Roche has questioned the methods used by NICE in its appraisal of Avastin (bevacizumab) after it was not recommended as a first line treatment for advanced breast cancer in draft guidance.

Avastin, in combination with Xeloda, was being appraised in patients whom treatment with chemotherapy options, including taxanes or anthracyclines, is not considered appropriate.

However, Roche said NICE had a “lack of belief in a biologically plausible explanation for why Avastin works so well” which resulted in the failure to recommend the treatment.

The Swiss-based company claim the Institute ignored the progression free survival (PFS) and overall survival benefits of the drug demonstrated in clinical trials. Instead Roche said NICE chose to review data in the context of the entire population of women with metastatic breast cancer.

NICE admits evidence supplied by Roche did suggest Avastin “could delay cancer from progressing” longer than Xeloda alone, but said there was no evidence which showed it led to “an improvement in overall survival”.

Sir Andrew Dillon added there was no information available on whether Avastin improves a patient’s quality of life. “Taking these uncertainties into account as well as the high cost of the drug, the committee concluded that bevacizumab was not a cost-effective use of NHS resources,” he said.

Patients with metastatic breast cancer can still apply for access of Avastin through the Cancer Drugs Fund.

Final guidance is now expected in August 2012.

Halaven (eribulin) has not been recommended by the SMC as a treatment option for locally advanced or metastatic breast cancer on the NHS in Scotland.

The Consortium analysed data from Phase III trials which showed patients had 2.5 months additional survival compared to existing treatments, but considered Halaven too expensive.

Nick Burgin, European Director of Market Access, Eisai, says the company is “hugely disappointed” and plans a resubmission later in the year to “reverse this unfair decision”.

Eisai launched Halaven in the UK in April and claims the price of the drug in Scotland is at “the lowest anywhere in the world”.

The medication is a novel monotherapy treatment indicated for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.

Eisai says it is the first single agent chemotherapy to demonstrate prolonged overall survival who have had prior anthracycline and taxane treatment.

During the appraisal, the Consortium analysed data from the EMBRACE trials which showed a median overall survival benefit of 13.2 months for patients receiving Halaven compared to 10.5 months for patients receiving a ‘treatment of physician’s choice’.

Andrew Wilson, Chief Executive of the UK Rarer Cancers Foundation, says the decision highlights the discrimination women north of the border currently face. “Scottish women with advanced breast cancer are currently prejudiced in Scotland as their chances of accessing a life extending cancer drug are now much lower than their neighbours in England”, he said.

“Our recent report ‘Nations Divided’ uncovered a profound difference in the availability of new cancer medicines between Scotland and England. Following the implementation of the Cancer Drug Fund (CDF) in England, patients in Scotland are now three times less likely than patients in England to receive the drugs that their clinician wishes to prescribe.”

Halaven is currently approved in the European Union, USA, Switzerland, Japan, and Singapore but recently failed a similar appraisal by NICE in draft guidance who raised concerns about the medication’s side effects.