Patient support programs (PSPs), patient assistant programs (PAPs), copay coupons, or whatever name you want to call them are designed to help patients afford and gain access to medications with high out-of-pocket (OOP) costs. The Pharmaceutical Research and Manufacturers of America (PhRMA) has even partnered with HCPs, pharmacists, patient advocacy organizations, and community groups to create the Medicine Assistance Tool (MAT), a search engine that provides information on more than 900 public and private assistance programs.

But these programs are not without controversy as many employers, payers, and pharmacy benefit managers (PBMs) complain that they lower patient costs while payers are still on the hook for the product’s high expense, which ultimately increases the cost of care for all. This led payers to design accumulator and maximizer programs to combat the impact of PSPs on their organizations. So, life sciences companies need to adjust their strategies.

“Manufacturers need to design programs to deliver benefit directly to patients, outside of the pharmacy claim,” explains Jason Zemcik, VP, Patient Affordability, TrialCard. “Additionally, the 2023 CMS Final Rule will force manufacturers to adjust to this direct-to-patient model to avoid the compounding effect on Best Price.”

Another key change that companies are or should be making is going beyond covering a patient’s copay cost. Kelly Davis Bennett, VP & Patient Lead, Patient Affordability, TrialCard, says, “While a patient’s financial concern is a common barrier to overcome, the value of providing palliatives, a simplified presentation of plan coverage, travel coordination, or nursing education can be just as impactful as a copay benefit.”

With life sciences companies rethinking their approach to PSPs, we asked 10 experts:

  • What are the latest trends in designing and implementing PSPs? What improvements, if any, should manufacturers consider making to these programs in 2022 and beyond?
  • Besides financial support, what other areas should pharma look to address within PSPs to best aid patients?
  • What does pharma need to do on their end about payer accumulator programs? What legislation and/or policy changes might also have an impact on copay programs?
  • How should PSPs differ due to indication or patient population? What changes are needed for specialty brands, which can be more expensive and difficult to access?

Aaron Crittenden

With the severe economic downturn that COVID brought, PAPs expanded their eligibility and enrollment channels so more people could access free or subsidized drugs. Now, in addition to uninsured patients, PAPs often also include insured patients with high OOP costs or those who face utilization management controls for the drug. Additionally, copay support is a cornerstone of most financial assistance programs as it helps commercially insured patients who have high copays.

It’s critical for brands to develop a deep understanding of their customers, their coverage type, and barriers to getting on therapy. This allows them to provide assistance to patients who don’t qualify for free goods or copay support through a cash buydown offer that directly lowers patient OOP and maintains/improves gross-to-net margins.

Offering Adherence and Clinical Solutions

With OOP spending outpacing wage growth twice as fast, copay programs are a key support mechanism to drive conversion to therapy. A holistic multichannel patient support strategy should include tailored adherence and clinical solutions encompassing education, disease management, community support, and behavior modification. These wrap-around services should be designed in an integrated manner that is less transactional and more tailored to living with the condition and managing comorbidities. Sixty-eight percent of providers are more likely to prescribe a product with good patient support.

Further, as patients are increasingly engaged in their healthcare decisions, they use companion apps and other tech solutions. Digital solutions provide access to a wealth of data in real time that can guide patient care and further program development. Market leaders are increasingly leveraging digital platforms to drive awareness and access to holistic and targeted patient support across conditions, patient groups, and caregivers.

Dave MacLeod

Imagine a treatment is available that may help manage your disease, but other barriers prevent you from accessing it. An effective PAP is tailored to the particular disease state, provides important information and education about treatment, and may help eligible patients address some financial burdens. Focusing on the holistic needs of the patient can have a big impact on the lives of eligible patients and their families once they have a medicine to help manage their disease.

In diseases where speech can be impacted, for example, patients may not have technology accommodations at home to effectively communicate about their care or treatment. ALS, a progressive and fatal disorder, can lead to deteriorating muscle function impacting daily life and can pose severe communication challenges.

Designing Programs to Meet Specific Patient Needs

In response, we aim to implement alternative communication options in our program that would allow individuals living with ALS to use eye gaze and physical gestures when connecting with their support team, which we hope will make communicating more effective and help increase autonomy for people living with ALS. A tailored communication approach can help provide timely, comprehensive, and individualized information to patients and set a new standard in focusing on patient needs.

Looking at PAPs for specialty brands, it’s critical to offer financial support for eligible patients who cannot afford access to treatment. It’s also essential PAPs communicate clearly about potential offerings and set clear expectations for patients. The offerings and guidelines of these programs can be confusing, and empowering individuals with information about the process and options gives them confidence to engage with physicians and seek better quality care.

Stephanie Hoops

The payer copay accumulator programs continue to disrupt manufacturer assistance at a time when patients are known to be skipping or discontinuing costly treatment. We expect this disruption will worsen amid rising inflation. Payers have also introduced copay maximizer programs, which apply the maximum value of manufacturer assistance evenly throughout the year, shifting costs back to manufacturers.

