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| Vol. 22, #44 • Monday, October 25, 2021 |
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OCTOBER IS HALLOWEEN SAFETY MONTH
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A message from Review’s Chief Medical Editor, Mark H. Blecher, MD: Playing the Game
I’ve written in the past about non-medical factors interfering with medical care and decision making. We spend so much time as ophthalmologists studying, researching, and evaluating new medical devices, drugs and treatment paradigms in a constant effort to find the best way to help our patients. We argue over which glaucoma drug is better, which MIGS works best, which anti-VEGF packs a bigger punch. And then we run the patient’s insurance and find out that many of these decisions have been made for us—and frequently not by MDs. While it shouldn’t be a surprise to see that insurance companies want value for their dollars, they have strayed far from informed decision making into cost control. No one can deny that most of our new technologies are expensive. And industry answers to its shareholders, not patients.
We don’t really talk very much about how to analyze the cost benefits of our care. There are models and formulae to do this, but literature in this area rarely garners much attention. Quality-adjusted life year (QALY) is one of the metrics used to make this determination, and incremental cost effectiveness ratio (ICER) is another. You may have heard of them. They’re used infrequently, if at all, to drive insurance coverage or insurance reimbursement. For example, most Medicaid plans don’t cover MIGS devices.
Yet, a recent study by Sood et al,1 has again demonstrated the QALY value of this technology. I seriously doubt Medicaid has looked at these metrics in making their determination. Most insurance companies don’t really care about this because the value is demonstrated over a longer timeline, and most people change insurance every couple of years. So, insurance companies don’t feel any responsibility for longitudinal health-care outcomes. They’re just watching their bottom line quarter to quarter. Meanwhile, we waste time trying to keep up with insurance companies’ ever-changing coverage that actually has little to no correlation with what we’ve determined to be the best care.
Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology
1. Sood S, Heilenbach N, Sanchez V, et al. Cost-effectiveness analysis of minimally invasive trabecular meshwork stents with phacoemulsification. Ophthalmol Glaucoma 2021; Sep 23. [Epub ahead of print].
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Relationship Between Macular Microvasculature and VA in Advanced Glaucoma
Researchers evaluated the correlation between structural parameters and visual acuity in advanced glaucoma, as part of a prospective, cross-sectional study.
A total of 238 eyes from 238 patients (82 men, ages 59.9 ±13.8 years) from a tertiary center were divided into an advanced (mean deviation of 24-2 visual field tests from -12.01 to -20.0 dB) and severe (<-20 dB) glaucoma group. Structural parameters were obtained by RTVue optical coherence tomography and angiography. Pearson correlation, partial correlation adjusted for age and axial length, and receiver operating characteristic curves to detect decreased VA (<20/25) were performed.
Here are some of the findings:
• In the advanced glaucoma group (133 eyes), superficial (Pearson correlation coefficient, γ=−0.46, p<0.001; partial correlation coefficient, γ’=-0.30, p<0.001) and deep macular vessel densities (γ=-0.47, p<0.001; γ’=-0.30, p<0.001) showed the highest correlation with VA.
• The AUROCs of the superficial parafoveal/macular vessel densities were 0.816 (0.735 to 0.897) and 0.808 (0.725 to 0.891), respectively.
• In the severe glaucoma group (105 eyes), deep nasal grid vessel densities (γ=-0.31, p=0.002; γ’=-0.35, p<0.001) showed the highest correlation with VA.
• Deep macular vessel density showed better correlation with VA than other structural parameters.
• The AUROCs of deep macular vessel densities and deep nasal grid vessel densities were 0.740 (0.632 to 0.849) and 0.748 (0.640 to 0.857), respectively.
Researchers found that macular vessel density showed a better correlation with VA in advanced glaucoma. As such, they wrote, deep macular vessel density, especially nasal grid, may be a promising structural parameter in severe glaucoma.
SOURCE: Hsia Y, Wang T-H, Huang J-Y, et al. Relationship between macular microvasculature and visual acuity in advanced and severe glaucoma. Am J Ophthalmol 2021; Oct 12. [Epub ahead of print].
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Long-term Outcomes of Bacillary Layer Detachment in nAMD
Investigators evaluated the clinical characteristics, multimodal imaging features, and long-term treatment outcomes of eyes with neovascular age-related macular degeneration and bacillary layer detachment (BALAD) treated with intravitreal anti-vascular endothelial growth factor therapy.
The retrospective, longitudinal, case series included treatment-naive nAMD patients (n=30) showing BALAD on optical coherence tomography undergoing anti-VEGF therapy.
Clinical records and multimodal imaging were reviewed up to four years after diagnosis. Best-corrected visual acuity values were compared over time. The cumulative risk and risk factors of subretinal fibrosis were assessed with Cox regression analyses, and the adjusted hazard ratio (aHR) was computed.
Thirty eyes of 30 patients were included. Here are some of the findings:
• Macular neovascularization subtypes were distributed as follows:
o type 1: 63 percent;
o type 2: 27 percent;
o mixed type 1 and type 2: 3 percent;
o type 3: 3 percent; and
o aneurysmal type 1: 3 percent.
• The BCVA significantly improved after anti-VEGF loading phase (Snellen equivalent, from 20/118 to 20/71, p=0.03), but it returned to baseline levels at four years (Snellen equivalent, 20/103, p=0.6).
• The cumulative risk of subretinal fibrosis was 77 percent at four years.
• Risk factors associated with subretinal fibrosis included hemorrhagic BALAD (aHR, 2.02; CI, 1.54 to 3.22; p<0.01) and the presence of subretinal hyperreflective material (aHR, 1.83; CI, 1.35 to 3.14; p<0.01).
Investigators found that BALAD was associated with all types of MNV in nAMD patients. They added that long-term observation revealed poor functional outcomes related to the high risk of subretinal fibrosis.
SOURCE: Ramtohul P, Malclès A, Gigon E, et al. Long-term outcomes of bacillary layer detachment in neovascular age-related macular degeneration. Ophthalmol Retina; 2021 Sep 26. [Epub ahead of print].
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Bowman’s Layer Inlay Transplantation for Treatment of Progressive Keratoconus
Scientists reported long-term clinical outcomes and estimated success rates after Bowman’s layer (BL) inlay transplantation in eyes treated for progressive keratoconus (KC).
Thirty-five eyes (29 patients) with progressive KC underwent BL inlay transplantation. Best-corrected spectacle and contact lens visual acuity, Scheimpflug-based corneal tomography (simulated and maximum keratometry [Kmax]), central corneal thickness, thinnest point thickness, complications and success rate were evaluated up to eight years postoperatively for the total group and two subgroups (group 1: preoperative Kmax >69 diopter (n=26); group 2: preoperative Kmax <69D (n=9)].
Here are some of the findings:
• Mean logMAR best contact lens-corrected visual acuity for the total group and the two subgroups didn’t change from preoperative up to the last available follow-up (all p>0.05) while best spectacle-corrected visual acuity improved for group 1 (p=0.03).
• Group 1 showed an average Kmax reduction of 7 D in the first month (p<0.001) with no further changes up to eight years postoperatively (p>0.05), while no significant changes were observed in group 2 (all p>0.05).
• Postoperative KC progression occurred in four eyes (n=3, group 1; n=1, group 2), and one eye (group 2) underwent retransplantation for unsatisfactory visual performance.
• Kaplan-Meier analysis showed an estimated success rate of 85 percent at five- to eight-year follow-up in group one, and 75 percent at five- to seven-year follow-up for group 2.
Scientists reported BL inlay transplantation stabilized KC in most eyes and preserved contact lens tolerance up to eight years postoperatively, and may be a successful treatment option—especially for eyes with progressive advanced KC (Kmax >69D).
SOURCE: van der Star L, van Dijk K, Vasiliauskaitė I, et al. Long-term outcomes of bowman layer inlay transplantation for the treatment of progressive keratoconus. Cornea 2021; Oct 6. [Epub ahead of print].
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Complimentary CME Education Videos
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Cost Analysis of a T&E Regimen with Anti-VEGFs in nAMD
This study investigated the per-patient costs associated with neovascular age-related macular degeneration treatment, when using aflibercept, bevacizumab, or ranibizumab with a treat-and-extend regimen.
