OBJECTIVES: To assess the potential market access outcomes of a novel drug-device and app combination for a chronic orphan disease, and the potential competitive advantage this would have in a crowded market with little differentiation.

METHODS: An analogue analysis was conducted where historical examples of drug-device with app combinations were documented, along with any HTA outcomes. Analogues were also assessed for their value propositions, and whether these claims were documented in a randomized controlled trial, which were henceforth published in a reputable journal. Only analogues which demonstrated improved disease control and cost-effectiveness were chosen for additional secondary research, to ascertain any outcomes of this competitive advantage, and if this advantage had been recognized by clinicians and payers.

RESULTS: Analogues which best matched the disease area, value propositions and technology advancement were: MyPKFit for Advate (for treatment of haemophilia A), Minimed 640G (type I diabetes) and RebiSMART (relapse-remitting multiple sclerosis). Although HTA bodies often do not assess drug-device combinations, Minimed 640G had been recommended by NICE for uncontrolled and disabling hypo/hyperglycaemia therefore supporting the perceived value by Payers. RebiSMART demonstrated the additional benefit of the medical device through improved Rebif (interferon beta-1a, the corresponding drug) sales, which increased by 15% upon the year of launch.

CONCLUSIONS: There are numerous examples of drug device and app combinations providing a competitive advantage over similar products in many chronic disease areas. There is a general upwards trend towards the production of medical devices which have a corresponding app to track patient adherence, cost-effectiveness and improve the efficacy of the drug through better disease control.