NICE has again failed to recommend the use of Eisai’s breast cancer drug Halaven (eribulin) after further questioning the treatment’s side-effects in new guidance.

Eisai had provided additional data after NICE’s original decision not to recommend the treatment back in November.

But NICE concluded the data, which analysed women previously treated with Xeloda (capecitabine), did not show “robust” survival advantage and decided there no “convincing cost effectiveness” for its use.

The Institute received one appeal on its earlier draft guidance. This was dismissed on all counts; however, the Appeal Panel did recommend that sections describing the adverse events experienced with the drug and its comparator were revised.

Halaven has been shown to potentially extend the life of women by 2.7 months compared with a ‘treatment of physician’s choice’. However, the cancer drug did not fulfil all of NICE’s end-of-life criteria.

Sir Andrew Dillon commented: “Although the evidence presented to the independent Advisory Committee indicated that eribulin may help some patients live for a little longer, it also caused more undesirable side effects than other treatments already available, and the committee felt that eribulin’s effects on health-related quality of life had not been adequately assessed.”

NICE’s Chief Executive added that the Committee heard from practising clinical experts who told the Institute that patients usually receive sequential treatment with Navelbine (vinorelbine), Xeloda and infrequently Gemzar (gemcitabine).

But Sir Andrew said that experts “stressed” that if Halaven were to be recommended it would “be unlikely” to replace existing treatments “because of its related side-effects”.

Common adverse effects of the treatment include fatigue, alopecia, peripheral, neuropathy, nausea, neutropaenia, leukopaenia and anaemia.

Eisai have again claimed they are “dismayed” at the decision and accused NICE of “not giving enough support to women” and the “physicians who want to treat them”.

Nick Burgin, European Director of Market Access, said: “We hope that NICE grant a rapid re-review as new data is constantly emerging that will help inform their decision.”

Despite the lack of NICE recommendation, Halaven is available through the Government’s Cancer Drugs Fund and is one of the top twelve drugs prescribed through the system.

On the same day as the final NICE guidance, Eisai signed a partnership deal with Valeant Pharmaceuticals to promote and distribute Halaven in eight central and eastern European countries.

NICE has failed to recommend the use of breast cancer drug Halaven (eribulin) in final draft guidance after raising concerns over the side effects of the treatment.

Its independent Advisory Committee indicated the medication may help patients live longer but, when compared to existing treatments, there were more  “undesirable side effects”.

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.

Eisai has revealed its surprise over NICE’s decision not to recommend its breast cancer drug Halaven (eribulin) in draft guidance.

NICE raised worries over the side-effects Halaven caused and the data supplied by Eisai which compared the drug with a ‘treatment of physician’s choice’ (TPC).

But Nick Burgin, European Director of Market Access, Eisai, says NICE’s “unwillingness” to recommend the treatment comes as a “real surprise”.

Eisai say the side-effect profile of Halaven was “expected and manageable”, and that serious adverse events and adverse events leading to therapy discontinuation actually occurred more in those on TPC than its injection.

The draft guidance is based on Phase III data which showed a median overall survival benefit of 13.1 months for patients receiving Halaven, compared to 10.6 months for those using a TPC. Before its approval in Europe, Eisai claims that no single treatment demonstrated a “statistically significant prolongation of median overall survival” than its clinical trial.

“We are hugely disappointed with the draft guidance issued by NICE,” said Nick Burgin. “It has not recommended an innovative treatment for a vulnerable group of women with heavily pre-treated locally advanced or metastatic breast cancer, with a proven overall survival benefit.”

Halaven is approved in the EU, USA, Switzerland, Japan, and Singapore. It was launched in the UK in April 2011 and Eisai say that patients have already started to benefit from the treatment.

A Patient Access Scheme had also been agreed with DH making the price of Halaven in the UK the lowest in the world. The ABPI says the example of Halaven highlights the need to switch to a value-based pricing approach to improve access of medicines to patients.

“There is serious concern in the research-based pharmaceutical industry about delay in new and innovative medicines reaching patients which potentially denies access to proven effective drugs for urgent clinical needs,” a statement said.

“The UK has amongst the lowest prices in Europe for our medicines but our uptake is both slow and low. The new pricing and reimbursement system needs to reduce bureaucracy and get the right medicines to patients as quickly as possible.”

