September 2015 decisions news release
The Scottish Medicines Consortium (SMC) has today published advice accepting seven new medicines for use in NHSScotland.
Two of these medicines, bevacizumab (Avastin) for ovarian cancer and pasireotide (Signifor) for acromegaly (a condition where the body produces too much growth hormone) were considered under SMC’s PACE (Patient and Clinician Engagement) process, which aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.
SMC was unable to recommend another medicine considered through the PACE process, elosulfase alfa (Vimizim) for the treatment of Morquio A syndrome, an inherited metabolic disease. Avanafil (Spedra) for erectile dysfunction was also not recommended.
Bevacizumab is used in combination with chemotherapy to treat ovarian cancer. During the PACE meeting, patient groups and clinicians highlighted that a diagnosis of ovarian cancer has a significant impact on the lives of women and their families and current treatment options are limited. Bevacizumab was also considered under SMC’s decision making process for medicines to treat very rare (ultra orphan) conditions. The committee was also able to apply the SMC’s modifying criterion relating to quality of life, as it may be substantially improved by bevacizumab.
Pasireotide (Signifor) is used to treat acromegaly, a rare condition usually caused by a non-cancerous tumour on the pituitary gland. Pasireotide was also considered under the ultra orphan decision-making process. Through the PACE process, patient groups stated that for patients who do not respond to conventional therapies, pasireotide offers a further treatment option.
Bortezomib (Velcade) may now be used to treat mantle cell lymphoma, a rare and aggressive blood cancer, in untreated adults who cannot have blood stem-cell transplantation. Bortezomib offers patients who currently have limited treatment options a potential improvement in both life expectancy and quality of life.
Ledipasvir-sofosbuvir (Harvoni) was accepted for use in the treatment of a particular type of chronic hepatitis C (CHC) known as genotype 3. There are currently very few treatment options for genotype 3 CHC and ledipasvir-sofosbuvir may offer the prospect of cure for many patients. SMC has previously accepted ledipasvir-sofosbuvir for the treatment of CHC caused by genotypes 1 and 4.
Aflibercept (Eylea) is used to treat impaired vision caused by macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO). The condition damages the central vision that is needed to see for everyday tasks such as driving, reading and recognising faces. Aflibercept offers another treatment option for patients who may not respond to or cannot be treated with current treatments.
Sitagliptin (Januvia) can be used in combination with insulin to help control type-2 diabetes in patients who are not satisfactorily controlled on insulin alone. A patient group submission from Diabetes Scotland stated that sitagliptin offers an alternative treatment option which may help self-management of diabetes.
Also accepted was lisdexamfetamine dimesylate (Elvanse Adult), which is used as part of a programme of treatment for adults with ADHD (attention deficit hyperactivity disorder) that is at least moderately severe. As the medicine is taken as a once daily tablet, it can make it easier for patients and their carers to manage and monitor treatment.
The committee was unable to recommend elosulfase alfa for Morquio A syndrome as considerable weaknesses in the company’s economic case raised uncertainties around the longer-term clinical benefits of the treatment in relation to its cost. Morquio A (also known as mucopolysaccharidosis type IVA) is an inherited disease affecting a very small number of patients. People with Morquio A don’t have enough of an enzyme (a kind of protein) needed to break down long chains of sugar molecules called glycosaminoglycans (GAGs). GAGS then build up in bones and organs, creating signs of the disease including short bones, difficulty moving and breathing, clouding of the eyes and hearing loss. Elosulfase alfa was considered through the PACE process and as an ultra-orphan medicine.
Also not recommended was avanafil (Spedra), another treatment option for men with erectile dysfunction, as SMC did not consider it to offer value for money.
Professor Jonathan Fox, chairman of SMC, said:
“The committee is pleased to be able to accept these medicines for routine use by NHS Scotland, two of which were considered through our PACE process. We know that patients will welcome the advice on bevacizumab for ovarian cancer and pasireotide for acromegaly. This brings the number of medicines so far accepted under the PACE process to 19, and a year on from our first PACE meeting, we are confident that patients and clinicians are seeing the benefits of increased access to effective new medicines.
“We are disappointed not to be able to recommend elosulfase alfa for routine use. Patient groups and clinicians at PACE gave a powerful testimony about the impact of this condition. While elosulfase alfa has the potential to improve quality of life in the short term, the case presented by the company was not robust enough to convince the committee about the longer-term benefits when balanced against its extremely high cost. While PACE was designed to increase access to medicines for these kinds of conditions, our responsibility is to consider whether individual medicines offer value for money to the NHS in Scotland, and take account of all those patients who need treatment, not just those affected by the medicine under consideration.”