In this cost-minimization model, the per-patient costs in the Netherlands were modeled using a health-care payers' perspective over a three-year time horizon with the assumption that efficacy of treatments was similar. Additionally, the break-even price of the different anti-VEGFs was calculated relative to the cheapest option and injection frequency.
Here are some of the findings:
• The injection frequency varied from 14.2 for aflibercept to 27.4 for bevacizumab in three years; nonetheless, bevacizumab remained the cheapest treatment option (€14,215; $16,487.27), followed by aflibercept (€18,202; $21,111.59) and ranibizumab (€31,048; $36,011.02).
• The medication covered the majority of the per-patient costs for aflibercept and ranibizumab, while administration covered the majority of the per-patient costs for bevacizumab.
• The break-even prices of aflibercept and ranibizumab were, respectively, €507 / $588.03 and €60.58 / $70.26 per injection.
• Brolucizumab, which was included in the analysis, was more expensive than aflibercept (€20,446; $23,713.78).
• Brolucizumab would need to reduce to 13.8 injections over three years to be in line with aflibercept’s cost.
Researchers determined that bevacizumab was the cheapest anti-VEGF treatment, followed by aflibercept.
SOURCE: Quist SW, de Jong LA, van Asten F, et al. Cost-minimisation analysis of a treat-and-extend regimen with anti-VEGFs in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2021; Oct 13:1-13.
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Industry News
Genentech's Port-delivery System with Ranibizumab Approved
This week, the FDA approved Genentech’s port-delivery system with ranibizumab, now called Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Genentech says that Susvimo is the only FDA-approved treatment for wet AMD that offers as few as two treatments per year. Susvimo is a refillable, permanent eye implant that continuously releases a customized formulation of ranibizumab to the eye. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.
The approval is based on the results of the Phase III Archway study, which the company says showed wet AMD patients treated with Susvimo achieved vision gains equivalent to monthly ranibizumab injections through 40 weeks of treatment. Read more.
Oyster Point Gets FDA Nod for Tyrvaya
Oyster Point Pharma received FDA approval for Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Tyrvaya is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Read more.
Senate FY2022 Appropriations Bill Doubles Funding for CDC’s Vision and Eye Health Program
The Prevent Blindness organization says that, as a result of its advocacy efforts, the Senate Appropriations legislation includes a total of $6 million for vision and eye health programs at the Centers for Disease Control and Prevention. This includes funding the Vision Health Initiative (VHI) at $2 million in FY2022—a $1 million increase over FY2021—and continued funding of $4 million for the Glaucoma project. If the legislation is enacted into law, the VHI’s funding level would be at its highest since FY2010, Prevent Blindness says.
Read more.
New Amblyopia Therapy Approved
Luminopia says its new software, Luminopia One, is the first FDA approved digital therapeutic for children with amblyopia—and the first for any neuro-visual disorder. The software is designed for use with compatible head-mounted displays. The program is indicated for children aged 4 to 7 with amblyopia associated with anisometropia and/or mild strabismus who are receiving treatment instruction by a trained eye-care professional. The company says Luminopia One allows kids to watch therapeutically modified versions of their favorite TV shows and movies with a virtual reality headset to improve their vision by training the eyes to work together. The therapy is prescribed for use at home for one hour per day, six days a week, for 12-week periods. Learn more.
Atsena Unveils XLRS Gene Therapy Program
Atsena Therapeutics unveiled its preclinical gene therapy program for X-linked retinoschisis using the company’s novel AAV capsid, AAV.SPR. A study in non-human primates demonstrated that AAV.SPR promoted transgene expression beyond subretinal injection bleb margins. At clinically relevant doses, AAV.SPR efficiently transduced foveal cones without the need for surgical detachment and didn’t cause inflammation, the company says. Read more.
Retrotope’s RT011 Findings
Retrotope announced that preclinical studies of RT011 demonstrated that RT011, which is being developed as an oral therapy for the treatment of dry age-related macular degeneration, provided dose-dependent protection in animal models of oxidative damage implicated in dry AMD. Read more.
Aurion Biotech Names Medical Advisory Board Members
Aurion Biotech announced members of the company’s medical advisory board. The board is chaired by Edward Holland, MD, recently appointed as Aurion’s chief medical advisor. View the board members.
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