Abstract:
:The cost of the development of a new drug product, from concept and synthesis of a new chemical entity to safety and efficacy testing, to the approval process and postmarketing surveillance, has more than quadrupled in the last 20 years. To amortise these costs, the pharmaceutical industry has taken on international dimensions. These efforts will not be enough. This review outlines many cost-saving and cost-containment suggestions that have been instituted or that need to be instituted in order to bring cost-effective drug therapy to individual patients. As the cost of illness continues to increase worldwide, it is imperative that new and cost-effective medications be developed and brought to worldwide markets. This article considers components of the drug discovery and development processes which are likely to be inefficient and correctable. It further reviews current knowledge about the conduct of different parts of the processes, including different types of clinical trials and proposals that have been made to address these in an efficient manner. Documented and proposed cost-containment measures are presented, using several large scale trials as examples. Particular emphasis is placed on statistical methods and their contribution to either efficiencies or inefficiencies. No facet of the drug/product development should be overlooked in the attempt to reduce costs, from reducing the time it takes to bring a product to market to simple but too-frequently occurring errors, such as failing to have trial material at hand at the optimum time.
journal_name
Pharmacoeconomicsjournal_title
PharmacoEconomicsauthors
Kitler MEdoi
10.2165/00019053-199202050-00005subject
Has Abstractpub_date
1992-11-01 00:00:00pages
371-87issue
5eissn
1170-7690issn
1179-2027journal_volume
2pub_type
杂志文章,评审abstract::The recent licensing of interferon-beta for use in patients with multiple sclerosis has caused concern, in view of the equivocal evidence of efficacy, pressure of public expectation towards its use and the high expected cost if widespread use were to be sanctioned. Whether such alarm is justified remains a moot point....
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199711030-00002
更新日期:1997-03-01 00:00:00
abstract:OBJECTIVE:Cost is an issue when prescribing two drugs with equivalent efficacy. We compared the direct medical costs of topical brinzolamide 1% (twice a day or three times daily) with topical dorzolamide 2% (twice a day or three times daily) in France, Italy, Portugal and Spain in patients with ocular hypertension or p...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.2165/00019053-200321030-00005
更新日期:2003-01-01 00:00:00
abstract::Pharmacoeconomic data may be obtained within the context of randomised clinical trials (RCTs) and from effectiveness studies in the 'real world'. The differences between the 2 types of study design have implications for the types of data that can be obtained and the interpretation of the resulting findings. Because RC...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199915050-00001
更新日期:1999-05-01 00:00:00
abstract::Direct administration of a drug into a vein guarantees bioavailability, i.e. the total amount of drug is fully available to the bloodstream for transport to all areas of the body. What is not ensured is the safety, need and 'value for money' of this route. Few workers would disagree that there is increased morbidity...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199201020-00007
更新日期:1992-02-01 00:00:00
abstract:BACKGROUND:Health-related quality of life (HRQoL) is a key outcome in cost-utility analyses, which are commonly used to inform healthcare decisions. Different instruments exist to evaluate HRQoL, however while some jurisdictions have a preferred system, no gold standard exists. Standard meta-analysis struggles with the...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-019-00843-z
更新日期:2020-01-01 00:00:00
abstract::Rheumatoid arthritis (RA) is a chronic, generally progressive autoimmune disease that causes functional disability, significant pain and joint destruction, and leads to premature mortality. It is estimated to affect between 0.5 and 1.0% of the adult population worldwide, increases in prevalence with age and affects mo...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200422001-00002
更新日期:2004-01-01 00:00:00
abstract::The regulation of pricing and trade for in-patent medicines within the European pharmaceutical sector presents a major challenge. In conditions of large sunk costs and consumers with differential willingness to pay--between different Member States--an efficient way of pricing in-patent medicines is through price discr...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200018001-00008
更新日期:2000-01-01 00:00:00
abstract::Lung cancer remains the leading cause of cancer-related death and economic burden worldwide. Despite the heavy toll of lung cancer, multiple new advances have improved patient outcomes, largely through precision medicine and targeted therapy. The associated rising economic burden however may impact the uptake of novel...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-017-0563-8
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:The recently completed ALEX trial demonstrated that alectinib improved progression-free survival, and delayed time to central nervous system progression compared with crizotinib in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer. However, the long-term clinical and economic impac...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0625-6
更新日期:2018-04-01 00:00:00
abstract::Since the inception of the National Health Service in 1948, successive British governments have taken various measures to restrain the growth of the medicines bill. A total of 10 different measures have been introduced with very limited success. The most effective measures have been those directed at increasing the le...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199610030-00003
更新日期:1996-09-01 00:00:00
abstract:OBJECTIVE:To estimate savings in the cost of caring for patients with Alzheimer's disease (AD) during 6 months, 1 year and 2 years of treatment with rivastigmine. An intermediate objective was to estimate the relationship between disease progression and institutionalisation. DESIGN AND SETTING:We assessed the relation...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200017040-00005
更新日期:2000-04-01 00:00:00
abstract::Deterministic sensitivity analyses (DSA) remain important to interpret the effect of uncertainties in individual parameters on results of cost-effectiveness analyses. Classic DSA methodologies may lead to wrong conclusions due to a lack of or misleading information regarding marginal effects, non-linearity, likelihood...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00979-3
更新日期:2021-01-01 00:00:00
abstract::This article explores the need to perform pharmacoeconomic evaluations of herbal medicines and assesses the extent to which this approach has been applied so far to these products. There seems to be no compelling need for pharmacoeconomic analyses of herbal over-the-counter medicines, but such analyses are certainly w...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200018010-00001
