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Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands
Eur J Vasc Endovasc Surg (2017) 54, 51e57
Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands D. Hageman a,b, H.J.P. Fokkenrood c, P.P.M. Essers d, M.J.W. Koelemay e, J.C. Breek f, A.C. Vahl g, M.R.M. Scheltinga h, J.A.W. Teijink a,b,* a
Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands c Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands d Centre of Expertise Care Control, CZ, Tilburg, The Netherlands e Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands f Department of Vascular Surgery, Martini Hospital, Groningen, The Netherlands g Department of Vascular Surgery, OLVG, Amsterdam, The Netherlands h Department of Vascular Surgery, Máxima Medical Centre, Veldhoven, The Netherlands b
WHAT THIS PAPER ADDS This was a follow-up study of a budget impact analysis regarding a supervised exercise therapy (SET) first strategy (stepped care model [SCM]) for patients with intermittent claudication (IC) in the Netherlands. The aim was to investigate whether several campaigns to improve the incorporation of SCM resulted in higher SET participation and corresponding savings after a 2 year period. A 22% increase in adherence to the SCM was attained between 2009 and 2011, conferring an estimated 6% reduction in the cost of IC treatment. As this study used a large database (3.5 million persons) with real world data, daily practice is well reflected in the results. The results of this study call for further SCM incorporation which will probably lead to additional healthcare resource savings. Objective/Background: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period. Methods: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. Results: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; þ22% [p < .001]) and INT in 44% (2009: 66%; 22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; þ13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; 16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; þ19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (V6885 vs. V7300; p ¼ .020). Conclusion: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system. Ó 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. Article history: Received 10 December 2016, Accepted 15 April 2017, Available online 20 May 2017 Keywords: Budget, Conservative treatment, Economic evaluation, Exercise, Exercise therapy, Intermittent claudication, Peripheral arterial disease, Walking * Corresponding author. Department of Vascular Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, P.O. Box 1350, 5602 ZA Eindhoven, The Netherlands. E-mail address: [email protected] (J.A.W. Teijink). 1078-5884/Ó 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2017.04.011
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INTRODUCTION Treatment strategies for peripheral arterial disease (PAD) are well described in international guidelines recommending supervised exercise therapy (SET) as first line treatment for patients with intermittent claudication (IC).1e3 The advocated treatment strategy for IC may be incorporated into a so called stepped care model (SCM), which aims initially to refer patients to a SET program and restrict revascularisation to those not responding to SET.4e6 Despite the overwhelming evidence supporting the effectiveness of SET, these programs are often not fully reimbursed.7e15 As a consequence, SCM participation may be suboptimal, leading to minimally effective “walking advice” or a more expensive but fully reimbursed vascular intervention as an alternative first line treatment strategy. A budget impact analysis investigating the overall economic consequences of SCM implementation in the Dutch healthcare system was previously published.12 The results indicated that the proportion of patients with IC who had received a SET first treatment strategy in 2009 was 14% while 28% had received invasive revascularisation. Conversely, the remaining 58% neither started SET nor underwent revascularisation as a first line of treatment. Based on hypothetical scenarios, it was concluded that SCM implementation could possibly lead to annual national savings up to V33 million. In recent years, the functional and economic advantages of a SET first strategy are increasingly appreciated.4,16e21 Also, a nationwide network of physiotherapists was created to improve the quality of SET in the Netherlands.5,6 Therefore, a follow-up study of the budget impact analysis was performed to reassess SCM implementation in the Dutch healthcare system after a 2 year period. It was hypothesized that SCM adherence was improved and revascularisation as the initial treatment decreased. As a consequence, a significant reduction in healthcare costs was expected.
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patients who had received an invoice related to PAD in the 24 months before presentation (2009 or 2010) were excluded. Patients who had changed health insurance in 2009 or 2010 and thus possibly harboured an unknown 2 year history of PAD were also excluded. To obtain a complete set of follow-up data, all patients who had changed health insurance in the 24 months after presentation (2012 or 2013) were also excluded. The presence of comorbidity was based on prescribed medication. The study was conducted in close collaboration with CZ and approved by its board members. The study complied with all privacy legislation. The insurance database was only accessible to staff. Extracted data were not traceable to individuals. Definition of groups Patients were divided into two groups based on their primary treatment, defined as IC treatment (SET or revascularisation) that was initiated between 12 months before and 3 months after presentation at a vascular surgery outpatient clinic (Fig. 1). The SET group had started community based SET between 12 months before and 3 months after outpatient presentation. SET initiation by the general practitioner was assumed in patients who had started SET prior to outpatient presentation. The intervention (INT) group was treated by endovascular or open revascularisation within 3 months of outpatient presentation.
MATERIALS AND METHODS Inclusion and exclusion The 2011 database of CZ, a large Dutch health insurance company (3,483,717 insured persons, approximately 21% of the Dutch population) was analysed (Fig. 1). CZ has nationwide coverage and has contracted all hospitals. Therefore, the data are assumed to be representative of the rest of the population. In the Netherlands, hospitals are reimbursed based on fixed combinations of diagnosis and treatment (diagnosis treatment combination system). A diagnosis code is registered by physicians at outpatient presentation and recorded in all invoices. All persons who received an invoice related to PAD Fontaine II (IC), as documented by a vascular surgeon (diagnosis code 418) in 2011, were identified. Only patients newly diagnosed with IC who were exclusively CZ insured for an entire 48 month period between 2009 and 2013 were eligible for inclusion. To restrict the study to patients newly diagnosed with IC, all
Figure 1. Flow diagram of patient selection. Note. Straight line indicates primary treatment; dashed line indicates secondary treatment. PAD ¼ peripheral arterial disease; IC ¼ intermittent claudication; SET ¼ supervised exercise therapy; INT ¼ intervention.
