May 2022 decisions news release

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday May 9) published advice on eight new medicines.

Two of the medicines accepted, pembrolizumab (Keytruda) and nivolumab (Opdivo), are for the treatment of oesophageal cancer – a cancer of the gullet which is the muscular tube that food passes through from the mouth to the stomach.  Patients are often diagnosed late and symptoms include bleeding, pain, life changing dysphagia (difficulty swallowing), weight loss, hoarseness, cough and feelings of persistent heartburn and indigestion.  Pembrolizumab and nivolumab are immunotherapies, a type of cancer treatment that stimulates the immune system to fight the cancer. 

Pembrolizumab was considered through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions.  In the PACE meeting, participants spoke of the importance of the survival benefit with this treatment option and the positive impact that it may have on quality of life and wellbeing, potentially allowing patients to live independently for longer.  Pembrolizumab is given in combination with chemotherapy to patients who are unable to have surgery.

Nivolumab is used in patients after surgery, where some cancer has remained despite initial treatment with chemotherapy and radiotherapy.  The risk of disease recurrence is high in these patients and nivolumab is expected to reduce this risk.

Venetoclax (Venclyxto) was accepted for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).  Patients begin to receive treatment when disease-related symptoms are present, such as large and painful lymph nodes or reductions in their red blood cell or platelet counts, which can lead to substantial fatigue and difficulties carrying out daily activities.  They may not be able to work or participate fully in family and social activities and have an increased risk of infection.  The incurable nature of the condition can cause anxiety and the reduction in quality of life may lead to mental health issues.  Venetoclax, given in combination with obinutuzumab, offers an additional treatment option that is relatively well tolerated.

Dapagliflozin (Forxiga) was accepted for the treatment of adults with chronic kidney disease (CKD), a long-term condition where the kidneys don’t work as well as they should.  CKD is a life-threatening, complicated disease where kidney function gradually declines over time, eventually leading to kidney failure, also known as end-stage kidney disease.  Symptoms can include tiredness, swollen ankles and shortness of breath and patients living with the disease are at an increased risk of cardiovascular events (an incident that causes damage to the heart muscle such as a heart attack or stroke).  Dapagliflozin is an add-on treatment given in tablet form and can reduce the risk of patients reaching end-stage kidney disease. 

Oritavancin (Tenkasi) is an antibiotic and was accepted for the treatment of acute (short-term) bacterial skin infections and infections of the structures beneath the skin.  This includes conditions such as cellulitis, skin abscesses and wound infections.  Oritavancin can be used to treat antibiotic resistant infections like MRSA which standard antibiotics don’t work against.

Liraglutide (Saxenda) was accepted for weight management in adults and is used alongside diet and exercise to help people lose weight.  It is used in patients who are obese and have additional health problems related to being overweight, such as raised blood sugars, blood pressure or cholesterol.  It is thought that liraglutide acts on receptors in the brain to help control appetite.  This may lead to increased feelings of fullness and reduce feelings of hunger, helping a person to eat less and contribute to weight loss.

The committee was unable to accept ropeginterferon (Besremi) for the treatment of polycythaemia vera, a rare and incurable cancer where too many red blood cells are produced by the body.  Ropeginterferon was not recommended as the company’s evidence around the clinical and cost effectiveness of the treatment compared to currently available options was not sufficient.

The committee was also unable to accept daratumumab (Darzalex) when used as part of a combination regimen, for the treatment of newly diagnosed myeloma, a cancer of plasma cells in the bone marrow.  The evidence provided by the company for daratumamab in this combination was not strong enough to satisfy the committee that it offers value for money to NHSScotland.

SMC chairman Mark MacGregor said:

“The committee is pleased to be able to accept six medicines for use by NHSScotland.”

“Patients living with oesophageal cancer often receive their diagnosis late, having a huge impact on the patient and their family.  The availability of pembrolizumab and nivolumab could improve outcomes for patients living with this condition.”

“For those with CLL, venetoclax offers another treatment option which may enable patients to continue to work and take part in family life.”

“Dapagliflozin can delay disease progression for patients with CKD and may reduce the risk of patients reaching end-stage kidney disease.”

“We know that antibiotic resistance is of increasing concern and the availability of another antibiotic, oritavancin, will be welcomed.”

“Obesity is a serious public health issue in Scotland.  Used alongside diet and exercise, liraglutide could assist carefully selected patients in their weight loss journey.”

“The committee was unable to accept ropeginterferon as the evidence provided by the company on the clinical and cost effectiveness of the treatment when compared to current treatments was not sufficient.”

“We were also unable to accept daratumumab as the evidence provided by the company on the benefits of using this medicine was not strong enough to justify its cost.”

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