On August 29th, the Biden Administration named the 10 drugs that will be subject to price negotiation with Medicare in the initial implementation of the Inflation Reduction Act (IRA) of 2022. Release of the list marked a milestone in a decades-long effort by Democrats to use the purchasing power of…
For years, lawmakers have been chomping at the bit to reduce the perceived power of the pharmaceutical industry — once the crown jewel of American business. Their efforts have finally come to fruition with the signing into law of the misnamed Inflation Reduction Act. The law, in part, allows Medicare…
Economic and clinical value has become the basis for both differentiation and maintaining premium pricing, and the importance of the economic and clinical value case is likely only to increase. This trend is truly global in scope, applies to multiple key stakeholder groups (payers, physicians, and patients), and is particularly…
Increasingly, pharmaceutical companies are being asked – if not required – to demonstrate that their products deliver economic and clinical value to a wide range of stakeholders, including payers, providers, pharmacy benefit managers (PBMs), and patients. In the past, regulatory approval alone was sufficient to successfully bring a new product…
There are several important reasons for stakeholders to be optimistic about prospects for biosimilars. During the past few years, questions about the underlying technology and market acceptance have begun to resolve themselves in a positive manner. Regulatory pathways are being defined, and major players and investments are lining up. Most…
In today’s global market environment, payers are looking hard to reduce reimbursement and resist paying for incremental product enhancements. On top of that, manufacturers’ revenue streams continue to be threatened by looming patent expiration dates and the simultaneous influx of generic competition. What actions should companies consider taking to protect…
