ABSTRACT
In this chapter, the authors will discuss some fundamental aspects of the drug industry and the reasons why drug pricing is so different from other industries. Many governments have a very strict approval process in place for pricing and/or reimbursement decision-making for drugs. Over the last few decades, we have seen waves of political and public dissent over drug pricing. Since the launch of Sovaldi in 2013, drug pricing has seen a substantial increase in public attention globally. Pricing, reimbursement and access are terms that are used in any set of combinations to describe the activities related to setting a drug price across markets that addresses third-party reimbursement or cash pay affordability in the context of each payer system and segment. In every healthcare system, drug companies must obtain regulatory approval or market authorization before they are legally authorized to promote prescription drugs. In most healthcare systems, effective market entry is not possible without pricing and/or reimbursement or access approval.
