More than 50 million Americans suffer from an autoimmune condition, such as lupus, diabetes, multiple sclerosis (MS), rheumatoid arthritis, psoriasis or Crohn’s disease. These conditions can significantly impact a person’s life. For years, chronic care for patients with autoimmune conditions involved treatments that managed common disease symptoms or non-specifically suppressed the immune system. Specialty therapies, however, offer providers more targeted treatment approaches by specifically acting on key biological mechanisms that contribute to overactive immune systems. These medications carry unique prescription access and adherence challenges, which can obscure patients’ path to wellness. Biopharma-sponsored patient support programs (e.g., hubs) have improved patient outcomes in numerous studies. However, there can be limitations to the classic support model for some patient populations and therapy types — and these challenges can limit program efficiency and patient awareness of support services. 

__This report describes the healthcare challenges encountered by patients prescribed specialty therapies for autoimmune conditions, discusses the limitations of current patient support programs and explores the impact to the patient journey. The report also highlights how an enhanced, tech-enabled alternative solution to patient support — AMP: Access for More Patients™, from CoverMyMeds and RxCrossroads by McKesson — offers support to providers through a single platform. __

## Introduction

Communicable infections from viral, bacterial or fungal pathogens account for three of the top 10 leading causes of death worldwide.[ref](https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death "The top 10 causes of death, World Health Organization, 2018") The body’s immune system is designed to protect against such diseases, optimized to recognize self from non-self (e.g., distinguishing resident proteins, cells and tissues from foreign proteins, cells and tissues) and eliminate invading germs, infections or viruses. While a functioning immune system is important for staying healthy, an overactive immune system can lead to serious and debilitating health complications.

An autoimmune disease develops when a person’s immune system mistakenly identifies healthy cells as foreign cells and attacks them. In such cases, a person is said to have autoimmunity — immunity against himself/herself. According to the American Autoimmune Related Diseases Association (AARDA), there are more than 100 autoimmune diseases and related conditions.[ref](https://www.aarda.org/news-information/statistics/ "AI Diseases Statistics, American AI Related Diseases Association (AARDA), 2019")

## Prevalence of Autoimmune Conditions

__More than 50 million Americans suffer from at least one autoimmune condition, which is more than twice the number of people with cancer.__[ref](https://www.aarda.org/news-information/statistics/ "AI Diseases Statistics, American AI Related Diseases Association (AARDA), 2019"),[ref](https://seer.cancer.gov/statfacts/html/all.html "Cancer Stat Facts: Cancer of Any Site, National Cancer Institute, 2019") Women are more likely than men to develop an autoimmune disease, with estimates indicating women comprise 75 percent of those affected. And, unlike typical genetic diseases — in which there’s a specific gene mutation — multiple genes are involved, collectively increasing susceptibility. As a result, autoimmune diseases tend to cluster in families. 

The immune system is a complex system that functions to prevent infection. A normal immune system makes proteins known as antibodies that recognize and prevent foreign organisms (bacteria, viruses) from causing infection. In some cases, immunodeficiency, or the decreased ability of the immune system to clear infections, may contribute to autoimmunity. In other cases, an over-active immune system can cause antibodies to attack healthy tissues by mistake.

Autoimmune conditions can affect many organs and tissues throughout the body and manifest through a variety of symptoms. Psoriasis, for example, affects the integumentary system (e.g., skin, nails, glands). Patients with this condition may experience persistent red rashes with white plaque on their skin. Rheumatoid arthritis, meanwhile, affects the skeletal system, so patients may experience pain, stiffness and inflamed joints, among other symptoms. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, affects the digestive system. These patients may experience food intolerance, stomach cramps, gas, bloating and alternating constipation and diarrhea.[ref](https://www.ncbi.nlm.nih.gov/books/NBK110089/ "Drug Class Review: Targeted Immune Modulators, Final Update 3 Report, Oregon Health & Science University, 2012") Multiple sclerosis is an autoimmune condition impacting the nervous system, which can lead to progressive motor decline for many patients, as described in a previous white paper.[ref](https://www.covermymeds.com/main/insights/articles/ms-patient-access-white-paper/ "Revolutionizing Patient Access and Support for Specialty Therapies: Multiple Sclerosis, CoverMyMeds, 2019") Such symptoms can make it difficult for patients to live normal lives.

