Institute of Health Economics, Edmonton, AB. menon@ualberta.ca
BACKGROUND: Provincial governments are responsible for administering publicly-funded anti-cancer drug benefit programs in Canada. This study examines inter-provincial variations in not only the content of such programs, but also the policies/processes used when considering a new drug for coverage. METHODS: Pharmaceutical manufacturers and provincial/regional cancer boards were surveyed to identify the drugs covered by public drug benefit plans. Kappa coefficients were calculated to determine inter-provincial coverage variations. The comprehensiveness of availability of anti-cancer drugs across the country was also assessed. A semi-structured survey of all 10 provincial/regional cancer board pharmacy and therapeutics (P&T) committees was employed to examine decision-making policies/procedures. It included questions on committee composition and processes and on factors influencing decisions regarding the introduction of new drugs. Completed surveys were analyzed using qualitative and quantitative techniques. RESULTS: All cancer boards and 75% of manufacturers contacted provided information on drugs covered in each province. Where lists were obtained from both sources, there was full agreement on content. Kappa values calculated ranged from - .403 to .594, indicating poor to moderate agreement on anti-cancer drug coverage between provinces. Only 7 of the 115 drugs were available in all 10 provinces. Regarding decision-making processes, while ratings for both the relative importance and use of factors involved in decision-making (clinical effectiveness, patient preference, etc.) were similar across provinces, those for the relative importance and use of different information types (clinical trials, expert opinion, etc.) varied. CONCLUSION: Access to anti-cancer drugs clearly varies across the country. In part, this may be due to differences in the views of P&T committees on the usefulness of information they use in their deliberations.
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School of Public Health, University of Alberta, Edmonton, AB, Canada. menon@ualberta.ca
Department of Public Health Sciences, University of Alberta, Edmonton AB T6G 2H5, Canada.
Despite the immature state of stem cell medicine, patients are seeking and accessing putative stem cell therapies in an "early market" in which direct-to-consumer advertising via the internet likely plays an important role. We analyzed stem cell clinic websites and appraised the relevant published clinical evidence of stem cell therapies to address three questions about the direct-to-consumer portrayal of stem cell medicine in this early market: What sorts of therapies are being offered? How are they portrayed? Is there clinical evidence to support the use of these therapies? We found that the portrayal of stem cell medicine on provider websites is optimistic and unsubstantiated by peer-reviewed literature.
Department of Public Health Sciences, Department of Public Health Sciences, School of Public Health, University of Alberta, Edmonton, AB, Canada. menon@ualberta.ca
OBJECTIVES: To assess the feasibility of using a citizens' jury to elicit public values on health technologies and to develop criteria for setting priorities for health technology assessment (HTA). METHODS: Sixteen individuals were selected from 1600 randomly sampled residents of the Capital Health Region in Alberta, Canada. They participated in a 2 (1/2) day jury which comprised presentations by 'expert witnesses', who represented innovators, patients, health-care policy-makers and clinicians, as well as a series of small and large group priority-setting exercises based on actual examples of technologies that had recently been considered for assessment by local and national HTA bodies. The session was audio-taped, and transcripts were independently reviewed by two researchers using content analytical techniques in order to ensure that no important concepts expressed by individual jurors were missed during group development of the final list of priority-setting criteria. Jurors evaluated the process by completing self-administered, semi-structured questionnaires at the end of the session. Responses were analysed using qualitative methods. RESULTS: The jury identified 13 criteria, which they subsequently ranked in order of importance. The top two criteria included 'potential to benefit a number of people' and 'extends life with quality'. Based on feedback from questionnaires, jurors valued the opportunity to become engaged in such a process, and expressed interest in participating in future juries. CONCLUSIONS: Citizens' juries offer a feasible approach to involving the public in priority-setting for HTA. Furthermore, technologies that may benefit a number of people and improve quality of life appear to be of greatest importance to the public.
School of Public Health, University of Alberta, Edmonton, Alta.
