England's Cancer Drugs Fund (CDF) has been sliding down a slippery slope lately, dealing with budget overruns and backlash from drugmakers and patients unhappy with the fund's decision to ax certain meds from its list. Now, in light of these problems, the country's cost watchdogs are planning to take the reins and give the fund a much-needed makeover.
The National Institute of Health and Care Excellence (NICE) will turn the CDF into a "managed access" fund for cancer drugs, setting out "clear entry and exit criteria" to determine which meds should be funded, according to a recent NHS England board meeting paper. Instead of simply rejecting a drug outright, like the CDF does now, NICE will give "conditional approval" to a med while it weighs evidence. At the end of a waiting period, the drug will go through a shortened approval process. A cancer med will either get a positive recommendation, moving into mainstream use, or a negative recommendation, which would restrict the drug to individual patients.
NHS England will release its plans for a new CDF model to the public in September 2015, it said in its board meeting paper. The current CDF fund is set to end in March 2016, and if everything goes accordingly, a new model should be in place by next April, it added.
NHS England's latest move stands in stark contrast to its original plans for the CDF, PMLiVE notes. The fund was established in 2010 to essentially bypass NICE and provide funding for treatments rejected by the cost-effectiveness gatekeeper.
But things haven't shaken out that way. The CDF has been going over budget almost since its inception, with British officials saying last year that the fund was expected to exceed its £200 million ($312 million) annual budget by £100 million by the end of its 2014/2015 fiscal year. The government offered an additional £160 million to make up for the difference and also granted the CDF power to trim its list of covered drugs. In January, the CDF said it would reduce its list to 62 approved indications from its original 84, sparking the ire of companies such as Novartis ($NVS), Sanofi ($SNY) and Eisai who caught wind of the plans.
|ABPI's Paul Catchpole|
The NHS' latest move could just be the first in a series of steps to undercut--or even do away with--the fund, giving NICE full control over cost determinations on cancer meds. As the NHS said in its board paper, the new approach would allow money in the fund "to be more effectively managed" and provide a system for new, innovative drugs to be evaluated "on a more robust evidence base."
Although NICE will have its work cut out for it, the proposed change "is a very encouraging start," Paul Catchpole, director of the Association of the British Pharmaceutical Industry, told PMLiVE. The CDF is "nothing more than a sticking plaster," he said, and NICE needs to find a "longer-term sustainable solution" to reviewing cancer meds.
"This move should help provide a much-needed bridge to greater reform of NICE so that all patients can benefit from improved access to new medicines," Catchpole said, as quoted by PMLiVE.
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