In all cases, drugs not included in the RMHP formulary have very similar therapeutic alternatives with good evidence for safety and efficacy. Often, non-covered drugs are isomers or active metabolites of covered medications with no data to support improved safety or efficacy.
In order to be approved, intended use of the requested drug must be in accordance with indications approved by the FDA and supported by approved CMS Compendia. Additionally, rationale must be supplied for the use of the non-covered drug versus the covered alternative(s). It must be demonstrated with supplied medical chart notes that there is high likelihood of an efficacy, tolerability, or safety advantage with the non-covered drug versus the covered alternatives. It must be demonstrated that covered therapeutic alternative medications have been tried, or that use of these medications would likely result in a poor outcome for the patient.