Author: Richard Van, VP Pharma & Biotech Solutions
Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin condition that has made a remarkable entrance into the specialty therapy space in the past 5 years and market size is forecasted to reach $6.41 billion by 2022 (Grand View Research, 2018). According to the National Eczema Foundation, approximately 16.5 million adults and 9.6 million children are afflicted with AD, with onset typically occurring in infancy and early childhood (Atopic dermatitis yardstick: Practical recommendations for an evolving therapeutic landscape, 2018). With the growing prevalence of AD and robust associated medication pipeline, there is and will continue to be a need within the specialty pharmacy industry for high-touch therapy management and patient care delivery.
In March 2017, Sanofi and Regeneron’s Dupixent (dupilumab) was granted approval for moderate to severe AD. It was the first specialty medication in the AD space, a monoclonal interleukin (IL) receptor antagonist in a subcutaneous injectable dosage format, for patients that were not adequately controlling their condition with traditional topical therapies. Prior to Dupixent’s approval and launch, Eucrisa (2016) and Elidel (2001) preceded its arrival, but it was clear in the marketplace that the rate of novel approvals and medication development did not meet the needs of the AD patient population to improve their quality of life.
This is changing drastically in the next 5 years, boding well for AD marketplace competition and choices for its patient population. IL-antagonists and janus kinase (JAK) inhibitors, in both oral and topical dosage formats, fill the pipeline with FDA approvals expected as soon as Q2/Q3 2021. Near-term key medications to monitor are Olumiant (Eli Lilly/Incyte; JAK1/2 Oral), Rinvoq (AbbVie; JAK1 Oral), Abrocitinib (Pfizer; JAK1 Oral), and Tralokinumab (LEO Pharma; IL-13 Subcutaneous). The first two referenced medications are inline medications currently treating the Rheumatoid Arthritis disease state with initial approvals in 2018 and 2019, respectively, and the latter two are novel compounds seeking entry in the coming months. In addition, there are over a dozen inline medications and novel compounds in Phase 2 & 3 clinical trials slated for potential approval in 2022 and on.
Therapy Management Opportunities
There are various quality of care and pharmacovigilance initiatives that can be implemented in a specialty pharmacy’s standard operating procedures, or into a therapy management software like TherigySTM, to deliver high-touch therapy management and patient care. For most specialty pharmacies, the majority of referral volume for AD-related prescriptions are written for biologics e.g., Dupixent, and will expand as more pipeline medications obtain FDA approval. With the sheer number of medications expected to be approved in 2021 alone and the growing AD patient population, there will be a heightened focus on specialty pharmacies to ensure therapy appropriateness and medication management on their own since clinical guidelines from the American Academy of Dermatology (AAD), American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy, Asthma and Immunology (ACAAI) have not been updated even prior to the launch of Dupixent.
Since the profile of AD patients can range from young children to adults and severity ranging from mild to severe, specialty pharmacies should ensure age and condition severity appropriateness at a baseline level. An enhancement example to baseline patient care delivery would be to implement clinical tools such as the EASI-75 (Eczema Area and Severity Index), POEM (Patient-Oriented Eczema Measure), and DLQI (Dermatology Life Quality Index) to measure disease state activity and patient quality of life for insights into real-world outcomes during the patient’s journey. Additionally, the potential expanded approvals for inline medications that have preexisting Black Box Warnings for treatments in other disease states such as Rheumatoid Arthritis present an opportunity to promote pharmacovigilance to address those drug safety challenges by implementing a program to screen and/or monitor patients throughout their course of therapy.
The aforementioned enhancement examples can present challenges for specialty pharmacies without a full-fledged, innovative therapy management software implemented to execute the complex rules, algorithms, and clinical diagnostic tools. TherigySTM has the inherent capability to manage and streamline specialty therapy care with built-in Care Plans that provide specialty pharmacy staff guided content leveraging best practices and latest clinical guidelines for efficient, high-touch patient care delivery. Enhancements to the Care Plans and operational workflow of the TherigySTM platform can be designed to achieve specialty therapeutic goals, such as facilitating prescription pull-through, promoting pharmacovigilance, bolstering adherence/compliance, and measuring real-world efficacy/outcomes.
So What’s Next?
As we approach the latter half of 2021 and expect several brand launches to create competition in the AD marketplace, there will certainly be a need from specialty pharmacies and manufacturers to provide high-touch patient care in a consistent manner while leveraging the best clinical tools available. Therigy is uniquely positioned with a robust network of over 150 high-performing specialty pharmacies of various settings utilizing the TherigySTM platform for specialty therapy management. Our team of clinicians and industry experts have the hands-on experience and knowledge depth to design, develop, and execute enhancement initiatives to facilitate achieving therapy management goals.
For any inquiries regarding Therigy’s Pharma & Biotech Solutions offerings and to discover therapy management enhancement opportunities for your organization or brand, please contact Richard Van, VP Pharma & Biotech Solutions at Richard.Van@Therigy.com and visit https://www.therigy.com/pharma-bio-tech-solutions to learn more.