by Helen Collis
LONDON, Jan 8 (APM) - Eisai has written to the UK prime minister urging him to intervene in what it sees is a hurried and flawed process to end funding for potentially half the drugs currently paid for by the Cancer Drugs Fund in England.
Speaking to APM on Thursday, Eisai director of communications (EMEA) Cressida Robson said: “We are asking David Cameron to call for a pause in the current process.”
She said, above all, the assessment of drugs’ efficacy and cost-effectiveness by the Cancer Drugs Fund has lacked transparency and consultation.
Eisai is calling for all stakeholders in the process to be included in negotiations on drugs funding, including patients, carers, doctors, regulators, industry and payers.
In November, NHS England informed industry that its Cancer Drugs Fund (CDF) was overstretched and a process of rationing the drugs funded by it therefore needed to take place.
A source told APM on Thursday that it is believed between one-third and one-half of the 44 drugs funded by the CDF will be delisted from Monday, effective from March.
This rationing process has involved a scoring system whereby drugs must reach a certain threshold from a combination of clinical efficacy and cost-effectiveness scores, to maintain their funding. (APMHE 41032
However, if a drug fails to achieve the CDF’s clinical efficacy threshold, it will automatically be delisted from the fund. Robson told APM that this is the current situation for its breast cancer drug Halaven (eribulin).
Flawed process by Cancer Drugs Fund
Robson said that the company had no opportunity to negotiate any kind of pricing discount for its drug, which to date has been the sixth most commonly prescribed treatment on the Cancer Drugs Fund.
Unlike NICE’s three-step health-technology assessment process, which gives companies the chance to provide answers to questions during multiple consultations processes, to provide additional data or discount schemes, there was no appeal process.
She said 15 pages had to be completed by the companies - compared with the hundreds of pages submitted for NICE’s assessments - followed by a 20-minute presentation on Dec 15. On Jan 5, the company was told in a short meeting of the drug’s fate. There is no chance for appeal or negotiation.
She said the assessors “cherry picked data” from their submission. Eisai was not aware of a score threshold, or what Halaven achieved. But simply that the drug failed to reach the acceptable clinical score and so would be dropped from funding.
“It was not robust or tested. It was made up and untransparent. We feel aggrieved as it wasn’t systematic or intelligent or based on science. The lack of transparency is particularly difficult.”
In addition, Robson pointed out that the Cancer Drugs Fund examined and reached decisions on 80 applications - since there are numerous drugs with numerous indications - within three weeks.
“How could they possibly do that?” she said.
She said Eisai does not know who carried out the assessments, if they were farmed out to external experts or carried out internally.
Eisai is not the only company speaking out against the process, and in doing so breaking a confidentiality agreement with NHS England.
Sanofi "shocked and disappointed"
In a statement, Sanofi revealed that both Jevtana (cabazitaxel) for prostate cancer and Zaltrap (aflibercept), a novel treatment for metastatic colorectal cancer, have been delisted from the Cancer Drugs Fund.
Sanofi UK’s general manager, Tarja Stenvall, said the company is “hugely shocked and disappointed" at the decisions against Jevtana and Zaltrap. "We will do everything in our power to appeal this decision and are willing to hold open discussions to find a way forward so that patients still have access to this important medicine.”
Stenvall said Sanofi has called for NICE, the Department of Health and NHS England to “quickly review and overhaul the evaluation process for cancer drugs, as promised”.
Her comments were echoed by Dr Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry (ABPI), who said in an email to APM: “We reiterate that we are very disappointed that NHS England did not address concerns about the flawed process they are following, raised by the ABPI and pharmaceutical companies, before proceeding to re-evaluate CDF medicines.
“Such a re-evaluation process would not be necessary if NICE quickly evolves the way it evaluates cancer medicines as part of more fundamental reforms.”
He urged that NICE undertake any further value assessments of cancer drugs, and not the CDF, describing its process as “crude” and risking missing “important costs and benefits” associated with a treatment.
“We urgently need a clear plan with a set of agreed timelines setting out how a sustainable solution will be achieved.”
NHS England said in an emailed statement to APM on Thursday that discussions around cancer drugs funding were ongoing and confidential, and full details will be published on Monday.