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• Expedite the approval of biogenerics. As the number and costs of expensive biologic drugs drastically increases, so does the urgency to begin the approval pathway for biogenerics as quickly as possible. Reducing the number of years a drug company has “exclusivity” or monopoly-pricing power would increase competition and lower costs for payers and consumers. The president’s budget proposes to “accelerate access to affordable generic biologics by modifying the length of exclusivity on brand name biologics. Beginning in 2014, this proposal would award brand biologic manufacturers seven years of exclusivity, rather than 12 years under current law, and prohibit additional periods of exclusivity for brand biologics due to minor changes in product formulations, a practice often referred to as ‘evergreening.’” According to the budget, these changes would result in $3 billion in savings for Medicare and Medicaid.
To lower health care costs, we need a competitive, flexible environment that fosters the ability of large and small payers to use key tools that improve quality, reduce costs and expand access. PBMs are part of the solution, and we’re looking forward to working with policymakers on new ways to achieve these goals.
Mark Merritt is president and CEO of the Pharmaceutical Care Management Association.