Company selection and internal evaluation of switch candidate
It is essential that the potential switch candidate is thoroughly evaluated prior to any SAM. This early evaluation of the benefit-risk profile should take into account all data available to you including:
- external expert advice
- non-prescription availability in other countries
- experience from previous switch applications
Early analysis using this framework will allow you to evaluate potential risk minimisation proposals which can then be discussed with the regulatory agency
However, the benefit-risk profile will only help to get the reclassification approved
To make the reclassification a commercial success, it is also important that you understand the patient journey as you transition them from reliance on a management in the clinical setting (patient) to self-care (consumer). You need to ensure the price point and pack sizes are correct for an OTC product and that you do not inadvertently cannibalise your Rx sales in the cases where a prescription medicine offering is maintained.