Oral anticancer and supportive care agents administered to cancer patients are costly and are associated with large copayment requirements or are often not fully reimbursed by private health insurers or Medicare.1 To facilitate access to oral medications, pharmaceutical manufacturers have developed patient assistance programs (PAPs) that provide selected oral medications at no or reduced cost to financially eligible patients. Eligibility criteria, application processes, and program administration for PAPs differ by manufacturer and by product, which can ultimately present logistical barriers.2–4 A systematic review of PAPs found improvements in disease indicator outcomes for patients with common chronic diseases who access these programs.5 However, knowledge about the use of PAPs among cancer patients is limited.6
The University of Texas MD Anderson Cancer Center (MDACC), the largest tertiary care cancer center in the country, has developed a systematic approach to administering a large number of PAPs. In 1996, the MDACC established an institutional program staffed by hospital pharmacy personnel, who navigate cancer patients through PAPs in inpatient and outpatient settings. This program removes the operational and administrative barriers often experienced by patients in smaller clinical settings.
Cancer patients eligible for PAPs at MDACC include those who are uninsured, those who are underinsured, those whose pharmacy benefit limits have been reached, and those whose private health or government insurance has denied coverage of certain oral medications. For example, the Texas Medicaid program limits its low-income beneficiaries to three prescriptions per month, which may lead some of them, particularly those with cancer, to require additional medication assistance through PAPs. As of April 2008, this institutional program established formal relationships with 29 pharmaceutical companies that provide 104 therapeutic or supportive care agents through PAPs to eligible cancer patients in the MDACC outpatient pharmacy.
Methods
Data source
Approval for this study was obtained from the MDACC Institutional Review Board. We conducted a retrospective, secondary analysis of noninvestigational prescription medications from the outpatient pharmacy at MDACC. Data from July 1, 2006, to December 31, 2007, were extracted from computerized pharmacy, medical, and cancer registry databases at MDACC. Prescriptions had to include both patient medical record and social security numbers to validate the patient’s identity as well as the date of pickup to validate that the medication had been dispensed during the study period. When the date of pickup was missing but billing was documented, the date the medication was dispensed was used as the pickup date. All data were de-identified prior to analysis.
PAPs
Prescriptions for oral medications were available to financially eligible individuals via two types of PAPs at MDACC: individual enrollment (60 distinct medications) and bulk drug replacement (44 distinct medications). Individual enrollment required that an eligible patient apply directly to a pharmaceutical company’s PAP for the medication (s) needed. Once approved, the requested medication was mailed directly to the patient or dispensed in the MDACC pharmacy. Given the purpose of this study, we were only interested in those PAP prescription medications dispensed at the outpatient pharmacy.
Bulk replacement PAPs provide available prescription medications in bulk quantities on a monthly (in some cases quarterly) basis to MDACC’s pharmacy to replace medications dispensed to patients who were classified as “indigent” by MDACC-established criteria. Financially indigent patients included those who were Texas residents, uninsured or insured by Medicaid, and not responsible for charges billed to MDACC. All eligible patients could apply for the 60 medications available through individual PAP enrollment, but only indigent patients qualified for the 44 medications available through bulk drug replacement to MDACC.
Patient classifications
Prescription data were extracted from a pharmacy administrative dispensing database; a systematic process was developed to identify case patients (based on financial eligibility) and control patients (similar to case patients with respect to treatments received but were nonusers of PAP programs). Only patients who were potentially eligible for PAPs were included in the study. The case selection was based on MDACC’s determination of a patient’s ability to pay, referred to as credit rating, at the time of a patient’s registration at the institution. Regardless of health insurance status, patients who had a low credit rating (responsible for 0%– 50% of their charges) were classified as being potentially eligible for PAPs. Patients with low credit ratings also included those who were indigent. The control selection identified a set of insured patients, including those with high credit ratings (responsible for 100% of their charges), who had been referred for special financial assistance to obtain specific medications through PAPs.
To be included in the study, patients identified based on a low credit rating had to receive at least 1 of the 104 medications through a PAP to be classified as a PAP user; these patients could receive other medications through traditional payment. PAP nonusers had to receive at least 1 of the 104 medications associated with PAPs through traditional payment or other third-party source, not through a PAP. Patients who had been referred for special assistance had to receive one or more of the PAP medications initially requested from a PAP.