England's Cancer Drugs Fund (CDF) reopens under its new model today, but the pharma industry and charities are already warning that it could do little to solve fundamental problems with drug reimbursement in the country.
The original CDF, a silo fund for cancer drugs deemed too expensive for the NHS by NICE, was closed in March after heavily overspending. The new system will hand all the decisions to NICE – if a drug is given a conditional recommendation, the CDF is allowed to fund the use of the medicine for up to 2 years while further evidence on long-term evidence is gathered.
After 2 years, NICE will conduct a review, using a shortened process, to consider the drug for routine commissioning on the NHS. This will either result in the medicine moving out of the CDF and into routine budgets, or if the company has not been able to demonstrate its case, made available on an exception basis only.
But Baroness Morgan, chief executive of the charity Breast Cancer Now, has said that the new CDF "will do next to nothing to solve the wider problems that are preventing NHS patients from accessing the best cancer drugs".
She added: "The CDF was set up because NICE's methodology was not working for cancer drugs and this new process offers little change. With the fund's drug assessment now being handed back to NICE, we worry that patients in England will miss out on effective drugs that are available in other countries."
Her sentiment has been echoed by Richard Erwin, general manager of Roche UK.
"Now that the assessment of new cancer medicines for reimbursement has been returned to NICE, we must, as a matter of urgency, address the challenge they have in assessing the real clinical value of cancer treatments – which necessitated the creation of the original CDF in 2010," he said.
"We are calling on government today to review NICE's assessment methodology to stop patients facing ongoing anxiety around the availability of existing and new cancer medicines.
He highlighted Roche's Perjeta (pertuzumab), for neoadjuvant treatment of HER2 positive early breast cancer, as one example: "We have been waiting more than two years for a final decision on Perjeta for the treatment of metastatic HER2 positive breast cancer, where NICE's methodology is unable to find combination treatments cost-effective, even when they significantly extend overall survival for late stage disease. This, despite Perjeta being the highest clinically-scored medicine ever assessed by the CDF."
"We – NICE, patient organisations, the pharmaceutical industry and NHS England – must all work together to ensure patients in the UK have access to the latest medicines. This means finding ways to ensure patients have access to effective and potentially game changing treatments. It is heartbreaking to think we may have years of R&D sitting on a shelf with patients unable to benefit."
The ABPI has said that it welcomes the way the new Fund "joins up the dots" between NICE and NHS England, but also pointed out that further evolution of NICE's appraisal process is required.
"Importantly, we also believe that given the fact that the old Fund consistently overspent significantly on its allocated budget, and that industry already underwrites the majority of expenditure on branded medicines over and above agreed levels, a fairer and more equitable system of financial risk must be prioritised," the Association added.
David Montgomery, Pfizer UK's oncology medical director, has also provided his own warning: "Developing these medicines takes an enormous investment of time, money and knowledge with thousands of scientists dedicating years to invent the latest treatments and cures. 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. It will impact our ability to make further medical progress if we do so."