As the largest pharmaceutical market worldwide, the U.S. provides a huge opportunity for market access, but it is complex and fragmented. The U.S. healthcare system is divided into federally-funded health insurance plans (Centers for Medicare & Medicaid Services; CMS) and private health insurance plans. While companies in the U.S. are free to set their own prices for drugs, the payers set the reimbursement rates, once they have been accepted for formulary inclusion by the Pharmacy and Therapeutics committee. This decision is based on clinical and economic evidence, drug acquisition costs and potential budget impact.
Public and private healthcare plans make their own decisions on coverage. The private healthcare plans may include tiers of co-payment depending on the plan coverage and the type and cost of the drug. Medicare and Medicaid pay for drugs based on the average sales price, the wholesale acquisition price or the maximum allowable cost, and also negotiate rebates and discounts with drug companies.
The U.S. Unapproved Drugs Initiative was launched in 2006 to allow companies to relaunch drugs that had entered the market before FDA oversight and were subsequently removed. In return for testing the older drugs against the new standards, companies gain limited market exclusivity rights.
During both pre-launch
, you should work towards:
Understanding the roles of the different government agencies and managed care organizations
Creating relationships with key stakeholders and decision-makers within the government and managed care
Understanding the timelines and processes for government and managed care
To guide you through your market access journey in the U.S., download our U.S. Value, Outcomes and Access Planner.
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