2 Reasons for developing guidance on SeQuent Please

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE CENTRE FOR HEALTH TECHNOLOGY EVALUATION EVALUATION PATHWAY PROGRAMME FOR MEDICAL TECHNOLOGIES 1 Technology Medical technologies guidance SCOPE SeQuent Please coronary balloon catheter 1.1 Description of the technology SeQuent Please is a coronary balloon catheter for percutaneous transluminal coronary angioplasty. The balloon section of the distal end of the catheter is coated with paclitaxel at a dose of 3 microgram/mm 2. The balloon is expanded for approximately 30 seconds and paclitaxel is released into the vessel wall. Paclitaxel is an antimitotic agent, thereby leading to a reduction in smooth muscle cell proliferation that can result in restenosis and a recurrence of angina symptoms. The aim of targeted delivery is to ensure that the drug remains in the vessel wall. The balloon catheter is also coated in iopromide, an X-ray contrast medium which improves the solubility and transfer of paclitaxel to the vessel wall. SeQuent Please combines balloon angioplasty with local delivery of paclitaxel to treat small calibre coronary artery stenosis or a restenotic lesion in a previously stented coronary artery. The aim is to reduce the incidence of restenosis. This scope covers SeQuent Please for use in restenotic lesions or in small calibre coronary arteries in a previously stented coronary artery. 1.2 Regulatory status SeQuent Please is CE marked for use within the coronary arteries for primary angioplasty within bare-metal stents and for restenosis. 2 Reasons for developing guidance on SeQuent Please The Medical Technologies Advisory Committee (MTAC or the Committee ) recognised that SeQuent Please may be beneficial for selected patients, specifically those with in-stent restenosis or with stenoses of small calibre coronary arteries. Trial data support the superiority of SeQuent Please over uncoated balloons, drug-eluting stents and bare-metal stents in defined patient groups. 1

2 There is some evidence that SeQuent Please may reduce the incidence of restenosis, which could allow NHS resources to be reallocated. The manufacturer also claims that SeQuent Please can reduce the duration of anti-platelet therapy. The Committee considered SeQuent Please to be a potential treatment for patients with in-stent restenosis or stenoses in small calibre coronary arteries. The Committee was advised that other indications might include complex coronary disease (for example, left main stem lesions, branch lesions and vessel bifurcations) or in situations where standard stent use is undesirable (for example, in calcified vessels or tortuous anatomy). The Committee did not consider this technology suitable for primary treatment of stenotic lesions. The Committee considered that long-term cost savings could be achieved using this technology in selected patients through reduced restenosis rate and costs associated with re-intervention. The Committee noted that there are other developing technologies, such as biodegradable drug-eluting stents, and considered these to be potential future comparators. 3 Relevant diseases and conditions SeQuent Please is indicated for use in patients with coronary heart disease, specifically patients with either in-stent restenosis or small calibre coronary artery stenosis. Coronary heart disease is the most common cause of mortality in the UK, accounting for nearly 117,500 deaths in the UK in 2002 (approximately 103,000 deaths in England and Wales) (source: The rate of restenosis after drug-eluting stent is approximately 5% and for bare-metal stents the figure is approximately 15% (source: British Cardiovascular Intervention Society (BCIS) audit data and expert advisers). Other indications for use may include complex coronary disease (for example, left main stem lesions, branch lesions and vessel bifurcations) or in situations where standard stent use is undesirable (for example, in calcified vessels or tortuous anatomy). 4 Patient benefit 4.1 Current management options (the comparator) The patient group includes patients with coronary heart disease, specifically patients with either in-stent restenosis or small calibre coronary artery stenosis. Patients with complex coronary disease (for example, left main stem lesions, branch lesions and vessel bifurcations) or in situations where standard stent use is undesirable (for example, in calcified vessels or tortuous anatomy) may also benefit from treatment with SeQuent Please. Current treatment options for patients with in-stent restenosis include repeat balloon angioplasty, repeat stenting, cutting balloon angioplasty, directional coronary atherectomy, rotational coronary atherectomy, 2

3 brachytherapy and drug-eluting stent. However, in-stent restenosis is extremely difficult to manage. Current treatment options for small calibre coronary stenosis include percutaneous transluminal coronary angioplasty and stent implantation. Other paclitaxel-eluting balloons are also available. The manufacturer of SeQuent Please claims that if re-intervention is required after treatment with SeQuent Please, there are more treatment options available compared with using a stent because of the absence of an underlying metallic scaffold. 4.2 Clinical outcomes relevant to the technology The clinical outcomes relevant to the technology are restenosis, late lumen loss, recurrence of angina symptoms, quality of life and successful device placement, as well as death, device failure and other complications. 5 Care pathway and system impact outcomes 5.1 Care pathway impact The technology is primarily relevant to the scenarios of in-stent restenosis or small calibre artery stenosis. SeQuent Please could provide an additional treatment option in the care pathway of patients with in-stent restenosis or small coronary artery stenosis. This has the potential to lead to improved patient outcomes compared to current treatment options. No other issues relating to the care pathway, such as supporting equipment, additional training and necessary infrastructure, were identified. 5.2 System impact Compared with drug-eluting stents, SeQuent Please reduces the incidence of restenosis, and therefore the costs associated with retreatment and recurrence of angina symptoms, as well as the duration of antiplatelet therapy after the procedure. If re-intervention is required, the manufacturer claims that there will be a wider range of treatment strategies available after treatment with SeQuent Please, compared with stenting, because of the absence of an underlying metallic scaffold. 6 Health inequalities and equality impact 6.1 Health inequalities Mortality and morbidity rates associated with coronary heart disease vary by socioeconomic group (rates are higher in lower socioeconomic groups), by geographical area (rates are highest in Wales, North West England, and the Northern England and Yorkshire regions, and lowest in South East England) and by ethnic group (coronary heart disease rates are highest among people from the Indian subcontinent living in the UK). The prevalence of coronary heart disease increases with age and is higher in men than women. Coronary heart disease is more common in people with high serum cholesterol, high blood pressure, in people with type 1 or 2 3

