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Biomedical subjects

Adrian Towse

Publications and source records attributed to Adrian Towse.

12 recordsLinked to original sources
PubMed2005

Advance price or purchase commitments to create markets for treatments for diseases of poverty: lessons from three policies.

New drugs and vaccines are needed for tackling diseases of poverty in low- and middle-income countries. The lack of effective demand or market for these products translates into insufficient investment being made in research and development to meet the need for them. Many have advocated cost-reducing (push) and market-enhancing (pull) incentives to tackle this problem. Advance price or purchase commitments (APPCs) funded by international agencies and governments offer one way forward. This paper looks at design issues for APPCs for drugs and vaccines for diseases of poverty drawing on experience and lessons from three case studies: the introduction of the meningitis C vaccine in the United Kingdom; the Orphan Drug Act (ODA) in the United States of America (US); and the newly legislated US Project BioShield for bioterrorist interventions. Our key conclusion is that that APPCs have the potential to be a powerful tool and should be tried. The correct structure and design may only be determined through the process of taking action to set one up.

Bioterrorism↗
PubMed2004

Genetic screening, health care and the insurance industry. Should genetic information be made available to insurers?

The potential use of genetic tests in insurance has raised concerns about discrimination and individuals losing access to health care either because of refusals to test for treatable diseases, or because test-positives cannot afford premiums. Governments have so far largely sought to restrict the use of genetic information by insurance companies. To date the number of tests available with significant actuarial value is limited. However, this is likely to change, raising more clearly the question as to whether the social costs of adverse selection outweigh the social costs of individuals not accessing health care for fear of the consequences of test information being used in insurance markets. In this contribution we set out the policy context and model the potential trade-offs between the losses faced by insurers from adverse selection by insurees (which will increase premiums reducing consumer welfare) and the detrimental health effects that may result from persons refusing to undergo tests that could identify treatable health conditions. It argues that the optimal public policy on genetic testing should reflect overall societal benefit, taking account of these trade-offs. Based on our model, the factors that influence the outcome include: the size of and value attached to the health gains from treatment; deterrent effects of a disclosure requirement on testing for health reasons; incidence of the disease; propensity of test-positives to adverse select; policy value adverse selectors buy in a non-disclosure environment; and price elasticity of demand for insurance. Our illustrative model can be used as a benchmark for developing other scenarios or incorporating real data in order to address the impact of different policies on disclosure and requirement to test.

Genetic Privacy↗
PubMed2004

Influencing prescribing in English primary care: the views of primary care organisations.

OBJECTIVE: The rapid rise of prescribing expenditure is a concern in many industrialised countries and methods to manage medicines are widely employed. The purpose of this study was to identify the approaches to improve primary care prescribing by primary care organisations (PCOs) in the National Health Service (NHS) in England. METHODS: A questionnaire (Management of Medicines, MANMED) was mailed to prescribing advisers and prescribing leads in 332 PCOs. RESULTS: A response rate of 66% (220/332) was achieved. Most PCOs report the improvement of the quality of prescribing as their top priority, followed by budget adherence at both practice and PCO levels. Prescribing advisers typically offer several forms of support: practice visits, prescribing reviews, indicators of prescribing, prescribing newsletters, hands-on support, seminars and local formularies. PCOs are pursuing a wide range of prescribing initiatives, covering, on average, seven different therapeutic areas. National targets are the main driver for prescribing initiatives but other key influences include inappropriate prescribing and clinical governance. Although cost considerations are important, improving the quality of prescribing is perceived as the overriding principle on which PCO prescribing strategy is based. Multifaceted prescribing support is widespread and national targets are the largest single factor influencing choice of therapeutic area for prescribing initiatives. CONCLUSIONS: Diversity in approaches presents the opportunity to improve the evidence base for medicines management. Not only could such research inform PCOs in their central aim of improving the quality of prescribing within the NHS, but it may also offer insights of relevance to other countries if the influence of process and context upon the effectiveness of medicines management is systematically explored.

Budgets↗
PubMed2003

Differential pricing for pharmaceuticals: reconciling access, R&D and patents.

This paper reviews the economic case for patents and the potential for differential pricing to increase affordability of on-patent drugs in developing countries while preserving incentives for innovation. Differential pricing, based on Ramsey pricing principles, is the second best efficient way of paying for the global joint costs of pharmaceutical R&D. Assuming demand elasticities are related to income, it would also be consistent with standard norms of equity. To achieve appropriate and sustainable price differences will require either that higher-income countries forego trying to "import" low drug prices from low-income countries, through parallel trade and external referencing, or that such practices become less feasible. The most promising approach that would prevent both parallel trade and external referencing is for payers/purchasers on behalf of developing countries to negotiate contracts with companies that include confidential rebates. With confidential rebates, final transactions prices to purchasers can differ across markets while manufacturers sell to distributors at uniform prices, thus eliminating opportunities for parallel trade and external referencing. The option of compulsory licensing of patented products to generic manufacturers may be important if they truly have lower production costs or originators charge prices above marginal cost, despite market separation. However, given the risks inherent in compulsory licensing, it seems best to first try the approach of strengthening market separation, to enable originator firms to maintain differential pricing. With assured market separation, originators may offer prices comparable to the prices that a local generic firm would charge, which eliminates the need for compulsory licensing. Differential pricing could go a long way to improve LDC access to drugs that have a high income market. However, other subsidy mechanisms will be needed to promote R&D for drugs that have no high income market.

Developing Countries↗
PubMed2002

National Institute for Clinical Excellence (NICE): Is economic appraisal working?

