From Free Drug to Paid Prescriptions: PATIENT ASSISTANCE STRATEGIES TO ENSURE ROI by Jan Nielsen, Division President, SonexusHealth
The Role of Patient Assistance Programs Healthcare affordability is reaching extreme measures in the United States. While the counry grapples with solutions like required health coverage through the Affordable Care Act, there are still millions who are either uninsured or underinsured. In fact, the underinsured population those who have insurance but can t afford expensive co-pays and out-of-pocket costs is still estimated to be 30 million people. Launched in the 1950s, the concept of Patient Assistance Programs (PAP) served to help those uninsured patients who need access prescription medicines. Pharmaceutical companies provided this service to individuals, based on their own eligibility criteria and application process. The concept of PAPs has changed very little since then, and many more manufacturers, foundations and advocacy groups offer these assistance programs today. In fact, CareNet Foundation, a PAP-service firm, estimated that the pharma industry now spends $15 billion on PAP support. Why the investment in PAP? In the world of specialty, orphan and ultraorphan drugs where the cost for a single dosage can be thousands of dollars, PAPs play a strategic role in getting patients access to often lifesaving therapy.
>> MANUFACTURER S ROLE: CREATIVE SOLUTIONS FOR SERVING PATIENTS IN NEED Manufacturers today invest in PAPs as a key strategy for improving patient uptake. The goal is to provide free drug for a limited period of time and then transition the patient to a commercially-covered or governmentassisted prescription, while also providing an ROI formula to track this benefit. While manufacturers are always committed to leaving no patient behind when it comes to care, the difference for manufacturers today is a increased focus on tracking these patients, providing alternate coverage as needed and balancing these programs with overall return on investment. Typically, three scenarios drive the need for PAPs: NEW PRODUCT LAUNCH: Patient assistance programs can play a significant role in getting a patient on a new therapy, especially if that therapy is classified as a specialty, orphan and ultra orphan drug. In some cases, the therapy may be a new class of medication, the first product available to treat a disease or a new pathway to administer the drug verses other drugs in that class or disease state. Or, the payer may have utilization barriers in place to manage the costs of the formulary such as prior authorization, appeals or step edits.. In each case, these scenarios can cause a delay in getting the drug added to the payer s formulary and ultimately cause a delay in treating the patient. Strategy: In cases like this, quick start programs or Rapid Therapy Initiation (RTI) can play a critical role in patient uptake and speed to therapy, especially for new drug launches. Patients are able to avoid delays in accessing therapy due to payer restrictions such as prior authorizations or appeals. Through an RTI program, a patient s prescription is forwarded to a noncommercial specialty pharmacy, where the patient will receive free drug for the first dosage. In many cases, this prescription fulfillment can be turned around in less than 48 hours from the time the patient or provider makes initial contact with the Hub. The manufacturer can then determine the length of time the patient will be treated through the RTI program (typically first dosage only). For the second dosage, the patient is converted to the commercial coverage. This ensures fast uptake and more effective care for the patient. CONTINUITY OF CARE PAP programs also serve to deliver continuity of care to patients. This could include patients who have recently lost a job and, therefore, lost insurance coverage or who are transitioning between insurance plans due to a job change or other event. If can also be a key role in retaining the large population of underinsured patients who cannot afford high out-of-pocket expenses. Strategy: Bridge programs are important to implement in order to address these situations and ensure continuity of care. In these cases, the manufacturer provides free drug during a specific timeframe, knowing that the patient will receive coverage at a future date. TRADITIONAL UNINSURED OR UNDERINSURED PATIENTS The third scenario in which a PAP or free drug program is implemented is the one for which patient assistance programs were initially intended to serve. While eligibility requirements vary among manufacturers, typically the patient must be a U.S. resident, have no private or public prescription coverage and must meet financial requirements (typically based on 200 percent of the Federal Poverty Level). Strategy: In the case of the uninsured, manufacturers can also take specific action steps to convert these patients to paid prescriptions, including: Quarterly, evaluate the patient s progress to see if the patient has insurance in place. Research low-cost coverage options for the patient and work with a foundation as needed to get coverage for the patient. Identify patients that qualify for Medicare Part D, and if the patient can t afford these premiums, provide financial assistance as needed. Educate and assist patients who may qualify for government or commercial health plans on the resources that are available to them and how to apply for this assistance.
