NICE cannot recommend breast cancer drugs
pharmafile | February 14, 2012 | News story | Sales and Marketing | GSK, Herceptin, NHS, NICE, Roche, Tyverb
NICE is not recommending GlaxoSmithKline’s Tyverb or Roche’s Herceptin for use in certain breast cancer patients.
The watchdog said in draft guidance it could not recommend the drugs with aromatase inhibitors as a first line treatment for patients with advanced breast cancer, and whose tumour cells both react with the hormones oestrogen or progesterone and have high levels of HER2.
NICE said they do not appear to represent value for money for the NHS because the extent to which they can improve overall survival compared to existing treatments is uncertain.
Experts estimate that between 50 and 2,000 postmenopausal women are diagnosed with this type and stage of breast cancer every year.
It is believed that most of these women are likely to be offered Roche’s drug alongside chemotherapy as their first line option.
Tyverb or Herceptin would usually be considered as first line options alongside aromatase inhibitors only when chemotherapy is deemed unsuitable – but NICE said it is unclear how many women could use this option.
Taking aromatase inhibitors in isolation is also another existing first line option for these women, the watchdog added, which is a much cheaper option for the NHS.
Sir Andrew Dillon, chief executive of NICE, said that whilst the drugs can reduce the growth and further spread of metastatic breast cancer tumours when taken alongside the aromatase inhibitors letrozole and anastrozole, the extent that these treatments can improve overall survival appears to be ‘small or undefined’.
“Furthermore, independent economic analyses indicate that both treatment combinations do not appear to be cost effective for the NHS because they have uncertain clinical benefits for the price that the NHS is being asked to pay,” he added.
For 15 months of treatment with intravenous Herceptin and anastrozole, the cost is estimated to be around £26,000, with anastrozole representing around £1,200 of that.
For around 13 months of treatment with Tyverb pills, plus letrozole, the total treatment costs £28,000. Neither firm offered a patient access scheme to discount the cost of the drugs to the NHS.
Herceptin is already recommended by NICE in a number of settings in women with certain types of breast and stomach cancers.
The drug is recommended, in combination with paclitaxel, for women who have tumours with excessive HER2 who have not had chemotherapy for metastatic breast cancer, and for whom anthracycline treatment is inappropriate.
In addition it can be used for women who have early-stage HER2-positive breast cancer after they have had surgery and chemotherapy and sometimes radiotherapy, and for HER2-positive metastatic gastric cancer.
Tyverb struggles to gain NICE recommendation
But GSK’s drug has had a more difficult road after NICE rejected Tyverb in June, citing high cost and limited benefit, and restricting its use in combination with Roche’s Xeloda to clinical trials of people with advanced or metastatic HER2-positive breast cancer.
Today’s decision will be a further blow to the UK firm, but there may be some reprieve after NICE has asked the Department of Health if it can appraise both Herceptin and Tyverb as a combination therapy for advanced breast cancer patients after progression.
NICE said in October that if it is granted permission it would start this new appraisal swiftly, which would include the continuing use of Tyverb post-progression.
Ben Adams
Related Content
GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and …
A community-first future: which pathways will get us there?
In the final Gateway to Local Adoption article of 2025, Visions4Health caught up with Julian …
The Pharma Files: with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust
Pharmafile chats with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust, about …
