Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective.

To air challenging issues related to patient and market access to new anticancer agents, the Biotherapy Development Association--an international group focused on developing targeted cancer therapies using biological agents--convened a meeting on 29 November 2007 in Brussels, Belgium. The meeting provided a forum for representatives of pharmaceutical companies and academia to interact with European regulatory and postregulatory agencies. The goal was to increase all parties' understanding of their counterparts' roles in the development, licensure, and appraisal of new agents for cancer treatment, events guided by an understanding that cancer patients should have rapid and equitable access to life-prolonging treatments. Among the outcomes of the meeting were a greater understanding of the barriers facing drug developers in an evolving postregulatory world, clarity about what regulatory and postregulatory bodies expect to see in dossiers of new anticancer agents as they contemplate licensure and reimbursement, and several sets of recommendations to optimize patients' access to innovative, safe, effective, and fairly priced cancer treatments.

Cost of skin cancer in England.

This paper estimates the financial cost of skin cancer in England. National Health Service (NHS) costs were calculated by combining published data on health service use by patients with skin cancer with published data on the unit cost of services. Indirect costs arising from individuals' inability to function in their usual role as a result of skin cancer were estimated from incapacity benefit claims and numbers of registered deaths due to skin cancer. The total costs of skin cancer were around pound240 million. Costs to the NHS represented 42% of the total.

Cost implications of using an atraumatic dressing in the treatment of acute wounds.

Three randomised controlled trials have compared a soft silicone dressing with traditional treatment on acute wounds. This analysis shows the former reduced overall costs by accelerating healing and reducing wound pain and resource use.

Assessing the relative costs of standard open surgery and laparoscopic surgery in colorectal cancer in a randomised controlled trial in the United Kingdom.

The role of laparoscopic surgery for the treatment of colorectal cancer is being explored in a multi-centre, randomised clinical trial in the UK, the MRC CLASICC Trial (Conventional versus Laparoscopic-assisted Surgery in Colorectal Cancer). An important end-point of the trial is the cost-effectiveness of laparoscopic surgery compared with that of conventional open surgery. The economic evaluation of this trial has been modelled on that in a similar trial being conducted in the USA in colon cancer. The aim of this paper is to discuss the rationale for modelling the UK trial on the US trial, and to describe the adaptations necessary for the UK trial. The parallel design of the economic evaluation in both trials will provide a unique opportunity to compare the cost implications of incorporating laparoscopic surgery in the UK and the USA, and to determine any cross-cultural differences. The UK trial will also provide information about the cost-effectiveness of laparoscopic surgery in rectal cancer.

The budgetary impact of 5-HT3 receptor antagonists in the management of chemotherapy-induced emesis.

The study examined the budgetary implications of using 5-hydroxytryptamine3 receptor antagonists (5-HT3RA), granisetron or ondansetron, in the management of chemotherapy-induced emesis (CIE). A treatment model was constructed to represent a baseline of efficacy and costs for treating a cohort of patients with conventional antiemetics. Groups of patients who would be expected to receive the most benefit from 5-HT3RA were then identified and the effect upon costs of using these compounds in a consecutively larger proportion of selected patients was calculated. On the basis of illustrative costs from The Cookridge Hospital in the UK, it was concluded that the new antiemetics can be used in acute emesis with substantial clinical benefit for an increase of 3-10% to total treatment costs. However, for delayed emesis these compounds have not yet shown a clinical advantage, and the increase in total costs of 12-34% is not justified.

Economic value of gemcitabine in non-small cell lung cancer.

Although cost considerations traditionally have not been important in cancer treatment decision making, there is increasing concern worldwide about the economic impact of therapeutic alternatives in the field of oncology. In particular, there is greater pressure for pharmaceutical companies to assess the economic value of new products. We have investigated and compared the clinical outcomes and corresponding cost savings of a novel nucleoside analog, gemcitabine, with other chemotherapy options in three different health care settings: Germany, the United States, and Spain. To date, most of the work with gemcitabine has been done in non-small cell lung cancer. Most non-small cell lung cancer patients present with advanced disease that is unsuitable for surgery and, in many cases, unsuitable for potentially curative chemotherapy. Chemotherapy for the majority of patients is therefore administered with palliative intent. For this reason, the comparative agents chosen for the economic models were palliative treatments (cisplatin/etoposide and ifosfamide/etoposide). As is customary with oncolytics, gemcitabine was investigated first as a single agent in noncomparative trials. Since data were not available from a comparator trial, we estimated comparative data from the literature sources and expert opinion (German and Spanish cost models) and from retrospective chart reviews (US cost model). In all three models, the efficacy was assumed to be equal, so a cost-minimization approach was used. Gemcitabine monotherapy showed cost savings compared with both cisplatin/etoposide and ifosfamide/etoposide in all treatment settings. The majority of these savings were due to differences in hospitalization for drug administration, and the incidence and treatment of nausea and vomiting and febrile neutropenia.

