pharmatimesNovember 27, 2018
Tag: Gazyvaro , SMC , Dupixent
The Scottish Medicines Consortium has cleared funds for use of four new medicines by NHS Scotland, including Sanofi’s biologic Dupixent for dermatitis.
Dupixent (dupilumab) is the first biologic drug made available routinely from NHS Scotland for the treatment of moderate to severe atopic dermatitis in adults who have had inadequate response to, or are considered unsuitable for treatment with, existing systemic immunosuppressants.
During the SMC’s PACE process, patients and clinicians said symptoms of the condition can have a significant impact on quality of life, and that current treatment options are limited "and often time consuming, involving the repeated application of topical treatments, bandages and frequent attendance at dermatology clinics".
Dupixent, 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, the cost watchdog noted.
The therapy "offers people with a more severe form of atopic eczema a much needed new treatment option in a disease area where therapies have been limited," noted Andrew Proctor, chief executive of the patient charity National Eczema Society.
The SMC also endorsed Roche/Chugai’s RoActemra (tocilizumab)for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Almost 15,000 patients develop GCA in the UK every year. The condition is a potentially life-threatening form of vasculitis that results in inflammation of blood vessels, which can be difficult to diagnose because of its wide range of symptoms, including severe headaches, scalp tenderness and jaw pain. If left untreated it can lead to blindness, aortic aneurysm or stroke.
To date, management of GCA has been limited to long-term high-dose steroids, but this can cause skin problems and weight gain, as well as diabetes and osteoporosis in the long-term. There have been no treatment advances for GCA for nearly 60 years.
RoActemra is an anti-IL-6 receptor licensed for the treatment of adult patients with moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older, and for the treatment of GCA in adults.
Clinical trial results show that after having RoActemra plus a tapering course of glucocorticoids for one year, more people stay in remission and need lower doses of glucocorticoids compared with people having glucocorticoids alone.
Elsewhere, NHS funding was approved for ViiV Heathcare’s Juluca (dolutegravir/rilpivirine), the first dual therapy treatment for HIV. "As a smaller, easier to swallow tablet, dolutegravir/rilpivirine offers a further maintenance treatment which may benefit some patients," the SMC noted.
Also for HIV, NHS Scotland can now routinely prescribe Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for the treatment of HIV, offering a new combination therapy for patients with the condition.
On the downside, the committee was unable to accept MSD’s Keytruda (pembrolizumab) for first-line treatment of urothelial cancer "due to uncertainties in the company’s evidence about both the long-term benefits of the medicine and its cost effectiveness," nor Roche’s Gazyvaro (obinutuzumab) for follicular lymphoma, "as there was too much uncertainty in the company’s evidence around the cost benefits compared to the treatment option already available in NHS Scotland."
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