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REPEAL OF TWO-LINE Rx FORM SHOULD BE KEY PRO-GENERIC GOAL AT STATE LEVEL; NEW HCFA REGS, MEDICARE LEGISLATION PROVIDE LEVERAGE -- AARP URGES NAPM INTEREST

Executive Summary

Repeal of the two-line prescription form should be the chief target of pro-generic lobbying at the state level, Retired Person's (American Association of Retired Person's) Pharmacy Service State Legislation Director Nick Willard told the National Association of Pharmaceutical Manufacturers (NAPM) annual meeting in Puerto Rico Jan. 22. The two-signature prescription blank, currently being used in 22 states, Willard maintained, is "the single most effective barrier to" generic substitution at the state level. As such, he said, maintaining the two-line forms is likely to replace safety and efficacy issues and re-emerge as the focus of state lobbying efforts by brandname companies. Willard cited studies conducted at the University of Texas College of Pharmacy and the Medical College of Virginia which found that in those two-line jurisdictions, prescribers routinely signed the "do not substitute" space for multisource entities 66% and 51% of the time, respectively. By contrast, the AARP Pharmacy Service staffer noted, "in informal samples our company has conducted on prescriptions written in one-liner states, prescribers allow substitution for multisource entities 92-95% of the time." Willard noted that the new Health Care Financing Administration Medicaid regulations and the proposed Medicare legislation provide a fulcrum for pro-generic forces to use in prompting the states to repeal the two-line forms. The HCFA regulations will require "brand medically necessary" to be written in the prescriber's own hand on a prescription for federal reimbursement of a brand in a multisource category. The handwritten certification is required regardless of state substitution practices. With the support of the new federal regulations and legislation, Willard said, "generic advocates can join hands with state Medicaid Directors and appear before state legislators to advocate that state policy be made consistent with federal law." The key propositions in the pro-generic argument, Willard said, will be that state policy with respect to substitution should "a) avoid creating chaos in the health care marketplace, and b) not cost the state money." On the other hand, Willard predicted, brandname companies will counter by switching their focus from safety and efficacy to states' rights issues. The argument will be made, he said, that HCFA can't preempt the states; that the "two-line substitution form is more strict and more protective than the federal rules and, therefore, should take precedence." Willard predicted that, in this election year, "many Medicaid directors are going to be requesting extensions from HCFA on the application of its rule," and that "brandname detailmen will be making more and more additional visits to remind the docs to write 'brand medically necessary'" on prescriptions. Along with the two-line prescription, Willard said, the other two most significant barriers to generic substitution are the authority of independent state formulary commissions and the provision mandating a full percentage savings pass-through to consumers. Willard maintained that "control of the formularies has been a powerful anti-generic tool for many years." He cited the example of Pennsylvania, where "the equivalents of Motrin, Valium and Inderal were held off the state formulary for 18 months after the ANDAs were granted." Willard predicted that "its going to be extremely difficult to pry that tool from the pioneer companies' grasp."
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