NICE under fire over Avastin decision

Tuesday, August 24th, 2010

NICE has come under attack following its decision not to recommend bowel cancer drug Avastin.

Manufacturer Roche and Bowel Cancer UK both questioned the decision after tests showed an increased survival rate of almost two years.

Critics argued the decision would see the UK fall ‘even further behind’ other countries for cancer treatment and hoped the new Interim Drugs Fund would finally bring widespread access to patients.

NICE’s independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme.

The UK is now one of a handful of developed countries that don’t provide Avastin to patients. Roche said the decision was ‘further evidence’ the current system was not appropriate after the cost-effectiveness and not clinical effectiveness of the drug contributed to the outcome of the appraisal.

“The recent International Variations Report has shown that patients in the UK have significantly poorer access to cancer medicines when compared to their European counterparts,” a statement from the pharma company said.

“The launch of the Interim Cancer Drugs fund will help address this ‘passport prescribing’ situation in the short term and is further recognition that the current drug evaluation process disadvantages end of life cancer medicines.”

Roche also highlighted how NICE has failed to recommend more than half of cancer drugs since January 2007 and hoped to see a ‘pricing and reimbursement system in the longer term that may be more mindful to the challenges of evaluating end of life therapies’.

Bowel Cancer UK revealed its disappointment at NICE’s decision, claiming the effectiveness of Avastin far outweighed its cost.

“I know that NICE has to be rigorous in its appraisal of treatments and that it looks in detail at individual drug trials to assess cost-effectiveness,” said Rob Glynne Jones, Chief Medical Adviser of the charity.

“However, as a practicing oncologist, if we simply look at survival in the UK, I can see that in even the most up-to-date national drug trials, such as COIN, patients with advanced bowel cancer have an average 19 months’ survival. This compares to up to 27 months’ survival for patients in countries that use bevacizumab (Avastin), such as in mainland Europe and the United States.
“I can’t argue with NICE’s decision, but I am disappointed. These statistics tell their own story and imply that we are likely to fall even further behind in worldwide league tables.”

It is estimated that around 6,500 patients a year in the UK could benefit from Avastin. The drug is currently used in the US and across Europe, but patients in the UK have to purchase the treatment privately or appeal to their local health authority for funding.

Avastin PAS too complex for NICE

Tuesday, August 24th, 2010

NICE has failed to recommend bevacizumab (Avastin) for the treatment of metastatic colorectal cancer in second draft guidance.

The independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme (PAS).

Sir Andrew Dillon, NICE Chief Executive, said the Institute was ‘disappointed’ not to recommend Avastin but highlighted a number of other treatments currently available.

Irinotecan, oxaliplatin, capecitabine, tegafur with uracil and cetuximab have all previously been recommended for various stages of colorectal cancer by NICE.

Roche originally proposed Avastin in a PAS where the drug would be free after 12 months of treatment. The cost of oxaliplatin would also be reimbursed. The new scheme included the same proposals plus an additional upfront payment to the NHS. But the Committee said the complexity and administrative costs were both likely to be higher than Roche had predicted.

“We have recommended several treatments for various stages of colorectal cancer, including cetuximab for the first-line treatment of metastatic colorectal cancer,” said Sir Andrew Dillon. “We are disappointed not to be able to recommend bevacizumab as well but we have to be confident that the benefits justify the considerable cost of this drug.”

The draft guidance has now been issued for consultation.

Pharma turning to hired help

Friday, August 20th, 2010

Pharmaceutical companies are turning to contractors instead of full-time employees, a report says.

The Global Life Science Hiring Index shows that 15% of sales and marketing positions are now hired out across Europe, the Middle East and Africa.

Flexible staff numbers and cheaper labour costs, which also result in a reduction in company benefits, were all believed to contribute to the rise of temporary workers.

Thirty global organisations, widely considered leaders in their respective field, participated in the study including GlaxoSmithKline, Pfizer, Roche and sanofi-aventis.

The Index, the first of its kind, was developed after an overwhelming industry demand for a simple indicator into the state of hiring within the life sciences and medical industry.

The results provide a critical insight into regional hiring trends, skill shortages and talent gaps across the world. For life sciences/pharma, the highest area for hiring includes accounting, finance and IT with nearly three out of ten employees on a temporary contract.

Medical devices and supplies was the most active sector for hiring across the world, providing 46% of job opportunities to contractors.

The overall figure for life science/pharma reflects nearly four positions in ten across the globe are now farmed out.

NICE backs cancer treatments

Wednesday, July 28th, 2010

NICE has recommended two new convenient cancer treatments in their final guidance.

Roche’s Xeloda (Capecitabine) has been recommended in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Iressa (gefitinib) has also been given the go-ahead for first-line treatment of locally advanced or metastatic non-small-cell lung cancer.

NICE said that Iressa, which has been proposed as a patient access scheme by AstraZeneca, offers patients added convenience in its oral form. It also noted the Xeloda tablet would allow patients less time in hospitals connected to infusion pumps.

Health Technology Evaluation Centre Director Dr. Carole Longson hoped the new treatments would help the thousands of people suffering from the conditions in the UK each year.

