Companies Should Make Sure Patient Assistance Is Robust, Keep Eye on External Factors

Pharma manufacturers began offering patient assistance programs (PAPs) as a way to help patients afford their medications. And as list prices of drugs continue to rise, so does that assistance. Companies can take a variety of steps to make sure that their offerings are not being hamstrung due to common pitfalls and instead are truly helping patients access and remain adherent to their medicines, say industry sources. In addition, manufacturers should be keeping an eye on copay offset programs, as well as the Inflation Reduction Act (IRA), for their potential impact on PAPs.

In 2023, manufacturer-provided copay assistance in the form of coupons and debit cards offset patient costs of $23 billion, according to the IQVIA Institute for Human Data Science report titled “The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028.” Released in April, the report also found that such assistance offset costs of $84 billon over the last five years.

But that assistance can’t help if stakeholders aren’t aware of it.

KPMG U.S. Sector Leader for Healthcare Ash Shehata says that manufacturers should engage with multiple stakeholders to make sure they know about drugmakers’ copay assistance programs. First, providers and their organizations are important because they are interacting with patients “and can offer information about copay assistance at the point of prescribing medication, which includes placing brochures and materials in clinics and having discussions during patient visits.”

Working with insurers to promote the programs is important because “insurance carriers can inform their members about available programs and how to access them,” he tells AIS Health, a division of MMIT.

Retail and specialty pharmacies can help by “provid[ing] rebate cards and discount information, especially for patients with private insurance,” adds Shehata. “Finally, conducting training and informational sessions for health care providers, pharmacists and insurance representatives ensures they are well-informed about the details and benefits of copay assistance programs.”

Manufacturers usually have teams that are focused on “designing, implementing and refining their PAPs,” explains Andrew Rouff, a senior consultant on the advisory services team at MMIT. “These teams work cross-functionally to support their various workstreams.”

Marketing strategies may include both personal and nonpersonal communication not only to patients, providers, office managers, payers and pharmacies but also to third-party entities such as nonprofit organizations and advocacy groups, he says. “It’s important to note that prescribers generally have office staff dedicated to helping patients navigate PAPs. These staff serve as well-suited audiences for HCP [health care professional] marketing campaigns.”

Lauren Westberg, executive vice president and managing director at Precision AQ, and Courtney Ottoson, senior vice president and director of client services at the company, recommend a blended approach of personal and nonpersonal approaches. For example, manufacturer reps may leave magnets, stickers, postcards with QR codes and patient affordability brochures. Point-of-care displays also may include postcards and brochures, as well as office posters, TV signage and tent cards. And digital tactics can involve banner ads, social media posts and emails to both patients and providers.

“To measure success around this blended approach, key performance indicators on awareness around the copay assistance program will be important for further optimization,” they tell AIS Health.

Should Companies Run PAPs Internally or Outsource Them?

When establishing a PAP, manufacturers should “identify and prioritize the full spectrum of patient needs before defining the core program elements,” say Westberg and Ottoson. For instance, a program for type 1 diabetes may include both financial help and education on nutrition. But a program for migraine patients “may not need to balance those priorities and thus can invest more in financial support.”

Companies may choose to operate PAPs internally or to outsource them, and both approaches have benefits as well as potential pitfalls.

“Internally managed programs offer full control over messaging, branding and execution, allowing for customization specific to patient needs and company goals,” points out Shehata. “This integration can ensure consistency with the company’s overall strategic initiatives.” Downsides, however, include that this approach is complex and “resource-intensive” in terms of staffing, time and technology.

Outsourcing the program to an external company offers manufacturers “limited control over program execution, potentially higher costs due to outsourcing fees and a dependency on an external organization for critical patient engagement efforts,” says Shehata.

But outsourcing a PAP to a company focused only on these programs means being able to take advantage of its experience and expertise, which, he says, “can lead to greater efficiency and scalability without needing to hire additional internal staff.”

