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Lipid‐modifying and glucose-lowering therapies in clinical practice: The impact of guidelines and changing reimbursement schemes
Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
2012 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

cardiovascular disease, which is still a major cause of death that creates large burdens to society in terms of costs and morbidity. Dyslipidemia and type 2 diabetes mellitus are the main risk factors for cardiovascular disease, and national and international guidelines recommend lipid-modifying and glucose-lowering treatments for prevention. In 2010, about 836,000 (9% of the population) and 372,000 patients respectively were treated with these therapies in Sweden.

Various pharmaceutical policies aimed at improving the efficiency of drug use have been introduced over the years. Health technology assessment (HTA) was introduced in Sweden in 2002 as a foundation for informing pricing and reimbursement decisions by the Dental and Pharmaceutical Benefits Agency (TLV). Following HTA reviews, new reimbursement schemes for lipid-modifying and glucose-lowering therapies were introduced in 2009 and 2010 respectively. To assess the impact of the changing reimbursement schemes on the use and costs of these therapies, we analyzed data from the Swedish drug registry, using a quasi-experimental design and interrupted time series analyses.

Our results showed that the new reimbursement scheme for lipid-modifying treatment had a major effect on use; following the implementation of this scheme, there was a substantial increase in both discontinuation and switching to higher doses. Conversely, the new reimbursement scheme for glucose-lowering therapies had overall only a minor effect on use. Larger savings in the lipid market were anticipated but not fully realized, while even the minor anticipated changes in costs in the glucose-lowering market were not realized due to increased costs for insulins. We found that changes in reimbursement schemes might lead to unintended effects, which should be considered before implementation. Softer demand-side policies, such as recommendations and guidelines, might be a better option under some circumstances.

Clinical and national guidelines are other policies aimed at improving quality of care and drug use. We assessed the impact of guidelines on the quality of lipid-modifying therapies, defined as proportions of patients attaining goal/normal levels according to guidelines for lipid management. A longitudinal retrospective observational study was carried out, covering time periods before and after initiation of lipid-modifying treatment. The findings show that about 40% of the patients attained the recommended low-density lipoprotein cholesterol goals following treatment, but only 18% attained goals/normal levels in all lipid parameters. Improvement in triglycerides was moderate, and low levels of high-density lipoprotein cholesterol persisted, showing only modest improvement following therapy. Treatment patterns were found to have a better degree of adherence to guidelines regarding low-density lipoprotein cholesterol as compared to other lipid parameters.

The overall objective of treatment of type 2 diabetes mellitus is to improve glycemic control without negatively affecting quality of life. Hypoglycemia is a common side effect of intensive blood glucose control, mostly seen in patients treated with insulins. Earlier studies have suggested that hypoglycemia has a negative impact on quality of life, even in patients treated with oral glucose-lowering therapies. We carried out a cross-sectional retrospective study to assess the impact of self-reported experience of hypoglycemia on quality of life in Swedish adult patients with type 2 diabetes mellitus treated with a combination of metformin and sulfonylureas. The results showed that about 40% of the patients achieved the goal of glycemic control. About 19% reported experience of moderate or more severe hypoglycemia, and these patients were found to have lower quality of life than those patients reporting no or mild hypoglycemia, as measured by EQ-5D, a generic quality of life instrument. This could be important to consider in clinical practice.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2012. , 96 p.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1285
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-75545ISBN: 978-91-7519-998-6 (print)OAI: oai:DiVA.org:liu-75545DiVA: diva2:508122
Public defence
2012-03-30, Berzeliussalen, Hälsouniversitetet, Campus US, Linköpings universitet, Linköping, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2012-03-07 Created: 2012-03-07 Last updated: 2017-06-30Bibliographically approved
List of papers
1. Utilization and costs of lipid modifying therapies following health technology assessment for the new reimbursement scheme in Sweden
Open this publication in new window or tab >>Utilization and costs of lipid modifying therapies following health technology assessment for the new reimbursement scheme in Sweden
2012 (English)In: Health Policy, ISSN 0168-8510, E-ISSN 1872-6054, Vol. 104, no 1, 84-91 p.Article in journal (Refereed) Published
Abstract [en]