>> PAP MANAGEMENT STRATEGIES TO ENSURE RETURN ON INVESTMENT While many manufacturers invest in PAP today, few are taking the extra steps to increase conversion, build brand value and drive return on investment. The following key steps are important to optimizing the value and reach of your PAP. 1. Set time limits. Most PAP programs provide assistance for one year. The patient must then re-enroll and re-qualify after this first year. Some manufacturers even offer two-year programs. No matter the length of your free drug assistance, determine a time limit and focus efforts on converting that patient to commercial or government coverage before that patient enrolls for renewal. 2. Budget your program based on the needs and demographics of your patient population. Traditionally, manufacturers have forecasted that an average of 10 to 15 percent of their population will meet the eligibility criteria required for PAP. The next step is to closely examine the patient population. How many of your patients are on Medicare? Are your patients on a fixed income? Does your therapy serve a youth population? Examine the demographics of your patient population to look for traits and trends, whether it s by economic status and geographic area. By examining the patient population, you can more closely estimate what should actually be invested into the PAP. 3. Build relationships with patient advocacy groups and church-affiliated organizations. Patient advocacy groups, church-affiliated organizations, specialty societies and foundations play an important role in funding both research and patient assistance. Through donations, these organizations can help patients with co-pay assistance, premium assistance and out-of-pocket expenses. Manufacturers have a responsibility to reach out to these organizations and build solid relationships. By doing so, manufacturers can recommend support services to patients, and these groups can ensure that the manufacturer is not providing free drug directly to patients. 4. Comply with regulatory guidelines. In managing a PAP, it s important to follow regulatory guidelines regarding distribution of the product. First, the patient must be on label, using the drug for the treatment for which it was intended. The manufacturer must be knowledgeable of the statemandated requirements for shipping into the state. They must also be aware of Federal guidelines in which they cannot distribute the free drug directly to patients. These must be provided through a third-party, such as a foundation. The drug must be provided with a patient-specific label, marked on the label as free drug, and may never be sold or charged. If the provider is dispensing the drug, then he or she must agree to not resell or bill for the product. All of these regulations serve as guardrails to prevent inducement. TRADITIONALLY, MANUFACTURERS HAVE FORECASTED THAT AN AVERAGE OF 10 TO 15 PERCENT OF THEIR POPULATION WILL MEET THE ELIGIBILITY CRITERIA REQUIRED FOR PAP.
WHILE MANY MANUFACTURERS INVEST IN PAP TODAY, FEW ARE TAKING THE EXTRA STEPS TO INCREASE CONVERSION, BUILD BRAND VALUE AND DRIVE RETURN ON INVESTMENT. 5. Build relationships with specialty pharmacies. Specialty pharmacies play an important role in getting free drug distributed to the patients in need. Whether or not the drug is mandated a REMS, it is important that the specialty pharmacy manage patient enrollment in order to track these patients, provide proof of eligibility and manage shipment of the product only when there is a prescription or renewal for the drug. This provides added control of the inventory and accounting reconciliation to ensures that no product waste is taking place. 6. Implement Compliance and Persistency programs. While Specialty pharmacies also play a critical role in adherence by educating the patient on how to properly take the drug, Compliance and Persistency programs can take patient engagement to the next level by providing personal outreach to patients at critical times in the treatment. Compliance and Persistency programs also play a critical role in ensuring patients receive positive guidance and encouragement and help patients to manage potential side effects, resulting in improved adherence. Field nurse support, through home visits, can also further secure patient adherence and ensure the patient stays on the free drug only as long as needed.. 7. Tie the success of your program to your brand. Often times, this patient assistance is not connected to the manufacturer of the product. The patient receives the product through a provider and the patient aligns the free product with the provider. Manufacturers can take a simple step in making sure their brand value is connected to the free drug contribution by providing a letter to the patient and the prescribing physician. In addition, provide a summary of the amount of free product given each month or each quarter to the physician and the payers. Sharing this information further aligns the brand to the recipient of the free drug.
>> METRICS OF ROI While these strategies help to manage and streamline these free drug programs, there are key metrics that also serve to represent the value of these programs to the organization s bottom line. Some of these key metrics include: Overall number of vials being sold compared to the dollars spent on copay and free drug Number of patients converted from RTI and/or Bridge programs to commercial or government assisted coverage These reports should be shared with payers to let them know the significant role the manufacturer is playing in this disease state. Metrics should also be shared with providers to let them know the difference the program has on the patient base. Finally, these numbers will prove the value of RTI programs and bridge programs, and the difference patient assistance makes in expanding the reach and effectiveness of the product. ABOUT THE AUTHOR Jan Nielsen provides the vision and direction for Sonexus Health s Access & Patient Support division. Beginning her career as a registered nurse, Nielsen has more than 20 years of experience in the healthcare arena providing innovation and leadership. She has developed and launched best-inclass patient adherence solutions both in the pharmaceutical and payer environments. Her inventive programs and technical solutions have demonstrated and delivered improved outcomes and measurable returns on investment. ABOUT SONEXUS HEALTH Delivering an exclusive model that fully integrates direct drug distribution to site-ofcare with non-commercial pharmacy services, patient access support, and financial programs, Sonexus Health helps specialty pharmaceutical manufacturers have a greater connection to the customer experience and better control of product success. Personalized service and creative solutions executed through a flexible technology platform means providers are more confident in prescribing drugs, patients can more quickly obtain and complete therapy, and manufacturers can directly access more actionable insight than ever before. With all services centralized in our custom-designed facility outside of Dallas, Texas, Sonexus Health helps manufacturers rethink how far their products can go. WWW.SONEXUSHEALTH.COM