IBD Treatment Options on the Rise

Specialty Pharmacy Pipeline | Drugs to Watch

Anticipated Launches | Q4 2020 – Q1 2021

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About 3.1 million Americans were diagnosed with inflammatory bowel disease (IBD) in 2015, according to the Centers for Disease Control and Prevention (CDC). That is an increase from 1999 when only two million adults were diagnosed — and prevalence continues to rise. More than $6.8 billion was spent in 2008 in direct treatment costs.https://www.cdc.gov/mmwr/volumes/65/wr/mm6542a3.htm.

People may be treated for IBD, but there is no cure.https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Once diagnosed, patients may stay on treatments for the rest of their lives. Many targeted treatments have come to market in the last few years as existing biologics originally approved to treat other conditions have obtained supplemental indications for IBD, and new biosimilars continue to launch increasing options for patients.https://practicalgastro.com/2019/04/10/the-ibd-therapeutic-pipeline-is-primed-to-produce/. With the increase of available medications and the rise in the number of patients being diagnosed, utilization is also increasing.

Autoimmune diseases, including IBD, are one of the top therapeutic categories driving trend. Carefully monitoring utilization to ensure appropriate use will be key to managing costs.

What is IBD?

IBD is characterized by chronic inflammation and impairment of the gastrointestinal (GI) tract. IBD can be diagnosed as one of two different diseases — Crohn’s disease (CD) and ulcerative colitis (UC). These diseases have significant differences that may affect treatment options.

UC involves only the large intestines and the rectum, whereas CD affects any part of the GI system. IBD is caused by a faulty immune system, which incorrectly reacts to various environmental triggers creating inflammation in the body. Common symptoms of IBD include abdominal pain, ongoing diarrhea, and rectal bleeding.https://www.cdc.gov/ibd/what-is-IBD.htm. People with IBD are more likely to experience other chronic health diseases such as cardiovascular or respiratory diseases. In addition, complications of IBD can lead to malnutrition, osteoporosis, anemia, and colon cancer.https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/ibd-and-irritable-bowel.pdf. While medical professionals are not sure what factors may have caused an increase in diagnoses, some suspect that the Western diet, children raised in environments considered too sterile, or a growth in the awareness of IBD have each played a significant role.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193090/pdf/GH-12-704.pdf.

Treatments

Forty-five percent of those 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 that require additional medical interventions and costs.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223449/. IBD treatments generally are 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. There are different classes of medications used to treat IBD — aminosalicylates (5-ASA), corticosteroids, immunomodulators, antibiotics, biologic disease-modifying antirheumatic drugs (DMARDs), and non-biologic DMARDs.

45% of those with IBD who have a prescription are likely to become non-adherent to medications once they start to feel better.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223449/.

Biologic DMARDs target proteins found in the body that cause inflammation. The biologic therapies approved by the U.S. Food and Drug Administration (FDA) for either CD, UC, or both, work with the body’s immune system to prevent the inflammation that is associated with IBD. In recent years, more biologic and non-biologic medications coming to market have created greater options for patients, often for when other classes become less effective.. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.

Utilization Management

Until the development of effective IBD medications, surgery was the standard treatment with 70 percent of people with IBD undergoing at least one abdominal surgery of the GI tract. Decades ago, people with IBD started receiving various conventional medications without long-term success.Cucchiara, Salvatore MD, MPH An Historical Overview of the Treatment of IBD: Why Do We Need Biological Therapies?, Journal of Pediatric Gastroenterology and Nutrition: November 2006 - Volume 43 - Issue - p S33-S35 doi: 10.1097/01.mpg.0000256223.70396.21. As more therapies that were able to better target the inflammation came to market, patients that failed non-specialty medications, 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.

Step Therapy

As treatments for IBD proliferate — including existing drugs obtaining supplemental indications — our utilization management (UM) strategies are designed to help clients manage costs by encouraging utilization of clinically appropriate, lowest net cost medications first. The Specialty Preferred Drug Step Therapy program uses evidence-based protocols that require the use of preferred drugs before non-preferred specialty drugs are covered. The program, built into the claim adjudication process, takes place in real-time. Plan members who require access to a non-preferred medication due to medical necessity can request a clinical exception.

Specialty Guideline Management

Specialty Guideline Management (SGM) criteria includes additional critical cost management components such as comprehensive clinical assessments, and day-one UM that reviews new-to-market drugs according to FDA labeling until drug-specific criteria is available. All IBD specialty treatments also require a prior authorization (PA). For specific drugs with high cost and utilization increases, additional management criteria are put in place.

Our Specialty Preferred Drug Step Therapy program along with Advanced Control Specialty Formulary utilize an indication-based strategy to encourage use of different preferred products depending on the indication.

Cross Benefit Management

Several IBD treatments are also covered under the medical benefit, which lacks the effective management tools of the pharmacy benefit. Our proprietary technology platform, Novologix, provides visibility across both 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.

Patient Care

UC and CD are both part of AccordantCare, a holistic patient support program for those with complex, chronic conditions receiving targeted interventions designed to meet each patient’s unique needs. The specialized CareTeam is composed of registered nurses, pharmacists, social workers, and a medical director — all backed by a medical advisory board — and can help improve outcomes.

Digital tools can help members manage the complexities of IBD and help provide member support.

Accordant nurses have rapid access to comprehensive member data through their medical health records enabling real-time notification alerts including physician visit summaries, hospital discharge and prescription changes. This means clinicians can intervene at times known for high probability of symptoms and help improve adherence and engagement while filling any potential gaps in care.

Secure messaging solutions enable real-time, digital conversations between members and trained CVS Specialty clinicians and improve outcomes.

Specialty Expedite helps members simplify their onboarding process, receive appropriate medication faster, and streamline PA. We continue to test additional approaches including remote monitoring, symptom tracking, wearable and connected devices, and apply the learnings from pilot programs to expand use of such solutions to other therapeutic areas.

As the prevalence of IBD and treatment options increase, potentially impacting payor spend, our focus remains on helping payors manage cost, while ensuring appropriate member access.