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Bayer wins Cancer Drugs Fund appeal

pharmafile | May 22, 2015 | News story | Sales and Marketing Bayer, CDF, Cancer Drugs Fund, Eisai, NHS, lilly 

Bayer is the only company to win its appeal to NHS England in the latest round of Cancer Drugs Fund reviews.

The German firm’s Stivarga (regorafenib) for the treatment of gastrointestinal stromal tumours, will remain on the Fund, while Eisai’s breast cancer medicine Halaven (eribulin) and Lilly’s lung cancer drug Alimta (pemetrexed) lost their appeals and will be dropped in July.

“We have been through a robust, evidence-based process to ensure the drugs available through the CDF continue to offer the best clinical benefit, getting the most for patients from every pound that we have,” says CDF chair Professor Peter Clark.

“These are difficult decisions, but if we don’t continue to prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline.”

The CDF’s newly proposed standard operating procedure has been changed so that if there are any other proven treatments available for that particular cancer, regardless of indication, medicines could be delisted.

In January it was announced that 25 treatments would be de-listed from the Fund. NHS England said that removing the drugs from the list will create estimated savings of approximately £80 million “through a combination of negotiated price reductions and improved clinical effectiveness”.

At the time Eisai president Gary Hendler spoke of his ‘outrage’ at NHS England’s ‘arbitrary removal of drugs’ from the fund, saying the firm would be “[appealing] against the decision by NHS England to remove Halaven from the Cancer Drugs Fund on the basis that the evaluation process was rushed and inconsistent”.

Hendler added: “In addition, the decision failed to recognise the clinical efficacy of eribulin, something that has been acknowledged by the hundreds of doctors who have ensured more than 2,000 women have already benefited from the life-extending treatment through the CDF since 2011.”

Commenting on the latest CDF shake-up a spokesperson for Eisai says: “Eisai strongly disagrees with Cancer Drugs Fund decision making process. Eribulin remains the only single agent chemotherapy to significantly improve overall survival in women with advanced breast cancer after anthracycline and taxane treatment. What’s more, it is one most affordable treatments on the Fund and has been since it was made available in 2011.

“That said, we will now work with the process spelled out in the new Standard Operating Procedure and will do all we can to ensure women with advanced breast cancer will continue to have access to this life-extending treatment,” commented an Eisai spokesperson.

Lilly says it is ‘deeply frustrated’ by the rejection, adding: “This decision is a disservice to patients and is based on the incorrect application of an overly simplistic scoring tool and a flawed assessment process”.

“The Cancer Drugs Fund Panel upheld a decision made based on a flawed process at a very real cost to the many people who could have benefited from this treatment,” says Phil Knott, UK director for Lilly Oncology.

“We believed the Cancer Drugs Fund was committed to putting patient need and clinician support at the heart of their decision making, but they have gone against the views of hundreds of members of the clinical community who signed a petition in support of this medicine. The CDF is failing cancer patients at the end of their lives.”

Novartis has been successful in preventing the delisting of its breast cancer drug Afinitor (everolimus) after ‘reaching an agreement’ with NHS England.

The review process looked at whether the standard operating procedures were fully followed – rather than the medical decisions made by doctors on the CDF panel.

On this latest news the ABPI’s director of value and access Paul Catchpole says: “The ABPI is very disappointed that a number of cancer medicines that were previously available will no longer be accessible to newly-diagnosed NHS cancer patients and those patients whose disease has progressed.

“The ABPI believes that the CDF re-evaluation process is fundamentally flawed and the CDF remains a sticking plaster covering a seeping wound. A sustainable solution is urgently required. This involves creating a holistic and joined up system encompassing both NHS England (NHSE) and NICE in order to transform the way that these medicines are evaluated and commissioned.”

George Underwood

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