OBJECTIVE: In recent years, laser treatments have re-emerged as options for treating benign prostatic hyperplasia (BPH). This paper reviews the safety, efficacy, effectiveness and economics of photoselective vapourization of the prostate (PVP), compared with transurethral resection of the prostate (TURP). METHODS: We conducted a comprehensive literature search to identify 14 studies comparing 80 W PVP and TURP. We then reviewed and pooled these studies. RESULTS : We identified 12 adverse events or complications; rates were similar in both groups. No PVP patient required a blood transfusion; 5%-11% of TURP patients did. PVP patients had a significantly lower likelihood of clot retention. Collectively, the 14 studies led to the conclusion that PVP is a safe procedure. PVP is favourable to TURP regarding length of hospitalization and catheterization times. There were no meaningful differences in operation times, reoperation rates, peak flow rates, postresidual volumes or quality of life scores. Sexual function and prostate specific antigen value changes were similar. Four economic evaluations of PVP and TURP (from Canada, Switzerland, Australia and the United States) concluded that PVP is less costly per case than TURP. Cost differences are attributable to disposables, capital equipment and hospitalization. Based on our analysis of limited Canadian data, the cost of PVP is estimated to be about one-half that of TURP, even after accounting for start-up costs. CONCLUSION: The 80 W PVP laser appears to be a viable treatment for BPH. With the recent regulatory approval of the 120 W High Performance System (HPS), an additional option has become available. Therefore, it is anticipated that PVP will soon be considered part of a physician's repertoire for managing BPH.
INTRODUCTION: In recent years, heightened public awareness of new medical advances that offer improved therapeutic and diagnostic options coupled with increased fiscal pressure on health care systems to deliver both equitable and efficient care have magnified the need to examine carefully how and by whom health care priorities are set. OBJECTIVE: To assess processes for setting health care priorities in Alberta, Canada. METHODS: A demographically representative sample of senior management within Regional Health Authorities (RHAs) and specialized provincial boards was selected to participate in key informant interviews. The interviews, which were audio-taped and transcribed, comprised open-ended questions addressing priority-setting approaches employed and the extent to which the public was involved. Through a series of iterations, transcripts were analyzed using content analytic techniques. RESULTS: In general, priority-setting was found to involve four steps:(1) identification of health care needs,(2) allocation of resources,(3) communication of decisions to stakeholders, and (4) management of feedback from them. While approaches to accomplishing each step varied across RHAs and specialized provincial bodies, public involvement did not. In all cases, mechanisms for engaging them in priority-setting focused almost exclusively on the first step. From an "accountability for reasonableness" perspective, none of the organizations surveyed had established processes that met all four principles.
Public Health Sciences, University of Alberta, Edmonton, Canada. menon@ualberta.ca
OBJECTIVES: This study sought to examine the safety, efficacy, and economic implications of the use of cerebral protection devices during carotid artery angioplasty and stenting (CAS) in high-risk patients with severe carotid artery disease (CAD). METHODS: A comprehensive search for peer- and non-peer-reviewed studies that compared carotid endarterectomy (CEA) or CAS without cerebral protection to CAS with cerebral protection and appeared in the English language literature between January 1990 and January 2005 was completed. Information from studies identified was extracted using a common data abstraction form and then critically appraised against published quality assessment criteria. RESULTS: Of the eight studies found, six provided information on technical or procedural success rates, with values ranging from 95.6 percent to 100 percent. Three of the four studies comparing groups of patients who received CAS with cerebral protection with those who received only CAS reported a non-statistically significantly higher 30-day incidence of death and stroke (major or minor) in the latter group. None of the three studies comparing CAS with cerebral protection to CEA demonstrated a statistically significant difference in the 30-day incidence of death, major stroke, or myocardial infarction between treatment groups. No economic analyses were found. CONCLUSIONS: In high-risk patients with severe CAD, the evidence suggests that CAS with cerebral protection may offer a safe and efficacious alternative to CEA, reducing the risk of embolic peri-procedural complications associated with CAS to acceptable levels.
Department of Public Health Sciences, University of Alberta.
"Evidence-informed" priority-setting in healthcare has become increasingly important in most health systems around the world. This paper presents the results of a two-part study of the role of academic health services research in healthcare priority-setting. First, a review of peer-reviewed literature was done to elicit the factors important to priority-setting. Second, a survey of authors of this literature was conducted to determine the value of relevant academic work to decision-making
Institute of Health Economics, 1200, 10405 Jasper Avenue, Edmonton, Alta., Canada T5J 3N4.
PURPOSE: To assess the effectiveness of SRS alone or in combination with WBRT compared to surgery and/or WBRT in prolonging survival and improving the quality-of-life and functional status of patients with brain metastases. METHODS AND MATERIALS: A meta-analysis of randomized controlled trials and concurrent cohort studies examining SRS versus SRS+WBRT, SRS versus WBRT +/- surgical resection, SRS versus surgical resection only, or SRS+WBRT versus WBRT was conducted. Trial registers, bibliographic databases, and reference lists from selected studies and recent issues of relevant journals were searched. Neuro-oncology specialists were also contacted. All studies were analyzed independently by two reviewers, applying validated critical appraisal techniques. RESULTS: The review identified three RCTs and one cohort study. Among patients with multiple metastases, no difference in survival between those treated with WBRT+SRS and those treated with WBRT was found. However, in patients with one metastasis, a statistically significant difference, favoring those treated with WBRT+SRS, was observed. Regarding local tumor control at 24 months, rates were significantly higher in the WBRT+SRS treatment arm, regardless of the number of metastases. CONCLUSIONS: Adding SRS to WBRT improves survival in patients with one brain metastasis. Combining SRS and WBRT improves local tumour control and functional independence in all patients.
Patti Power,
Gavin Stuart,
Amit Oza,
D Provencher,
James R Bentley,
Wilson H Miller Jr,
Jean-François Pouliot
Dr. H. Bliss Murphy Cancer Centre, 300 Prince Philip Drive, St. John's, Newfoundland, Canada A1B 3V6.
OBJECTIVES: Pegylated liposomal doxorubicin is one of the preferred alternatives for ovarian cancer patients with early relapse (<6 months) and taxane/carboplatin for late relapse (>12 months), but the optimal therapy for the partially platinum-sensitive (6-12 months) population has not been defined. This single-arm phase II trial was designed to assess the efficacy of pegylated liposomal doxorubicin (PLD)/carboplatin in ovarian cancer patients who relapse between 6 and 12 months after initial treatment with platinum-based chemotherapy. METHODS: Ovarian cancer patients who previously completed a course of therapy with paclitaxel/carboplatin were administered PLD 30 mg/m(2) followed by carboplatin AUC 5 mg/mL/minute every 4 weeks. RESULTS: Fifty-eight patients were enrolled in the study and 54 were eligible for the efficacy analysis, of whom most (75%) received at least 6 cycles of PLD/carboplatin. The objective response rate was 46%(4% CR and 42% PR), with an additional 33% experiencing disease stabilization >6 months. For those patients with measurable CA-125, the response rate was 66%(28% CR and 38% PR), with an additional 18% experiencing disease stabilization >6 months. Median time-to-progression was 10 months (1.5-25). Median overall survival was 19.1 months (2.2-38.9). The most frequent adverse effects were neutropenia, thrombocytopenia, and constipation. CONCLUSIONS: The combination of PLD/carboplatin is efficacious and well tolerated in women with partially platinum-sensitive ovarian cancer and represents a valuable alternative for patients who relapse within 6-12 months of completing paclitaxel/carboplatin chemotherapy.
Department of Obstetrics and Gynecology, Medical University of Graz, Auenbruggerplatz 14, A-8036 Graz, Austria.
