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September 2017 decisions news release

SMC accepts four new medicines for use by NHSScotland

The Scottish Medicines Consortium (SMC) has today (Monday 11 September) published advice accepting four new medicines for use by NHSScotland.

Stiripentol (Diacomit) was accepted for the treatment of children with a very rare type of epilepsy known as Dravet’s syndrome. This type of epilepsy appears in young children during their first year of life and can cause prolonged and repeated seizures. Through SMC’s Patient and Clinician Engagement (PACE) process for medicines used for rare conditions, it was highlighted that children with Dravet’s syndrome may require intensive support for a range of issues including developmental delays in speech and language.  There are currently no treatment options for this condition. Stiripentol, which was accepted for use in combination with two other medicines, clobazam and valproate, may significantly reduce the frequency of seizures, allowing children to attend school more regularly and interact with their peers.

Nivolumab (Opdivo) was also accepted through the PACE process for the treatment of squamous cell cancer of the head and neck (SCCHN), which includes cancers of the mouth and throat. PACE participants spoke of how patients have a limited life expectancy after treatment with a platinum-based cancer medicine and how they have to live with pain, breathing difficulties,  an inability to speak and swallow and disfigurement to the face and neck. Nivolumab can improve overall survival and help patients maintain quality of life during their remaining months. 

Baricitinib (Olumiant) was accepted for the treatment of severe rheumatoid arthritis in adults who have not responded to or are intolerant of other current treatments.  As an oral treatment, baricitinib offers an effective treatment to other medicines which are given by injection or infusion. 

Also accepted was rolapitant (Varuby) for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults. This provides an alternative to similar preventative treatments.

The committee was unable to accept roflumilast (Daxas) for the treatment of severe chronic obstructive pulmonary disease (COPD) as the company’s evidence on the clinical and economic benefits of using the medicine was not strong enough.

Etelcalcetide (Parsabiv), for the reduction of high levels of parathyroid hormone in adults with chronic kidney disease who are on haemodialysis therapy, was also not recommended.  The committee was unable to accept etecalcetide because the long term benefits of the medicine were unclear compared to another similar treatment. 

Dr Alan MacDonald, chairman of the SMC, said:

“The committee is pleased to be able to accept these four new medicines for use by NHS Scotland. 

“Stiripentol provides a much needed treatment for children with this rare form of epilepsy, and we know from the evidence given through PACE that our decision on this medicine will be welcomed.” 

“For those suffering from a cancer of the head or neck, nivolumab offers the potential for improved survival and may help make their remaining months of life more comfortable.

“Baricitinib will provide another valuable treatment option for those with rheumatoid arthritis, while our acceptance of rolapitant adds another treatment option for treating those suffering from vomiting or nausea after undergoing chemotherapy.”

“We were unable to accept roflumilast for COPD as the evidence provided by the company on its benefits was not strong enough to justify allocating limited NHS resources to it.  

“For etelcalcetide, the committee felt that there was insufficient evidence about the benefits the medicine may bring when compared to other currently available treatments, and therefore it may not represent a good use of NHS resources.”