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Today, fifteen UK cancer charities, including Leukaemia CARE, have presented a letter to David Cameron, calling on him to urgently review the health technology appraisal process carried out by the National Institute for Health Care Excellence (NICE). The letter follows apprehension over the recent NICE and Cancer Drugs Fund (CDF) reform proposals that was revealed to stakeholders earlier in the year.
The CDF was established in England in 2011 as a proposal in the Conservative manifesto following growing concern over patient access to clinically effective cancer drugs that were not routinely available to patients on the NHS. The CDF was introduced as an additional source of funding for cancer treatments that were not considered cost effective enough by NICE to be routinely funded. It was a means to ensure more clinically effective treatments for rarer cancers were accessible to patients that needed them.
The Cancer Drugs Fund has helped over 84,000 families since its conception and whilst this is an extremely welcome outcome of the Fund, by 2015 it had severely overspent and over time it became apparent that it was unsustainable and reform was required.
In 2015, it was concluded that the operating model for the CDF needed to change and NHS England, in partnership with NICE, proposed a new model and launched a twelve week consultation. Leukaemia CARE, alongside nearly 300 other organisations, submitted their views on the new operating model. Whilst aspects of the new model seem positive, concerns were expressed over certain features of it that would make rarer-cancer patient access to drugs more difficult. Despite feedback from many patient advocacy organisations voicing their concerns, there were hardly any changes to the proposed strategy, leaving many frustrated and worried.
The new process, due to begin on July 1st, will now see NICE give new treatments a “yes”, “no” or “maybe” decision. The new model will see the CDF move to the beginning of the appraisal process and is now an opportunity for patients to access clinically effective drugs earlier, whilst more data is being collected to further demonstrate their clinical and cost effectiveness for the “maybe” drugs. The CDF will now have clear entry and exit criteria, whilst drugs seen to show no promise at all will not be allowed to enter it or not have the opportunity to receive interim funding. Whilst the concept of earlier access is appreciated, the model to appraise drugs is outdated and the reform does not address the intrinsic issue in that the process does not taken into account that drugs for rarer cancers have smaller patient populations. As such, the data is limited and this often means that drugs will not be recommended based on the health economic modelling.
The letter to the Prime Minister, endorsed by the Chief Executives of some of the UK’s top cancer charities, articulates that they are “deeply concerned by the lack of reform proposed” and calls on the Prime Minister to consider altering the methodology to make the appraisal process more flexible for drugs for indications with smaller patient populations. The letter highlights to the Prime Minister that the process is simply reverting back to an archaic method that reduced access to certain patient populations which sparked the creation of the CDF in the first place.
The reformed process and changes to the Cancer Drugs Fund could see thousands of patients being denied clinically effective, life-extending treatment, with many blood cancer drugs on the CDF that have previously been rejected by NICE due to be reviewed soon. As the approach of development of treatment is shifting towards more personalised medicine (due to small patient populations), it will be less and less likely that such innovative medicines will be routinely recommended by NICE unless the methodology changes.
Furthermore, as Scotland and Wales have their own health technology appraisal bodies, the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG) respectively, many of the drugs that were originally funded via the Cancer Drugs Fund for patients in England are already routinely available to patients there. This means that NHS patients in Scotland and Wales are able to access life-extending treatment that patients in England might no longer be able to access when the changes are in place. Whilst retained access for patients in Scotland and Wales is imperative, it is inequitable that patients in England are denied access due to the area that they live in. Access to these clinically effective drugs should be readily available and consistent for all NHS patients in the UK, regardless of the cost or number of patients who need the treatment.
Monica Izmajlowicz, Chief Executive at Leukaemia CARE, commented:
“Whilst we understand that the Cancer Drugs Fund has severely overspent its budget over the last five years because of the CDF, patients have had access to clinically effective, life-extending drugs considered not cost-effective enough by the National Institute for Health and Care Excellence (NICE) to be made routinely available. The Prime Minister and NICE must take this message on board and make the necessary changes to the appraisal process to ensure that patients are not denied treatment that could give them more time with their families. Increased flexibility of the system is key in retaining and improving access to drugs for patients with rarer cancers in England (and necessary if access in England is to be in line with Scotland and Wales). We hope that the charities coalition’s comments are considered and we will continue to campaign for a reformed appraisal process that encourages access for patients, not challenges it.”
For information and advice on what these changes will mean, contact email@example.com