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Table 1. Patient characteristics in 2009 and 2011. SET group INT group SETeINT difference 2009 2011 p 2009 2011 p 2009 2011 Total 701 (34.0) 944 (55.9) < .001 1363 (66.0) 746 (44.1) < .001 e e Male 402 (57.3) 556 (58.9) .528 883 (64.8) 472 (63.3) .488 .001 .067 Mean SD age (y) 69.4 10.2 68.6 9.4 .101 65.2 10.7 64.2 10.9 .053 < .001 < .001 CHF 67 (9.6) 99 (10.5) .536 119 (8.7) 68 (9.1) .766 .534 .348 DM2 48 (6.9) 75 (7.9) .403 95 (7.0) 50 (6.7) .816 .917 .332 HCL 214 (30.5) 272 (28.8) .451 399 (29.3) 197 (26.4) .162 .555 .273 Note. Data are n (%) unless otherwise indicated. Significant values are in bold. SET ¼ supervised exercise therapy; INT ¼ intervention; CHF ¼ congestive heart failure; DM2 ¼ diabetes mellitus type 2; HCL ¼ hypercholesterolaemia.
Based on the diagnosis 418 code, a substantial number of persons who received neither SET nor revascularisation within 3 months of outpatient presentation was identified. This population, termed the “REST” group, contained not only patients with IC, but also an unknown proportion of individuals without PAD. As this group was highly heterogeneous (patients receiving initial treatment other than SET or revascularisation (e.g., a walking advice, medication only, etc.), treatment delay, as well as individuals wrongly labeled as having IC), it was decided by consensus to exclude the REST group from analysis. Secondary treatment was defined as IC treatment (SET or revascularisation) that was initiated between 3 and 24 months after outpatient presentation. Secondary treatment included secondary ipsilateral intervention and primary contralateral intervention. Differentiating between these groups was impossible because of the nature of the database. SCM implementation between 2009 and 2011 SCM implementation was estimated by calculating change in SET as the initial treatment as measured in 2009 and 2011. Costs of IC treatment Physician based and physiotherapist based invoices for primary and secondary treatment of IC within 24 months of follow-up were analysed. Total costs per group were calculated by adding all costs of IC treatment in the group of initial allocation. Mean total costs (MTCs) per patient in each group were calculated by dividing total costs per group by number of patients allocated per group. Average costs of IC treatment per patient were calculated by dividing total costs of IC treatment by total number of patients. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. Mean costs of IC treatment in 2009 were updated to 2011 levels using the Dutch inflation index (http://statline.cbs.nl). Data analysis The insurance database was analysed with SAS (SAS Institute Inc., Cary, NC, USA). Differences in continuous and categorical variables between groups were assessed using the independent two sample t test or chi-square test. Statistical analyses were performed using SPSS 23 software
(IBM, Armonk, NY, USA). A p value < .05 was considered statistically significant. Calculations of costs were made using Excel 2010 software (Microsoft, Redmond, WA, USA). RESULTS Patient characteristics A total of 5869 patients with invoices related to PAD Fontaine II (IC) were identified from the 2011 CZ database (Fig. 1). After exclusion of 1734 patients as per protocol, 4135 patients were potentially eligible for inclusion. As 2445 patients neither started SET nor underwent revascularisation within 3 months of presentation (REST group; n ¼ 2890 in 2009; p ¼ .445) and were thus excluded, a total of 1690 patients were analysed. Details of the 2009 patient selection were reported previously.12 Patient characteristics of the two groups are shown in Table 1. A significant difference was only found regarding age as patients in the SET group were approximately 4 years older than those in the INT group. In contrast, comorbidity was similar between groups. SCM implementation between 2009 and 2011 Of 1690 patients in 2011, 56% (n ¼ 944) started SET as initial treatment versus 34% (n ¼ 701) in 2009 (þ22%; p < .001), whereas 44% (n ¼ 746) were treated with revascularisation as initial treatment versus 66% (n ¼ 1363) in 2009 (22%; p < .001), resulting in 22% (95% confidence interval [CI] 19e25) increased adherence to the SCM. Primary and secondary treatment Primary and secondary treatments are shown in Tables 2 and 3. In the SET group, 19% (n ¼ 176) were subsequently treated by revascularisation within 2 years of presentation versus 6% (n ¼ 45) in 2009 (þ13%; p < .001). In the INT group patients (n ¼ 746), 571 endovascular and 236 open surgical procedures were performed as initial treatment. Within 2 years of presentation, 29% (n ¼ 214) were later on referred for SET versus 10% (n ¼ 141) in 2009 (þ19%; p < .001), whereas 19% (n ¼ 144) were subsequently treated by additional revascularisation versus 35% (n ¼ 480) in 2009 (16%; p < 0001). Overall, 55% (746 patients in the INT group and 176 patients in the SET group) were treated by revascularisation within 2 years of presentation versus 68% (1363 INT and 45 SET patients) in 2009
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Table 2. Vascular interventions in 2009 and 2011. Primary treatment Secondary treatment INT group SET group INT group 2009 2011 2009 2011 p 2009 2011 p Patients with vascular interventions (%) 1363 746 45 176 < .001 480 144 < .001 (100) (100) (6.4) (18.6) (35.2) (19.3) Total invoices 1373 813 47 218 e 480 181 e Interventional radiology 1056 496 45 166 e 464 118 e Vascular surgery 317 317 2 52 e 16 63 e Endovascular 9 75 Open 308 236 Unspecified 0 6 Note. Data are n unless otherwise indicated. Significant values are in bold. INT ¼ intervention; SET ¼ supervised exercise therapy. Table 3. Supervised exercise therapy (SET) sessions in 2009 and 2011. Primary treatment Secondary treatment SET group SET group 2009 2011 p 2009 2011 p Patients with SET, n (%) 701 944 e NR NR NR (100) (100) Mean SD (min.emax.) SET 48 42 46 35 0.293 NR NR NR sessions per patient (1e272) (1e263) Note. Significant values are in bold. INT ¼ intervention; NR ¼ not relevant.