Lymphoedema: an underestimated health problem.

BACKGROUND: Lymphoedema/chronic oedema is an important cause of morbidity in the population, but little is known of its epidemiology and impact on patients or health services. AIM: To determine the magnitude of the problem of chronic oedema in the community, and the likely impact of oedema on use of health resources, employment and patient's quality of life. DESIGN: Questionnaire-based survey. METHODS: Health professionals from dedicated lymphoedema services, specific out-patient clinics, hospital wards and community services (GP clinics and district nurses) were contacted to provide information on patients from within South West London Community Trust. A subset of the identified patients was interviewed. RESULTS: Within the catchment area, 823 patients had chronic oedema (crude prevalence 1.33/1000). Prevalence increased with age (5.4/1000 in those aged > 65 years), and was higher in women (2.15 vs. 0.47/1000). Only 529 (64%) were receiving treatment, despite two specialist lymphoedema clinics within the catchment area. Of 228 patients interviewed, 78% had oedema lasting > 1 year. Over the previous year, 64/218 (29%) had had an acute infection in the affected area, 17/64 (27%) being admitted for intravenous antibiotics. Mean length of stay for this condition was 12 days, estimated mean cost pound 2300. Oedema caused time off work in > 80%, and affected employment status in 9%. Quality of life was below normal, with 50% experiencing pain or discomfort from their oedema. DISCUSSION: Chronic oedema is a common problem in the community with at least 100 000 patients suffering in the UK alone, a problem poorly recognized by health professionals. Lymphoedema arising for reasons other than cancer treatment is much more prevalent than generally perceived, yet resources for treatment are mainly cancer-based, leading to inequalities of care.

Venous ulcer healing: effect of socioeconomic factors in London.

OBJECTIVE: To determine which social and clinical factors are associated with healing in patients with venous ulceration. DESIGN: Patients were questioned about social factors at their first visit to a community ulcer clinic. They were treated by high compression bandage system and were interviewed again after 12 weeks. SETTING: Community leg ulcer clinics held in health centres throughout Riverside Health Authority in London. PATIENTS: All patients referred to five community leg ulcer clinics with venous ulceration over a six month period. MAIN OUTCOME MEASURES: These were factors significantly associated with healing within 12 weeks of beginning treatment, measured by odds ratio (OR) given by logistic regression analysis. MAIN RESULTS: Of 168 patients with venous ulceration, 87 (52%) healed after 12 weeks of treatment. Univariate analysis showed that low social class (OR = 3.44, 95% CI 1.17, 10.14), lack of central heating (OR = 2.22, 95% CI 1.18, 4.18), and being single (OR = 2.77, 95% CI 1.15, 6.69) were all significantly associated with delayed healing. After adjustment for the known risk factors of ulcer size, ulcer duration, and general mobility only lack of central heating was still significant (OR = 2.27, 95% CI 1.11, 4.55). The remaining factors failing to achieve statistical significance because of their inter-relationship with the known risk factors. CONCLUSIONS: Clinical features of the ulcer seem to determine the progress of healing in patients with leg ulceration. Although there were associations between socio-economic factors and poor healing, adjustment for clinical risk factors generally led to lower non-significant associations. Only lack of central heating retained its association and may play a part in prolonging healing of venous ulceration.

Tax harmonization and the reduction of European smoking rates.

Amidst growing optimism that smoking in Europe can be greatly reduced by the year 2000, this paper simulates the possible impacts of European tax harmonization in the context of rising incomes. A range of price and income elasticities are chosen from econometric studies which use micro information. This is justified by the aggregation problems associated with studies in the smoking literature which use aggregate data. Using micro elasticities, the simulations reported in this paper show that the aims of fiscal harmonization are at variance with the aims of health promotion.

