On "New Cardiovascular Drugs: Pattern of Use and Association with Non-Drug Health Expenditures".

Inquiry: a journal of medical care organization, provision and financing (Impact Factor: 0.55). 02/2006; 43(1):80-2; author reply 82-4. DOI: 10.5034/inquiryjrnl_43.1.80
Source: PubMed
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    ABSTRACT: Citing evidence from studies conducted by Frank Lichtenberg, some health policy advocates have argued that, on average, use of new prescription drugs reduces total health care costs. While recognizing that the cross-sectional research design cannot guard against many biases that could overstate the results, we replicated the original study results and examined the findings' sensitivity to different analytical approaches. Using the same data, we were able to replicate the original results; however, the original findings are not maintained under plausible alternative assumptions. More rigorous research on specific drugs and conditions is necessary before one can claim that newer drugs lower total health care costs.
    Full-text · Article · May 2007 · Health Affairs
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    ABSTRACT: On the surface it would seem that everyone - industry, patients and regulators - would be in favour of faster drug approvals. Approval times in developed countries vary significantly. One major cause of slow approval times is resource availability. In the face of government reluctance to increase funding to regulatory agencies through tax dollars, user fees (payments from industry) have been adopted in many countries. In the US, user fees were accompanied by a commitment to faster approvals, whereas in other countries there seems to have been a tacit agreement between industry and the regulator that approval times would become shorter. Information from the US, Australia and Canada shows that user fees have resulted in more rapid drug approvals and a greater percentage of new drug applications being approved. To the extent that new drugs improve health outcomes, patients have benefited, and there is some contested evidence that an increase in the use of new drugs leads to better health but the large majority of new drugs do not offer any significant therapeutic gains. At the same time as improving drug approval times, user fees have also resulted in the shunting of agency resources into the approval system and away from other regulatory functions, such as postmarketing surveillance. Furthermore, for the US Food and Drug Administration, the introduction of user fees also seems to have led to increased workloads for agency staff and lower staff moral. There is a major ongoing debate about whether or not faster approvals subsequently lead to more drug withdrawals for safety reasons. There is a body of evidence that seems to indicate that this is not the case but other metrics, such as the fate of drugs that are approved just prior to legislated deadlines, show higher rates of withdrawals for this group of drugs. Finally, many prominent doctors and academics believe that user fees have fundamentally changed the relationship between regulators, the public and industry, and there are calls in the US for the abolition of user fees.
    No preview · Article · Dec 2007 · Pharmaceutical Medicine
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    ABSTRACT: This study examines the effect of changes in the vintage distribution of cardiovascular system drugs on hospitalization and mortality due to cardiovascular disease using longitudinal country-level data. The vintage of a drug is the first year in which it was marketed anywhere in the world. We use annual data on the utilization of over 1100 cardiovascular drugs (active ingredients) in 20 OECD countries during the period 1995–2003. Countries with larger increases in the share of cardiovascular drug doses that contained post-1995 ingredients had smaller increases in the cardiovascular disease hospital discharge rate, controlling for the quantity of cardiovascular medications consumed per person, the use of other medical innovations (computed tomography scanners and magnetic resonance imaging units), potential risk factors (average consumption of calories, tobacco, and alcohol), and demographic variables (population size and age structure, income, and educational attainment). The estimates also indicate that the use of newer cardiovascular drugs has reduced the average length of stay and the age-adjusted cardiovascular mortality rate, but not the number of potential years of life lost due to cardiovascular disease before age 70 per 100 000 population. The estimates indicate that if drug vintage had not increased during 1995–2004, hospitalization and mortality would have been higher in 2004. We estimate that per capita expenditure on cardiovascular hospital stays would have been 70% ($89) higher in 2004 had drug vintage not increased during 1995–2004. Per capita expenditure on cardiovascular drugs would have been lower in 2004 had drug vintage not increased during 1995–2004. However, our estimate of the increase in expenditure on cardiovascular hospital stays is about 3.7 times as large as our estimate of the reduction in per capita expenditure for cardiovascular drugs that would have occurred ($24). Copyright
    Full-text · Article · May 2009 · Health Economics
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