Four Medicines Approved for NHS Scotland

Peter Russell

September 13, 2018

Four new medicines have been approved this month for NHS use in Scotland, the Scottish Medicines Consortium (SMC) has announced.

It said two of the medicines were accepted through the SMC's Patient and Clinician Engagement (PACE) process, used to evaluate medicines for treating end of life and very rare conditions.

Two medicines were rejected for use by NHS Scotland.

Giant Cell Arteritis

The SMC accepted tocilizumab (RoActemra, Roche) for the treatment of Giant Cell Arteritis (GCA) in adults.

GCA is a rare condition in which blood vessels, usually in the head, become inflamed.

Current treatment involves high doses of steroids given over a prolonged period of time, which may give rise to serious side effects.

Evaluation of tocilizumab was subject to a PACE review in which patients and doctors explained how symptoms including severe headache, scalp tenderness, jaw discomfort, and temporary and permanent sight loss, lead to reduced quality of life and a higher risk of falls, and reduced mobility.

The SMC accepted that tocilizumab may reduce the amount of steroids required for treatment and better control symptoms.

Atopic Dermatitis

Dupilumab (Dupixent, Sanofi), an injectable medicine for adult patients with uncontrolled, moderate-to-severe atopic dermatitis, also known as atopic eczema, was approved for NHS Scotland use.

The drug has been shown to improve symptoms and improve quality of life. The SMC said it was a viable alternative to current treatments that were often time-consuming and dependent on frequent visits to dermatology clinics.

Dupilumab was recommended following a PACE review in which patients and clinicians described the extreme itching and painful skin caused by the condition.


The SMC approved dolutegravir/rilpivirine (Juluca, ViiV Healthcare) as the first dual therapy treatment for HIV.

It said that dolutegravir/rilpivirine offered the benefit of being a small, easier to swallow tablet than existing treatments.

Advice was subject to the continuing availability of the drug via a Patient Access Scheme (PAS) in NHS Scotland, or a list price that was equivalent or lower.

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

The SMC said it took account of a PAS that made the drug more affordable.

Urothelial Cancer

The SMC did not approve pembrolizumab (Keytruda, Merck) for the initial treatment of urothelial cancer that is advanced or has spread to other parts of the body, in patients who are unsuitable for chemotherapy.

Dr Alan MacDonald, the SMC's chairman, said: "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."

The decision took account of the views from a PACE meeting, the SMC said.

Follicular Lymphoma

The SMC said it was unable to approve obinutuzumab (Gazyvaro, Roche) in combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.

Dr MacDonald said it was unable to recommend obinutuzumab because "evidence provided by the company about the cost effectiveness of the medicine when compared to the current treatment option was not strong enough".

An evaluation via the PACE process was not sufficient to overturn the decision, the SMC said.

The PACE Process

PACE meetings were established in Scotland in 2014 after the Scottish Government recognised that existing cost-effectiveness thresholds were not always appropriate for end of life medicines or for medicines to treat very rare conditions.

As a result, the SMC asks pharmaceutical companies to state whether their submission for approval could be considered an end of life, orphan, or ultra-orphan medicine, and to provide supporting evidence.

An ultra-orphan medicine is defined as a medicine used to treat a condition with a prevalence of one in 50,000, or less, of the population – approximately 100 people in Scotland.


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