The epidemic of Alzheimer's disease. How can we manage the costs?

Alzheimer's disease is one of several diseases of the elderly that has recently come into prominence for a number of reasons. First, its prevalence is set to increase as a result of the aging of Western populations. Secondly, the use of institutional care has fallen as a result of major policy changes in many countries, and this has caused a shift in the pattern of care for the elderly. Finally, the advent of innovative pharmacotherapy has caused third-party payers and clinicians to question the way in which this disease is best managed. International epidemiological data for Western populations point to a potentially considerable increase in the prevalence of the disease over the next 2 decades. Although the cost estimates of the disease vary widely among, or indeed, within different Western countries, they may be considerable. It is clear that innovative strategies, e.g. the use of respite care, sheltered housing and pharmacotherapy, might serve to limit the amount of time patients spend in institutional care. Even a small reduction in this form of care might be sufficient to offset the costs of treatment. What is lacking today are clear demonstrations as to how these new strategies might contribute to the overall management of this complex and multifactorial disease: this should be the joint focus of care providers and the pharmaceutical industry in the near future.

Changes in general practice organization: survey of general practitioners' views on the 1990 contract and fundholding.

BACKGROUND: General practitioners' views on two major changes in the organization of general practice--the 1990 contract for general practitioners and fundholding, introduced in 1991--have not been researched in any great detail. AIM: A study in 1993 sought to investigate the views of general practitioners from group practices and of single-handed general practitioners, in family health services authority areas with different socioeconomic characteristics, on the 1990 contract for general practitioners, fundholding and the effects of these two changes in general practice organization. METHOD: One general practitioner partner from each of 323 group practices in six family health services authority areas of England was invited for interview and 142 single-handed general practitioners in the study areas were sent a postal questionnaire. The interview and questionnaire sought general practitioners' views on the 1990 contract and fundholding, reasons for their opinions, and views on the effects of these reforms on workload and the quality of service. Other information was recorded on fundholding status, workload pressures, outreach clinics, budget surpluses, retirement plans, and opinions on a salaried service. RESULTS: A total of 260 group practice general practitioners (80%) participated in the study and 80 single-handed general practitioners (56%) returned questionnaires, 78 of which could be analysed. Over half of all respondents were opposed or strongly opposed to both the 1990 contract and fundholding. However, despite this opposition, a sizeable minority of group practice practitioners (38%) agreed that the quality of services provided had improved or considerably improved since the 1990 contract. Workload appeared to have increased, with the proportion of respondents who reported being always under pressure increasing from 12% in 1987 to 41% in 1993. All but one respondent considered administration to have increased. Some respondents were considering early retirement. One of the solutions proposed to alleviate problems in inner city general practice, a salaried service, received little support, even from those general practitioners working in areas which might be expected to benefit. CONCLUSION: Dissatisfaction of general practitioners with the National Health Service reforms was expressed in continued opposition, in concerns about workload and levels of administration, and in a desire to retire early. Suitable ways of improving general practitioner morale must be sought.

The implementation of evidence-based medicine in general practice prescribing.

BACKGROUND: Research on the implementation of evidence-based medicine has focused on how best to influence doctors through information and education strategies. In order to understand the barriers and facilitators to implementation, it may also be important to study the characteristics of those doctors and practices that successfully implement evidence-based changes. AIM: To determine the relationship between practice and doctor characteristics and the implementation of recommended evidence-based changes in the area of prescribing. METHOD: Visits were made to 39 practices in southern England. Audits of three key prescribing changes were carried out and amalgamated to produce an 'implementation score' for each practice. These scores were related to a wide range of practice and doctor variables obtained from a questionnaire survey of doctors and practice managers. RESULTS: There was wide variation between the practices' implementation scores (mean 67%, range 45% to 88%). The only factors that had a significant relationship with implementation of these important prescribing changes were an innovative approach among the doctors (most practitioners were cautious of change), and fundholding status. Use of clinical protocols, disease registers, or computers was not associated with overall implementation score, nor was the doctor's age. Doctors complained of information overload. CONCLUSIONS: The emphasis on the need for evidence in medicine, and better transmission of information, needs to be balanced by a recognition that most general practitioners are pragmatic, averse to innovation, and already feel overwhelmed with information. Important advances in therapy may be crowded out. More attention should be given to the facilitation of priority changes in practices.

The evaluation of a mental health facilitator in general practice: effects on recognition, management, and outcome of mental illness.

BACKGROUND: Facilitation uses personal contact between the facilitator and the professional to encourage good practice and better service organisation. The model has been applied to physical illness but not to psychiatric disorders. AIM: To determine if a non-specialist facilitator can improve the recognition, management, and outcome of psychiatric illness presenting to general practitioners (GPs). METHOD: Six practices were visited over an 18-month period by a facilitator whose activities included providing guidelines and organising training initiatives. Six other practices acted as controls. Recognition (identification index of family doctors), management (psychotropic prescribing, psychological consultations with the GP, specialist mental health treatment, and the use of medical interventions and investigations), and patient outcome at four months were assessed before and after intervention. RESULTS: The mean identification index of facilitator GPs rose from 0.51 to 0.64 following intervention, while that of the control GPs fell from 0.67 to 0.59 (P = 0.046). The facilitator had no detectable effect on management or patient outcome. CONCLUSIONS: The facilitator improved recognition of psychiatric illness by GPs. Generic facilitators can be trained to take on a mental health role; however, the failure to achieve more fundamental changes in treatment and outcome implies that facilitator intervention requires development.

Forecasting the impact of demographic change: the case of the British National Health Service.

By projecting trends over the period 1971-85 in discharge rates and lengths of stay in acute and geriatric National Health Service hospitals in England, it is estimated that by 1995 the discharge rate will have risen by 13% and average lengths of stay will have fallen by 26%. Combining these projections with current population projections for England, it is estimated that 13% fewer beds will be in daily use. These changes are shown to vary widely across specialties. The projections reveal that demographic change per se is a less important source of change than are changing activity rates. The 'trend' projections suggest that purchasers and providers within internal markets will have to take account of very different degrees of pressure between specialties. They can provide information which is essential for negotiations about local needs and local contracts.

Alzheimer's disease in the United Kingdom: developing patient and carer support strategies to encourage care in the community.

Alzheimer's disease is a growing challenge for care providers and purchasers. With the shift away from the provision of long term institutional care in most developed countries, there is a growing tendency for patients with Alzheimer's disease to be cared for at home. In the United Kingdom, this change of direction contrasts with the policies of the 1980s and 90s which focused more attention on controlling costs than on assessment of the needs of the patient and carer and patient management. In recent years, the resources available for management of Alzheimer's disease have focused on institutional care, coupled with drug treatment to control difficult behaviour as the disease progresses. For these reasons, the current system has led to crisis management rather than preventive support--that is, long term care for a few rather than assistance in the home before the crises occur and institutional care is needed. Despite recent innovations in the care of patients with Alzheimer's disease, the nature of the support that patients and carers receive is poorly defined and sometimes inadequate. As a result of the shift towards care in the community, the informal carer occupies an increasingly central role in the care of these patients and the issue of how the best quality of care may be defined and delivered is an issue which is now ripe for review. The objective of this paper is to redefine the type of support that patients and carers should receive so that the disease can be managed more effectively in the community. The needs of patients with Alzheimer's disease and their carers are many and this should be taken into account in defining the quality and structure of healthcare support. This paper shows how new initiatives, combined with recently available symptomatic drug treatment, can allow patients with Alzheimer's disease to be maintained at home for longer. This will have the dual impact of raising the quality of care for patients and improving the quality of life for their carers. Moreover, maintaining patients in a home environment will tend to limit public and private expenditure on institutional care due to a possible delay in the need for it.

Primary health care in London--changes since the Acheson report.