Additionally, the new CMS “best price” rule, which goes into effect January 1, 2023 puts the burden on manufacturers to ensure the full value of drug coupons go exclusively to patients. That is a daunting task considering accumulator programs are downstream cost adjustments and manufacturers don’t have access to PBM or health plan data and policies. CMS suggests manufacturers can do so by using point-of-sale reduction data from the electronic prescription claims highway. CMS urges manufacturers to tap into their contracts with the switches and brokers that are electronically connected to the highway.

Alternatively, CMS directs manufacturers to take advantage of their PBM relationships “to better understand how the PBMs are using the manufacturer assistance.” Finally, CMS suggests manufacturers consider redesigning assistance programs to require patients to pay for drugs first and collect rebates from manufacturers. While rebate processing may be easier to implement as it’s outside the electronic claims process, it would have to be implemented well to please patients.

Also of note, state lawmakers have been active in prohibiting health plans from using copay programs to exclude coupons when calculating total cost-sharing contributions. To date, 13 states (AZ, AR, CA, CT, GA, IL, KY, LA, OK, OR, TN, VA, and WV) have enacted varying laws. For example, Kentucky’s new law, which took effect on Jan. 1, 2022, only prohibits programs for drugs having no generic alternatives, or where the enrollee has accessed the branded drug through a utilization management process.

Dan Teisler

PAPs are often based on X times the federal poverty level. This qualifying measure may be adequate for a variety of disease states, but it often falls short when applied to oncology. While I understand this takes out all subjective evaluation and eliminates any possible accusations of bias, it is inadequate when it comes to evaluating the entire patient burden.

Many cancer types have a significant impact on future earnings as well as increases in medical expenses. The diagnosis might impact the total household earnings due to the patient’s ability to work as well as their caregiver’s needs and the time off work they may need to take.

A Different Qualifying Measure for PAPs

The oncology sector (perhaps others as well) might better support these patients’ needs by incorporating a more global evaluation instead of simply comparing income to the poverty level. Considering a patient’s future earnings and increased medical costs could be a more equitable valuation of their needs.

Perhaps something as simple as a multiplier for various diagnosis. For example, a multiplier is a value that would increase the poverty level threshold. The poverty level for one person is $14,000. So, if a simple program mandates 5x the poverty level, then it would be 5 x $14,000 = $70,000. But based on the multiplier, the new threshold might be 1.2 x $70,000 = $84,000.

Maria Kirsch

Now is a pivotal time for manufacturers to initiate a digital-first approach for any PAP. For example:

  • Affordability programs should automate and streamline copay claims processing, benefit verification, and prior authorization handling to speed up patient onboarding.
  • Access to real-time electronic benefits verification provides HCPs the ability to view patient out-of-pocket costs prior to prescribing therapy.
  • Secure self-service websites with virtual chatbot coordinators can guide the patients through the enrollment process, reducing the burden of the HCP and office staff.

Digital enrollment at the point of prescription secures patient access, affordability, and adherence, ultimately leading to better patient outcomes.

Necessary Changes Due to CMS’ Final Rule

CMS’ “final rule” will have a dramatic effect on the market, manufacturer, and patient experience. It will create an immediate need to update or change most copay programs and establish new payment solutions. Once in effect, the rule would substantially affect the manufacturer’s gross-to-net and best price. For example, if a PBM “adjusts” one patient, it could have a material impact across best-price-assessed programs such as Medicaid. Additionally, the final rule will upend the patient experience, dramatically affecting adherence and outcomes. Patients will be faced with navigating an increasingly complex journey to affordable access and left to choose between their health and financial well-being. Progress in technological advancements in patient engagement and adherence will be stymied and the commercialization of specialty medication will decrease.

Pharma companies should examine how brands can adapt to the final rule changes to meet patient and provider needs by developing a “patient-first” approach to access and affordability. Failing to pilot now could result in a lower best price, noncompliant copay program, and an increase in untreated patients down the road.

Chad W. Bower

Many patients have high-deductible insurance plans that make them responsible for high OOP healthcare costs. We must continue to provide copay solutions that are innovative to help patients afford their medicines. But designing and implementing successful PAPs requires companies to understand the patient journey from end to end with clarity regarding site of care and distribution.

What to Include in PAPs?

Important components of any successful specialty program include driving awareness and appropriately educating stakeholders about the program design and benefit as well as simplifying the enrollment-to-claim adjudication process. One way that companies are accomplishing this is through technology solutions such as EMR/EHR coupon delivery and workflow platforms, which are becoming more popular. However, this still requires a clear understanding of how an HCP’s billing/adjudication process operates to effectively educate Revenue Cycle Managers on the end-to-end process as well as the operations of the program. Typically, the most effective member within a pharma company to provide education on this process are Field Reimbursement Managers.

Moving forward, it is critical that we further evolve our copay solutions as payers implement new payment structures such as accumulator adjustment programs, which will lead to higher costs to the patient. To adjust to these programs from payers, pharma companies can design their copay solutions in such a way that patients are benefited directly through a debit card model.

