Copayments are common measures intended to control drug expenditures and promote rational prescribing. In Finland, new antiglaucoma drugs start with a high copayment, but once sufficient clinical experience is available, they are reevaluated and can receive a lower copayment status.
This study assessed the effect of changes in copayment level on the adoption of 2 antiglaucoma drugs.
A retrospective analysis was performed from 1997 to 2001 using the Finnish national register of reimbursed drug purchases, which covers approximately 98% of all antiglaucoma drug purchases in the country. There were 172,293 purchases of dorzolamide (plain or combined with timolol) and 281,377 purchases of latanoprost. An interrupted time-series design from approximately 30 months before and 20 months after the change in copayment was used in the analysis. The main outcome measures were the numbers of defined daily doses (DDDs) purchased and the monthly numbers of patients who purchased the study drugs for the first time before and after the change in copayment.
A substantial increase in consumption of both dorzolamide and latanoprost was seen immediately after the introduction of the lower copayment. The monthly consumption of dorzolamide was 60,713 DDDs higher and the monthly consumption of latanoprost was 49,330 DDDs higher than expected according to the utilization trend during the higher copayment period. Twelve months later, the observed consumption of dorzolamide was 109% higher and that of latanoprost was 21% higher than if the copayment had remained the same. The number of new patients using the study drugs peaked within 2 months of the lower copayment, but the amount consumed per patient per day remained quite stable.
Decreasing the copayment of a new antiglaucoma drug to the same level as the copayments of alternative drugs accelerated the adoption of these new products in Finland.
To study the relations between postnatal maternal morbidity, child morbidity and welfare interventions in families with prenatal alcohol or substance abuse.
A register-based longitudinal retrospective cohort study. The exposed cohort included 638 children born to 524 women followed-up during pregnancy for alcohol or substance abuse 1992-2001. Non-exposed children (n = 1914) born to control women were matched for maternal age, parity, number of foetuses, month of birth and delivery hospital of the index child. Perinatal and follow-up data of both cohorts were collected from national registers until 2007.
Postnatal maternal abuse-related healthcare utilization and use of medication were associated with child out-of-home care. Significant differences were in particular observed in the categories of maternal mental and behavioural disorders caused by psychoactive substance use as well as injury and poisoning. Maternal inpatient care for mental and behavioural disorders peaked at the time of child out-of-home care. Maternal abuse-related healthcare utilization was associated with early child healthcare utilization and use of medication for mental and behavioural disorders. These associations were largely explained by the association with child out-of-home care.
Postnatal maternal abuse-related morbidity is associated with significant early child morbidity, use of medication and timing of out-of-home care.
Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway's practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge.
Cites: Lancet. 2005 Feb 12-18;365(9459):579-8715708101
For rare diseases it may be difficult to generate data from randomized trials to support funding of a drug. Enzyme replacement therapies for diseases of inherited metabolic enzyme deficiency provide an example of this dilemma. The Ontario Public Drug Programs convened the Drugs for Rare Diseases Working Group to develop a policy for assessing these drugs.
The Drugs for Rare Diseases Working Group developed terms of reference expecting that the ideal policy product would be transparent and consistent and address unique aspects of the treatment of a specific rare condition while being adaptable to other dissimilar conditions. The perspective was that of a public payer addressing requests for funding generated for a specific drug, and included respect for the principles of "accountability for reasonableness" of Daniels and Sabin.
A seven-step framework was developed and tested by using the case study of idursulfase for mucopolysaccharidosis II (Hunter disease). Estimation of clinical effectiveness was done by using decision modeling. The model developed informed funding recommendations and ultimately led to an agreement with the manufacturer allowing funding of idursulfase in Ontario.
This policy framework attempts to address the policy challenges of funding drugs for rare diseases. The framework will be used to assess other drugs in future and will inevitably require modification with experience. It is hoped that it may be of value to other policymakers.
Self-reported angina symptoms are collected in epidemiological surveys. We aimed at validating the angina symptoms assessed by the Rose Questionnaire against registry data on coronary heart disease. A further aim was to examine the sex paradox in angina implying that women report more symptoms, whereas men have more coronary events.
Angina symptoms of 6601 employees of the City of Helsinki were examined using the postal questionnaire survey data combined with coronary heart disease registries.
The self-reported angina was classified as no symptoms, atypical pain, exertional chest pain, and stable angina symptoms. Reimbursed medications and hospital admissions were available from registries 10 years before the survey. Binomial regression analysis was used.
Stable angina symptoms were associated with hospital admissions and reimbursed medications [prevalence ratio (PR), 6.75; 95% confidence interval (CI), 4.56-9.99]. In addition, exertional chest pain (PR, 5.31; 95% CI, 3.45-8.18) was associated with coronary events. All events were more prevalent among men than women (PR, 2.36; 95% CI, 1.72-3.25).
The Rose Questionnaire remains a valid tool to distinguish healthy people from those with coronary heart disease. However, a notable part of those reporting symptoms have no confirmation of coronary heart disease in the registries. The female excess of symptoms and male excess of events may reflect inequality or delay in access to treatment, problems in identification and diagnosis, or more complex issues related to self-reported angina symptoms.
We tested the traditional format of the American Rheumatism Association (ARA) 1987 revised criteria for the classification of rheumatoid arthritis (RA) in a cohort of 220 subjects with drug reimbursement for chronic rheumatic diseases extracted from the National Sickness Insurance Register, in a community of 18,000 people in Finland. One hundred and nine of the 193 who consented to the study both met the new ARA criteria for RA and had disease onset after 16 years of age, giving a cumulative prevalence of 0.8% in the population of 13,300 over 16 years. The disease of 6 of them, however, fulfilled the criteria and clinical picture of some other rheumatic disease. Thus 103 patients had RA as the only diagnosis. The female:male ratio in the 103 patients was 1.7:1. Ninety-one (88%) had seropositivity at some time in their disease and 99 (96%) had erosive joint disease. In most instances the 12 seronegatives had either mild or nontypical RA and only one of them was male. The 103 patients who met the new ARA criteria had significantly more interventions, such as hospitalization, drug treatment and orthopedic surgery, than the subjects (n = 42) who despite a clinician's primary diagnosis of RA did not fulfill the criteria. Thus the new ARA criteria distinguish clinical and severe cases of RA from nonclinical or non-RA cases when applied to a population based cohort of subjects with chronic rheumatic diseases registered for drug reimbursement.
Older people are the largest and fastest growing group of patients with end-stage renal disease (ESRD), and, due to advanced age and a heavy burden of comorbidities, they are usually not candidates for renal transplantation or home-based dialysis treatment. Some of the barriers for home treatment are non-modifiable, but the majority of physical disabilities and psychosocial problems can be overcome provided that assistance is offered to the patients at home.In the present review, we describe the programs for assisted peritoneal dialysis (PD) in France and Denmark, respectively. In both nations, assisted PD is totally publicly funded, and the cost of assisted PD is comparable to the cost of in-center HD. Assisted continuous ambulatory PD (aCAPD) is the preferred modality in France whereas assisted automated PD (aAPD) is the preferred modality in Denmark. Assistants are professional nurses or healthcare technicians briefly educated by expert PD nurses from the dialysis unit.The establishment of a program for assisted PD may increase the number of patients actually treated with PD and may reduce the risk of PD technique failure and prolong PD duration. Compared with autonomous PD patients, patients on assisted PD may have shorter patient survival and peritonitis-free survival indicating that, besides advanced age and the burden of comorbidities, dependency on help may be an independent risk factor for poorer outcome.Assisted PD is an evolving dialysis modality, and may in the future prove to be a feasible complementary alternative to in-center hemodialysis (HD) for the growing group of dependent older patients with ESRD.
On March 1st 2009, restrictions on the dispensing of selective serotonin reuptake inhibitors (SSRI) in Iceland were lifted. Incident rates and changes in early discontinuation and switching before and after the change were investigated.
New users of antidepressants between March 1st 2006 and March 1st 2010 were selected from the Icelandic Prescriptions Database. The study population was split into one intervention cohort (2009) and three comparison cohorts (2006, 2007, and 2008). Incidence rate ratios (IRR) and odds ratios (OR) were used to compare incidence rates and early discontinuation.
The overall incidence rates of antidepressant use decreased from 33.10 to 28.71 per 1000 persons per year (IRR 0.87; 95% confidence interval (CI), 0.78-0.97) from the 2006 to the 2009 cohort. The incidence rate for SSRIs did not change over the period. Early discontinuation for SSRIs increased from 30.2% in 2006 to 34.1% in 2009 (OR 1.19; 95% CI 1.06-1.33).
The change in reimbursement does not seem to have affected incidence rates but it may be related to increased early discontinuation, which can lead to increased drug wastage. It might be more clinically rational to initiate patients on smaller supply, allowing for more frequent check-up visits.