Assessment of an In-Sourced Patient Assistance Program at a Health System in West Virginia

Abstract

Background: Lack of insurance coverage in conjunction with the high cost of prescription drugs plays a large role in patient’s obtaining and properly taking their medications. Many drug manufacturers provide assistance opportunities for indigent patients lacking the financial means to obtain the medication. It is hypothesized that providing a dedicated insourced team to coordinate this process can successfully increase medication access for indigent patient populations. Methods: Patients with little or no means for payment whom the patient assistance team was contacted to obtain a medication were included. Information collected included the medication requested, the drug manufacturer, the cost of the medication, the dose required, the number of doses approved, and whether the request was approved or denied. This data was analyzed for approval rate, most common medications requested, total cost of medications provided, as well as which system hospitals are utilizing the program most frequently. Results: In total, 153 patients were assessed to obtain medication assistance through the program. With an overall approval rate of 59.5%, 91 patients were provided medication through this program. 58% of patients received insurance approval and were therefore denied no-cost drug. The program was able to obtain 283 fills of no-cost medications for patients with a total value of $2 060 633.83. Conclusion: A dedicated patient assistance program is effective in obtaining financial assistance for patients to obtain high-cost medications for which they otherwise could not provide payment. With the continued expansion of biologic medication development, the necessity for programs to aid indigent populations increases exponentially.

Background

Healthcare costs, especially those associated with brand-name prescription medications, continue to rise exponentially year over year. ¹ These costs affect low-income patients at alarmingly higher rates than those patients of higher income status. ² Despite expansions to Medicaid access, large amounts of low-income Americans remain uninsured and therefore at risk of healthcare being cost-prohibitive. With more than a quarter-million individuals living in poverty as of 2019, West Virginia has the sixth highest poverty rate of any state within the United States. ³ West Virginians also hold the second lowest median household income in the United States. ³

Significant costs are associated with many new biologic and specialty agents utilized to treat malignancies and other specialized disease states. These medications often come with price tags upwards of $20 000 per dose and annual costs exceeding $100 000. In a state with a median household income of under $50 000, patients who do not qualify for government-funded insurance and do not have effective private insurance, cost substantially prohibits access to these medications.

Drug manufacturer sponsored patient assistance programs provide access to medications for uninsured or underinsured low-income patients. These programs may often be unknown to patients may also be difficult to navigate without guidance and assistance from a medical provider. Previously, at West Virginia University Hospitals a third-party company aided patients and providers in navigating these programs. Outsourcing this program came with an administrative fee billed to the institution in addition to a perceived limited scope of services. It was then hypothesized that providing this assistance locally could allow for program expansion and improved coordination of care through greater access within the electronic health record to patient information and provider communication.

Methods

One clinical pharmacy technician FTE, due to the background pharmacy experience and medication knowledge to allow for educated conversations with patients and providers during the enrollment process, was designated to launch our local patient assistance program. Initial training for this technician involved discussions with an external company and financial counselors within our local cancer center to determine the process for the program within our electronic health record. The team also met with health-systems familiar with the infrastructure necessary for maintaining a program such as this. Requests for medication assistance are initially routed through our local patient financial services and prior authorization teams who forward these requests along to our clinical pharmacy technician.

Patient and medication request information is gathered from the provider and patient or his/her representative and then entered into a third-party software containing the necessary documents required to apply for the manufacturer-sponsored programs. Much of this work may be completed for the patient while still admitted to the hospital during his/her initial diagnosis. Patient privacy is ensured through a business associate agreement (BAA), requiring maintained security of PHI and HIPAA compliance, entered annually with the third-party company. Patient consent is obtained at time of program application. Once the application is complete the manufacturer responds with either an approval or denial. Approval duration varies by manufacturer and medication but is generally 1 year from the time of initial approval, at which point the patient must be re-enrolled in the program. Delivery and medication administration is then coordinated on a recurring basis for doses delivered to the patient’s home or prior to each appointment for facility-administered medications. Further appeals may be conducted for any denials that may occur upon initial enrollment or re-enrollment if the patient’s situation or manufacturer’s requirements changed after the initial approval.

The primary aim of this analysis was to assess the rates of approval of medications requested through our insourced patient assistance program from January 1, 2020 through December 31, 2020. Secondary objectives include determining the value of medications provided to patients and assessing reason for denial. The analysis was a retrospective, IRB-approved analysis of patient data collected by our patient assistance program. Patients were included if the patient assistance program was contacted regarding obtaining a medication for that patient. Data collected included medication requested, dose requested, approved/denied, number of doses approved, and denial reason if applicable. Requests were then separated by each system hospital to determine program utilization throughout the WVU Medicine enterprise.

Results

Between January 1st, 2020 and December 31st, 2020, 153 patients requested medications through the patient assistance program. Of these 153 patients, 91 (59.5%) were approved and able to obtain a medication through the program. Of the 62 patients who were not approved for medication assistance through the program, 36 (58.1%) were rejected related to insurance coverage of the requested medications. The remaining 26 (16.9%) patients were not approved for no-cost medication for other reasons including, but not limited to, loss of follow up. These unapproved patients were often due to loss of follow up. Patients also may have not been approved if the medication was prescribed for an unapproved indication for which the manufacturer could not supply the medication.

For the 91 patients approved for medication through the program, there were 283 unique fills of medication (Table 2) providing a total patient savings of $2 060 633.83 (Table 1). Patients were referred from 6 different hospitals within our, then 18-member, health system. The majority, 81 (89%) patients, were referred from the flagship academic medical center. The most common (14%) no-cost medication obtained for patients was ocrelizumab (Ocrevus^®) followed by other high-cost monoclonal antibodies and immune globulin (Table 3).

Table 2.

Number of Patients Provided No-Cost Medication Through the Patient Assistance Program and the Number of Medication Fills Completed for the Patients During the First Full Year of the Program.

Hospital	Patients assisted	Prescriptions filled
Camden Clark Medical Center	4	12
Reynolds Memorial Hospital	2	5
St. Joseph’s Memorial Hospital	2	6
United Hospital Center	1	2
Wheeling Hospital	1	2
West Virginia University Hospitals	81	256
Grand total	91	283

Table 1.

Value of No-Cost Medication Obtained for Patients Through the Patient Assistance Program at Each System Hospital During the First Full Year of the Program.

Hospital	Dollars saved
Camden Clark Medical Center	$104 790.86
Reynolds Memorial Hospital	$18 247.54
St. Joseph’s Memorial Hospital	$56 958.90
United Hospital Center	$65 000.00
Wheeling Hospital	$65 000.00
West Virginia University Hospitals	$1 750 636.53
Grand total	$2 060 633.83

Table 3.

The 5 Medications Most Commonly Obtained for Patients Through the Patient Assistance Program During the First Full Year of the Program.

Medication	N (%)
Ocrelizumab (Ocrevus®)	25 (13.9)
Pembrolizumab (Keytruda®)	17 (9.4)
Immune Globulin (Privigen®)	12 (6.7)
Rituximab (Rituxan®)	11 (6.1)
Bevacizumab (Avastin®)	10 (5.6)

Discussion

Though not specifically targeted by the program, patients referred to and assisted by this program are commonly ordered medications for debilitating and life-threatening diseases such as multiple sclerosis and various malignancies. Many of these patients now have a limited ability to work as a result of their disease. Concerns regarding their ability to provide for their family, continue to pay their bills, and keep a roof over their head are only amplified by the fear of not being able to afford treatment for their disease. Our staff feel an overwhelming sense of purpose in assisting these patients who often express gratitude toward our clinical pharmacy technician who works tirelessly obtaining medications and financial assistance for them. The rewarding nature of assisting patients through this program was one of the key barriers to overcome when initially transitioning this program from its previous department to live within the pharmacy department.

With continued expansion of the health system into more disproportionately low-income, rural areas of West Virginia, there is a consistent increase in volume of patients with need for patient assistance programs to access medication therapy. This patient population represents a vulnerable group who frequently have high readmission rates. ⁴ By assisting these patients through provision of medication access, adherence to therapy may be improved, in turn, potentially reducing readmission rates.

Through calculation of an estimated per-bed savings based on data from the hospitals with patients assisted through the program, an additional estimated $1 M per year could be saved across the health system with the addition of new sites. Healthcare costs rising at rates higher than that of inflation may also lead to more patients requiring financial assistance to continue to afford their healthcare which may inflate this number even further. Additionally, through the continued expansion of biologic and other high-cost medication development, the necessity for a program such as this increases exponentially. Through the first half of 2021, 11 new medications with available patient assistance were added to the health system formulary.

Conclusions

Our in-sourced patient assistance program is effective in obtaining financial assistance for patients to obtain high-cost medications. Growth and expansion of the patient assistance team will be key to its continued. The program’s ability to provide these services to all patients in need throughout our health system hinges upon the resources we are able to allocate to handle requests promptly and efficiently. Programs such as ours have opportunity throughout the entire country but their greatest impact can be seen in poverty-stricken areas with large income disparities.

Further research should be done to determine any links between obtaining no-cost medications and readmission rates of patients as gathering clinical outcomes are not currently obtained by our team and determining these may be crucial to ensuring continued success and support for the program as it matures. Additionally, further analyzing treatment adherence rates for patients receiving no-cost medications compared to those who did not may prove beneficial. Finally, a link to treatment outcomes should also be researched. Results of these further studies could allow for additional support for implementation of programs such as these.