1 of 19 Protocol Minimally Invasive Glaucoma Surgery (MIGS) for individuals with open-angle glaucoma. A health technology assessment Title Minimally Invasive Glaucoma Surgery (MIGS) for individuals with open-angle glaucoma. A health technology assessment Short title HTA of MIGS for individuals with glaucoma Short project description The Ordering Forum, Regional Health Authorities (RHA Forum) commissioned Norwegian Institute of Public Health (NIPH) to carry out a HTA of MIGS, through the National System for Managed Introduction of New Health Technologies. We will assess the relative effect, safety, and cost-effectiveness of the method(s) for treatment of individuals with open-angle glaucoma. Short summary Glaucoma refers to a group of diseases in which there is progressive damage to the optic nerve. Globally, glaucoma is considered as the leading cause of irreversible vision loss and one of the leading causes of blindness (1;2). In Norway, approximately 40,000 individuals have diagnosed glaucoma (3). Glaucoma incidence is expected to increase in the coming years because of demographic changes (4). MIGS represents a class of various new surgical procedures and devices developed since the early 2000s in an attempt to provide a minimally invasive surgical approach to glaucoma treatment that limits damage to the conjunctiva. Experts suggest that MIGS may result in shorter procedure times and patient recovery times than traditional surgical procedures, making it possible to perform MIGS treatment at an earlier stage of glaucoma. The indications for each specific MIGS-procedure can vary depending on its mechanism of action and the individual patient’s target intraocular pressure (IOP). MIGS procedures and devices can be used as a stand-alone procedure or in conjunction with cataract surgery. In general, there is a growing demand for use of MIGS both in Norway and globally (5;6). This HTA will assess the relative effect, safety, and cost-effectiveness of the method(s) for treatment of individuals with different types of open-angle glaucoma (the most common type of glaucoma). We will report health gain, resource use, severity, and cost effectiveness according to the prioritization criteria (7). In addition, we will aim to include patient partners’ perspectives and experiences, organizational consequences, and ethical issues related to MIGS use in Norway. Project number: ID2018_072 Plan prepared: October 2019
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
1 of 19
Protocol
Minimally Invasive Glaucoma Surgery (MIGS) for individuals with open-angle glaucoma. A health technology assessment
Title
Minimally Invasive Glaucoma Surgery (MIGS) for individuals with open-angle glaucoma. A
health technology assessment
Short title
HTA of MIGS for individuals with glaucoma
Short project description
The Ordering Forum, Regional Health Authorities (RHA Forum) commissioned Norwegian
Institute of Public Health (NIPH) to carry out a HTA of MIGS, through the National System for
Managed Introduction of New Health Technologies. We will assess the relative effect, safety,
and cost-effectiveness of the method(s) for treatment of individuals with open-angle glaucoma.
Short summary
Glaucoma refers to a group of diseases in which there is progressive damage to the optic nerve.
Globally, glaucoma is considered as the leading cause of irreversible vision loss and one of the
leading causes of blindness (1;2). In Norway, approximately 40,000 individuals have diagnosed
glaucoma (3). Glaucoma incidence is expected to increase in the coming years because of
demographic changes (4). MIGS represents a class of various new surgical procedures and
devices developed since the early 2000s in an attempt to provide a minimally invasive surgical
approach to glaucoma treatment that limits damage to the conjunctiva. Experts suggest that
MIGS may result in shorter procedure times and patient recovery times than traditional
surgical procedures, making it possible to perform MIGS treatment at an earlier stage of
glaucoma. The indications for each specific MIGS-procedure can vary depending on its
mechanism of action and the individual patient’s target intraocular pressure (IOP). MIGS
procedures and devices can be used as a stand-alone procedure or in conjunction with cataract
surgery. In general, there is a growing demand for use of MIGS both in Norway and globally
(5;6). This HTA will assess the relative effect, safety, and cost-effectiveness of the method(s) for
treatment of individuals with different types of open-angle glaucoma (the most common type of
glaucoma). We will report health gain, resource use, severity, and cost effectiveness according
to the prioritization criteria (7). In addition, we will aim to include patient partners’
perspectives and experiences, organizational consequences, and ethical issues related to MIGS
use in Norway.
Project number: ID2018_072
Plan prepared: October 2019
2 of 19
Norsk
Protokoll
Minimal-invasiv glaukomkirurgi (MIGS) for individer med åpenvinklet glaukom. En metodevurdering
Tittel
Minimal-invasiv glaukomkirurgi (MIGS) for individer med åpenvinklet glaukom. En
metodevurdering
Kort tittel
Metodevurdering av MIGS for individer med glaukom
Kort prosjektbeskrivelse
Bestillerforum regionalt helseforetak (RHF) har gitt Folkehelseinstituttet (FHI) i oppdrag å
utarbeide en fullstendig metodevurdering for MIGS, gjennom det nasjonale systemet for
introduksjon av nye metoder. Vi vil undersøke relativ effekt, sikkerhet, og kostnadseffektivitet
av metoden(e) til behandling av individer med åpenvinklet glaukom.
Kort oppsummering
Glaukom refererer til en sykdomsgruppe som innebærer progressiv ødeleggelse av synsnerven.
Globalt betraktes glaukom som den vanligste årsaken til irreversibelt synstap og en av de
vanligste årsakene til blindhet (1;2). I Norge er om lag 40 000 individer diagnostisert med
glaukom (3). Insidensen er forventet å øke i påfølgende år på grunn av demografiske endringer
(4). MIGS representerer en gruppe av nye kirurgiske prosedyrer og utstyr utviklet, siden tidlig
2000-tallet, i forsøk på å levere en minimal-invasiv kirurgisk tilnærming til glaukom
behandling, som begrenser skade på øyets bindehinne. I følge eksperter kan MIGS resultere i
kortere prosedyretider og restitusjonstid for pasient sammenlignet med tradisjonelle kirurgiske
prosedyrer, som gjør det mulig å utføre MIGS på et tidligere sykdomsstadie. Indikasjonene for
hver enkelt MIGS-prosedyre kan variere avhengig av dets virkningsmekanisme og pasientens
individuelle mål for intraokulært trykk (IOP). MIGS prosedyrer og utstyr kan utføres alene eller
i kombinasjon med katarakt kirurgi. Generelt, er det økende etterspørsel for bruk av MIGS i
Norge og globalt (5;6). Denne metodevurderingen vil undersøke relativ effekt, sikkerhet, og
kostnadseffektivitet av metoden(e) for behandling av individer med ulike typer åpenvinklet
glaukom (den vanligste formen for glaukom). Vi vil rapportere helsegevinst, ressursbruk,
alvorlighet, og kostnadseffektivitet i henhold til prioriteringskriteriene (7). I tillegg tar vi sikte
på å inkludere brukerrepresentanters’ perspektiv og erfaringer, organisatoriske konsekvenser,
og etiske aspekter relatert til bruk av MIGS i Norge.
