Treatment Regimen Patient Brochure
We are looking to develop a patient resource that focuses on a treatment regimen made up of multiple therapies. Our client's product is indicated for use in this regimen in conjunction with these therapies, however, Part III of the Product Monograph only provides an overview (e.g., side effects, dosing guidance, etc.) of our client's treatment. What is the PAAB's opinion on leveraging Part III from the Product Monographs of the other treatments (NOTE: our client is not the DIN holder for these treatments) to develop a patient brochure or similar resource? The main driver behind this is a significant patient and stakeholder demand for a "one-stop-shop" brochure/resource, especially considering many of the additional treatments are genericized and not actively promoting—ultimately there is a gap/unmet need for patients to be comprehensively informed of all treatments and expectations that are associated with this regimen. An overview of any alternative paths forward for this type of resource would be greatly appreciated.
Jennifer Carroll last edited by
This question appears to be about a specific product with specific considerations which are hard to anticipate in a general context. Part 3 of the Market Authorization Holder’s (MAH’s) TMA and the information/statements it contains regarding the use of the other therapies will help determine what may be included in a patient brochure. However, in general, a patient should not be exposed to product information for a product they have not been currently prescribed. It may be possible to discuss two products in a single piece if it is clear upfront that the piece is intended to only be distributed to patients currently on both products. An additional consideration is that the content must be within the limitations of the MAH’s TMA. Off-label content from other TMAs would not be considered acceptable. Remember to keep patient information non-promotional and see Q&A 573 for some additional guidance.
We’d suggest submitting for an opinion where you can provide more context for assessment.