17. March 2022

Imminent blindness is a situation comparable to a state of emergency

Retinitis Pigmentosa: Health insurance company must retroactively cover costs for OkuStim therapy

A recent ruling by a German social court (Landessozialgericht Niedersachsen-Bremen, LSG) paves the way for the retroactive reimbursement of OkuStim therapy for retinitis pigmentosa (RP). A patient had filed a lawsuit because her health insurance company refused to cover the costs on the grounds that an imminent blindness was not to be expected and that the therapeutic benefit of TES had not yet been evaluated by the Federal Joint Committee (G-BA).

The LSG justified its decision on the basis that the concrete prognosis period for RP could not be determined. Accordingly, the irreversible loss of residual vision and the threat of blindness itself constitute a situation comparable to an emergency, even if the point in time at which the irreparable damage occurs cannot be predicted. With a narrowing of the plaintiff’s field of vision to 10°, the disease had reached a stage where further waiting would no longer be reasonable. Transcorneal electrical stimulation (TES) with the OkuStim system would no longer have any medical benefit for the plaintiff at a later stage. The plaintiff’s health insurance fund must now reimburse the costs for the purchase of the OkuStim system and cover her future therapy costs.

The plaintiff had unsuccessfully applied to her health insurance company in December 2017 for the costs of OkuStim therapy to be covered. At that time, she still had a visual field of 10 degrees and a visual acuity of 0.8. In the meantime, the plaintiff had started the OkuStim therapy at her own expense. Following a medical opinion, the Regional Social Court stated in the reasons for the ruling that the TES had already had a noticeable positive effect on the course of the disease.

With the OkuStim therapy, the progressive loss of the visual field in retinitis pigmentosa can be slowed down. In an ongoing trial commissioned by the G-BA, the effectiveness and long-term benefit of the therapy are being investigated. Only with a positive benefit assessment can a regular coverage of the therapy costs by the health insurance companies take place. For self-payers, the CE-marked OkuStim system is available through clinical competence centres in several European countries.