(13%, p < .001), whereas 69% (944 SET and 214 INT patients) were referred for SET within 2 years of presentation versus 41% (701 SET and 141 INT patients) in 2009 (þ28%; p < .001). Costs of IC treatment Costs of IC treatment are shown in Table 4. Compared with the 2009 cohort, physician based invoices and MTCs increased in both groups (þ139% and þ12% increased physician based invoices, and þ54% and þ14% increased MTCs in the SET and INT groups, respectively). Physiotherapist based invoices increased in the INT group only (5% and þ175% in the SET and INT groups, respectively). In contrast to the 2009 cohort, MTCs depended most on physician based invoices and least on physiotherapist based invoices in both groups. Even in the SET group, physician based invoices (V2142) were almost twice as high as the physiotherapist based invoices (V1251). MTCs in the INT group (V11,303) were more than three times higher than in the SET group (V3393). Average costs of IC treatment per patient were V6885 in 2011 versus V7300 in 2009, resulting in an estimated 6% reduction in costs of IC treatment (V415 [95% CI 64e766] per IC patient; p ¼ .020). Based on 1690 patients in 2011, this would equal annual cost reductions of approximately V0.7 million for CZ and V3.4 million for the Dutch population, respectively. DISCUSSION The aim of this study was to reassess adherence to SET as first treatment strategy (SCM) for patients with IC in the Netherlands after a 2 year period. The present study demonstrates a 22% increase in adherence to a SET first approach between 2009 and 2011, conferring an estimated
INT group 2009 141 (10.3) 38 35 (1e176)
2011 214 (28.7) 37 32 (1e151)
p < .001 .782
6% reduction in costs of IC treatment. This shift from revascularisation to SET as first line treatment for patients with IC suggests successful SCM implementation in the Dutch healthcare system. Despite changing rates of secondary interventions, costs of IC treatment in the SET group were still less than a third of those of the INT group. Apart from a growing number of studies supporting the effectiveness of SET as first line treatment, this study again demonstrates that SET is a less expensive treatment option for patients with IC. Stimulating further SCM incorporation will probably lead to additional savings of healthcare resources. Several causes of a shift towards a SET first approach in IC may be identified. In recent years, awareness of the social and economic consequences of PAD and IC has increased among physicians and health insurers. SET has gained attention in scientific research and received some emphasis at conferences. Several meta-analyses and cost effectiveness analyses have been published favouring a SET first treatment strategy for IC.4,16e21 Moreover, contemporary guidelines on the management of PAD were revised and updated recommending SET as first line treatment for all patients with IC.1,22,23 Furthermore, a nationwide network of physiotherapists was created in January 2011 in the Netherlands, improving the quality and availability of well organised community based SET programs.5,6 However, the effect of this network is possibly limited during the period between 2009 and 2011 as nationwide coverage was only attained at the beginning of 2014. Nevertheless, this set of parallel strategies probably resulted in improved rates of SET as the first treatment option in IC. Moreover, it is assumed that the proportion of SET referrals further increased after 2011 and it is also expected that this trend will continue in the coming years.
Change 10.7% (p < .001) þ60.7% (p < .001) 5.7% (p [ .020) 2011 V6055 (134e66,412) V829 (28e7403) V6885 2009a V6784 (99e50,173) V516 (28e7187) V7300 Change 2011 Change Physician þ139.0% V11,007 þ12.2% based invoices (p < .001) (1581e66,412) (p < .001) Physiotherapist 4.5% V296 þ174.7% based invoices (p ¼ .265) (28e4256) (p < .001) Mean total costs þ53.8% V11,303 þ13.9% (p < .001) (p < .001) Note. Significant values are in bold. SET ¼ supervised exercise therapy; INT ¼ intervention. a Mean costs of IC treatment in 2009 were updated to 2011 levels using the Dutch inflation index (http://statline.cbs.nl). 2011 V2142 (134e31,821) V1251 (28e7403) V3393
INT group Mean (min.emax.) 2009a V9813 (2515e50,173) V108 (28e4914) V9920 SET group Mean (min.emax.) 2009a V896 (99e14,428) V1310 (28e7187) V2206
Table 4. Costs of intermittent claudication (IC) treatment per patient in 2009 and 2011.
Average costs of IC treatment per patient Mean (min.emax.)
