Assessing real world outcomes in a topical therapy for a skin condition

Real world study to assist market access activities

The challenge

Our client wished to understand the burden of treatment relating to a dermatological condition in a real world setting to inform market access activities.

Their topics of interest included factors which influence patients such as:

• Adherence and persistence.
• Treatment satisfaction.
• Quality of life.
• Resource utilisation.
• Work productivity.
• Prescribing trends.

There was very little real world evidence for this dermatological condition available in the public domain.

The solution

We conducted a real world study that recruited over 200 patients from three European countries (Germany, France and the UK). A multi-disciplinary approach was deployed, utilising the skills of our four integrated practices and our sister company Adelphi Research.

Patients completed an online questionnaire every two weeks to understand treatment patterns (including switching and cessation), for a maximum of 14 weeks.

Validated patient-reported outcome (PRO) measures EQ-5D-5L, WPAI and SKINDEX-16 were included.

Key results

Two-thirds of patients remained on their baseline treatment for more than 10 weeks, suggesting long treatment durations that may add burden to the patient and society.

The presence of local skin reactions did not lead to treatment switching or cessation but did increase the amount of contact patients had with healthcare professionals, demonstrating an unmet need that could be associated with a high economic burden.

Results from PRO instruments showed that this dermatological condition reduced productivity at work and reduced the performance of daily activities, again highlighting the burden of the condition.

Value to the client

The insight into the unmet need provided by this study gave our client an understanding of the real world patient treatment pathways.

The results of the study were used by our client to communicate the humanistic and economic burden of the condition to regulatory agencies to assist with the attainment of reimbursement in Europe. This real world evidence was also used by our client to support local and regional market access activities in Europe.