SMC briefing note. The following medicines were accepted for use: Contact details. About SMC. Media contact. Number 98 January 2016

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1 Monthly briefings are produced in order to help members of the media and other interested people understand the work and advice of the Scottish Medicines Consortium. The detailed advice for each medicine that we have assessed in full can be found at Number 98 January 2016 SMC briefing note Scottish Medicines Consortium advice to NHSScotland The following medicines were accepted for use: albiglutide (Eperzan ) dulaglutide (Trulicity ) netupitant/palonosetron (Akynzeo ) sorafenib (Nexavar ) tolvaptan (Jinarc ) About SMC The purpose of the Scottish Medicines Consortium (SMC) is to accept for use those newly licensed medicines that clearly represent good value for money to NHSScotland. SMC analyses information supplied by the medicine's submitting company on the health benefits of the medicine and justification of its price. Because the NHS has limited resources, SMC works to make sure that those medicines which represent good value for money are accepted for routine use as quickly as possible so that they can benefit patients. The Consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry, the public and the Scottish Government. SMC is part of Healthcare Improvement Scotland. Contact details If you are interested in the work of SMC you can visit our website at: or contact us at: Scottish Medicines Consortium Delta House (8th floor) 50 West Nile Street Glasgow G1 2NP smcsecretariat@nhshealthquality.org Media contact Members of the media should contact Caroline Foulkes on

2 SMC looks at how well medicines work in relation to how much they cost this is to make sure that they provide value for money for the NHS by providing extra benefits over current treatments at an additional cost that is reasonable. Medicines which represent good value for money are accepted for routine use to benefit patients. SMC has accepted the following medicines for use in NHSScotland: albiglutide (Eperzan ) What is albiglutide used for? Albiglutide 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 longterm diabetes complications such as heart disease, blindness, stroke and kidney failure. SMC briefing note Albiglutide is one of a class of anti-diabetic medicines called glucagon-like peptide-1 (GLP-1) agonists. GLP-1 agonists lower blood sugar levels by stimulating the release of insulin only when blood sugar levels are raised and not during periods of normal or low blood sugar concentrations. It is injected under the skin once weekly on the same day each week. SMC has accepted albiglutide for restricted use for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control in combination with other glucose-lowering medicinal products when these, together with diet and exercise, do not provide adequate glycaemic control. SMC has restricted albiglutide to use as an alternative once weekly glucagon-like peptide-1 (GLP-1) agonist for use in combination with oral anti-diabetic agents as a third-line pre-insulin treatment option. Studies have shown that adding albiglutide to basal insulin or in combination with other anti-diabetic medicines reduced HbA1c (a measure of how well diabetes is controlled) better than placebo (a dummy medicine containing no active treatment); it was also better than some oral anti-diabetic medicines when used as add-on therapy. An economic analysis compared albiglutide to another GLP-1 agonist that is given once weekly as a third-line, pre-insulin treatment in patients with type 2 diabetes who were uncontrolled on oral antidiabetic medicines. It was found that albiglutide offered value for money for the treatment of this patient group. SMC has accepted albiglutide for restricted use because the balance of costs and benefits meant it was considered to offer value for money. This SMC advice is dependent upon the continuing availability of the PAS 1 or a list price that is equivalent or lower. 1

3 dulaglutide (Trulicity ) What is dulaglutide used for? Dulaglutide is a treatment for type 2 diabetes mellitus. Diabetes mellitus is 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. Dulaglutide is one of a class of anti-diabetic medicines called glucagon-like peptide-1 (GLP- 1) analogues. GLP-1 analogues lower blood sugar levels by stimulating the release of insulin only when blood sugar levels are raised and not during periods of normal or low blood sugar concentrations. It is given by injection under the skin once weekly. SMC has accepted dulaglutide for restricted use for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control as add-on therapy in combination with other glucoselowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. SMC has restricted the use of dulaglutide to part of a triple therapy in patients with inadequate glycaemic control on two oral anti-diabetic medicines, as an alternative glucagon-like peptide 1 (GLP-1) agonist option. SMC has accepted dulaglutide for restricted use for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control as add-on therapy in combination with other glucoselowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. SMC has restricted the use of dulaglutide to part of a triple therapy in patients with inadequate glycaemic control on two oral anti-diabetic medicines, as an alternative glucagon-like peptide 1 (GLP-1) agonist option. SMC has accepted dulaglutide for restricted use because the balance of costs and benefits meant that it was considered to offer value for money.

4 netupitant/palonosetron (Akynzeo ) What is netupitant/palonosetron used for? Netupitant/palonosetron is used to prevent and treat nausea (feeling sick) and vomiting (being sick) as a result of chemotherapy (a type of cancer treatment). Netupitant/palonosetron is a combination of two medicines in one capsule. When chemotherapy is given to treat cancer patients it can release substances in the body which act on receptors in the sickness centres of the brain and gut leading patients to feel sick or be sick. Netupitant blocks NK1 receptors in the brain (which cause delayed nausea and vomiting) and palonosetron blocks 5HT 3 receptors in the gut (which cause acute nausea and vomiting), reducing the sickness. SMC has accepted netupitant/palonosetron for restricted use for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic (vomit inducing) cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. SMC has restricted netupitant/palonosetron to use with highly emetogenic cisplatin-based cancer chemotherapy. A study in patients receiving a first course of cisplatin highly emetogenic chemotherapy showed that treatment with netupitant/palonosetron plus dexamethasone resulted in a higher proportion of patients achieving a complete response (no vomiting and no need for a further anti-sickness medicine) compared with palonosetron plus dexamethasone, An economic analysis compared netupitant/palonosetron with aprepitant plus ondansetron for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based chemotherapy. The analysis found that netupitant/palonosetron offered value for money for the treatment of these patients. SMC has accepted netupitant/palonosetron for restricted use because the balance of costs and benefits meant that it was considered to offer value for money. This SMC advice is dependent upon the continuing availability of the PAS 2 or a list price that is equivalent or lower. 2

