Patient Assistance Programs (PAPs) have existed for years, but often fly under the radar. Most pharmaceutical companies offer these programs voluntarily to help patients with access and affordability to needed medications.
Traditionally, these programs existed to help people who lacked health insurance obtain access to costly treatments. But today, costs are shifting to the patient in the form of higher health care premiums and out-of-pocket costs that make it difficult for patients to afford treatment.
This is a growing problem in the United States. In 2014, there were an estimated 31 million underinsured adults in the US — a whopping 23% of the adult population ages 19- to 64-years-old.
Although the health care marketplace, Medicaid expansion, and other provisions covered under the Affordable Care Act have given patients more options than ever before, it is increasingly difficult for them to navigate this new health care landscape and understand their prescription drug benefits.
With 90% of the American population now having health insurance delivered into a complex health care system, PAPs can play a meaningful role in the patient’s health care experience — providing access to treatment and ensuring continuity of care. PAPs combined with other patient support offerings can help manage change and minimize impact in the patient’s insurance journey.
Patient support programs can also help patients improve medication adherence by eliminating unforeseen barriers that discourage patients from taking their medication in the first place.
Successful PAPs leverage several components, including eligibility criteria, bridge programs, and more. Here are some key considerations for building a successful and effective Patient Assistance Program under this new landscape:
- Eligibility Criteria: Each PAP has its own set of rules and eligibility requirements. These often include proof of income, health insurance documents, and prescription information. Typically, povery level and mean income data help determine the income guidelines for PAPs. Manufacturers have the option to increase of decrease income requirements, but many are increasing allowable income levels due to the rising underinsured population and escalating out-of-pocket costs.
- Bridge Programs and Reimbursement: Most insurance plans limit eligibility and reimbursement for prescription treatments with a variety of utilization mangagement strategies. Tiered formularies, pre-certification, prior authorization and/or appeals may be implemented. For each patient, this needs to be investigated and then coordinated with both the patient and the health care provider. This can be a time-intensive process, depending on many factors, including the product and therapeutic area. Additionally, any change to the patient's insurance policy, employment status or treatment guidelines may also produce a gap in treatment access due to the change in coverage.
- a bridge program -- a short-term or temporary fill of the medication -- can mitigate impact to patients by initiating therapy sooner, and then maintaining patients on therapy without treatment interruption.
- Unproven newer technologies offer the opportunity to provide real-time benefit verifications and investigations to verify continued enrollment.
- Tier exceptions and appeals coordination ensure that all insurance options to facilitate access and reduce out-of-pocket costs are leveraged.
- Counseling and Clinical Support: For products that have more complicated routes of administration (infusion, injectible, etc), stability (refrigerated, frozen, etc), monitoring or risk evaluation and mitigation strategies, clinical resources can help patients start and stay on medication. Psychosocial and emotional support is often helpful to patients as they are diagnosed or during disease progression.
- Patient Navigation: Navigating the health insurance marketplace and understanding health benefits can be tricky for consumers. Through program design, patients can be engaged about insurance options and how to avail themselves of coverage with Medicaid, Medicare, or the exchanges.
- Alternative Funding: In specific cases, the patient may not qualify for the manufacturer’s patient assistance program or may exhaust benefits. Being prepared with alternate funding sources will provide potential options in these scenarios. Alternative sources of funding coordination may include state pharmaceutical assistance programs (SPAPs), 501(c)(3) non-profit charitable foundations, and any other available private or government funded programs.
- Data Analytics and Reporting: The shift to value-based and outcome-based health care delivery is steeped in measurable performance. Aggregating and integrating patient support data with other hetergenous data sources can add new insights. Data can be compiled to measure and manage adherence and compliance to therapy. Wearables, apps, and other mobile monitoring tools can be integrated into workflows and added to the data warehouse. Robust business intelligence platforms with contextualized data and self-service options can accelerate innovation and continuous improvement.
Change is on the rise in PAPs, with the shift to support the underinsured, but it will be driven by empowered consumers, and will require patient-centric redesign. The fundamentals still largely apply.
Access and affordability will remain central to any go-to-market strategy for drug companies. But innovation underpinned by strong communication plans, detailed program requirements, and stakeholder collaboration will result in long-term treatment success.
About the Author
Hari Rayapudi is vice president and general manager of TMS Health Patient Access Solutions, a Xerox Company