NICE has once again rejected Roche’s Avastin, the world’s biggest selling cancer drug, this time for its new licence in ovarian cancer. 

In final guidance the Institute said it could not back Roche’s Avastin (bevacizumab) for two types of advanced ovarian cancer.

Specifically, it is saying no to the drug when used in combination with the chemotherapy drugs paclitaxel and carboplatin as a first treatment for advanced ovarian cancer.

It is also refusing NHS funding for use with carboplatin and Lilly’s Gemzar (gemcitabine) to treat the first recurrence of advanced ovarian cancer if it has returned six months or more after initial treatment with platinum-based chemotherapy (platinum-sensitive disease).

In both pieces of final guidance published for the health service, NICE concludes that funding the treatment on the NHS “does not represent the best use of taxpayers’ money”.

Sir Andrew Dillon, NICE chief executive, explained: “The NHS has finite resources so it’s important that only the most cost-effective treatments – drugs that work well considering their cost and potential side-effects – are recommended.

“NICE has published guidance on two specific uses of bevacizumab as an advanced ovarian cancer treatment and we’re naturally disappointed that we can’t recommend it in either instance. Unfortunately, the evidence provided to the Appraisal Committee - which developed these two pieces of guidance for NICE - highlighted that, in both cases, bevacizumab was not cost-effective.”

Cancer Drugs Fund

Once again Roche has bemoaned this latest and final decision – which has been a consistent no from NICE throughout its previous rounds of draft guidance – and said that patients must now rely on England’s Cancer Drugs Fund to gain access to the medicine.

But this Fund, set up in 2010 to inject an £650 million into the NHS to pay for new oncology drugs not recommended by NICE or under appraisal, is coming to an end in March next year.

Roche says there is “considerable uncertainty” about how medicines currently funded through the CDF will continue after this end date, although the government has said those receiving medicines prior to March 2014 will continue to have them funded.

The Swiss firm added: “There needs to be a clear transition plan for these medicines to provide reassurance for patients eligible for treatments currently funded by the CDF. It is still uncertain how the new method of medicines assessment (value-based pricing) will be applied to existing medicines.”

It added that there are further concerns that VBP – which is meant to replace the PPRS pricing scheme in January next year  - “may miss its planned introduction” in 2014, leaving “a potential gap in access to medicines that improve clinical outcomes”.

Roche does not say why this concern exists, but there is still much ambiguity on just how VBP will work and whether PPRS will still have a place in the UK. The president of the ABPI Deepak Khanna recently told PharmaTimes UK news, however, that there are “no plans to delay VBP”, and the UK pharma group is “on track” for an evolved drug pricing scheme to take hold on January 2014.

Avastin is currently – and always has been – the most commonly funded drug via the CDF. Speaking to PharmaTimes UK News before his departure last month, the former chair of NICE Sir Michael Rawlins acknowledged Avastin’s top spot in the Fund, but said it was right that NICE didn’t recommend as the drug’s “benefits are small and its price is very high”.

He added that the creation of the Fund was clearly a “political decision” by the coalition government, but would not go as far to criticise its implementation. Since his departure the Fund has been handed over to the NHS England (formerly the NHS Commissioning Board) who will now handle all applications for funding.

NICE and Avastin

Avastin has been rejected by NICE in all five of its European licences – including colorectal and lung cancers - as the watchdog has consistently found its cost to simply be too high for its minimal benefit.

It received European approval for ovarian cancer last year, its most recent licence, but in an unusual move, Roche has not submitted the drug for approval in the USA.

Analysts have speculated that this is most likely because its clinical trial data is not good enough to warrant approval by the FDA.