November 2014 decisions news release
This month’s advice from the Scottish Medicines Consortium (SMC) will benefit patients with a range of conditions across Scotland.
SMC is the body that advises NHSScotland on the clinical and cost-effectiveness of all newly licensed medicines.
Among the decisions announced today are five medicines accepted for use that will help treat hepatitis C, skin cancer, kidney cancer and diabetes. These medicines will benefit over 5000 patients in Scotland. Pertuzumab (Perjeta) for HER-2 positive metastatic breast cancer was not recommended as the committee was not satisfied about its cost effectiveness.
Two medicines for diabetes are among the medicines featured in today’s announcement. Saxagliptin (Onglyza) is used to improve blood glucose control in diabetes while aflibercept (Eyelea)) is used to treat macular odema, a loss of vision caused by a build up of fluid in the retina in patients with diabetes.
SMC also accepted Daclatasvir (Daklinza) for treatment of the more severe types of chronic hepatitis C. The decision makes Scottish patients the first in Europe to routinely access this medicine through the health service. Daclatasvir is the fourth medicine for hepatitis C to be accepted by SMC in 2014. These new direct-acting antiviral treatments may offer the prospect of cure for hepatitis C infection, which is associated with serious liver disease, among other complications, and is an important public health priority.
The other two medicines accepted for use are used to treat different types of cancer: everolimus (Afinitor) for the most common type of kidney cancer and ipilimumab (Yervoy), which is accepted for first-line use in advanced melanoma, a type of skin cancer. Ipilimumab is the second medicine that SMC has accepted under the new, more flexible PACE (Patient and Clinician Engagement) process, aimed at improving patient access to new medicines for the treatment of end of life and very rare conditions.
Professor Jonathan Fox, Chairman of SMC, said:
“This month we have accepted medicines that will benefit people with a range of different conditions. Our new PACE process, developed by working closely with patient groups and clinicians who are in contact with patients every day, has enabled us to accept ipilimumab as a first-line therapy in melanoma. Clinicians and patient group representatives at our PACE meeting explained that this is a very effective medicine which can benefit patients and their families.”
In addition to these five medicines, SMC did not recommend pertuzumab (Perjeta) for HER-2 positive metastatic breast cancer. This medicine was resubmitted under SMC’s new processes for orphan medicines. At the PACE meeting patient groups and clinicians had highlighted that pertuzumab can allow women with metastatic breast cancer to live significantly longer with a good quality of life. Pertuzumab is given in addition to other medicines, and a 6 month course of treatment of pertuzumab with relevant combination medicines costs over £100,000 (pertuzumab on its own costs £70,000). The standard measure of cost-effectiveness used by SMC is the cost per Quality Adjusted Life Year (QALY) and this was estimated to be extremely high at around £125K per QALY. Although the views from the PACE meeting are a major influence on the committee’s decision, the committee was unable to accept pertuzumab. The new processes allow manufacturers the opportunity to offer a new or revised Patient Access Scheme (PAS), a confidential discount that can improve the cost effectiveness of a medicine, enabling patients to access innovative medicines. The company did not offer a PAS for this resubmission.
Professor Fox said:
“Despite the very strong support from patient groups and clinicians for pertuzumab and applying as much additional flexibility as we could through our PACE process, the committee was unfortunately not satisfied that it would be a cost effective use of NHS Scotland resources.
“We know this decision will disappoint patients and clinicians alike as we understand the devastating impact of breast cancer. We have to take account of the needs of all patients who need treatment. NHS Scotland does not have infinite resources and companies are well aware of this.
“We would encourage the manufacturer to make a resubmission for pertuzumab, reflecting on the issues raised by SMC.”