Managed Care - May 2008 - (Page 18) MEDICATION MANAGEMENT GAO describes possible effect of BTC class of drugs A ccording to a report by the General Accountability Office titled “Pharmacist-Controlled Nonprescription Drugs,” the economic effect of creation of a three-tier system drug distribution is unclear. The report refers to the proposed behind-the-counter class of drugs as an “intermediate class.” It lists four possible scenarios: • The availability of an intermediate class of drugs might prompt a change in manufacturers’ pricing patterns. For example, if the introduction of an intermediate class permitted a drug to be switched from prescription status, the price might decline. If drugs were switched from general sale to the intermediate class, they would be available in fewer retail outlets. It is possible that the decrease in the number of retailers selling these drugs could adversely affect retail competition and, as a result, drive up prices. However, the availability of mail-order pharmacies and other outlets (provided they sold the drugs in the intermediate class), and the likelihood of new pharmacies opening, could mitigate or eliminate this effect. If drugs were moved to the intermediate class from the general sale category, the greater role of pharmacists might lead to higher prices if a counseling fee is implemented. The effect of an intermediate class of drugs on consumers’ out-of-pocket drug expenses would depend on the behavior of third-party payers such as health insurers, which often pay all or most of the cost of prescription drugs but generally do not pay for over-thecounter products. If insurers elected not to cover drugs that were moved from prescription status to an intermediate class, consumers’ out-of-pocket expenditures would increase. However, if fewer drugs were covered, health insurance costs might decrease and partially or fully offset consumers’ greater out-of-pocket drug expenditures. • • • “An intermediate class of drugs could also produce savings in other health care costs,” concludes the report. “The cost of obtaining a prescription drug includes not only the cost of the drug itself but also the cost of the visit to a physician. Patients would be saved the cost of the visit to the physician.” BTC drugs could increase pharmacists’ income through consulting fees. The National Association of Chain Drug Stores states that the change to a three tiered system “could offer yet another way for pharmacists to serve their patients.” FDA interested “There have been some changes over the years, and most recently they have been driven by an increased trend toward consumer involvement and patient empowerment in their decisions and responsibilities that they take for health care,” said Randall Lutter, MD, FDA deputy commissioner for policy, at a public meeting on the subject late last year. “What we have now is the Internet and increased consumer and patient awareness and the need for information about their own decisions. Given that new technology, it seems an appropriate time to ask whether or not there are ways of improving public health through increased access by behind-the-counter availability.” Any switch to a three-tiered system would no doubt create some regulatory challenges. Because of this, the FDA has not announced any drug categories that may be considered if a BTC system were to be fully rolled out. So the criteria to be used for determining which drugs would enter BTC status are unknown. Internationally, suitability for self-diagnosis and lowpotential for serious side effects of overdose are used to qualify candidates for BTC status, according to a report on the issue by IMS Health. The issue raises “valid concerns” for insurers, agrees Daniel A. Hussar, PhD, a professor of pharmacy at the University of the Sciences in Philadelphia. Hussar favors creation of a BTC class. “Although some insurance companies do not cover OTC medications in their prescription plans, others are willing to reimburse patients for the cost of certain OTC medicines, such as Prilosec OTC, which offer a less-expensive alternative to similar prescription medications,” says Hussar. Employers and other organizations that pay insurers to provide these programs “should not only expect, but should insist on continued coverage of these medications.” MC 18 MANAGED CARE / MAY 2008
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