Funding Innovation Thanks to Anti-TNF-α Biosimilars Uptake: The Economic Impact in Italy

INTRODUCTION: Anti-TNF-α biosimilars (ATB) hold the promise of reducing costs leading in improving access to bio-logical therapies. There is limited insight into how the savings generated by biosimilars may translate into patient benefit in other disease areas.AIMS: To assess the economic savings for Italian National Health System (NHS) due to the expansion of ATB market, together with a reduction in their price and to illustrate how this potential savings can be used by NHS to fund orphan drugs.METHODS: Trend of IMS Health monthly sell-in units (August 2016-December 2019) were used to estimate the current biologic and biosimilar market for rheumatic and inflammatory bowel disease in Italy and its evolution up to 2022. The scenario for 2019-2020 was compared with the future evolution (2021-2022) assuming an increasing uptake of biosimilars in the Italian market. Finally, it was estimated how these savings can potentially fund the treatment of orphan drugs, without increasing the Italian NHS budget.RESULTS: Italian biologic and biosimilar market remains stable in the next years (about 4 million units both in the current scenario and in the future evolution market) with a slight decreasing of less than 2%. However, according to our assump-tions, ATB market is expected to increase of about 33% in the next two years, covering 67% of the total Italian market, mostly due to biosimilar etanercept. Total savings due to biosimilars increases from € 96 million in 2019 to € 161 million in 2022 corresponding to a mean annual savings of about € 130 million. Such savings would permit funding 17.4% of the actual orphan drugs market corresponding to 2,600-4,800 new patients.CONCLUSIONS: The introduction of biosimilars in a range of rheumatic, dermatological and inflammatory bowel disease can be an opportunity to increase patient access to innovative treatments. Potential savings due to biosimilars uptake could lead to a re-allocation of economic resources to fund innovative therapies.

Download Full-text

Cutaneous Manifestations in Biological-Treated Inflammatory Bowel Disease Patients: A Narrative Review

Journal of Clinical Medicine ◽

10.3390/jcm10051040 ◽

2021 ◽

Vol 10 (5) ◽

pp. 1040

Author(s):

Jo L. W. Lambert ◽

Sofie De Schepper ◽

Reinhart Speeckaert

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Cutaneous Manifestations ◽

Cutaneous Infections ◽

Tnf Α ◽

Common Skin ◽

Receptor Blockers ◽

Infusion Reactions ◽

Inflammatory Bowel ◽

Lichenoid Reactions

The biologic era has greatly improved the treatment of Crohn’s disease and ulcerative colitis. Biologics can however induce a wide variety of skin eruptions, especially those targeting the TNF-α and Th17 pathway. These include infusion reactions, eczema, psoriasis, lupus, alopecia areata, vitiligo, lichenoid reactions, granulomatous disorders, vasculitis, skin cancer, and cutaneous infections. It is important to recognize these conditions as treatment-induced adverse reactions and adapt the treatment strategy accordingly. Some conditions can be treated topically while others require cessation or switch of the biological therapy. TNF-α antagonists have the highest rate adverse skin eruptions followed by ustekinumab and anti-integrin receptor blockers. In this review, we provide an overview of the most common skin eruptions which can be encountered in clinical practice when treating IBD (Inflammatory bowel disease) patients and propose a therapeutic approach for each condition.

Download Full-text

Myeloproliferative disorders in patients with inflammatory bowel disease on anti-TNF-α therapy

Inflammatory Bowel Diseases ◽

10.1002/ibd.21291 ◽

2011 ◽

Vol 17 (2) ◽

pp. 674-675 ◽

Cited By ~ 2

Author(s):

Monika Fischer ◽

Debra J. Helper ◽

Michael V. Chiorean

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Myeloproliferative Disorders ◽

Tnf Α ◽

Inflammatory Bowel

Download Full-text

PTH-052 How The New Inflammatory Bowel Disease Registry And Patient Management System (ibd-r/pms) Has Help Define The Future Of Our District General Ibd Service

Gut ◽

10.1136/gutjnl-2014-307263.498 ◽

2014 ◽

Vol 63 (Suppl 1) ◽

pp. A231.2-A232 ◽

Cited By ~ 1

Author(s):

MW Johnson ◽

K Lithgo ◽

T Price

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Management System ◽

Patient Management ◽

Disease Registry ◽

The Future ◽

Inflammatory Bowel

Download Full-text

Inflammatory bowel disease: the role of inflammatory cytokine gene polymorphisms

Mediators of Inflammation ◽

10.1080/09511920410001713529 ◽

2004 ◽

Vol 13 (3) ◽

pp. 181-187 ◽

Cited By ~ 45

Author(s):

Joanna Balding ◽

Wendy J. Livingstone ◽

Judith Conroy ◽

Lesley Mynett-Johnson ◽

Donald G. Weir ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Disease Incidence ◽

Strong Association ◽

Tnf Α ◽

Genes Encoding ◽

Inflammatory Processes ◽

Inflammatory Bowel ◽

Cytokine Gene Polymorphisms

THE mechanisms responsible for development of inflammatory bowel disease (IBD) have not been fully elucidated, although the main cause of disease pathology is attributed to up-regulated inflammatory processes. The aim of this study was to investigate frequencies of polymorphisms in genes encoding pro-inflammatory and anti-inflammatory markers in IBD patients and controls. We determined genotypes of patients with IBD (n=172) and healthy controls (n=389) for polymorphisms in genes encoding various cytokines (interleukin (IL)-1β, IL-6, tumour necrosis factor (TNF), IL-10, IL-1 receptor antagonist). Association of these genotypes to disease incidence and pathophysiology was investigated. No strong association was found with occurrence of IBD. Variation was observed between the ulcerative colitis study group and the control population for the TNF-α-308 polymorphism (p=0.0135). There was also variation in the frequency of IL-6-174 and TNF-α-308 genotypes in the ulcerative colitis group compared with the Crohn's disease group (p=0.01). We concluded that polymorphisms in inflammatory genes are associated with variations in IBD phenotype and disease susceptibility. Whether the polymorphisms are directly involved in regulating cytokine production, and consequently pathophysiology of IBD, or serve merely as markers in linkage disequilibrium with susceptibility genes remains unclear.

Download Full-text