The Recent unveiling of the new Cancer Drugs Fund (CDF) in the UK highlights a major shift within the market access landscape, although it has caused trepidation amongst pharma and patient groups, in addition to raising some difficult questions about HTA processes.


The newly proposed CDF structure was delayed, partly due to the political vacuum that followed the UK's Brexit vote in June to leave the European Union but also due to the Department of Health due to standard operating procedures being unfinished.


Now, with a Prime Minister in place and CDF processes finalised, the Fund has put decisions about access to cancer drugs firmly into the hands of NICE.


Meaning the public body of department of health will appraise all drugs, and interim funding will be available for up to two years to provide patients access to medicines that either have draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF.


The appraisal process will aim to deliver a verdict before new drugs are licensed, and NHS England is predicting that access to treatments could be accelerated by 'up to four months', taking the UK ahead in Europe.


The new CDF started operating at the end of July, with four new cancer drugs made available under the scheme. The drugs which gained a greenlight were Novartis' Zykadia for lung cancer,melanoma combination Tafinlar and Mekinist, and Servier's Lonsurf for bowel cancer.


Since the CDF began operating, NICE's deliberations over how to apply the new rules have caused considerable uncertainty for Novartis' breast cancer therapy Afinitor and Janssen's Imbruvica for mantle cell lymphoma.


NICE said its recently published guidance on the two does not recommend they should be removed from the new version of the CDF. However NICE did state it “is advising the two drugs are not cost-effective, which means they may be removed from the CDF list”. The verdict on both treatments is, so far, just a preliminary one and still open for consultation, with the Institute likely hoping to stimulate negotiations on further pricing reductions. Novartis and Janssen had already offered a discount in patient access schemes for the two medicines.


Meanwhile, three other manufacturers reported to be facing the possible expulsion of their drugs from the CDF have cut prices during the reappraisal process in order to win NICE backing for routine NHS use, according to The Guardian. The UK newspaper names the three drugs as Pfizer's Bosulif (bosutinib) for chronic myeloid leukaemia, Eli Lilly's Alimta (pemetrexed) for NSCLC and Sanofi's Jevtana (cabazitaxel) for advanced prostate cancer.


“This is a high risk industry and it is not as simple as, or sustainable, to continuously ask companies to drop the price of these specialist medicines” stated David Montgomery, oncology medical director at Pfizer UK.

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