Section 5 of 6

Economic information and modeling report

52 evidence topics · 36 sources

Modeling overview

Summary

No AXPAXLI-specific cost-effectiveness analysis, budget impact analysis, health technology assessment, or announced price was identified. The manufacturer's Form 10-K states that the U.S. exudative retinal disease market accounted for approximately $9.4 billion in estimated revenues in 2025 and that approximately 1.7 million people in the United States had wet AMD in 2025. In its second quarter 2026 results, the manufacturer reported a post hoc SOL-1 analysis estimating up to a 72% reduction in treatment burden over 60 weeks versus a projected on-label aflibercept 2 mg every 8 weeks schedule (56% when loading doses are included), and stated that Tier 1 Medicare Advantage and commercial payers "have indicated that a label demonstrating superior durability could command premium pricing".

Published U.S. models of intravitreal anti-VEGF therapy show that results depend on drug acquisition price and injection frequency. In an 11-year cost-utility analysis, average cost-utility ratios were $11,033 per QALY for bevacizumab, $79,600 per QALY for ranibizumab, and $44,801 per QALY for aflibercept, with an incremental ratio of $1,151,451 per QALY for aflibercept versus bevacizumab. A 20-year model based on CATT reported an incremental ratio above $10 million per QALY for monthly ranibizumab versus monthly bevacizumab. A Medicare Part B model estimated $18 billion in savings over 10 years (2010 to 2020) if all patients received bevacizumab. A sponsor-funded lifetime model reported lower total costs for aflibercept every 8 weeks than for monthly ranibizumab ($33,745 vs $48,031) because of fewer injections. An independent 5-year U.S. payer model found faricimab dominant over aflibercept 2 mg (US$52,797 vs US$62,367; 2.80 vs 2.72 QALYs), driven by 22.6 versus 34 injections, whereas faricimab every 8 weeks had an incremental ratio of US$162,175 per QALY. A Regeneron-sponsored 3-year model estimated total costs US$1,978.74 lower with aflibercept 8 mg than with faricimab (12.25 vs 14.80 injections).

For sustained-delivery and one-time therapies, a U.S. cost-utility analysis of the ranibizumab port delivery system reported an incremental ratio of $75,497 per QALY at 1 year, $304,108 per QALY at 5 years, and $761,646 per QALY at 12 years versus ranibizumab injections. A Medicare-based cost analysis found that the port delivery system with one refill cost more than ranibizumab or aflibercept injections when approximately 11 or 10 or fewer injections, respectively, are required in the first year. A discounted cash flow analysis valued a one-time alternative to lifelong anti-VEGF injections at $208,420.61 (aflibercept), $219,093.31 (ranibizumab), and $17,379.41 (bevacizumab).

In health technology assessments of longer-interval agents, NICE recommended faricimab based on a cost comparison with aflibercept and ranibizumab, and both Canadian reviews required a price no higher than the lowest-cost funded comparator. CADTH estimated an incremental ratio of $695,839 per QALY for faricimab versus bevacizumab. For aflibercept 8 mg, CDA-AMC found that the sponsor's projected 3-year budget savings of $158,158,913 became additional costs of $18.8 million and $21.5 million over 3 years in scenarios varying administration frequency and vial sharing. European cost-minimization models (Netherlands, Switzerland, Norway) estimated the lowest per-patient costs for aflibercept 8 mg because of lower injection frequency. A U.S. budget impact model of brolucizumab for a health plan with 1 million enrollees estimated annual cost increases of $824,696 (as-needed regimen) and $163,101 (treat-and-extend regimen) and annual savings of $93,068 and $94,170 under the manufacturer-recommended and real-world regimens, showing that budget impact depends on the dosing regimen assumed.

AXPAXLI-specific cost-effectiveness or budget impact analysis

No evidence found.

AXPAXLI price

No evidence found.

Institute for Clinical and Economic Review assessment of AXPAXLI or nAMD therapies

No evidence found.

Manufacturer market estimates: U.S. exudative retinal disease and wet AMD

“AXPAXLI is seeking to address segments of the exudative retinal diseases market, which in the aggregate is estimated to include up to 8.3 million patients in the United States by 2030 and accounted for approximately $9.4 billion in U.S. annual estimated revenues in 2025, according to the Market Scope 2025 Exudative Retinal Disease Pharmaceuticals Report, published in October 2025, or the Market Scope 2025 Retina Report.” (opens the source at this quote in a new tab)
“According to the Market Scope 2025 Retina Report, there were approximately 14.8 million people globally and 1.7 million people in the United States who suffered from wet AMD in 2025, and this population is expected to grow at a 3.0% and 3.3% compound annual growth rate, or CAGR, respectively, through 2030.” (opens the source at this quote in a new tab)
“The market for the treatment of wet AMD consists predominantly of five anti- VEGF, drugs, including four drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD” (opens the source at this quote in a new tab)

Manufacturer statements on pricing, reimbursement risk, and treatment burden

“if we are not able to achieve the pricing and reimbursement coverage we anticipate for AXPAXLI, if approved, our net product revenues would be impacted significantly” (opens the source at this quote in a new tab)
“Our prolonged constant rate of axitinib delivery over a nine-to-twelve-month period could make it possible to reduce patients’ treatment burden by reducing the frequency of treatment for wet AMD.” (opens the source at this quote in a new tab)

Manufacturer payer research and market research after SOL-1

“Commercial readiness activities, including market and payer research, advancing rapidly ahead of a potential 2027 launch of AXPAXLI, if approved.” (opens the source at this quote in a new tab)
“Following SOL-1's results, market research found that approximately 80% of retina specialists surveyed would likely use a product with AXPAXLI’s profile based on SOL-1 data alone, with more than 90% expected to adopt such a product within its first year, if approved.” (opens the source at this quote in a new tab)
“Ocular's payer team has also engaged 100% of Tier 1 Medicare Advantage and commercial payers, who have indicated that a label demonstrating superior durability could command premium pricing.” (opens the source at this quote in a new tab)

Manufacturer post hoc projection of treatment burden reduction in SOL-1

“Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI relative to a projected on-label dosing regimen of aflibercept (2 mg) every 8 weeks.” (opens the source at this quote in a new tab)
“The proportion of SOL-1 patients who would have remained rescue-free under the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline was 66.5% at Week 52.” (opens the source at this quote in a new tab)
“Applying the observed mean rescue treatment rates in SOL-1 to the estimated 33.5% of subjects requiring rescue under the SOL-R criteria corresponded to an average of 0.95 aflibercept (2 mg) rescues per subject for all subjects in the AXPAXLI arm through Week 52 after a single AXPAXLI injection at baseline.” (opens the source at this quote in a new tab)
“The total estimated mean injection burden with AXPAXLI represents a 72% reduction counting from the first screening visit at Week -8 excluding loading doses and a 56% reduction when loading doses are included, as compared to a projected on-label dosing regimen of aflibercept (2 mg) with no rescues.” (opens the source at this quote in a new tab)

U.S. cost-utility analysis of bevacizumab, ranibizumab, and aflibercept over 11 and 2 years

“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.” (opens the source at this quote in a new tab)
“Bevacizumab and ranibizumab each conferred an 11-year, 1.339 QALY gain versus observation. Aflibercept conferred a 1.380 QALY gain.” (opens the source at this quote in a new tab)
“Aflibercept conferred greater QALY gain for less cost than ranibizumab but was not cost-effective compared to bevacizumab ($1,151,451/QALY incremental CUR).” (opens the source at this quote in a new tab)
“The average ophthalmic cost perspective CUR for bevacizumab was $11,033/QALY, $79,600/QALY for ranibizumab, and $44,801/QALY for aflibercept.” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

U.S. societal cost-benefit analysis of anti-VEGF monotherapies

“Bevacizumab monotherapy had an individual, 11-year $14,772 treatment cost and net $357,680 societal return (11-year 2,421% return on investment [ROI]). Ranibizumab therapy cost $106,582 and returned $265,870 to society (249% ROI), whereas aflibercept treatment cost $61,811 and returned $310,611 to society (503% ROI).” (opens the source at this quote in a new tab)
“Substituting bevacizumab for ranibizumab and aflibercept in the 2018 new-onset NVAMD patients would save an estimated $1.343 billion over 11 years.” (opens the source at this quote in a new tab)

U.S. cost-effectiveness analysis of monthly and as-needed bevacizumab and ranibizumab based on CATT

“Using a mathematical 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.” (opens the source at this quote in a new tab)
“Monthly ranibizumab gains an additional 0.02 QALYs versus monthly bevacizumab at an incremental cost-effectiveness ratio of more than $10 million/QALY. As-needed ranibizumab was dominated by monthly bevacizumab, meaning it was more costly and less effective.” (opens the source at this quote in a new tab)
“In sensitivity analyses assuming a willingness to pay of $100 000/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/QALY.” (opens the source at this quote in a new tab)

U.S. payer Markov model of bevacizumab versus ranibizumab

“A hypothetical cohort of 1000 patients was simulated through the model for 20 years.” (opens the source at this quote in a new tab)
“The cost-effectiveness ratios (CER) for bevacizumab and ranibizumab were $1405 per QALY and $12,177 per QALY, respectively. The ICER for bevacizumab was dominant compared to ranibizumab.” (opens the source at this quote in a new tab)

Medicare Part B population model of bevacizumab substitution

“Ophthalmologic use of these drugs has increased, now accounting for roughly one-sixth of the Medicare Part B drug budget.” (opens the source at this quote in a new tab)
“Our results show that if all patients were treated with the less-expensive bevacizumab instead of current usage patterns, Medicare Part B, patients, and the health care system would save $18 billion, $4.6 billion, and $29 billion, respectively.” (opens the source at this quote in a new tab)

Medicare Part B counterfactual spending simulation by community agent mix

“From 2013-2023, 5,178 providers billed Part B for 34.5 million anti-VEGF injections.” (opens the source at this quote in a new tab)
“Equalizing anti-VEGF mix to that of the highest-poverty quartile would have resulted in approximately $4.2 billion lower spending.” (opens the source at this quote in a new tab)

U.S. cost analysis of an intravitreal bevacizumab biosimilar and anti-VEGF biosimilars

“If an intraocular bevacizumab biosimilar were to be priced at $500, costs to Medicare would increase by $457 million from $3.01 billion to $3.47 billion (15.2% increase).” (opens the source at this quote in a new tab)
“If bevacizumab were $500/dose, switching all patients currently receiving ranibizumab or aflibercept to respective biosimilars would compensate for only 28.8% of the increased cost.” (opens the source at this quote in a new tab)

Sponsor-funded U.S. cost-effectiveness analysis of aflibercept 2 mg versus ranibizumab

“Over a lifetime, IAI 2q8 provided equal health benefits with Rq4 (5.44 QALYs) at a lower total cost ($33,745 vs. $48,031) as a result of fewer injections.” (opens the source at this quote in a new tab)
“IAI 2q8 yielded slightly greater QALYs versus ranibizumab PRN (5.44 vs. 5.40) at a slightly higher cost ($33,745 vs. $33,652), with an incremental cost per QALY gained of $2,583.” (opens the source at this quote in a new tab)
“Results were sensitive to variations in drug acquisition costs and number of injections of both drugs and the baseline age of the cohort.” (opens the source at this quote in a new tab)
“This study was funded by Regeneron Pharmaceuticals, the manufacturer of aflibercept.” (opens the source at this quote in a new tab)

U.S. cost-utility analysis of faricimab versus aflibercept 2 mg: model structure

“The model was conducted from a healthcare payer perspective in the US and developed over a 5-year time horizon in the base-case analysis.” (opens the source at this quote in a new tab)
“Costs and health outcomes accrued beyond the first year were discounted at an annual rate of 3%, consistent with established economic evaluation guidelines [15].” (opens the source at this quote in a new tab)
“A cycle length of 3-months was selected to align with the dosing schedules of faricimab and aflibercept and to adequately capture treatment-related changes in visual outcomes over time [20].” (opens the source at this quote in a new tab)
“Health states were defined in 15-letter increments as follows: VA ≥ 84 letters, 69–83 letters, 54–68 letters, 39–53 letters, and VA ≤ 38 letters, with an additional absorbing death state.” (opens the source at this quote in a new tab)

U.S. cost-utility analysis of faricimab versus aflibercept 2 mg: cost inputs

Cost input	Value (USD)
Faricimab (6.0 mg cost per dose)	“$2089.44”
Aflibercept (2.0 mg cost per dose)	“$1670.798”
Intravitreal injection (CPT 67028)	“$125.28”
Initial office visit (per visit; CPT 99204)	“$226.53”
Subsequent office visit (per visit; CPT 92014)	“$157.64”
Optical coherence tomography (OCT; CPT 92134)	“$54.17”
Fluorescein angiography (FA; CPT 92235)	“$114.37”
Management of endophthalmitis	“$3958.12”

U.S. cost-utility analysis of faricimab versus aflibercept 2 mg: base case and scenario results

“In the base case, faricimab yielded 2.80 QALYs for US$52,797, whereas aflibercept produced 2.72 QALYs at US$62,367. Faricimab was therefore dominant (- US$9570; + 0.08 QALY), with an incremental NMB of US$17,981. Faricimab required markedly fewer injections over 5 years (22.6 vs 34).” (opens the source at this quote in a new tab)
“Under the Q8W regimen, faricimab was more costly than aflibercept (US$76,008 vs US$62,368) despite higher effectiveness (2.801 vs 2.716 QALYs; incremental QALYs 0.084). The resulting ICER of US$162,175 per QALY exceeded commonly cited WTP thresholds, indicating that faricimab was not cost effective at this dosing interval.” (opens the source at this quote in a new tab)
“The Q16W regimen further increased cost savings (> US$20,000) and achieved the highest NMB (US$238,042).” (opens the source at this quote in a new tab)
“In Table 6, the neutral scenario, where both treatment arms shared identical transition matrices, effectiveness outcomes were equal (2.759 QALYs for both treatments), and economic differences were driven entirely by costs.” (opens the source at this quote in a new tab)
“Probabilistic analysis showed a 97% probability of faricimab being cost effective at US$100,000/QALY.” (opens the source at this quote in a new tab)

U.S. cost-utility analysis of faricimab versus aflibercept 2 mg: authors' interpretation of durability and price

“This finding emphasizes that treatment durability may outweigh unit price differences when cumulative costs are considered over time.” (opens the source at this quote in a new tab)
“Injection frequencies were derived from pooled estimates of two global phase III trials, which may not fully reflect real-world treatment patterns.” (opens the source at this quote in a new tab)

Sponsor-funded U.S. cost model of aflibercept 8 mg versus faricimab

“Direct costs were estimated based on modeled mean injection numbers and 2025 wholesale acquisition costs per injection (aflibercept 8 mg: 2677.50 USD; faricimab: 2289.65 USD) plus medical monitoring costs.” (opens the source at this quote in a new tab)
“Indirect costs included caregiver and patient time and travel costs.” (opens the source at this quote in a new tab)
“Over a 3-year time horizon, the mean number of injections was lower with aflibercept 8 mg versus faricimab for nAMD (12.25 vs. 14.80 injections) and DME (11.80 vs. 15.65 injections). Total costs (direct and indirect) associated with aflibercept 8 mg were 1978.74 USD lower than faricimab for nAMD and 6032.90 USD lower than faricimab for DME.” (opens the source at this quote in a new tab)
“For patients with nAMD, total costs associated with aflibercept 8 mg were marginally higher (115.59 USD) versus faricimab in year 1 despite similar injection numbers (5.65 vs. 6.40).” (opens the source at this quote in a new tab)
“In the sensitivity analysis that considered direct costs only over 3 years, aflibercept 8 mg was consistently associated with lower total direct costs than faricimab for both nAMD (1313.50 USD lower total direct costs) and DME (4942.31 USD lower total direct costs)” (opens the source at this quote in a new tab)
“Limitations of the present analysis include an indirect comparison of injection frequencies across the pivotal trials, as randomized head-to-head data are not available.” (opens the source at this quote in a new tab)

U.S. budget impact analysis of brolucizumab dosing regimens

“A Microsoft Excel-based budget impact model was developed for different treatment regimens of brolucizumab over a 1-year time frame from a US payer perspective.” (opens the source at this quote in a new tab)
“Model inputs included drug costs, administration costs, physician visit costs, and disease monitoring costs. Outcomes in the budget impact model included the cost per member per month, annual health plan cost, and the US patient population-based annual cost.” (opens the source at this quote in a new tab)
“The maximum increase in expenditure for a hypothetical health plan with 1 million enrollees was associated with the PRN regimen ($824,696), followed by the T&E regimen ($163,101). In contrast, using the manufacturer-recommended and RWE regimens led to an annual saving of $93,068 and $94,170 for the health plan, respectively.” (opens the source at this quote in a new tab)
“Payers need to evaluate the cost impact of different treatment regimens of existing and new anti-VEGFs when making formulary decisions in nAMD management.” (opens the source at this quote in a new tab)

U.S. cost-utility analysis of the ranibizumab port delivery system

“Ophthalmic patient, time tradeoff utilities, direct medical and societal cost perspectives, 12-year, 1-year, and 5-year timelines, United States 2022 real dollars, and a 3% annual discount rate were employed.” (opens the source at this quote in a new tab)
“One-year direct PDS ophthalmic costs totaled $21 825 with 2 ranibizumab fills, whereas ranibizumab injection therapy totaled $18 405 with 11.8 injections.” (opens the source at this quote in a new tab)
“The 1-year incremental PDS $/QALY versus injections was cost effective at $75 497/QALY. Five-year PDS therapy was not incrementally cost effective at $304 108/QALY, nor was the 12-year therapy at $761 646/QALY.” (opens the source at this quote in a new tab)
“Vision gain was the major determinant of participant value gain and was the same for both interventions.” (opens the source at this quote in a new tab)

U.S. Medicare cost analysis of the ranibizumab port delivery system versus intravitreal injections

“The mean (SD) number of ranibizumab, aflibercept, and bevacizumab injections to break even with the cost of ranibizumab PDS with 1 refill was 10.8 (1.3), 9.3 (1.1), and 34.5 (4.2), respectively.” (opens the source at this quote in a new tab)
“Over 5 years, monthly intravitreal ranibizumab projected to cost $25 581 (95% CI, $2275-$48 887; P = .04) more, aflibercept cost $44 374 (95% CI, $18 623-$70 125; P = .008) more, and bevacizumab cost $67 793 (95% CI, -$82 501 to -$53 085; P < .001) less than PDS with fixed refills (mean [SD] cost, $89 218 [$8921]).” (opens the source at this quote in a new tab)
“In scenario analyses, ranibizumab PDS with refills as needed offered cost savings compared with real-world intravitreal ranibizumab or aflibercept use at 5 years but not at 1 year.” (opens the source at this quote in a new tab)
“Long term, if less than 4.4 and 3.8 injections are needed per refill, intravitreal ranibizumab and aflibercept is lower cost. Ranibizumab PDS costs more than intravitreal bevacizumab injections throughout scenarios.” (opens the source at this quote in a new tab)

U.S. discounted cash flow valuation of a one-time anti-VEGF gene therapy

“Discounted cash flow analysis of intravitreal anti-VEGF treatment for nAMD resulted in a base-case valuation of $208 420.61, $219 093.31, and $17 379.41 for a 1-time alternative treatment to aflibercept, ranibizumab, and bevacizumab, respectively.” (opens the source at this quote in a new tab)
“This figure covaried significantly with anti-VEGF agent according to the patient age at first injection ($78 323.19-$292 449.87) and frequency of injections ($148 422.91-$388 096.81).” (opens the source at this quote in a new tab)
“Given the high present values for these therapeutics, innovative costing and reimbursement mechanisms should be further explored, with contingencies for sustained efficacy.” (opens the source at this quote in a new tab)

U.S. model of examination-directed treatment paradigms and injection frequency

“Although yearly examinations and optical coherence tomography costs were higher for injection series, T&E, and as-needed protocols compared with automatic treatment, our model predicts reduced yearly injection and travel costs for those same treatment scenarios also, saving $2.9 billion (injection series), $7.2 billion (T&E), and $6.1 billion (as-needed) annually for the US population.” (opens the source at this quote in a new tab)

NICE cost comparison of faricimab

“A cost comparison suggests faricimab has similar costs and overall health benefits to aflibercept or ranibizumab.” (opens the source at this quote in a new tab)
“If patients and their clinicians consider faricimab to be 1 of a range of suitable treatments (including aflibercept and ranibizumab), choose the least expensive treatment. Take account of administration costs, dosage, price per dose and commercial arrangements.” (opens the source at this quote in a new tab)

“The company base case assumed there would be fewer injections and monitoring visits needed for faricimab compared with the comparators. But the committee was aware that in NHS clinical practice faricimab may have a similar dosing regimen as aflibercept and ranibizumab.” (opens the source at this quote in a new tab)
“The committee acknowledged that if the time needed between injections is lengthened, then the cost of faricimab would reduce.” (opens the source at this quote in a new tab)

CADTH pharmacoeconomic review of faricimab: cost-utility reanalysis

“The CADTH reanalysis resulted in a deterministic incremental cost-effectiveness ratio (ICER) for faricimab versus bevacizumab of $695,839 per quality-adjusted life-year (QALY); incremental costs were $68,328, with 0.098 incremental QALYs.” (opens the source at this quote in a new tab)
“A 79% price reduction would be required for faricimab to be cost-effective relative to bevacizumab; however, this may need to be greater than 98% if there is no difference in the frequency of administrations and efficacy regarding visual acuity (VA).” (opens the source at this quote in a new tab)
“The scenario analysis assuming equal administration frequency and equal efficacy shows that the total costs associated with faricimab approach that of other alternatives, confirming that the degree of cost difference shown in the base-case analysis is derived from an assumed difference in administration frequency.” (opens the source at this quote in a new tab)
“To ensure cost-effectiveness, the cost of faricimab per administration should therefore be no more than that of the lowest-cost comparator that is funded.” (opens the source at this quote in a new tab)

CADTH pharmacoeconomic review of faricimab: budget impact analysis

“The analysis was taken from the perspective of the Canadian public drug plans using an epidemiology-based approach with only drug acquisition costs included in the base case. A 3-year time horizon was used, from 2023 to 2025, with 2022 as a base year.” (opens the source at this quote in a new tab)
“Based on the CADTH base case, the estimated cost savings of the reimbursement of faricimab for the treatment of adults with nAMD are expected to be $6,821,777 in year 1, $27,446,705 in year 2, and $55,736,999 in year 3, for a 3-year total cost savings of $90,005,481.” (opens the source at this quote in a new tab)
“A scenario analysis was conducted in which multiple administrations were assumed possible from one vial of aflibercept or ranibizumab. The budget impact from this analysis was $61,586,628 in additional costs (i.e., incremental costs) over 3 years. Thus, the budget impact is highly sensitive to assumptions about vial sharing.” (opens the source at this quote in a new tab)

CDA-AMC pharmacoeconomic review of aflibercept 8 mg: cost-utility analysis

“In sequential analysis, aflibercept 8 mg every 16 weeks was associated with an incremental cost-effectiveness ratio (ICER) of $51,463 versus bevacizumab ($9,515 in incremental costs: 0.18 QALYs), with a 45% probability of being cost-effective at a willingness-to-pay threshold of $50,000 per QALY gained.” (opens the source at this quote in a new tab)
“The sponsor’s model estimated 0.002 incremental QALYs with aflibercept 8 mg every 16 weeks treatment compared with bevacizumab in the first year of treatment (the approximate duration of the PULSAR trial), indicating that approximately 99% of the incremental benefit are accrued during the extrapolated portion of the model.” (opens the source at this quote in a new tab)
“To ensure cost-effectiveness, aflibercept 8 mg should be priced no more than the lowest cost anti-VEGF that is funded for the treatment of nAMD.” (opens the source at this quote in a new tab)

CDA-AMC pharmacoeconomic review of aflibercept 8 mg: budget impact analysis

“The BIA was undertaken using an epidemiologic approach from the perspective of a Canadian public payer over a three-year time horizon (January 2024 to December 2026).” (opens the source at this quote in a new tab)
“Results of the sponsor analysis suggest that the reimbursement of aflibercept 8 mg for the treatment of nAMD will be associated with an incremental savings of $21,217,778 in year 1, $56,283,529 in year 2, and $80,657,606 in year 3, for a 3-year incremental budgetary savings of $158,158,913.” (opens the source at this quote in a new tab)
“results of these analyses suggested that the introduction of aflibercept 8 mg would not be cost saving, rather, it would result in $18.8 million and $21.5 million additional costs over 3 years, respectively, indicating that the cost savings associated with the reimbursement of aflibercept 8 mg may have been overestimated in the sponsor’s base case.” (opens the source at this quote in a new tab)
“In addition, the predicted cost savings associated with the introduction of aflibercept 8 mg was highly influenced by assuming a hypothetical price of an aflibercept 2 mg biosimilar with an estimated decline in cost savings of 67% compared to the sponsor’s base-case analysis.” (opens the source at this quote in a new tab)

Dutch cost-minimization analysis of anti-VEGF agents with lower injection frequency

“Based on list prices, aflibercept 8 mg led to the lowest treatment costs (€16,251 per patient over a 3-year time horizon), closely followed by bevacizumab (€17,616 per patient over a 3-year time horizon). Ranibizumab led to the highest per-patient costs (€31,746 over a 3-year time horizon).” (opens the source at this quote in a new tab)
“To be cost-equal to bevacizumab with current list prices, anti-VEGFs should be administered with a maximum of 12.7 to 13.8 injections over a 3-year time horizon.” (opens the source at this quote in a new tab)

Swiss cost-minimization and break-even analysis of anti-VEGF agents

“Aflibercept 8 mg was estimated to be associated with the lowest treatment costs for both indications (CHF 11,814 for nAMD; CHF 11,242 for DMO).” (opens the source at this quote in a new tab)
“Break-even analyses for nAMD showed that prices would need to drop by -22% (faricimab, CHF 644) to -64% (ranibizumab reference, CHF 218) relative to aflibercept 8 mg.” (opens the source at this quote in a new tab)
“The OWSA highlighted medication price and injection frequency as primary cost drivers.” (opens the source at this quote in a new tab)

Norwegian cost-minimization model including non-drug and patient costs

“Over 2 years, the switching regimen had the highest per-patient cost (146 722 NOK), followed by Eylea 2 mg (100 481 NOK), Vabysmo (93 207 NOK), Avastin (86 262 NOK) and Eylea 8 mg (68 738 NOK).” (opens the source at this quote in a new tab)
“Avastin had the lowest drug cost, but its high injection frequency increased non-drug costs.” (opens the source at this quote in a new tab)

Dutch budget impact analysis of switching to faricimab based on real-world injection counts

“A meta-analysis of 19 real-world studies (2231 patients) was conducted.” (opens the source at this quote in a new tab)
“The base-case analysis projected annual savings of approximately €79 million, corresponding to 96,235 fewer injections nationwide.” (opens the source at this quote in a new tab)
“Scenario analyses showed that substantial savings (€16 to €75 million) can be achieved when using faricimab in second- and third-line settings, although replacing first-line bevacizumab would increase costs.” (opens the source at this quote in a new tab)

Break-even pricing framework for anti-VEGF agents with outcome equivalence

“Bevacizumab defined the lowest-cost benchmark (€4,130). Cost-neutral first-line use of newer agents required price reductions of 84-98%.” (opens the source at this quote in a new tab)
“Key drivers were acquisition price, injection frequency, and monitoring costs.” (opens the source at this quote in a new tab)

Spanish model of cost per optimal responder by agent, regimen, and administration format

“The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of €6214 per patient and a cost per optimal responder of €27 155.” (opens the source at this quote in a new tab)
“Faricimab with DSF VF ranked second, with a total cost of €5847 and a cost per optimal responder of €28 652, treating 171 patients and achieving 34 responders.” (opens the source at this quote in a new tab)

UK non-drug service costs and durability in cost-effectiveness analysis

“Scenario analysis using cost magnitudes estimated annual per-patient clinic cost at £845 (within capacity) to £13,960 (under strain) compared to an HTAmin estimate of £210.” (opens the source at this quote in a new tab)
“Given potential undertreatment due to strain, durability is suggested as one of the relevant factors in CEA of nAMD anti-VEGF treatments due to robustness under limited capacity conditions affecting UK ophthalmology services.” (opens the source at this quote in a new tab)

Systematic review of economic evidence for retinal diseases targeted by gene therapy

“A total of 28 research studies were identified and included in the review that varied in terms of disease of interest, size, country setting, methodology, as well as how costs were reported and valued.” (opens the source at this quote in a new tab)
“While many retinal diseases were considered, almost half of the articles related to the costs of neovascular age-related macular degeneration (nAMD).” (opens the source at this quote in a new tab)

Model structure of a United States budget impact analysis of brolucizumab

“Two Microsoft Excel–based budget impact models (BIMs) were developed: one for a health plan with hypothetical enrollees and the other based on actual US populations using 2022 US census data.” (opens the source at this quote in a new tab)
“The 4 treatment regimens included (1) the manufacturer-recommended regimen, as prescribed in the US Food and Drug Administration (FDA) label; (2) PRN; (3) T&E; and (4) the RWE regimen using data from RWE studies.” (opens the source at this quote in a new tab)
“The direct medical cost associated with anti-VEGFs in the 4 regimens differed primarily on the annual ophthalmologist visits and the number of anti-VEGF injections.” (opens the source at this quote in a new tab)
“The market share of anti-VEGFs was determined before and after the introduction of brolucizumab.” (opens the source at this quote in a new tab)

Perspective and time frame of the brolucizumab budget impact analysis

“Both models estimated the budget impact of brolucizumab using 4 treatment regimens over a 1-year time frame.” (opens the source at this quote in a new tab)
“A separate analysis was performed to estimate the budget impact from a US patient population perspective.” (opens the source at this quote in a new tab)
“The budget impact for the health plan was reported as total annual cost and per member per month (PMPM) cost.” (opens the source at this quote in a new tab)

Eligible population inputs of the brolucizumab budget impact analysis

“A 1-year BIM utilized a health plan with 1 million hypothetical enrollees.” (opens the source at this quote in a new tab)
“The treatment-eligible population was further divided into 1- (83.5%) and fellow-eye (16.5%) involvement based on the literature.” (opens the source at this quote in a new tab)
“The uptake of anti-VEGF among the eligible population in the base model was assumed to be 80%.” (opens the source at this quote in a new tab)
“For a health plan with a hypothetical 1 million enrollees, 3,460 patients (1-eye = 2,888 and fellow-eye = 572) with nAMD were estimated to be on anti-VEGFs. For the 2022 US population, 1,151,923 patients (1-eye = 961,418 and fellow-eye = 190,504) with nAMD were estimated to be on anti-VEGFs.” (opens the source at this quote in a new tab)
“The market share before brolucizumab was determined using 664,766 eye-level data taken from 3 RWE studies that used patient registries and health plan data.” (opens the source at this quote in a new tab)

Cost inputs and Medicare Part B payment assumptions of the brolucizumab budget impact analysis

“The BIM included direct medical costs related to drug acquisition, office visits, administration, and disease monitoring” (opens the source at this quote in a new tab)
“The cost associated with drug administration, office visits, and monitoring were based on per-visit service costs using Current Procedural Terminology codes reported in the Centers for Medicare and Medicaid Services physician fee schedule national payment.” (opens the source at this quote in a new tab)
“The number of annual office visits and OCT examinations were assumed to be equivalent to the number of injections for all regimens except PRN.” (opens the source at this quote in a new tab)
“For Part B drug payment, Medicare pays 80% to an ASP and an additional 6% of ASP (ASP + 6% × ASP). To this amount, a 2% sequester Medicare payment reduction is applied under the Budget Control Act of 2011.” (opens the source at this quote in a new tab)

Base case results of the brolucizumab budget impact analysis for a 1 million member plan

“The maximum increase in expenditure was associated with the PRN regimen (health plan = $824,696 and PMPM = $0.069), followed by the T&E regimen (health plan = $163,101 and PMPM = $0.014).” (opens the source at this quote in a new tab)
“The manufacturer-recommended regimen led to an annual savings of $93,068 (PMPM =$0.008), and the RWE regimen led to an annual savings of $94,170 (PMPM = $0.008).” (opens the source at this quote in a new tab)
“In the US population model, the introduction of brolucizumab resulted in a savings of $30.99 million and $31.35 million in the manufacturer and RWE regimens, respectively.” (opens the source at this quote in a new tab)

Medicare payment scenario and one-way sensitivity analyses in the brolucizumab budget impact analysis

“A scenario analysis was conducted for the US population model by incorporating the percentage of patients with nAMD enrolled in public and commercial health plans.” (opens the source at this quote in a new tab)
“Introducing brolucizumab as a treatment for nAMD increased the net budgetary impact for all the treatment regimens except RWE, which resulted in a savings of $3.14 million.” (opens the source at this quote in a new tab)
“In the PRN regimen, an increased prevalence of nAMD resulted in a budgetary increase of $1,168,319 compared with a budgetary increase of $824,696 in the base case model.” (opens the source at this quote in a new tab)
“In the T&E regimen, a decrease in brolucizumab WAC by 10% resulted in a net budgetary decrease and annual savings of $41,177 compared with the base model budgetary increase of $163,101.” (opens the source at this quote in a new tab)

Authors' interpretation and limitations of the brolucizumab budget impact analysis

“The differences in the outcome of the existing nAMD economic studies are primarily due to the differences in the cost and/or frequency of injections, as anti-VEGFs have shown similar outcomes in RCTs.” (opens the source at this quote in a new tab)
“Besides the cost and frequency of injections, a difference in the economic outcomes could arise because of the 1-eye vs 2-eye model, with 2-eye models generating a more accurate estimation of economic outcomes.” (opens the source at this quote in a new tab)
“Second, the study did not include adverse event–related cost differences among anti-VEGFs.” (opens the source at this quote in a new tab)
“Finally, 100% adherence to treatments and the stable prevalence of nAMD were assumed.” (opens the source at this quote in a new tab)

Cost perspectives, time horizon, and discounting in a United States cost-utility analysis of anti-VEGF agents

“The cost-utility methodology was similar to that used in other value-based medicine ophthalmic cost-utility analyses using patient utilities, an average national Medicare Fee Schedule, and a 3% annual discount rate for QALY outcomes and costs” (opens the source at this quote in a new tab)
“Using the ophthalmic cost perspective, the direct ophthalmic costs expended typically result in a positive CUR because the ophthalmic direct medical costs expended generally exceed ophthalmic direct medical costs saved (e.g., low-vision costs).” (opens the source at this quote in a new tab)
“Use of a societal cost perspective more commonly has a negative CUR because the direct ophthalmic medical costs expended are much more likely to be exceeded by the costs saved (caregiver costs, medical costs such as trauma and depression, wage loss prevented, and others).” (opens the source at this quote in a new tab)

First-eye, second-eye, and fellow-eye conversion assumptions in a United States cost-utility analysis of anti-VEGF agents

“The second-eye model assumes that the first eye already has vision loss from NVAMD or another cause. Thus, patient value gain begins immediately at the time of initiation of therapy in the second eye.” (opens the source at this quote in a new tab)
“With the first-eye model, it is assumed that the fellow eye has good vision.” (opens the source at this quote in a new tab)
“With the first-eye model, fellow eyes were treated if they converted from atrophic AMD to NVAMD over the 2- or 11-year model” (opens the source at this quote in a new tab)
“With the first-eye model, QALY gains were assumed to occur only when second eyes were treated for conversion for NVAMD and experienced decreased vision.” (opens the source at this quote in a new tab)