Prosjekt nummer: ID2018_072
Plan utarbeidet: Oktober 2019
3 of 19
Project category and commissioner
Product: Health technology assessment
Thematic areas: Surgery, eye disease, health technology assessment
Commissioner: Ordering Forum, The Regional Health Authorities (RHA
Forum) (Bestillerforum RHF), consisting of four medical
directors (one for each regional health authority) and two
delegates from the Norwegian Directorate of Health
Project management and participants
Project leader: Ulrikke Højslev Lund, Health Economist
Responsible for the project: Øyvind Melien, Department Director
Internal project participants: Julia Bidonde, Researcher
Beate Charlotte Fagerlund, Health Economist
Martin Lerner, Senior Advisor
Lien Nguyen, Information Specialist
Bjarne Robberstad, Health Economist
External clinical experts:
External patient partners:
External ethicist:
Jon Henrik Tveit, MD, Oslo University Hospital
Marit Fagerli, MD, Trondheim University Hospital
Hildegunn Halvorsen, MD, Haukeland University
Hospital, Bergen
Are Lindland, MD, Hospital of Southern Norway, Arendal
Asle Haukaas, Board Member, Norwegian Glaucoma
Association
Mette Mellem, Low Vision Teacher, Norwegian Association
of the Blind and Partially Sighted
Arne Tømta, Low Vision Teacher, Norwegian Association of
the Blind and Partially Sighted
Lars Øystein Ursin, Associate Professor, Department of
Public Health and Nursing, Norwegian University of Science
and Technology
Plan for replacement by project
participants’ absence:
Replacements will be decided by the person responsible for
the project
Internal reviewers: For the protocol: Hege Kornør and Kåre Birger Hagen
For the full report: To be decided
External reviewers: For the protocol: Clinical experts and patient partners
participating in this project. For the full report: To be
decided
4 of 19
Commission
On June 21st, 2018 Glaukos Corporation submitted a proposal for a new national HTA
regarding the use of trabecular bypass MIGS device implantation with iStent inject in patients
with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma (8).
The RHA Forum in the National System for Managed Introduction of New Health
Technologies, assessed the proposal, together with a horizon scanning report (9), on September
24th 2018, and commissioned NIPH to conduct a single HTA (i.e. the assessment of a single
MIGS device). Because there several suppliers of MIGS devices, a single HTA is not
appropriate, and on October 22th 2018 the RHA Forum instead commissioned NIPH to conduct
a multiple HTA to assess relative effect, safety, cost-effectiveness of all MIGS devices for
treatment of individuals with glaucoma in Norway (10;11).
Goals
According to the prioritization criteria in Norway (7), the goals of this HTA are to
1) Systematically identify, assess and summarize available research evidence regarding
clinical effect and safety of (selected) MIGS devices and procedures versus each other or
another comparator (i.e. pharmacotherapy, laser therapy, filtration surgery, cataract
surgery), both as a stand-alone procedure or performed in combination with cataract
surgery, in the treatment of open-angle glaucoma.
2) Conduct a health economic evaluation and quantify the severity criterion by calculating
absolute shortfall for individuals with glaucoma that receive conventional care. We will
report health gain, resource use, severity, and cost effectiveness of MIGS compared to
conventional care in a Norwegian setting.
3) Assess organisational challenges and consequences linked to establishing MIGS as a
treatment option in Norway.
4) Assess potential ethical issues raised by the use of MIGS in treatment of glaucoma in
Norway.
We will include patient partners’ in the assessment team in order to understand their own
perspectives and experiences regarding glaucoma treatment and healthcare services, as well as
the perspectives of their caregivers.
Background
Glaucoma
Glaucoma refers to a group of disease, in which there is a progressive damage to the optic nerve,
which can lead to visual loss (1). Optic nerve damage can occur in the event of an imbalance
between access and drainage of eye fluid in the area between iris and cornea, where drainage
are prevented and the eye pressure increases (figure 1) (12). Glaucoma is a slowly progressing
disease, sometimes called the “silent thief of sight”. Because central vision often remains intact
as the disease progresses, irreversible harm can result before the patient notices “tunnel
visions” or other types of visual impairment. Early diagnosis and appropriate treatment could
help prevent permanent visual defects and blindness. The cause of glaucoma remains unknown.
However, some factors have been identified to possibly increase the risk of developing the
5 of 19
disease. Examples of such risk factors are: age, family history, ethnicity, eye injuries, long-term
cortisone treatment, high IOP, diabetes and cardiovascular disease (13-15). There are several
types of glaucoma, the two main types being primary open-angle glaucoma (POAG) and closed
angle glaucoma, which are marked by an increase of intraocular pressure (IOP), or pressure
inside the eye (16).
Globally, glaucoma is regarded as the leading cause of irreversible vision loss and one of the
leading causes of blindness (1;2). According to Peters et al., there is a 26.5% risk of blindness in
one eye after 10 years and a 5.5% for bilateral blindness. After 20 years the risks are 38.1% and
13.5% respectively (17).
Figure 1. Illustration of the drainage route for aqueous humor flow (18).
Incidence and prevalence
In Norway, approximately 40,000 individuals have diagnosed glaucoma. Glaucoma is most
common among the elderly population. It is estimated that 2.19% of the population aged 40
and over have glaucoma; the estimated prevalence of the whole population is 0.92% (3).
Glaucoma incidence is expected to increase in the coming years because of demographic
changes that result in an ageing population and an increase in life expectancy (4).
Current glaucoma treatment in Norway
There is no curative treatment for glaucoma and vision loss from glaucoma is irreversible. The
goal of current treatment is to address the only reversible risk factor for glaucoma, IOP, and
thereby to prevent further nerve damage and loss of vision. By achieving a significant and
sustained decrease in IOP the subsequent risk of disease progression is reduced and the quality
of life is preserved (1). Choice of treatment is often dependent on the severity of the disease
(19).
The conventional treatment for glaucoma upon diagnosis of the disease is to introduce topical
medication with an IOP-lowering eye drop as monotherapy or a combination of eye drops with
Extract data on efficacy and safety and conduct statistical analyses ML/JB 01.11.2019 29 30.11.2019 Evaluate the methodological quality in included articles (Risk of Bias) ML/JB 02.12.2019 15 17.12.2019 GRADE evaluation for outcomes ML/JB 18.12.2019 2 20.12.2019 Gather data and plan models for health economic analysis UHL/BCF 19.08.2019 73 31.10.2019 Gather data regarding organizational consequences UHL/BCF 12.08.2019 80 31.10.2019 Health economic analyses performed UHL/BCF 01.11.2019 49 20.12.2019 Chapter about ethical issues are written LØU 07.10.2019 74 20.12.2019 Write first draft HTA report UHL 06.01.2019 30 05.02.2019 Internal project participants review of first draft report UHL 05.02.2019 16 21.02.2020 Revise and send draft of report to external clinical experts and patient partners for review UHL 21.02.2020 21 13.03.2020
Corrections for final draft UHL 13.03.2020 14 27.03.2020 Internal and external peer-review of report UHL 30.03.2020 21 20.04.2020 Finalize report UHL 20.04.2020 21 11.05.2020 Approval and submittal of report
Head of departments/UHL 11.05.2020 14 25.05.2020
Send finalized report to RHA Forum (Bestillerforum RHF) and publish at NIPHs webpage ØM/UHL 25.05.2020 4 29.05.2020
1. Gupta N, Aung T, Congdon N, Dada T, Lerner F, Olawoye S, et al. International Council
of Ophthalmology Guidelines for Glaucoma Eye Care. California: 2015. 2. Pillunat LE, Erb C, Jünemann AGM, Kimmich F. Micro-invasive glaucoma surgery
(MiGS): a review of surgical procedures using stents. Clinical Ophthalmology 2017;11:1583-600.
3. Goldschmidt E, Fuchs J, Raitta C. Glaucoma prevalence in the Nordic countries. Acta Ophthalmologica 2009;67(2):204-10.
4. King A, Azuara-Blanco A, Tuulonen A. Glaucoma. British Medical Journal 2013;346. 5. Expert opinion, Personal communication with clinical experts working in Health
Authorities in Norway. August. 6. Wong SH, Panarelli JF. Update on Microinvasive Glaucoma Surgery. International
Ophthalmology Clinics 2018;58(3):101-15. 7. Helse- og omsorgsdepartementet. Meld. St. 34. Verdier i pasientens helsetjeneste.
