Health Evidence Review Commission's Value-based Benefits Subcommittee

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Endovascular stent insertion for intracranialanial atherosclerotic disease Interventional procedure guidance Published: 23 July 2012 nice.org.uk/guidance/ipg429 This guidance replaces IPG233. 1 Guidance This document replaces previous guidance on endovascular stent insertion for intracranial atherosclerotic disease (interventional procedure guidance 233). 1.1 Current evidence on the efficacy of endovascular stent insertion for intracranial atherosclerotic disease shows no substantial differences in clinical outcomes compared with medical treatment after 1–2 years. <strong>Evidence</strong> on its safety shows that there is a significant risk of periprocedural stroke and death. Therefore, this procedure should only be used in the context of research. Research should clearly define patient selection and be designed to provide outcome data <strong>based</strong> on follow-up of at least 2 years. 2 The procedure 2.1 Indications and current treatments 2.1.1 Intracranial atherosclerotic disease is the narrowing or obstruction of arteries within the skull that supply blood to the brain. It is caused by atheromatous © NICE 2012. All rights reserved. Page 1 of 6
Endovascular stent insertion for intracranial atherosclerotic disease (IPG429) plaques, which can reduce blood flow and may be associated with thrombosis or embolism, leading to transient ischaemic attacks (TIA), stroke or death. Intracranial atherosclerotic disease is usually diagnosed only after a patient has presented with a TIA or stroke. 2.1.2 Symptomatic intracranial atherosclerotic disease is usually treated with antiplatelet medication together with a statin and attention to risk factors for atherosclerosis such as smoking, hypertension and diabetes. 2.1.3 Direct intervention to treat intracranial atherosclerotic disease is not commonly used. It involves balloon angioplasty to dilate diseased arteries, which may then be followed by stent insertion, with the aim of improving patency compared with balloon angioplasty alone. 2.2 Outline of the procedure 2.2.1 The procedure is carried out with the patient under general or local anaesthesia. Under fluoroscopic control, a catheter is introduced percutaneously through an artery in the arm or leg and guided into the affected intracranial artery. Balloon angioplasty of the target lesion is normally done to dilate it before inserting a stent. It is possible to insert more than 1 stent or to treat more than 1 lesion in a treatment session. 2.2.2 Two main types of stent have been used – balloon expandable and selfexpanding. Some studies have also used drug-eluting stents. The technology has evolved over the past decade and continues to do so. Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview. 2.3 Efficacy 2.3.1 The efficacy outcomes described below include stroke or death occurring more than 30 days after the procedure (unless specified otherwise). Stroke or death occurring on or before 30 days is considered to be a safety outcome. © NICE 2012. All rights reserved. Page 2 of 6
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or one letter with two signatures i
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is known as a transwoman; and the i
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• liposuction • mastopexy • n
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58573 Laparoscopy, surgical, with t
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21127 Augmentation, mandibular body
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Such operating subsidiaries include
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Gender Reassignment Surgery D. Age
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Gender Reassignment Surgery number
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Gender Reassignment Surgery 15775 P
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Gender Reassignment Surgery June 30
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Acupuncture for Tobacco Cessation Q
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Evidence: 1) White 2014 i , Cochran
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especially acupuncture combined wit
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HERC staff summary Four meta-analys
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Acupuncture and related interventio
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Main results We included 38 studies
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The American Journal of Chinese Med
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CLINICAL RESEARCH STUDY Alternative
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Current guideline note: GUIDELINE N
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. Patient has a wound classified as
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National Coverage Determination (NC
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National Coverage Determination (NC
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Section 7.0 New Discussion Items
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From Dr. Ruscher I am a Pediatric S
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Evidence—pectus excavatum 1) de O
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d. Exercise capacity or other patie
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Other policies 1) NICE 2009 a. Curr
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spurt. (Goretsky, 2004) Requests fo
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HERC staff recommendations: 1) Keep
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Disposition of submitted literature
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Data collection and analysis Two re
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Cardiac Function Before and After S
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European Journal of Cardio-thoracic
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The American Journal of Surgery (20
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Normalized cardiopulmonary exercise
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Journal of Pediatric Surgery (2005)
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REVIEW C URRENT OPINION Pectus cari
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Journal of Pediatric Surgery 50 (20
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Placement of pectus bar for pectus
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CIGNA covers surgical repair of pec
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optimal age for surgical repair is
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Professional Societies/Organization
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http://www.plasticsurgery.org/medic
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36. Liu SL, Li L, Cheng W, Hou WY,
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Pectus Excavatum and Poland's Syndr
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growth and subsequently require sur
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650 Bae et al controversial, but do
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652 Bae et al capacity of adults wh
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Telemedicine for Retinopathy of Pre
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impact on stroke recurrence (Afzal
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hypertrophic cardiomyopathy, and ar
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Downloaded from http://heart.bmj.co
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Cardiac Event Monitors file://dhs.s
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Cigna Medical Coverage Policy Subje
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• long-term continuous 48- to 21-
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Literature Review Continuous 24- to
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(46/56) of the patients were receiv
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presymptom memory loop recorders (a
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Covered when medically necessary to
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patient selected events transmitted
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19. Joshi AK, Kowey PR, Prystowsky
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46. U.S. Food and Drug Administrati
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Electric Tumor Treatment Fields for
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10) Industry sponsored trial Major
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d. Essential Health Benefit (EHB) d
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h. Wisconsin - up to 35 units of PT
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Appendix A Diagnoses which appear o
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t. 99468-99480 NICU/PICU 2) Service
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In any event, the proposed quantita
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March 2, 2016 Via Email: Darren.d.c
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Mr. Darren Coffman Director, Health
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Section 8.0 Coverage Guidances
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Background - Skin Ulcers • Common
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Background - Skin Substitutes • S
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Background - Skin Substitutes • T
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Key Questions 1. What is comparativ
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Evidence Sources • Medline search
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Evidence Summary Evidence shows mod
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Public Comment • Submitted by Sol
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Late breaking studies • Late brea
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Prerequisites • Based on combinat
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RATIONALE FOR GUIDANCE DEVELOPMENT
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Coverage question: Should Apligraf
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Dermagraft® Coverage question: Sho
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OASIS® Wound Matrix Coverage quest
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Coverage question: Should EpiFix®
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Coverage question: Should Graftjack
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TheraSkin® Coverage question: Shou
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tissue and replace the wound with f
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Products derived from human donor t
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o Multilayered compression therapy
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Table 3. Summary of Included Random
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The prescribing information contain
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Important Outcome: Adverse Effects
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Critical Outcome: Quality of Life N
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infection, and response to usual ca
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leeding surface wounds, abrasions,
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group developed an infection in ano
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illuminate the comparative effectiv
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Other considerations Expert input a
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leg ulcers, but do not provide reco
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pe=All&PolicyType=Final&s=All&KeyWo
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Coverage guidance is prepared by th
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Low: The subcommittee’s confidenc
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Indication No. of Studies Study Des
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Indication Adverse Effects No. of S
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Adverse Effects DFU 1 RCT High Unkn
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Abbreviations: DFU - diabetic foot
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OASIS® versus Dermagraft® Indicat
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substitute,” or “bioengineered
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APPENDIX D. APPLICABLE CODES CODES
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Q4146 Q4147 Q4148 Q4149 Q4150 Q4151
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APPENDIX E: FREQUENCY OF APPLICATIO
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CG-Skin substitutes for diabetic fo
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Public Comments HERC Coverage Guida
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HERC Coverage Guidance - Skin Subst
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Bariatric Surgery Draft Coverage Gu
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Background - Obesity • Obesity is
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Background - Treatments • Structu
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Background - Surgery Vertical sleev
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Background - Surgery • Biliopancr
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Background - Surgery 2011 2012 2013
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Key Questions 1. Should coverage be
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Evidence Strengths and Limitations
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Evidence Review - Adults • WA HTA
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Evidence Review - Adults • Chang
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Evidence Review - Adults • Kwok (
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Evidence Summary - Adults • Baria
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Evidence Summary - Reoperation •
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Evidence Review - Children • Gene
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Evidence Review - Children • Blac
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Evidence Summary - Children • Bar
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HEALTH EVIDENCE REVIEW COMMISSION (
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GRADE‐INFORMED FRAMEWORK The HERC
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Coverage question: Should bariatric
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Coverage question: Should bariatric
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EVIDENCE OVERVIEW Clinical backgrou
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These procedures can be performed l
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Critical outcomes selected for incl
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Systematic Review (Quality) Total N
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Kwok (2014) Kwok et al. (2014) is a
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ias were included. The average base
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Thirteen of the included studies (a
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Mahawar, Graham, Carr, Jennings, Sc
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primary). Quantitative cumulative o
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Thomas (2012) Thomas & Agarwal (201
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EVIDENCE SUMMARY Despite the existe
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Bariatric surgery for children is a
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POLICY LANDSCAPE SOURCES Quality me
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Non‐Covered Procedures Aetna, Cig
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Black, J. A., White, B., Viner, R.
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Fitch, A., Fox, C., Bauerly, K., Gr
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APPENDIX A. METHODS Scope Statement
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United States Preventive Services T
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Low: The subcommittee’s confidenc
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Quality Assessment (Confidence in E
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APPENDIX D. MORTALITY BENEFIT OUTCO
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Johnson (2013) Retrospective cohort
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APPENDIX E. BARIATRIC SURGERY COVER
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Table E2. Bariatric Surgery Coverag
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Table E3. Pre‐Surgical Requiremen
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(BPD/DS) for individuals with a BMI
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Table E5. Repeat Surgery Coverage P
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Distal gastric bypass (long limb ga
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45.51 Isolation of segment of small
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APPENDIX G. OUTCOMES BY BASELINE ME
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APPENDIX H. COST‐EFFECTIVENESS ES
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GUIDELINE NOTE 8, BARIATRIC SURGERY
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Bariatric/Metabolic Surgery for Obe
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Bariatric/Metabolic Surgery for Obe
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Bariatric/metabolic surgery for obe
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Health Evidence Review Commission's Value-based Benefits Subcommittee

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