NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Health Technology Appraisal Daclizumab for treating relapsing-remitting multiple Draft scope (pre-referral) Draft remit/appraisal objective To appraise the clinical and cost effectiveness of daclizumab within its marketing authorisation for treating relapsing-remitting multiple. Background Multiple is a chronic, disabling neurological disease. It occurs when the body s immune system destroys myelin, a protective sheath around nerve cells in the brain and spinal cord. People with multiple experience symptoms which can include; pain, disturbance to muscle tone including weakness or spasticity, chronic fatigue, unsteady gait, speech problems, incontinence, visual disturbance and cognitive impairment. Relapsing-remitting multiple is one form of multiple which is characterised by periods of remission followed by relapses (which may or may not result in underlying disability). Relapsing-remitting multiple is the most common form of multiple which affects approximately 85% of people at diagnosis. It is estimated that up to 126,669 people in the UK had multiple in 2010, and approximately 6003 new cases were diagnosed 1. People with relapsing-remitting multiple can progress to develop secondary progressive multiple. This is characterised by more persistent or gradually increasing disability. Current pharmacological management of relapsing-remitting multiple includes disease-modifying agents to reduce the frequency and severity of relapses. These include beta interferon and glatiramer acetate which are not currently recommended by NICE (NICE Technology appraisal guidance 32), but are available in the NHS through a risk-sharing scheme. NICE Technology appraisal guidance 312 recommends alemtuzumab as an option for treating adults with active relapsing remitting multiple. NICE Technology appraisal guidance 320 and 303 recommend dimethyl fumarate or teriflunomide respectively as options for treating people with relapsingremitting multiple who have had 2 clinically significant relapses in the previous 2 years. The technology Daclizumab (Zinbryta, Biogen Idec) is a monoclonal antibody that blocks the alpha subunit of the interleukin-2 receptor. Daclizumab is administered in a sub-cutaneous injection. Issue Date: May 2015 Page 1 of 7

2 Daclizumab does not currently have a marketing authorisation in the UK for relapsing-remitting multiple. It has been studied in a randomised controlled trial compared with beta interferon in adults with relapsing-remitting multiple. Intervention(s) Population(s) Daclizumab Adults with relapsing-remitting multiple. Comparators alemtuzumab beta-interferon dimethyl fumarate glatiramer acetate teriflunomide natalizumab (for patients with rapidly-evolving severe relapsing-remitting multiple ) fingolimod (for patients with highly active relapsing-remitting multiple who have received treatment with beta interferon) Outcomes The outcome measures to be considered include: relapse rate severity of relapse disability (for example, expanded disability status scale [EDSS]) symptoms of multiple (such as fatigue, cognition and visual disturbance) freedom of disease activity mortality adverse effects of treatment health-related quality of life. Issue Date: May 2015 Page 2 of 7

3 Economic analysis Other considerations Related NICE recommendations and NICE Pathways The reference case stipulates that the cost effectiveness of treatments should be expressed in terms of incremental cost per quality-adjusted life year. The reference case stipulates that the time horizon for estimating clinical and cost effectiveness should be sufficiently long to reflect any differences in costs or outcomes between the technologies being compared. Costs will be considered from an NHS and Personal Social Services perspective. The availability of any patient access schemes for the intervention or comparator technologies should be taken into account. This includes the arrangements within the risk-sharing scheme, which was agreed for the supply of disease modifying treatments for multiple in the NHS (see Health Service Circular 2002/004). Guidance will only be issued in accordance with the marketing authorisation. Where the wording of the therapeutic indication does not include specific treatment combinations, guidance will be issued only in the context of the evidence that has underpinned the marketing authorisation granted by the regulator. If the evidence allows, the following subgroups of patients will be considered: patients with relapsing-remitting multiple whose disease has inadequately responded to treatment with disease modifying therapy patients with relapsing-remitting multiple whose disease is intolerant to treatment with disease modifying therapy patients with highly active relapsing-remitting multiple patients with rapidly evolving severe relapsingremitting multiple Related Technology Appraisals: Beta interferon and glatiramer acetate for the treatment of multiple, January NICE Technology Appraisal 32. Static guidance. Review decision date June 2013 (review decision: review of guidance to be planned into the NICE work programme). Natalizumab for the treatment of adults with highly active relapsing-remitting multiple, August NICE Technology Appraisal 127. Review decision Issue Date: May 2015 Page 3 of 7

