May 2020

Respond to today’s need with PAP support – Guiding principles for patient support program design

For patients who are living with a complex disease, there can be many barriers for medication access – including economic, psycho-social factors, logistics, culture and education. And with the COVID-19 crisis, its economic impact and accompanying job losses, more and more Americans may be losing their employer-provided health coverage. For the pharmaceutical industry, understanding how to address these barriers is the first step toward ensuring that every patient has the chance to receive the full benefit of therapy.

While many biopharma companies invest in PAPs today, few are taking the extra steps to optimize these programs to deliver the maximum benefit for patients. The following principles are important to ensure your PAP delivers the full benefit to all stakeholders.

1. Set clear eligibility requirements. The process of enrolling patients in your PAP will be streamlined if you set clear eligibility requirements. While these standards may vary company by company, typically the patient must be a U.S. resident who does not have access to prescription drug coverage (due to either lack of insurance or delays in coverage approvals) and must meet certain financial requirements.
2. Evaluate your patient population. On average, 5 to 15 percent of patients will meet the eligibility criteria required for PAPs. As you begin to design your PAP, examine your patient population to verify this is accurate. How many of your patients are on Medicare? Are they on fixed incomes? Does your therapy serve a pediatric population? Evaluating patient demographics will help you determine how to structure your program, what the time limits should be, and how to conduct outreach. Today’s current events, where many Americans are facing job losses must also be taken into consideration, particularly if your patient population is predominantly working age and commercially insured.
3. Build relationships with patient advocacy, specialty society and patient community groups. These organizations play an important by helping patients find copay assistance, premium assistance and help with out-of-pocket expenses and other resources. By forming solid relationships with these groups, you can recommend additional support opportunities to patients and ensure community awareness of your support
4. Comply with regulatory guidelines. When managing a PAP, it’s imperative to follow regulatory guidelines regarding distribution of the product. First, to help reduce the risk of PAP being viewed as an improper inducement, free drugs should be dispensed from a non-commercial pharmacy that focuses exclusively on free drug programs. In addition, your company must understand the state-mandated requirements for shipping into the state and must be aware of federal guidelines for free drug distribution. For example, the drug must include a patient-specific label that states it is free drug and the drug can never be sold. If a provider is dispensing the drug, they must agree to not resell or bill for the product. All of these regulations serve as safeguards to prevent inducement.
5. Build relationships with specialty pharmacies. While free drugs should be dispensed through a non-commercial specialty pharmacy, commercial specialty pharmacies may still play an important role in managing a PAP. For example, specialty pharmacies can identify and enroll patients, collect proof of eligibility, and gather data that may be needed for a risk evaluation and mitigation strategy (REMS). Creating alignment between your specialty pharmacy network and your PAP team will provide greater control over your product and ensure a smoother experience for your patients.
6. Implement compliance and persistency programs. While specialty pharmacies help facilitate adherence by providing patient education, it’s also important to consider adherence programs which can enhance engagement by providing personal outreach to patients at critical times during treatment. Adherence programs also play key roles in ensuring patients receive positive guidance to help them manage potential side effects, resulting in improved outcomes. Field nurse support through home visits can further improve patient adherence and ensure the patient stays on free drug only as long as needed.
7. Leverage technology to enhance program compliance and convenience. 
   • Electronic income verification reduces the burden on patients to fax W-2s or bring them to their healthcare provider's office. By tapping into leading credit bureaus, soft credit checks can be run and assessed against program qualifications. The success rate of electronic income verification can be as high as 90%.
   • The use of electronic benefits verification, particularly solutions that can batch and run multiple records at a time, can enable more frequent eligibility checks.
   • With the majority of uninsured patients being under 35 years of age, texting and email capabilities can help engage digital natives in their care, speaking to them through preferred communication channels.
8. Connect the success of your program to your brand. Branding your PAP program appropriately can help create awareness among providers and patients of the assistance that is available, regardless of hurdles a patient may be facing. Often, patients may assume their physician is providing the free drug, not the biopharma company — or they may not be aware of the components of the program or how to enroll. Your company can take simple steps to bridge this information gap by providing a letter to the patient and the prescribing physician that includes the most up-to-date PAP program details. Providing monthly or quarterly reporting to physicians and payers regarding use of your PAP program can also help increase awareness.

Cardinal Health Sonexus™ Access & Patient Support was the first hub services provider to introduce a non-commercial specialty pharmacy as part of our offering, to help mitigate risk while helping patients in need. OIG considers non-commercial pharmacies an important factor in free goods programs that lower risks under the Anti-Kickback Statute. On an annual basis, the Sonexus™ pharmacy sends over 400,000 shipments to patients across the country and registered pharmacists deliver clinical information and support to patients to ensure safe and effective use. To understand how to connect with the experts at Sonexus™ Access & Patient Support, contact your CRM.