Eliminating Visual Acuity and Dilated Fundus Examinations Improves Cost Efficiency of Performing Optical Coherence Tomogrpahy-Guided Intravitreal Injections.

PURPOSE: The clinic efficiency and cost savings achieved by eliminating formal visual acuity (VA) and dilated fundus examinations (DFEs) were assessed for established patients receiving optical coherence tomography (OCT)-guided intravitreal injections. DESIGN: Comparative cost analysis. METHODS: Two different treatment models were evaluated. The first model included patients undergoing routine VA assessment, DFEs, OCT imaging, and intravitreal injections. The second model eliminated the routine VA assessment and DFE while using OCT imaging through an undilated pupil followed by the intravitreal injection. The 2 models incorporated both bevacizumab and aflibercept. The number of patients per clinic day, the cost per visit, and the daily revenues were compared between the 2 models. RESULTS: Optimized schedules with and without VA assessments and DFEs allowed for 48 and 96 patients to be injected per day, respectively. Excluding drug costs, the cost per encounter for the visits with and without a DFE were $39.33 and $22.63, respectively. Including the drug costs, the costs per encounter for the visits with and without a DFE were $85.55 and $68.85 for bevacizumab and $1787.58 and $17770.88 for aflibercept, respectively. Once the reimbursements for each visit type were included, the clinics that eliminated the VA and DFEs were more cost efficient. CONCLUSION: Eliminating both VA assessments and DFEs for patients undergoing OCT-guided retreatment with intravitreal injections resulted in decreased exposure times between patients and clinic staff, decreased cost per encounter, and increased patient volumes per clinic day, resulting in improved clinic efficiency and safety while seeing more patients in a clinic day.

Cost-Utility Analysis of VEGF Inhibitors for Treating Neovascular Age-Related Macular Degeneration.

PURPOSE: To perform 11- and 2-year health care sector (ophthalmic) and societal cost perspective reference case, cost-utility analyses comparing bevacizumab, ranibizumab, and aflibercept monotherapies for neovascular age-related macular degeneration (NVAMD). DESIGN: Cost-utility analysis. METHODS: The authors performed 11-year and 2-year ophthalmic and societal cost perspective, cost-utility analyses comparing bevacizumab, ranibizumab, and aflibercept monotherapies for neovascular age-related macular degeneration (NVAMD). We employed patient utilities, bilateral outcomes, 2018 U.S. dollars, vision-related mortality, a Medicare fee schedule, and CATT (Comparison of Age-Related Macular Degeneration Treatments) study and VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) trial. Cochrane data were also used. SETTING: Center for Value-Based Medicine. Patient/study population: patients with NVAMD. INTERVENTION: Cost-utility analyses using published data. Data-modeled 10-year vision outcomes were modeled forward to year 11. MAIN OUTCOME MEASUREMENT: These included cost-utility ratios (CURs), costs, and quality-adjusted life-years (QALYs) gained. $100,00/QALY was considered the US cost-effectiveness upper limit. RESULTS: Bevacizumab and ranibizumab each conferred an 11-year, 1.339 QALY gain versus observation. Aflibercept conferred a 1.380 QALY gain. Aflibercept conferred greater QALY gain for less cost than ranibizumab but was not cost-effective compared to bevacizumab ($1,151,451/QALY incremental CUR). The average ophthalmic cost perspective CUR for bevacizumab was $11,033/QALY, $79,600/QALY for ranibizumab, and $44,801/QALY for aflibercept. Eleven-year therapies saved a 1.0 year-of-life loss without treatment from the 11.0-year life expectancy. Early treatment was 138%-149% more cost-effective than late treatment. Two-year therapy prevented a 1-month-of-life loss, and revealed bevacizumab, ranibizumab, and aflibercept conferred 0.141, 0.141, and 0.164 QALY gains, respectively, with corresponding average CURs of $40,371/QALY, $335,726/QALY, and $168,006/QALY, respectively. CONCLUSIONS: From an ophthalmic (medical) cost perspective, bevacizumab, ranibizumab, and aflibercept NVAMD monotherapies were all cost-effective over 11 years, with bevacizumab 6.21× more cost-effective than ranibizumab and 3.06× more cost-effective than aflibercept. Two-year modeling revealed bevacizumab was cost-effective, whereas ranibizumab and aflibercept were not. Early treatment was critical for obtaining optimal vision and cost-effectiveness, as is long-term follow-up and adherence to treatment.

Presumed ocular histoplasmosis syndrome in a commercially insured population, United States.

PURPOSE: To describe epidemiologic features of patients with presumed ocular histoplasmosis syndrome (POHS) in the United States using insurance claims data and compare POHS patients with and without choroidal neovascularization (CNV). DESIGN: Retrospective cohort study. METHODS: Patients with International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for histoplasmosis retinitis on an outpatient claim in the 2014 IBM® MarketScan® Commercial Database and the Medicare Supplemental Database who were enrolled for at least 2 years after the POHS code. MAIN OUTCOME MEASURES: Data related to testing, treatment, and direct medical costs. RESULTS: Among >50 million total MarketScan enrollees, 6,678 (13 per 100,000) had a POHS diagnosis code. Of those, 2,718 were enrolled for 2 years; 698 (25%) of whom had a CNV code. Eleven of the 13 states with the highest POHS rates bordered the Mississippi and Ohio rivers. CNV patients had significantly more eye care provider visits (mean 8.8 vs. 3.2, p<0.0001), more ophthalmic imaging tests, higher rates of treatment with anti-vascular endothelial growth factor injections (45% vs. 4%, p<0.0001), and incurred higher mean total yearly costs ($1,251.83 vs. $251.36, p<0.0001) than POHS patients without CNV. CONCLUSIONS: Although the relationship between Histoplasma and POHS remains controversial, geographic patterns of POHS patient residence were consistent with the traditionally reported range of the fungus. CNV in the context of POHS was associated with additional healthcare use and costs. Further research to understand POHS etiology, risk factors, prevalence, and complications is needed, along with early diagnosis and treatment strategies.

Cost-effectiveness of Intravitreal Ranibizumab With Verteporfin Photodynamic Therapy Compared With Ranibizumab Monotherapy for Patients With Polypoidal Choroidal Vasculopathy.

Importance: The EVEREST II trial showed that for patients with polypoidal choroidal vasculopathy (PCV), intravitreal ranibizumab in combination with verteporfin photodynamic therapy improves visual acuity relative to ranibizumab monotherapy. However, whether combination therapy is incrementally cost-effective relative to monotherapy during a lifetime is unclear. Objective: To assess the incremental cost-effectiveness of combination therapy compared with ranibizumab monotherapy in patients with PCV. Design, Setting, and Participants: This model-based, economic evaluation used 2018 unit cost data from a tertiary eye hospital in Singapore, first- and second-year outcomes and resource use data from a multicenter trial across various Asian countries (EVEREST II) to model a hypothetical cohort of patients with symptomatic PCV. Scenario analyses and deterministic and probabilistic sensitivity analyses were performed to examine uncertainty. Data were collected from October 2018 through April 2019 and analyzed from March through October 2019. Interventions: This model used data from the EVEREST II trial, in which all participants were given 0.5 mg of intravitreal ranibizumab once every 4 weeks for the first 3 months. Subsequent administration occurred as needed. For participants receiving combination therapy, standard fluence (50 J/cm3) photodynamic therapy with 6-mg/m2 verteporfin was administered once during the first 3 months and thereafter as needed. Main Outcomes and Measures: Incremental cost per quality-adjusted life-year (QALY) gained for combination therapy relative to monotherapy for patients with PCV. Results: In this model based on a cohort of 1000 patients aged 68 years, a patient with PCV incurred a total cost in Singapore dollars (SGD) of 92 327 (US $67 399) with combination therapy and SGD 92 371 (US $67 431) with monotherapy during a lifetime horizon, generating a modest cost savings of SGD 44 (US $32) per patient undergoing combination therapy. Lifetime QALYs were estimated to be 7.87 for combination therapy and 7.85 for monotherapy, for an incremental gain of 0.02 QALYs. Combination therapy remained cost-saving or cost-effective in all lifetime scenarios modeled, but during shorter time horizons and at lower monotherapy costs, it may not be cost-effective. Conclusions and Relevance: This study found combination therapy to be a dominant (more effective and less costly) strategy, being similar in costs and slightly more effective than ranibizumab monotherapy during a lifetime horizon. However, decreasing the time horizon to less than 10 years and/or reductions in the cost of monotherapy may result in combination therapy no longer being cost-effective.

Economic Value of Anti-Vascular Endothelial Growth Factor Treatment for Patients With Wet Age-Related Macular Degeneration in the United States.

Importance: Anti-vascular endothelial growth factor (anti-VEGF) is a breakthrough treatment for wet age-related macular degeneration (wAMD), the most common cause of blindness in western countries. Anti-VEGF treatment prevents vision loss and has been shown to produce vision gains lasting as long as 5 years. Although this treatment is costly, the benefits associated with vision gains are large. Objective: To estimate the economic value of benefits, costs for patients with wAMD, and societal value in the United States generated from vision improvement associated with anti-VEGF treatment. Design, Setting, and Participants: This economic evaluation study used data from the published literature to simulate vision outcomes for a cohort of 168 820 patients with wAMD aged 65 years or older and to translate them into economic variables. Data were collected and analyzed from March 2018 to November 2018. Main Outcomes and Measures: Main outcomes included patient benefits, costs, and societal value. Each outcome was estimated for a newly diagnosed cohort and the full population across 5 years, with a focus on year 3 as the primary outcome because data beyond that point may be less representative of the general population. Drug costs were the weighted mean across anti-VEGF therapies. Two current treatment scenarios were considered: less frequent injections (mean [SD], 8.2 [1.6] injections annually) and more frequent injections (mean [range], 10.5 [6.8-13.1] injections annually). The 2 treatment innovation scenarios, improved adherence and best case, had the same vision outcomes as the current treatment scenarios had but included more patients treated from higher initiation and lower discontinuation. Results: The study population included 168 820 patients aged 65 years at the time of diagnosis with wAMD. The underlying clinical trials that were used to parameterize the model did not stratify visual acuity outcomes or treatment frequency by sex; therefore, the model parameters could not be stratified by sex. The current treatment scenario of less frequent injections generated $1.1 billion for the full population in year 1 and $5.1 billion in year 3, whereas the scenario of more frequent injections generated $1.6 billion (year 1) and $8.2 billion (year 3). Three-year benefits ranged from $7.3 billion to $11.4 billion in the improved adherence scenario and from $9.7 billion to $15.0 billion if 100% of the patients initiated anti-VEGF treatment and the discontinuation rates were 6% per year or equivalent to clinical trial discontinuation (best-case scenario). Societal value (patient benefits net of treatment cost) ranged from $0.9 billion to $3.0 billion across 3 years in the current treatment scenarios and from $0.9 billion to $4.3 billion in the treatment innovation scenarios. Conclusions and Relevance: This study's findings suggest that improved vision associated with anti-VEGF treatment may provide economic value to patients and society if the outcomes match published outcomes data used in these analyses; however, future innovations that increase treatment utilization may result in added economic benefit.

Intravitreal Ziv-Aflibercept: Clinical Effects and Economic Impact.

During the past decade, drugs that inhibit the actions of vascular endothelial growth factor (VEGF) have become standard-of-care treatment for a variety of chorioretinal vascular conditions. The off-label, intravitreal use of ziv-aflibercept (Zaltrap) has provided clinicians with an additional cost-effective drug. The commercial preparation of ziv-aflibercept contains the same aflibercept (VEGF-trap) molecule as Eylea but has a much higher osmolarity (1000 mOsm/kg vs 300 mOsm/kg). Initial concerns regarding cytotoxicity and long-term safety of intravitreal ziv-aflibercept have been largely negated after a series of publications failed to identify adverse ocular and systemic side effects. Both treatment-naive and anti-VEGF‒resistant cases of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and choroidal neovascular membrane (CNVM) may respond as well to ziv-aflibercept as to aflibercept. A higher dose of ziv-aflibercept (2 mg in 0.08 mL) does not cause any adverse effects during short-term follow-up period (1 month). Data from various sources suggest that ziv-aflibercept may be as cost effective as bevacizumab, thereby making it an attractive treatment option in low- and middle-income countries. However, problems with off-label use, compounding, and counterfeiting limit its availability in many countries. Data from prospective, randomized, multicenter clinical trials are still required to convince physicians and regulatory bodies of its clinical efficacy and potential as early therapy.

Cost of myopic patients with and without myopic choroidal neovascularisation. / Costes en pacientes miopes magnos con y sin neovascularización coroidea miópica.

OBJECTIVE: To study the costs associated with high myopia (HM) with choroidal neovascularisation (mCNV) or without mCNV. METHODS: Observational, retrospective, cross-sectional, and multicentre study (HM and mCNV) conducted on adult patients. Annualised medical direct cost (MDC) from the perspective of the National Health System, the non-medical direct cost (nMDC) from the patient perspective, and productivity losses were calculated. RESULTS: A total of 137 mCNV and 48 HM patients were included (mean age [SD]: 55.1 [2.8] vs. 54.7 [13.8]; P=.2), with 80% women in both groups. The observation time (months) ranged from 17.9 (9.6) right eye (RE) and 20.0 (9.7), left eye (LE) in mCNV and 47.1 (21.5) RE/45.5 (20.7) LE in MM. A higher percentage of emergency room visits was observed in mCNV vs. HM patients (41.7 vs. 25%; P=.06) and retinal specialists (91.2 vs. 77.1%; P=.01). The MDC was higher in mCNV: € 1,985 (95% CI: 1772-2198) vs. € 356 (251-480) HM, P<.001. The nMDC was also higher in mCNV: € 256 (11-524) vs. €19 (11-26) HM, P>.4. The number of affected eyes, the follow-up time, and the mCNV were factors associated with direct costs. The impact on work productivity was higher in mCNV (quite/very concerned): 27.7 vs. 10.4% HM. The mCNV showed a significant association with activity impairment (OR: 3.47, 95% CI: 10.101-1.195). CONCLUSIONS: mCNV involves higher medical costs than HM. In addition, mCNV patients have a greater need of care and assistive devices, and greater impact of the disease in their work productivity.

Cost-effectiveness of bevacizumab and ranibizumab for newly diagnosed neovascular macular degeneration (an American Ophthalmological Society thesis).

PURPOSE: To determine the most cost-effective treatment for patients with newly diagnosed neovascular macular degeneration: monthly or as-needed bevacizumab injections, or monthly or as-needed ranibizumab injections. METHODS: Using a Markov model with a 20-year time horizon, we compared the incremental cost-effectiveness of treating a hypothetical cohort of 80-year-old patients with newly diagnosed neovascular macular degeneration using monthly bevacizumab, as-needed bevacizumab, monthly ranibizumab, or as-needed ranibizumab. Data came from the Comparison of Age-Related Macular Degeneration Treatment Trial (CATT), the Medicare Fee Schedules, and the medical literature. RESULTS: Compared with as-needed bevacizumab, the incremental cost-effectiveness ratio of monthly bevacizumab is $242,357 per quality-adjusted life year (QALY). Monthly ranibizumab gains an additional 0.02 QALYs vs monthly bevacizumab at an incremental cost-effectiveness ratio of more than $10 million per QALY. As-needed ranibizumab was dominated by monthly bevacizumab. In sensitivity analyses assuming a willingness to pay of $100,000 per QALY, the annual risk of serious vascular events would have to be at least 2.5 times higher with bevacizumab than that observed in the CATT trial for as-needed ranibizumab to have an incremental cost-effectiveness ratio of <$100,000 per QALY. In another sensitivity analysis, even if every patient receiving bevacizumab experienced declining vision by one category (eg, from 20/25-20/40 to 20/50-20/80) after 2 years but all patients receiving ranibizumab retained their vision level, as-needed ranibizumab would have an incremental cost-effectiveness ratio of $97,340 per QALY. CONCLUSION: Even after considering the potential for differences in risks of serious adverse events and therapeutic effectiveness, bevacizumab confers considerably greater value than ranibizumab for the treatment of neovascular macular degeneration.

Ranibizumab versus bevacizumab for the treatment of neovascular age-related macular degeneration.

PURPOSE OF REVIEW: This paper reviews the recent literature regarding the effectiveness, efficacy and safety of intravitreal bevacizumab as compared with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD). RECENT FINDINGS: Numerous randomized clinical trials have demonstrated the safety and efficacy of ranibizumab for the treatment of nAMD. Bevacizumab, developed, labeled and approved for the management of colorectal cancer, has been used off-label for the management of nAMD. However, given its lower cost and effectiveness, it is commonly used for many cases of nAMD. Recent clinical trials have demonstrated similar effectiveness between the two compounds in terms of visual acuity and central macular thickness. However, emerging data have suggested that these two compounds may have different ocular and systemic adverse event profiles; bevacizumab has been linked to both a higher risk of severe intraocular inflammation and a higher risk of incident arterial thromboembolic events. This incremental risk for both ocular and systemic adverse events may have an impact on the incremental cost-effectiveness ratio derived from health economic models that directly compare one anti-vascular endothelial growth factor (VEGF) compound to the other. SUMMARY: Numerous clinical trials, including the Comparison of AMD Treatment Trial, are underway examining the comparative efficacy of ranibizumab versus bevacizumab for the treatment of nAMD. While these studies may demonstrate clinical noninferiority of one anti-VEGF compound over another, they may not be adequately powered to detect important differences in ocular and systemic safety. Large-scale, appropriately powered safety studies need to be conducted to evaluate differences in safety.

Pharmacologic management of neovascular age-related macular degeneration: systematic review of economic evidence and primary economic evaluation.

OBJECTIVE: To examine the economic implications for the Canadian health system of pharmacologic treatment of neovascular age-related macular degeneration (AMD). DESIGN: Systematic review of economic literature and a primary economic evaluation. PARTICIPANTS: Economic literature search identified 392 potentially relevant articles, 12 of which were included for final review. METHODS: Studies were included if they met the following criteria: (i) provision of a summary measure of the trade-off between costs and consequences; (ii) participants of 40 years and older with neovascular AMD; (iii) interventions and comparators: comparison of photodynamic therapy using verteporfin (V-PDT), pegaptanib, bevacizumab, ranibizumab, anecortave acetate, intravitreal triamcinolone, placebo, or clinically relevant combinations; and (iv) outcome reported as an incremental measure of the implication of moving from the comparator to the intervention. The following databases were searched through the OVID interface: MEDLINE, EMBASE, BIOSIS Previews, CINAHL, PubMed, Health Economic Evaluations Database (HEED), and the Cochrane Library. For the economic evaluation, we took a decision analytic approach and modeled a cost-utility analysis, conducting it as a microsimulation of a Markov model. RESULTS: In general, V-PDT is more cost effective than conventional macular laser, and pegaptanib is likely more cost effective than V-PDT. The primary economic analysis revealed ranibizumab to be effective but at an unacceptably high cost per quality-adjusted life year (QALY)(>$50,000 per QALY). CONCLUSIONS: Although ranibizumab is effective for wet AMD, its cost is unacceptably high based on cost-utility theory.

A cost-effectiveness analysis of three treatments for age-related macular degeneration.

PURPOSE: The purpose of this study was to evaluate the cost effectiveness of pegaptanib sodium and ranibizumab injections compared with photodynamic therapy (PDT) with verteporfin for the treatment of choroidal neovascularization secondary to age-related macular degeneration. METHODS: The analyses were performed using outcomes data from the pivotal trials for each treatment and the medicare reimbursable costs for each treatment and associated medical procedures. A multistate transition model with 3-month cycles was created to compare incremental medical costs associated with pegaptanib or ranibizumab versus PDT for patients with starting vision of 20/40, 20/80, and 20/200 Snellen equivalent. RESULTS: Two-year medical treatment costs ranged from $3,100 to $54,100 depending on treatment and lesion type. Photodynamic therapy was less costly and more effective than pegaptanib for predominantly classic and minimally classic lesions. Ranibizumab was not only more effective but also more costly than PDT for all lesion types. CONCLUSION: Compared with PDT, pegaptanib is inferior in both cost and effectiveness, whereas ranibizumab has a greater effectiveness. Because ranibizumab does not meet 1 of the common thresholds for being considered cost effective (<$50,000 per quality-adjusted life year), there is rationale to seek other therapies that are more cost effective.

Cost-effectiveness of ranibizumab compared with pegaptanib in neovascular age-related macular degeneration.

OBJECTIVE: To assess the cost-effectiveness of ranibizumab compared with pegaptanib in the treatment of patients with minimally classic/occult neovascular age-related macular degeneration (AMD), from a societal perspective in Spain. METHODS: We constructed a Markov model with five states defined by visual acuity (VA) in the better-seeing eye (Snellen scale): VA >20/40, < or =20/40 to >20/80, < or =20/80 to >20/200, < or =20/200 to >20/400, < or =20/400, and an additional death state. Two cohorts of patients were distributed along the VA states, and treated with either ranibizumab or pegaptanib. Transition probabilities assigned for movement between these states with both drugs were obtained from published randomized clinical trials. Medical costs related to AMD treatment and follow-up, medical costs related to AMD comorbidities, and non-medical-related costs were taken into account. Costs (2008 Euro), health outcomes (Quality-adjusted life years--QALYs), both discounted at a 3.5% annual rate, and incremental cost-effectiveness ratios (ICER: euro/QALY), were determined for a lifetime horizon in the base case analysis. Sensitivity analyses were conducted to explore different scenarios and assumptions in the model. RESULTS: Treating patients with varying degrees of visual impairment with monthly ranibizumab instead of pegaptanib was 71,206 euro more costly and provided 2.437 additional QALYs (29,224 euro/QALY). When administered on an as-needed basis, as in the Prospective Optical Coherence Tomography Imaging of Patients with Neovascular AMD Treated with Intraocular Ranibizumab (PrONTO) trial, the cost per QALY gained with ranibizumab was reduced to 4,623 euro. CONCLUSIONS: The cost per QALY gained with monthly ranibizumab compared with pegaptanib in the minimally classic/occult neovascular AMD population is just below the 30,000 euro threshold below which new drugs are sometimes regarded as cost-effective strategies in Spain. In this model, the key variables with greater impact on the cost-effectiveness results were the selected time horizon and the chosen extrapolation method, the source for data on pegaptanib efficacy and the number of ranibizumab injections. When administered on an as-needed basis, ranibizumab was a cost-effective strategy compared to pegaptanib in this population.

The treatment of wet AMD in Canada: access to therapy (policy review).

Age-related macular degeneration (AMD) is the leading cause of blindness in North America, affecting 2 million Canadians older than age 50 years. AMD is subdivided into 2 types: an atrophic form, so-called "dry" AMD, and an exudative or "wet" form, characterized by the presence of choroidal neovascularization (CNV). Since 2000, after decades with no effective therapy aside from thermal obliterative laser treatment of CNV, 3 new treatments have been approved, each offering significant therapeutic advances at increasingly higher prices, and in an increasingly cost-containment-oriented payer environment. Many of Canada's public drug plans have been relatively slow to fund evidence-based, approved treatments. This paper reviews the disease, as well as the current private and public coverage for wet AMD treatments.

Computerized model of cost-utility analysis for treatment of age-related macular degeneration.

PURPOSE: To present a computerized model assessing individualized cost utility for current treatments for neovascular age-related macular degeneration (AMD) to enhance discussion regarding treatment options. DESIGN: Case- and eye-specific cost-utility analysis using individual case scenarios. PARTICIPANTS: Visual acuity data from published randomized controlled trials are incorporated into this analysis. METHODS: Computerized model (Microsoft Visual Basic 6.0 programming) to establish preference-based cost-utility analysis in association with individual cost of treatment and blindness for neovascular AMD for both the better and worst seeing eye, with extrapolation of results over a 5-year term. MAIN OUTCOME MEASURES: Cost per quality-adjusted life-year (QALY) and cost per QALY gained for comparison of treatments for specific visual acuities. RESULTS: All treatments show an increase in utility in comparison with best supportive care (BSC) if the better-seeing eye is treated. Ranibizumab, using the Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularisation (CNV) with or without Classic CNV Secondary to AMD (PIER) regimen, is the most cost effective at $626 938 per QALY gained for treatment of the better seeing eye. To increase utility value when treating the worst seeing eye, the vision must improve to such a degree that it becomes the better seeing eye. This level of improvement is only possible if there is <9 letters difference between the 2 eyes and treated with ranibizumab. Over 5 years, increasing influence from the cost of blindness results in increasing costs for those treatments unable to stabilize vision. Within 5 years, the cost per QALY for the BSC is greater than all treatments except monthly ranibizumab injections. CONCLUSIONS: Assessment of cost of treatment incorporates both effectiveness of treatment, cost of treatment, and cost of blindness. Cost analysis enables incorporation of these aspects of treatment with the quality of life data to provide a better comparison of treatments over time. This analysis has provided a method for individual analysis and therefore can provide the structure for resource allocation. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.

A value-based medicine analysis of ranibizumab for the treatment of subfoveal neovascular macular degeneration.

OBJECTIVE: To assess the conferred value and average cost-utility (cost-effectiveness) for intravitreal ranibizumab used to treat occult/minimally classic subfoveal choroidal neovascularization associated with age-related macular degeneration (AMD). DESIGN: Value-based medicine cost-utility analysis. PARTICIPANTS: MARINA (Minimally Classic/Occult Trial of the Anti-Vascular Endothelial Growth Factor Antibody Ranibizumab in the Treatment of Neovascular AMD) Study patients utilizing published primary data. METHODS: Reference case, third-party insurer perspective, cost-utility analysis using 2006 United States dollars. MAIN OUTCOME MEASURES: Conferred value in the forms of (1) quality-adjusted life-years (QALYs) and (2) percent improvement in health-related quality of life. Cost-utility is expressed in terms of dollars expended per QALY gained. All outcomes are discounted at a 3% annual rate, as recommended by the Panel on Cost-effectiveness in Health and Medicine. Data are presented for the second-eye model, first-eye model, and combined model. RESULTS: Twenty-two intravitreal injections of 0.5 mg of ranibizumab administered over a 2-year period confer 1.039 QALYs, or a 15.8% improvement in quality of life for the 12-year period of the second-eye model reference case of occult/minimally classic age-related subfoveal choroidal neovascularization. The reference case treatment cost is $52652, and the cost-utility for the second-eye model is $50691/QALY. The quality-of-life gain from the first-eye model is 6.4% and the cost-utility is $123887, whereas the most clinically simulating combined model yields a quality-of-life gain of 10.4% and cost-utility of $74169. CONCLUSIONS: By conventional standards and the most commonly used second-eye and combined models, intravitreal ranibizumab administered for occult/minimally classic subfoveal choroidal neovascularization is a cost-effective therapy. Ranibizumab treatment confers considerably greater value than other neovascular macular degeneration pharmaceutical therapies that have been studied in randomized clinical trials.

Eye-related medicare costs for patients with age-related macular degeneration from 1995 to 1999.

OBJECTIVE: Age-related macular degeneration (AMD) is the leading cause of blindness and severe visual impairment among the elderly in the United States. This study aims to assess eye-related Medicare costs from 1995 to 1999 in patients with both nonneovascular and neovascular AMD as compared with controls, and to delineate whether variations exist across demographic and clinical subgroups in eye-related Medicare costs over 5 years. DESIGN: Retrospective, observational, population-based analysis. PARTICIPANTS: Five percent random sample of Medicare beneficiaries. METHODS: Data were obtained from the 5% random sample of Medicare beneficiaries with diagnoses of nonneovascular and neovascular AMD. A control group was selected based on diagnoses of blepharitis, chronic conjunctivitis, or blepharoconjuctivitis and no diagnosis of AMD. Eye-related claims were totaled and compared for each group over the 5-year study period. Demographic and clinical factors potentially influencing eye-related costs were also examined. MAIN OUTCOME MEASURES: Eye-related Medicare costs during the 5-year study period. RESULTS: Median eye-related Medicare costs were estimated at $1607 for neovascular AMD patients, $832 for nonneovascular AMD patients, and $658 for controls. Cost differences across groups were significant based on univariate and multivariate analyses (P<0.001). In linear regression analysis, males and blacks had significantly lower eye-related Medicare costs than females and whites, respectively (P<0.001). CONCLUSIONS: Age-related macular degeneration represented a significant economic burden to the U.S. health care system for a single ophthalmic disease entity based on Medicare reimbursed eye-related costs before the availability of photodynamic therapy and anti-vascular endothelial growth factor therapy. Given that direct eye-related costs associated with the treatment of neovascular AMD are estimated at $569 million annually before the availability of therapy for subfoveal lesions, effective therapeutic measures may be associated with substantial cost offsets.