Bowel cancer treatment will return to ‘dark ages’ after CDF decision

Campaigners say bowel cancer treatment will be set back by 10 years after new cuts introduced today. Can a new approach in 2016 reverse this and deliver ‘sustainable’ access to cancer medicines?

People who have advanced bowel cancer will be among those hit hardest by new cuts to drug funding in England which take effect today.

The ‘de-listing’ of three drugs from the Cancer Drugs Fund (CDF) was first announced two months ago but, unlike some other treatments (such as breast cancer drug Kadcyla), the CDF wasn’t open to last-minute price negotiations to keep them on the Fund.

Roche’s Avastin, Merck Serono’s Erbitux and Amgen’s Vectibix will all see their use cut back, a move which oncologists say will plunge bowel cancer care back into the ‘dark ages’.

The CDF panel judged all the de-listed indications to be not ‘a step change’, especially in patient sub-types with advanced or metastatic disease. But while oncologists accept their limitations, they nevertheless firmly believe the drugs have helped advance treatment beyond chemotherapy.

Moreover, only England has severely restricted access, and the new cuts puts it out of step with virtually any other advanced nation.

Critics say the latest de-listings are driven by the need to find savings, and that the whole medicines access system in England – CDF, NICE and Department of Health mechanisms – needs urgent fixing.

NHS England has already set out plans for a new Version 2 of the CDF, as a ‘managed access’ fund overseen by NICE, which is due to come in from April 2016.

This is growing appetite among NHS decision makers and pharma to develop more flexible systems with greater ‘risk sharing’ – but no-one is under any illusion that a new system will mean an end to difficult funding decisions.

In particular, there are no guarantees that drugs de-listed from today would be restored to access in the new system.

De-listing:

Roche’s Avastin (bevacizumab) will no longer be funded by the CDF to treat advanced bowel cancer

Merck Serono’s Erbitux (cetuximab) will only be funded as a first-line treatment in combination with FOLFOX chemotherapy (Oxaliplatin + 5FU) or FOLFORI chemotherapy (Irinotecan + 5FU)

Amgen’s Vectibix (panitumumab) will now only be funded for the first time as first-line treatment in combination with FOLFOX chemotherapy (Oxaliplatin + 5FU)

 

A group of oncologists has protested against the decision in a letter to the media. They said they had not complained about the first round of de-listings in bowel cancer drugs in January, acknowledging the need for budget cuts, but felt compelled to speak out about the latest de-listings.

They stated that the decision will push treatment “back to the ‘dark ages’ of constantly having to say ‘sorry’ to our patients because we will no longer be able to provide the internationally accepted standard of care for them.”

A total of 16 indications have been marked for de-listing this week, but bowel cancer patients will be hit particularly hard.

Drug prices and risk sharing

Talking to pharmaphorum recently, one of the pharma firms involved, Merck Serono, agreed the decision would be a major backwards step for the UK.

Its drug Erbitux was first approved in Europe as a first-line treatment for colorectal cancer in 2008, but has had numerous market access struggles in the UK since then.

Elisabeth Prchla has just taken up the role of UK managing director for Merck Serono, and says there have been no such problems in the rest of Europe:

“In all the European countries we’ve found a solution for granting access to Erbitux, in all the necessary indications, so actually it is just the UK that stands out.”

She said she was cautiously optimistic that a solution to England’s cancer drugs access could be found, but said there were already signs the country was slipping behind the rest of Europe.

Merck Serono was recently unable to recruit any NHS patients for a clinical trial of a new drug for gastric or gastroesophageal junction cancer because UK patients did not have access to existing drugs considered standard of care in the rest of the world.

She said this picture contrasted greatly with aim of the Accelerated Access Review, championed by Life Sciences minister George Freeman, which published its interim report last week.

“On one hand the UK wants to be a leader in innovation, but on the other hand the patients aren’t getting access to innovative therapies – that poses a threat to the UK being at the forefront,” said Prchla.

She added that the company was open to new risk-sharing approaches – something which the CDF chairman Professor Peter Clark called for recently. However Prof Clark, Merck Serono and the wider industry say the Department of Health is currently blocking moves towards greater risk sharing.

Keir Woods, head of Merck Serono’s oncology business in the UK added that there was ‘good intent’ to create a new system that would allow sustainable access to cancer drugs. However he pointed out that there were new ‘noises emanating from government’ about drug prices, which were a cause for concern.

A NICE review of Erbitux and Vectibix for the first-line treatment of metastatic colorectal cancer (mCRC) is expected to conclude in April 2016, and is likely to be even more important for access. If the drugs are rejected in this setting, it would mean that no biologics would be NICE-approved (Avastin already not recommended), putting England far out of line with other developed countries.

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