A CANCER support group has called for a shake-up in the way drugs are approved after a fourth drug for the prolonging of the lives of those with advanced incurable secondary breast cancer was not recommended for use in within NHS Scotland.
The Scottish Medicines Consortium said the submitting company "did not present a sufficiently robust economic analysis" for the "ground-breaking" Afinitor (everolimus) to gain acceptance for the treatment of incurable secondary breast cancer by the SMC.
But Breast Cancer Care criticised the decision saying it created a "postcode lottery" and called on the SMC and the Scottish Government to urgently review the process for approving medication. Breast Cancer Now voiced "extreme concern".
The SMC went against the feedback from the new Patient and Clinician Engagement (PACE) system of evaluating end of life medicines and medicines to treat very rare conditions which was implemented in May 2014.
The SMC said it took account of the PACE meeting with patient group representatives and clinical specialists which heard that the Novaratis drug was the only recent development for patients with HER2 negative breast cancer tumours.
The SMC said the group thought that it was a "novel treatment that restores hormone sensitivity in tumours that have developed resistance thereby extending effectiveness of existing hormonal therapies".
The PACE group gave strong support for its use "on the basis that a delay in time to chemotherapy leads to a longer period of valuable high quality productive life for the patient".
The US Food and Drug Administration approved the treatment three years ago, and Breast Cancer Care say the medication will be available in England and Wales through the Cancer Drugs Fund SMC took into account a clinical study also presented to the FDA called BOLERO-2 that showed that Afinitor boosted the average progression-free survival by 4.6 months.
Patients with advanced breast cancer have a life expectancy typically of around two to three years.
According to Cancer Research UK, almost 4500 women in Scotland are diagnosed with breast cancer each year, while 1000 women die from the disease annually.
Patient groups had told the SMC that Afinitor was considered "ground-breaking" as it works by restoring hormone sensitivity to a tumour which has developed resistance, allowing hormone therapy to work for longer. This means that progression of disease can be slowed and patients may be able to delay chemotherapy treatment.
SMC said it could not recommend everolimus due to "uncertainties surrounding the overall clinical benefit" it could provide for patients at the end of their lives, concluding the drug "may not be an effective use of NHS resources".
Chairman Professor Jonathan Fox said it was "disappointing we were not able to recommend everolimus", but he defended the decision.
He said: "We know this decision will be disappointing to both patients and clinicians, as we understand the devastating impact of breast cancer.
"However, uncertainty about the clinical benefits of everolimus meant we were unable to accept it."
Nicolas White, head of Scotland at Breast Cancer Care, said: "Yet again women in Scotland living with incurable secondary breast cancer have been failed – everolimus is the fourth drug they have been denied in the past year. This devastating decision also creates a UK-wide postcode lottery, given the medicine is available in England and Wales, but not Scotland.
“The new system is clearly not working for women with incurable breast cancer. Rather than just paying lip service to the views of patients, the Scottish Medicines Consortium and Scottish Government urgently need to review this process - ensuring the patient voice is at the very heart of decision making.
“Announcing this the day before Secondary Breast Cancer Awareness Day just adds insult to injury. Women with this incurable disease have seen their treatment options diminish drastically. Not only is this process putting a price on giving someone additional time with loved ones – but it is also denying them this precious time.”
Three years ago there were calls for the drug to be made available to patients in Scotland following its approval by the European Commission.
Health Secretary Shona Robison said she understood the disappointment of breast cancer charities over the decision and said that details of a review of the SMC's new approach to dealing with new medicines will emerged later this month.
"This will provide an opportunity for charities, such as Breast Cancer Care and Breast Cancer Now, and others to have their say on what further evolution is needed for the assessment system that will ensure access to new medicines at a fair price," she said.
The SMC did recommend approval for six new medicines, treating conditions including prostate cancer, gastric cancer and pulmonary fibrosis.
The group recommended trastuzumab, or Herceptin, for treating stomach cancer, and radium 223, or Xofigo, and abiraterone, or Zytiga, for prostate cancer.
Nintedanib, or Ofev, was recommended for use treating pulmonary fibrosis, a long-term disease of the lungs, while Ciclosporin eye drops, also called Ikervis, were approved for use treating dry eye disease and insulin degludec/liraglutide, or Xultophy, for treating diabetes.
Prostate Cancer UK welcomed the "fantastic news" that two new medicines were being approved.
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