Four new medicines approved by Scottish Medicines Consortium

The Scottish Medicines Consortium (SMC) has approved four new medicines for routine use in NHS Scotland.

The approved drugs are:

• Co-careldopa gel (Duodopa) for advanced Parkinson’s disease
• Blinatumomab (Blincyto) for acute lymphoblastic leukaemia (ALL)
• Mepolizumab (Nucala) for severe asthma
• Febuxostat (Adenuric) for patients at risk of Tumour Lysis Syndrome (TLS), a complication due to the breakdown of cancer cells leading to a rise in uric acid level in the blood which can then cause kidney damage.

Co-careldopa and blinatumomab were both accepted after consideration under the SMC’s Patient and Clinician Engagement process (PACE) for medicines that treat end of life and very rare conditions.

For patients with advanced Parkinson’s disease where other medical options have been unsuccessful, co-careldopa gel can be given directly into the small intestine. The gel is administered via a pump and tubing which has to be surgically inserted into the gut. In the PACE meeting, patient groups and clinicians described the impact that advanced Parkinson’s disease can have on patients and their carers. They highlighted how co-careldopa gel, which would only be suitable for a small number of patients, can help to control symptoms of the disease. 

Blinatumomab was accepted for treatment of ALL, a rare and aggressive form of leukaemia. During the PACE meeting, patient groups and clinicians spoke of how patients are often diagnosed in their mid to late 30s, when many have work and family commitments. There is currently a lack of treatment options for this condition and blinatumomab may also provide a bridge to bone marrow transplant for some patients. 

Mepolizumab is used with other medicines in patients with severe eosinophilic asthma (a type of asthma characterised by an excess of inflammatory cells known as eosinophils), which is not well controlled with previous treatments. In a patient group submission, Asthma UK highlighted how there is an unmet need for people with severe asthma in the treatment options available to them.

Also accepted was febuxostat, which is used to treat or prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy and at risk of TLS. Febuxostat offers another treatment option for patients who are intolerant of or unsuitable for current treatments.

However, the Committee was unable to accept cabazitaxel (Jevtana) for advanced prostate cancer and evolocumab (Repatha) for high cholesterol. 

Cabazitaxel, a chemotherapy for advanced prostate cancer, was considered through the PACE process, but the Committee was unable to recommend it as the overall health benefits of the medicine were not sufficient to justify the cost to the NHS. A meeting between the company and the SMC has been held to discuss next steps and the company has indicated its intention to resubmit.

Also not recommended was evolocumab, a medicine administered by injection for high cholesterol, which is one of a number of risk factors for cardiovascular disease. While evolocumab reduces high cholesterol levels, the Committee felt the lack of evidence about the long-term clinical benefits it can bring in relation to its cost, meant it was not a good use of NHS resources. 

Professor Jonathan Fox, chairman of the SMC, said: “I am pleased we were able to accept these new medicines for routine use in NHS Scotland. From the powerful testimony we heard from patients and clinicians about co-careldopa, we know this decision will be welcomed by patients and carers alike. Blinatumomab, which is a further treatment option for acute lymphoblastic leukaemia, and can provide a bridge to bone marrow transplant for some patients, is also to be welcomed. The lack of treatment options for those with severe asthma means mepolizumab will be of benefit, while febuxostat will help to treat those unable to tolerate current treatments for Tumour Lysis Syndrome.” 

Further details of all medicines can be found on our website, www.scottishmedicines.org.uk.