August 2022 decisions news release
The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday August 8) published advice on five new medicines.
Atezolizumab (Tecentriq®) was accepted for use in some adult patients with non-small cell lung cancer. It is used to help prevent the cancer coming back after it has successfully been removed by surgery. Lung cancer is the most common type of cancer in Scotland and around 80% to 85% of cases are non-small cell lung cancer. Patients suffer breathlessness, weight loss, fatigue and chest pain. Atezolizumab is one of the first targeted treatments that can be used for patients after successful surgery. It helps the immune system to fight the cancer and may prolong the time until the condition progresses.
The committee accepted the orphan medicine, daratumumab (Darzalex®) through the Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. Daratumumab is for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This rare, complex disease causes proteins in the body to bind together and form deposits in organs. The build-up of amyloid deposits in the body can cause progressive organ failure affecting the kidneys, heart and nerves. The addition of daratumumab to current standard treatment may help to reduce harmful proteins in the blood. A PACE meeting with patient group representatives and clinical specialists highlighted a significant unmet need as there are currently no licensed treatments approved for the treatment of AL amyloidosis in Scotland. Patients often present late with a high symptom burden and significant frailty which can make the condition difficult to treat.
Roxadustat (Evrenzo®) was accepted for the treatment of symptomatic anaemia due to chronic kidney disease (CKD), in adult patients who are non-dialysis dependent at the time of treatment initiation. People with CKD often have anaemia, where they have low levels of haemoglobin or too few red blood cells in the blood. Roxadustat is the first in a new class of medicines that may offer another treatment option for symptomatic anaemia in patients with CKD.
Potassium citrate and potassium hydrogen carbonate (Sibnayal®) was accepted for the treatment of people with distal renal tubular acidosis (dRTA). This is a rare condition where the kidneys do not remove acid through the urine properly causing it to build up in the blood. In the PACE meeting participants highlighted that this disease can affect growth and development causing failure to thrive in children, weakness, bone pain and poor bone growth. If left untreated it can also cause significant renal stone disease, particularly in adults, which can affect renal function. The combined long-acting formulation of potassium citrate and potassium hydrogen carbonate has a reduced dosing frequency and it may be more palatable than current treatment. This could lead to improved compliance for some patients and is expected to improve tolerability.
The committee was unable to accept remimazolam (Byfavo®), a sedative that can be given before some medical procedures such as colonoscopy and bronchoscopy. There was uncertainty around its cost effectiveness compared to other options currently available for procedural sedation.
SMC chairman Mark MacGregor said:
“I am pleased we were able to accept these medicines for use by NHSScotland."
“Atezolizumab is a targeted treatment that may delay lung cancer recurrence in some patients. Improved quality of life, symptom management and even small extensions in duration of life are of considerable importance to patients and families."
“The addition of daratumumab for AL Amyloidosis may reduce symptom burden and improve quality of life for patients and in turn reduce the caring responsibilities for family and carers."
“Roxadustat will offer another treatment option for patients with anaemia in CKD with the added flexibility of being an oral treatment."
“The consequences of poorly controlled dRTA can be serious and we hope this new formulation will help some patients manage their condition better.”