Preventing Avoidable Vision loss from Diabetic Retinopathy in Indian Country

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1 Diabetes in Indian Country Preventing Avoidable Vision loss from Diabetic Retinopathy in Indian Country Albuquerque, NM 20 September2017 Mark B. Horton, OD, MD Director, IHS/JVN Teleophthalmology Program

2 Diabetes Mellitus in Indian Country Non-Hispanic Whites Asian Americans Hispanics Non-Hispanic Blacks AI/AN* 2.3 X DM Prev Rate % *6%-24% by region CDC National Diabetes Statistics Report Endemic nature of diabetes paralleled by diabetic eye disease

3 Eye Complications of Diabetes Ocular Tissue Lids Orbit Cornea Iris Lens Retina Optic Nerve Cranial Nerves CNS Conditions Xanthelasma, Blepharitis Cellulitis Keratitis, Epithelial erosions, Keratitis Poor dilation, Rubeosis Transient refraction changes Cataract (and surgical outcomes) Retinopathy/Maculopathy Retinal vein occlusions Retinal artery occlusions Ischemic syndromes Papillopathy, Ant Isch Optic Neuropathy Glaucoma 3 rd, 4 th, 5 th, 7 th CN palsies CVA associated vision loss

4 Eye Complications of Diabetes Ocular Tissue Lids Orbit Cornea Iris Lens Retina Optic Nerve Cranial Nerves CNS Conditions Xanthelasma, Blepharitis Cellulitis Keratitis, Epithelial erosions, Keratitis Poor dilation, Rubeosis Transient refraction changes Cataract (and surgical outcomes) Retinopathy/Maculopathy Retinal vein occlusions Retinal artery occlusions Ischemic syndromes Papillopathy, Ant Isch Optic Neuropathy Glaucoma 3 rd, 4 th, 5 th, 7 th CN palsies CVA associated vision loss

5 Eye Complications of Diabetes Ocular Tissue Lids Orbit Cornea Iris Lens Retina Optic Nerve Cranial Nerves CNS Conditions Xanthelasma, Blepharitis Cellulitis Keratitis, Epithelial erosions, Keratitis Poor dilation, Rubeosis Transient refraction changes Cataract (and surgical outcomes) Retinopathy/Maculopathy Retinal vein occlusions Retinal artery occlusions Ischemic syndromes Papillopathy, Ant Isch Optic Neuropathy Glaucoma 3 rd, 4 th, 5 th, 7 th CN palsies CVA associated vision loss

6 Diabetic Retinopathy Virtually all diabetics eventually have DR Diabetic Retinopathy is the leading cause of new blindness in adults Blindness due to diabetes can be eliminated by timely Dx and Tx D R E x a m R a t e 80% 70% 60% 50% 40% 30% 20% Annual DR Exam Rate in Indian Country Half of AI/AN population with DM do not get timely Dx and Tx

7 Diabetic Retinopathy Standard of Care - Standard of Care - annual DR exam ADA AAO AOA VHA* DoD HEDIS DR severity CSME f/u (mths) Minimal NPDR No 12 Mild-Moderate No 6-12 NPDR Yes 2-4 Severe No 2-4 NPDR Yes 2-4 Low Risk No 2-4 PDR Yes 2-4 High Risk No 3-4 PDR Yes 3-4

8 Visual Acuity Less than 20/800 Proliferative Diabetic Retinopathy Event Rate (%) DRS Untreated Eyes ETDRS by eye Untreated high risk DR Treated high risk DR ETDRS by person Years after PDR Dx

9 Half of AI/AN population with DM do not get timely Dx and Tx D R E x a m R a t e 80% 70% 60% 50% 40% 30% 20% Annual DR Exam Rate in Indian Country D R E x a m R a t e 90% 80% 70% 60% 50% 40% 30% 20% 46% Annual DR Exam Rate by Area % 68% 61% 63% 55% 56% 56% 49% 50% 52% 65% 10% Every system is perfectly designed to achieve the results it gets. Donald Berwick Director CMS CEO, IHI

10 Diabetic Retinopathy Legacy DR Surveillance Workflow

11 Half of general US population with DM do not get timely Dx and Tx A DR surveillance program limited to conventional eye exams by eye doctors has not been an effective public health approach for this problem in Indian Country or elsewhere NCQA 2015 Report State of Health Care Quality 80% 75% 70% 65% 60% 55% 50% 45% 40% IHS Comm MC MA Series5

