Flares in gastrointestinal indications are characterised by a shift in the proportion of bacterial species in either the gut or skin microbiome. The development of microbiome-targeted therapeutics for the treatment of gastrointestinal indications has become a hot area in the immunology space in recent years, with the potential to introduce an innovative drug class to the immunology market. The novelty of this mechanism of action (MOA) brings into question the potential pricing and reimbursement of this new drug class. How will US payers respond to the launch of these non-traditional therapies?

Taking a closer look at the current pricing and reimbursement strategies in the gastrointestinal space in the US market, payers interviewed by GlobalData indicated there is a similar reimbursement mechanism for Crohn’s disease and ulcerative colitis (UC), but the strategy differs for irritable bowel syndrome (IBS) due to the vastly different therapies available for treatment.

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The Crohn’s disease and UC treatment landscape is marked with numerous marketed therapies, with payers requiring the use of non-biologics, such as aminosalicylates, immunomodulators, and steroids, before a biologic is eligible for reimbursement, due to the higher annual cost of therapy (ACOT) of biologics, which is upwards of $45,000 in both indications. Within the biologic space, payers indicated a preferred biologic, such as Humira or Remicade, must be prescribed before a non-preferred biologic, such as Stelara, is eligible for reimbursement. Reimbursement mechanisms for the IBS market are vastly different from Crohn’s disease and UC, as treatment options for IBS are dominated by lifestyle changes and generics.

Microbiome-targeted therapies in late-stage development

There are currently two gut microbiome-targeted therapies in late-stage development: Qu Biologics’ QBECO-SSI, a site-specific immunomodulator derived from inactivated enteropathic E. coli in Phase IIb development for Crohn’s disease and Phase IIa development for UC, and Synthetic Biologics’ SYN-010, a modified-release reformulation of lovastatin lactone designed to reduce methane production by M. smithii in the gut in Phase IIb/III for IBS with constipation (IBS-C).

Focusing on the former, GlobalData anticipates QBECO-SSI will launch for the treatment for moderate to severe Crohn’s disease in 2023 prior to UC, with an anticipated ACOT of approximately $30,000 as indicated by US payers. With a high price tag, GlobalData anticipates QBECO-SSI will not only compete with generics and oral small molecules, but also the numerous biologics approved for this indication.

In regards to the pricing and reimbursement of SYN-010 for IBS-C in the US market, payers indicated a key factor to consider when pricing this therapy is the large IBS patient population and the financial consequences of reimbursement. Payers also expressed that the consequence of treatment failure in irritable bowel syndrome is not as high as in inflammatory bowel disease because patients do not commonly undergo surgery – a factor that needs to be taken into consideration when pricing SYN-010. Assuming SYN-010 will primarily face competition from Allergan’s Linzess (linaclotide), Mallinckrodt/Takeda’s Amitiza (lubiprostone), and their generics, US payers anticipate the therapy will cost around $300 to $400 a month, translating to an ACOT of $3,600 to $4,800.

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Across all immunology indications, US payers interviewed by GlobalData indicated the two most important factors considered when evaluating a drug are the cost of the therapy and level of unmet need in the indication. Despite microbiome-targeted therapies presenting a non-traditional mechanism of action, GlobalData anticipates microbiome-targeted therapies in the gastrointestinal space to gain reimbursement if priced strategically, while still showing a strong safety and efficacy profile in comparison with the standard of care.

Related Reports

GlobalData (2018). Microbiome-Targeted Therapeutics in Immunology, March 2018, GDHCHT001