OBJECTIVE: To examine changes in primary care in London in the 11 years since the Acheson report on primary health care in inner London. DESIGN: Analysis of key data from the family health services authority performance indicators and from the Department of Health; study of trends since the time of the Acheson report; examination of the provision of primary care in 1990-1 and its relation to health and social factors. SETTING: Comparisons between the family health services authorities of inner London, outer London, and England as a whole, with a special study of Birmingham, Liverpool, and Manchester. SUBJECTS: The family health services authorities of England. RESULTS: There has been an improvement in the provision of primary care in inner London as judged by the criteria of the Acheson report, but these improvements have occurred only as part of an overall improvement in the provision of primary care in the country as a whole. None of the recommendations of the Acheson report specifically oriented to London have been implemented. There are some worrying trends in inner London, such as the increasing proportion of practices with more than 2500 patients. The problems faced by practitioners in inner London resemble those in other large inner city areas, but the primary care provision to deal with them is relatively poor.

High and low incomes in general practice.

The Review Body on Doctors' and Dentists' Remuneration deals with average incomes and costs, and little evidence is available on local variability. In a study on general practice the distribution of high and low incomes was assessed. High income practices (defined as those with net incomes per partner of more than 35,000 pounds a year) were more likely to be larger, to have younger partners, and to be located in affluent areas. Low income practices (with a net income of less than 20,000 pounds per partner) were smaller, located in more urban areas, and more likely to have Asian partners. High income practices had higher costs per patient and more staff resources. Low income practices had fewer practice resources and faced great disincentives to investment. These practices were concentrated in less affluent areas, where the need for improved organisation of practices is greatest. General practice is becoming increasingly divided between high income, high cost practices and those with low incomes and few resources.

Change in general practice and its effects on service provision in areas with different socioeconomic characteristics.

OBJECTIVE: To investigate the changes in the structure and service provision of general practice in areas with different socioeconomic characteristics. DESIGN: Interview survey; postal questionnaire. SETTING: 260 group and 80 singlehanded general practices in six family health services authorities in England. MAIN OUTCOME MEASURES: Changes in computerisation, premises, staffing, incomes, and service provision since the introduction of the 1990 contract, including comparison with data from a study in 1987. RESULTS: In 1993, 94% (245) of group practices were computerised compared with 38% in 1987, and 35% (90) of practices had used the cost rent scheme since 1987. Practice managers were employed in 88% (228) of group practices, and practice nurses in 96% (249) (61% and 60% respectively in 1987). Diabetes and asthma programmes were generally more common in the more affluent areas than elsewhere. A minority of practices (27% (9/33)) in the London inner city area achieved the higher target level for cervical smear testing, compared with 88% (230) overall. A similar trend was apparent for childhood immunisation. Perceived workload increased sharply between 1987 and 1993. Differences in the mean net incomes of general practitioners between areas were much lower than in 1987. Singlehanded practices generally had more problems than group practices in improving service provision. CONCLUSIONS: Practices in all areas have shown a strong response to the new incentives. The evidence suggests, however, that generally the urban and inner city practices still lag behind practices in rural and suburban areas in terms of practice structure and service provision.

Family doctors and change in practice strategy since 1986.

OBJECTIVES: To investigate the changes in practice strategy that have taken place since 1986. DESIGN: Comparison of practices in 1986 and 1992. SETTING: 93% of group practices (26 practices) in a single family health services authority. MAIN OUTCOME MEASURES: Changes in staffing, premises, equipment, clinic services, and incomes between 1986 and 1992. RESULTS: In 1986, 28% of practices employed a nurse; in 1992, 92% did so. Between 1986 and 1992, 14 cost-rent schemes costing more than 10,000 pounds had been started. Certain practices, designated innovators, were more likely to possess specified items of equipment than other practices. Computer ownership was widespread: 77% of practices had a computer, compared with 36% in 1986. In 1992, 16 practices had a manager, compared with 10 in 1986. Clinic services provided by more than half of practices were well established services (antenatal, for example), new services for which a payment had been introduced (such as diabetes, asthma, minor surgery), or the more readily provided "new" clinic services (diet, smoking cessation). Gross income increased, but so did practice costs, especially for innovators. Practices in the more affluent area of the family health services authority were still more likely to invest in their premises and staff, and to provide more services than those in the declining area. In the more affluent area, practices had higher costs but also higher incomes. CONCLUSION: Between 1986 and 1992, practices in this area invested heavily in equipment and services, but differences remain, depending on the location of the practice. Investment has increased, particularly in the more deprived part of the area, so that the inconsistency in standards has been much reduced. Practice incomes have risen, but so also have workload and costs.