Debates about market access in the specialty drug realm are heating up. This is especially true for products targeting indications with exceedingly high levels of medical need. These are the diseases we call “breakthrough innovation areas” since rapid advancements in the standard of care are either occurring or planned. Major breakthrough innovation drugs are being introduced to treat cancer, autoimmune diseases, rare genetic disorders, Alzheimer’s, and pandemic infectious diseases. Approaches to product development, marketing and pricing are already unique in these areas, and the landscape is still evolving.