This paper analyses the 32 technology appraisals completed by the National Institute for Clinical Excellence (NICE) in the UK from its establishment to the end of January 2002. It looks at why technologies have been rejected, what has happened to products reviewed at launch, evidence of rationing on cost-effectiveness grounds, and the issues raised for manufacturers and for NICE in the collection and analysis of economic data. It finds that around two-thirds of NICE appraisals have been of pharmaceuticals. Only two 'first in class' products have been reviewed at launch, with quite different results. There is clear evidence of the use of cost-effectiveness criteria to restrict or reject technologies, although these are not the only criteria used in decision making. While a number of concerns with the appraisal process raised by manufacturers have been addressed by NICE, and while the Department of Health is currently consulting on changes to the referral system whereby products are selected for review by NICE, manufacturers remain concerned about the timing of referrals in the product life cycle and about the quality and consistency of the reviews of evidence undertaken by academic groups for NICE. Concerns in the National Health Service centre on whether the right technologies are being referred to NICE and also on the opportunity cost of positive NICE recommendations. Given global budget constraints and the difficulty of withdrawing services, the NICE recommendations tend to preempt growth money that could be used for more cost-effective purposes. NICE should be asked to look at established technologies that may not be cost effective and whose discontinuance could therefore release resources for other more cost-effective treatments.

Academies and Institutes↗
PubMedDate not supplied

The economics of gene therapy and of pharmacogenetics.

This paper focuses on the economic issues arising from two uses of genomics: 1) the development of gene therapy; 2) and use of pharmacogenetics to identify a patient's genotype before treatment to exclude those who will not benefit or who may be harmed. We conclude that private-sector investment aimed at developing gene therapy for monogenic diseases is likely to be socially suboptimal. Short-term administration regimens yielding long-term therapeutic benefits are likely to meet payer resistance to large "one-off" costs because of budget constraints or, in competitive systems, concerns that the savings would accrue to future insurers or would attract high-cost patients. For some monogenic diseases, patient numbers may be too small to support commercial development without changes to orphan drug legislation or payer willingness to accept higher cost-effectiveness thresholds. In the case of pharmacogenetics, we conclude that it can often be socially optimal to test before treatment, particularly if the proportion of nonresponders is high, if there is a potential for serious adverse reactions, or if the test is inexpensive. Genetic testing that fragments the patient population could reduce incentives for R&D unless prices are adjusted to reflect the higher expected benefits of targeted treatment per patient. Even in situations where prices are adjusted, patient populations may be too small to make commercial development viable. This problem with small numbers is analogous to that associated with gene therapy for monogenic diseases and may require similar remedies if society values developing treatments for these diseases.

Antibodies, Monoclonal↗
PubMedDate not supplied

Variability of cost-effectiveness estimates for pharmaceuticals in Western Europe: lessons for inferring generalizability.

OBJECTIVES: It has long been suggested that, whereas the results of clinical studies of pharmaceuticals are generalizable from one jurisdiction to another, the results of economic evaluations are location dependent. There has been, however, little study of the causes of variation, whether differences in study results among countries are systematic, or whether they are important for decision making. METHODS: A literature search was conducted to identify economic evaluations of pharmaceuticals conducted in two or more European countries. The studies identified were then classified by methodological type and analyzed to assess their level of variability and to identify the main causes of variation. Assessments were also made of the extent to which differences in study results among countries were systematic and whether they would lead to a different decision, assuming a range of values of the threshold willingness-to-pay for a life-year or quality-adjusted life-year (QALY). RESULTS: In total 46 intercountry drug comparisons were identified, 29 in multicountry studies and 17 in comparable single country studies that were considered to be sufficiently similar in terms of methodology. The type of study (i.e., trial-based or modeling study) had some impact on variability, but the most important factor was the extent of variation across countries in effectiveness, resource use or unit costs, allowed by the researcher's chosen methodology. There were few systematic differences in study results among countries, so a decision maker in country B, on seeing a recent economic evaluation of a new drug in country A, would have little basis on which to predict whether the drug, if evaluated, would be more or less cost-effective in his or her country. Given the extent of variation in cost-effectiveness estimates among countries, the importance of this for decision making depends on decision makers' thresholds in willingness-to-pay for a QALY or life-year. If a cost-effectiveness threshold (i.e., willingness-to-pay) for a life-year or QALY of dollar 50,000 were assumed, the same conclusion regarding cost-effectiveness would be reached in most cases. CONCLUSION: This review shows that cost-effectiveness results for pharmaceuticals vary from country to country in Western Europe and that these variations are not systematic. In addition, constraints imposed by analysts may reduce apparent variability in the estimates. The lessons for inferring generalizability are not straightforward, although the implications of variation for decision making depend critically on the cost-effectiveness thresholds applying in Western Europe.

Clinical Trials as Topic↗
PubMedDate not supplied

The efficient use of pharmaceuticals: does Europe have any lessons for a Medicare drug benefit?

Managing drug use in a way that maximizes the value obtained from total health care spending faces obstacles; hence, payers and policymakers tend to look at pharmaceutical expenditures in isolation from the rest of health care spending. Currently there are both regulatory and putative market-based approaches to containing pharmaceutical spending worldwide. But evidence suggests that regulatory efforts in Europe and elsewhere have not proved effective in containing costs or improving efficiency or access, and supposedly market-based solutions now in vogue, such as reference pricing, pose their own set of challenges and may in practice violate market principles. In the end, silo-based budgeting is short-sighted; the emphasis in Europe and in the United States should be on measures that achieve efficient health care rather than the containment of drug spending.

Aged↗