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.

Meaningful endpoints for therapies approved for hematologic malignancies.

BACKGROUND: Overall survival (OS) is considered the gold standard for determining treatment efficacy in oncology trials, but the relation between treatment and OS can be challenging to assess because of long study durations and the impact of subsequent therapies on outcome. Using OS can be particularly difficult for new therapies in hematologic malignancies (HMs). METHODS: This retrospective analysis was conducted to characterize the primary endpoints used to support US Food and Drug Administration (FDA) approvals for new drug or novel HM indications between January 2002 and July 2015. Data on approvals were retrieved from the FDA and CenterWatch websites, and from the FDA prescribing information on respective products at the time of approval. RESULTS: Sixty-three FDA approvals involving 35 drugs and 16 HMs were identified. Of the 63 approvals, 45 (71.4%) included response rate (RR), and 17 (27%) included progression-free survival (PFS; n = 14) or time to progression (n = 3), and 1 approval included OS. Twenty-three approvals (36.5%) included trials with an active comparator arm. The median relative magnitude of benefit versus comparator was 71% improvement (range, 26%-127%), with a median hazard ratio of 0.55 (range, 0.16-0.72). CONCLUSIONS: FDA approvals for new drug or novel HM indications are often based on endpoints other than OS, such as RR and PFS. Tools for determining the magnitude of clinical benefit and treatment value in HMs should take into account the importance of RR, PFS, and other non-OS endpoints. Cancer 2017;123:1689-1694. © 2017 American Cancer Society.

Experiences of People with Diabetes by Payer Type: An Analysis of the Roper Diabetes Data Set.

INTRODUCTION: The study details the experiences of Medicare, Medicaid and privately insured patients with diabetes in the United States by focusing on how these distinct populations perceive their disease and manage their treatment. METHODS: A national survey was fielded among a representative sample of 2,307 US adult diagnosed diabetes patients to investigate demographic, lifestyle, treatment, access to information, and socioeconomic status. This was achieved using a combination of telephone-based interviews and internet-based questionnaires administered via KnowledgePanel®, the only large-scale online panel based on a representative random sample of the US population. RESULTS: Patients with Medicaid-based insurance face significant differences in diagnosis, treatment and intensity of their diabetes as compared to their Medicare and privately insured counterparts. Medicaid patients develop diabetes at an earlier age with an increased level of severity, and face significant socioeconomic concerns. Medicaid patients also have different health information seeking preferences than their counterparts, impacted by technology use patterns and education preferences. All groups report challenges in paying for their diabetes care, though cost-sharing requirements are relatively low. CONCLUSIONS: Significant variation in experience between Medicaid, Medicare, and privately insured patients can inform disease management and patient engagement strategies. Payers, clinicians and public health agencies can leverage these findings to design initiatives more effectively and understand how intergroup variability impacts program uptake and disease outcomes.