Market access of a new innovative method for diagnostics of RA in Sweden : An initial investigation of the development of a market access strategy for a new product enabling earlier diagnostic of an autoimmune disease.

Rheumatoid Arthritis (RA) is a chronic autoimmune disease that affects 0,5-1% of the general population worldwide. The disease is a complex genetic disease, meaning that several genes, environmental factors and stochastic factors act as players in the development of the disease. RA causes inflammation in the joints typically in the hands and feet. It also can affect surrounding tissue and organs in the body. RA affects mostly women in their middle age, but the disease can occur at every age and in both genders. New research indicates that early treatment can improve quality of life and living conditions for the patients since medical treatment of the disease can cause remission. Thermo Fischer Scientific ImmunoDiagnostic Division in Uppsala started the development of a new diagnostic tool, ISAC, to provide early diagnosis for RA patients and consequently enable early treatment. The report will discuss the costs associated with the disease today and in connection to diagnosis, medication, hospital admissions and sick leave in Sweden. This will lead to a discussion and presentation of a market strategy for the first phase of the introducing the product. The results from the latest study done with ISAC shows that ISAC is “as good as” the present and competitive diagnostic method such as ELISA/CCP2 tests but ISAC has the ability to diagnose 18% more patients. Early diagnosis allows cost savings and during year 4 and with patient base of 3600 patients the savings are 154 million SEK or more for the healthcare system. From the selected group of patients around 900 new patients will be added annually. The associated cost savings for the healthcare system can be up to 25% for each patient compared to present methods. In addition, there is a great value for each additional year of working life for the patient. However this added value is extremely difficult to predict