12 Diabetic Retinopathy Surveillance Best Practices This is not a problem with eye doctors Pts with an asymptomatic chronic condition Inconvenient examination A primary care diabetes management problem Programs that depend upon appointed visits to an eye doctor usually fail standard of care for 40%-50% of DM pts Must be smarter than the disease Must understand the patient

13 Telemedicine-DR: A better tool to address this universal public health problem VHA 1.3 million veterans with DM (25%) 400 Tmed-DR deployments / 500,000 annual exams UK ~2.9 million with DM 2.1 million annual tmed DR exams For the first time in 5 decades of survey, DR is no longer the leading cause of new blindness among working age adults in UK Liew G, Michaelides M, Bunce C.A Comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), with BMJ Open 2014;4:e

14 IHS- Joslin Vision Network (JVN) Teleophthalmology Program Developed collaboratively with VA, DoD, IHS, and the Joslin Diabetes Center Clinical Deployments in IHS began 2000 National Distribution in 25 states

15 DR Surveillance Reporting IHS HQ requirement, 16 May 2012 All agency hospitals shall have IHS-JVN by end of FY2013 All agency facilities with DM prevalence >500 shall have IHS-JVN by end of FY2014 All agency facilities with IHS-JVN must meet or exceed the GPRA goal AND 125% of predeployment rate

16 JVN Physical Components JVN Image Acquisition Station Retinal Image Acquisition by certified imager in primary care clinic No pupil dilation Patient Education Data transmission to Reading Center Images Health Summary

17 JVN Physical Components JVN Diagnostic Workstation Image analysis Automated diagnosis with reader validation Automated documentation

18 IHS/JVN: A Primary Care Tool IAS in Primary Care Clinic Focused recruitment Patients with no retinal exam w/i 1 year Active vs passive Generalized recruitment All individuals with DM Routine component of DM intake

19 IHS/JVN: A Primary Care Tool IAS in Primary Care Clinic Focused recruitment Patients with no retinal exam w/i 1 year Active vs passive Generalized recruitment All individuals with DM Routine component of DM intake

20 JVN Validation Studies ETDRS- gold standard (ATA Category 3) Clinical- community standard Non-diabetic pathology The use of the JVN system and imaging device can produce a determination of clinical diabetic retinopathy that is comparable with ETDRS photographs, thereby satisfying the standard of care for DR surveillance. The use of the JVN system and imaging device can produce a determination of non-diabetic pathology residing within the fields captured.

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23 Outcome Linked to Intervention (prevention of vision loss) Diabetes Care- Feb 2005 (28: ) JVN resulted in a 50% increase in DR surveillance and 51% increase in laser treatment for DR ( ) Annual rates of retinal screening and laser treatment Annual Rate of Retinal Screening and Treatment Laser treatment rate Retinal exam rate Lasre Therapy per 1000 diabetic personyears Exam Rate Laser Rate Retinal exams per 100 diabetic personyears Year 0

24 Diabetic Retinopathy Cost Effectiveness Whited JD, et al. A Modeled Economic Analysis of the Joslin Vision Network as used by Three Federal Healthcare Agencies for Detecting Proliferative Diabetic Retinopathy. Telemedicine Journal and e-health IHS/JVN is both less costly and more effective for: Detecting DR Identifying IHS patients that require laser tx Preventing severe vision loss $5.00 $4.00 Total Costs Indian Health Service $3.35 $3.54 $4.44 $ Effectiveness Indian Health Service $ (in millions) $3.00 $2.00 $1.75 $2.27 Cases $ $0.00 Proliferative Diabetic Retinopathy Detected Panretinal Laser Photocoagulation Severe Vision Loss Effectiveness Measure Black Bars = Joslin Vision Network White Bars = Ophthalmoscopy with Dilation 0 Proliferative Diabetic Retinopathy Detected Black Bars = Joslin Vision Network Panretinal Laser Photocoagulation Effectiveness Measure Severe Vision Loss White Bars = Ophthalmoscopy with Dilation

25 IHS/JVN Experience

26 Diabetic Retinopathy Surveillance IHS-JVN Teleophthalmology Program 88 Fixed/Hybrid sites + 10 Portable Sites in 25 States

27 Public Health Case Compliance with DR Standards of Care Re-tasking of recovered resources Staff $ Targets of opportunity Person-years of sight preserved secondary impact Family, Society, Health Care System