Perry Venugopal

The COVID-19 pandemic has exacerbated the medication affordability challenges patients face. According to the 2022 Medication Access Report, 79% of patients have gone to pick up their prescription and found out it cost more than they expected. As a result, over half of patients have made sacrifices to afford their medications in the last year. More than half also had to forgo medications to pay for essential items and bills, and 56% tried to make both work by stretching out or modifying treatment.

For patients, financial, relational, social, and environmental factors can impact available care options and account for up to 80% of health outcomes. Biopharma-sponsored programs alone aren’t enough to best support patients and the multidimensional medication access barriers they face—especially considering the growth of specialty medications, which will make up nearly two-thirds of drug launches in the next five years.

More Coordinated Patient Support

Comprehensive affordability strategies require coordinated effort across multiple stakeholders. Charitable financial assistance, community health resources, federal and state safety net programs such as the Supplemental Nutrition Assistance Program (SNAP), Temporary Assistance for Needy Families (TANF), and Medicare assistance can also play a critical role in helping patients.

But access and affordability are just the start. The industry must also deliver on adherence and outcomes. As the industry evolves to develop holistic patient support strategies, some biopharma companies are looking to add services and financial support to help patients with transportation, housing, food, and childcare. Integrating these holistic strategies into hub programs is key to a comprehensive patient experience. These programs can connect patients with a variety of resources at various stages in their journey, starting with access and affordability and continuing through adherence to drive toward positive health outcomes.

Robyn Stoy

Reimbursement support, copay programs, and patient assistance programs fulfill a critical role in the patient journey by eliminating the financial barriers to treatment. But for many patients, the pathway to starting and staying on treatment goes beyond the financial hurdles and can often be confusing and overwhelming.

A patient navigator can help to unravel the complexity by connecting the patient or caregiver to the needed resources at the right time in the patient journey. A deep understanding of the HCP, patient, and caregiver friction points is essential to inform the role and can provide meaningful impact to patients and caregivers.

Helping Patients Navigate the Treatment Journey

The navigator can support patients prior to prescription by providing disease education and links to additional resources which can include sites of care, advocacy groups, disease awareness content, and conversation guides to improve HCP interactions. At the point of prescription, the patient navigator can continue as the primary point of contact throughout the treatment journey and foster the relationship with the patient or caregiver through identification of the specific patient need.

Rather than applying a pre-set cadence to the interactions, which often ignores the most immediate need of the patient, the patient or caregiver sets the pace, with the navigator providing the right education and resources at the right time, through the patient’s preferred channel of communication. This approach provides ongoing and holistic support to empower patients throughout their treatment journey.

Seamus Cole

Every year, the number of plans that leverage copay accumulator and copay maximizer programs continues to rise, and they’re getting more effective at shifting costs away from payers. What’s more, payers have a couple of years’ worth of data on these programs and are sharing the numbers with health plans. The more proof of savings the programs have, the more likely they will continue to grow and become more efficient. As such, pharmacy tiers will be even more important to manufacturers. With coupons, tiers weren’t as relevant because a patient cost share may be the same on different tiers. If a manufacturer’s product is on a higher tier, patients could be incentivized to use a competitor’s product on a lower tier.

While most manufacturers are taking a wait-and-see approach, many are doing a cost-benefit analysis of how much money can be saved to circumvent the programs versus the cost of implementing them. However, if they are able to circumvent them, they risk payers taking competitive action.

Policy Changes to Watch

When it comes to impending policy changes, 12 states enacted legislation prohibiting copay accumulator programs, and it’s likely we’ll see more changes. With CMS’ best price rule, manufacturers will have to include the value of their copay assistance offers in their best price calculations.

If the rule goes through as proposed, it will create more transparency for Medicare Advantage and Medicare Part D beneficiaries and result in savings for them. And, not surprisingly, payers are likely to look for ways to minimize the financial impact. Oftentimes when a CMS rule goes through, the opposing party finds a way to comply while circumventing the financial impact for their organization.

Adrian Garcia

With the continued evolution of patient cost-sharing in the health insurance marketplace, affordability has become a key deterrent to patient initiation and adherence. So, the starting point for tailoring a PAP must include an investment that leads to improved patient outcomes. This can mean that these programs must not only be tailored by therapeutic category but also by indication and patient population.

Beyond that, today’s PAPs need to be as unique as the products—and conditions—they support. While hemophilia and type 1 diabetes are both lifelong conditions, the support that patients and their caregivers need differ dramatically.

Going Beyond Copay Support

What meaningful support looks like can vary widely even within therapeutic categories. Consider someone taking an oral oncolytic versus a specific therapeutic intervention, like a novel CAR-T. The latter face challenges that include access to specialists and clinics, health literacy, and equity in coverage that creates significant barriers to initiation.

Therefore, PAPs must evolve from the historical focus of copay support to more robust offerings and resources needed to ensure initiation and compliance. Solutions such as transportation to clinics, overnight lodging, and 24-hour nurse support are meaningful tools that help meet the needs of these patients.

But don’t stop there. If patients, caregivers, advocacy groups, providers, and systems don’t know the extent of the support, the effort will be in vain. Be sure they are aware of the resources—as well as the insights behind them—so they’re useful and utilized.

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