Melding om prioritering. 2016. 8. Falvey H, Sandhu H. Trabecular bypass micro-invasive glaucoma surgery (MIGS) device
implantation with iStent injectin patients with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma. London: Nye Metoder; 2018.
9. Folkehelseinstituttet. Trabekulær stent bypass mikrokirurgi (iStent) for pasienter med grønn stær. Oslo: MedNytt; 2018.
10. Sekretariatet Nye Metoder. Protokoll fra møte i Bestillerforum RHF Mandag 22. oktober. Gardermoen: 2018.
11. Sekretariatet Nye Metoder. Protokoll fra møte i Bestillerforum RHF Mandag 24. september. Oslo: 2018.
12. Norges Blindeforbund. En orientering om grønn stær (glaukom). Oslo2017. 13. Helse Nord. Regional plan for øyefaget i Helse Nord 2015-2025. 2015. 14. BMJ Best Practice. Glaucoma (open angle). Patient information from BMJ: BMJ
Publishing Group Limited [lest]. Tilgjengelig fra: https://bestpractice.bmj.com/patient-leaflets/en-gb/pdf/1581709449852.pdf
15. CADTH. Optimal use of minimally invasive glaucoma surgery: a health technology assessment. Ottawa: CADTH; 2019. CADTH optimal use report. 8. 1b.
16. Norsk Glaukomforening. GlaukomtyperHaslum[lest]. Tilgjengelig fra: https://glaukomforeningen.no/om-glaukom/primaere-glaukomer/
17. Peters D, Bengtsson B, Heijl A. Lifetime risk of blindness in open-angle glaucoma. American Journal of Ophthalmology 2013;156(4):727-30.
21. European Glaucoma Society. Terminology and guidelines for glaucoma. 4th utg. Italy: 2014.
22. Szigiato A-A, Podbielski DW, Ahmed IIK. Sustained drug delivery for the management of glaucoma. Expert Review of Ophthalmology 2017;12(2):173-86.
23. Ministry of Health Malaysia. Microinvasive Glaucoma Surgery (MIGS). Malaysia: 2018. Health Technology Assessment Report.
24. Covidence. Covidence. A Cochrane technology platform. 2019. 25. Shea BJ, Reeves BC, Wells G, Thuku M, Hamel C, Moran J, et al. AMSTAR 2: a critical
appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ 2017;21(358).
26. Higgins JPT, Sterne JAC, Savović J, Page MJ, Hróbjartsson A, Boutron I, et al. A revised tool for assessing risk of bias in randomized trials Cochrane Methods [lest]. 10 (Suppl 1):[Tilgjengelig fra: https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool
27. Sterne JAC, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions: BMJ [lest]. 355;i4919:[Tilgjengelig fra: https://sites.google.com/site/riskofbiastool/welcome/home
28. BMJ Publishing Group Limited. What is GRADE?[lest]. Tilgjengelig fra: https://bestpractice.bmj.com/info/toolkit/learn-ebm/what-is-grade/
29. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, et al. Chapter 12: Interpreting results and drawing conclusions. 5.2.0 utg.: Cochrane; 2017. Tilgjengelig fra: https://training.cochrane.org/handbook
30. RevMan. The NCC. Review Manager (RevMan) (Computer program). . Copenhaugen: The Cochrane Collaboration; 2014.
31. European Network for Health Technology Assessment (EUnetHTA). HTA Core Model Version 3.0. 2016. Tilgjengelig fra: https://www.eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf
32. Kunnskapssenteret. Etikk i vurdering av helsetiltak. 2008. Tilgjengelig fra: https://www.fhi.no/publ/eldre/etikk-i-vurdering-av-helsetiltak.-utvikling-av-en-metode-for-a-synliggjore-/
33. Miljeteig I. Ethical concerns of accepting off-label use of rituximab for multiple sclerosis. 2019.