DRUG COUNCIL TO STUDY COSTS, QOL

Recent amendments to President Clinton's Health Security Act have added new tasks for the proposed Advisory Council on Breakthrough Drugs in the USA.

The final version of the bill, as it has been introduced into Congress (HR 3600 and S 1757), now states that the Council will consider the cost-effectiveness of a breakthrough New Chemical Entity "relative to the cost of alternative course of treatment options, including nonpharmacological medical interventions." It will also be required to assess "improvements in quality of life offered by the new product, including ability to return to work, ability to perform activities of daily living, freedom from attached medical devices and other appropriate measurements of quality of life improvements."

These new powers are in addition to the requirements of the Council outlined in the draft of the health care reform legislation published on October 27. This stated that it could evaluate the reasonableness of the launch price of a New Chemical Entity which offers significant advances over existing products, based on the prices of other drugs in the same therapeutic class, cost information supplied by the manufacturer, the drug's price in certain other countries, and projected prescription volume, economies of scale, product stability, special manufacturing requirements and research costs.