More Treatments, Costs for Patients with Inflammatory Bowel Disease

Payors can counter increases with comprehensive utilization management

BRIEFING
January 20, 2022
Vice President & Head of PBM & Specialty Product Innovation
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Autoimmune diseases, including inflammatory bowel disease (IBD), are one of the main therapeutic categories driving drug trend. IBD can be diagnosed as one of two different diseases: Crohn’s disease (CD) or ulcerative colitis (UC). There is no cure for IBD. Once diagnosed, patients with IBD may require treatment for the rest of their lives. Health care costs for patients with IBD are much higher ($22,987) than health care costs for those without IBD ($6,956).*Park, K T et al. “The Cost of Inflammatory Bowel Disease: An Initiative From the Crohn's & Colitis Foundation.” Inflammatory bowel diseases vol. 26,1 (2020): 1-10. doi:10.1093/ibd/izz104

Generally, IBD drug therapy is tailored to the disease — CD or UC — and its progression. In some cases, treatment may include surgery to remove part of the GI tract.Bewtra M, Johnson FR. Assessing patient preferences for treatment options and process of care in inflammatory bowel disease: a critical review of quantitative data. Patient. 2013; 6(4):241-255. doi:10.1007/s40271-013-0031-2 Many targeted treatments for IBD have come to market in recent years; existing biologics originally approved to treat other conditions have obtained supplemental indications; and new biosimilars continue to launch. All increase options for patients and providers, but many have the potential to increase costs for payors.https://practicalgastro.com/2019/04/10/the-ibd-therapeutic-pipeline-is-primed-to-produce/

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

What is the prevalence of IBD?

One estimate suggests that one in 209 adults are affected by IBD.Yizhou Ye, PhD, Sudhakar Manne, MS, William R Treem, MD, Dimitri Bennett, MD, Prevalence of Inflammatory Bowel Disease in Pediatric and Adult Populations: Recent Estimates From Large National Databases in the United States, 2007–2016, Inflammatory Bowel Diseases, Volume 26, Issue 4, April 2020, Pages 619–625, https://doi.org/10.1093/ibd/izz182 Forty-five percent of those diagnosed with IBD who have a prescription are likely to become non-adherent to medications once they start to feel better. Such non-adherence can cause long-term difficulties requiring additional medical interventions and costs.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223449/

With the increase of available medications to treat IBD and the rise in the number of patients being diagnosed, utilization is also increasing. Carefully monitoring utilization to ensure appropriate use is key to managing costs in this treatment area.

Want to learn how our solutions can help manage costs? Contact us
Want to learn how our solutions can help manage costs?
 
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What are the upcoming notable drugs for IBD in the pipeline?

In 2021, the U.S. Food and Drug Administration (FDA) approved interchangeable biosimilar status for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), a subcutaneous (SC) tumor necrosis factor (TNF) blocker for treatment of moderate to severe CD or UC. Cyltezo, which is not expected to launch until 2023, is a biosimilar to Humira.https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira Additional biosimilars to Humira are also expected to launch in 2023.

Approved by the FDA in 2014, Entyvio (vedolizumab) from Takeda is an integrin receptor antagonist and monoclonal antibody (mAb) administered by an intravenous (IV) infusion for adults with moderately to severely active UC or CD.https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf A new formulation for SC injection for treatment of moderate to severe UC has an anticipated launch in 2023.https://www.takeda.com/newsroom/statements/2021/update-on-the-us-development-program-for-the-investigational-subcutaneous-formulation-of-entyvio-vedolizumab-as-a-maintenance-therapy-in-adults-with--moderate-to-severe-ulcerative-colitis/ Certain patients can transition to SC injections every two weeks after at least two IV infusions.https://www.takeda.com/en-ca/newsroom/news-releases/2021/ready-to-use-self-injectable-formulation-of-entyvio-vedolizumab-now-available-for-canadians-for-the-maintenance-treatment-of-moderately-to-severely-active-crohns-disease-and-ulcerative-colitis/

Jyseleca (filgotinib), an oral Janus Kinase (JAK) inhibitor from Galapagos/Gilead Sciences, is projected to launch in late 2022 for use in treating moderate to severe UC with treatment for CD following in 2023.https://www.clinicaltrialsarena.com/comment/manta-and-manta-ray-safety-readouts-boost-jyselecas-prospects-in-the-us/

Rinvoq (upadacitinib), an oral JAK inhibitor from AbbVie, received approval in 2019 for rheumatoid arthritis. In September 2021, AbbVie applied to the FDA requesting approval of Rinvoq for a supplemental indication to treat moderate to severe UC and may launch for moderate to severe CD in 2022.https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-upadacitinib-rinvoq-for-treatment-adults-with-moderately-to-severely-active-ulcerative-colitis.htmhttps://www.fiercepharma.com/pharma/abbvie-s-rinvoq-notches-crohn-s-disease-win-amid-class-wide-jak-safety-concerns

