February 2015 decisions news release
The Scottish Medicines Consortium (SMC), whose purpose is to review newly licensed medicines, has today published advice that includes four new medicines accepted for use in NHSScotland.
Two of these medicines, paclitaxel albumin (Abraxane) for pancreatic cancer and bosutinib (Bosulif) for chronic myelogenous leukaemia (CML) were accepted after consideration under the SMC’s more flexible PACE (Patient and Clinician Engagement) process, which aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.
A third medicine considered under the PACE process, abiraterone acetate (Zytiga) for the treatment of prostate cancer in men who have not yet received chemotherapy, was not recommended. Abiraterone has previously been accepted by SMC for restricted use in patients who have received chemotherapy. Colestilan (BindRen), which is used to manage high levels of phosphate in the blood in patients with chronic kidney disease, was also not recommended by an Independent Review Panel.
Paclitaxel albumin can be used to treat pancreatic cancer. Given in combination with gemcitabine chemotherapy, it offers patients a significant improvement in survival in the context of very limited remaining months of life. It also has improved tolerability compared with currently available treatments.
Bosutinib for chronic myelogenous leukaemia (CML), a rare cancer of the white blood cells, was also accepted via the PACE process. Bosutinib offers patients who cannot tolerate or do not respond to other currently available treatments the chance to live longer with a better quality of life. Through PACE, patient groups stated that as well as helping patients maintain independence and dignity, bosutinib could also help reduce the significant costs associated with the intensive hospital care patients would otherwise have to receive.
Also accepted after a resubmission was umeclidinium/vilanterol (Anoro), a combination inhaler for the treatment of chronic obstructive pulmonary disease (COPD). COPD covers several conditions, including long term bronchitis and emphysema, in which the airways or the lungs are blocked or narrowed, usually by inflammation of the airways. SMC also accepted the biosimilar medicine follitropin alfa (Bemfola), used to treat female infertility and hypogonadism (a condition in which the body does not produce enough testosterone) in men.
Professor Jonathan Fox, chairman of SMC, said:
“We are pleased to be able to accept these four medicines for use in NHSScotland, two of which were considered via our PACE process. The valuable additional input from patient groups and clinicians through the PACE process was helpful in highlighting the benefits of nab-paclitaxel and bosutinib for patients. The acceptance of these medicines by SMC now brings the number of medicines approved under the PACE process to eight.”
In addition to the four medicines accepted for use, SMC did not recommend abiraterone for the treatment of prostate cancer in men who have not yet received chemotherapy. Abiraterone was considered under the SMC process for medicines for end of life and rare conditions. This submission related to its use at an early stage in the treatment pathway for prostate cancer. SMC has previously accepted abiraterone for restricted use in patients who have already had chemotherapy. Patient groups and clinicians who participated in the PACE meeting spoke strongly about the improved quality of life it offers men in the early stages of prostate cancer. However, the committee felt there was insufficient evidence about the overall benefits of using abiraterone at this stage in the treatment pathway. The cost of the medicine includes a confidential discount to NHS Scotland (called a Patient Access Scheme) but is still substantial. Despite applying the increased flexibility that PACE allows, SMC was unable to recommend abiraterone due to concerns that the benefits may not justify the price. The company will be meeting with SMC to discuss the next steps.
Professor Fox said:
“While patient groups and clinicians spoke strongly in support of early use of abiraterone, after considering all the available evidence and applying as much flexibility as we could, the committee was unable to accept it. We realise this decision will disappoint patients and clinicians alike, but SMC has to consider clinical and cost effectiveness in making its decisions. In doing this, we have to take account of the needs of all patients in Scotland, not just those who would benefit from the medicine under consideration.”
The former Cabinet Secretary, Mr Alex Neil, asked SMC to implement a package of measures to improve access to new medicines in January 2014. In relation to SMC’s progress in implementing the Scottish Government’s recommendations, Professor Fox said:
“We have made substantial changes to SMC processes in the past year and we have been clear since the outset that we would need to review the impact of these changes on patient access to new medicines and public understanding of what SMC does. We have been gathering regular feedback from public observers and patients groups, most of which has been very positive, and we plan to formally review this. We are committed to continuously improving how SMC works.”
The other medicine not recommended was colestilan, which is used to treat high phosphate levels in patients with chronic kidney disease who are on dialysis. Colestilan was considered by an Independent Review Panel (IRP). The IRP did not recommend colestilan because key weaknesses in the clinical and economic case presented by the submitting company meant the medicine was not considered to offer value for money.
For medicines that are not recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient.