Pharmaceutical formulation and healthcare expenditures.
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Ondansetron: a pharmacoeconomic and quality-of-life evaluation of its antiemetic activity in patients receiving cancer chemotherapy.
Ondansetron is more effective than high-dose metoclopramide in the prevention of acute nausea and vomiting due to highly emetogenic chemotherapy, and, unlike metoclopramide, is rarely associated with extrapyramidal effects. Pharmacoeconomic analyses have demonstrated that, in specified clinical settings, ondansetron (8mg 4-hourly for 3 doses or 8mg followed by 1 mg/h for 24 hours) is equally cost-effective as high-dose metoclopramide (3 mg/kg followed by 0.5 mg/kg/h for 8 hours) in the prophylaxis of emesis in patients receiving highly emetogenic chemotherapy, at an acquisition cost 4- or 5-fold higher than that of the metoclopramide regimen. Furthermore, the combination of dexamethasone plus ondansetron has been shown to be more effective than ondansetron monotherapy in controlling emesis. In patients receiving high-dose ( greater than 50 mg/m2) cisplatin-based chemotherapy, antiemetic therapy with ondansetron (8mg intravenously as a single dose) plus dexamethasone (16mg total intravenous dose) was shown to be more cost-effective than the combination of high-dose metoclopramide (11 mg/kg total intravenous dose), dexamethasone (8mg intravenously as a single dose) plus lorazepam (1 to 1.5mg intravenously as a single dose). In a limited number of studies, quality-of-life scores, as assessed using the Rotterdam Symptom Checklist or the Functional Living Index--Emesis instrument, were significantly higher with ondansetron than with other antiemetic agents, including metoclopramide. Together, these results suggest that ondansetron, as an alternative to antiemetic regimens including high-dose metoclopramide, is appropriate cost-effective therapy for the prevention of acute nausea and vomiting in patients receiving highly emetogenic chemotherapy. Ondansetron is effective in controlling acute emesis associated with moderately emetogenic chemotherapy, and its use in this clinical setting may best be reserved for patients who have not responded well to previous antiemetic therapy with more traditional agents. However, poorly controlled emesis can lead to anticipatory nausea and vomiting in subsequent courses of chemotherapy, thus, consideration should also be given to the use of ondansetron in patients receiving moderately emetogenic chemotherapy, although further pharmacoeconomic investigations are required to clarify its use in this clinical setting.
Costs and Cost Analysis↗
Epoetin: a pharmacoeconomic review of its use in chronic renal failure and its effects on quality of life.
Epoetin (recombinant human erythropoietin) is an effective treatment for the anaemia of patients with chronic renal failure. It is well tolerated, and the risk of adverse effects that are caused by too rapid a correction of anaemia, for example hypertension, can be reduced in most cases by lower starting dosage regimens. Epoetin improves the quality of life of anaemic patients with end-stage renal disease (ESRD), and significant improvements in most parameters of the Kidney Disease Questionnaire, the Sickness Impact Profile and the Nottingham Health Profile have been reported by patients. However, acquisition costs of epoetin are high, thereby adding a considerable cost to ESRD therapy despite a reduction in blood transfusion requirements. Notwithstanding, although cost-effectiveness studies have indicated that epoetin is associated with higher costs of therapy, cost-benefit analysis indicates that these costs can be reduced markedly with low-dose regimens and may be completely recovered if patients regain employment.
Adolescent↗
Methods of minimising the cost of aminoglycoside therapy to hospitals.
Aminoglycoside agents are used for a wide variety of systemic infections and can profoundly affect hospital expenditures depending upon the amounts used, acquisition costs, and costs incurred during therapy. Significant cost advantages can be gained through selection and proper use of the appropriate aminoglycoside. Institutions can improve the selections by using inservice training and other educational methods, drug-use audits, and therapeutic substitution. Institutions may also restrict or delete certain aminoglycosides from the drug formularies to help minimise costs. Therapeutic drug monitoring can reduce the incidence of aminoglycoside adverse effects. However, some methods of monitoring, such as certain clinical pharmacokinetic services, can be time consuming and require additional manpower. These measures can be shown to be cost effective if they can decrease the length of therapy, minimise toxicity, decrease the length of hospitalisation, or affect mortality. Experimental data and preliminary clinical evidence suggest that once-daily regimens of aminoglycoside agents have some possible advantages over the standard regimens. If this regimen can be widely used, cost savings secondary to decreased use of aminoglycosides can be realised in the future. Potent, broad spectrum beta-lactam monotherapy has threatened to replace conventional combination therapies that include aminoglycosides in some infectious processes and a few studies have found certain single-drug therapies to be cost effective.
Aminoglycosides↗
Oral ciprofloxacin: a pharmacoeconomic evaluation of its use in the treatment of serious infections.
The broad spectrum of antibacterial activity and favourable pharmacokinetic profile of ciprofloxacin permit oral treatment of many serious infections which have traditionally necessitated parenteral antibacterial therapy. This has been demonstrated in comparative studies, in which ciprofloxacin was as effective and well tolerated as standard parenteral therapies (usually aminoglycoside/beta-lactam combinations or broad spectrum cephalosporins) in small numbers of patients with infections of the lower respiratory tract, urinary tract, skin and soft tissue, and bones and joints. Oral ciprofloxacin is considerably less expensive than most parenteral therapies, does not necessitate therapeutic drug monitoring and can be administered on an outpatient basis. In addition, administration by the oral route is more comfortable and convenient for the patient. Pharmacoeconomic studies have confirmed that substitution of oral ciprofloxacin for parenteral therapy in the treatment of serious infections can achieve considerable savings in drug acquisition costs, and labour and supplies associated with parenteral drug administration, and may allow early discharge from hospital, resulting in even greater savings. Mean reductions of 43 to 83% were achieved in antibacterial costs in 3 randomised prospective studies, when patients received oral ciprofloxacin instead of various parenteral agents, from the beginning of treatment, or after 3 days' parenteral therapy. It can be concluded that oral ciprofloxacin offers considerable scope for cost avoidance when appropriately substituted for parenteral therapy in the treatment of serious infections.
Administration, Oral↗
Economic impact of cost-containment strategies in third party programmes in the US. Part II.
This is the second article in a 2-part series that examines the economic impact of several different strategies used to control costs in third party programmes. This article investigates 5 different methods: (a) formularies; (b) capitation; (c) drug utilisation review; (d) prior approval; and (e) drug product selection. The published literature indicates that use of formularies decreases drug expenditures, but these savings may be offset by expenditures in other areas of healthcare programmes. Capitation, though less well studied than other strategies, may show some effectiveness in reducing costs by increasing generic dispensing and promoting switching from prescription drug to over-the-counter. Drug utilisation review, as a systematic programme of claims data review, has been shown to yield positive economic return in a variety of areas, including both impersonal and face-to-face educational interventions with healthcare practitioners. Prior approval and drug product selection both result in savings when examined in isolation from other aspects of healthcare. Cost-shifting, administrative costs and costs incurred because of possible decreased access to care have yet to be fully accounted for.
Capitation Fee↗
Idarubicin: a pharmacoeconomic evaluation of its use in adult patients with acute myeloid leukaemia.
Idarubicin is an effective agent in the treatment of acute myeloid leukaemia (AML), inducing complete remission in 39 to 80% of newly diagnosed patients. Although it also demonstrates efficacy as monotherapy, and is of use in relapsed or refractory disease, most comparative clinical trials have administered idarubicin intravenously in combination with cytarabine in newly diagnosed patients. These trials indicate that improved survival and response rates, and rapid achievement of remission, are more likely with idarubicin than with daunorubicin, when both agents are given in combination with cytarabine. In elderly patients, however, response rates are lower than in younger patients, and there is less disparity in efficacy between idarubicin and daunorubicin induction therapy. Although AML is an expensive disease to treat, the majority of costs are associated with the length of hospitalisation, with the acquisition cost of the chemotherapy agents contributing less than 10% to overall expenditure. Idarubicin combined with cytarabine therapy achieved higher response rates with the first cycle of therapy than daunorubicin, thereby reducing the requirements for a second cycle of therapy and further hospitalisation. Compared with daunorubicin plus cytarabine induction treatment, idarubicin plus cytarabine reduced the costs of achieving a complete response by between 22 and 39% in patients with a median age less than 60 years. In patients with a median age of 62 years, who are more representative of the AML population, costs of achieving a complete response were reduced by 3 to 6%. Thus, idarubicin is more cost effective than daunorubicin as induction therapy in combination with cytarabine, in adult patients with AML. The pharmacoeconomic position of idarubicin in postinduction therapy remains to be established.
Adult↗
Cyclosporin: a pharmacoeconomic evaluation of its use in renal transplantation.
Cyclosporin is a powerful immunosuppressive agent which has markedly improved the outcome of renal transplantation, a technique now well established as the treatment of choice for patients with end-stage renal disease (ESRD). Comparison of cyclosporin-based regimens with a regimen of azathioprine and a glucocorticoid (conventional immunosuppression) indicates an improved clinical course and increased long term graft survival rate with cyclosporin which is most apparent in the recipients of a kidney from a living related donor (human leucocyte antigen mismatched) or cadaver donor source. Cyclosporin has also improved the clinical outcome in patient subgroups previously associated with a higher risk of graft failure with conventional immunosuppression, namely older patients and those with diabetes mellitus. Cost-of-treatment studies conducted over the first post-transplant year in the US have found that higher pharmacy charges with cyclosporin-based regimens are associated with lower hospitalisation charges and total billed charges compared with conventional immunosuppression. Lower hospitalisation charges reflect an improved post-transplant clinical course with cyclosporin and this has been associated with an improved quality of life in the recipients of a cadaver donor kidney. Longer term, the direct cost to society of using cyclosporin-based dual therapy (in combination with a glucocorticoid) may be higher than that with conventional immunosuppression, although the difference is likely to be small compared with the ongoing cost of dialysis. Clinical research continues to focus on modified regimens which maximise the clinical benefits of cyclosporin while minimising the associated adverse events, in particular the potential for nephrotoxicity. Sequential drug therapy (induction with globulin, azathioprine and a glucocorticoid followed by delayed administration of cyclosporin) has been associated with an improved clinical course compared with dual therapy, as well as cost containment to a level comparable to that for conventional immunosuppression. Compared with sequential therapy, triple drug therapy (cyclosporin, azathioprine plus a glucocorticoid) has been associated with a similar clinical course and lower acquisition cost during the first post-transplant year, although its overall impact on the longer term cost of transplantation has yet to be assessed. Elimination of cyclosporin from the immunosuppressive protocol of carefully selected patients can be safely achieved during the first post-transplant year. However, it remains to be established whether savings in the long term acquisition cost of immunosuppression are more than offset by the cost of treating a potentially less favourable clinical course.(ABSTRACT TRUNCATED AT 400 WORDS)
Costs and Cost Analysis↗
High technology drugs for cancer: the decision process for adding to a formulary.
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Cost Control↗
The formulary decision-making process in a health maintenance organisation setting.
The goal of a health maintenance organisation (HMO) is to provide high quality, cost-effective healthcare services and products which meet the needs of the membership. Providing and managing pharmaceutical products and services within the HMO is a major aspect of accomplishing this goal. Several decisions must be made in developing, implementing and maintaining a formulary system. The numbers of people seeking their healthcare from HMOs in the US has increased 4-fold in 10 years, and several model types of HMOs have developed, including network HMOs, group HMOs, independent practitioner associations and staff models. HMOs utilising formulary systems provided cover to 76% of enrollees in 1992. Formulary system management and decision making entails the use of open vs closed formularies and the role of the pharmacy and therapeutics (P & T) committee. Product selection takes into account efficacy, safety, costs, patient acceptance, ease of use, dosage forms, preparation requirements, stability and storage requirements and the reputation of the manufacturer and the service it provides. We list and describe various policy decisions which HMO pharmaceutical decision makers must address if the formulary system is to become an efficient tool for the HMO.
Consumer Product Safety↗
Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF): an appraisal of its pharmacoeconomic status in neutropenia associated with chemotherapy and autologous bone marrow transplant.
Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF) expedites neutrophil recovery in cancer patients receiving chemotherapy with or without autologous bone marrow transplant (ABMT). The limited cost analyses available in patients undergoing ABMT support a cost reduction of about 25 to 35% with rGM-CSF therapy, relative to placebo, generated primarily by decreases of 20 to 30% in hospitalisation costs reflecting reductions in length of hospitalisation. Results of 1 trial show equivalent cost savings of 40% versus placebo with either rGM-CSF or recombinant granulocyte colony-stimulating factor (rG-CSF) in patients with chemotherapy-induced febrile neutropenia. Whether reduced infection rates seen with rGM-CSF may lessen costs of antimicrobial therapy is undetermined; however, a 16% decrease in this cost factor was reported in 1 evaluation of high dose chemotherapy with ABMT. No analyses have assessed the cost effectiveness of rGM-CSF as prophylaxis in patients receiving chemotherapy. Survival rates have increased in patients treated with rGM-CSF after bone marrow graft failure. In contrast, with the exception of one small trial, improvements in mortality or relapse rates have not occurred with rGM-CSF used prophylactically with chemotherapy, despite favourable effects on neutrophil recovery and facilitation of dose-intensified chemotherapy regimens. Similarly, survival has not increased in patients undergoing ABMT. The long term economic impact of rGM-CSF in these indications is thus unknown. Other factors predicted to produce modest cost savings include possible reductions in expenditure related to treating mucositis, and lowered transfusion requirements in some patients. Whether rGM-CSF may provide benefits in other areas that can be expressed in economic terms, such as quality of life, also remains to be established. On the whole, rGM-CSF has a good tolerability profile, obviating the need for costly monitoring procedures. Like other expensive biotechnology products, its cost effectiveness will be aided by implementation of appropriate prescribing techniques and protocols to minimise wastage. Thus, at present rGM-CSF therapy appears to offer a means of reducing hospitalisation costs, and therefore a substantial component of treatment expenditure, in patients undergoing ABMT or with chemotherapy-induced febrile neutropenia.
Anti-Bacterial Agents↗
Hepatitis B vaccine: a pharmacoeconomic evaluation of its use in the prevention of hepatitis B virus infection.
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute and chronic hepatitis, cirrhosis and hepatocellular cancer. Infants and children are at the greatest risk of becoming chronically infected with HBV, and therefore at the greatest risk of developing long term sequelae. Immunisation against HBV represents an important means of controlling the disease. Hepatitis B vaccines are effective in preventing HBV infection and are well tolerated. In addition, they are suitable for integration into mass neonatal vaccination programmes. While there are considerable economic data concerning hepatitis B vaccination, differing methodologies and end-points present a challenge in reviewing these studies for consistent findings. Immunisation strategies should be implemented in accordance with local area disease incidence and patterns of HBV transmission, and will be influenced by regional budgetary constraints. In conclusion, universal neonatal vaccination is both cost effective and appropriate for control of HBV infection in regions of medium or high endemicity. In low endemicity areas, selective vaccination of high-risk groups is cost effective, but its impact on the incidence of HBV infection will depend on the ability to reach these groups. Expanded vaccination strategies may be appropriate where local conditions prohibit efficient access to high-risk groups.
Adolescent↗
Hormone replacement therapy: II. A pharmacoeconomic appraisal of its role in the prevention of postmenopausal osteoporosis and ischaemic heart disease.
The reduction in estrogen production that occurs at menopause is associated with several long term sequelae. There is an accelerated decrease in bone mineral density leading to an increased risk of osteoporotic fracture. Furthermore, changes in plasma lipid profiles and other cardiovascular parameters increase the risk of cardiovascular and cerebrovascular pathology. These effects are additional to the menopausal symptoms experienced by many women. The effectiveness of estrogen-based hormone replacement therapy (HRT) is well established in preventing bone mineral loss and also in ameliorating menopausal symptoms, with the addition of progestogen maintaining or possibly enhancing the bone-conserving effects. However, prolonged therapy appears to be necessary to conserve bone mineral density and prevent osteoporotic fracture, particularly in women aged greater than or equal to 75 years, and compliance with long term therapy is likely to be poor. Estrogen favourably alters plasma lipid profiles, improves coronary blood flow and inhibits the central distribution of body fat. Effects on haemostatic mechanisms and coronary vasomotor response to acetylcholine have also been suggested as mechanisms for the beneficial effects of estrogen on ischaemic heart disease. The effects of concomitant progestogens on plasma lipids are variable, and may depend on the type, dosage regimen and duration of therapy. Pharmacoeconomic analyses of HRT have used a variety of risk assumptions. Relative risk rates of osteoporotic fracture and mortality from myocardial infarction are assumed to reduce to 0.5 after greater than 5 years' therapy. Long term HRT is associated with a relative risk of approximately 1.3 for breast cancer, whereas the relative risk of endometrial cancer is 4.0 to 8.0 in women with intact uteri receiving prolonged unopposed estrogen therapy. HRT that includes progestogens is assumed to incur no added risk of endometrial cancer, and this treatment is generally recommended for women with intact uteri. Data concerning the effect of HRT on quality of life are limited and utility values for hip fracture of 0.95 to 0.36 have been assigned, depending on assumptions of disability. Cost-benefit, cost-effectiveness and cost-utility studies evaluating HRT in the prevention of osteoporotic fracture have differed widely in methodology, making comparison of results difficult. HRT appears to be most economically useful in the prevention of fracture if used in women who have undergone hysterectomy, in women with high risk of osteoporotic fracture or ischaemic heart disease, and/or in women with menopausal symptoms.(ABSTRACT TRUNCATED AT 400 WORDS)
Breast Neoplasms↗
Ranitidine: a pharmacoeconomic evaluation of its use in acid-related disorders.
Ranitidine is a histamine H 2-receptor antagonist which, on the basis of its well established tolerability and efficacy profile, has been widely prescribed for the treatment of ulcer disease and mild to moderate reflux oesophagitis. However, the advent of more powerful gastric acid inhibitors (e.g. acid pump inhibitors) and the realisation of the role of Helicobactor pylori infection in duodenal ulcer disease could have considerable clinical and economic implications for the use of ranitidine (and other H 2-receptor antagonists). Simulation modelling studies based on current pricing policies in Europe predict that ranitidine-based treatment will be less cost effective than omeprazole in the short term healing of duodenal ulcer and reflux oesophagitis disease. During longer term treatment, omeprazole is expected to be the dominating strategy over ranitidine-based therapy in Europe and the US. However, the inherent limitations of modelling studies reinforce the need for randomised prospective trials, preferably conducted in a general practice setting and including a quality-of-life analysis. Of the currently accepted approaches for the long term management of recurrent duodenal ulcer disease, daily maintenance therapy with ranitidine has been shown to be more cost effective than intermittent treatment for up to 2 years in the US. The annual cost of providing continuous maintenance therapy with ranitidine 150 mg/day is higher than with cimetidine 400 mg/day, although the extra benefits include a reduced risk of pain and discomfort from an expected lower rate of ulcer recurrence with ranitidine. Simultaneous ulcer healing and eradication of H. pylori markedly reduces relapse rates and is likely to become the management strategy of choice in H. pylori-positive patients, particularly with the advent of more convenient, well tolerated and effective regimens. Moreover, widespread clinical acceptance of H. pylori eradication may yield substantial cost savings to society by reducing the overall need for long term antisecretory therapy. Nonetheless, maintenance therapy with histamine H 2-receptor antagonists remains indicated for patients at high risk of ulcer recurrence who are poorly responsive to or cannot tolerate H. pylori eradication regimens. In summary, the proven efficacy and tolerability of ranitidine will ensure its continued use in the treatment of many patients with duodenal ulcer and mild to moderate reflux oesophagitis. However, there is increasing clinical and economic data favouring the selection of omeprazole in patients with more severe symptoms of these diseases.(ABSTRACT TRUNCATED AT 400 WORDS)
Administration, Oral↗
Using cost-effectiveness analysis for formulary decision making: from theory into practice.
The growth of expenditures on healthcare and pharmaceutical products is a concern to third-party payers because of the absence of market discipline (price signals that consumers face). Cost-effectiveness analysis is a method that allows third-party payers to systematically make judgements about the 'value for money' of these products. It moves beyond simple unit price comparisons of alternate interventions/products to consider the full stream of relevant cost and benefits. As formulary committees begin to adopt the systematic use of cost-effectiveness analyses to inform the debate, the exercise will move from an academic to a more practical application. This transition will require several important changes including defining the purpose of cost-effectiveness analysis, measurement of outcomes and data, format of reports, and contractual arrangements between the pharmaceutical industry and analysts. As more 'real world' experience is gained in the practical application of cost-effectiveness analysis, the quality of data will improve as will its value as an aid to decision making.
Cost-Benefit Analysis↗
Metoprolol: a pharmacoeconomic and quality-of-life evaluation of its use in hypertension, post-myocardial infarction and dilated cardiomyopathy.
Metoprolol is a beta 1-selective adrenoceptor antagonist that is widely used in several indications. A recent investigation has also highlighted a potential role for metoprolol in selected patients with idiopathic dilated cardiomyopathy. Pharmacoeconomic and quality-of-life data for metoprolol are limited to the areas of hypertension, post-myocardial infarction and idiopathic dilated cardiomyopathy. In these settings, metoprolol has shown beneficial effects on morbidity and mortality, or closely-related end-points. Controlled release formulations offer the potential to maximise the confirmed antihypertensive benefits of metoprolol by maintaining clinically effective plasma drug concentrations within a narrow range over a 24-hour interval between doses. Recent data support the use of controlled release metoprolol at the low dose of 50 mg/day. Metoprolol is at least as effective as many other antihypertensive drugs, although compared with thiazide diuretics at relatively high doses in the MAPHY (Metoprolol Atherosclerosis Prevention in Hypertensives) trial, metoprolol was associated with a more favourable effect on mortality. Pharmacoeconomic analysis, also based on the MAPHY trial, indicates that metoprolol is more cost effective than high dose thiazide diuretics in middle-aged men with mild to moderate hypertension. However, the advantage for beta-blockade in this trial is not supported by results of other studies, and the applicability of these data to current medical practice using lower thiazide doses is therefore questionable. Quality of life in patients with mild to moderate hypertension did not deteriorate in most investigations with metoprolol. Furthermore, quality of life was similar for controlled release metoprolol and atenolol. With conventional/matrix-based sustained release metoprolol, quality of life was less satisfactory than with lisinopril but was only marginally different from that with diltiazem (at lower than usual therapeutic doses). Nevertheless, these newer agents have no proven beneficial effect on mortality, and further studies are also warranted with controlled release metoprolol 50 mg/day. When administered post-myocardial infarction, conventional metoprolol was associated with significant improvements in quality of life and was cost saving over a 3-year period. Significant improvements in quality of life were also evident for metoprolol-treated patients with idiopathic dilated cardiomyopathy. In summary, available data support the continued extensive usage of metoprolol as treatment for hypertension and as therapy post-myocardial infarction. Pharmacoeconomic data supporting an advantage for metoprolol over high dose thiazides in hypertension needs further assessment in settings reflecting usual general practice approaches to managing patients with hypertension, while differences in quality of life between metoprolol and other antihypertensive agents appear to be marginal.(ABSTRACT TRUNCATED AT 400 WORDS)
Cardiomyopathy, Dilated↗
Selective serotonin reuptake inhibitors. Assessment for formulary inclusion.
