Getting Real: Leveraging Real-World Evidence in the Specialty Pharmacy Domain

Interest in the use of real-world evidence (RWE) among specialty pharmacies continues to mount, and for good reason: RWE provides invaluable information to guide companies through the complex process of a product development cycle.

Collected beyond the confines of clinical trials, RWE is defined as clinical evidence from real-word data (RWD) on the safety and effectiveness of medical products collected from a variety of sources and resulting from routine healthcare delivery. Such data are gleaned from electronic health records, product or disease registries, patient/caregiver-reported outcomes, claims information, and patient analytics from wearables or mobile devices. Among its applications, RWE can impact regulatory approvals, product development and funding and reimbursement decisions.

AscellaHealth leverages the indispensable insight provided by RWE to help manufacturers reach one of their utmost priorities: improving quality of life for patients with complex, chronic conditions, including rare, orphan, ultra-orphan diseases.

Informing Patient Journeys and Drug Program Design

Optimizing patient outcomes and well-being begins with patient journey mapping — a pillar of AscellaHealth’s pre-launch support toolkit. Patient journey mapping is an exercise fueled by RWE that helps manufacturers and other stakeholders, including physicians, regulators and payers, better comprehend how patients interact with their health system throughout their care delivery. It also outlines patient touch points during each stage of interaction. This process allows AscellaHealth to establish a strategic plan augmenting patient engagement and satisfaction. Furthermore, use of RWE aids in the assessment of patient compliance with prescribed treatment, alignment of key players in the patient journey, understanding of patient priorities, and determining whether the best standards of care are being followed in clinical practice. It allows informed decisions to be made around the ideal management approach for patients.

Armed with this information, AscellaHealth supports customized, personalized patient engagement through the following services:

• specialized programs designed for care continuity and customized communications;
• personalized patient care plan programs that include detailed outreach based on patient therapy and tailored interventions;
• dedicated patient care coordinators who improve patient adherence to therapy and nurture longstanding patient relationships, and
• solutions for patient financial burdens through customized copay assistance programs and innovative services conducted on behalf of the manufacturer.

Along with informing patient journey mapping, RWE plays a critical role in drug program design. Specifically, AscellaHealth collaborates with manufacturers to utilize RWE in developing and refining target product profiles (TPPs) by evaluating disease incidences and prevalence as well as drug interactions and safety issues. In turn, TPPs aid AscellaHealth’s process of supporting manufacturers in optimizing drug candidates, fine-tuning clinical research strategies, communicating with regulatory agents, and improving decision-making overall.

Challenge Accepted: Overcoming Obstacles to RWE

Real-word evidence is essential in optimizing end-to-end solutions for life science and healthcare companies, but it has its challenges. Hurdles include data complexity; lack of data standards; and data privacy and regulation issues. Likewise, operational needs regarding feasibility, governance and sustainability pose potential complications. All of these issues call for continual scrutiny and problem-solving.

To address these barriers, AscellaHealth designs its programs to ensure the wealth of information is available through its distribution model. This model provides insights such as post-marketing safety surveillance, which strengthens the evidence base for marketed products and can potentially improve reimbursement and regulatory compliance. Additionally, within our model, RWE optimizes decisions regarding patient care strategies and product delivery, and enhances market understanding. Our model fosters a culture of agility and innovation that can ultimately improve patient care.

Distributing Results

By tracking data through AscellaHealth’s distribution model, manufacturers gather detailed information that bolsters RWE. Our Specialty Pharmacy and Distribution Center, Optime Care, is a nationally recognized pharmacy, distribution and patient management company that, among offerings, provides pharmaceutical manufacturers with an exclusive distribution model featuring an array of financial benefits, customized product launches, and patient support/HUB services that boost patient compliance to therapy and optimize outcomes.

Likewise, our European footprint provides pre-commercialization, market access and, supply chain and distribution strategies, financial solutions, and related strategic services.

RWE’s Role in Payer Contracts

Real-world evidence also plays a significant role in payer contracting. With value-based contracts (VBCs), for instance, pharmaceutical manufacturers and payers coverage and reimbursements to a therapy’s short and long-term effectiveness and real-world outcome. A form of risk-sharing agreement, VBCs tie the price, amount, or nature of reimbursement to clinical, economic, and other patient outcomes endpoints. Use of these contracts is poised to grow, according to the National Pharmaceutical Council, and there will be increased reliance on RWE for data collection, evidence development, and outcome measures.

Drug warranties, which are another form of risk-sharing agreements, draw from RWE as well. These insurance instruments are paid for by manufacturers and spread risk over a treatment population, guaranteeing a particular therapy-driven health or clinical outcome. If a patient does not achieve outcomes in a certain time frame, the warranty covers all or portion of the cost. This option drives alignment, among manufacturers and payers in particular, with the mutual goal of improving patient outcomes for patients with complex, chronic conditions, including rare, orphan, and ultra-orphan diseases.

The Real Metric Delivered

Real-world evidence, overall, is an invaluable metric that enables AscellaHealth to ascertain long-term safety and effectiveness data beyond clinical trials, inform patient-journey mapping, improve drug program design, leverage distribution analytics, and lock in payer contracting details. From real-world evidence to real-life impact, AscellaHealth harnesses the power of RWE to provide leading end-to-end solutions for life sciences and healthcare companies.