5 sorafenib (Nexavar ) What is sorafenib used for? Sorafenib can be used to treat hepatocellular carcinoma (HCC). HCC develops from the main cells of the liver which are called hepatocytes and is the most common type of primary liver cancer. It is diagnosed more frequently in people who have a damaged liver e.g. cirrhosis. Despite this, HCC only affects a small number of patients and is considered a rare disease. Sorafenib is a multi-protein kinase inhibitor. It blocks the activity of protein kinases which are proteins that help cancer cells to grow and spread in various ways including helping them grow new blood vessels. By blocking these proteins sorafenib can slow the growth and spread of the cancer. It is taken as tablets twice a day. SMC has accepted sorafenib for restricted use for the treatment of hepatocellular carcinoma. SMC has restricted use of sorafenib to patients with advanced hepatocellular carcinoma who have failed or are unsuitable for surgical or loco-regional therapies. A study of patients with advanced HCC showed that sorafenib treatment led to an improvement in overall survival time compared with placebo (a dummy medicine with no active treatment). However it did not improve time to symptomatic progression of the cancer. An economic analysis compared sorafenib with best supportive care for the treatment of patients with advanced HCC who had failed or were unsuitable for surgical or loco-regional therapies. There were some limitations with the analysis. However as sorafenib in this setting meets SMC orphan criteria, greater uncertainty in the economic case can be accepted. This advice takes account of the views expressed at a Patient and Clinician Engagement (PACE) 3 Meeting. Participants highlighted that the three month survival benefit seen in the key SHARP trial was considered highly significant for these patients who have a very poor prognosis. Clinicians emphasised that sorafenib is recognised as a standard treatment for advanced HCC in many other countries. Sorafenib also met some of the additional criteria that SMC can take into consideration in reaching a decision (known as modifiers). These were: that it is an orphan medicine (a medicine for a rare condition), that it may offer a substantial improvement in life expectancy in the targeted patient population and that there is an absence of other treatments of proven benefit. After considering all the available evidence, application of the appropriate modifiers and consideration of the output from the PACE meeting, SMC has accepted sorafenib for restricted use because it is an effective treatment that may offer additional patient benefits. This SMC advice is dependent upon the continuing availability of the PAS 4 or a list price that is equivalent or lower. 3 In May 2014, SMC introduced PACE meetings for medicines used at the end of life and for very rare conditions to gather detailed information on the benefits of a medicine, from both patient and clinician perspectives, including how it can impact the quality of a patient s life. This information may not always be fully captured within the conventional assessment process. This evidence is taken into consideration in the SMC decision. More information can be found at PACE/PACE_factsheet_FINAL.pdf 4

6 tolvaptan (Jinarc ) What is tolvaptan used for? Tolvaptan is a treatment for autosomal dominant polycystic kidney disease (ADPKD). ADPKD is an inherited condition where fluid filled cysts grow in the kidney. This puts pressure on the surrounding tissues and prevents the kidneys from working properly eventually leading to kidney failure in many patients. Tolvaptan is a vasopressin antagonist. It blocks the effects of vasopressin which is a hormone involved in helping the kidneys reabsorb water. By blocking vasopressin tolvaptan slows the rate at which the fluid-filled cysts develop in the kidney and increases the volume of urine produced. It is taken as tablets twice a day. SMC has accepted tolvaptan as a treatment to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. A study compared tolvaptan with placebo (a dummy medicine with no active treatment) for the treatment of adult patients with ADPKD who were deemed to be at high risk of disease progression and had relatively preserved renal function. It found that tolvaptan, after 3 years, had slowed the rate of disease progression (as measured by increase in kidney volume) in ADPKD patients. An economic analysis compared tolvaptan with usual care for patients with ADPKD. There were a number of weaknesses and uncertainties in the analysis. However, as tolvaptan meets SMC orphan-equivalent criteria greater uncertainty in the economic case can be accepted. This advice takes account of the views expressed at a Patient and Clinician Engagement (PACE) 5 Meeting. Participants emphasised the importance of tolvaptan as the first medicine to address the underlying cause of ADPKD. Clinicians highlighted that the estimated delay in time to dialysis of 2-6 years would be particularly beneficial for patients and their families. Tolvaptan also met some of the criteria that SMC can take into consideration in reaching a decision (known as modifiers). These were: that it is an orphan-equivalent medicine (a medicine for a rare condition) and that there is an absence of other treatments of proven benefit. After considering all the available evidence, application of the appropriate modifiers and consideration of the output from the PACE meeting, SMC has accepted tolvaptan for use because it is an effective treatment that may offer additional patient benefits. This SMC advice is dependent upon the continuing availability of the PAS 6 or a list price that is equivalent or lower. 5 In May 2014, SMC introduced PACE meetings for medicines used at the end of life and for very rare conditions to gather detailed information on the benefits of a medicine, from both patient and clinician perspectives, including how it can impact the quality of a patient s life. This information may not always be fully captured within the conventional assessment process. This evidence is taken into consideration in the SMC decision. More information can be found at PACE/PACE_factsheet_FINAL.pdf 6

7 For medicines that have not been recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient. SMC has told the submitting company why the medicine was not recommended and would be pleased to receive any resubmission. For further information and to view the complete advice for the medicines listed above, visit our website at: For further information and to view the complete advice for the medicines listed above, visit our website at: