IBD Treatment Options on the Rise

Contain Costs with Utilization Management

IBD Treatment Options on the Rise
FEATURE
October 27, 2020
Senior Vice President, CVS Health and Chief Medical Officer, CVS Caremark
Specialty Report PDF cover image, click to download

Specialty Pharmacy Pipeline | Drugs to Watch

Anticipated Launches | Q4 2020 – Q1 2021

Download Drug List >

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.

Pictogram of a magnifying glass inspecting the CVS Health heart logo

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.

Pictogram of several puzzle pieces connecting together

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.

IBD Treatment Options on the Rise Accordion

Anti-Tumor Necrosis Factor Agents
Anti-tumor necrosis factor (anti-TNF) agents work to inhibit the TNF-a, which is one of the main proteins to cause the inflammation found in IBD...

Anti-tumor necrosis factor (anti-TNF) agents work to inhibit the tumor necrosis factor-alpha (TNF-a), which is one of the main proteins to cause the inflammation found in IBD.

  • Humira, from AbbVie, has FDA approval to treat UC for adults, and to treat moderate to severe CD for those 6 years and older. Dosing varies with Humira, an anti-TNF agent, which is delivered through a subcutaneous (SC) injection.https://www.rxabbvie.com/pdf/humira_medguide.pdf.
  • Remicade, which is also an anti-TNF agent, uses an intravenous (IV) delivery system administered by a health care professional. A patient’s physician determines the dosing. This therapy from Janssen treats those with UC and CD from 6 years old.http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/REMICADE-pi.pdf.
  • Simponi, another treatment from Janssen, is approved for adults with UC using an SC delivery. Initial doses generally start with a 200 mgs injection with 100 mg administered in the second week of treatment. After those two injections, patients then receive 100 mgs every four weeks.http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf.
  • Cimzia, an SC treatment from UCB, treats adults with CD. A patient receives a 400 mg starter dose, with that same dosage administered every four weeks thereafter.https://www.cimzia.com/themes/custom/cimzia/docs/CIMZIA_full_prescribing_information.pdf.
Integrin Receptor Antagonists
The integrin receptor antagonist class specifically targets inflammation in the gut...

The integrin receptor antagonist class specifically targets inflammation in the gut.

  • Tysabri, departing from anti-TNF agents, is an IV-administered integrin receptor antagonist agent. This Biogen therapy treats adults with CD every four weeks with a 300 mg infusion of Tysabri.. https://www.tysabri.com/content/dam/commercial/tysabri/pat/en_us/pdf/tysabri_prescribing_information.pdf.
  • Entyvio from Takeda, approved by the FDA in 2014, is also an integrin receptor antagonist. Adults diagnosed with moderately to severely active UC or CD are prescribed Entyvio. Administered by IV, patients start with a 300 mg infusion in the first, second and sixth weeks. Then patients receive a 300 mg IV every eight weeks.https://general.takedapharm.com/ENTYVIOPI.
Interleukin-12 and -23 Antagonist
This class of drugs acts against the interleukin-12 and -23 pathway that is key to the intestinal inflammation of IBD...

This class of drugs acts against the interleukin-12 and -23 pathway that is key to the intestinal inflammation of IBD.

  • The FDA has approved Stelara from Janssen for use in treating patients 18 years and older with moderate to severe CD and UC. Stelara became the first biologic to focus on the interleukin-12 and -23 to minimize the body’s IBD inflammation response. Patients prescribed Stelara first receive an IV infusion with SC injections eight weeks afterward.http://www.janssenlabels.com/package-insert/product-patient-information/STELARA-medication-guide.pdf.
Janus Kinase (JAK) Inhibitor
Non-biologic DMARDs such as Janus kinase (JAK) inhibitors target small molecules in the body that can cause inflammation...<fn>Benjamin O, Bansal P, Goyal A, et al. Disease Modifying Anti-Rheumatic Drugs (DMARD) [Updated 2020 Jul 4]. In: StatPearls [Inter

Non-biologic DMARDs such as Janus kinase (JAK) inhibitors target small molecules in the body that can cause inflammation.Benjamin O, Bansal P, Goyal A, et al. Disease Modifying Anti-Rheumatic Drugs (DMARD) [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan https://www.ncbi.nlm.nih.gov/books/NBK507863/#article-20574.s2.

  • In 2018, Pfizer’s Xeljanz received approval to treat UC and is the only oral therapy for IBD. The following year, the extended-release oral tablet, Xeljanz XR, received FDA approval to treat UC. Adults with moderate to severe UC may take two 10 mg Xeljanz tablets or one 22 mg Xeljanz XR tablet per day for a maximum of 16 weeks. A doctor may then prescribe the lowest maintenance dose to manage UC symptoms. Xeljanz is the first JAK inhibitor used to treat UC.http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Biosimilars
Biosimilars for treating UC and CD continue to be approved. The FDA approved four biosimilars in 2019 and 2020 to treat IBD...

Biosimilars for treating UC and CD continue to be approved. The FDA approved four biosimilars in 2019 and 2020 to treat IBD.

  • Avsola, a biosimilar anti-TNF agent from Amgen launched in July 2020, is approved to treat both UC and CD for adults and children over 6 years old. It is the third biosimilar for Remicade to launch in the U.S.https://www.centerforbiosimilars.com/view/study-slow-start-for-infliximab-biosimilars. The other two biosimilars for Remicade also available in the U.S. are Janssen Biotech’s Inflectra and Merck’s Renflexis.https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade.https://www.merck.com/product/usa/pi_circulars/r/renflexis/renflexis_pi.pdf.
  • Hadlima, which is an anti-TNF agent biosimilar from Samsung, is approved to treat adults with either UC or CD and is expected to launch in 2023. It is the fourth biosimilar to Humira to be approved.https://www.biosimilarsresourcecenter.org/fda-approves-hadlima/. Three previously approved biosimilars for Humira — Amgen’s Amjevita, Sandoz’s Hyrimoz, and Boehringer Ingelheim’s Cyltezo — expect to launch in 2023.https://www.biopharmadive.com/news/abbvie-boehringer-ingelheim-settle-humira-patent-biosimilar/554729/.
  • Abrilada, from Pfizer is a biosimilar anti-TNF agent approved to treat adult UC or CD that is expected to launch in 2023, and is the fifth biosimilar to Humira approved by the FDA.https://biosimilarsrr.com/abrilada/.
  • Hulio, an FDA approved biosimilar anti-TNF agent from Mylan and Fujifilm Kyowa Kirin Biologics. Hulio, which is approved to treat adults with UC or CD, is expected to launch in 2023. It is the sixth biosimilar to Humira.https://www.centerforbiosimilars.com/view/mylan-gains-fda-approval-for-hulio-adalimumab-biosimilar1.

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.

Pictogram of a laptop showing the CVS Health heart logo

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.

Pictogram of a cellphone showing the Rx for prescription

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.

Want to know how UM strategies lower your trend? Ask Us
FEATURE
October 27, 2020
Senior Vice President, CVS Health and Chief Medical Officer, CVS Caremark

Dosage information is subject to change.

Specialty Expedite is available exclusively for providers who use compatible electronic health record (EHR) systems including Epic Systems and others that participate in the Carequality Interoperability Framework. All data sharing and usage complies with applicable privacy laws.

Data source, unless noted otherwise, CVS Health Enterprise Analytics, 2020.

CVS Health uses and shares data as allowed by applicable law, and by our agreements and our information firewall.

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

Image source: Licensed from Getty Images, 2020.

©2020 CVS Health. All rights reserved.