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Optimizing treatment for inflammatory bowel disease

New drugs in the pipeline and tools to manage appropriate dosage


Arpana Mathur, MD, MBA Executive Medical Director, Medical Affairs, CVS Health


Specialty Pharmacy Pipeline: Drugs to Watch Report

Anticipated launches | Q2 2023 – Q3 2023

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Approximately 70,000 new cases of inflammatory bowel disease (IBD) are diagnosed each year1; 1.7 million Americans suffer from IBD.2 Many experience onset between the ages of 15 and 35, the most productive years of adulthood.3 The causes of IBD are unknown, but can include:

  • Genetics
  • Lifestyle factors such as smoking, diet, and sleep4
  • Infection and immune response
  • Environment

IBD is divided into two major types: Crohn’s disease and ulcerative colitis. Both of these conditions are incurable and may require lifetime treatment. IBD accounts for approximately $10 billion in direct medical costs annually.5


Health care costs for those with IBD are $22,987 versus $6,956 for those without.6


Crohn’s disease and ulcerative colitis are treated with different classes of medications including brand-name biologics and biosimilars. The global IBD market was valued at $23.9 billion in 2021 and is expected to grow at nearly 6 percent by 2029.7

These agents act selectively, precisely targeting the factors responsible for IBD.8 While this can offer a distinct advantage for treatment, 45 percent of patients with a prescription are likely to become non-adherent once they begin to feel better.9

For those who do not respond to treatment, dosage escalation is common. In these instances, providers may increase the dose of the prescription or shorten the interval between doses. Although this may be effective in certain patients with IBD, it effectively becomes an off-label use of the drug outside of standard coverage criteria. Therefore, plan members may experience denials that hinder access to their medication.

Fortunately, CVS Specialty has tools that allow us to foresee potential dosage escalations, including Intelligent Medication Monitoring.* Our built-in process and EHR connectivity allow us to review these prescriptions and work with providers to get patients started on therapy. This is especially important for pediatric patients, who are growing in number. Some experts estimate that as many as 80,000 children under age 15 suffer from IBD.10

In this way, we can support clinically appropriate drug therapy that helps lower costs. By communicating with providers to evaluate optimal dosing options, patient-specific dosing limits helps eliminate waste.


>$100K estimated annual plan savings per de-escalated member**11


Notable drugs in the pipeline to treat IBD

Rinvoq (upadacitinib, AbbVie) is pending FDA approval for a supplemental indication for the induction and maintenance treatment of moderate-to-severe Crohn’s disease in adults who have not responded to or cannot tolerate other conventional or biologic therapies. It was approved to treat ulcerative colitis in March 2022. If the supplemental indication is approved, Rinvoq would provide an oral alternative to such brand-name IV biologics such as Entyvio (vedolizumab), Skyrizi (risankizumab-rzaa), Humira (adalimumab), Remicade (infliximab), and Stelara (ustekinumab). Rinvoq is a Janus kinase (JAK) inhibitor; these agents have raised some recent safety concerns.

Etrasimod (Pfizer) could provide an alternative oral option for members ages 16 and over with moderate-to-severe ulcerative colitis who may be taking IV or subcutaneous therapies. It is similar to Zeposia (ozanimod).

These therapies are being reviewed by the FDA this year. Their likely impact for plan sponsors is replacement spend for other medications already in use.



*CVS Specialty pharmacy patients only

**Savings are estimated based on utilization of Stelara 90mg successfully de-escalated from once every 28 days to once every 42 days

This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

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