[Usefulness and necessity of unsynchronized photosolotherapy and bath-PUVA--two variants of balneophototherapy--in funded ambulatory health care].

The Standing Committee of Statutory Health Insurance Physicians and Sickness Funds is the legal body that makes decisions on reimbursement for health care services in the German ambulatory health care sector. In 1994 the committee declined the reimbursement of balneophototherapy. Balneophototherapy comprises a bath in a saline solution followed by ("non-synchronous") or simultaneous ("synchronous") UVB-irradiation. Photochemotherapy with bath-water delivery of psoralens combined with UVA light is also covered by the term balneophotherapy. The main indication for both procedures is serious psoriasis. Bath PUVA was also recommended for atopic dermatitis, pityriasis lichenoides, lichen ruber and mycosis fungoides. An effectiveness study sponsored by the sickness funds with rather poor methodological design and conduct was not able to show an unbiased effect of balneophototherapy despite inclusion of thousands of patients. On the contrary, a poor adherence of patients and doctors was documented, since 63% of patients suffering from psoriasis and treated with saline bath followed by UVB-irradiation stopped early or used additional therapies like cortisone or vitamin D3 derivatives. Only 43% of patients suffering from psoriasis and treated by bath PUVA did not stop the initial therapy and did not receive additional therapy (UVB, cortisone). In addition, the committee also conducted a thorough review of the literature, guidelines and status in other health care systems. Finally the two modifications of balneophototherapy were again declined from reimbursement in the German ambulatory health care sector. There were no controlled clinical trials showing efficacy of saline bath followed by UVB irradiation. Up to now bath PUVA was only evaluated in small equivalence trials which despite the fact that a drug was tested did not apply basic ICH standards (international conference on harmonisation) for equivalence trials. Additionally, the long-term cancer risk inherent to the application of psoralenes must be considered. Since the definition of "severe psoriasis" is not trivial a wide use of bath PUVA in ambulatory health care has to be based on the results of rigorously conducted clinical trials showing the effectiveness, safety and appropriateness in comparison to other treatment modalities. In reaction to the decision of of the committee two randomised controlled trials for the evaluation of the efficacy of balneophototherapy are planned.