## Historical Care for Autoimmune Conditions

Initial treatment for autoimmune conditions often involves simply managing the symptoms of the disease. Corticosteroids can be used to help reduce inflammation for patients with rheumatoid arthritis or psoriasis, while antidiarrheal medications are used to help patients with an IBD. Depending on severity and progression of symptoms, it can be necessary to take treatment a step further with medications that address the source of the disease: the immune system.

These treatments involve medication — like methotrexate — that non-specifically suppresses the immune system. While typically successful at slowing disease progression, these medications may not work for all patients and can lose effectiveness over time. Additionally, non-specific immunomodulating medications can have significant side effects, including infection as a result of a weakened immune system.[ref](https://www.managedhealthcareconnect.com/articles/management-rheumatoid-arthritis/ "Management of Rheumatoid Arthritis, First Report Managed Care, 2019"),[ref](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5713267/ "Old and New Biological Therapies for Psoriasis, International Journal of Molecular Medicine, 2017"),[ref](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5506195/ "Drugs for AI Inflammatory Diseases: From Small Molecule Compounds to Anti-TNF Biologics, Frontiers in Pharmacology, 2017")

## Specialty Therapies to Treat Autoimmune Conditions 

Targeted immune modulators, commonly referred to as biological response modifiers or biologics, are a class of medications used to treat certain types of immunologic and inflammatory diseases. Targeted immune modulators work by selectively blocking mechanisms involved in the inflammatory and immune response, significantly improving treatments for autoimmune conditions. 

Many immunomodulating biologics have similar mechanisms of action and therefore have indications across several therapeutic categories, such as rheumatoid arthritis, psoriasis and IBD. As symptoms and severity of autoimmune conditions vary significantly among patients, it’s fairly common for patients to try several medications before selecting one that works best for them. While many specialty therapies for autoimmune conditions require unique administration, via injection or infusion, and necessitate strict temperature control during distribution, some are administered orally. 

The first biologic therapy for rheumatoid arthritis achieved approval from the U.S. Food & Drug Administration (FDA) in 1998.[ref](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf "Enbrel etanercept Label - FDA") Since then, more than 15 biologic therapies have been approved to treat rheumatoid arthritis, psoriasis and IBD.[ref](# "American College Of Rheumatology Updated Guideline for the Management of Rheumatoid Arthritis, Project Plan, 2018"),[ref](https://www.aad.org/public/diseases/psoriasis/treatment/medications/biologics "PSORIASIS TREATMENT: BIOLOGICS, American Academy Of Dermatology"),[ref](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961645/ "Prashanth Rawla, Tagore Sunkara, Jeffrey Pradeep Raj, Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives, J Inflamm Res. 2018; 11: 215–226. Published online 2018 May 16. doi: 10.2147/JIR.S165330") As a result of these medications' efficacy, their utilization by providers has increased significantly. The growth in the specialty share of total medicine spending will approach 50 percent by 2023 and is expected to increase spend across developed markets to $475-$505 billion by the same year. Nearly 50 percent of this growth is being driven by the two largest specialty therapeutic classes — oncology and autoimmune.[ref](https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us---a-review-of-2018-outlook-to-2023.pdf?_=1568815629544 "Medicine Use and Spending in the U.S., A Review of 2019 and Outlook to 2023, IQVIA Institute for Human Data Science, January 2019") 

In addition to recently approved biologics therapies, the pipeline to treat rheumatoid arthritis, psoriasis and IBD continues to expand, with hundreds of new agents in development.[ref](https://www.rheumatologynetwork.com/view/status-report-the-rheumatoid-arthritis-drug-pipeline "Status Report: The Rheumatoid Arthritis Drug Pipeline, Rheumatology Network, June 17, 2020"),[ref](https://practicalgastro.com/2019/04/10/the-ibd-therapeutic-pipeline-is-primed-to-produce/ "The IBD Therapeutic Pipeline Is Primed to Produce, Practical Gastro, April 2019"),[ref](# "CoverMyMeds Biologics Market Research Data, 2021") Dozens of these agents are in late-stage or advanced clinical trials, and there's a significant opportunity that a number of these potential biologic therapies will be able to improve the therapeutic management of patients and offer greater personalization of therapeutic strategies, both in the choice of treatments as well as their role in therapeutic sequences. As more new therapies are approved by the FDA and are available to treat patients, medical societies are reviewing treatment guidelines to include biologics in combination treatment approaches. In some cases, they’re reviewing biologics as first-line therapies, where previous therapies have not been effective.[ref](# "American College Of Rheumatology Updated Guideline for the Management of Rheumatoid Arthritis, Project Plan, 2018"),[ref](# "Steven R Feldman, MD, PhD, Treatment of psoriasis in adults, UptoDate, May 2020"),[ref](# "Joseph D. Feuerstein, Kim L. Isaacs, Yecheskel Schneider, Shazia Mehmood Siddique, Yngve Falck-Ytter, and Siddharth Singh, on behalf of the AGA Institute Clinical Guidelines Committee, AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis, Gastroenterology 2020;158:1450–1461")

