Diabetes Outcomes: Comparison of Patient Assistance Programs to 340B Drug Pricing

Challen, Laura; Kelso, Christine; Pautler, Heather M.; Benanti, Grace

doi:10.1353/hpu.2016.0108

Cited by 2 publications

(10 citation statements)

References 7 publications

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“…Of the 44 included studies, all were observational studies, and none were experiments; 18 were single-site case studies, 38,39,41,42,45,46,[49][50][51]56,[59][60][61][62][63][70][71][72] 1 was a single-site observational study (comparing patients receiving 340B discounts with those on patient assistance programs [PAPs] for medication affordability), 47 17 were multisite descriptive studies, 40,43,44,[53][54][55]57,58,[64][65][66]68,73,74,76,77,79 1 study assessed the feasibility of a quasi-experimental identification strategy, 69 and 7 were quasi experiments. 30,31,48,52,67,75,78 We grouped the studies by suitability of study design for internal validity, as defined above.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…30,31,48,52,67,75,78 We grouped the studies by suitability of study design for internal validity, as defined above. Nineteen studies were least suitable, 38,39,41,42,[45][46][47][49][50][51]56,[59][60][61][62][63][70][71][72] with 16 case studies, [38][39][40][41]45,46,[49][50][51]56,59,60,63,[70][71][72] 2 case series, 42,62 and 1 single-site observational study. 47 Seventeen studies had moderate suitability, 40,43,44,[53][54]...…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Fifteen 340B studies had at least one outcome that related to care delivery, access, and implementing enhanced treatment modalities. 38,39,41,42,47,[49][50][51]53,56,62,63,[70][71][72] These studies did not have a common research question. Instead, they had a similar structure: They were (mostly) case studies (1 moderate suitability [multisite survey of HTCs], 14 least suitability) of hospitals or clinics that credited the 340B program as an enabling factor for enhancing service capacity in a way that would benefit low-income patients.…”

Section: Categorized Outcomes and Frequently Asked Research Questionsmentioning

confidence: 99%

“…Ten of these studies examined FQHCs, 38,39,41,42,49,50,56,62,71,72 of which two were in partnership with Indian Health Service clinics, 38,71 one was in partnership with a Ryan White clinic, 56 and another was in partnership with a local substance use disorder harm reduction organization. 72 Four focused on DSHs, 47,51,63,70 and one focused on HTCs. 53 Seven studies described the implementation of an improved pharmacy model.…”

Section: Categorized Outcomes and Frequently Asked Research Questionsmentioning

confidence: 99%

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Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer‐Reviewed Literature

LEVENGOOD,

CONTI,

CAHILL

et al. 2024

Milbank Quarterly

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Policy Points The 340B Drug Pricing Program accounts for roughly 1 out of every 100 dollars spent in the $4.3 trillion US health care industry. Decisions affecting the program will have wide‐ranging consequences throughout the US safety net. Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. The highest‐quality evidence indicates that nonprofit, disproportionate share hospitals may be using the 340B program in margin‐motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. ContextDespite remarkable growth and relevance of the 340B Drug Pricing Program to current health care practice and policy debate, academic literature examining 340B has lagged. The objectives of this scoping review were to summarize i) common research questions published about 340B, ii) what is empirically known about 340B and its implications, and iii) remaining knowledge gaps, all organized in a way that is informative to practitioners, researchers, and decision makers.MethodsWe conducted a scoping review of the peer‐reviewed, empirical 340B literature (database inception to March 2023). We categorized studies by suitability of their design for internal validity, type of covered entity studied, and motivation‐by‐scope category.FindingsThe final yield included 44 peer‐reviewed, empirical studies published between 2003 and 2023. We identified 15 frequently asked research questions in the literature, across 6 categories of inquiry—motivation (margin or mission) and scope (external, covered entity, and care delivery interface). Literature with greatest internal validity leaned toward evidence of margin‐motivated behavior at the external environment and covered entity levels, with inconsistent findings supporting mission‐motivated behavior at these levels; this was particularly the case among participating disproportionate share hospitals (DSHs). However, included case studies were unanimous in demonstrating positive effects of the 340B program for carrying out a provider's safety net mission.ConclusionsIn our scoping review of the 340B program, the highest‐quality evidence indicates nonprofit, DSHs may be using the 340B program in margin‐motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. Future studies should examine heterogeneity by covered entity types (i.e., hospitals vs. public health clinics), characteristics, and time period of 340B enrollment. Our findings provide additional context to current health policy discussion regarding the 340B program.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Categorized Outcomes and Frequently Asked Research Questionsmentioning

confidence: 99%

Section: Categorized Outcomes and Frequently Asked Research Questionsmentioning

confidence: 99%

See 2 more Smart Citations

Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer‐Reviewed Literature

LEVENGOOD,

CONTI,

CAHILL

et al. 2024

Milbank Quarterly

View full text Add to dashboard Cite

show abstract

“…34 For federally qualified health centers (FQHCs), the extra revenue from selling higher cost branded drugs when generics are available is less likely a windfall and more likely a substantial portion of the budget for these providers, which are statutorily required to provide care on a sliding scale based on a patient's ability to pay. 35 FQHCs reduce cost-related access barriers and provide culturally-competent care that is tailored to patient populations disproportionately burdened by HIV, including LGBTQ individuals. In January 2022, Gilead ended its practice or reimbursing 340B providers dispensing PrEP for patients on Gilead's Advancing Access patient assistance program at a usual and customary price.…”

Section: Role Of 340bmentioning

confidence: 99%

Opportunities and Challenges of Generic Pre-Exposure Prophylaxis Drugs for HIV

Ballreich¹,

Levengood²,

Conti³

2022

J. Law. Med. Ethics

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Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.

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Diabetes Outcomes: Comparison of Patient Assistance Programs to 340B Drug Pricing

Abstract: This study may serve as a platform for future research.

Cited by 2 publications

References 7 publications

Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer‐Reviewed Literature

Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer‐Reviewed Literature

Opportunities and Challenges of Generic Pre-Exposure Prophylaxis Drugs for HIV

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