Unit cost sources and price-year conversion in a United States cost-utility analysis of anti-VEGF agents

“The ophthalmic direct medical costs (paid by insurers and patient out-of-pocket dollars) were taken directly from the 2018 national average Medicare fee schedule” (opens the source at this quote in a new tab)
“All non-2018 nominal dollar amounts were converted to 2018 U.S. real dollars by using the Consumer Price Index for All Urban Consumers (CPI-U).” (opens the source at this quote in a new tab)
“The U.S. city average all-items index was used for nonmedical costs such as transportation, activities of daily living, and residence-related costs.” (opens the source at this quote in a new tab)

Utility values, adverse-event disutility, and mortality inputs in a United States cost-utility analysis of anti-VEGF agents

“Mean vision measurements in the VEGF-I cohorts and control cohorts each year were converted to utility format, ranging from a utility of 0.80 for 20/40 vision in the better-seeing eye to 0.538 associated with 20/630 vision, to calculate the yearly QALY accrual associated with therapy versus none” (opens the source at this quote in a new tab)
“The 11-year QALY loss from adverse events was 0.070 QALY per eye in the bevacizumab and ranibizumab cohorts and 0.035 QALY per eye in the aflibercept cohort receiving fewer intravitreal injections.” (opens the source at this quote in a new tab)
“Referent to 20/20 vision with a hazard ratio of 1.0 for the chance of dying within 8 years, the hazard ratio for 20/40 vision was 1.03, 1.08 for 20/80, and 1.18 for 20/200.” (opens the source at this quote in a new tab)
“the mean treated patient in each of the bevacizumab, ranibizumab, and aflibercept cohorts had a life expectancy of 11.0 years, whereas the mean person in the untreated control cohort was calculated to have a mean life expectancy of 10.0 years.” (opens the source at this quote in a new tab)

Injection-frequency and early-versus-late-treatment scenarios in a United States cost-utility analysis of anti-VEGF agents

“When aflibercept was given with one-third the frequency of bevacizumab and ranibizumab after year 2, the end of the randomized trial, the cost-effectiveness drug order remained unchanged.” (opens the source at this quote in a new tab)
“Doubling the aflibercept injections to match the number of bevacizumab and ranibizumab injections made no difference in the cost-effectiveness order.” (opens the source at this quote in a new tab)
“The early treatment and late treatment, average, ophthalmic cost perspective, CURs for bevacizumab were $9,957/QALY and 25,152/QALY, for ranibizumab were $71,840/QALY and $181,481/QALY, and for aflibercept were $40,697/QALY and $99,296/QALY.” (opens the source at this quote in a new tab)
“Increasing and decreasing the costs or the QALY gain of one drug or each drug by 20% did not change the cost-effectiveness order of bevacizumab > aflibercept > ranibizumab.” (opens the source at this quote in a new tab)

Medicare Part B reimbursement methodology for physician-administered anti-VEGF agents

“Under Medicare Part B, physician-administered drugs are reimbursed based on an average sales price methodology (average sales price + 6%, effectively reduced by sequestration).” (opens the source at this quote in a new tab)
“Sensitivity analyses excluding these codes demonstrated that mean reimbursement remained stable at approximately $50 per injection, consistent with historical pricing patterns.” (opens the source at this quote in a new tab)

U.S. Medicare cost analysis of the ranibizumab port delivery system: unit cost inputs

“The PDS (Susvimo) injection and initial fill carton (National Drug Code 50242-078-55) was $8000. The WAC of the implant with insertion tool assembly carton was $1250 for a total of $9250.” (opens the source at this quote in a new tab)
“The total cost for PDS implantation was $12 239.” (opens the source at this quote in a new tab)
“The total cost for a PDS refill was $8354 (Table 1).” (opens the source at this quote in a new tab)
“This resulted in a total cost of $1742 for ranibizumab, 0.5 mg, $2056 for aflibercept, 2 mg, and $186 for bevacizumab, 1.25 mg (Table 1).” (opens the source at this quote in a new tab)

U.S. Medicare cost analysis of the ranibizumab port delivery system: one-year costs by refill strategy

“In the base case with fixed 6-month interval dosing, the mean (SD) total cost of the ranibizumab PDS with refills over 1 year was $21 016 ($2102) (Table 4).” (opens the source at this quote in a new tab)
“With PDS refills PRN, the mean (SD) total cost of PDS over 1 year was $16 054 ($1605) (Table 5).” (opens the source at this quote in a new tab)

Refill frequency as the determinant of sustained-delivery cost

“In our cost model, we found the most sensitive parameter was the number of refills needed.” (opens the source at this quote in a new tab)
“Thus, ranibizumab PDS with refills at intervals longer than 6 months is more economically attractive.” (opens the source at this quote in a new tab)
“Ranibizumab PDS used on an as-needed or PRN basis is a competitive alternative to fixed anti-VEGF regimens.” (opens the source at this quote in a new tab)

Budget impact model

Approach and framework

No evidence found.

Perspective and time frame

No evidence found.

Epidemiology and eligible population inputs

No evidence found.

Cost assumptions

No evidence found.

Model outcomes

No evidence found.

Results

Base case

No evidence found.

Scenario analyses

No evidence found.

Budget impact model discussion

No evidence found.