4 diabetes, in people who smoke and in people who are physically inactive or obese. 6.2 Equality impact There is no evidence to demonstrate variation in effectiveness of SeQuent Please according to the age, gender, class or ethnicity of the target audience. There appears to be no differential impact on inequalities in health within and between different population groups. A medical technology evaluation of SeQuent Please is not likely to have an impact on the current burden of disease or to reduce inequalities in health. 7 Approach to cost measurement and health economic analysis The direct costs of Sequent Please are the price of the device and the costs of co-medication. The direct costs of the comparator are the same. The list price of SeQuent Please (device only) is 1035 plus three months comedication (clopidogrel) costs of 120. The list price of the comparator paclitaxel-eluting stent is approximately 750 for the device plus clopidogrel co-medication costs of 480 for 12 months of treatment. Co-medication costs after using SeQuent Please are reduced because drug therapy is required for a shorter period after treatment. Surgical time is not expected to differ significantly between SeQuent Please and its comparators at the first operative procedure. The cost analysis should begin after the patient has been diagnosed with symptomatic restenosis or when treatment is indicated for symptomatic and small vessel coronary artery disease. The analysis should take into account initial hospital care (surgical time and recovery), and the long-term management of the disease. Adverse events relating to use of the device (including re-intervention) and co-medication should be considered. 8 External organisations 8.1 Professional organisations Specialist societies contacted for Expert advice British Cardiovascular Intervention Society Societies or organisations for consultation British Cardiovascular Intervention Society British Cardiovascular Society 8.2 Patient organisations NICE s Patient and Public Involvement Programme contacted the following organizations for patient commentary: Action Heart 4

5 Arrhythmia Alliance British Cardiac Patients Association British Cardiovascular Society British Heart Foundation Cardiomyopathy Association Circulation Foundation CORDA Counsel and Care Grown Up Congenital Heart Patients Association HEART UK Heartcare Partnership UK National Heart Forum (UK) Royal College of Surgeons Patient Liaison Group SADS UK Vascular Society. 8.3 NHS trusts or other organisations with experience of the technology At the time of briefing note completion, SeQuent Please was understood by NICE to be being used at the following hospitals: Blackpool Victoria Hospital BMI hospitals, Manchester and Coventry Freeman Hospital, Newcastle Frenchay Hospital, Bristol James Cook University Hospital, Middlesbrough Leeds General Infirmary The Lister Hospital, Stevenage Liverpool Heart and Chest Hospital Manchester Royal Infirmary Morriston Hospital, Swansea Norfolk and& Norwich University hospital The Northern General Hospital, Sheffield The Queen Elizabeth Hospital, Birmingham Royal Cornwall Hospital The Walsgrave Hospital, Coventry Wythenshawe Hospital, South Manchester 9 Other issues Costs could vary significantly across regions because of commercial sensitivities and differences in purchasing contracts. 5

6 10 Related NICE guidance 10.1 Published Drug-eluting stents for the treatment of coronary artery disease. NICE technology appraisal guidance 152 (2008). Available from Ischaemic heart disease coronary artery stents (review). NICE technology appraisal guidance 71 (2003). Available from Under development None identified Suspended or terminated None identified. 11 Statement of the decision problem Population Intervention Comparator(s) Outcomes Cost analysis Subgroups to be considered Special considerations, including issues related to equity or equality Final scope issued by NICE Patients with in-stent restenosis and patients with small calibre coronary artery stenosis. SeQuent Please iopromide/paclitaxel-eluting balloon catheter for percutaneous transluminal coronary angioplasty. For in-stent restenosis: Repeat balloon angioplasty, repeat stenting, cutting balloon angioplasty, directional coronary atherectomy, rotational coronary atherectomy, brachytherapy and drug-eluting stents. For small calibre coronary stenosis: percutaneous transluminal coronary angioplasty and stent implantation. Restenosis, late lumen loss, recurrence of angina symptoms, quality of life, successful device placement. Death, device failure, other complications. Comparative cost analysis of SeQuent Please and the relevant UK comparator(s) for the treatment of symptomatic restenosis and symptomatic small vessel coronary artery disease. Cost analysis should account for hospital care, long-term disease management, adverse events (including re-intervention) and co-medications, including the longterm costs. Patients with complex coronary disease (for example, left main stem lesions, branch lesions and vessel bifurcations) or in situations where standard stent use is undesirable (for example, in calcified vessels or tortuous anatomy). No special considerations. 6