Table 2 Summary of the recommendations for the biosimilars’ policy framework in Egypt
Domain | Framework policy recommendation |
|---|---|
Pricing | Mandatory discount of 30% for the first biosimilar from the originator's price |
For subsequent biosimilars (2nd or later), a 10% discount should be applied from the preceding biosimilar introduced | |
Biosimilars' prices should be revised at pre-specified intervals, annual or every two years | |
Reimbursement | HTA, specifically CEA & BIA, should be used when the manufacturer applies for extending the reimbursed indication compared to the originator |
Immunity for one year or more against removal from the formulary should be provided for biosimilars that offer at least a 50% discount compared to the originator | |
Prescribing practices should be proactively and routinely monitored against financing protocols. Furthermore, in case of deviation from the financing protocol, financial disincentives should be applied to prescribers | |
Switching of existing patients should be done under medical supervision | |
More expensive biological medicine/s should be disincentivized by health care payers, such as moving them to the second line of therapy | |
More expensive biological products should be excluded from the formulary if they fail to reduce the price gap below 30% | |
Biosimilars’ uptake | Share information with patients & prescribers’ on how biosimilar adoption improves patient access to biological medicines. Better access should be explained—treating more patients from the same budget, earlier initiation of biological treatment or longer treatment duration |
Introduce financial protocols to advocate the first-line use of biosimilars for de novo patients by prescribers | |
Generate real-world evidence about biosimilars to address safety and effectiveness concerns |