# Autoimmune Patient Journeys

It’s estimated more than 10 million Americans have an autoimmune condition like psoriasis, rheumatoid arthritis or IBD.

- Psoriasis: __7.4 million Americans__ [ref](# "Rachakonda TD et al, Psoriasis prevalence among adults in the United States, Journal of American Academy of Dermatology, 2014; 70(3):512-516")
- Rheumatoid arthritis: __1.3 million Americans__ [ref](# "American College Of Rheumatology Updated Guideline for the Management of Rheumatoid Arthritis, October 2018")
- Inflammatory bowel disease: __1.6 million Americans__ [ref](# "Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. https://www.cdc.gov/mmwr/volumes/65/wr/mm6542a3.htm. Accessed May 2, 2018."),[ref](# "The Facts About Inflammatory Bowel Diseases; Crohn’s & Colitis Foundation of America; November 2014")

## Rheumatoid Arthritis

Rheumatoid arthritis is a systemic autoimmune disease characterized by chronic inflammation of the joints. Untreated, it can lead to the destruction of joints through the erosion of cartilage and bone, resulting in pain and loss of physical function. Rheumatoid arthritis can first show up at any age, though it occurs generally between 30 and 50, with women more likely to develop the condition than men. Rheumatoid arthritis is often difficult to diagnose in its early stages, as symptoms mimic those of other diseases. During a physical exam, doctors check patients’ joints for swelling, redness and warmth and may also check reflexes and muscle strength. There isn’t a single blood test or physical finding to confirm the diagnosis, so patients are often subjected to multiple blood tests and medical imaging tests, including X-rays, MRI and ultrasound.

Early treatment is important to control disease activity and to prevent joint destruction. The type of medication prescribed varies, depending on the severity of symptoms and how long the patient has had the condition. There isn’t a cure for rheumatoid arthritis, but clinical studies indicate symptom remission is more likely when treatment begins early with physical therapy to promote joint flexibility and medications, known as disease-modifying antirheumatic drugs (DMARDs). Biologic agents, a newer class of DMARDs, have shown promise targeting parts of the immune system that trigger inflammation that causes joint and tissue damage. While biologic agents may increase the risk of infection, they’re usually most effective when paired with a nonbiologic DMARD, such as methotrexate.

## PSORIASIS

In psoriasis, immune system blood cells, called T-cells, collect in the skin, stimulating skin cells to reproduce rapidly and producing silvery, scaly plaque on the skin’s surface. Psoriasis patches range from a few spots to major eruptions that cover large areas. The most commonly affected areas are the lower back, elbows, knees and scalp. Psoriasis symptoms typically start between ages 15 and 25 — though they can begin at any age. Most types of psoriasis go through cycles, flaring for a few weeks or months, then subsiding for a time or even going into remission. Inflammation caused by psoriasis can impact other organs and tissues in the body, resulting in other health conditions, including psoriatic arthritis. The National Psoriasis Foundation says mild psoriasis affects less than 3 percent of the body; 3 to 10 percent is considered moderate; more than 10 percent is considered severe. The severity of psoriasis is also measured by how the condition affects a person's quality of life. Nearly 25 percent of people with psoriasis have cases that are considered moderate to severe.[ref](# "Helmick, Charles G et al. “Prevalence of psoriasis among adults in the U.S.: 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys.” American journal of preventive medicine vol. 47,1 (2014): 37-45. doi:10.1016/j.amepre.2014.02.012")

While there's no cure for psoriasis, there are more treatment options than ever before. Treating psoriasis can help improve symptoms as well as lower the risk of developing other health conditions, such as diabetes or other autoimmune conditions. During the diagnostic process, patients may have a skin biopsy to help determine the type of psoriasis and rule out other disorders. The goal of treatment is to stop skin cells from growing so quickly and to remove scales. Treatment options include corticosteroid creams and ointments (topical therapy), light therapy (phototherapy) and oral or injected medication. Patients are often prescribed several drugs or combinations of drugs to find a therapeutic approach that works. Biologics therapies are designed to alter the immune system in a way that disrupts the disease cycle and improves symptoms and signs of disease within weeks. Several of these drugs are approved for the treatment of moderate to severe psoriasis in people who haven't responded to first-line therapies.

## Inflammatory Bowel Disease

In an IBD, the immune system attacks the lining of the intestines, causing episodes of diarrhea, rectal bleeding, urgent bowel movements, abdominal pain, fever and weight loss. Ulcerative colitis and Crohn's disease are the two major forms of IBD. While Crohn's disease can occur at any age, most people who develop the condition are diagnosed between the ages of 20 and 30. Crohn's disease can affect any ethnic group. While it’s more common among Caucasians, the incidence of Crohn's disease is increasing among other ethnic groups. According to the Crohn’s and Colitis Foundation, there’s a genetic component, with as many as one in five people with Crohn's disease having a family member with the disease. In ulcerative colitis, only the colon and rectum, also known as the large intestine, are affected. Like many autoimmune conditions, no single test can confirm a Crohn’s or ulcerative colitis diagnosis, and symptoms are often similar to other conditions, including bacterial infection. Diagnostic tests often include lab tests for blood and stool, X-rays of the GI tract, an endoscopy or colonoscopy and biopsy.

There isn’t a cure for Crohn's disease or other IBD varieties, and treatment can include the use of medication, alterations in diet and nutrition and, often, surgical procedures to repair or remove affected portions of the GI tract. The goal of medical treatment is to reduce the inflammation and improve long-term prognosis by limiting complications. Several types of drugs are used to treat IBD. The first step usually involves reducing inflammation and may be used in combination with drugs that stop the immune system from causing inflammation. Biologic drugs are often prescribed when a person with IBD doesn't respond to the standard treatments of 5 ASA-containing drugs, corticosteroids and immunosuppressants.

# Challenges for Autoimmune Patients Prescribed Specialty Therapies

While specialty therapies have changed and continue to change the standard of care for many autoimmune conditions, they're often accompanied by distinct challenges that can disrupt the patient journey.

## Medication Administration and Infection Risk

Specialty medications to treat autoimmune conditions can require unique administration via injection, infusion or nebulizer. Medication administration via injections or infusions can have a negative influence on patient adherence to prescribed specialty therapies for autoimmune conditions due to anxiety regarding injections, transportation considerations, infusion-site capacity, skin reactions or pain.[ref](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309782/ "Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective, Patient Preference and Adherence, 2015"),[ref](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3883032/ "Facilitating Medication Adherence in Patients with Multiple Sclerosis, International Journal of MS Care, 2013") __As these medications can be much more complex than traditional pharmaceuticals and can have severe side effects, patient education and consistent patient monitoring through regular lab tests or office check-ups is often necessary.__

Medications for autoimmune conditions suppress the immune system, leading to increased risk for communicable infections and other health complications. Such programs help the FDA confirm if the clinical benefits of a medication to patients outweigh the risks. Biopharma often sponsors patient support programs (e.g., hubs) to help patients understand their prescribed specialty therapies and navigate safety concerns with crucial resources and guidance.

## Medication Cost

Specialty medications' share of total pharmacy spending grew from 44.7 percent in 2018 to 47.7 percent in 2019, while accounting for only 2.2 percent of prescription volume.[ref](# "2019 Drug Trend Report, Express Scripts") While high and rising prices were thought to be the primary factors contributing to such growth, recent IQVIA data indicates that utilization of specialty medications has increased at more than twice the rate of traditional medications.[ref](https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us---a-review-of-2018-outlook-to-2023.pdf?_=1568815629544 "Medicine Use and Spending in the U.S., A Review of 2019 and Outlook to 2023, IQVIA Institute for Human Data Science, January 2019") For example, there has been a 17.1 percent spending increase for drugs used to treat rheumatoid arthritis, psoriasis and other autoimmune conditions.[ref](# "2019 Drug Trend Report, Express Scripts")

Even with insurance, affording specialty medication can be difficult. Patient cost sensitivity increases as costs rise. While abandonment rates are less than 5 percent when the prescription carries no out-of-pocket costs, it increases to more than 60 percent when the cost is over $500.[ref](# "Medicine Spending and Affordability in the U.S., Understanding Patients’ Costs for Medicines, IQIVIA Institute for Human Data Science, August 2020") __A study found that nearly a third of patients abandon prescriptions for specialty medications while in the deductible period of their health plan.__[ref](# "Medicine Use and Spending in the U.S., A Review of 2016 and Outlook to 2021, IQVIA Institute for Human Data Science, 2017")

Nearly a third of patients abandon prescriptions for specialty medications

Patient support services can be crucial for communicating availability of biopharma-sponsored financial assistance to patients. However, patient awareness surrounding such support is historically poor — only one in five patients are aware of patient support programs.[ref](https://www.accenture.com/_acnmedia/accenture/next-gen/patient-services-survey/accenture-mc814-patient-servicesls-research-note2015-v7.pdf "Patient Services – Pharma’s Best Kept Secret, Accenture Life Sciences, 2015")

## Medication Access

As a result of high cost and increased utilization, specialty medications are among the most managed of all drugs.[ref](# "Magellan Rx Management Medical Pharmacy Trend Report™ 2015") Payers managing spend on specialty medications for autoimmune conditions often lean on utilization management tools such as product preferencing or tiered drug formularies, step therapy, prior authorization (PA) and others. __A recent report ranking payer management of specialty autoimmune medications found that 97 percent of Medicare Part D plans, and 48 percent of commercial plans, impose severe restrictions on access through the application of three or more utilization management tools.__[ref](https://static1.squarespace.com/static/59a55aa28dd041cc6f74be62/t/5cd2238c53450ac689f044f1/1557275532912/LMDD-Emory-Study-web.pdf "Impact of Prescription Drug Benefit Design on Access to AI Disease Medications under Medicare and Commercially Available Health Plans, Emory University, 2019")

97% of government plans (Medicare Part D) impose severe restrictions on access

Whether specialty medications are covered under the medical or pharmacy benefit can also influence patient access. While Medicare Part B and commercial health plans impose fewer restrictions on access to physician-administered medicines covered under a plan’s medical benefit, most plans impose severe restrictions on medication access at the pharmacy.[ref](https://static1.squarespace.com/static/59a55aa28dd041cc6f74be62/t/5cd2238c53450ac689f044f1/1557275532912/LMDD-Emory-Study-web.pdf "Impact of Prescription Drug Benefit Design on Access to AI Disease Medications under Medicare and Commercially Available Health Plans, Emory University, 2019") Currently, about half of claims for specialty medications are covered under the pharmacy benefit and the remainder under the medical benefit.[ref](https://payorsolutions.cvshealth.com/insights/managing-specialty-drug-spend-under-the-medical-benefit "Managing Specialty Drug Spend Under the Medical Benefit: Innovations and Automation for More Efficient Management, CVS Health, Payor Solutions, 2017") As a result, complicated benefits investigation (BI), benefits verification (BV) and PA steps must be completed before patients can access or secure reimbursement for specialty therapies.

Another consideration affecting patient access involves payer formulary strategy that's often based on collective therapeutic review for all autoimmune diseases indicated for a specialty medication.[ref](# "Management of Rheumatoid Arthritis, First Report Managed Care, 2018") These reviews are usually based on the indication with the largest patient population while not considering other indications, which can negatively impact formulary placement and limit treatment options for the smaller patient populations. 

Access restrictions can be difficult for healthcare experts to navigate, let alone patients. Patient support programs offer services that help patients through reimbursement-related activities that might otherwise lead to prescription abandonment.

## Switching and Adherence

Symptoms, severity and medication side effects can vary significantly among patients with autoimmune conditions. Everyone’s immune system and experience with autoimmune disease is slightly different, meaning an effective medication for one patient with a given diagnosis may not be effective for another patient with the same diagnosis. As a result, intraclass switching among specialty therapies is common, with providers often using complicated decision trees to guide treatment decisions based on how severe the disease is and if a particular treatment is working. __In a survey of 428 rheumatologists, over 94 percent reported switching patients from one specialty therapy to another due to side effects or lack of clinical response.__[ref](# "Use of tumor necrosis factor inhibitors in rheumatoid arthritis: a national survey of practicing United States rheumatologists, Joint Bone Spine, 2006")

94% of rheumatologists switched patients from one specialty therapy to another

Remaining adherent to specialty therapies can be a struggle for patients. Comorbidities are common among patients with autoimmune conditions, with one study finding that 16.3 percent of these patients take 20 or more medications compared to only 5.5 percent of other patients.[ref](https://www.managedhealthcareconnect.com/articles/management-rheumatoid-arthritis "The Disease Burden of the Most Common Autoimmune Diseases, Managed Care, 2016") In addition to considerations like injection and infusion concerns, comorbidities for patients with autoimmune conditions also lead to struggles with poor medication adherence — or the extent to which a patient takes a prescribed medication — and persistence — or the duration of time a patient remains on therapy. __In fact, a recent study reported adherence rates for common specialty biologic therapies as low as 16 percent and persistence rates as low as 34 percent.__[ref](# "Medication Adherence and Persistence in Patients with Rheumatoid Arthritis, Psoriasis, and Psoriatic Arthritis: A Systematic Literature Review, Patient Preference and Adherence, 2018") Patient support programs can help identify reasons for medication non-adherence while providing resources and tools to help patients remain on their prescribed therapies.

# Success of Patient Support Services for Specialty Medications

For specialty therapies arriving to market, patient support programs are recognized as essential for patient safety, access and adherence. Such support programs help patients navigate challenges that can accompany specialty medications for autoimmune conditions described in the previous section. 

One study monitoring nearly 11,000 patients on a specialty medication indicated for several autoimmune conditions recorded a __72 percent decrease in risk__ for therapy discontinuation and a higher probability of therapy adherence for patients enrolled in a support program, relative to unsupported patients.[ref](https://www.clinicaltherapeutics.com/article/S0149-2918(18)30050-X/fulltext "Impact of Adalimumab Patient Support Program’s Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study, Clinical Therapeutics, 2018") Another study found __medication adherence rate was 14 percent greater__ and discontinuation rate was 14 percent lower for program-supported autoimmune patients, leading to 23 percent lower 12-month medical costs.[ref](# "Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis, Journal of Managed Care & Specialty Pharmacy, 2017") Healthcare savings and positive patient outcome measures attributed to patient support services for autoimmune conditions have been reported in several peer-reviewed studies.[ref](# "Impact of adherence to biological agents on health care resource utilization for patients over the age of 65 years with rheumatoid arthritis, Patient Preference and Adherence, 2017"),[ref](https://www.clinicaltherapeutics.com/article/S0149-2918(18)30050-X/fulltext "Impact of Adalimumab Patient Support Program’s Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study, Clinical Therapeutics, 2018")

72% decrease in risk for therapy discontinuation when enrolled in a patient support program

# The Traditional Patient Support Hub Model

Patients have compared the beginning of the specialty therapy access journey to a full-time job, sometimes requiring 30 or more phone calls to providers, insurance companies and specialty pharmacies.[ref](# "The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study"),[ref](https://www.jmir.org/2018/10/e11168/ "CoverMyMeds Multiple Sclerosis Patient Advisory Board, 2019") Hub programs sit at the center of the healthcare ecosystem, uniting all the disparate stakeholders to help patients on specialty therapies access, afford and adhere to their medications. Hubs can provide a central access point for patients, but as few as one in five patients are aware of this support.[ref](https://www.accenture.com/_acnmedia/accenture/next-gen/patient-services-survey/accenture-mc814-patient-servicesls-research-note2015-v7.pdf "Patient Services – Pharma’s Best Kept Secret, Accenture Life Sciences, 2015") While patients may rely on their providers for hub information and enrollment, limited time and resources can impact rapid care coordination and delay time to therapy. __When patients coordinate their own therapy, they may wait eight weeks to begin, increasing risk of abandoning therapy by 27 percent in some cases.__[ref](# "Medicine Use and Spending in the U.S., A Review of 2016 and Outlook to 2022, IQVIA Institute, 2017")

# AMP: Access for More Patients™ Transforms Patient Support Services for Specialty Autoimmune Medications

AMP: Access for More Patients is an end-to-end electronic platform for patient support services from CoverMyMeds and RxCrossroads that uses technology and network connectivity to overcome the limitations of the traditional hub model. Fundamentally changing the way patient support is provided, this configurable platform allows for patient intake to begin at the point-of-prescribing in real-time before the patient leaves the provider’s office. By leveraging electronic patient support service developed by CoverMyMeds and RxCrossroads, such as enrollment, prescription intake, PA, BV, copay and financial assistance programs and other clinical support programs, AMP seamlessly connects these services together within a single platform.

Through the established network and technological capabilities of CoverMyMeds, AMP facilitates stakeholder collaboration and electronic completion of all access requirements, allowing for rapid completion of reimbursement (e.g., BI, BV, PA, financial assistance) and clinical steps (e.g., lab test scheduling, prescription titration). A connected view within CoverMyMeds gives providers and other stakeholders the real-time visibility needed to effectively complete assigned tasks and coordinate care so that prescriptions can be quickly triaged to an appropriate specialty pharmacy for dispense.

__In a two-month pilot study, AMP achieved a 94 percent enrollment completion rate with 48 percent of enrollments completed electronically.__[ref](# "End-to-End Electronic Support Improves Patient Access for Specialty Medications: AMP, Access For More Patients, Reduces Time-To-Therapy by 27%, CoverMyMeds Case Study, 2019") As a result, nearly 1,250 patients who were prescribed a specialty medication for an autoimmune condition experienced streamlined support.

In contrast to the full time employee structure of traditional hubs, this electronic framework creates a consistent workflow for beginning patients on specialty therapies, making human intervention only necessary for managing exceptions. When support is needed, AMP is staffed with full-time case managers dedicated to programs and regions of the country. This ensures quality support for providers, patients and caregivers on any access issues that might delay therapy. These improvements to patient support services contributed to a 27 percent reduction in time-to-therapy for patients in the pilot study.[ref](# "End-To-End Electronic Support Improves Patient Access for Specialty Medications: AMP, Access For More Patients, Reduces Time-To-Therapy by 27%, CoverMyMeds Case Study, 2019") __Further, continued improvements to this product since the pilot program have helped patients enrolled in CoverMyMeds-supported programs reach therapy up to 34 percent faster.__[ref](# "CoverMyMeds data on file, 2020")

Patients enrolled in programs supported by AMP realize up to 34% faster speed to therapy

AMP was developed as a product extension of the CoverMyMeds provider portal with an existing user base of over 750,000 providers. __Over 70 percent of national provider identifiers using CoverMyMeds for select autoimmune therapeutic areas have accessed the portal in the last 90 days.__

The CoverMyMeds portal can serve as the single access point for sponsored specialty medications for all healthcare stakeholders where patient case status and progress can be tracked, giving providers, patient service coordinators and case managers a longitudinal view of their patients journey.

AMP delivers consistent, omnichannel support that leverages data to meet patients where they are in their treatment journey. Tech-enabled tools and programs may be used to help patients remain on therapy. When a patient case deviates from the standardized AMP workflow, expert case managers are on standby to assist with any outstanding questions or tasks for starting therapy.

While specialty therapies can be a source of relief for patients suffering from autoimmune conditions, myriad challenges restrict access. The impact autoimmune conditions have on patients’ lives — physically, emotionally and financially — is too great to sit idly by without a solution to support better access to the treatments and support they need. Through technology, strategically aligned patient support services and dedicated support, AMP can transform the way patients get — and stay on — the specialty medications they need to be well.

__To discover more about how CoverMyMeds is helping patients to access their  medications, visit [www.covermymeds.com](https://www.covermymeds.com "www.covermymeds.com")__

CoverMyMeds-AutoimmuneSpecialtyTherapies-WhitePaper-2021

This report details specific healthcare challenges patients prescribed specialty therapies for autoimmune conditions may encounter. It also introduces opportunities for tech-enabled patient support programs such as AMP: Access for More Patients™, from CoverMyMeds and RxCrossroads by McKesson to improve patient access, affordability and adherence.

Patient-centricity is the key to building a configurable hub solution that supports the nuances of disease states, like autoimmune conditions, that enable patients to start and stay on therapy.

Helping Patients Access Specialty Therapies: Autoimmune Conditions

Specialty Therapy

The top 10 causes of death, World Health Organization, 2018

AI Diseases Statistics, American AI Related Diseases Association (AARDA), 2019

Cancer Stat Facts: Cancer of Any Site, National Cancer Institute, 2019

Drug Class Review: Targeted Immune Modulators, Final Update 3 Report, Oregon Health & Science University, 2012

Revolutionizing Patient Access and Support for Specialty Therapies: Multiple Sclerosis, CoverMyMeds, 2019

Management of Rheumatoid Arthritis, First Report Managed Care, 2019

Old and New Biological Therapies for Psoriasis, International Journal of Molecular Medicine, 2017

Drugs for AI Inflammatory Diseases: From Small Molecule Compounds to Anti-TNF Biologics, Frontiers in Pharmacology, 2017

