Anti-VEGF Pharmaceutical Prior Authorization in Retina Practices

Key Points

Question

What percentage of prior authorizations (PAs) for anti–vascular endothelial growth factor (VEGF) medications were approved and what administrative burdens were experienced by retina practices associated with PA procedures?

Findings

In this quality improvement study including 9 retina practices and 2225 PA requests across the US, more than 96% of PAs for anti-VEGF medications were approved. Most PAs were associated with a delay of care, and each PA required a median of 100 minutes of clinic staff time.

Meaning

The results of this study support reconsideration of use of PAs for anti-VEGF medications due to administrative burdens placed on health care systems.

Abstract

Importance

Anti–vascular endothelial growth factor (VEGF) intravitreal injections, a mainstay of treatment for many retinal diseases to optimize visual outcomes, have been included in prior authorization (PA) initiatives. However, if clinicians are extremely accurate in their use of anti-VEGF medications, such administrative burdens may need reconsideration.

Objective

To quantify PA for anti-VEGF medications (aflibercept, ranibizumab, and bevacizumab) that were approved and determine associated administrative burdens experienced by retina practices.

Design, Setting, and Participants

Prospective multicenter quality improvement study conducted from January 2022 through June 2022, and participants were 9 private retina practices across the US.

Main Outcomes and Measures

Overall rate of approval of PA requests, reasons for requesting PA, and overall rate of delay of care resulting from PA procedures.

Results

In total, 2365 PA requests were recorded, 2225 of which met inclusion criteria. Overall, 2140 (96.2%) requests were approved. The most common reason for requesting PA, at 64% (1423 of 2225 requests), was reauthorization for a previously utilized medication. Of the 2140 approvals, 59.6% (1277) resulted in a delay in care greater than 24 hours, and 40% (863) were given on the date of service. In a granular analysis of a subset of delayed approvals, 23.9% (173 of 725) were approved within 1 day, 15.9% (115 of 725) were approved within 2 to 3 days, 21.5% (156 of 725) were approved within 4 to 7 days, 26.3% (191 of 725) were approved within 8 to 31 days, and 12.4% (90 of 725) were approved within more than 31 days. Overall, PA denial for step therapy was 2.9% (65 of 2225) of requests and uncovered diagnoses was 0.9% (20 of 2225) of requests. The median staff time spent to obtain a single PA was 100 (range, 0-200) minutes.

Conclusions and Relevance

In this study, PA requests were almost always approved but led to a delay in patient care in most patients. The current study suggests that the PA process may not be effective for retina specialists if these results can be generalized to other practices in the US and if less burdensome and less costly approaches could result in similar approval rates. Potential short-term solutions may include eliminating the PA process for bevacizumab and reauthorizations for established patients.

This quality improvement study quantifies the approval rate of prior authorization for anti-vascular endothelial growth factor (VEGF) medications and assesses the clinical and administrative burden implications.

Introduction

Since 2006, anti–vascular endothelial growth factor (VEGF) agents have become an essential part of daily retina practices and have altered the manner in which patients are treated for numerous exudative retinal diseases, including neovascular age-related macular degeneration, retinal venous occlusive disease, diabetic retinopathy, and diabetic macular edema. US ophthalmologists perform an estimated 3.6 million injections annually and this number is expected to grow with expanded indications, novel therapeutics, and aging populations.¹ As a result, anti-VEGF pharmaceuticals account for a substantial proportion of Medicare expenditures, with aflibercept and ranibizumab reaching 12% of total Medicare Part B drug spending.² In 2020, the total amount Medicare Part B spent on aflibercept and ranibizumab was $4.1 billion dollars.³

In the 1990s, in an effort to curb health care costs, insurance companies and pharmacy benefit managers implemented utilization management measures including prior authorization (PA) and step-therapy requirements. These initiatives were intended to discourage provision of high-cost low-value services, with the ultimate goal being to reduce health care expenditures.⁴ Anti-VEGF agents were included in these initiatives, as there can be a substantial cost differential between agents within the same class of drugs.⁵

An unintended consequence of PAs is an associated increase in administrative burden, health care costs, and potentially worse medical outcomes associated with delays in care delivery. It has been reported that PA requirements increased 3-fold between 2007 and 2019, from 8% to 24%.⁴ The 2021 American Medical Association survey⁶ reported that 93% of physicians reported care delays associated with PA and 82% said that these delays lead to patients abandoning treatments, with similar findings observed across multiple subspecialties.⁷ In terms of health care costs, conservative analyses have estimated that the current PA model imposes a $1.9 billion cost on the overall US health care system annually.⁸ Furthermore, there are estimates that waste in health care (including administrative complexity) contributes to more than 20% of total health care expenditures.⁹

While studies have investigated the administrative burden and rates of PA approval in other specialties, to our knowledge, no study to date has specifically quantified these issues associated with anti-VEGF pharmaceutical usage.^10,11,12 The purpose of the current study was to investigate the approval rate of PA for anti-VEGF medications and to provide greater understanding of the clinical implications that current PA policies have with regard to administrative burden.

Methods

Prospective data during the PA process for 3 of the most commonly used anti-VEGF medications, aflibercept, ranibizumab, and bevacizumab, were collected from 9 retina practices across the US, from January 2022 through June 2022. The St Luke’s Hospital institutional review board exempted this study for review as no personal health care data were collected. Specific retina practice sites were selected to represent multiple unique geographic markets within the US. Each medical practice was instructed to log the results of their anti-VEGF PA requests on a standardized data form (Google Forms; Google). Each site logged patients for which a PA request was made on or after the date of service where administration of anti-VEGF treatment was indicated; PA requests submitted in anticipation of a future treatment were excluded. The data form captured which medication was used, indication for treatment, results of the PA request, the number of days required to obtain PA, and the cumulative staff time required to obtain the PA. Within a subset of the total population for which definitive granular data were available, further analyses were performed to evaluate the precise time from submission to PA. No patient-specific-data were collected. The data were analyzed using Tableau version 2023.1.4 (Tableau Software LLC) to provide descriptive statistics. The Standards for Quality Improvement Reporting Excellence (SQUIRE) reporting guideline has been followed.

Results

There were 9 practices included in this analysis that have provided care for a mean (SD) of 41.3 (28.1) years. These practices were spread across 6 states; 6 of these practices were physician-owned private practices, and 3 were private equity-based practices. Of the 9 practices, 7 represented retina-only practices and 2 represented multispecialty practices. A total of 2365 intravitreal injection PA requests were logged from 9 clinical practices, of which 2225 met the inclusion criteria. The 140 PA requests that were excluded were submitted before the patient’s scheduled date of service.

Of the overall 96.2% (2140 of 2225) PA approval rate, 40% (863 of 2140) were approved the same day as PA submission and 59.6% (1277 of 2140) of PA requests led to a delay in care delivery. In a subset of the population in which same-day authorization was not obtained, a more granular analysis was performed to assess the number of days to PA approval (n = 725). In this analysis, 23.9% (173 of 725) were approved within 1 day, 15.9% (115 of 725) were approved within 2 to 3 days, 21.5% (156 of 725) were approved within 4 to 7 days, 26.3% (191 of 725) were approved within 8 to 31 days, and 12.4% (90 of 725) were approved within more than 31 days (Figure 1).

Figure 1. Time in Delay to Authorization Stratified by Number of Days.

Analysis by anti-VEGF agent found that PA approval rates were 99% (405 of 409) for bevacizumab, 95% (1185 of 1243) for aflibercept, and 96% (550 of 573) for ranibizumab (Table 1). Denials were noted for 3.8% (85 of 2225) of PA requests, with step therapy being the reason in 76% (65 of 85) of these cases. In the remaining 24% (20 of 85) cases of denial, PA was denied due to the PA being submitted for an uncovered diagnosis. Age-related macular degeneration was the most common diagnosis for PA, followed by diabetic macular edema and retinal venous occlusive disease.

Table 1. PA Results Stratified by Anti-VEGF Drug.