4 date June 2013 (review decision: review of guidance to be planned into the NICE work programme). Fingolimod for the treatment of highly active relapsingremitting multiple, April NICE Technology Appraisal 254. Review decision date June 2013 (review decision: review of guidance to be planned into the NICE work programme). Teriflunomide for treating relapsing-remitting multiple, January NICE Technology Appraisal 303. Review proposal date January Alemtuzumab for treating relapsing-remitting multiple, May NICE Technology Appraisal 312. Review proposal date May Dimethyl fumarate for treating relapsing-remitting multiple, August NICE Technology Appraisal 320. Review proposal date August Terminated appraisals: Cladribine for the treatment of relapsing-remitting multiple (suspended appraisal) (2011). NICE Technology Appraisal ID64. Laquinimod for the treatment of relapsing-remitting multiple (suspended appraisal) (2013). NICE Technology Appraisal ID560. Related Guidelines: Clinical Guideline No. 186, October 2014, Management of multiple in primary and secondary care. Review date December Related Interventional Procedures: Percutaneous venoplasty for chronic cerebrospinal venous insufficiency for multiple (2012). NICE Interventional Procedures guidance 420. Related NICE Pathways: multiple/managing-multiple- Multiple (2014) NICE pathway Related National Policy Clinical Commissioning Policy: Disease Modifying Therapies for Patients with Multiple Sclerosis (MS), April NHS England Clinical Commissioning Policy. Issue Date: May 2015 Page 4 of 7

5 Department of Health, NHS Outcomes Framework , Nov Domains /attachment_data/file/256456/nhs_outcomes.pdf Questions for consultation Has the population for daclizumab for treating relapsing-remitting multiple (RRMS) been defined appropriately? In particular, is the population likely to include; People with previously untreated RRMS? People whose disease has inadequately responded to prior disease modifying therapy? People with highly active RRMS? People with rapidly evolving severe RRMS? Have all relevant comparators for daclizumab been included in the scope? Which treatments are considered to be established clinical practice in the NHS for relapsing-remitting multiple? Are the subgroups suggested in other considerations appropriate? Are there any other subgroups of people in whom daclizumab is expected to be more clinically effective and cost effective or other groups that should be examined separately? Where do you consider daclizumab will fit into the existing NICE pathway for multiple? NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the proposed remit and scope may need changing in order to meet these aims. In particular, please tell us if the proposed remit and scope: could exclude from full consideration any people protected by the equality legislation who fall within the patient population for which daclizumab will be licensed; could lead to recommendations that have a different impact on people protected by the equality legislation than on the wider population, e.g. by making it more difficult in practice for a specific group to access the technology; Issue Date: May 2015 Page 5 of 7

6 could have any adverse impact on people with a particular disability or disabilities. Please tell us what evidence should be obtained to enable the Committee to identify and consider such impacts. Do you consider daclizumab to be innovative in its potential to make a significant and substantial impact on health-related benefits and how it might improve the way that current need is met (is this a step-change in the management of the condition)? Do you consider that the use of daclizumab can result in any potential significant and substantial health-related benefits that are unlikely to be included in the QALY calculation? Please identify the nature of the data which you understand to be available to enable the Appraisal Committee to take account of these benefits. NICE intends to appraise this technology through its Single Technology Appraisal (STA) Process. We welcome comments on the appropriateness of appraising this topic through this process. (Information on the Institute s Technology Appraisal processes is available at Issue Date: May 2015 Page 6 of 7

7 References 1. Mackenzie IS, Morant SV, Bloomfield GA et al. (2013) Incidence and prevalence of multiple in the UK : a descriptive study in the General Practice Research Database. J Neurol Neurosurg Psychiatry 2014;85:76 84 Issue Date: May 2015 Page 7 of 7