Introduction: A new reimbursement scheme (RS) for lipid modifying therapies (LMT) was implemented in Sweden in June 2009. Products on the market were continued, restricted or excluded in the new RS. The aim of this study was to compare utilization, costs and switching behavior in patients treated with LMT before and after the new RS. less thanbrgreater than less thanbrgreater thanMaterials and methods: This is a quasi-experimental study using data on dispensed LMT and costs from a database on dispensed individual prescriptions in Sweden. Segmented regression analyses were used to assess utilization and costs of LMT. less thanbrgreater than less thanbrgreater thanResults: Number of patients treated with products with restricted reimbursement increased in level (P=0.0336) following the changes in the scheme, while decreased in level (Pandlt;0.0001) for products excluded from the RS. Patients initially treated with products excluded from the RS discontinued to a greater extent, and switched to higher doses of the same substance or to generic simvastatin. The total annual costs decreased moderately. less thanbrgreater than less thanbrgreater thanConclusions: The decreasing trend in utilization of low-dose atorvastatin and rosuvastatin was accelerated and so was the increasing trend in utilization of generic simvastatin following the new RS. Switching to higher doses and discontinuation increased and expected savings were overestimated.

Place, publisher, year, edition, pages
Elsevier, 2012
Keyword
Pricing and reimbursement policy, Lipid modifying therapies, Drug utilization, Health technology assessment, Health economics
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-75289 (URN)10.1016/j.healthpol.2011.10.010 (DOI)000299761200011 ()
Available from: 2012-02-27 Created: 2012-02-24 Last updated: 2017-12-07
2. Prevalence of lipid abnormalities before and after introduction of lipid modifying therapy among Swedish patients with dyslipidemia (PRIMULA)
Open this publication in new window or tab >>Prevalence of lipid abnormalities before and after introduction of lipid modifying therapy among Swedish patients with dyslipidemia (PRIMULA)
Show others...
2010 (English)In: BMC PUBLIC HEALTH, ISSN 1471-2458, Vol. 10Article in journal (Refereed) Published
Abstract [en]

Background: Data on the prevalence of dyslipidemia and attainment of goal/normal lipid levels in a Swedish population are scarce. The objective of this study is to estimate the prevalence of dyslipidemia and attainment of goal/normal lipid levels in patients treated with lipid modifying therapy (LMT). Methods: This longitudinal retrospective observational study covers time periods before and after treatment. Data were collected from 1994-2007 electronic patient records in public primary healthcare centers in Uppsala County, Sweden. Patients were included if they had been treated with LMT and had at least one lipid abnormality indicating dyslipidemia and if complete lipid profile data were available. Thresholds levels for lipids were defined as per Swedish guidelines. Results: Among 5,424 patients included, at baseline, the prevalence of dyslipidemia (andgt;= 1 lipid abnormality) was by definition 100%, while this figure was 82% at follow-up. At baseline, 60% had elevated low-density lipoprotein (LDL-C) combined with low high-density lipoprotein (HDL-C) and/or elevated triglycerides (TG s), corresponding figure at follow-up was 36%. Low HDL-C and/or elevated TGs at follow-up remained at 69% for patients with type 2 diabetes mellitus (T2DM), 50% among patients with coronary heart disease (CHD) and 66% among patients with 10 year CHD risk andgt;20%. Of the total sample, 40% attained goal levels of LDL-C and 18% attained goal/normal levels on all three lipid parameters. Conclusions: Focusing therapy on LDL-C reduction allows 40% of patients to achieve LDL-C goal and helps reducing triglyceride levels. Almost 60% of patients experience persistent HDL-C and/or triglyceride abnormality independently of LDL-C levels and could be candidates for additional treatments.

