Study Finds Biologics Improve Outcomes in IBD, Are Cost Ineffective

A recent study published in PLOS One found that, while biologic agents improved outcomes in patients with inflammatory bowel disease (IBD), they incurred such high costs that they were deemed cost ineffective, particularly for use as maintenance therapy. However, Nadia Pillai and colleagues at the Institute of Social and Preventive Medicine in Lausanne, Switzerland, noted that, as market prices fall and more biosimilars are introduced, the cost effectiveness of biologic agents may improve: “As patents for older biologic agents expire, biosimilars are entering the market, creating an important opportunity for increasing access and reducing costs.”

In March 2017, the investigators performed an extensive systematic literature search of English-language publications to identify economic evaluations of pharmacological and surgical interventions for adults diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC). They analyzed data from 49 full-text studies (24 of which focus on CD and 25 on UC) to determine costs and incremental cost-effectiveness ratios (ICERs) adjusted to reflect 2015 purchasing power parity (PPP).

With respect to CD, the study found the following:

• Infliximab and adalimumab induction and maintenance treatments were cost effective compared with standard care in patients with moderate or severe CD, but in patients with CD refractory to conventional drugs, fistulizing CD, or surgically-induced remission of CD, ICERs were above acceptable cost-effectiveness thresholds.
• Front-line induction therapy using infliximab in newly diagnosed CD patients was cost effective. This was an important finding in that current treatment guidelines reserve biologic agents as second-line treatment for moderate to severe disease or for cases in which conventional treatments fail.

With respect to UC, the study found the following:

• In mild UC, induction of remission using high-dose mesalazine had lower costs and higher effectiveness than using the standard dose of the drug
• In UC refractory to conventional treatments, infliximab and adalimumab induction and maintenance treatment were not cost effective compared with standard care
• ICERs for treatment with vedolizumab and surgery were favorable

The authors conclude that, while biologic agents help to improve outcomes in terms of quality-adjusted life years and remission rates, at current prices, they do not provide good value for money in the majority of clinical situations compared with conventional therapies. In particular, when administered to maintain remission and when compared with current conventional therapies, biologic agents are not cost effective in both CD and UC.

The authors pointed out that evidence from studies of CD illustrate the potential for biologic agents to be cost effective if initiated early and when the patient’s lifetime clinical management is considered. “Early management of CD with infliximab reduced the rate of relapse and hospitalization compared with patients who received upfront steroids,” they explain. According to the authors, early intervention with biologic agents in patients who are at high risk of complications may provide long-lasting benefit and help alter the clinical course of the disease; stratifying patients based on their risk of complications soon after diagnosis may be one way to ensure the value for money of biologic agents is captured.

Finally, the authors note that the cost effectiveness of individual biologic agents compared with each other remains inconclusive, reflecting a major gap in the literature. They further recommend that future economic models strengthen the existing literature by more accurately reflecting real-world treatment pathways, ensuring that the chronic and dynamic nature of IBD is captured and accounting for both direct and indirect costs incurred by the health system and the patients.