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Despite improved SCM adherence, SET is still underutilised in clinical practice. The worldwide implementation of SET programs is hampered for three different reasons.13,15 First, there is patient resistance as SET places a particular burden on patients in terms of effort and responsibility, rather than offering a “quick fix” for their discomfort. Second, the self interest of doctors performing interventions that involve fee for service is undoubtedly a contributor. Moreover, outdated arguments favouring an invasive intervention, instead of prescribing SET, such as IC due to aorto-iliac lesions and cardiopulmonary comorbidity, still prevail.9,12 The third, and most important factor hindering a wider implementation of SET, is lack of access and reimbursement. As a result, even clinicians who fully endorse SET as initial treatment for IC may end up performing invasive interventions if their patients cannot find a qualified SET practitioner. Recently, efforts aimed at changing the reimbursement issues were met with success as from 1 January 2017 SET is fully covered by the basic health insurance in the Netherlands.24,25 This decision is based, in part, on a previous study showing that SCM implementation could possibly lead to annual national savings of up to V33 million.12 Apart from a decreased primary intervention rate, the present study also demonstrated an increase of secondary interventions in the SET group and a decrease of secondary interventions in the INT group compared with the previous study.12 The increased secondary intervention rate in the SET group may be a consequence of gradual SCM implementation as some patients with IC initially referred for SET fail to achieve sufficient results and may need additional revascularisation. Unfortunately, potential predictors of failing a SET program are not yet defined. However, many of the factors that may render a patient a poor candidate for SET may also apply as relative contraindications for an invasive treatment.3 Nonetheless, > 80% of the SET group did not require invasive treatment within 2 years of presentation. This percentage is possibly even higher than reported by Fakhry et al.,26 who found that almost half of the population randomised to SET demonstrated a sustained improvement in functional performance and quality of life after 7 years without the need for any secondary intervention. These findings clearly lend credit to a SET first approach for IC, thereby excluding patients from invasive endovascular or surgical treatments and potential complications. The decreased secondary intervention rate in the INT group may be a consequence of an increased rate of SET referrals within 2 years of presentation as the addition of a SET program may prevent deterioration despite restenosis or progression of atherosclerotic lesions. This phenomenon was also found in the ERASE trial, which demonstrated that only 4% receiving a combination of endovascular revascularisation and SET required a secondary intervention at the 1 year follow-up because of recurrent IC symptoms, even though almost one third showed a restenosis of their initially revascularised lesion.27 Similarly, Mazari et al. found that combining the two treatments had a sustained effect,
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while reducing the rate (and costs) of re-interventions.28 These studies clearly suggest that SET may play an important role as an adjuvant therapy after revascularisation in patients with IC. It may well be that a combination of therapies for IC may prove more effective in improving walking impairment compared with a single treatment approach. The ERASE trial showed that a combination of endovascular revascularisation followed by SET resulted in significantly greater improvement in walking distances and health related quality of life scores than SET only.27 However, an important condition to achieve this synergistic effect is to have a well established standardised and accessible SET program for patients to follow after the endovascular revascularisation procedure, which is not the case in most countries. Therefore, the results of the ERASE trial should not be interpreted as evidence supporting increases in rates of lower extremity revascularisation, but rather as an incentive for strategies required to ensure that effective SET programs are accessible for all patients with IC.29 Increasingly unaffordable healthcare costs necessitate economically viable and efficient healthcare plans.30 Although the present study demonstrates an estimated V415 reduction in healthcare costs per patient with IC, these savings are lower than one would expect based on the results of a previous study.12 When comparing the 2011 and 2009 data, physician based invoices increased in both groups, whereas physiotherapists based invoices did not significantly change or hardly contributed to the change in costs of IC treatment. Even in the INT group, physician based invoices increased despite a decreased secondary intervention rate. Consequently, the results of the present study call for SCM optimisation. In the future, further efforts should be made to stimulate a SET first approach for all patients with IC, restricting expensive imaging techniques and invasive treatments to those not responding to SET. Limitations This study has potential limitations. First, it may be argued that the insurance database was dated. However, as a standard such databases are completed retrospectively. A complete set of invoice data are only available after 2 years. Second, a more serious concern is the large number of patients in the REST group. Limitations of the insurance database do not allow for determining with certainty that a person suffers from PAD. As the focus is on cost registration, details of treatment are often unclear. For instance, when a person is referred to a vascular surgeon for evaluation of suspected IC, an “IC” invoice is registered. However, if PAD is ruled out following testing, this invoice is often not replaced by a “ruling out PAD” invoice. These faulty assignments may have contaminated the data sets. Third, a potential selection bias may be present as patients with aorto-iliac lesions or cardiopulmonary comorbidity may have been treated primarily by revascularisation, based on surgeon preferences.9,12 However, all included patients were diagnosed with IC and should have started SET
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according to contemporary guidelines.1e3 Fourth, a significant difference in age between groups was found. Unfortunately, it was impossible to adjust the analyses for this covariate because of limitations of the insurance database. Fifth, it was also impossible to differentiate between secondary ipsilateral and primary contralateral treatment. This is an important limitation because SET and revascularisation have different influences on the vascular branch. SET trains both legs, whereas revascularisation just repairs one leg. Therefore, the number of primary contralateral revascularisations in the INT group would be interesting to investigate as these may have been unnecessary in the SET group. Last, it would be of interest to take other important outcomes, such as walking distances, health related quality of life, and cost effectiveness, into consideration. However, this was impossible as data on these parameters were not included in the insurance database. CONCLUSION A 22% increase in adherence to SET as first treatment strategy in Dutch patients with IC was achieved between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system. CONFLICT OF INTEREST None. FUNDING None. REFERENCES 1 Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/ AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006;113(11):e463e654. 2 Layden J, Michaels J, Bermingham S, Higgins B. Diagnosis and management of lower limb peripheral arterial disease: summary of NICE guidance. BMJ 2012;345:e4947. 3 Conte MS, Pomposelli FB, Clair DG, Geraghty PJ, McKinsey JF, Mills JL, et al. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg 2015;61(3 Suppl.):2Se41S. 4 O’Brien-Irr MS, Harris LM, Dosluoglu HH, Dryjski ML. Endovascular intervention for treatment of claudication: is it costeffective? Ann Vasc Surg 2010;24(6):833e40.