Place, publisher, year, edition, pages
BioMed Central, 2010
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-64581 (URN)10.1186/1471-2458-10-737 (DOI)000285596300001 ()
Note
Original Publication: Billie Pettersson, Baishali Ambegaonkar, Vasilisa Sazonov, Mats Martinell, Jan Stalhammar and Per Wandell, Prevalence of lipid abnormalities before and after introduction of lipid modifying therapy among Swedish patients with dyslipidemia (PRIMULA), 2010, BMC PUBLIC HEALTH, (10), 737. http://dx.doi.org/10.1186/1471-2458-10-737 Licensee: BioMed Central http://www.biomedcentral.com/ Available from: 2011-01-28 Created: 2011-01-28 Last updated: 2012-03-07
3. Utilization and Costs of Glucose‐ lowering Therapies following Health Technology Assessment for the new reimbursement scheme in Sweden
Open this publication in new window or tab >>Utilization and Costs of Glucose‐ lowering Therapies following Health Technology Assessment for the new reimbursement scheme in Sweden
2012 (English)In: Health Policy, ISSN 0168-8510, E-ISSN 1872-6054, Vol. 108, no 2-3, 207-215 p.Article in journal (Other academic) Published
Abstract [en]

Objectives: A new reimbursement scheme (RS) for glucose lowering therapies (GLT) was implemented in Sweden on March 1, 2010. Products on the market were retained, restricted, excluded or excluded for new courses in the new RS. The aim of this study was to compare utilization and costs of GLT for type 2 diabetes Mellitus (T2DM) before and after the implementation of the changed RS.

Methods: This was a quasi-experimental study using data on dispensed GLT and costs from adatabase on dispensed individual based prescriptions in Sweden.  Segmentedregression analyses were used to assess utilization and costs.

Results: Following the changed reimbursement status, there was an accelerated increasing trend in number of patients treated with restricted (P=0.0007) or retained (P=0.0021) insulins, as well as in costs for insulin based GLT (P=0.0014). No impact was detected in the total number of patients treated with oral GLT, but a slightly negative trend in total costs for oral GLT was detected following the intervention (P=0.0177).

Conclusions: The new reimbursement scheme had a minor impact on utilization and costs of oral GLT. Despite restricted reimbursement for patients with T2DM, the utilization of insulin based GLT and related costs increased faster following the intervention.

Place, publisher, year, edition, pages
Elsevier, 2012
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-75538 (URN)10.1016/j.healthpol.2012.10.008 (DOI)000313535300012 ()
Available from: 2012-03-07 Created: 2012-03-07 Last updated: 2017-12-07Bibliographically approved
4. Self-reported experience of hypoglycemia among adults with type 2 diabetes mellitus (Exhype)
Open this publication in new window or tab >>Self-reported experience of hypoglycemia among adults with type 2 diabetes mellitus (Exhype)
Show others...
2011 (English)In: DIABETES RESEARCH AND CLINICAL PRACTICE, ISSN 0168-8227, Vol. 92, no 1, 19-25 p.Article in journal (Refereed) Published
Abstract [en]

Aims: To evaluate the experience of hypoglycemia in patients treated with metformin in combination with sulphonylureas (SUs) and the impact on patients quality of life (QoL) and worry about hypoglycemia. Methods: This was a national, cross-sectional, multicenter study. Patients with type 2 diabetes treated with metformin and SU dual therapy were recruited by 54 investigators between January 2009 and August 2009. The patients were asked to complete a QoL instrument, the EuroQol-5 Dimensions questionnaire (EQ-5D), and the Hypoglycemia Fear Survey (HFS-II). Investigators completed a web-based case report form on laboratory values, medical history and anti-diabetic treatment. Results: A total of 430 patients (60% male) were included in the study. Mean age was 69 years. Approximately one fifth of the patients experienced moderate or worse symptoms of hypoglycemia. Patients who experienced moderate or worse hypoglycemia had lower QoL as measured by the weighted EQ-5D summary score (0.81 vs. 0.88; p andlt; 0.001) than patients who experienced mild or no hypoglycemia. Conclusions: Experience of hypoglycemia was found to be associated with lower QoL inpatients with type 2 diabetes on dual treatment with metformin and sulphonylurea. This should be taken into consideration when selecting treatment for these patients in clinical practice.

Place, publisher, year, edition, pages
Elsevier Science B.V., Amsterdam., 2011
Keyword
Quality of life and hypoglycemia, QoL, Hypoglycemia, Diabetes, EQ-5D
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-67973 (URN)10.1016/j.diabres.2010.12.005 (DOI)000289558300012 ()
Available from: 2011-05-04 Created: 2011-05-04 Last updated: 2012-03-07

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