Assessing and Managing Biopharmaceuticals: A Market Worth 4bn Euros

RESULTS FROM THREE YEARS OF RESEARCH BY CESBIO, THE CENTER FOR STUDY AND RESEARCH ON HEALTHCARE BIOTECHNOLOGIES AND THE BIOTECH SECTOR: A JOINT CERGAS BOCCONI AND UNIVERSITA' DEL PIEMONTE ORIENTALE PROJECT, IN COLLABORATION WITH ASSOBIOTEC, THE NATIONAL ASSOCIATION FOR THE DEVELOPMENT OF BIOTECHNOLOGIES, A PART OF FEDERCHIMICA

The Third Annual Report and two scientific monographs have been presented by CeSBIO, the Center for Study and Research on Healthcare Biotechnologies and the Biotech Sector.

The Third Annual Report The Distribution of Biopharmaceuticals, Policies on Biosimilars and Evidence of Cost-Effectiveness shows that biopharmaceuticals represent 35.2% of hospital pharmaceutical spending and 13.6% of overall pharmaceutical spending (2014 data). 94% of spending for biopharmaceuticals (€3.96bn in 2014) is concentrated in hospitals and is growing at a rate similar to hospital pharmaceutical spending (8.3% vs. 7.9% per year between 2009 and 2014). There is also an increase in the market share of biosimilars (pharmaceuticals introduced on the market after the expiration of the original product's patent), compared to the total market of the molecules of reference (original + biosimilar), from 1.3% in 2009 to 32.9% in 2014.

Biopharmaceuticals are often characterized by both increased effectiveness compared to other pharmaceuticals, and a higher cost. The latter is due to the fact that, in the majority of cases, it is a targeted pharmaceutical aimed at patients with an increased chance of reaction. It is therefore important to understand the cost-effectiveness of these products. The first monograph, Evidence of the Cost-Effectiveness of Biopharmaceuticals focuses on this particular aspect. Researchers analyzed different pieces of evidence (from literature reviews to payer appraisal documents to original Italian articles) and considerable variety of results emerged: while Italian studies provide rather positive results, reviews of international literature indicate a balance between studies with cost-effectiveness values above and below commonly accepted limits. The variability of results leads to a reflection on the suitability of integrating cost-effectiveness with other parameters, for a multidimensional assessment of the pharmaceutical, including the importance of the therapeutic target, the degree of market crowding, the clinical advantage and the impact on spending.

The presence of biomarkers and their association with a pharmaceutical for identifying patients with increased expected reactions represent important factors for sustainability of treatments. The second monograph, titled Oncological Pharmaceuticals Associated with Molecular-Genetic Tests: New Dynamics in the Outlook for Businesses, Regulators and Oncologists, tackles various policy topics related to biomarkers associated with pharmaceuticals. In addition, a survey was conducted targeted at oncologists, in collaboration with the Italian Association of Medical Oncologists. Results that emerged include a demand for a national or regional system for the selection of centers licensed to administer tests, considerable variability in the number of tests actually prescribed and aspects perceived as more critical in the management of tests, i.e. the availability of biological samples, times for performing tests, interpreting results and coordinating among various professional roles.

"The three-year collaboration with CeSBIO has generated interesting evidence in particular aspects of applying biotechnologies in the area of healthcare that continue to be little known and studied, such as the value of biopharmaceuticals and the role of biomarkers," explains Riccardo Palmisano, President of ASSOBIOTEC. "Intense research and study today provide us with a detailed and in-depth economic-social analysis that may represent an independent and – we hope – useful tool to support the future management and policies of biotechnologies applied to life sciences for the world of research, policy makers, industry and healthcare companies."
 
The Center for Study and Research on Healthcare Biotechnologies and the Biotech Sector (CeSBIO) was founded in 2012 by a joint proposal by CERGAS Bocconi and the Department of Pharmaceutical Sciences at Università del Piemonte Orientale, on the initiative of ASSOBIOTEC, the National Association for the Development of Biotechnologies, a part of FEDERCHIMICA. The Center aims to analyze the topic of applying biotechnologies in the area of healthcare, regarding economics, policy and management. In its three years of research, the Study Center has produced the following studies: "First Research Report 2013: Biopharmaceuticals and National and Regional Policies for their Governance;" "Second Research Report 2014: The Distribution of Biopharmaceuticals, Their Cost-Effectiveness and Trends Related to Pharmaceutical-Test Association for Biomarkers;" "Third Research Report 2015: The Distribution of Biopharmaceuticals, Policies on Biosimilars and Evidence of Cost-Effectiveness" and the two monographs: "Evidence of Cost-Effectiveness of Biopharmaceuticals" and "Oncological Pharmaceuticals Associated with Molecular-Genetic Tests: New Dynamics in the Outlook for Businesses, Regulators and Oncologists."

by Fabio Todesco
Translated by Jenna Walker