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4 Strategies to Improve Affordability and Availability
Pages 125-134

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From page 125...
... Nevertheless, many aspects of how drugs are developed and delivered to the public today have made it more difficult to achieve that goal and threaten to dampen the promise of the field. In developing policy solutions to the challenges in the biopharmaceutical supply chain, high priority should be place on optimizing the health and well-being of the people -- including relief from the burden of unaffordable medical bills.
From page 126...
... This sole conclusion is intended to refocus and refresh the priorities of the entire biopharmaceutical sector as well as to serve as the basis for the following eight recommendations and the implementing actions that accompany each. RECOMMENDATIONS As is often the case in providing policy guidance on complicated matters, each recommendation is invariably accompanied by counterarguments.
From page 127...
... Department of Health and Human Services, related federal agencies, and asso 2  Supporting findings for Recommendation B include 2-8, 2-9, 2-11, and 2-12. 3  Alan Weil dissents from Recommendation B-1.
From page 128...
... The U.S. Department of Health and Human Services should require biopharmaceutical companies to submit an annual public report stating list prices; rebates and discounts to payers, including changes thereto; and the average net price of each drug sold in the United States.
From page 129...
... The U.S. Congress should direct the Centers for Medicare & Medicaid Services to modify the designs of plans offered through Medicare Part D and governmental health insurance exchanges to limit patients' out-of-pocket payments for drugs when there is clear evidence that treatment adherence for a particular indica 5  Supporting findings for Recommendation D include 3-12 and 3-13.
From page 130...
... Department of Health and Human Services to provide increased oversight and regulation of the 340B program to assure that participation by covered entities, contract pharmacies, and drug manufacturers is consistent with the intent of the original legislation. Oversight should include systematic collection and assessment of data from qualified medical providers and par ticipating drug manufacturers regarding the volume of drug purchases eligible for 340B discounts, revenues generated from 340B program participation, and safety-net services funded by these revenues.
From page 131...
... • Ensuring that drugs with orphan designation receive program  benefits under the act only for the target rare disease, not for ancillary non-orphan indications. • Eliminating unnecessary sub-classifications of disease catego  ries that create artificial eligibility for orphan drug status, and limiting eligibility to only one orphan condition per drug.
From page 132...
... Devoting such a large share of the nation's fiscal resources to this one particular human need limits investments in other national priorities, from education to infrastructure to the environment, thus affecting international competitiveness, jobs, quality of life, and standard of living. The biopharmaceutical sector is critically important to public health, social equity, economic development, and, in some circumstances, the national security of the United States.
From page 133...
... As a major public health issue, the effects of the unaffordability of prescription drugs to people in the United States are very clear: they ultimately harm the health of individuals, sometimes even resulting in death. If the actions recommended in this report are implemented, it should be possible to achieve a significantly improved system for making drug therapies affordable to patients.


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