SMC briefing note. The following medicines were accepted for use: The following medicine has not been recommended for use: About SMC.

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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 64 March 2013 SMC briefing note Scottish Medicines Consortium advice to NHSScotland The following medicines were accepted for use: infliximab (Remicade ) ingenol mebutate gel (Picato ) rivaroxaban (Xarelto ) sugammadex (Bridion ) The following medicine has not been recommended for use: bevacizumab (Avastin ) 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 Stephen Ferguson 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. The following medicines were accepted for use in NHSScotland: infliximab (Remicade ) What is infliximab used for? Infliximab is an anti-inflammatory medicine that can be used in the treatment of several conditions. In this submission it has been proposed as a treatment for ulcerative colitis in patients aged between 6 and 17 years with severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments. Ulcerative colitis is a form of inflammatory bowel disease affecting the large intestine (an organ that absorbs water from material passing from the small intestine). The condition causes the large intestine to become inflamed, and ulcers (large sores) develop on the lining of the intestine which can bleed and produce pus. Symptoms of active ulcerative colitis include bloody diarrhoea, stomach pain, increased frequency of bowel movements and weight loss. It is a long-term condition, with flareups of symptoms and then periods of remission (symptom-free periods). SMC briefing note Infliximab is licensed for use in both induction and maintenance treatment of severely active ulcerative colitis. However, the submitting company requested that SMC considers infliximab when positioned for use as a rescue therapy in acutely ill patients as an alternative to ciclosporin in patients who do not respond to treatment with steroids. Induction treatment involves the use of three doses only. Infliximab is an immunomodulator (a substance that modifies the immune system) and is one of a group of drugs called monoclonal antibodies. It is used when standard treatments do not control symptoms and acts by blocking TNF-alpha, one of the substances that cause the inflammation. Infliximab is an infusion given by a drip which is repeated 2 and 6 weeks after the first dose, then every 8 weeks. SMC accepted infliximab for the treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or when there are reasons why the conventional therapy may not be used. It is restricted to use as an alternative to one of the commonly used medicines, ciclosporin, in patients with acute, severe paediatric ulcerative colitis (rescue therapy) who do not respond to treatment with steroids. One small study in 60 children showed that 73% of patients responded to treatment with infliximab at week eight and 40% achieved clinical remission. Some weaknesses in the clinical evidence presented lead to uncertainty about the extent of treatment benefits. On balance, however, infliximab was considered to offer value for money as an acute treatment. SMC accepted infliximab for restricted use because it provides the first licensed treatment for this group of patients and as a medical rescue therapy it may be a valuable alternative to surgery in some patients.

3 SMC briefing note ingenol mebutate gel (Picato ) What is ingenol mebutate used for? Ingenol mebutate is proposed as a treatment for actinic keratoses, which are small crusty, scaly or crumbly patches of skin which commonly occur in people that have had a lot of sun exposure. The lesions may be red, light brown or skin-coloured, and dry or rough to touch. Ingenol mebutate is a gel used to treat actinic keratoses on the face and scalp. It is not yet fully understood how the medicine works. It is thought to have a toxic effect on the skin lesions as well as promoting an inflammatory response. Together, these actions lead to the death of the cells affected by actinic keratosis. It is applied to the affected area once daily. The duration of treatment is limited to 2 or 3 consecutive days depending on the dose. SMC accepted ingenol mebutate for cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. Four studies showed that a higher proportion of patients treated with ingenol mebutate achieved complete clearance of actinic keratosis compared with a dummy gel containing no active treatment. An economic analysis compared ingenol mebutate with a range of other treatments. The length of treatment required with ingenol mebutate is much shorter than for other treatments which is beneficial to patients and may improve compliance. SMC accepted ingenol mebutate for use because the balance of costs and benefits meant that it was considered to offer value for money.

4 SMC briefing note rivaroxaban (Xarelto ) What is rivaroxaban used for? Rivaroxaban can be used to prevent and treat a range of conditions associated with abnormal blood clotting including deep vein thrombosis (DVT), which is a blood clot that forms in a vein in the legs. Blood flow can be restricted around the clot and may cause pain and swelling. There is a risk that all or part of the clot breaks off and is transported through the venous system to become lodged in the lungs where it forms a clot known as a pulmonary embolism (PE), which can be fatal. Rivaroxaban can also be used to treat and prevent recurrence of PE. SMC has previously accepted rivaroxaban for the treatment of venous thromboembolism (VTE) in hip and knee surgery; the prevention of stroke and systemic embolism in non-valvular atrial fibrillation in adults with one or more risk factors; and the treatment of DVT and prevention of recurrent DVT and pulmonary embolism (PE). This submission relates to the use of rivaroxaban to treat PE and to prevent recurrent DVT and PE in adults. Rivaroxaban is a blood-thinning medicine (anticoagulant) used to prevent harmful blood clots. It works by blocking Factor Xa, which is an important component of blood clotting. In this indication it is given as a 15 mg tablet twice daily for the first 3 weeks, then as 20 mg once daily for the duration of therapy. SMC accepted rivaroxaban for treatment of PE, and prevention of recurrent DVT and PE in adults. Two large studies showed that rivaroxaban was as effective as a regimen for the treatment of PE and the prevention of recurrence of DVT or PE. An economic analysis compared rivaroxaban with other anticoagulants. Although there were some limitations with the analysis, it suggested that rivaroxaban could be as effective as other anticoagulants at a reduced cost. SMC accepted rivaroxaban for use because the balance of costs and benefits meant that it was considered to offer value for money.

5 SMC briefing note sugammadex (Bridion ) What is sugammadex used for? During surgery, patients are often given neuromuscular blocking drugs (NMDs), or muscle relaxants, to relax their muscles, including the muscles that help the patient to breathe. This makes it easier for the surgeon to do the operation. This effect usually requires to be reversed at the end of surgery. Sugammadex is a medicine which is proposed for use to speed up the recovery from two muscle relaxants, rocuronium and vecuronium. In this submission it has been proposed for use in the routine reversal of profound neuromuscular blockade. SMC previously accepted sugammadex for restricted use for immediate reversal of neuromuscular block by rocuronium in adults. Sugammadex binds to the muscle relaxant, forming a complex that inactivates the muscle relaxants and stops them having an effect. As a result, the effect of blockade of the muscles due to rocuronium and vecuronium is reversed, and the muscles begin to work normally again. It is given by injection and should only be administered by, or under the supervision of, an anaesthetist. SMC accepted sugammadex for restricted use in the routine reversal of neuromuscular blockade induced by rocuronium or vecuronium in high-risk patients (eg those with morbid obesity, respiratory problems, significant heart disease, or following major abdominal/chest surgery) or where prompt reversal of neuromuscular block is required. Three studies have shown that sugammadex reverses the shallow and deep neuromuscular blocking effects of rocuronium and vecuronium more quickly than another medicine commonly used for this purpose. An economic analysis compared sugammadex with another medicine commonly used to reverse neuromuscular block. The company proposed that sugammadex could lead to cost savings because the more rapid action of sugammadex would lead to a quicker recovery time for the patient and decrease time in surgery. SMC clinical experts were uncertain about this assumption as other factors can influence the time that patients spend in surgery, but acknowledged that it could be useful in high-risk cases. SMC accepted sugammadex for restricted use because the balance of costs and benefits meant that it was considered to offer value for money.

6 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 NHSScotland. SMC has not recommended the following medicine for use in NHSScotland: bevacizumab (Avastin ) What is bevacizumab used for? Bevacizumab is used to treat a range of different types of cancer. In this submission it has been proposed as a treatment, when given in combination with carboplatin and gemcitabine, for women with a first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer. These women should not have received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Ovarian cancer is the fifth most common cause of death from cancer in women. Cancer of the ovaries (female reproductive organs) commonly starts in cells of the surface lining the ovaries called the epithelium and this type is known as epithelial ovarian cancer. Cancer can also affect other parts of the female reproductive system such as the fallopian tubes (tubes that link the ovaries to the womb). Cancer occurring in the lining of the abdomen (peritoneum) is known as primary peritoneal cancer and this rare cancer behaves in a similar way to epithelial ovarian cancer. SMC briefing note Cancer chemotherapy is given to try and kill cancer cells or stop them spreading further. Bevacizumab is given in combination with other cancer chemotherapy medicines. This medicine helps block the growth of new blood vessels that supply the cancer cells with nutrients. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours. Bevacizumab is given once every 3 weeks as an infusion (via a drip). SMC did not recommend bevacizumab, in combination with carboplatin and gemcitabine, for treatment of adult patients with first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents. The indication for recurrent platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer, under consideration in this submission, is an extension to the marketing authorisation for bevacizumab. In a study, patients with recurrent ovarian cancer receiving bevacizumab plus carboplatin and gemcitabine survived without cancer progression for 4 months longer compared with those receiving only carboplatin and gemcitabine. However, there is uncertainty around the difference that bevacizumab makes to overall survival. An economic analysis compared carboplatin and gemcitabine with the same combination plus bevacizumab. The main limitation of the analysis was that the cost in relation to the health benefit was significantly above the threshold normally accepted by SMC. SMC did not recommend bevacizumab for use because the balance of costs and benefits meant that it was not considered to offer value for money. 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: