The European Medicines Agency’s (EMA) human medicines committee (CHMP) have released a paper outlining key criteria for improving consistency when defining therapeutic indications in the product information of medicines.
Their aim is to guide regulatory authorities who are evaluating marketing authorisations and extension of indication applications, which in-turn, can improve clarity in the understanding of the wording of indications for stakeholders, such as healthcare professionals and health technology assessment (HTA) bodies. For example, does the therapeutic indication clarify whether the medicine is a first- or second- line treatment or whether it should be used in combination with another medicine?
According to the regulatory framework, the therapeutic indication should be clearly stated in section 4.1 of the Summary of Products Characteristics (SmPC). “The scientific basis for and the reasoning behind the final wording of the indication should be clearly documented in the CHMP assessment report, namely the benefit/risk section.” The paper further discusses components which can be applied when deciding on the final wording, such as target disease, target population, place in therapy, use in monotherapy or combination therapy, and mandatory conditions of product usage. Finally, the CHMP have included a useful template wording of a therapeutic indication.
The therapeutic indication is the primary source of information for the use of a given medicine. Stakeholders have raised concerns that therapeutic indications have been worded inconsistently, and can vary in detail. Healthcare professional require this essential information to suggest the best treatment for their patients. HTA bodies require concise indications to enable them to make pricing and reimbursement recommendations for medicines. Furthermore, European Union (EU) healthcare payers rely on consistent information to distinguish a medicine’s cost-effectiveness and impact on the healthcare budget.
Improving the consistency of therapeutic indications when assessing centralised applications can help to enhance the timely and affordable access to new medicines. To view the CHMP’s paper, click here. The EMA may develop further guidance via continuous discussion with stakeholders.