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Incidental AEs in HCP/ patient interactions

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  • John
    14/08/2019 22:00
    Dear members, Could you please provide your thoughts on the following scenarios and if entry in the safety database is required, if both drug 1 and 2 are for the same MAH? Drug 1: primary therapy for breast cancer Drug 2 second line therapy for breast cancer for patients who have progressed on primary therapy Scenario 1 spontaneous setting: In a discussion between the HCP and sales rep, the sales rep asks if the HCP can identify patients who had progression of their disease who may benefit from moving to second line therapy. The HCP responds yes I have 1 patient who has progressed and meets the approved indication criteria for drug 2. Is this considered a report of disease progression? Knowing that progression is likely to occur at some point as part of the natural course of the disease. Scenario 2: a patient support programme is conducted to support reimbursement for drug 2. To ascertain whether the patient would meet the insurance criteria the call handler needs to determine if their disease has progressed/ there is a lack of effect from existing treatment with drug 1. Is this considered disease progression/ lack of effect that needs to be databased? As the information has been solicited Via a predefined question to understand the patient current disease status, and the disease progression has been somewhat solicited to support reimbursement. Thanks for your opinions!
  • John B
    03/09/2019 14:21
    MedDRA Points to Consider states the following: "Pre-existing conditions that have changed may be considered ARs/AEs, especially if the condition has worsened or progressed …" In both scenarios, the conservative approach would be to database both and code appropriately, probably with LLT of disease progression, unless the reporter considers drug A to be ineffective
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