Innovation Pharmaceuticals Inc (IPIX)

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Coverage Perspectives:

Developing Brilacidin as a New Drug Application (NDA), via the 505(b)(1) pathway, significantly improves Brilacidin’s commercialization prospects in the OM therapeutic area. OM products, such as MuGard, GelClair, Episil, and Caphosol, which were developed as devices and not drugs, have struggled to show clinical benefit, as they are primarily palliative in nature, and from a government payer perspective are not covered under Medicare Part D. Reimbursement Landscape: At least 2 approved drugs in all therapeutic drug classes must be made available under Medicare Part D, per USP Medicare Model Guidelines. The guidelines establish the framework (the rules) that drive payer formularies.

*Given there are no approved drugs for OM in HNC, should Brilacidin be approved, it is highly likely it would be included in payer formularies as a pharmacy benefit.