Expert review of pharmacoeconomics & outcomes research
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Expert Rev Pharmacoecon Outcomes Res · Jan 2016
ReviewSaving orphan drug legislations: misconceptions and clarifications.
Orphan-drug sales are rocketing, with revenue expected to total $176 billion annually by 2020. As a share of the industry, orphan drugs now account for close to 15% of all prescription revenue globally (excluding generics) and the sector is set to grow at more than twice the rate (10.5%) of the overall prescription market (4.3%). ⋯ With ever more such expensive drugs reaching the market, the situation is becoming unsustainable and putting the survival of the orphan drug legislation itself at risk. Here the authors consider why there has been an increase in orphan drug designations, how orphan drug prices are set and regulated, before discussing proposals for how changes which could save the legislation.
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Expert Rev Pharmacoecon Outcomes Res · Jan 2016
Prevention of treatment-related fluid overload reduces estimated effective cost of prothrombin complex concentrate in patients requiring rapid vitamin K antagonist reversal.
Fresh frozen plasma (FFP) is a frequently used human blood product to reverse the effects of vitamin K antagonists. While FFP is relatively economical, its large fluid volume can lead to hospitalization complications, therefore increasing the overall cost of use. ⋯ FFP is commonly used to acutely reverse the effects of vitamin K antagonists. However, its use requires significant time for infusion, may lead to fluid overload, and is not fully effective in compete anticoagulation reversal. One alternative therapy for anticoagulant reversal is use of prothrombin complex concentrates, which are rapidly infused, are not associated with fluid overload, and are effective in complete reversal of coagulation measurements. This should be considered for patients with acute bleeding emergencies.
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Expert Rev Pharmacoecon Outcomes Res · Jun 2015
The lag from FDA approval to published cost-utility evidence.
The lag between FDA approval and publication of cost-utility evidence can hamper payers from accounting for value for money in coverage and reimbursement decisions. We examine this gap, and whether it has changed over time. ⋯ Compared with drugs approved from 2000 to 2003, a greater proportion of those approved from 2004 to 2006, and from 2007 to 2010, was associated with a CUA published in the 3 years following approval (13 vs 25% [p = 0.06] and 13 vs 32% [p < 0.01], respectively). Study findings indicate that payers now have slightly more rapid access to published CUAs.
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Expert Rev Pharmacoecon Outcomes Res · Jun 2015
EditorialHow can we assess the value of complex medical innovations in practice?
Rapid proliferation of medical innovations in the face of demographic changes and scarce resources is demanding a value-conscious entry of medical innovations into health care systems. An inquiry into value gains significance during the early diffusion phase of an innovation and becomes indispensable as the complexity of an innovation increases. ⋯ Promises and practices represent real-world value as they account for both outcomes and costs in practice. A systematic exploration of these loci of value, using insights from constructive technology assessment, enables us to make well-informed decisions on complex medical technologies.