Legislation was introduced that provided five years of additional exclusivity for new antibiotics intended to treat serious or life-threatening infections. The client, a leader in the field of antifungals, sought to amend the bill so that these products would likewise qualify for additional exclusivity.
Executed a bipartisan lobbying effort focused on educating the bill’s sponsors and other lawmakers on the House Energy & Commerce and Senate Health, Education, Labor & Pensions (HELP) Committees on the need to include other antimicrobials, such as antifungals. The campaign focused on both the increased costs to society and the healthcare system posed by the paucity of effective antifungals, as well as the critical importance of data exclusivity in encouraging investment and continued innovation in this largely overlooked segment of the market.
Lawmakers expanded the definition of a “qualified infectious disease product” to include antifungals and the measure was signed into law.
When one of the world’s largest biopharmaceutical companies was faced with an extension of a transitional pass-through payment program under Medicare that would have given biosimilar competitors an unfair advantage, they enlisted the help of Roberti Global.
Engaged and educated lawmakers in House and Senate leadership, as well as those serving on relevant committees of jurisdiction, on the history of the pass-through program (e.g., its limited application to innovator products) and the perverse incentives created by its application to biosimilars (e.g., encouraging hospitals to use biosimilars even in cases where the branded biologic is the better and lower cost option).
Roberti Global successfully limited the scope of the extension such that the pass-through payments inured to the benefit of only a handful of products – none of which were competing biosimilars.