How do I define the study population for my evaluation study?
WIG2 Institut
Scientific Institute for Health Economics and Health System Research in Germany
In theory
Proof of the positive healthcare effect of a DiGA must be provided for a specific and clearly defined patient population. If the proof is successful and the DiGA is listed in the DiGA directory, the DiGA can only be prescribed and reimbursed for this previously defined patient population. This definition is based on one or more indications (ICD-10 codes), whereby according to the Federal Institute for Drugs and Medical Devices (BfArM) only three- or four-digit ICD-10 codes are permitted.
If a manufacturer specifies several indications, the positive healthcare effect must also be demonstrated separately for all specified indications. However, evidence can also be provided jointly for several indications provided the indications are comparable, aligned with the positive healthcare effect to be demonstrated, and a summary appears reasonable. The prerequisite for this is that the investigated study population covers all these indications and that a detailed justification regarding the comparability of the indications is available.
It should also be noted that the diagnosis must always be made by a doctor or a psychotherapist, both in the context of the evaluation study and in the later standard of care.
In practice
As of June 20, 56 applications are listed in the DiGA directory, 35 of which are permanent. Most DiGA (n=26) are assigned to the indication area of the psyche. Other indications include muscles, bones, and joints (n=7); hormones and metabolism (n=8); nervous system (n=4); reproductive organs, kidneys, and urinary tract (n=3); cancer (n=3); ears (n=2); other areas (n=2); respiratory tract (n=0), digestion (n=1), and heart and circulation (n=3). In addition, the DiGA directory shows that most applications have provided evidence of positive healthcare effect for one (n=25) or two (n=14) indications. One exception is the manufacturer of the DiGA vivira, whose application can be prescribed for a total of 20 different indications. It is also clear that— contrary to the statements in the BfArM DiGA guidelines— it is possible to list DiGAs that provide proof of positive healthcare effect for five-digit ICD-10 codes. This is shown, for example, by DiGA manufacturers such as companion patella powered by medi - proved by Dt. Kniegesellschaft (M79.66 Pain in the extremities: Lower leg [fibula, tibia, knee joint]), HelloBetter Panik (F40.01 Agoraphobia: With panic disorder), HelloBetter Chronische Schmerzen (F45.40 Persistent somatoform pain disorder, F45.41 Chronic pain disorder with somatic and psychological factors) or priovi - digitale Unterstützung der Borderline-Behandlung (F60.31 Emotionally unstable personality disorder: Borderline type).
Our experience
Most DiGA manufacturers provide evidence of the positive healthcare effect for one or two indications. Our experience also shows that the patient population should be as homogeneous as possible to be able to detect a positive healthcare effect. If the addressed indications are comparable, connected to the positive healthcare effect to be detected, and a summary appears reasonable, then the evidence can also be provided jointly for several indications. Our experience shows that a detailed description of the standard of care is necessary first. Above all, it should be emphasized that the standard of care is as homogeneous as possible across the individual indications. If this is not the case, a scientific justification of the transferability of this standard of care to other indications is required. These points should already be considered during the systematic literature research.
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Although the BfArM clearly states in the manufacturer guidelines that inclusion in the DiGA directory is only possible with three- or four-digit ICD-10 codes, some manufacturers have achieved permanent listing with only a five-digit ICD-10 code.
If the aim is to prescribe a DiGA for all genders and all age groups, sufficient data must be collected for the different characteristics of both variables as part of the evaluation study. As an example: A DiGA addresses patients with high blood pressure. Most of the participants in the evaluation study are female; due to the low absolute number of male participants and the resulting lack of a clear positive healthcare effect for this patient group, prescribability is restricted to female patients.
It is also important to record and document all relevant characteristics of the study population to be able to rule out possible influences on the effects achieved (e.g. through co-interventions such as concomitant therapy or additional medication). For example: Patients with a medically confirmed diagnosis of back pain (ICD-10 code M54) are included in the evaluation study. During the individual data collection points, medication is noted, and the accompanying therapies are queried. This ensures that the proven positive healthcare effect is not due to pain medication or physiotherapy.
One last tip: The indication or diagnosis must always be made by a doctor or psychotherapist. There are also special features here, because not only can medical certificates be taken into consideration, but also proof of diagnosis via structured interviews with trained interviewers (for example, using the Mini-International Neuropsychiatric Interview (MINI)).
The WIG2 Institute's DiGA-FAQ addresses the questions we are frequently asked by DiGA manufacturers.
As a scientific institute, we support DiGA manufacturers in planning, conducting, and analyzing the evaluation study. We ensure that the processing of the results meets the formal requirements of the Federal Institute for Drugs and Medical Devices (BfArM) and that it contributes to the evaluation concept for the DiGA-Fast-Track in the best possible way. Our DiGA expert Tonio Sch?nfelder will be happy to answer any questions you may have.
DiGA-FAQ // Evaluation study // Question 5: How do I define the study population for my evaluation study?