In a previous column, I discussed how pharmaceutical and medical device companies are adapting their commercial model approaches in critical areas to address growing economic, market and other competitive pressures. This adaptation is underscored in our new Numerof & Associates 2023 Commercial Model Report, which reveals the strategic changes that manufacturers are making in how they engage with customers, manage large enterprise accounts and restructure their sales teams. Our survey also found that manufacturers are being forced to quickly rethink many other long-held assumptions about their commercial model playbook, prompted by profound shifts taking place in the global regulatory environment.

For some time, U.S. manufacturers have been bracing for the impact of the Inflation Reduction Act (IRA) and its drug price “negotiation” provision, now law. The IRA was a stunning and predictable legislative defeat for big pharma, as I explored in a previous column. While it is the most significant U.S. healthcare policy change since the passage of the Affordable Care Act (ACA) and Medicare Part D, what has now come to pass is just the tip of the regulatory iceberg.

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