SOURCE: Cutting Edge Information

Cutting Edge Information

June 10, 2015 11:06 ET

Pharmaceutical Companies Compete Early for US Government Reimbursement

Establishing Procedures Helps Address Regulatory-Based Inquiries, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 10, 2015) - Even without pricing considerations, securing reimbursement status starts with being proactive. US pharmaceutical companies typically begin developing drug reimbursement strategies during Phase 3 development by incorporating state price negotiation committee (PNC) schedules and the drug's therapeutic class processes. However, according to recent study findings by primary pharmaceutical intelligence firm Cutting Edge Information, some companies begin communicating with reimbursement agencies during Phase 2.

The study, "US Government Reimbursement: Winning Key Formulary Positions and Managing Pricing Systems" includes detailed best practices that pharmaceutical companies employ to maximize product reimbursement. By the time reimbursement activities are underway, for example, companies have generally had the chance to learn the makeup of each state's PNC committee, what the review processes are and how PNC expectations vary from state to state. That allows reimbursement teams to develop product dossiers that address each state's specific processes and needs prior to making a reimbursement decision.

"To be successful from a reimbursement perspective, drug companies need to understand PNC schedules and the associated therapeutic class processes," said Jacob Presson, senior research analyst at Cutting Edge Information. "For instance, companies may examine the types of products that states review, as well as how states conduct these evaluations."

According to Cutting Edge Information's study, drug companies will hold an average of 11 meetings with US government payers during Phase 3 development, each of which lasts more than one hour. At least two companies examined in the study begin these meetings during Phase 2 development.

"US Government Drug Reimbursement" provides a roadmap for better navigating government drug reimbursement amidst the growing influence of the Affordable Care Act. The report, which focuses exclusively on US government reimbursement strategies and trends, draws on quantitative and qualitative data from top-performing life science executives to provide actionable insights for winning and maintaining formulary position. Additional guidance outlined in the report includes:

  • Anticipating government payer needs and developing strong market access strategies;
  • Managing payer relationships before and after product launches to maintain formulary position; and
  • Understanding compliant government reimbursement practices in the United States' new healthcare environment.

To learn more about Cutting Edge Information and its research report offerings, please visit

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