Improved Adherence to a Stepped-care Model 5 Lauret GJ, Gijsbers HJ, Hendriks EJ, Bartelink ML, de Bie RA, Teijink JA. The ClaudicatioNet concept: design of a national integrated care network providing active and healthy aging for patients with intermittent claudication. Vasc Health Risk Manag 2012;8:495e503. 6 Fokkenrood HJ, Lauret GJ, Scheltinga MR, Spreeuwenberg C, de Bie RA, Teijink JA. Multidisciplinary treatment for peripheral arterial occlusive disease and the role of eHealth and mHealth. J Multidiscip Healthc 2012;5:257e63. 7 Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation 2011;123(5):491e8. 8 Saxton JM, Zwierska I, Blagojevic M, Choksy SA, Nawaz S, Pockley AG. Upper- versus lower-limb aerobic exercise training on health-related quality of life in patients with symptomatic peripheral arterial disease. J Vasc Surg 2011;53(5):1265e73. 9 Lauret GJ, van Dalen HC, Hendriks HJ, van Sterkenburg SM, Koelemay MJ, Zeebregts CJ, et al. When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. Eur J Vasc Endovasc Surg 2012;43(3):308e12. 10 Makris GC, Lattimer CR, Lavida A, Geroulakos G. Availability of supervised exercise programs and the role of structured homebased exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg 2012;44(6):569e75. 11 Mays RJ, Regensteiner JG. Exercise therapy for claudication: latest advances. Curr Treat Options Cardiovasc Med 2013;15(2):188e99. 12 Fokkenrood HJ, Scheltinga MR, Koelemay MJ, Breek JC, Hasaart F, Vahl AC, et al. Significant savings with a stepped care model for treatment of patients with intermittent claudication. Eur J Vasc Endovasc Surg 2014;48(4):423e9. 13 Popplewell MA, Bradbury AW. Why do health systems not fund supervised exercise programmes for intermittent claudication? Eur J Vasc Endovasc Surg 2014;48(6):608e10. 14 Evans T, Roberts M, Lewis M. Re: ‘Why do health systems not fund supervised exercise programmes for intermittent claudication?’. Eur J Vasc Endovasc Surg 2015;49(4):487. 15 Gommans LN, Teijink JA. Attitudes to supervised exercise therapy. Br J Surg 2015;102(10):1153e5. 16 Treesak C, Kasemsup V, Treat-Jacobson D, Nyman JA, Hirsch AT. Cost-effectiveness of exercise training to improve claudication symptoms in patients with peripheral arterial disease. Vasc Med 2004;9(4):279e85. 17 Bendermacher BL, Willigendael EM, Teijink JA, Prins MH. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev 2006;(2):CD005263. 18 Lee HL, Mehta T, Ray B, Heng MS, McCollum PT, Chetter IC. A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication. Eur J Vasc Endovasc Surg 2007;33(2):202e7.
57 19 Spronk S, Bosch JL, den Hoed PT, Veen HF, Pattynama PM, Hunink MG. Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial. J Vasc Surg 2008;48(6):1472e80. 20 van Asselt AD, Nicolai SP, Joore MA, Prins MH, Teijink JA. Costeffectiveness of exercise therapy in patients with intermittent claudication: supervised exercise therapy versus a ‘go home and walk’ advice. Eur J Vasc Endovasc Surg 2011;41(1):97e103. 21 Ahimastos AA, Pappas EP, Buttner PG, Walker PJ, Kingwell BA, Golledge J. A meta-analysis of the outcome of endovascular and noninvasive therapies in the treatment of intermittent claudication. J Vasc Surg 2011;54(5):1511e21. 22 Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45(Suppl. S):S5e67. 23 Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 2011;32(22):2851e906. 24 Schippers EI. Letter to the House of Representatives on Health insurance package per 2017 [Kamerbrief over Zvw-pakket per 2017] (Dutch). Dutch Ministery of Health, Welfare and Sport; 2016. 25 van Eijndhoven M, Hermsen L, de Wit J. Report on supervised exercise therapy for intermittent claudication [Rapport over gesuperviseerde oefentherapie bij claudicatio intermittens] (Dutch). Dutch National Health Care Institute; 2016. 26 Fakhry F, Rouwet EV, den Hoed PT, Hunink MG, Spronk S. Longterm clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial. Br J Surg 2013;100(9):1164e71. 27 Fakhry F, Spronk S, van der Laan L, Wever JJ, Teijink JA, Hoffmann WH, et al. Endovascular revascularization and supervised exercise for peripheral artery disease and intermittent claudication: a randomized clinical trial. JAMA 2015;314(18): 1936e44. 28 Mazari FA, Khan JA, Carradice D, Samuel N, Abdul Rahman MN, Gulati S, et al. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg 2012;99(1):39e48. 29 McDermott MM. Erasing disability in peripheral artery disease: the role of endovascular procedures and supervised exercise. JAMA 2015;314(18):1921e3. 30 Report ‘Healthcare: how much is it worth extra?’ [Raport ‘De zorg: hoeveel extra is het ons waard?’] (Dutch). Dutch Ministery of Health, Welfare and Sport; 2012.
Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands D. Hageman a,b, H.J.P. Fokkenrood c, P.P.M. Essers d, M.J.W. Koelemay e, J.C. Breek f, A.C. Vahl g, M.R.M. Scheltinga h, J.A.W. Teijink a,b,* a
Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands c Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands d Centre of Expertise Care Control, CZ, Tilburg, The Netherlands e Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands f Department of Vascular Surgery, Martini Hospital, Groningen, The Netherlands g Department of Vascular Surgery, OLVG, Amsterdam, The Netherlands h Department of Vascular Surgery, Máxima Medical Centre, Veldhoven, The Netherlands b
WHAT THIS PAPER ADDS This was a follow-up study of a budget impact analysis regarding a supervised exercise therapy (SET) first strategy (stepped care model [SCM]) for patients with intermittent claudication (IC) in the Netherlands. The aim was to investigate whether several campaigns to improve the incorporation of SCM resulted in higher SET participation and corresponding savings after a 2 year period. A 22% increase in adherence to the SCM was attained between 2009 and 2011, conferring an estimated 6% reduction in the cost of IC treatment. As this study used a large database (3.5 million persons) with real world data, daily practice is well reflected in the results. The results of this study call for further SCM incorporation which will probably lead to additional healthcare resource savings. Objective/Background: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period. Methods: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. Results: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; þ22% [p < .001]) and INT in 44% (2009: 66%; 22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; þ13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; 16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; þ19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (V6885 vs. V7300; p ¼ .020). Conclusion: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system. Ó 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. Article history: Received 10 December 2016, Accepted 15 April 2017, Available online 20 May 2017 Keywords: Budget, Conservative treatment, Economic evaluation, Exercise, Exercise therapy, Intermittent claudication, Peripheral arterial disease, Walking * Corresponding author. Department of Vascular Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, P.O. Box 1350, 5602 ZA Eindhoven, The Netherlands. E-mail address: [email protected] (J.A.W. Teijink). 1078-5884/Ó 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2017.04.011
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INTRODUCTION Treatment strategies for peripheral arterial disease (PAD) are well described in international guidelines recommending supervised exercise therapy (SET) as first line treatment for patients with intermittent claudication (IC).1e3 The advocated treatment strategy for IC may be incorporated into a so called stepped care model (SCM), which aims initially to refer patients to a SET program and restrict revascularisation to those not responding to SET.4e6 Despite the overwhelming evidence supporting the effectiveness of SET, these programs are often not fully reimbursed.7e15 As a consequence, SCM participation may be suboptimal, leading to minimally effective “walking advice” or a more expensive but fully reimbursed vascular intervention as an alternative first line treatment strategy. A budget impact analysis investigating the overall economic consequences of SCM implementation in the Dutch healthcare system was previously published.12 The results indicated that the proportion of patients with IC who had received a SET first treatment strategy in 2009 was 14% while 28% had received invasive revascularisation. Conversely, the remaining 58% neither started SET nor underwent revascularisation as a first line of treatment. Based on hypothetical scenarios, it was concluded that SCM implementation could possibly lead to annual national savings up to V33 million. In recent years, the functional and economic advantages of a SET first strategy are increasingly appreciated.4,16e21 Also, a nationwide network of physiotherapists was created to improve the quality of SET in the Netherlands.5,6 Therefore, a follow-up study of the budget impact analysis was performed to reassess SCM implementation in the Dutch healthcare system after a 2 year period. It was hypothesized that SCM adherence was improved and revascularisation as the initial treatment decreased. As a consequence, a significant reduction in healthcare costs was expected.
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patients who had received an invoice related to PAD in the 24 months before presentation (2009 or 2010) were excluded. Patients who had changed health insurance in 2009 or 2010 and thus possibly harboured an unknown 2 year history of PAD were also excluded. To obtain a complete set of follow-up data, all patients who had changed health insurance in the 24 months after presentation (2012 or 2013) were also excluded. The presence of comorbidity was based on prescribed medication. The study was conducted in close collaboration with CZ and approved by its board members. The study complied with all privacy legislation. The insurance database was only accessible to staff. Extracted data were not traceable to individuals. Definition of groups Patients were divided into two groups based on their primary treatment, defined as IC treatment (SET or revascularisation) that was initiated between 12 months before and 3 months after presentation at a vascular surgery outpatient clinic (Fig. 1). The SET group had started community based SET between 12 months before and 3 months after outpatient presentation. SET initiation by the general practitioner was assumed in patients who had started SET prior to outpatient presentation. The intervention (INT) group was treated by endovascular or open revascularisation within 3 months of outpatient presentation.
MATERIALS AND METHODS Inclusion and exclusion The 2011 database of CZ, a large Dutch health insurance company (3,483,717 insured persons, approximately 21% of the Dutch population) was analysed (Fig. 1). CZ has nationwide coverage and has contracted all hospitals. Therefore, the data are assumed to be representative of the rest of the population. In the Netherlands, hospitals are reimbursed based on fixed combinations of diagnosis and treatment (diagnosis treatment combination system). A diagnosis code is registered by physicians at outpatient presentation and recorded in all invoices. All persons who received an invoice related to PAD Fontaine II (IC), as documented by a vascular surgeon (diagnosis code 418) in 2011, were identified. Only patients newly diagnosed with IC who were exclusively CZ insured for an entire 48 month period between 2009 and 2013 were eligible for inclusion. To restrict the study to patients newly diagnosed with IC, all
Figure 1. Flow diagram of patient selection. Note. Straight line indicates primary treatment; dashed line indicates secondary treatment. PAD ¼ peripheral arterial disease; IC ¼ intermittent claudication; SET ¼ supervised exercise therapy; INT ¼ intervention.
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Table 1. Patient characteristics in 2009 and 2011. SET group INT group SETeINT difference 2009 2011 p 2009 2011 p 2009 2011 Total 701 (34.0) 944 (55.9) < .001 1363 (66.0) 746 (44.1) < .001 e e Male 402 (57.3) 556 (58.9) .528 883 (64.8) 472 (63.3) .488 .001 .067 Mean SD age (y) 69.4 10.2 68.6 9.4 .101 65.2 10.7 64.2 10.9 .053 < .001 < .001 CHF 67 (9.6) 99 (10.5) .536 119 (8.7) 68 (9.1) .766 .534 .348 DM2 48 (6.9) 75 (7.9) .403 95 (7.0) 50 (6.7) .816 .917 .332 HCL 214 (30.5) 272 (28.8) .451 399 (29.3) 197 (26.4) .162 .555 .273 Note. Data are n (%) unless otherwise indicated. Significant values are in bold. SET ¼ supervised exercise therapy; INT ¼ intervention; CHF ¼ congestive heart failure; DM2 ¼ diabetes mellitus type 2; HCL ¼ hypercholesterolaemia.
