Patient-First Approach Is Improving Access to Clinical Trials for Specialty Pharmacy

The clinical trials market is projected to reach $65.2 billion by 2025, with oncology anticipated to be the fastest growing segment.¹ The coronavirus disease 2019 (COVID-19) pandemic has exacerbated the high cost of these studies, as well as challenges surrounding patient recruitment. This is especially true for the rare and orphan market.

Thirty million Americans live with a range of 7000 rare or orphan diseases. Although many patients have already struggled with reduced care, isolation, and adherence challenges for most of their lives, self-isolation during the pandemic has affected their quality of life. These individuals now face elevated stressors resulting from immunosuppression, concern about potential infection, and hypersensitivity to viral threats.²

Despite restrictions, patients continue to require a high level of therapy adherence support at a time when some pharmacies have reduced their hours. This can impede communication with physicians and other advocates, which has already been severely disrupted because of the need for social distancing.

Many drug manufacturers also report that patient enrollment in clinical trials has been compromised, prompting contract research organizations (CROs) and their partners to seek technology solutions that mitigate the impact of the pandemic and other challenges.

According to client needs, customizing IT, tech, and data solutions can help resolve these issues and improve patient engagement—from clinical trials to commercialization and adherence.

A patient-first approach is sharply focused on orphan diseases to better address the patient experience, outcomes, and clinical trial requirements. It is a model that focuses on and adapts services for small patient populations, with targeted programs and services that deliver specialized expertise beyond the scope of traditional legacy care organizations.

Optimized Clinical Trials

COVID-19 has catalyzed improved clinical trial solutions, with manufacturers seeking to get patients enrolled in clinical trials more rapidly to advance research goals, including goals involving the pandemic. However, for other conditions, clinical trials lag in response to COVID-19 restrictions, making it crucial to identify innovative ways to move trials forward.

Tools that enable home-based clinical services, direct-to-patient support, and remote monitoring offer critical value for keeping clinical trials running. The FDA published guidance on managing clinical trials during the pandemic in March 2020, with updates made as recently as January 2021. The guidance was offered to benefit the safety of trial participants, maintain good clinical practice, and minimize risks to trial integrity during the pandemic. Carrying out assessments by telephone or by virtual visits and offering additional safety monitoring for clinical trial participants who can no longer access an investigational product or site are among the suggested methods.³

As a preferred care partner for manufacturers, the patient-first methodology provides a streamlined approach that includes a single-source, direct-to-patient distribution model, a more controlled patient experience, and national access to therapy. Products are properly and promptly distributed directly to the patient, and patient services are designed to ensure adherence and retention and alleviate the need to schedule an onsite visit to obtain clinical trial medication.

An unnamed pharmacy, distribution, and patient management organization for the treatment of orphan and rare disorders was involved in 2 clinical trials at the outset of the pandemic. This participation helped patients access products without going to the doctor’s office, with the help of telehealth to oversee the process. As a result, the trials had significantly more patients involved, despite the national lockdown, and the organization was able to ensure that patients and staff remained safe while participating in the clinical trials.

Advantages of a Patient-First Strategy

With a patient-first approach, the clinical trial sites, CROs, specialty pharmacy, physicians, patients, site coordinators, and care coordinators connect effortlessly, instead of operating independently. The continuity across the entire patient journey—beginning with clinical trials—strengthens communication, yields rich data for more informed decision-making, and improves the overall patient experience. This dedicated clinical team seamlessly manages the transition from clinical trial product to commercial product and ensures there are no treatment gaps for the patient.

A patient-first focus also addresses all variables around collecting data, while maintaining frequent communication with patients and their families to ensure adherence and positive outcomes. This approach benefits drug manufacturers by bringing care continuity that is critically missing from the legacy care model. As a result, patients have a better experience, which is critical for the product’s value.

In the specialty space, most manufacturers have worked with multiple specialty pharmacy partners and an internal or external product hub, but this unique patient-first approach offers key advantages:

• Single source: When a manufacturer uses several specialty pharmacies and a patient in a clinical trial switches to the commercial drug, the payer will almost always have a distribution preference inside its network, forcing patients to change pharmacies—potentially disrupting care. The single pharmacy, patient-focused model finds the right drug for the patient. When there’s only 1 place you can get this drug, it will be covered by insurance.

• Competitive edge: Patients with rare and orphan disorders and their physicians must overcome massive hurdles in achieving any level of consistent care. When a new therapy is available on the market, switching to that new drug can lead to physical, emotional, clinical, and economic challenges. These drugs can cost hundreds of thousands of dollars per patient per year, and insurance companies pay close attention to the value received for every dollar spent, prompting doctors and patients to think twice before considering a new therapy. The patient-first methodology specializes in helping patients and providers overcome this reluctance. This provides a competitive edge in addressing clinical and insurance challenges.

• Pharmacy pricing model: A core difference between the legacy and patient-first model is how pharmacies are compensated. With the legacy care model, pharmacies earn a margin on the products sold as they strive to keep millions of patients adherent to maintenance medications. When the focus is on the product instead of the patient, the pharmacy’s incentives can become misaligned. They’re focused more on monthly profits, leading them to focus on how much time employees spend on the phone. These incentives prevent pharmacies from being truly patient focused and able to deliver the best possible care.

Patients with rare and orphan diseases require a high level of support and have much to gain from high-touch service. A care team, including program managers, care coordinators, pharmacists, nurses, and specialists, is 100% dedicated to the disease state, patient community, and therapy. This is a critical differentiator that improves the standard specialty pharmacies and hub service providers, which rely too heavily on technology solutions that fail to address human needs and variability.

Manufacturer Benefits

Manufacturers of every size can leverage this continuity of care for a streamlined, one-stop-shop approach to optimize the patient journey. What’s more, the longer a patient is adherent to treatment, the more manufacturers will recognize the benefits of a branded program.

This patient-first approach also improves patient outcomes and can drive an adherence rate of nearly 90% for orphan and rare disease therapies, compared with industry standards of about 70% to 80% for specialty drugs and 50% for nonspecialty drugs.

DONOVAN QUILL is president and CEO of Optime Care in Earth City, Missouri.

REFERENCES

1. Global clinical trials market projected to exceed $65 billion by 2025—shift towards personalized medicine drives market growth—ResearchAndMarkets.com.News release. Business Wire. August 1, 2019. Accessed November 20, 2020. https://www.businesswire.com/news/home/20190801005504/en/
2. Breining G. Rare diseases difficult to diagnose, cures hard to come by. Association of American Medical Colleges. April 11, 2017. Accessed October 14, 2020. https://www.aamc.org/news-insights/rare-diseases-difficult-diagnose-cures-hard-come
3. FDA. FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency.Updated September 21, 2020. Accessed November 20, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency