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By Rebecca Leemputte, Associate Partner, Director of Patient Services Strategy

For some patients who are prescribed specialty therapies, insurance coverage limitations or cost share requirements prevent them from accessing necessary treatments. Manufacturer patient support programs (PSPs) play a critical role in addressing payer coverage gaps and ensuring treatments are affordable for patients. PSPs provide resources to facilitate access – from benefits investigation and prior authorization support for provider office staff, through financial assistance and treatment onboarding and adherence support for patients. Without these services, patients may face delays in treatment or abandon treatment altogether. Payer/third-party implementation of management tactics such as specialty carveouts and copay accumulator/maximizer programs make patient affordability and manufacturer program resourcing more difficult, forcing manufacturers to reevaluate their program designs to ensure appropriate use and sustainability. Here’s what manufacturers need to know about access landscape changes and evolving PSP solutions to safeguard patient access to treatment.

Specialty benefit carveouts are implemented by organizations called alternative funding vendors (AFVs). These vendors partner with smaller, self-insured plans by “carving out” the specialty benefit (for example, not covering specialty products) and funneling patients to manufacturer patient assistance programs (PAPs). Manufacturers have designed PAPs to ensure treatment accessibility for patients with a true financial need, such as underinsured or uninsured patients, who otherwise would not be able to afford appropriate medications. Specialty carveouts are risky for patient health because they assume manufacturer PAPs will cover therapy costs; however, patients whose specialty benefits are carved out may be ineligible for PAP for other reasons, such as not meeting household income requirements. While the manufacturer, payer, and AFVs are determining the appropriate coverage path for these patients, resulting therapy delays can have a significant impact on patient health outcomes. Not only are specialty carveouts risky for patients, but they are also challenging for manufacturers because they inflate PAP enrollments, creating concerns around appropriate use and program sustainability.

Copay accumulator/maximizer programs are another set of tactics impacting patient treatment access and affordability. When implementing copay accumulator programs, payers prevent manufacturer copay support from counting toward patient deductibles. Once funds are exhausted, patients are often left with unaffordable out-of-pocket costs, which can lead to patient therapy abandonment. In copay maximizer programs, payers reset patient out-of-pocket costs to extract the maximum amount of copay program funds available. While maximizer programs have a less direct impact on individual patient out-of-pocket costs, they leave fewer funds available across the entirety of the copay program for patients with a truly high cost share and a need for the full copay benefit. Both tactics reduce the effectiveness and long-term viability of manufacturer copay programs, which are intended to alleviate patient affordability barriers.

With increasing payer/third-party implementation of specialty carveout and copay accumulator/maximizer tactics, manufacturers are seeing costs associated with maintaining copay programs and PAPs grow unsustainably. To avoid misuse and make sure these programs serve their original intent – to provide financial assistance for patients with a true need – manufacturers are responding by:

  • Evolving PAP eligibility criteria: Some manufacturers are either no longer allowing commercial patient eligibility for PAP or are putting language in their enrollment forms to disqualify AFV patients from gaining access to the PAP, ultimately to prevent AFVs from misusing PAP funds.
  • Leveraging HUB/field staff to identify vendors and secure coverage: Some manufacturers are training their HUB staff and field teams to identify when AFVs are carving out the specialty benefit and to educate providers on how to appeal the initial coverage denial triggered by the AFV. While this type of support is valuable, it is difficult to implement broadly. It is highly manual and time-consuming and requires HUB staff to be knowledgeable of AFV “warning signs” and the types of questions to ask health plans to identify AFV involvement.
  • Evolving copay offerings & program design: In response to copay accumulators and maximizers, some manufacturers are changing their copay program strategies by limiting transparency around the maximum benefit available, or in some cases reducing the maximum benefit available or setting monthly caps, with the goal of limiting payer ability to extract maximum funds and disincentivizing inappropriate program use.

While these strategies can be effective in curbing inappropriate use of copay and PAP offerings, manufacturers are also considering the potential negative impact of program changes on patient affordability and are looking to minimize these implications. For example, manufacturers recognize that reducing the copay program maximum benefit will be particularly challenging for patients on high-deductible health plans requiring greater copay support. Thus, manufacturers may either implement an exceptions process for these patients or reduce the maximum benefit for patients subject to a copay accumulator/maximizer only. Understanding the unique financial needs of their patient populations can help manufacturers design programs that are sustainable in the long-term while also providing sufficient support for needy patients.

The specialty therapeutic access landscape is changing quickly. By understanding the evolving landscape and implementing proactive strategies that balance patient financial needs, program resourcing, and payer/third-party incentives, manufacturers can ensure patient support programs serve their intended purpose – providing access to life-saving therapies.

To learn more about The Dedham Group’s strategic consulting services, contact us.