Based on the diagnosis 418 code, a substantial number of persons who received neither SET nor revascularisation within 3 months of outpatient presentation was identified. This population, termed the “REST” group, contained not only patients with IC, but also an unknown proportion of individuals without PAD. As this group was highly heterogeneous (patients receiving initial treatment other than SET or revascularisation (e.g., a walking advice, medication only, etc.), treatment delay, as well as individuals wrongly labeled as having IC), it was decided by consensus to exclude the REST group from analysis. Secondary treatment was defined as IC treatment (SET or revascularisation) that was initiated between 3 and 24 months after outpatient presentation. Secondary treatment included secondary ipsilateral intervention and primary contralateral intervention. Differentiating between these groups was impossible because of the nature of the database. SCM implementation between 2009 and 2011 SCM implementation was estimated by calculating change in SET as the initial treatment as measured in 2009 and 2011. Costs of IC treatment Physician based and physiotherapist based invoices for primary and secondary treatment of IC within 24 months of follow-up were analysed. Total costs per group were calculated by adding all costs of IC treatment in the group of initial allocation. Mean total costs (MTCs) per patient in each group were calculated by dividing total costs per group by number of patients allocated per group. Average costs of IC treatment per patient were calculated by dividing total costs of IC treatment by total number of patients. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. Mean costs of IC treatment in 2009 were updated to 2011 levels using the Dutch inflation index (http://statline.cbs.nl). Data analysis The insurance database was analysed with SAS (SAS Institute Inc., Cary, NC, USA). Differences in continuous and categorical variables between groups were assessed using the independent two sample t test or chi-square test. Statistical analyses were performed using SPSS 23 software
(IBM, Armonk, NY, USA). A p value < .05 was considered statistically significant. Calculations of costs were made using Excel 2010 software (Microsoft, Redmond, WA, USA). RESULTS Patient characteristics A total of 5869 patients with invoices related to PAD Fontaine II (IC) were identified from the 2011 CZ database (Fig. 1). After exclusion of 1734 patients as per protocol, 4135 patients were potentially eligible for inclusion. As 2445 patients neither started SET nor underwent revascularisation within 3 months of presentation (REST group; n ¼ 2890 in 2009; p ¼ .445) and were thus excluded, a total of 1690 patients were analysed. Details of the 2009 patient selection were reported previously.12 Patient characteristics of the two groups are shown in Table 1. A significant difference was only found regarding age as patients in the SET group were approximately 4 years older than those in the INT group. In contrast, comorbidity was similar between groups. SCM implementation between 2009 and 2011 Of 1690 patients in 2011, 56% (n ¼ 944) started SET as initial treatment versus 34% (n ¼ 701) in 2009 (þ22%; p < .001), whereas 44% (n ¼ 746) were treated with revascularisation as initial treatment versus 66% (n ¼ 1363) in 2009 (22%; p < .001), resulting in 22% (95% confidence interval [CI] 19e25) increased adherence to the SCM. Primary and secondary treatment Primary and secondary treatments are shown in Tables 2 and 3. In the SET group, 19% (n ¼ 176) were subsequently treated by revascularisation within 2 years of presentation versus 6% (n ¼ 45) in 2009 (þ13%; p < .001). In the INT group patients (n ¼ 746), 571 endovascular and 236 open surgical procedures were performed as initial treatment. Within 2 years of presentation, 29% (n ¼ 214) were later on referred for SET versus 10% (n ¼ 141) in 2009 (þ19%; p < .001), whereas 19% (n ¼ 144) were subsequently treated by additional revascularisation versus 35% (n ¼ 480) in 2009 (16%; p < 0001). Overall, 55% (746 patients in the INT group and 176 patients in the SET group) were treated by revascularisation within 2 years of presentation versus 68% (1363 INT and 45 SET patients) in 2009
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Table 2. Vascular interventions in 2009 and 2011. Primary treatment Secondary treatment INT group SET group INT group 2009 2011 2009 2011 p 2009 2011 p Patients with vascular interventions (%) 1363 746 45 176 < .001 480 144 < .001 (100) (100) (6.4) (18.6) (35.2) (19.3) Total invoices 1373 813 47 218 e 480 181 e Interventional radiology 1056 496 45 166 e 464 118 e Vascular surgery 317 317 2 52 e 16 63 e Endovascular 9 75 Open 308 236 Unspecified 0 6 Note. Data are n unless otherwise indicated. Significant values are in bold. INT ¼ intervention; SET ¼ supervised exercise therapy. Table 3. Supervised exercise therapy (SET) sessions in 2009 and 2011. Primary treatment Secondary treatment SET group SET group 2009 2011 p 2009 2011 p Patients with SET, n (%) 701 944 e NR NR NR (100) (100) Mean SD (min.emax.) SET 48 42 46 35 0.293 NR NR NR sessions per patient (1e272) (1e263) Note. Significant values are in bold. INT ¼ intervention; NR ¼ not relevant.
