discussed the de-listing of 16 drugs across 25 indications - the first occurrence of de-listing after the change in the CDF's drug appraisal methodology. Product de-listing decisions have came following a review of the therapies on the list by NHS England, a process which included conducting pricing negotiations and clinical-effectiveness assessments for drugs.
In September, NHS England further revised the CDF list, this time removing another 23 indications across 16 drugs. The revision which is set to kick in in November was estimated to impact around 5,500 patients by the Rarer Cancers Foundation. The move was done in a bid to avoid a GBP100 million (USD152.6 million) overspend towards which the fund was heading this year. The conclusion by the NAO was thus in no way unexpected, but the question still remains over where the fund, which is currently set to run till March 2016, is headed.
Although the report by the NAO estimated that the fund cost GBP 968 million between October 2010 and March 2015, with the allocated budget for the fund in 2013-14 and 2014-15 having been overspent by GBP 31 million and GBP 48 million respectively, the report also found that since the Fund came into place in October 2010 over 74,000 patients gained access to treatment via the fund, with CDF becoming " a part of mainstream services". Thus, even though the impact on patient outcomes could not be assessed, there is no denying that CDF and its activities would affect thousands of patients.
So what is the word on the future of the fund at the moment?
NHS England, as reported in NAO findings, is at the moment looking into making the CDF a "managed access" fund, which would fund drugs prior to a decision by National Institute for Health and Care Excellence (NICE). NHS England deems this would enable real-world evidence to be collected, which in its turn would support a more informed technology appraisal to be carried by NICE. These proposals are set to be issued for consultation in autumn this year, with the intent of implementing them next year.
Although further details over the document, the process in the future, and existence of the CDF itself are expected to be confirmed with the publication of the proposals, it is fairly clear that NHS England has a steep hill to climb given the challenges and questions that will need to be addressed. The biggest of these questions will revolve around the ongoing conundrum of making innovative medications available to patients while at the same bearing in mind and working within the confounds of the cost-containment efforts within the NHS. Another question which perhaps could be asked would be around the medications that are already there on the current list but which have received a negative reimbursement decision from the National Institute for Health and Care Excellence (NICE) due to cost-effectiveness issues. What would happen to the funding of these medications once the new process is put in place? Presumably if the CDF begins to cover only medicines awaiting NICE review, those cancer drugs that have been reviewed and rejected by NICE would no longer be funded by the CDF.
The next months would thus be decisive with respect to the existence of the fund and the shape it would take. These months would also be essential for determining the market access policy outlook for cancer drugs in the UK in terms of enabling access to innovative drugs, while also staying within budgetary confines.
Kavita Rainova is a life sciences analyst for IHS
Posted 9 November 2015
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