Anti-VEGF drug	PA result, No./total No. (%)
	PA was denied due to step therapy	PA was denied due to uncovered diagnosis	Same day PA was obtained	Unable to obtain same day PA, but later approved
Aflibercept	43/1243 (3.46)	15/1243 (1.21)	457/1243 (36.77)	728/1243 (58.57)
Bevacizumab	2/409 (0.49)	2/409 (0.49)	184/409 (44.99)	221/409 (54.03)
Ranibizumab	20/573 (3.49)	3/573 (0.52)	222/573 (38.74)	328/573 (57.24)

Abbreviations: anti-VEGF, anti–vascular endothelial growth factor; PA, prior authorization.

Reauthorization for an anti-VEGF agent that a patient had previously received was the most frequent indication for a PA request and accounted for 64.0% (1423 of 2225) of all PA requests (Table 2); of these patients, 0.05% (8 of 1423) were denied. Established patients to the medical practice who required initiation of anti-VEGF treatment accounted for 8.3% (185 of 2225) of PA requests; of these patients, 15% (27 of 185) were denied. Established patients currently receiving anti-VEGF treatment who required a change in medication accounted for 15.6% (347 of 2225) of PA requests; of these patients, 4.6% (16 of 347) were denied.

Table 2. Reasons for 2225 PAs.

Patient type and reason for PA	Approval status	Approval status No./reason for PA No. (%)	Percent of 2225 total PAs
Established patient
No PA needed to initiate treatment	Approved	1/1 (100)	0.04
PA required for change in treatment	Approved	331/347 (95.4)	14.9
	Denied	16/347 (4.6)	0.7
PA needed to initiate treatment	Approved	158/185 (85.4)	7.1
	Denied	27/185 (14.6)	1.2
Repeat PA for continued treatment	Approved	1415/1423 (99.4)	63.6
	Denied	8/1423 (0.6)	0.4
New patient
Initiation of treatment	Approved	235/269 (87.3)	10.6
	Denied	34/269 (12.7)	1.5

Abbreviation: PA, prior authorization.

Administrative burden was also investigated in this study. In total, 1742 hours were invested in processing these 2225 PA requests. More specifically, a median of 100 (range, 0 to 200) minutes of staff time was invested into each PA request. Notably, 0.54% (12 of 2225) of requests required more than 20 hours of administrative staff time to obtain and 0.31% (7 of 2225) of patients waited more than 1 month to successfully obtain PA approval; these included patients with time-sensitive diagnoses such as retinal venous occlusive disease and neovascular age-related macular degeneration that when untreated or undertreated risk irreversible vision loss. Among the subset of 725 patients, nearly half (42.8%) of patients experienced a delay in PA by at least 1 week, while 14.0% experienced a delay in PA by at least 1 month. In this subset of the population in which same-day authorization was not obtained, 3.7% (27 of 725) of requests required less than or equal to 5 minutes of staff time, 22.9% (166 of 725) required from 6 to 15 minutes, 48.1% (349 of 725) required from 16 to 30 minutes, 21.8% (158 of 725) required from 31 to 60 minutes, and 3.5% (25 of 725) required more than 60 minutes (Figure 2).

Figure 2. Estimated Staff Time Required to Obtain Prior Authorization Stratified by Number of Minutes.

Discussion

The current prospective analysis found a very high overall approval rate of PAs submitted for anti-VEGF pharmaceuticals. Considering that these medications are used to treat the most common causes of irreversible blindness in the US, it is notable that 57.4% of patients experienced a delay in care delivery within this study, consistent with previous reports,^6,7 although we were not able to measure how these delays may have translated to temporary or permanent visual acuity loss. Nevertheless, numerous studies have suggested that delay of anti-VEGF pharmaceutical treatment after diagnosis is associated with worse visual outcomes, although the delays may be different from delays associated with PA delays.^13,14,15 In our study, 0.31% (7 of 2225) of patients experienced a delay in PA by at least 1 month, presumably requiring treatment with anti-VEGF samples to prevent the risk of irreversible vision loss. Among the subset of 725 patients, nearly half (42.8%) of patients experienced a delay in PA by at least 1 week, while 14.0% experienced a delay in PA by at least 1 month. This granular data further emphasizes the delay in care associated with PA.

