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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Hugh Freeman
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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 66 May 2013 Scottish Medicines Consortium advice to NHSScotland The following medicines were accepted for use: lisdexamfetamine dimesylate (Elvanse ) mirabegron (Betmiga ) ranibizumab (Lucentis ) The following medicine has not been recommended for use: crizotinib (Xalkori ) 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: lisdexamfetamine dimesylate (Elvanse ) What is lisdexamfetamine used for? Lisdexamfetamine is used as part of a comprehensive treatment programme for attention deficit hyperactivity disorder (ADHD) when the response to previous methylphenidate treatment has been inadequate. ADHD is one of the most commonly diagnosed behavioural disorders among children and adolescents. Symptoms of the disorder include inappropriate levels of activity and impulsiveness, with difficulty concentrating and paying attention. Lisdexamfetamine is converted in the body to an active substance called dexamfetamine and increases the activity of some chemicals in the brain. It is not yet fully understood how this helps to improve symptoms of ADHD. It is given as a capsule once a day. SMC accepted lisdexamfetamine as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. A study has shown that lisdexamfetamine was associated with a shorter time to first response in improvement in function compared with another commonly used medicine. A greater proportion of lisdexamfetamine -treated patients achieved improvements in symptom scores and functioning compared with the other medicine. An economic analysis compared lisdexamfetamine with another commonly used medicine. There were some uncertainties in the analysis but SMC was satisfied that these did not significantly influence the results. SMC accepted lisdexamfetamine for use because the balance of costs and benefits meant that it was

3 mirabegron (Betmiga ) What is mirabegron used for? Mirabegron is a treatment for the symptoms of overactive bladder syndrome, a condition in which the bladder contracts suddenly without the patient having control, and when the bladder is not full. It is a common condition and usually no cause can be found. Symptoms include increased urinary frequency (need to pass urine often), urgency (sudden urge to pass urine) and urgency incontinence (sudden lack of control resulting in urine leaking before the person can get to the toilet). Mirabegron is a new type of medicine that is thought to work by increasing the bladder s capacity to store urine. It is taken once daily as a tablet, with or without food. SMC accepted mirabegron for symptomatic treatment of urgency, increased urinary frequency and/ or urgency incontinence as may occur in adult patients with overactive bladder syndrome. Studies have shown that mirabegron improved symptoms of overactive bladder syndrome including frequency and incontinence compared with placebo (a dummy medicine containing no active treatment). An economic analysis compared mirabegron with other medicines used for the treatment of overactive bladder syndrome, some of which cost less than mirabegron. SMC accepted mirabegron for use because the balance of costs and benefits meant that it was

4 ranibizumab (Lucentis ) What is ranibizumab used for? Ranibizumab can be used to treat loss of vision caused by macular oedema, which is a build up of fluid in the area of the eye called the macula. Macular oedema can occur due to blockages in the veins of the eye. Such blockages include retinal vein occlusion (RVO); there are two types of retinal vein occlusion, branch RVO or central RVO. The type of RVO refers to where the blockage occurs in the eye. Ranibizumab helps to stop the growth and leakage of new blood vessels in the eye. It is given as a monthly injection into the eye under local anaesthetic. SMC has previously accepted ranibizumab for restricted use in patients with macular oedema secondary to central retinal vein occlusion (CRVO). In this resubmission, the submitting company requested that SMC considers the use of ranibizumab in the treatment of visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). SMC accepted ranibizumab for the treatment of visual impairment due to macular oedema (MO) secondary to retinal vein occlusion (RVO) (branch RVO or central RVO) in adults. This resubmission relates to branch RVO only. One study in patients with BRVO has shown that ranibizumab improved vision over 6 months compared with a dummy injection. 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 ranibizumab with another medicine given as an intravitreal implant and laser therapy. Although there were some uncertainties in the analysis, SMC was satisfied that these did not significantly influence the results. SMC accepted ranibizumab for the treatment of macular oedema secondary to BRVO because the balance of costs and benefits meant that it was considered to offer value for money when the PAS was taken into account.

5 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 medicines for use in NHSScotland: crizotinib (Xalkori ) What is crizotinib used for? Crizotinib is a second-line treatment for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Cancer is the term given to a group of abnormal cells which have clumped together and grow to form a tumour. ALK-positive NSCLC is a type of lung cancer which is characterised by a abnormality in a particular gene. Crizotinib is a medicine that blocks the action of an abnormal protein which signals cancer cells to grow and divide, thereby slowing or stopping the spread of cancer cells. It is taken twice daily as a capsule. SMC did not recommend crizotinib for treatment of adults with previously treated ALK-positive NSCLC. A study showed that crizotinib delayed cancer progression by 4.7 months compared with standard chemotherapy. However, it was not clear if this would lead to an increase in overall survival. An economic analysis compared crizotinib with best supportive care or a commonly used medicine for the second-line treatment of patients with ALK-positive NSCLC. However, there were weaknesses in the analysis and the cost in relation to the health benefit was above the limit normally accepted by SMC. SMC did not recommend crizotinib for use because the balance of costs and benefits meant that it was not 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:

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

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