A Framework to Optimize Patient Access and Drive Value in the Care Continuum

Produced in conjunction with Drug Channels.

Healthcare in the U.S. is rife with process inefficiencies and structural barriers that can prevent individuals from receiving necessary therapeutic care. The key “P” stakeholders – patients, providers, pharmacies, payers/PBMs, and pharma – all share the goal of optimal outcomes, but their respective definitions of value-based outcomes may differ. To address these considerations, patient access professionals like Mercalis (formerly TrialCard) use frameworks to design, implement, and operate manufacturers’ patient support programs (PSPs) to simplify access, affordability, and adherence for all parties involved.

The Rise in Patient Access Complexities

Scientific advancements in the understanding of disease pathways, technologies that alter genes, and rational design of drugs/biologics have contributed to the growing number of FDA-approved specialty therapeutics. Access considerations are multi-factorial and may start at diagnostic workup, continuing throughout the patient’s journey to access, afford, and optimize therapy. Examples of access considerations include the product profile; its route of administration; patient benefits design; payer coverage policy; resulting coverage restrictions; financial affordability solutions; and engineering a successful start to therapy.

Since many new therapies target exact molecular pathways, the resulting indications are specific, and payers’ coverage policy often mirrors the label. As such, access considerations necessitate additional questions. For example, does proper patient selection require additional molecular, laboratory, and/or clinical subtyping? If so, does the prescriber’s attestation to an ICD-10 code (indication) reflect the actual subtype(s); or will payers require documentation of clinical necessity? What is the PSP’s role to support coverage and reimbursement of differential diagnostics? Gaining direct information relative to payer coverage policies for diagnostics and other therapies was part of the investment thesis for Mercalis' (formerly TrialCard) acquisitions of Policy Reporter and Canary Insights and the subsequent integration of those payer knowledgebases into its comprehensive suite of patient access services.

Optimizing Patient Engagement at Enrollment

Clients often cite two common reasons for encouraging enrollment into their PSPs: 1) to increase probability of paid claims; and 2) to accelerate time-to-fill. When, where, and how our clients facilitate PSP enrollment is highly correlated to whether the access model is prescription-based (e.g., eRx), or starts with a patient enrollment form (PEF). Traditional models include: 1) prescribers sending an eRx to a preferred pharmacy, or 2) providers directing the eRx to TC Script, Mercalis' (formerly TrialCard) non-commercial dispensing pharmacy, where free goods or a bridge supply are dispensed to qualified eligible patients (QEPs). Emerging prescription models utilize TC Script as an intake pharmacy to amplify the use of eServices by working collaboratively with commercial pharmacies via shared technology platforms and/or service agreements.

Patient/provider authorizations are usually required to start PSP services. Obtaining authorization/consent often involves a separate workstream from the prescription referral. Because of this, Mercalis (formerly TrialCard) routinely collaborates directly with its clients’ consumer and digital agencies to create multi-channel tactics focused on how and why patients should engage their PSP. The actual tactics are guided by our clients’ compliance counsel. Recent programs include the use of QR Codes to offer patients a choice to opt-in via SMS text, a secure email with a hyperlink to the PEF, or a download of the Mango Health app. Mango Health is Mercalis' (formerly TrialCard) digital communications platform that provides a compliant, consistent, and curated experience for patients to navigate their journey to access specialty therapeutics. Mango also provides direct visibility into the patient’s reimbursement status, their co-pay offers, and delivery of approved product and disease content, all via the patient’s mobile device.

Mercalis' (formerly TrialCard) ultimate goal is to resolve any identified coverage and reimbursement barriers that increase the probability of a paid claim and a quick time-to-fill. Mercalis (formerly TrialCard)hub operations focus on quick assessment of the coverage requirements that will determine reimbursement. Since reimbursement services now rely more on eServices (e.g., eBIs, ePAs, eRTBC), the next value-added service is helping patients navigate their complex cost share obligation, which is highly correlated to their benefits.

Engineering a Successful Start to Therapy

Our clients know Mercalis (formerly TrialCard) as the best-in-class co-pay solution partner, particularly now that co-pay benefits are routinely subject to accumulators, maximizers, and soon, CMS best price implications. Published data now recognizes the value of combining reimbursement and co-pay solutions under one partner. Our management of financial affordability solutions extends beyond co-pay to include commercial FGPs, referral to 501(c)(3) foundations, and patient assistance programs.

The right PSP successfully engineers the patient’s start to therapy. These patient access considerations fundamentally require a deep understanding of the product profile, setting of care, routes of administration, educational requirements, and the need for clinical support services. At any point in their journey, patients may encounter barriers to access. To identify/prioritize all these patient access complexities, Mercalis' (formerly TrialCard) framework helps clients design a solution that meets their needs.