Enbrel etanercept Label - FDA

American College Of Rheumatology Updated Guideline for the Management of Rheumatoid Arthritis, Project Plan, 2018

PSORIASIS TREATMENT: BIOLOGICS, American Academy Of Dermatology

Prashanth Rawla, Tagore Sunkara, Jeffrey Pradeep Raj, Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives, J Inflamm Res. 2018; 11: 215–226. Published online 2018 May 16. doi: 10.2147/JIR.S165330

Medicine Use and Spending in the U.S., A Review of 2019 and Outlook to 2023, IQVIA Institute for Human Data Science, January 2019

Status Report: The Rheumatoid Arthritis Drug Pipeline, Rheumatology Network, June 17, 2020

The IBD Therapeutic Pipeline Is Primed to Produce, Practical Gastro, April 2019

CoverMyMeds Biologics Market Research Data, 2021

Steven R Feldman, MD, PhD, Treatment of psoriasis in adults, UptoDate, May 2020

Joseph D. Feuerstein, Kim L. Isaacs, Yecheskel Schneider, Shazia Mehmood Siddique, Yngve Falck-Ytter, and Siddharth Singh, on behalf of the AGA Institute Clinical Guidelines Committee, AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis, Gastroenterology 2020;158:1450–1461

Rachakonda TD et al, Psoriasis prevalence among adults in the United States, Journal of American Academy of Dermatology, 2014; 70(3):512-516

American College Of Rheumatology Updated Guideline for the Management of Rheumatoid Arthritis, October 2018

Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. https://www.cdc.gov/mmwr/volumes/65/wr/mm6542a3.htm. Accessed May 2, 2018.

The Facts About Inflammatory Bowel Diseases; Crohn’s & Colitis Foundation of America; November 2014

Helmick, Charles G et al. “Prevalence of psoriasis among adults in the U.S.: 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys.” American journal of preventive medicine vol. 47,1 (2014): 37-45. doi:10.1016/j.amepre.2014.02.012

Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective, Patient Preference and Adherence, 2015

Facilitating Medication Adherence in Patients with Multiple Sclerosis, International Journal of MS Care, 2013

2019 Drug Trend Report, Express Scripts

Medicine Spending and Affordability in the U.S., Understanding Patients’ Costs for Medicines, IQIVIA Institute for Human Data Science, August 2020

Medicine Use and Spending in the U.S., A Review of 2016 and Outlook to 2021, IQVIA Institute for Human Data Science, 2017

Patient Services – Pharma’s Best Kept Secret, Accenture Life Sciences, 2015

Magellan Rx Management Medical Pharmacy Trend Report™ 2015

Impact of Prescription Drug Benefit Design on Access to AI Disease Medications under Medicare and Commercially Available Health Plans, Emory University, 2019

Managing Specialty Drug Spend Under the Medical Benefit: Innovations and Automation for More Efficient Management, CVS Health, Payor Solutions, 2017

Management of Rheumatoid Arthritis, First Report Managed Care, 2018

Use of tumor necrosis factor inhibitors in rheumatoid arthritis: a national survey of practicing United States rheumatologists, Joint Bone Spine, 2006

The Disease Burden of the Most Common Autoimmune Diseases, Managed Care, 2016

Medication Adherence and Persistence in Patients with Rheumatoid Arthritis, Psoriasis, and Psoriatic Arthritis: A Systematic Literature Review, Patient Preference and Adherence, 2018

Impact of Adalimumab Patient Support Program’s Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study, Clinical Therapeutics, 2018

Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis, Journal of Managed Care & Specialty Pharmacy, 2017

Impact of adherence to biological agents on health care resource utilization for patients over the age of 65 years with rheumatoid arthritis, Patient Preference and Adherence, 2017

The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study

CoverMyMeds Multiple Sclerosis Patient Advisory Board, 2019

Medicine Use and Spending in the U.S., A Review of 2016 and Outlook to 2022, IQVIA Institute, 2017

End-to-End Electronic Support Improves Patient Access for Specialty Medications: AMP, Access For More Patients, Reduces Time-To-Therapy by 27%, CoverMyMeds Case Study, 2019

End-To-End Electronic Support Improves Patient Access for Specialty Medications: AMP, Access For More Patients, Reduces Time-To-Therapy by 27%, CoverMyMeds Case Study, 2019

Helping Patients Access Specialty Therapies: Autoimmune Conditions

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