Westberg and Ottoson agree. “An outsourced copay assistance program partner can offer end-to-end best practices when it comes to program design, development and deployment. This is especially true if the product or service represents a new therapeutic area for a manufacturer.”

Manufacturers can work with outside companies on the design of the PAP, including its goals and how to “calculate optimal support and eligibility”; its implementation; how the program’s success may be measured; and any refinement needed based on the program’s results, Rouff says.

Aligning the workstreams of the partner with the manufacturer’s commercial operations team is important, say Westberg and Ottoson, and may be done in the following ways:

• “Establishing cross-functional working groups,
• Planning and conducting weekly stakeholder meetings, and
• Holding check-ins with additional partners (communications agency, PR agency, etc.).”

Head Off Missteps

Regardless of whether manufacturers choose to go it alone or outsource their PAP, they should keep in mind some missteps that could trip up their patient assistance offerings.

Failing to understand initial access barriers and offering features that do not adequately address what patients actually need can be issues, Westberg and Ottoson say, but conducting market research can help overcome them. Similarly, Rouff says, less-than-optimal design, such as eligibility criteria that are too strict or too lenient and financial support that is too generous or inadequate, can be problematic.

“Not considering the needs of underinsured and uninsured patients can limit program effectiveness,” contends Shehata. “Collaborating with federal and state programs and social workers who can connect patients with available resources is crucial to address this gap.”

A burdensome enrollment process for patients, providers and manufacturers also can hinder uptake of PAPs. In addition, says Rouff, a long approval process can be a problem. “These can be avoided by targeted PAP design and refinement according to brand objectives.”

Companies should make sure their PAPs are integrated with providers, insurers and pharmacies to avoid “confusion and underutilization,” maintains Shehata. “To avoid this, companies should ensure programs are well-coordinated with these stakeholders.”

All of the experts who spoke with AIS Health agree that a lack of awareness of programs — among not only patients, providers and pharmacists but also caregivers — can be an issue. Companies should “mak[e] sure patients and caregivers are aware of the full suite of support services, including nutrition, transportation, foundation support, patient advocacy and more,” say Westberg and Ottoson.

That said, “over-reliance on consumers to navigate the assistance process independently…can be overwhelming,” states Shehata. “Providing robust support through health care providers and social workers can mitigate this issue.”

Be Aware of Copay Offset Programs’ Impact

While many patients and providers extol the virtues of manufacturer assistance, some plan sponsors have taken a different stance. They claim that such programs incentivize patients to use high-cost specialty medications over less expensive generic alternatives. To counter these offerings, many plans have turned to copay accumulators, copay maximizers and alternative funding programs.

Before these tools, manufacturer assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those were reached, health plans would cover the remainder of costs for the year.

With accumulators — which are operated by PBMs — patients can still use that assistance, but it does not help reduce those out-of-pocket costs. Once the total annual assistance is depleted, usually fairly early in the year, beneficiaries must pay for often-costly drugs until they hit their out-of-pocket maximums, shifting payers’ financial responsibilities to their members and manufacturers.

The next-generation copay maximizer model sets a patient’s out-of-pocket spend to the maximum value of a copay program. These programs are usually offered by a third-party vendor separate from but partnered with the PBM. They work by declaring certain drugs non-essential health benefits under the Affordable Care Act, and then the maximizer secures funding for patients who are prescribed those drugs from manufacturers’ or charitable foundations’ PAPs, allowing patients to get their medication for free. Similar to accumulators, the patient assistance is not applied to patients’ out-of-pocket costs.

And alternative funding programs — which are sometimes referred to as specialty carve-out programs and are not usually affiliated or partnered with PBMs — eliminate coverage for specialty drugs so patients are uninsured for those agents, and then the vendors reach out to the PAPs on patients’ behalf to secure coverage for them.

“Given that a majority of payers implement these programs [accumulators and maximizers], manufacturers need to consider them when designing PAPs…to avoid excessive costs,” maintains Rouff. He tells AIS Health that these tactics have prompted manufacturers to make some changes to their PAPs, including design modifications given the “non-decreasing patient cost-sharing responsibility.” In addition, they have had to prepare for “high patient cost-sharing responsibility once PAP runs out” and turn to “innovative mechanisms to deliver patient support to avoid payer detection (i.e., debit cards, [direct] reimbursement to patient, etc.).”

The use of all of these models means that “it can be difficult at times to truly identify uninsured and underinsured patients,” he explains. “Manufacturers can work to prevent PAPs from getting into the wrong hands by optimizing their design and vetting the situation during the approval process.”

“To prevent accumulators and maximizers from undermining copay assistance programs and ensure assistance reaches uninsured and underinsured patients, manufacturers should work closely with providers and insurers to develop programs that comply with regulations and maximize patient benefits,” recommends Shehata. “Collaborating with state and federal programs to reach uninsured and underinsured patients is essential. This includes engaging with social workers and health care providers who can guide patients through the eligibility process for these programs,” as well as “educating patients about their rights and the details of their insurance plans and advocating for regulatory changes that limit the use of accumulators and maximizers.”

Might IRA Have Impact?

Another external influence that potentially will impact PAPs is the IRA. Even though it targets Medicare, and most PAPs are focused on commercial plan beneficiaries, the IRA may have a broader impact on the pharma and market access landscape, says Rouff.

Andy Cournoyer, senior vice president and director of the access experience team at Precision AQ, explains that Medicare beneficiaries can use PAPs “when Medicare doesn’t cover any portion of a drug’s cost because CMS has deemed them a violation of the Anti-Kickback Statute. However, when a Part D plan sponsor does not cover a drug, the beneficiary can use a PAP to cover drug costs.”

He tells AIS Health that Medicare Part D and Medicare Advantage plan sponsors “have indicated from the outset that in order to offset higher liabilities resulting from the IRA’s [Part D] redesign, 2025 formularies would limit brand access to leverage higher rebates.” Indeed, a recent Precision AQ survey found that about 70% of plan sponsor respondents said their formularies “would have a stronger focus on generics and biosimilars with more restricted access to brand medications. As a result, I would expect formulary exclusion lists to expand, which could then result in higher demand for PAPs, placing strain on the available funds to sustain them.”

In addition, Cournoyer says, “plan sponsors have signaled that actions they take within their Medicare formulary designs could spill over into the commercial benefit. Hence, added pressure for PAPs could become widespread.”

“It is impossible to predict exactly how this policy will impact PAPs, so manufacturers need to continuously monitor their unique situation to address their brand’s needs,” urges Rouff. “MCOs with a high number of Medicare lives are likely to be impacted most and consequently can expect greater shifts in PAP design and implementation.”

According to Cournoyer, manufacturers will need to weigh a variety of considerations, with those varying among companies, “as each situation is unique. These considerations include forecasting impacts to PAPs resulting from negative formulary actions and reviewing program qualification criteria to minimize loopholes.” Companies also need to scrutinize where any waste and inappropriate use of a PAP exists, he says.

“Achieving access, however, should remain a priority, as this could ultimately be most important in reducing resource burden on PAPs,” he says. “Hence, continued focus on robust clinical evidence generation activities including HEOR [health economics and outcomes research] and RWE [real-world evidence] remains paramount, as well as maintaining a pricing and contracting strategy that supports the organization’s access goals.”

Ultimately, observes Rouff, “PAPs are highly diverse from company to company and brand to brand. They go by different names, have different objectives, are designed differently and often have little in common. They are often the most expensive aspects of brands and thus are highly scrutinized.

“Depending on the goals of a brand, PAPs can be used for a wide variety of objectives, including facilitating stakeholder education, encouraging patients to begin treatment, incentivizing switching from competitors, maximizing adherence, providing advocacy, etc.,” he continues. “A strong PAP can support multiple goals and thus should be considered based on the strategic objectives of the brand.”