The Scottish Medicines Consortium (SMC) looks at how well medicines work in relation to how much they cost to make sure they provide value for money by providing extra benefits over current treatments at an additional cost that is reasonable. Medicines that represent good value for money are accepted for routine use to benefit patients.
The SMC accepted the following medicines for use in NHSScotland:
The Scottish Medicines Consortium (SMC) looks at how well medicines work in relation to how much they cost to make sure they provide value for money by providing extra benefits over current treatments at an additional cost that is reasonable. Medicines that represent good value for money are accepted for routine use to benefit patients.
The SMC accepted the following medicines for use in NHSScotland:
Canagliflozin (Invokana)
What is canagliflozin used for?
Canagliflozin is a treatment for type 2 diabetes mellitus, a condition in which there is too much sugar present in the blood. Type 2 diabetes develops when the body does not make enough insulin (a hormone which helps sugar to be used by the body) or the insulin that is produced does not work properly. Keeping blood sugar levels as near to normal as possible reduces the risk of long-term diabetes complications such as heart disease, blindness, stroke and kidney failure.
How does it work?
Canagliflozin blocks a salt-sugar transporter in the kidney and removes excess blood sugar in the urine. It is taken as a tablet once daily, before the first meal of the day.
What has the SMC advised?
SMC accepted canagliflozin for restricted use for the treatment of adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on therapy with other glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Canagliflozin is restricted for use in the following situations:
• dual therapy in combination with metformin
• triple therapy in combination with metformin plus standard care
• add-on to insulin therapy in combination with insulin plus standard care.
What is the evidence to support this advice?
The submitting company requested that SMC considered the use of canagliflozin as:
• dual therapy in combination with metformin
• triple therapy in combination with metformin plus standard care
• add-on to insulin therapy in combination with insulin plus standard care.
Studies showed that treatment with canagliflozin reduces glycosylated haemoglobin (HbA1c) (a measure of blood sugar control) significantly more than placebo (a dummy medicine containing no active treatment) when used in combination with various anti-hyperglycaemic regimens (metformin, metformin and sulfonylurea, metformin and pioglitazone, insulin with/without additional anti-hyperglycaemic agents). In addition to metformin, canagliflozin was as effective as a sulfonylurea and a dipeptidyl peptidase-4 (DPP-4) inhibitor. In combination with metformin and sulfonylurea, canagliflozin was as effective as a DPP-4 inhibitor. Canagliflozin is also associated with reductions in body weight and systolic blood pressure.
Economic analyses compared canaglifozin with several alternative treatment options.
SMC accepted canagliflozin for restricted use because the balance of costs and benefits meant it was considered to offer value for money.
Defibrotide (Defitelio)
What is defibrotide used for?
Defibrotide is used to treat severe hepatic veno occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), which is a condition in which some of the veins in the liver are blocked. It is a rare, potentially life-threatening, complication of high-dose chemotherapy that usually occurs very early in the course of haematopoietic stem-cell transplantation (HSCT).
How does it work?
Defibrotide is given as an infusion for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve. It is not completely understood how the medicine works.
What has the SMC advised?
SMC accepted defibrotide for the treatment of severe hepatic VOD in HSCT therapy.
What is the evidence to support this advice?
• A study showed that defibrotide was associated with improved complete response rate (defined as the level of bilirubin [a waste product of red blood cells breakdown] below a certain threshold and resolution of multi-organ failure) and survival in patients with severe VOD, compared with a historical control group (a group of patients who were observed at some time in the past).
• This SMC advice takes account of the benefits of a patient access scheme (PAS). A PAS is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and thus enable patients to receive access to new medicines that may otherwise not have been judged to be a cost-effective use of NHS resources. The proposed PAS gives a discount on the price of the medicine.
• An economic analysis compared defibrotide with best supportive care. There were some limitations with the analysis but allowances were made because the medicine is for a rare disease for which there are limited treatment options (this is known as ‘orphan status’) and expected benefits of the treatment outweighed its relatively high cost.
SMC accepted defibrotide for use in NHSScotland because it satisfied a number of factors that the SMC can take into account about the balance of costs and benefits of medicines; these were that it has orphan status and offered substantial improvement in life expectancy. This SMC advice depends upon the continuing availability of the PAS or an equivalent or lower list price in NHS Scotland.
Fluticasone furoate/vilanterol (Relvar Ellipta)
What is fluticasone furoate/vilanterol used for?
Fluticasone furoate vilanterol is a combination preparation for the treatment of asthma, which is a long-term lung condition in which the airways are inflamed and narrowed, making it harder to breathe normally. Symptoms can include wheeze, cough, chest tightness and shortness of breath and severity can vary. Measuring the maximum amount of air that a person can force out of their lungs in 1 second can indicate if a person has asthma and how severe the condition is. This is termed the forced expiratory volume (FEV) and is usually expressed as a percentage of the volume that would be predicted for a patient of that age.
How does it work?
Medicines that help to improve symptoms and control asthma include bronchodilators to expand the airways and corticosteroids to reduce inflammation. Fluticasone furoate/vilanterol is a combination inhaler of fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting
beta2 agonist, which open the airways and increase air supply to the lungs. It is inhaled once daily.
What has SMC advised?
SMC accepted fluticasone furoate/vilanterol for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2 agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting beta2-agonists.
What is the evidence to support this advice?
• A study showed that there is no difference between fluticasone furoate/vilanterol and another alternative inhaled corticosteroid/long acting beta2 agonist combination inhaler for change in one measure of lung function at 24 weeks.
• An economic analysis compared fluticasone furoate/vilanterol with a number of inhaled corticosteroid/long acting beta2 agonist combination comparators and showed that fluticasone furoate/vilanterol offered cost savings but some alternative combination inhalers are available at a lower daily cost.
SMC has accepted fluticasone furoate/vilanterol because the balance of costs and benefits meant that it was considered to offer value for money and the once daily dose could improve patient compliance.
Sofosbuvir (Sovaldi)
What is sofosbuvir used for?
Sofosbuvir is a treatment for chronic hepatitis C (CHC), which is an infection caused by a virus that is transmitted by infected blood and causes inflammation and damage to the liver. There are six distinct genotypes of hepatitis C worldwide. A genotype is a classification of a virus based on the genetic material. At the onset of hepatitis C (acute phase), some people have no symptoms or only mild symptoms including muscle ache, tiredness, nausea, joint pain and loss of appetite, and they clear the infection naturally. However, some people cannot clear the virus and it remains active in the liver and bloodstream long term (this is known as a chronic hepatitis C infection).
While some people with a chronic infection remain free of symptoms and well throughout life, some develop cirrhosis (scarring of the liver) after many years of infection, and a few develop liver cancer. Treatment of chronic hepatitis C infection aims at eliminating the virus and consequently preventing cirrhosis and its complications.
How does it work?
Sofosbuvir is the first medicine in a new class and stops the virus from multiplying. It can be used to treat all genotypes of hepatitis C. It must be given in combination with ribavirin or peginterferon plus ribavirin. Sofosbuvir is taken as a tablet, taken orally, once daily with food.
What has the SMC advised?
SMC accepted sofosbuvir for restricted use in patients with genotypes 1 to 6. Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa. Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
What is the evidence to support this advice?
• Studies showed that sofosbuvir in combination with ribavirin, or peginterferon plus ribavirin, produced sustained virological suppression (defined as virus levels below a certain threshold) in patients with all genotypes of hepatitis C.
• The submitting company presented economic analyses comparing various sofosbuvir regimens in different patient populations according to genotype, previous treatments and suitability for interferon treatment. For many of the patient populations, the medicine was considered to offer value for money. SMC can use a number of factors in their decision-making – for the genotype 1 patients who were treatment naive and unsuitable for interferon-based treatments, the committee considered that in the absence of other treatment options, the relatively high cost was acceptable for this group given the expected benefits of the treatment.
SMC accepted sofosbuvir for restricted use because it is effective and is the first medicine licensed for use in interferon-free regimens, offering improved tolerability among patients who are unable to receive interferon thereby addressing an unmet treatment need.
SMC looks at how well medicines work in relation to how much they cost. Sometimes, when SMC considers the information submitted for a medicine, the committee is not convinced by the health benefit claims made by the company. On other occasions, the health benefits do not justify the cost of the medicine, or the company does not provide appropriate evidence to give SMC assurance that the medicine offers value for money. In any of these circumstances, SMC is unable to recommend that medicine for routine use in NHS Scotland.
SMC has not recommended the following medicine for use in NHSScotland.
Paclitaxel albumin (Abraxane)
What is paclitaxel albumin used for?
Paclitaxel albumin is a medicine for the treatment of adenocarcinoma of the pancreas, which is a cancer that starts in the cells of the pancreas. The pancreas makes a fluid that contains enzymes (chemicals) that are needed to digest food. In metastatic adenocarcinoma, the cancer cells have spread to other parts of the body. SMC has previously accepted paclitaxel albumin for restricted use within NHS Scotland for the treatment of metastatic breast cancer.
How does it work?
Paclitaxel albumin works by stabilising structures within cancerous cells. This prevents the cancer cells from replicating and leads to their eventual death. It is given by infusion, in combination with gemcitabine, over 30 minutes on days 1, 8 and 15 of each 28-day cycle of treatment. It is given in a formulation that is not solvent based and therefore avoids solvent-related side effects.
What has SMC advised?
SMC did not recommend paclitaxel albumin in combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
What is the evidence to support this advice?
• A study showed that paclitaxel albumin plus gemcitabine treatment improved overall survival by 1.8 months compared with gemcitabine alone.
• An economic analysis compared paclitaxel albumin plus gemcitabine with gemcitabine alone. SMC can use a number of factors in its decision-making and although they agreed that the medicine offered a substantial improvement in life expectancy, the cost-effectiveness of the medicine was above the threshold that is normally accepted.
SMC did not recommend paclitaxel albumin for use because the balance of costs and benefits meant that it was not considered to offer value for money.