Within the current study, the most common reason for PA denial was for step therapy in 2.9% (65 of 2225) of requests. In a recent study¹⁶ examining step-therapy protocols of 17 of the largest commercial health plans in the US, 55.6% of the protocols were more stringent than published clinical guidelines. The highest rate of denials in the current study were for established patients initiating anti-VEGF therapy (15%), followed by those where a change of medicine was required (4.6%). Thus a disproportionate share of denials may end up targeting the most vulnerable patients, those without prior treatment and those where the medication was deemed ineffective, necessitating a switch.

In an effort to initiate treatment in a timely manner, some retina clinicians may be forced to use sample medications while pursuing the insurance authorization process,¹⁷ and some university-based and other practices preclude use of sample medications out of concerns for unintended bias in choosing medications. A recent study¹⁷ noted that the mean (SD) time to first injection among patients who received a sample medication was shorter compared with those who did not (0.31 [1.84] vs 1.19 [3.38] days [mean difference, 0.88 days]). The authors also noted that once a patient began receiving a more expensive sample medication such as aflibercept, they were less likely to switch to a less expensive option such as bevacizumab, which paradoxically may lead to overall greater costs.¹⁷ Sampling medications is also an unsustainable approach to address the delay in care associated with PA. Another potential concern is that the authors have noted pharmaceutical companies have stopped providing sample medications for therapeutics they are phasing out. Moreover, the authors note that sample medications are not provided for biosimilar anti-VEGFs which often lower cost to the health care system.

The substantial administrative burden associated with PAs highlighted in the current work are associated with increased costs to the US health care system. More than 1700 hours were spent to obtain PAs for an overall approval rate of 96.2% and most PA requests required at least 15 minutes of staff time. One model estimated that the total administrative costs (not just from PAs) to the US health care system was $4.8 billion. In the same analysis, it was estimated that if using higher cost estimates, the total PA-induced costs could be $19.4 billion with a total net cost of $13.2 billion.⁸

Based on the high approval rate of PAs for these anti-VEGF agents, one might question the utility of PAs and consider a more effective model to limit burgeoning health care costs. One potential solution involves the use of an electronic PA submission system. Use of electronic PA systems has been associated with decreased time to approval, which might allow patients to initiate therapy in a more timely fashion.¹⁸ While this seems to hold potential in theory, there is also evidence that electronic PA systems may not decrease the time required to prepare or submit PA requests.¹⁹

In addition to electronic PA, bipartisan bills have been introduced that are intended to mitigate administrative burdens associated with PA. The Getting Over Lengthy Delays in Care as Required by Doctors Act of 2022,²⁰ if approved, would exempt physicians from having to obtain PA from Medicare Advantage plans who have a 90% PA acceptance rate in the previous 12 months. Given that the rate of PA approval for all 3 anti-VEGF agents in the current study exceeded 95%, it is likely that most retina clinicians would be exempt from PAs under such a proposed system.

A practical initial solution to this challenge may be to eliminate the need for PAs for bevacizumab completely, given the 99% approval rate observed in this study. Additionally, reauthorization of anti-VEGF accounted for 64% of the PA requests, accounting for a substantial amount of the burden; since just 0.05% of those requests were denied, targeting this area may lead to a meaningful improvement in the current situation for many patients.

Limitations

There were several limitations of the current study. Though the 9 retina practices included in this study represent several types of practices in different regions of the US, they remain a subset of practices, and these findings may be more or less generalizable to different practice settings. Similarly, while we believe these results are likely generalizable across the US retina health care ecosystem, there may be regional differences that were not identified in this study. Additionally, while this study observed a meaningful administrative burden associated with the PA process, the current work does not include an estimate of the associated costs related to the time and personnel involved in the process on both the practice and insurance carrier sides.

Conclusions

Though well intentioned to mitigate rising costs, the use of current PA procedures is associated with an administrative burden on retina practices and health care systems overall. As this study has found, substantially less than half of PA requests were denied, yet many hours of staff time were used, and there were delays to patient care delivery, which might lead to vision loss. Based on these 9 retina practices, the current application of PAs in retina practices does not appear to be a cost-effective measure and the authors believe its use warrants reconsideration.

Supplement.

Data Sharing Statement