Novartis says CDF proposals place “unreasonable” risk on pharma
Novartis has criticised some of the proposed changes to the way in which the UK Cancer Drugs Fund (CDF) is operated, as the consultation period on the proposals come to an end, saying a number of the suggestions are “not workable”.
The Swiss-based company, one of the largest pharma companies in the world, says changes due to come in from April 2016 could result in patients being “denied access to new, potentially life-saving treatments for more than six months, due to the proposed closure of the fund to new medicines, as the Fund seeks to move to a more financially sustainable model.
While Novartis accepted that reform was needed as it was not sustainable in the long-term- as evidenced in its opinion by the removal of more than 50 cancer indications and the closure of the fund to new medicines in 2015- and that the new proposals are “a step in the right direction”, the company also said pharma was being asked to take on an unfair proportion of financial risk.
In a statement, it said: “A main aim of CDF reform is to ensure that promising, new medicines reach patients as early as possible. The proposals to deliver this expect companies to underwrite 100% of the risk of the fund being overspent. Novartis believes that this is unreasonable and calls for a fairer balance of risk between the pharmaceutical industry and the NHS to maintain patient access to the widest possible range of treatment options.”
In addition, Novartis added that a sustainable CDF and sustainable patient access to innovative oncology medicines could not be delivered without reform of the NICE methodology “to reflect the broader value assessment needed for cancer medicines.”
The company urged NHS England “to act without delay, listen carefully to stakeholder concerns and revise the proposals to reflect them,” the statement concluding: “It is vital that a new scheme is implemented as soon as possible so patients in urgent need of treatment can obtain access to the latest cancer medicines; patients with limited time left cannot afford to wait any longer and deserve clarity about the future of their treatment.”
Key changes proposed to the Cancer Drugs Fund from April
- NICE will appraise all cancer drugs that are expected to receive a Marketing Authorisation
- NICE will normally issue draft guidance prior to Marketing Authorisation
- NICE will normally publish their final guidance within 90 days of Marketing Authorisation
- NICE will make a recommendation falling into one of 3 categories: - Recommended for routine use - Not recommended for routine use - Recommended for use within the Cancer Drugs Fund
- At the point of Marketing Authorisation, all drugs with a draft recommendation for routine use, or a draft recommendation for conditional use within the CDF will receive interim funding from the CDF budget
- An additional option would be to provide interim funding for drugs or indications that NICE has not been able to produce an interim recommendation for at the time of Market Authorisation. This would have consequences for continuity of care and the use of funds in the CDF, should NICE issue negative draft guidance.