Across the United States, approximately 50 million Americans suffer from autoimmune (AI) conditions that can significantly impact day-to-day lives. For years, chronic care for patients with AI conditions involved treatments to merely manage common disease symptoms or non-specifically suppress the immune system. Specialty therapies specifically act on key biological contributors to overactive immune systems, allowing providers more targeted treatment approaches. These medications carry unique prescription access and adherence challenges that can obscure the path to wellness for patients. While manufacturer-sponsored patient support programs (i.e., hubs) have improved patient outcomes in numerous clinical studies, deficiencies in the classic support model limit program success and patients are often unaware of support services. This report describes health care challenges encountered by patients prescribed specialty therapies for AI conditions, exposes weak areas limiting current patient support programs and introduces AMP: Access for More Patients™, from CoverMyMeds and RxCrossroads by McKesson, as a tech-enabled alternative.
Communicable infections from viral, bacterial or fungal pathogens account for three of the top ten leading causes of death worldwide.1 Humanity’s greatest asset against such diseases is the immune system, which has been evolutionarily optimized to recognize self from non-self (i.e., distinguishing resident proteins, cells and tissues from foreign proteins, cells and tissues) and eliminate invading dangers. While a functioning immune system is important for staying healthy, an overactive immune system can lead to serious health complications and debilitation. Despite normal proteins, cells, tissues and organs presenting as self, they are mistakenly targeted for destruction by the immune system. In such cases, a person is said to have autoimmunity – immunity against himself/herself. To date, more than 100 autoimmune (AI) conditions have been classified with varying prevalence rates.2
Prevalence of Autoimmune Conditions
According to the American Autoimmune Related Diseases Association (AARDA), upwards of 50 million Americans suffer from AI conditions, which is more than twice the number of people with cancer.2,3 It is estimated that 1 in 30 Americans on average suffer from prevalent AI conditions like psoriasis, rheumatoid arthritis, and inflammatory bowel disease (i.e., ulcerative colitis and Crohn’s disease).4
5.3 Million Americans
1.5 Million Americans
Inflammatory Bowel Disease
1.2 Million Americans
(590,000 – UC) (570,000 – CD)
As the immune system is pervasive throughout the entire body, AI conditions can affect many organs and manifest through a variety of symptoms. For example, psoriasis affects the integumentary system (i.e., skin, nails, glands) so patients may experience persistent red rashes with white plaques on their skin.5 Rheumatoid arthritis affects the skeletal system so patients may experience pain, stiffness and inflamed joints among other symptoms.5 Inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, affects the digestive system so patients may experience food intolerances, stomach cramps, gas, bloating and alternating constipation and diarrhea.5 Multiple sclerosis is an AI condition impacting the nervous system, which can lead to progressive motor decline for many patients as described in a previous white paper.6 Such symptoms can make it difficult for patients with AI conditions to live normal lives.
Historical Care for Autoimmune Conditions
Early treatment for AI conditions can involve simply managing symptoms of the disease. For example, corticosteroids can be used to help reduce inflammation for patients with rheumatoid arthritis or psoriasis and antidiarrheal medications can help patients with inflammatory bowel disease.4,7 Depending on severity and progression of symptoms, it can become necessary to take treatment a step further with medications that address the source of the disease: the immune system. Such treatments involve medications that non-specifically suppress the immune system like methotrexate.4,7 While typically successful at slowing disease progression, these medications may not work for all patients and can lose effectiveness over time.8 Additionally, non-specific immunomodulating medications can have significant side effects, including infection as a result of a weakened immune system.8,9
Specialty Therapies to Treat Autoimmune Conditions
With the advent of recombinant DNA technologies capable of producing large and complex biologic molecules with specificity to a single target, treatments for AI conditions have improved significantly.4 The first biologic therapy for rheumatoid arthritis achieved FDA approval in 199810 – since then, more than ten biologic therapies have been approved to treat rheumatoid arthritis,11 psoriasis12 and inflammatory bowel disease.13 These relatively new medications work by interfering with crucial steps mediating the immune system’s response to stimuli. In effect, biologic therapies help to put brakes on a runaway immune system, bringing stability to patients with AI conditions that tend to worsen as time goes on.
Many immunomodulating biologics have similar mechanisms of action and therefore have indications across several therapeutic categories, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.4 As symptoms and severity of AI conditions can vary significantly among patients, it is fairly common for patients to try several of these medications before selecting one that works best for them. While many specialty therapies for AI conditions require unique administration via injection or infusion and necessitate strict temperature control during distribution, some can be administered orally.
As these medications are often effective at managing disease symptoms and progression, their utilization by providers has increased significantly over the past decade with prescription volume for AI specialty therapies in 2018 increasing 55 percent since 2013.14 To put this in perspective, it is estimated that 2 of 3 rheumatoid arthritis patients take a biologic therapy.4
Challenges for Autoimmune Patients Prescribed Specialty Therapies
While specialty therapies have changed and continue to change the standard of care for many AI conditions, they are often accompanied by distinct challenges that can disrupt the patient journey.
