During normal times – pre-COVID-19 pandemic – research to identify causes or develop strategies for prevention and early detection of rare cancers is highly challenging. During the current crisis, all of these challenges have been greatly amplified, especially around meeting protocol-specified procedures, such as administration, adherence and laboratory/diagnostic testing for clinical trials.[1]

Self-isolation, site closures, travel limitations and interruptions to the supply chain have jeopardized progress for drugs being manufactured for rare cancers and hematological malignancies. This includes those that affect the blood, bone marrow and lymph nodes, including leukemia, chronic lymphocytic, acute myeloid, chronic myeloid, myeloma and lymphoma.[2]

In the United States, 1 in 5 cancers diagnosed is a rare cancer, which is defined as an incidence of fewer than six cases per 100,000 people per year. This means that 200 forms of rare cancer compose around 20-25% of all U.S. cancer diagnosis and affect more than 400,000 Americans per year.[1]

Typically, oncology takes a physician-driven approach to therapies. But for cancer patients—during the pandemic and beyond—a patient-first approach to specialty Rx is more effective, no matter what the disease. Patient-first strategies include tools to enable in-home clinical services, direct-to-patient support and remote monitoring for keeping clinical trials on track. This is important because patient-first strategies can shorten the time from the clinical trial to commercialization, enhancing patient access to the medication and capturing 90% of patients during the transition period within 30 days.

Multiple scientific and operational challenges are inherent for these specialized populations across the clinical trial ecosystem, including the adoption of new strategies, operating models and processes, according to a report from Tufts Center for the Study of Drug Development. The COVID-19 pandemic also presents additional issues for patients, providers and drug manufacturers for the rare cancer market, from covering the high cost of clinical trials to patient recruitment, enrollment and retention.

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Spotlight on COVID-19 Challenges
During the pandemic, rare cancer patients have encountered difficulties in accessing much-needed therapy adherence support. While many of these patients have struggled with reduced care, isolation and treatment adherence issues for most of their lives, they now face elevated stressors because they are immunosuppressed, conscious of infection and hypersensitive to viral threats.

What’s more, some pharmacies have reduced their hours. This impacts communication with physicians and local pharmacists, which has already been severely disrupted due to curtailed hours and the need for social distancing.

Partnering with Patient-First Management Solution
While traditional models are built for scale, stakeholders are now seeking a more individualized approach that puts rare cancer patients at the center of care. These more focused, customized services deliver personalized expertise to overcome the limitations of legacy care models and provide cost-effective programs for small patient populations.

A patient-first model means more streamlined care delivery that offers financial advantages, with assurance that products are properly and promptly distributed, and patient services are designed to ensure compliance and quick, accurate reimbursement processing.

Take for example the case of a specialty Rx patient management partner that was involved in two clinical trials that began at the outset of the COVID-19 pandemic. An integrated telehealth program enabled patients to get the products delivered without going to the doctor’s office. As a result, the trials had significantly more patients involved, despite the national lockdown.

This level of innovation can also build awareness and introduce education programs that aid a drug manufacturer’s understanding of patient groups. As a result, manufacturers know they have the support to develop a drug and a comprehensive program based upon specific needs. This added layer of patient advocacy helps physicians better understand the patient journey, facilitates the creation of a patient registry and gives manufacturers an opportunity to obtain patient-reported outcomes outside of the clinical trial protocol.

Vital Role of Pharmacists
As an integral part of the care team for rare cancer patients, pharmacists serve as lifelines by helping to prevent lapses in continuity of care. By partnering with a patient-first organization that integrates specialty pharmacy services, product distribution and patient management into a dedicated program, pharmacists with specialized training in rare disease management enable patients to receive the intense care, outreach and dependable support they require to ensure positive outcomes.

This model also adds an essential level of support for the patient’s family and caregivers, allowing them to become more engaged and take ownership in the care process, which leads to a stronger partnership and better patient care.

In the COVID-19 oncology era, it is more important than ever to acknowledge the challenges posed for expediting clinical trials, enhancing compliance and improving the patient experience for the nation’s vulnerable cancer patients. Adopting a patient-first approach is the most optimal way to help patients and caregivers manage rare disorders and improve quality of life during this difficult time.

Patient-First Specialty Rx Solutions Expedite Clinical Trials, Enhance Compliance and Improve Experience for Patients with Cancer and Hematological Malignancies

[1] Rare Cancers. Congressionally Directed Medical Research Programs (CDMRP). Online. Last accessed on October 14, 2020
[2] Clinical Trial Conduct During the COVID-19 Pandemic. U.S. Food and Drug Administration (FDA). Online. Last accessed on October 14, 2020

Feratured image: Doctor discussing treatment options with a patient. Photo courtesy: © 2016 – 2019 Fotolia/Adobe

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