Review of Key Provisions of FDA’s User Fee Reauthorization Bill

In the latest post on the IVI-sponsored Health Affairs featured blog series, Rachel Sachs addresses key provisions of the FDA's proposed user fee reauthorization bill. Included in her assessment are details of new language changes and amendments added to the bill, as well as a look forward to potential obstacles to the bill's final passage. Read [...]

2017-07-14T05:24:06-04:00May 15th, 2017|Viewpoints|

Hwang and Kesselheim Analyze the Impact of Taxing Drug Price Spikes

In a recent post on the IVI-sponsored Health Affairs featured blog series,Thomas Hwang and Aaron Kesselheim examine proposed new legislation taxing manufacturers of pharmaceuticals with medications exhibiting significant pricing spikes. Hwang and Kesselheim break down the criteria for the tax, and also offer some insight into potential policy implications. Read the full article here. About the Health [...]

2017-07-14T05:24:15-04:00May 12th, 2017|Viewpoints|

Lakdawalla and Balch Make the Case for Patient-Centered Assessment of Value

In a recent post on the IVI-sponsored Health Affairs featured blog series, IVI’s Darius Lakdawalla and Alan Balch stress the importance of incorporating the patient perspective into value assessments in healthcare, and of developing tools to help patients make value-based decisions in the marketplace. The Balch and Lakdawalla piece reflects IVI’s view that value in healthcare rests [...]

2017-07-14T05:24:44-04:00May 8th, 2017|Viewpoints|

Orphan Drugs, Pursuing Value, and Avoiding Unintended Effects of Regulations

In a recent post on the IVI-sponsored Health Affairs featured blog series, Joshua Liao and Mark Pauly examine the role of government regulation of orphan drugs in rising drug prices, providing some specific examples and how they relate to the provisions of the Orphan Drug Act. Liao and Pauly also present some potential solutions to the problem, including [...]

2017-07-14T05:24:58-04:00May 4th, 2017|Viewpoints|

Bateman-House, McBride-Folkers and Caplan Examine “Right to Try” Bill

In a recent post on the IVI-sponsored Health Affairs featured blog series, Alison Bateman-House, Kelly McBride-Folkers and Arthur Caplan discuss the Trickett Wendler Right to Try Act of 2017. The authors outline key obstacles likely to limit the effectiveness of the law and present some alternative measures for achieving access to experimental drugs for patients. Read [...]

2017-07-14T07:18:56-04:00May 3rd, 2017|Viewpoints|

FDA’s Scott Gottlieb and The Goldilocks Theory

In a recent post on the IVI-sponsored Health Affairs featured blog series, Ian Spatz outlines the challenges facing new FDA commissioner Scott Gottlieb. Among the challenges identified are the determination of new criteria for the control of medical information and the encouragement of competition to control drug costs. Read the full article here. About the Health Affairs/IVI Featured [...]

2017-07-14T05:25:13-04:00May 1st, 2017|Viewpoints|

Lakdawalla, Sachs, and Bagley Focus on Medicaid’s Best-Price Rule and Trump Administration Opportunity to Advance Value-Based Pricing

In a recent post on the IVI-sponsored Health Affairs featured blog series, IVI's Executive Director, Darius Lakdawalla, along with Rachel Sachs and Nicholas Bagley, examine how Medicaid's best-price rule complicates the development of value-based pricing and suggest a potential solution that could come out of the new Trump administration CMS policies. Read the full article here. About [...]

2017-07-14T05:25:23-04:00April 27th, 2017|Viewpoints|

A Win-Win Strategy for Improving Access to Hepatitis C Medicines

In a recent post on the IVI-sponsored Health Affairs blog series, Neeraj Sood, Gillian Buckley, and Brian Strom present a novel "win-win" scenario for improving patient access to Hepatitis C medicines. By arranging for pharmaceutical patent holders to license their patents to the federal government, the agreement could potentially provide curative treatment to nearly a half [...]

2017-07-14T07:19:45-04:00April 24th, 2017|Viewpoints|

Balancing the Use of Cost-Effectiveness Analysis in Healthcare Innovations

In a recent post on the IVI-sponsored Health Affairs featured blog series, Peter Neumann and James Baumgardner addresses cost effectiveness analysis as applied across different types of of healthcare interventions, and the disproportionate emphasis placed on pharmaceuticals relative to overall healthcare spending. Neumann and Baumgardner outline some reasons why surgical CEAs are more challenging that drug CEAs, [...]

2017-07-14T07:19:55-04:00April 14th, 2017|Viewpoints|

Unique Challenges of Assessing the Value of Treatments for Rare Diseases

In a recent post on the IVI-sponsored Health Affairs featured blog series, IVI's Executive Director, Darius Lakdawalla, and Anupam Jena recommend that creators of value frameworks recognize the unique issues associated with valuing treatments for rare diseases by adopting societal, as well payer-oriented perspectives. Included in this assessment are the important roles of treatment spillovers, societal preferences about health [...]

2017-07-14T07:20:06-04:00April 12th, 2017|Viewpoints|
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