In market access and payer evaluation of new drugs, patient reported outcomes are as important for payers as are other “quantitative” measures (Biomarker levels in the blood, survival, radiological imaging, etc.). They allow payers to adequately assess the value that the new drug brings.

Patient reported outcomes (PRO)

Evaluators rely in general on documented, specific and measurable “quantitative” outcomes to assess if a medicinal product is safe and effective. In some cases however, disease does not have any “apparent” measurable symptom and evaluators would need to rely on “qualitative” factors such as outcomes reported by patients.

PRO in depression

Depression is usually hard to define since it is a general state of fatigue and mental weakness that is felt by the patient. There are no biologic indicator identifying the state and degree of depression and physicians cannot evaluate that since only the patient knows how he/she feels. HAMilton rating scale for Depression (HAMD) questionnaire (administered by the physician) has been developed in order to quantify patients’ feeling and therefore be able to determine patient’s depression level. Through this questionnaire patient evaluates his depression and therefore reports outcomes related to his treatment, since treatments are supposed to improve his/her depression state. These patient reported outcomes have been used by regulators and payers in order to evaluate the effectiveness of anti-depressive medication and to decide on their authorization/ reimbursement.