Transparency of Industry-Sponsored Oncology Patient Financial Assistance Programs Using a Patient-Centered Approach.

OBJECTIVE: Pharmaceutical manufacturers sponsor drug-specific patient assistance programs that provide eligible patients with financial assistance, either in the form of providing the drug free of charge or copayment assistance. Describing these programs and determining who receives assistance is an important first step in understanding the impact and role of financial assistance in cancer care. Our objective was to describe eligibility criteria and benefits for cancer-specific, manufacturer-sponsored patient assistance programs. METHODS: We conducted a prospective review of patient assistance program Web sites and called patient assistance program telephone hotlines from the perspective of a patient or caregiver requesting program details. RESULTS: We identified 24 manufacturers with patient assistance programs, covering 87% of Food and Drug Administration-approved oncology drugs. For free drug programs, the average maximum annual income for qualification was $86,279. For copayment assistance programs, the average was $104,790. Thirty-five percent of free drug programs and 53% of copayment assistance programs declined to provide details on how financial need was determined. None of the programs shared details on patient usage statistics. CONCLUSION: Variation exists in the quality and quantity of data available to patients seeking financial assistance for cancer treatment via manufacturer Web sites and hotlines. Greater transparency among patient assistance programs would enhance utility for patients and help to determine the net impact on costs and adherence.

Variation in transcription factor binding among humans.

Differences in gene expression may play a major role in speciation and phenotypic diversity. We examined genome-wide differences in transcription factor (TF) binding in several humans and a single chimpanzee by using chromatin immunoprecipitation followed by sequencing. The binding sites of RNA polymerase II (PolII) and a key regulator of immune responses, nuclear factor kappaB (p65), were mapped in 10 lymphoblastoid cell lines, and 25 and 7.5% of the respective binding regions were found to differ between individuals. Binding differences were frequently associated with single-nucleotide polymorphisms and genomic structural variants, and these differences were often correlated with differences in gene expression, suggesting functional consequences of binding variation. Furthermore, comparing PolII binding between humans and chimpanzee suggests extensive divergence in TF binding. Our results indicate that many differences in individuals and species occur at the level of TF binding, and they provide insight into the genetic events responsible for these differences.