The FIGO has invited the GCIG to make contributions for possible changes of the FIGO staging system. We report on the consensus within the GCIG committee to propose the following changes in the current FIGO classification. Cervical cancer: Since fertility-preserving surgery is increasingly used in early disease, stage IB1-A may include tumors of up to 2cm in diameter. Endometrial cancer: Positive peritoneal cytology alone should not classify this patient to be allotted to stage IIIA disease. Lymphadenectomy should be recommended in high-risk clinical stage I patients and in those with adverse histologies. Ovarian cancer: In early stage disease, grading and in advanced disease, the amount of residual disease should be reported. Vulvar cancer: The lymph node status should always be reported. In the case of enlarged inguinal nodes, histology should be obtained by any means. Vaginal cancer: Besides bladder and rectal tumor involvement urethral mucosal involvement should be added. Gestational trophoblastic disease: The modified WHO scoring system which is widely accepted should be adopted.
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The Hospital for Sick Children, Toronto, Ontario.
OBJECTIVES: To review the status of universal newborn screening programs in Canada. METHODS: A brief questionnaire (seven questions) was circulated to one key individual in each province (n=10) and territory (n=3). These individuals were usually physicians or clinical biochemists closely involved in the diagnosis and treatment of genetic metabolic diseases. RESULTS: Universal newborn screening is under provincial jurisdiction. The number of diseases screened for varies and ranges from three to 28. Nine provinces/territories have a central computerized system for tracking initially positive cases. Only five provinces/territories have adequate personnel and resources for follow-up and treatment. Treatment costs are only partially covered in most jurisdictions. Only five provinces/territories have formal advisory committees with official mandates. Expensive, restricted access treatment products for adults with inherited metabolic diseases are only fully available in six provinces/territories. There is very limited access to these products in an additional four provinces/territories. To date, specific informed consent for newborn screening is not required in any province or territory. CONCLUSIONS: Canada is far behind the rest of the developed (and some 'emerging') countries of the world in the field of universal newborn screening. New strategies for advocating expanded screening, follow-up and (long-term) payment of treatment costs on behalf of the potentially affected infants and their families must be devised, and such initiatives should include participation from the new Public Health Agency of Canada.
Scientist, Population Health Sciences, The Hospital for Sick Children, Assistant Professor, Department of Health Policy, Management and Evaluation, University of Toronto, Adjunct Scientist, Institute for Clinical Evaluative Sciences Toronto, ON.
BACKGROUND: As debate continues regarding pharmacare in Canada, little discussion has addressed appropriate drug plan coverage for vulnerable populations, such as children. The primary objective of this study was to determine the extent of medication coverage for children in publicly administered programs in each province across Canada. METHODS: Data were collected on provincial, territorial and federal government drug plans, and 2003 formulary updates were obtained. A simulation model was constructed to demonstrate costs to a low-income family with an asthmatic child in each province. Programs were compared descriptively. The extent of interprovincial variation in 2003 formulary approvals was summarized statistically. RESULTS: There was 39% variation between provinces with respect to 2003 formulary approvals (chi-square p < .0001) and 48% variation for 2003 paediatric-labelled products (chi-square p < .0001). Across Canada, only 8% of 2003 formulary approvals were indicated primarily for paediatric conditions. In the simulation model, costs were less than or equal to 3% of household income in provinces with plans for low-income families, catastrophic costs (Ontario) or for the population. Families who failed to qualify for low income plans or who resided in New Brunswick or Newfoundland faced costs up to 7% of household income. INTERPRETATION: With regard to pharmaceutical benefits for children, provincial drug programs vary considerably in terms of whom they cover, what drugs are covered and how much subscribers must pay out of pocket. Unlike seniors and social assistance recipients, the provinces do not agree on the importance of providing comprehensive coverage for all children. For many Canadian children, significant financial barriers exist to medication access.
Department of Health and Pharmaceutical Policy Research; Department of Insurance Policy Research, Fraser Institute, Toronto, Ontario, Canada.
Available evidence indicates that patients who have private sector drug insurance are immediately covered for all new medically necessary drugs certified by Health Canada, with few exceptions. The experience for patients who are dependent on public drug programmes is much worse. Evidence indicates that, on average across the provinces, far less than half of the drugs certified by Health Canada are finally approved by the provinces for public reimbursement. Publicly insured patients also wait up to 1 year longer than privately insured patients to get insurance coverage for new drugs. Evidence also shows that public drug coverage varies widely across provinces.