THERADIAG: Monitoring of Biotherapeutic Treatments of Crohn’s Disease Could Produce Savings of More Than €130 Million in France

Regulatory News:

THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER, PEA-PME eligible), a company specializing in theranostics and in vitro diagnostics, has announced the results of a pharmaco-economic report which demonstrates that the use of anti-TNF monitoring and anti-TNF antibodies in the treatment of patients with Crohn’s disease treated by biotherapies can save up to 25% of the cost of treatment, or €131mio over 5 years in France alone.

"The results of a pharmaco-economic study highlight the value of Theradiag’s theranostic tests,” noted Michel Finance, Theradiag’s Chief Executive Officer. "Auto-immune diseases represent a major challenge for public health services and the cost to social security systems of using biotherapies is substantial, particularly for patients showing treatment resistance. The results of this study show economic benefits of using a monitoring test in patient management and the adoption of a personalized therapeutic approach. Lisa Tracker theranostic tests represent significant potential to control the cost of biotherapies, and could generate savings of more than €130mio.”

Anti-TNF: a widely used range of biotherapies with established efficacy, but which can frequently be unsuitable and costly

Diseases related to immune system disorders, such as rheumatoid arthritis, ankylosing spondylitis and inflammatory bowel disease, are chronic pathologies which affect more than 28 million people around the world¹. Biotherapies, frequently trigger immune responses from the patient, leading to treatment loss of response. There is a need for therapeutic drug monitoring to allow clinicians to assess patient responses in order to anticipate, optimize and change treatment.

Given the ever more frequent use of anti-TNF treatments (in France, around 85,000 patients are treated with Anti-TNF alpha including 30,000 inflammatory bowel diseases patients), their cost (of €14,000 to €16,000 per patient per year) and the severity of the diseases concerned, it seems essential to rationalize their use so as to gain greater control over their cost.

Study methodology

The study looked at a double cohort of patients (3,000 and 10,000) suffering from Crohn’s disease and treated with anti-TNFa over a given period (1, 3 and 5 years). It was run by Professors Duru (Honorary Research Director at CNRS) and Lamure (Professor at University Claude Bernard, Lyon), who were responsible for the methodology, and three experts in gastroenterology: Dr Attar (Hôpital Beaujon, Clichy), Professor Peyrin-Biroulet (CHU, Nancy) and Professor Roblin (CHU, Saint-Etienne).

¹ Data Monitor, Commercial Insight: Autoimmune overview. December 2007.

The parameters used in the model were drawn from the literature, assumptions and actuarial calculations.

Study results

The study served to determine firstly an estimate of the cost of treatment by anti-TNF for each of the two cohorts over periods of one year, three years and five years, and secondly the impact on these costs of introducing a biological test to allow optimized use of the biotherapies.

The results of this analysis confirmed that there is a significant financial impact on health budgets from the use of dosage monitoring, with savings of up to 22% over 3 years and 25% over 5 years, just for patients with Crohn’s disease treated with biotherapies.

The savings for the cohorts of 3,000 and 10,000 patients are set out in the tables below:

Pr Roblin will present these results at United European Gastroenterology Week, in Vienna, Austria between 18 and 22 October 2014:
https://uegw.congress-online.com/guest/ID52c7de4a9c120b/AbstractView?ABSID=7565

If this study were extrapolated to all countries using these biotherapies in the treatment of Crohn’s disease, and patients suffering from other auto-immune diseases treated by biotherapies, the savings for health systems would be in the hundreds of millions of euros.

About Theradiag

Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag notably markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter theranostics solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of HIV/AIDS and rectal cancer. Theradiag is thus participating in the development of "personalized medicine”, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 65 employees.

For more information about Theradiag, please visit our website: www.theradiag.com