Simponi (golimumab), an mAb and anti-TNF treatment from Janssen, is approved for adults with UC using an SC delivery. A projected filing for Simponi to expand treatment for patients with UC aged 2 to 17 is anticipated in 2022 with a projected launch in 2023.http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf

Skyrizi (risankizumab-rzaa), an interleukin antagonist and mAb from AbbVie, was approved for plaque psoriasis in 2019. An application for a supplemental indication for the biologic was submitted in 2021 for approval to treat those 16 and older with moderate to severe CD. UC is expected to launch in 2024. Patients will receive an IV treatment followed by SC maintenance therapy.https://www.pharmacytimes.com/view/abbvie-announces-application-of-skyrizi-to-fda-for-treatment-of-crohn-s-disease

Tremfya (guselkumab) is a SC interleukin antagonist treatment approved for psoriasis. Janssen is seeking to launch supplemental indications for CD and UC in 2023.https://www.jnj.com/janssen-reports-positive-topline-week-48-phase-2-results-for-tremfya-guselkumab-in-adults-with-moderately-to-severely-active-crohns-disease

Zeposia (ozanimod), a once-daily oral sphingosine-1-phosphate (S1P) receptor modulator from Bristol Myers Squibb, launched in 2021 to treat UC. The launch for the CD indication is expected in 2024.https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Zeposia-ozanimod-an-Oral-Treatment-for-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis1/default.aspx

etrasimod is a once-daily oral S1P from Arena Pharmaceuticals that is in development for both CD and UC. The UC indication is expected to launch first, in 2023.https://www.arenapharm.com/pipeline/etrasimod/

etrolizumab is a new biologic from Genentech/Roche. Administered by SC injection, this integrin inhibitor and mAb for moderate to severe CD may launch in 2023.https://www.roche.com/research_and_development/who_we_are_how_we_work/pipeline.htm

mirikizumab, an interleukin antagonist and mAb treatment from Eli Lilly, is expected to treat those with UC and CD. The method of delivery for mirikizumab, a new biologic, is by IV or SC injections. The drug may launch for UC in 2023 and CD in 2024.https://investor.lilly.com/news-releases/news-release-details/mirikizumab-improves-fatigue-patients-crohns-disease-phase-2

What cost management strategies are available for IBD therapies?

As more therapies targeting inflammation come to market, patients whose disease doesn’t respond to non-specialty medications often are moved to specialty medications.Randall CW, Vizuete JA, Martinez N, et al. From historical perspectives to modern therapy: a review of current and future biological treatments for Crohn's disease. Therap Adv Gastroenterol. 2015; 8(3):143-159. doi:10.1177/1756283X15576462 Our utilization management (UM) strategies are designed to help clients manage costs by encouraging use of clinically appropriate, lowest net cost therapeutic categories by leveraging our size and scale. Payors can take actions that will help manage utilization.

Specialty Guideline Management

Robust UM criteria and high-touch clinical review helps ensure safe, clinically appropriate and cost-effective coverage of specialty medications. The Specialty Guideline Management (SGM) program employs comprehensive prospective and concurrent clinical assessments, step therapy, generics first, day-one UM control and medical director review for added clinical oversight. Retrospective clinician review of members’ clinical profiles and claims history helps to ensure clinically appropriate coverage of complex cases.

Advanced Control Specialty Formulary (ACSF) integrates multiple trend management approaches, including hyperinflation management, formulary exclusions, new-to-market drug management, tiering strategy and SGM to help ensure clinically appropriate and cost-effective coverage. Formulary preferencing rules apply before prior authorization (PA) review to help ensure members start on preferred products.

Cross-Benefit Management

Several IBD treatments are also covered under the medical benefit, which should be managed with the same tools as the pharmacy benefit for these drugs. Our proprietary technology platform, Novologix, provides visibility across pharmacy and medical benefits and enables payors to efficiently manage spend in either one. The platform offers real-time, online access to an automated PA process across both benefits with a single front-end system. This enables precision across both benefits for maximum savings.

Intelligent Medication Monitoring

To help control costs, Intelligent Medication Monitoring (IMM), an innovative solution that leverages patients’ increasing digital adoption, engages patients and their providers to facilitate utilization management throughout the duration of drug therapy.

IMM uses advanced analytics, digital outreach and live clinical support to help identify when patients may no longer be benefitting from their medication and intervene appropriately. For IBD, a validated tool (IBD-Control-8) monitors disease activity and condition severity so that providers can optimize drug treatment and identify gaps in care.

Questions about how to best manage the treatment pipeline for IBD? Ask Us
BRIEFING
January 20, 2022
Vice President & Head of PBM & Specialty Product Innovation

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