Depression is a common and significant health problem associated with impairment in a patient's ability to function in their role (e.g. student, worker, home-maker), and may have a fatal outcome in the case of suicide. Recently there has been progress in developing new antidepressant medications, such as the selective serotonin reuptake inhibitors (SSRIs). These agents, while no more effective than the tricyclic antidepressant (TCA) drugs, are generally better tolerated than traditional medications used to treat depression. Further, because of their adverse effect profiles, they are generally better tolerated, and safer in overdose, than the TCAs. In response to concerns about aggregate healthcare costs, formularies are being employed to control the direct costs of prescription drugs. When direct drug costs alone are considered, the TCAs are initially less expensive than the SSRIs. However, compared with those taking SSRIs, patients taking TCAs withdraw from treatment more frequently, have more accidents, experience more adverse effects that require treatment, and are more likely to die from an overdose (if it occurs). Furthermore, unsuccessful treatment may be due to noncompliance, which is frequently related to adverse effects. Medications have effects on indirect costs. For example, adverse effects may impair productivity and lead to accidents in the home and at work. There are increased hospital and indirect costs of drugs used in overdose. Medication non-compliance may lead to failure to recover from depression, which results in ongoing expense to the state in the form of disability benefit payments. The largest cost savings are often associated with indirect costs, such as reduced benefit payments and improved productivity and earnings when treatment is successful. Taking all these considerations together, it does not appear that TCAs, taken over time, are any less expensive than the newer antidepressant medications.
Depressive Disorder↗
Using pharmacoeconomic analysis to make drug insurance coverage decisions.
Our objective was to institute a cost-effectiveness-based reimbursement eligibility and coverage scheme for drugs in the Canadian province of British Columbia. All applications from drug manufacturers requesting Pharmacare (British Columbia government-funded drug insurance plan) coverage were evaluated by the Pharmacoeconomic Initiative (PI) of British Columbia. PI recommendations are according to a majority decision reached by a multidisciplinary volunteer expert committee and are based on a critical evaluation of pharmacoeconomic studies submitted by manufacturers seeking reimbursement eligibility. Coverage for drugs is universal and completely free for the financially indigent. Others are charged a small copayment and/or a deductible. PI assessments are evidence-based. Published guidelines from the Canadian Coordinating Office of Health Technology Assessment (CCOHTA) and/or Ontario Ministry of Health guidelines for the economic evaluation of pharmaceuticals are recommended for preparing submissions to the PI. Between January 1996 and December 1996, the PI made recommendations on 21 submissions; 4 of these were cost-effectiveness or cost-utility analyses; 3 were cost-minimisation analyses; 6 were cost comparisons or cost-consequence analyses; and 8 were provincial formulary budget impact studies. Of the 21 PI recommendations, 18 were accepted by Pharmacare and decisions are pending for 2 others, thus providing a concordance rate of 95% (18/19; kappa = 0.89). A total of 7 of the 21 products were recommended for formulary inclusion by the PI; 4 were as per drug company requests (i.e. full-benefit status) and 3 were recommended under restricted use. Only 5 of 21 submissions, of which 4 had favourable reviews, complied with either the CCOHTA or the Ontario Ministry of Health guidelines. Most studies were conducted, not from a societal perspective, but from the perspective of the provincial healthcare system. Most of the analysis were short term and therefore discounting was not applied. Sensitivity analysis was not performed in more than half (52%) of the submissions, and 48% of applications used inappropriate comparators. Ontario is the only other Canadian province with a similar process, with cost-effectiveness criteria for reimbursement eligibility. However, analysis in that province during the same approximate time period demonstrated a low concordance between Ontario Drug Benefit and PI decisions (kappa = 0.07). Currently, the mandated or suggested use of technology assessments of pharmaceuticals with cost effectiveness as the primary end-point is a reality in several countries worldwide. Our results, based on actual experience from implementing such a programme, suggest that while industry is slow to adapt to the new reporting requirements it may also be sceptical about the importance of cost effectiveness and guideline compliance in decision-making.
British Columbia↗