28 Diabetic Retinopathy Clinical Levels- Diabetic Retinopathy Non proliferative DR Asymptomatic Proliferative DR Asymptomatic Treatment needed Severe Vision Loss

29 Diabetic Retinopathy Clinical Levels- Diabetic Macular Edema Diabetic Macular Edema (DME) Asymptomatic Clinically Significant DME ± Asymptomatic Treatment needed Moderate Vision Loss

30 Diabetic Retinopathy Clinical Levels Mild nonproliferative DR Moderate nonproliferative DR Severe nonproliferative DR Proliferative DR Proliferative DR Diabetic macular edema

31 Severe Vision Loss Due to DR Tx d PDR: ( / )

32 Diabetic Retinopathy Current Ophthalmic Treatment Proliferative DR (PDR)- Laser photocoagulation (PRP)

33 Diabetic Retinopathy Current Ophthalmic Treatment Diabetic macular edema (DME)- Intravitreal injections

34 Diabetic Retinopathy Current Ophthalmic Treatment Vitreous hemorrhage/retinal Detachment Vitrectomy (PPV)

35 Diabetic Retinopathy Pathophysiology and Treatment of Vision Loss Retinal Capillary Endothelium damage Vascular permeability Laser, Steroids, Anti-VEGF Retinal edema CSME Moderate Retinal Capillary Endothelium damage Neovascularization Laser and/or Anti-VEGF Vitrectomy Vitreous Hemorrhage Scarring Severe Retinal Detachment

36 Cost Avoidance Opportunities Cataract and Vitrectomy Surgery Laser Tx (PRP)- ~$1,000 Vitrectomy- ~$9,000 Uncomplicated Single procedure Range- $9-20K Result- variable but rarely 20/20 visual result Cataracts usually occur downstream Cataract surgery ~$4,000

37 Cost Avoidance Opportunities Cataract and Vitrectomy Surgery Simple Tx cost avoidance calculations for Dx and Tx of DR # patients with DM 1000 Proceedure Cost DR Exam Rate 50.0% PRP $1,000 High risk DR detected 23 PPV $9,000 High risk DR un-detected 23 Cat $4,000 Prev High Risk DR= 4.5% Cost: Laser Tx= $1,000; PPV= $9,000 (no reops) Simple Direct Costs Excess to Examinations DR Exam Rate 0% 50% 75% 100% Laser tx and/or IVT $0.00 $22, $33, $45, PPV (vitrectomy) $405, $202, $101, $0.00 Total $405, $225, $135, $45, PPV cataracts $180, $90, $45, $0.00 TOTAL $585, $315, $180, $45,000.00

38 Diabetic Retinopathy Primary Care management of DR Control of risk factors Blood Pressure- 130/85 Blood Glucose- A1c 6.5%-7.0% Blood lipids DM management best practices

39 Diabetic Retinopathy Primary Care management of DR ~ 50% reduction in the prevalence of DR over the past two decades NPDR 17.7% PDR 2.3% DME 2.3% STR 4.2% Similar reduction in prevalence of diabetes related ESRD over the same period, which aligns temporally with SDPI implementation

40 Diabetic Retinopathy 78% reduction of progression among pts with pre-existing retinopathy 31% reduction in need for treatment (progression to sight threatening DR) Diabetic Retinopathy 36% reduction of progression (all cases) 78% reduction of progression (mild NPDR)

41 Fenofibrate Mechanism of Action Not related to lipid effects Treat early in the course of DR but precise timing is not determined Possible collateral benefits to other microvasculopathic end organ processes Renal Peripheral neuropathy High patient safety

42 Fenofibrate Clinical Use On label use for DR in Australia and other countries DM clinical practice guidelines Canadian Diabetes Association, 2016: Though not recommended for CVD prevention or treatment, fenofibrate, in addition to statin therapy, may be used in patients with type 2 diabetes to slow the progression of established retinopathy. American Diabetes Association, 2017: collaboration between the ophthalmologists (eye care providers) and the medical physician to consider this treatment for people affected with diabetic retinopathy.

43 Photo courtesy of Lloyd P Aiello, MD, PhD Diabetes in Indian Country Preventing Avoidable Vision loss from Diabetic Retinopathy in Indian Country Discussion 20 September 2017 Mark B. Horton, OD, MD Director, IHS/JVN Teleophthalmology Program Mark.horton@ihs.gov

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