MEDICATION ADMINISTRATION AND INFECTION RISK
Specialty medications to treat AI 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 AI conditions – due to anxiety regarding injections, transportation considerations, infusion-site capacity, skin reactions or pain.15,16 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 AI conditions suppress the immune system, leading to increased risk for communicable infections and other health complications.4 FDA approval for specialty medications with serious safety concerns can be contingent on manufacturer-sponsored risk evaluation and mitigation strategy (REMS) programs. Such programs help the FDA confirm if a medications clinical benefits to patients outweigh the risks. Pharmaceutical manufacturers often sponsor patient support programs (i.e., hubs) to help patients understand their prescribed specialty therapies and navigate safety concerns with crucial resources and guidance.
Specialty medications accounted for 45.4 percent ($218.6 billion) of total pharmacy spending ($482 billion) in 2018, while accounting for only 2.2 percent of prescription volume.14 While high and rising prices were thought to be the primary factors contributing to such growth, recent data indicates that utilization of specialty medications has increased at more than twice the rate of traditional medications.14 In fact, prescription volume for specialty medications to treat AI conditions has increased by 55 percent since 2013.17 As a result, specialty spending for the AI therapeutic area is second only to oncology.18
Even with insurance, affording specialty medication can be difficult. A study found that nearly a third of patients abandon prescriptions for specialty medications while in the deductible period of their health plan.19 Patient support services can be crucial for communicating availability of manufacturer-sponsored financial assistance to patients. Patient awareness surrounding such support is historically poor – only one in five patients are aware of patient support programs.20
As a result of high cost and increased utilization, specialty medications are among the most managed of all drugs.4 Payers managing spend on specialty medications for AI conditions often lean on utilization management tools such as product preferencing (e.g., tiered drug formularies), step therapy, prior authorization (PA) and others.21 A recent report ranking payer management of specialty AI medications found that 97 percent of government plans (Medicare Part D), and 48 percent of commercial plans, impose austere restrictions on access (i.e., application of three or more utilization management tools).21
Whether specialty medications are covered under the medical or pharmacy benefit can also influence patient access. While most plans apply significant specialty medication access restrictions on the pharmacy benefit, comparatively few restrictions are placed on the medical benefit.21 Currently, ~half of claims for specialty medications are covered under the pharmacy benefit and the remainder under the medical benefit.22 As a result, complicated benefits investigation (BI), benefits verification (BV) and PA steps must be completed before patients can access or ensure insurance coverage for specialty therapies.
Another consideration affecting patient access involves payer formulary strategy that is often based on collective therapeutic review for all AI diseases indicated for a specialty medication.23 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 health care experts to navigate, let alone patients. Patient support programs offer services that help patients through coverage-related activities that might otherwise lead to prescription abandonment.
SWITCHING AND ADHERENCE
Symptoms, severity and medication side effects can vary significantly among patients with AI conditions. Everyone’s immune system and experience with AI disease is slightly different such that an effective medication for one patient with a given diagnosis may not be effective for a patient with the same diagnosis. As a result, intraclass switching among specialty therapies is common with providers often using complicated decision trees to help guide treatment choice based on how severe the disease is and if a particular treatment is working.4 In a survey to 428 rheumatologists, over 94% reported switching patients from one specialty therapy to another due to side effects or lack of clinical response.24
Remaining adherent to specialty therapies can be a struggle for patients. Comorbidities are common among patients with AI conditions with a study finding that 16.3 percent of these patients take 20 or more medications compared to only 5.5 percent of other patients.25 Such factors, in addition to other considerations (e.g., injection and infusion concerns), has contributed to poor medication adherence (i.e., extent to which patient takes a prescribed medication) and persistence (i.e., duration of time patient remains on a therapy) among patients with AI conditions. 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.26 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 the market, patient support programs are recognized as essential for patient safety, access and adherence. Such support programs help patients to navigate through the challenges that can accompany specialty medications for AI conditions described in the previous section.
One study monitoring nearly 11,000 patients on a specialty medication indicated for several AI 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.27 Another study found medication adherence rate was 14 percent greater and discontinuation rate was 14 percent lower for program-supported AI patients, leading to 23 percent lower 12-month medical costs.28 Health care savings and positive patient outcome measures attributed to patient support services for AI conditions have been reported in several peer-reviewed studies.27-30
Limitations of the Traditional Hub Model for Patient Support
Despite evidence that patient support programs can positively affect patient outcomes,27-30 deficiencies of the traditional hub model limit patient enrollment into support services. For example, a study of 10,000 patients found that as few as one in five had heard of support programs for their prescribed medications.20 Patients rely on their providers to communicate availability of support services,31 but providers may have few options for completing program enrollment documentation. As a result, patients can slip through the cracks.
Poor communication and information exchange through outdated phone- and fax-based methods can also restrict health care stakeholder ability to rapidly coordinate care for patients and can delay time-to-therapy.6 While hub programs were designed to sit at the center of the health care ecosystem and unite all the disparate stakeholders necessary to start patients on specialty therapies, lack of connectivity can leave patients without their medications or struggling to find answers on their own. In fact, patients have compared trying to navigate through the steps needed to begin therapy to a full-time job, requiring 30 or more phone calls to providers, insurance companies, hubs and specialty pharmacies.32,33
Within the traditional hub model, health care stakeholders are siloed and lack sufficient visibility for quickly identifying outstanding patient case work. While online portals have been developed to help overcome such challenges, keeping track of individual login credentials for each site can quickly lead to provider portal fatigue and a decline in program usefulness.34 As hub programs are primarily used within 2-3 years of product launch and operate via a full-time employee (FTE) cost structure35 (i.e., more manual work results in more hours and a high amount of FTEs required to complete corresponding case work), efforts to improve current standards and streamline patient access have been minimal.
AMP: Access for More Patients™ Transforms Patient Support Services for Specialty AI Medications
AMP: Access for More Patients is a next-generation platform for patient support services from CoverMyMeds and RxCrossroads by McKesson that uses technology and network connectivity to overcome the limitations of the traditional hub model.
To help ensure that every patient prescribed a specialty medication has opportunity for support, AMP meets providers where they are with omni-channel enrollment capabilities. In addition to traditional phone- and fax-based methods, providers can begin enrollment electronically at the point-of-prescribing. E-prescription of a given specialty medication triggers enrollment within the CoverMyMeds portal, which is regularly used by over 700,000 providers. If not e-prescribing, providers can also directly begin enrollment within the portal. In a recent two-month pilot study, AMP achieved a 94 percent enrollment completion rate with 48 percent of enrollments completed electronically.36 As a result, nearly 1,250 patients prescribed a specialty medication for an AI condition experienced streamlined support.
AMP also allows for rapid completion of coverage (e.g., BI, BV, PA, financial assistance, etc.) and clinical (e.g., lab test scheduling, prescription titration, etc.) steps. Through established network and technological capabilities of CoverMyMeds, AMP facilitates collaboration and electronic completion of access requirements. An online dashboard gives needed visibility for effectively completing tasks and coordinating care so that prescriptions can be quickly triaged to an appropriate specialty pharmacy for dispense. In contrast to the FTE structure of traditional hubs, this electronic framework creates a consistent workflow for starting patients on specialty therapies such that human intervention is only needed for unique exceptions.
These improvements to patient support services contributed to a 27 percent reduction in time-to-therapy for patients in the pilot study.36
AMP also provides patients with expert adherence support. Tech-enabled tools allow patients to communicate any challenges or concerns which could be affecting their adherence and may require intervention. Adherence concerns can vary by disease state, so RxCrossroads by McKesson provides expertise and insight on how to help patients overcome.
While specialty therapies can be a source of relief for patients suffering from AI conditions, a myriad of challenges restrict access. AMP transforms the way support for specialty medications is delivered to help patients get the medications they need to be well. To learn more about AMP and its pilot performance, view the case study.
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- AI Diseases Statistics, American AI Related Diseases Association (AARDA), 2019
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- For AI Ills, Biologics Bring Promise – And Problems, Managed Care, 2016
- 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
- Drugs for AI Inflammatory Diseases: From Small Molecule Compounds to Anti-TNF Biologics, Frontiers in Pharmacology, 2017
- Immunomodulatory Drugs: Oral and Systemic Adverse Effects, Med Oral Patol Cir Bucal, Oral Medicine and Pathology, 2014
- Enbrel (etanercept) Label - FDA
- Understanding Biologic Treatments for Rheumatoid Arthritis, healthline, 2017
- Old and New Biological Therapies for Psoriasis, International Journal of Molecular Medicine, 2017
- Biologic Therapies in Inflammatory Bowel Disease. Journal of Laboratory and Clinical Medicine
- Medicine Use and Spending in the U.S., A Review of 2018 and Outlook to 2023, IQVIA Institute for Human Data Science, 2019
- 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
- Specialty Spending Soars. Can Formulary Management Bring It to Earth? Managed Care, 2019
- Measuring Success in Specialty Pharmacy Practice, Pharmacy Times, 2017
- 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
- 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
- Impact of infliximab adherence on Crohn’s disease-related healthcare utilization and inpatient costs, Advances in Therapy, 2011
- The Patient Is IN – Pharma’s Growing Opportunity in Patient Services, Accenture Life Sciences, 2016
- The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study
- CoverMyMeds Multiple Sclerosis Patient Advisory Board, 2019
- Combating Compassion Fatigue and Burnout: An Interview with Dike Drummond, MD, MPR The Right Dose of Information, 2018
- Hub Services Special Report 2016, Pharmaceutical Commerce, 2016
- 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