September 2018 decisions news release

The Scottish Medicines Consortium (SMC), has today (Monday 10 September) published advice accepting four new medicines for use by NHSScotland. Two of the medicines were accepted through SMC’s Patient and Clinician Engagement (PACE) process, which is used to consider medicines for treating end of life and very rare conditions.

Tocilizumab (RoActemra) was accepted for the treatment of Giant Cell Arteritis (GCA) in adult patients. GCA is a rare condition in which arteries, usually of the head, are inflamed. At the PACE meeting, patients and clinicians described how symptoms including severe headache, scalp tenderness, jaw discomfort and temporary and permanent sight loss impact on quality of life, increase the risk of falls and reduce mobility. Current treatment involves high doses of steroids given over a prolonged period of time which can have a number of serious side effects. Tocilizumab may reduce the amount of steroids required for treatment and better control symptoms.

Also accepted through PACE was dupilumab (Dupixent). Dupilumab can be used to treat moderate to severe atopic dermatitis (also known as atopic eczema), a distressing and disabling long-term skin condition. Through PACE, patients and clinicians spoke of how symptoms including extreme itching and painful skin can have a significant impact on quality of life. Current treatment options in patients who fail to respond to existing systemic therapies (tablets or injections) are limited and often time consuming, involving the repeated application of topical treatments, bandages and frequent attendance at dermatology clinics. Dupilumab, which is given every other week by injection, has been shown to improve symptom control, offering patients the opportunity for a substantial improvement in quality of life.

Dolutegravir / rilpivirine (Juluca) was accepted for the treatment of HIV. Unlike other current treatment options which are normally a combination of three medicines, this is the first dual therapy treatment for the condition. As a smaller, easier to swallow tablet, dolutegravir / rilpivirine offers a further maintenance treatment which may benefit some patients.

Bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy) was also accepted for the treatment of HIV. As a new combination therapy, it offers another treatment option for patients with HIV.

The committee was unable to accept pembrolizumab (Keytruda) for the initial treatment of urothelial cancer (a cancer of the bladder and urinary tract) that is advanced or has spread to other parts of the body, in patients who are unsuitable for chemotherapy. Following consideration under the PACE process, the committee did not recommend pembrolizumab due to uncertainties in the company’s evidence about both the long-term benefits of the medicine and its cost effectiveness.

Obinutuzumab (Gazyvaro) for follicular lymphoma was also not recommended following consideration through PACE. Despite the additional flexibility the PACE process allows, the committee was unable to recommend obintuzumab as there was too much uncertainty in the company’s evidence around the cost benefits compared to the treatment option already available in NHSScotland.

SMC Chairman Dr Alan MacDonald said:

“I am pleased we have been able to accept these four medicines for use by NHSScotland.”

“Evidence from PACE participants showed the significant burden patients with Giant Cell Arteritis have to endure in terms of steroid treatment. Our decision on tocilizumab offers them the chance to reduce that burden and better control their symptoms.”

“For those with severe atopic dermatitis, dupilumab can provide a significant improvement in quality of life for what can be a very distressing condition.”

“Tackling HIV is high on the agenda for Scotland, and the committee’s decisions on dolutegravir / rilpivirine and bictegravir / emtricitabine / tenofovir alafenamide will hopefully be of benefit to patients.”

“Unfortunately the committee was unable to accept pembrolizumab for initial treatment of urothelial cancer as the company’s evidence about the long term benefits and cost effectiveness of the medicine was not clear."

“We were also unable to accept obintuzumab for follicular lymphoma as the evidence provided by the company about the cost effectiveness of the medicine when compared to the current treatment option was not strong enough.”

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