By Robert Hand

In the United States, there has been growing acceptance of the Academy of Managed Care Pharmacy (AMCP) Drug Dossier format for submitting consistent, evidence-based information about drugs. And Australia, Great Britain, Germany, and other countries have national systems to provide clinicians with comparable information about new drugs. But drug makers fear that they could lose the confidentiality of proprietary pharmacoeconomic data and models that they submit. This is especially true for government agencies, which may be subject to freedom-of-information requirements.

Off the record, executives at two major pharmaceutical companies told us that their firms are eager to make their pharmacoeconomic data public. In fact, they actively publish the data; indeed, one of them said that compromising trade secrets had never been a problem with any of the products he had worked with.

For certain drugs, however, the confidentiality of proprietary pharmacoeconomic information can be an important issue. A consultant to one of the world’s largest pharmaceutical companies cited the example of a drug for chronic obstructive pulmonary disease. In that case, a competitor’s drug had received a favourable price from a regulatory authority. The consultant’s client would certainly have been interested to see what economic data and modelling had been used to gain such a strategic advantage.

Inappropriate disclosure can be a threat for several reasons. Committees making formulary decisions, of course, need to know the price of a drug to determine its cost effectiveness. However, if competitors gain access to price information before the drug becomes commercially available, the manufacturer might sustain economic damage. Furthermore, dossier submissions may contain unpublished clinical data, information on clinical development plans, or hints to market positioning, any of which would be valuable intelligence to competitors.

How can companies protect their proprietary information?

The questions to ask are: Is this nothing more than institutional paranoia? Is this information in the public domain? Will letting the information out really turn into a commercial threat? Will transparency hurt or harm our case? Should our information be made public in a more therapeutically-focused journal or conference rather than at meetings where the audience is primarily health economists from competing organisations?

The current situation is in a state of flux. Many healthcare agencies face growing pressure for transparency of their decision making. This means that they may want to make public as much of their pharmacoeconomic information as possible. Processes and systems for facilitating healthcare policy decisions are changing.

One answer is to be careful to designate sensitive information as “commercial-in-confidence.” Be aware that changing circumstances may result in information considered confidential today becoming public tomorrow. In planning your publication strategy, make sure that the policies of your target journals do not bar publication of clinical data that have already appeared in submissions. And keep up with all the procedural and policy changes!