Breast cancer drug Halaven (eribulin) has not been recommended by NICE in draft guidance for people whose disease has progressed after at least two chemotherapeutic regimens.

The decision follows worries over the number of negative side effects of the solution, and after clinical experts stressed it would only be considered as a back-up option to existing treatments.

Sir Andrew Dillon, NICE Chief Executive, says the “majority of evidence” submitted by Eisai compared Halaven to a ‘treatment of physician’s choice’.

In this study, Halaven was found to potentially extend life by 2.7 months compared with the ‘physician’s choice’.

However, NICE’s independent Appraisal Committee heard from clinical experts that if Halaven were approved, it would be unlikely to replace capecitabine and vinorelbine because of its toxicity profile.

Eisai had agreed a Patient Access Scheme with the Department of Health for the use of Halaven.

Comments on the preliminary recommendation are now open for public consultation from relevant stakeholders. These will then be considered before the next draft guidance is issued.

A new treatment for breast cancer patients with advanced or metastatic disease has launched in the UK.

Eisai’s Halaven (eribulin) is indicated in patients who have progressed after at least two chemotherapeutic regimens, preferably an anthracycline and a taxane.

The drug is a non-taxane, microtubule dynamics inhibitor and a synthetic analog of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

In clinical trials, patients treated with eribulin survived a median of 2.5 months longer than patients who received treatment of physician’s choice.

In the UK breast cancer is the second most common cause of female cancer death after lung cancer.

“Eribulin addresses an urgent need for new treatment options for women with advanced breast cancer who have previously received multiple treatments,” said Dr Andrew Wardley, Consultant Medical Oncologist and Co-Chair of the Breast Group at The Christie Hospital in Manchester.

Eribulin received European Commission approval in March 2011.

“As a charity that supports patients living with metastatic (secondary) breast cancer, we have heard from many UK women that they feel there are limited treatment options available to them. The UK launch of eribulin is a step towards a drug being made available to these patients which could help give them precious extra time,” commented Maria Leadbeater, Clinical Nurse Specialist, Breast Cancer Care.

The European Commission has approved Eisai’s Halaven (eribulin) for the treatment of patients with locally advanced or metastatic breast cancer.

The treatment is indicated in patients who have progressed after at least two chemotherapeutic regimens, which included an anthracycline and a taxane where possible.

When compared to the ‘treatment of physician’s choice’ in clinical trials, Halaven was shown to increase survival by an average of 2.6 months.

Halaven, a natural product made from the marine sponge Halichondria okadai, is the first single-agent therapy to demonstrate a significant overall survival benefit in patients with advanced breast cancer.

In a statement, the pharmaceutical company said: “Eisai's commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications.”

The product will be launched in the EU in April 2011. It was approved in the USA in November 2010 and Singapore in February 2011.

The CHMP has given a positive opinion to Eisai’s breast cancer drug Halaven (eribulin) in the treatment of patients with advanced disease.

The treatment has been recommended by the CHMP as a monotherapy for locally advanced (LA) or metastatic breast cancer (MBC) in patients who have progressed after therapy with an anthracycline and a taxane, unless patients were not suitable for these treatments.

In Phase III trials, Halaven has been proven to improve overall survival by 2.7 months compared to the current treatment of choice.

“This is very positive news for women with pretreated locally advanced or metastatic breast cancer,” said Professor Gordon McVie, senior consultant at the European Institute of Oncology, Milan. “Halaven is a promising therapy for these patients who currently have very limited treatment options.”

Other drugs recommended for marketing authorisation by the CHMP this month include:

· Sanofi-aventis’ Jevtana (cabazitaxel) for the treatment of patients with hormone refractory metastatic prostate cancer (in combination with prednisone or prednisolone)

· Pravafenix (fenofibrate/pravastatin) from Laboratoires S.M.B. S.A., for the treatment of adults at high risk of coronary heart disease with mixed dyslipidaemia

· Glaxo’s adjunctive epilepsy treatment Trobalt (retigabine).

The CHMP also gave positive opinions for the following extensions of indication:

· Bristol-Myers Squibb’s Baraclude (entecavir), to include treatment of chronic hepatitis B virus infection and decompensated liver disease

· INO Therapeutics’ INOmax (nitric oxide), to include treatment of pulmonary hypertension peri- and post heart surgery

· Janssen-Cilag’s Prezista (darunavir), to include the second-line treatment of HIV infection in adults.