更新日期:2000-07-01 00:00:00
abstract::The current US drug innovation financing framework rests on the notion that a defined period of marketing exclusivity combined with the expectation of reimbursement for clinically valuable, cost-effective therapies, followed by vigorous price competition from generic drugs and biosimilars ensures a sufficient return o...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00926-2
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Pharmacogenetics offers the potential to improve health outcomes by identifying individuals who are at greater risk of harm from certain medicines. Routine adoption of pharmacogenetic tests requires evidence of their cost effectiveness. OBJECTIVE:The present review aims to systematically review published ec...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-016-0397-9
更新日期:2016-08-01 00:00:00
abstract::The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the conti...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00927-1
更新日期:2020-10-01 00:00:00
abstract:OBJECTIVES:Patients with chronic kidney disease (CKD) are commonly treated with renin-angiotensin-aldosterone system inhibitors (RAASi) in order to delay progression of renal disease. However, research has shown that RAASi in CKD patients increases hyperkalaemia (HK) prevalence, which leads to RAASi discontinuation or ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00902-w
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:Probabilistic sensitivity analysis (PSA) in cost-effectiveness analysis involves sampling a large number of realisations of an economic model. For some parameters, we may be uncertain around the true mean values of the variables, but the ordering of the values is known. Typical sampling approaches lack eithe...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-017-0584-3
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:In many healthcare systems, affordability concerns can lead to restrictions on the use of expensive efficacious therapies. However, there does not appear to be any consensus as to the terminology used to describe affordability, or the thresholds used to determine whether new drugs are affordable. OBJECTIVES...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-017-0514-4
更新日期:2017-08-01 00:00:00
abstract::There is growing interest in using observational data to assess the safety, effectiveness, and cost effectiveness of medical technologies, but operational, technical, and methodological challenges limit its more widespread use. Common data models and federated data networks offer a potential solution to many of these ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00981-9
更新日期:2020-12-18 00:00:00
abstract::In an effort to control escalating health expenditures, especially in hospitals, many countries are planning or experimenting with prospective budgeting systems. Belgium is no exception and has recently introduced, with some success, limited fixed charges per hospital admission and/or per hospitalisation day for labor...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199609030-00006
更新日期:1996-03-01 00:00:00
abstract::The objective of this study was to demonstrate the cost effectiveness of long term maintenance treatment with citalopram versus standard therapy (defined as short term antidepressant treatment) in patients with major depression in Germany. We chose doxepin, amitriptyline and trimipramine as standard therapy because th...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199508020-00007
更新日期:1995-08-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to evaluate the cost effectiveness of no prophylaxis, primary prophylaxis (PP), or secondary prophylaxis (SP) with granulocyte colony-stimulating factors (G-CSFs), i.e., pegfilgrastim, lipegfilgrastim, filgrastim (6- and 11-day), or lenograstim (6- and 11-day), to reduce the in...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-016-0474-0
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND:Heart failure (HF) is a well-recognized public health concern and imposes high economic and societal costs. Decision analytic models exist for evaluating the economic ramifications associated with HF. Despite this, studies that appraise these modelling approaches for augmenting best-practice decisions remain...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0755-x
更新日期:2019-03-01 00:00:00
abstract::Vaccination is an underutilised, low cost and effective method of preventing illness. Cost-effectiveness analysis discloses a beneficial role of influenza vaccination in preventing illness especially in patients over 65 years of age and in high risk patients. In one large study, when 150 million doses of influenza v...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199202030-00003
更新日期:1992-09-01 00:00:00
abstract::Pneumocystis carinii pneumonia (PCP) is the most common severe opportunistic infection, and one of the most costly, among people with AIDS. Over 50% of patients experience toxic effects of the major anti-PCP medications- cotrimoxazole (trimethoprim-sulfamethoxazole) and pentamidine. Recently, the US Food and Drug Admi...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章
doi:10.2165/00019053-199609060-00007
更新日期:1996-06-01 00:00:00
abstract:OBJECTIVE:Pertussis is a highly contagious infection affecting mainly children. Acellular pertussis vaccines were recently introduced in Canada based on evidence of improved safety and efficacy over whole cell vaccines, the current standard of care. The following study reports the economic impact of replacing the whole...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200119050-00009
更新日期:2001-01-01 00:00:00
abstract::We estimated the cost effectiveness of adding the ACE inhibitor ramipril to conventional treatment in patients with heart failure after acute myocardial infarction. These estimates were based on the Acute Infarction Ramipril Efficacy (AIRE) study and on complementary Swedish healthcare resource use data for a subset o...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章
doi:10.2165/00019053-199712020-00016
更新日期:1997-08-01 00:00:00
abstract::The National Institute for Health and Care Excellence (NICE) is only one of several organisations internationally that uses economic evaluation as part of decision making regarding funding and pricing of new medical technologies. However, it can be argued that NICE has developed a more prominent international profile ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-019-00882-6
更新日期:2020-03-01 00:00:00
abstract:AIM:To determine the economic impact (cost-benefit analysis) of childhood varicella vaccination, with the Oka/Merck varicella zoster virus vaccine live (Varivax) in Italy. METHODS:This analysis is based on an epidemiological model of varicella zoster virus (VZV) dynamics adapted to the Italian situation. Cost data (Eu...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200422130-00003
更新日期:2004-01-01 00:00:00