Could <scp>OTC</scp> Devices Reduce Disparity of Care? A Comparison of the Spectral Output of Home‐Based Narrow‐Band <scp>UVB</scp> Phototherapy Devices to a Prescription Device

Narrowband UVB (NB-UVB) with emission peak at 311–313 nm is a widely used treatment for vitiligo, psoriasis and other dermatoses [1]. Home-based light device use has increased due to convenience and affordability, with many available to be purchased online [1]. However, the efficacy and technical specifications of many of these products have not been assessed. The preliminary data on a recent Patient-Centered Outcomes Research Institute (PCORI) study in patients with psoriasis showed that prescription total body home phototherapy was not inferior to office-based treatments [2]. Our current study sought to compare a popular over-the-counter (OTC) NB-UVB device (Kernel KN-4003) purchased online to a prescription-required home NB-UVB device (Daavlin Dermapal). The spectral output for both devices was measured using a calibrated spectroradiometer with an integrating sphere (OL 756, Optronics, Florida, USA). Measurements were made at a distance of 1 cm from the lamp following a 10-min warmup period. The output of both devices peaked with the highest intensity at 311 nm. The spectral output within the UVB waveband (290–320 nm) was around 47% for both devices. The total UVB intensity averaged at 4.94 mW/cm2 for the OTC device compared to 6.42 mW/cm2 for the prescription device. These spectral output graphs can be seen in Figures 1 and 2, respectively. Both devices displayed similar characteristics in terms of spectral output. The prescription device had a higher intensity compared to the OTC devices, meaning treatment times would be shorter. For example, if a standard treatment dosage goal for one patient is 200 mJ/cm2, it would take the prescription device approximately 5.5 min where it would take the OTC device closer to 7 min. The prescription device requires entry of a unique code to start a set number of cycles. When they expired, the user would need to obtain a new code from the prescriber. The OTC device can be turned on without a code and will solely automatically shut off after 60 min of use. At the time of this study, the OTC device was available for US$299 online, while the prescription device costs upwards of US$800. Considering the similar spectral output between both devices, a similar clinical efficacy can be expected, however, no comparative study on clinical efficacy between these devices has been performed. In the United States, there is limited coverage by payers for prescription home-based NB-UVB, which are different from OTC purchased devices. A 2021 study found that office-based NB-UVB therapy was not covered by insurance in 20% of the 50 US States [3]. In that same study, out of 17 insurance companies surveyed with regional or national coverage policies, 56% did not include coverage for NB-UVB phototherapy [3]. In another study comparing Center for Medicare and Medicaid Services' (CMS) national coverage determinations against private payer policies for 47 medical devices, CMS policies were less restrictive in about a quarter of the time [4]. Lastly, when queried, 43% of patients given a NB-UVB prescription, whether being for a hand-held phototherapy device or total body device, did not follow through with the purchase. Furthermore, 73% of these cases were due to high out-of-pocket expenses from the lack of insurance coverage [5]. One of the few disadvantages of recommending OTC devices is the potential for difficulties that arise due to the lack of standardization. Safety is a primary concern, as improper use or lack of protective measures, especially for UV devices, can result in skin damage or eye injury. Additionally, consumers may not receive clear instructions with their devices, leading to inconsistent results or misuse, so providers must ensure to have a proper treatment plan set in place to prevent user harm. Regulatory oversight is another key issue, as these devices often may not undergo the same rigorous testing as FDA-cleared prescription treatments, further raising concerns of safety. Exaggerated marketing claims can mislead users, creating unrealistic expectations, which further emphasizes the need for patient education. Moreover, certain populations may still find these devices cost-prohibitive, limiting their benefits. Addressing these issues through better education, clear labelling and adherence to safety standards is crucial for the successful promotion of OTC phototherapy devices. A suggestion is for patients to bring their devices in to clinic or share their device information with their physician for further education. There is a clear gap in access to efficacious home-based phototherapy devices. Limited insurance coverage for medical devices creates higher costs of therapy to patients. Future policies should focus on increasing access to low cost, effective medical devices that are available for purchase. Home-based NB-UVB therapy offers convenience and compliance benefits, but patients must be counseled on potential adverse effects. This lower cost of free-market devices will increase access to patients while also encourage innovation. Nonetheless, further studies on OTC devices are warranted. Mohsen Mokhtari, Mavra Masood and Redina Bardhi helped in collecting and analysing the data as well as writing the manuscript sections. Henry W. Lim, Indermeet Kohli and Iltefat Hamzavi helped with editing and reviewing the manuscript. The authors have nothing to report. The authors declare no conflicts of interest. The data that support the findings of this study are available from the corresponding author upon reasonable request.