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Earlier this month we blogged about the proposals for how the Cancer Drugs Fund will operate from April 2016. Since then we’ve had details of how the drugs currently being funded through the Cancer Drugs Fund (CDF) will transition to the new system.
There are currently four breast cancer drugs available through the CD – trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), everolimus (Afinitor) and eribulin (Halaven).
NICE (The National Institute for Health and Care Excellence) have now published proposals for how these drugs will be re-assessed under the new CDF. It must be remembered that these proposals are subject to change, depending on the outcome of the wider ongoing CDF consultation.
It is intended that all of the drugs currently funded through the CDF will be re-appraised in a rapid version of their current process, predicted to take around 25 weeks from start to finish. This process will be very similar to NICE’s current process but NICE will have three potential options for guidance they can issue at the end.
Companies who manufacture drugs currently being funded through the CDF need to tell NICE by the end of February whether they wish their product to be consider through this process. If they do not, their product will no longer be available for use on the NHS.
NICE have divided the drugs that are currently being funded by the CDF into three groups:
Group 1: Those where NICE guidance has been published or is due to be published very soon
Group 2: Those with an ongoing NICE appraisal
Group 3: Drugs that NICE have never appraised (likely to be drugs for rarer cancers)
Kadcyla, Perjeta and Afinitor all fall within Group 1 and Halaven falls within Group 2. NICE will hold a meeting in May to consider drugs in group 1. If there are too many drugs to consider in one meeting, NICE will hold a second meeting in July. NICE anticipates publishing guidance for the first batch of drugs to go through this process in July if no consultation is necessary or September if consultation is necessary. Usually NICE will only consult on guidance if their recommendation is negative.
Drugs currently being funded through the CDF will continue to be available to new and existing patients until NICE publishes new guidance. If NICE issues negative guidance for a drug later this year, anyone currently taking the drug will continue to take it until they and their doctor agree that it is no longer appropriate but no new patients will then be able to access that drug.
While we appreciate the need for NICE to plan ahead for the implementation of the new proposals, we are concerned that by making detailed plans for transition, NICE is assuming that the proposals will go ahead as set out. NICE have said that this will not be the case but it is difficult to see how alternative plans for transition, as asked for in the consultation document, could be implemented if NICE are already setting out their plans.
We are also concerned about the lack of patient involvement in the transition processes. There does not currently appear to be any opportunity for patients and patient groups to contribute to the process and this is something that we will be seeking clarification on when we respond.
We don’t know at this stage what the impact of these arrangements will be on individual breast cancer drugs. We do know that companies will have the opportunity to offer renewed Patient Access Schemes (in effect, discounts) to ensure that their products remain available but we don’t know how many companies will be taking up this opportunity or whether the discounts will be substantial enough to allow drugs to remain available to patients who need them.
If you have any questions or concerns about the CDF, you can contact the Policy team by emailing firstname.lastname@example.org