The development of biological drugs has represented a paradigm shift in the management of psoriasis, allowing for long-term disease control with a good safety profile1,2. However, their use can have a significant economic impact on the Spanish National Health System3 (NHS).

Because of the specific characteristics of the Spanish NHS, each autonomous community (AC) manages the health services of its territory and can decide on the conditions and requirements to prescribe drugs3,4. In the cross-sectional EQUIDAD study, a situation of disparities in the conditions of access to biological drugs for psoriasis among different ACs was observed, with diversity in criteria at both regional and local levels. The criteria did not appear to be based on decision-making methods that demonstrate the integration of scientific evidence5.

Independently, the Spanish Academy of Dermatology and Venereology Psoriasis Working Group (AEDV PWG) developed the minimal disease activity (MDA) variable for the management of psoriasis6, with the intent of using it as a measure of adequate disease management by characterizing patients with well-controlled psoriasis. After it was defined, a study was conducted at the end of 2022 to describe the situation of MDA, evaluating the percentage of psoriatic patients who meet the MDA criteria in a routine clinical practice in Spain (reference for MDA study).

The objective of the present study was to investigate the association between the probabilities of achieving MDA and the restrictions observed in access to new drugs in the treatment of psoriasis at both regional and local levels, combining data from the independent EQUIDAD and MDA trials of the AEDV.

In the MDA study, a final sample of 830 patients was obtained, although only 825 were considered for this work, representing a total of 17 different ACs (5 patients did not have their region on record). The mean age was 51.4 years (SD, 14.2) and 49.6% were on biological therapy. The MDA criteria were met in 40.8% of the patients included in the study. A total of 62.4% of patients are still being followed in 9 ACs without regional restrictions (although local restrictions may exist). Combining the MDA data with the levels of restrictions in the ACs based on the EQUIDAD study5, a trend can be seen, with 28.4% of patients with MDA in the 3 most restrictive ACs vs 50.7% of MDA in the 7 least restrictive ACs, with statistically significant differences (p <0.001) (fig. 1). The distribution of patients in the different AC groups based on the level of restrictions, as well as the characteristics of these groups are shown in Table 1.

Figure 1.

Graphic representation of the level of restrictions in each autonomous community included in the study, as well as the proportion of patients with well-controlled psoriatic disease (measured according to minimal disease activity).

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In the crude multilevel logistic model (Supplementary data Table 1), this gradient of probability of achieving MDA was replicated at the same time the level of restrictions decreased. Being treated in an AC without regional restrictions (although local ones may exist) was independently associated with a higher probability of meeting the MDA criteria (OR, 2.39; 95%CI, 1.04-5.51). Although adjustment for the use of biological drugs (Supplementary data Table 1, adjusted model) showed a clear association with achieving MDA (OR, 5.86; 95%CI, 4.18-8.23), it did not eliminate the effect of geographical restrictions (OR, 2.64; 95%CI, 1.08-6.42). The model that categorized restrictions ordinally also showed a gradient of probability of achieving MDA as the level of restrictions dropped (OR, 1.27; 95%CI, 1.06-1.52; p=0.011).

As sensitivity analysis, the variable with the level of restrictions was regrouped into fewer categories, finding similar results in all cases (data not shown). The graphic representation of the percentage of MDA found in each AC and its level of restrictions is shown in Figure 1.

The presence of fewer restrictions, both local and regional, in access to new drugs for psoriasis seems to be associated with a higher probability of meeting the MDA criteria and, therefore, achieving adequate control of psoriatic disease. This association is independent of other factors, such as age or sex, and is maintained when including the use of biological drugs by the patient in the model.

The relationship found between controlling psoriatic disease and other factors such as the use of biological drugs or socio-economic level are factors already evaluated previously7,8. However, few studies have evaluated the impact of drug access-related restrictions on the control of psoriasis, focusing on comparisons across different countries9. The differences between ACs reported in this study are more relevant as they are differences within the same country where equitable health care for all patients is presumed.

It seems logical to think that the absence of specific restrictions could favor the prescription of drugs based on clinical needs, without being conditioned by financial or organizational factors. The fact that the relationship between restrictions and MDA is maintained when including the binary variable “biologicals” in the model raises the possibility that the ease of access to new drugs does not fully explain the better disease control in areas with fewer restrictions. Therefore, persistent differences could be due to reasons other than treatment with new drugs (which are also associated with the number of restrictions), or to the possibility of selecting specific new drugs that are more effective based on national or international recommendations2.

An alternative explanation is that access to a dermatologist may be easier in ACs with fewer restrictions, finding a higher proportion of patients with milder psoriasis who would more likely meet MDA criteria.

The strength of this study is that it is based on data from independent studies conducted before generating the hypothesis, which makes it unlikely that MDA measurements could be biased by the description of local restrictions. As for the limitations, the main one is that it is an ecological study, meaning that data on limitations are collected at AC level and the patients in whom MDA was measured may not be the same as those who experienced limitations in drug use. It is also possible that restrictions allow the total number of prescriptions in the AC to be higher and, although the benefit for each patient is smaller, the overall benefit for the population is higher. On the other hand, the use of consecutive sampling may not be equally representative of the population of psoriatic patients in all ACs. Additionally, evaluating restrictions from a regional perspective probably does not accurately reflect the specific restrictions existing at each hospital level.

In conclusion, the observed findings suggest that there is a relationship between a lower level of restrictions on access to biological drugs and a higher probability of adequate control of psoriatic disease. It would be desirable to homogenize the prescription criteria among the different Spanish ACs to promote greater equity in the treatment of psoriasis nationwide

Manuel Sánchez Díaz has received funding for attending conferences from Sanofi, Lilly, Novartis, and Almirall.

Ángeles Flórez has received fees and/or support for educational activities and/or acted as a speaker and/or consultant and/or conducted clinical trials and/or research projects for Abbvie, ACELYRIN Inc, Alcedis GmbH, Almirall, Amgen, BMS, Celgene, Galderma, Incyte Corporation, Janssen-Cilag, Kyowa Kirin, Leo Pharma, Lilly, Novartis, Pfizer, Roche Farma, Sanofi-Aventis, Sun Pharma, Takeda, and UCB Biosciences GmbH.

Mercè Grau-Pérez has received funding for attending courses or conferences from Abbvie, Almirall, Janssen, Lilly, and Novartis.

Ignacio García-Doval has received funding for attending conferences from Abbvie, MSD, Pfizer, and Sanofi.

José-Manuel Carrascosa has received fees and/or support for educational activities and/or acted as a speaker and/or consultant and/or conducted clinical trials and/or research projects for Abbvie, Almirall, Amgen, BMS, Celgene, Galderma, Janssen-Cilag, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi-Aventis, UCB, Sandoz, and Boehringer Ingelheim.