The highly anticipated consultation document on the proposed new system for commissioning cancer drugs has arrived and is an important milestone for those drugs currently on the Cancer Drugs Fund (CDF) and for all future oncology launches in the UK.
As widely expected the new proposals are based on the National Institute for Health and Care Excellence (NICE) now reviewing all new oncology products as well as significant license extensions and making one of THREE recommendations:
- Recommended for routine use (funding through baseline commissioning) – this would require the cost-effectiveness ratio to fall between £20,000 and £30,000 per quality-adjusted life year (QALY), taking into account end-of-life criteria where appropriate
- Not recommended for routine use (funding only through individual funding requests) – if the drug does not display the potential to reach a QALY of £30,000 including end-of-life criteria where appropriate it will not be funded
- Recommended for use within the CDF (funding provided by the CDF) – this would require the drug to display the potential to satisfy criteria for routine use taking into account the end-of-life criteria where appropriate
How will the initial NICE process work?
One of the key implications for the pharmaceutical industry is the proposed timing of the NICE review.
Companies will be expected to submit evidence to NICE along with any approved patient access scheme at the same time as submitting to the European Medicines Agency (EMA). This will enable NICE to issue draft guidance prior to marketing authorisation and to provide the final guidance (subject to no appeals) within 90 days of marketing authorisation. These changes to timing will need to be built into the companies pre-launch timelines to ensure a robust NICE submission can be developed prior to EMA approval.
So what are the implications for those drugs that are recommended for use within the CDF?
To be funded by the CDF companies would need to agree to fund the collection of pre-determined data, set out by NICE in its recommendation. In addition, companies will need to agree a commercial access scheme with a joint committee of NHS England and NICE (the CDF Investment Group). The number of patients needed for the data collection will be determined by NICE and for any additional patients above that number, the company would be expected to fund any costs of treatment.
At the end of the data collection period, NICE will undertake a short technology appraisal and will issue either a ‘recommended’ or ‘not recommended’ for routine use decision. If a drug is not recommended then it will be removed from the CDF and the company will be expected to fund any patients who had previously received the treatment (except in the case of drugs currently on the CDF). If a drug is recommended its funding will be moved into baseline commissioning.
What are the proposals for ensuring the CDF does not overspend?
The CDF Investment Group will be responsible and accountable for keeping CDF spending within budget. The development of a contingency fund is proposed to cover any overspend, by setting spending levels consistently below 100% of what would be expected under commercial access arrangements.
If the CDF overspends, and this cannot be met by the contingency fund, then the money paid to companies from the fund will be reduced across the board. If the CDF underspends then money from the contingency fund will be repaid to companies.
What are the implications for those drugs on the CDF at the moment?
No transition arrangements have been discussed in the consultation but NHS England and NICE will have provisional discussions with those products remaining in the CDF in November 2015. The process of appraising drugs currently in the CDF in line with the new CDF criteria will be completed during the course of 2016/17.
How can OPEN Health support you?
At OPEN Health we can help you in developing your strategy, scenario planning, collecting the right kind of real-world data and supporting you throughout the entire process. Let us help you navigate the uncertainty.
For any further information please contact:
Sean McGrath (Chairman and Director of Oncology, Succinct Medical Communications and OPEN Health, email@example.com)
Cathy Wright (Joint Managing Director, OPEN Access Consulting, firstname.lastname@example.org)
Cathy Jarrold (Joint Managing Director, OPEN Access Consulting, email@example.com)
To discuss your real-world evidence needs please contact:
Sam Oliver, Director of Real-World Evidence Solutions, pH Associates (SamOliver@phassociates.com)