“Non-small-cell lung cancer and gastric cancer can both be devastating conditions, with gastric cancer affecting approximately 8,200 people in the UK every year and non-small-cell lung cancer approximately 38,000,” she said. “We are very pleased to be able to recommend both capecitabine and gefitinib for use on the NHS.”

Weak trial evidence fails Avastin

Tuesday, July 13th, 2010

NICE has decided not to recommend Roche’s Avastin (bevacizumab), in combination with a taxane, as a first-line treatment for metastatic breast cancer due to a lack of evidence in its favour.

Clinical evidence was submitted that Avastin could slow tumour growth for five and a half months longer when added to paclitaxel. However, there was no improvement to overall survival rates, the drug only extending patients’ lives by around an extra seven weeks (1.7 months).

NICE also pointed out that Roche did not compare Avastin with docetaxel – a ‘gold standard’ breast cancer treatment – despite research data being available.

The Appraisal Committee concluded that the cost of bevacizumab is too high for the limited and uncertain benefit it may offer patients. Roche acknowledged that its own calculations on cost-effectiveness were ‘optimistic’.

Sir Andrew Dillon, NICE Chief Executive, said: “The Committee did hear evidence from a clinical expert and patient representative that the amount of time a drug can slow the growth and spread of the cancer is highly valued by patients but evidence of the length of time bevacizumab could keep the cancer under control was not robust.

“It is important to remember that current breast cancer treatments like paclitaxel and docetaxel are very effective in helping to extend the lives of patients with metastatic breast cancer. For example, the study comparing bevacizumab plus paclitaxel with paclitaxel monotherapy highlighted that paclitaxel could prolong lives by just over two years, on average.”

The preliminary guidance is now available for public consultation until 30 July 2010.

Herceptin not recommended in stomach cancer

Tuesday, July 6th, 2010

NICE has decided not to recommend Roche’s Herceptin (trastuzumab) for use in stomach cancer due to doubts over the extent to which it can extend life.

In preliminary draft guidance, NICE says it is “unable” to recommend Herceptin in combination with cisplatin and capecitabine or 5 fluorouracil for the treatment of people with HER2-positive metastatic gastric cancer.

Gastric cancer affects approximately 8,200 people in the UK every year – of whom just 500 would be eligible for treatment with trastuzumab.

Andrew Dillon, Chief Executive of NICE, said: “Although clinical trials suggest that trastuzumab can extend life for patients with HER2-positive metastatic gastric cancer, there is considerable uncertainty about the data on how long this extension would be.

“The manufacturer and other consultees now have an opportunity to help the independent Appraisal Committee resolve this uncertainty, to the extent that they can. All comments received will be fully considered by the Committee at their next meeting.”

NICE is also appraising capecitabine for gastric cancer and has recommended it as a treatment option in draft guidance.

NICE issues more good news for RA patients

Friday, July 2nd, 2010

RoActemraNICE has reversed its original negative decision on RoActemra (tocilizumab) for rheumatoid arthritis, following a review of further data on the use of the drug at specific stages of the treatment pathway.

Earlier draft guidance published in March 2010 was minded not to recommend the use of the drug, and the committee asked for additional information from manufacturer Roche.

The latest final draft recommendations state that RoActemra, in combination with methotrexate, is recommended for the treatment of moderate to severe active rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more TNF-α inhibitors and rituximab.

Dr Carole Longson, Director of the Centre for Health Technology  at NICE, said: “The use of tocilizumab after rituximab was raised as a potentially important place for this drug in the treatment pathway during consultation on previous draft guidance. The additional information provided by the manufacturer on use in these circumstances has enabled the appraisal committee to now produce positive recommendations – which we hope will be good news for people with rheumatoid arthritis.”

RoActemra is a modern biologic and is used to reduce inflammation in the joints, to help prevent long-term damage.

Roche also recently presented data at the European League Against Rheumatism (EULAR), which showed that the drug is effective in the treatment of Juvenile Idiopathic Arthritis.

NICE ‘unable’ to recommend Tarceva

Thursday, June 17th, 2010

NICE says it is unable to recommend Tarceva (erlotinib) as a maintenance treatment for people with non-small-cell lung cancer.

Despite a proposed patient access scheme by manufacturer Roche in which the cost of Tarceva would be reduced by 14.5%, the appraisal committee concluded that the drug “would not be a good use of NHS money”. It was also ruled that the total population for whom Tarceva is licensed is not small enough to qualify for the end-of-life criteria.

Tarceva was recommended in November 2008 as a first line treatment for non-small-cell lung cancer.

Maintenance treatment is a relatively new concept in lung cancer care. Its goals are to prolong the benefits of treatment and to maximise quality of life for as long as possible.

Sir Andrew Dillon, Chief Executive of NICE, said: “Erlotinib has been shown to have some clinical benefit, with the manufacturer estimating it can potentially extend life by approximately 3.3 months. However, our independent advisory committee felt that a number of assumptions in the manufacturer’s economic model were not appropriate; for example, the overall cost of erlotinib had been underestimated.”

The manufacturer and other consultees now have the opportunity to consider and respond to comments made by the independent Appraisal Committee.