Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Rx-to-OTC Switch - Opportunities And Risks With Focus On Statins

Dr. Wolfgang Meder (Abschlußjahr: 2004)

Over-the-Counter (OTC) switching, though not the preferred lifecycle management strategy for mature products to defend generic competition, has proven successful, in some cases, at maintaining a compound's revenue stream.

Multiple criteria have to be considered in order to evaluate if a product is suitable for a prescription-to-OTC switch. While regulatory, reimbursement & pricing considerations as well as market exclusivity and advertisement aspects are important general switch factors, the company s strategic orientation and resources also play a major role. Most importantly, the product must display a high safety level and be suitable for treatment in an OTC setting without the supervision of a physician.

OTC switches in the past mainly focused on improving the quality of life. In the meantime it has become difficult to find new products in new therapeutic areas which would allow safe use in an OTC setting - the "easy" switches are done. Therefore, the next step in OTC history could be trying to extend life with self-medication as well.

One such new therapeutic area for self-medication potentially is statin treatment to prevent coronary heart disease. The main difficulty with statins is the question of how to switch a product for OTC use for a chronic disease like hypercholesterolemia to improve conditions without acute symptoms or direct impairment of the living quality?

Other questions that arise when evaluating the switch of a statin are

How to establish a clinical benefit of statin treatment in an OTC population?
Can the patient understand the information on the package label and the material inside the package and therefore safely use the product?
Can the patient recognise and diagnose the condition specified in the proposed indication?
This thesis focuses on risks and opportunities of statins available over-the-counter in the light of the recent switch of Zocor Heart Pro® (10 mg simvastatin) to nonprescription status in the United Kingdom and the potential switch of Mevacor® (20 mg lovastatin) in the USA.

Pages: 45