(13%, p < .001), whereas 69% (944 SET and 214 INT patients) were referred for SET within 2 years of presentation versus 41% (701 SET and 141 INT patients) in 2009 (þ28%; p < .001). Costs of IC treatment Costs of IC treatment are shown in Table 4. Compared with the 2009 cohort, physician based invoices and MTCs increased in both groups (þ139% and þ12% increased physician based invoices, and þ54% and þ14% increased MTCs in the SET and INT groups, respectively). Physiotherapist based invoices increased in the INT group only (5% and þ175% in the SET and INT groups, respectively). In contrast to the 2009 cohort, MTCs depended most on physician based invoices and least on physiotherapist based invoices in both groups. Even in the SET group, physician based invoices (V2142) were almost twice as high as the physiotherapist based invoices (V1251). MTCs in the INT group (V11,303) were more than three times higher than in the SET group (V3393). Average costs of IC treatment per patient were V6885 in 2011 versus V7300 in 2009, resulting in an estimated 6% reduction in costs of IC treatment (V415 [95% CI 64e766] per IC patient; p ¼ .020). Based on 1690 patients in 2011, this would equal annual cost reductions of approximately V0.7 million for CZ and V3.4 million for the Dutch population, respectively. DISCUSSION The aim of this study was to reassess adherence to SET as first treatment strategy (SCM) for patients with IC in the Netherlands after a 2 year period. The present study demonstrates a 22% increase in adherence to a SET first approach between 2009 and 2011, conferring an estimated
INT group 2009 141 (10.3) 38 35 (1e176)
2011 214 (28.7) 37 32 (1e151)
p < .001 .782
6% reduction in costs of IC treatment. This shift from revascularisation to SET as first line treatment for patients with IC suggests successful SCM implementation in the Dutch healthcare system. Despite changing rates of secondary interventions, costs of IC treatment in the SET group were still less than a third of those of the INT group. Apart from a growing number of studies supporting the effectiveness of SET as first line treatment, this study again demonstrates that SET is a less expensive treatment option for patients with IC. Stimulating further SCM incorporation will probably lead to additional savings of healthcare resources. Several causes of a shift towards a SET first approach in IC may be identified. In recent years, awareness of the social and economic consequences of PAD and IC has increased among physicians and health insurers. SET has gained attention in scientific research and received some emphasis at conferences. Several meta-analyses and cost effectiveness analyses have been published favouring a SET first treatment strategy for IC.4,16e21 Moreover, contemporary guidelines on the management of PAD were revised and updated recommending SET as first line treatment for all patients with IC.1,22,23 Furthermore, a nationwide network of physiotherapists was created in January 2011 in the Netherlands, improving the quality and availability of well organised community based SET programs.5,6 However, the effect of this network is possibly limited during the period between 2009 and 2011 as nationwide coverage was only attained at the beginning of 2014. Nevertheless, this set of parallel strategies probably resulted in improved rates of SET as the first treatment option in IC. Moreover, it is assumed that the proportion of SET referrals further increased after 2011 and it is also expected that this trend will continue in the coming years.
Change 10.7% (p < .001) þ60.7% (p < .001) 5.7% (p [ .020) 2011 V6055 (134e66,412) V829 (28e7403) V6885 2009a V6784 (99e50,173) V516 (28e7187) V7300 Change 2011 Change Physician þ139.0% V11,007 þ12.2% based invoices (p < .001) (1581e66,412) (p < .001) Physiotherapist 4.5% V296 þ174.7% based invoices (p ¼ .265) (28e4256) (p < .001) Mean total costs þ53.8% V11,303 þ13.9% (p < .001) (p < .001) Note. Significant values are in bold. SET ¼ supervised exercise therapy; INT ¼ intervention. a Mean costs of IC treatment in 2009 were updated to 2011 levels using the Dutch inflation index (http://statline.cbs.nl). 2011 V2142 (134e31,821) V1251 (28e7403) V3393
INT group Mean (min.emax.) 2009a V9813 (2515e50,173) V108 (28e4914) V9920 SET group Mean (min.emax.) 2009a V896 (99e14,428) V1310 (28e7187) V2206
Table 4. Costs of intermittent claudication (IC) treatment per patient in 2009 and 2011.
Average costs of IC treatment per patient Mean (min.emax.)
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Despite improved SCM adherence, SET is still underutilised in clinical practice. The worldwide implementation of SET programs is hampered for three different reasons.13,15 First, there is patient resistance as SET places a particular burden on patients in terms of effort and responsibility, rather than offering a “quick fix” for their discomfort. Second, the self interest of doctors performing interventions that involve fee for service is undoubtedly a contributor. Moreover, outdated arguments favouring an invasive intervention, instead of prescribing SET, such as IC due to aorto-iliac lesions and cardiopulmonary comorbidity, still prevail.9,12 The third, and most important factor hindering a wider implementation of SET, is lack of access and reimbursement. As a result, even clinicians who fully endorse SET as initial treatment for IC may end up performing invasive interventions if their patients cannot find a qualified SET practitioner. Recently, efforts aimed at changing the reimbursement issues were met with success as from 1 January 2017 SET is fully covered by the basic health insurance in the Netherlands.24,25 This decision is based, in part, on a previous study showing that SCM implementation could possibly lead to annual national savings of up to V33 million.12 Apart from a decreased primary intervention rate, the present study also demonstrated an increase of secondary interventions in the SET group and a decrease of secondary interventions in the INT group compared with the previous study.12 The increased secondary intervention rate in the SET group may be a consequence of gradual SCM implementation as some patients with IC initially referred for SET fail to achieve sufficient results and may need additional revascularisation. Unfortunately, potential predictors of failing a SET program are not yet defined. However, many of the factors that may render a patient a poor candidate for SET may also apply as relative contraindications for an invasive treatment.3 Nonetheless, > 80% of the SET group did not require invasive treatment within 2 years of presentation. This percentage is possibly even higher than reported by Fakhry et al.,26 who found that almost half of the population randomised to SET demonstrated a sustained improvement in functional performance and quality of life after 7 years without the need for any secondary intervention. These findings clearly lend credit to a SET first approach for IC, thereby excluding patients from invasive endovascular or surgical treatments and potential complications. The decreased secondary intervention rate in the INT group may be a consequence of an increased rate of SET referrals within 2 years of presentation as the addition of a SET program may prevent deterioration despite restenosis or progression of atherosclerotic lesions. This phenomenon was also found in the ERASE trial, which demonstrated that only 4% receiving a combination of endovascular revascularisation and SET required a secondary intervention at the 1 year follow-up because of recurrent IC symptoms, even though almost one third showed a restenosis of their initially revascularised lesion.27 Similarly, Mazari et al. found that combining the two treatments had a sustained effect,
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while reducing the rate (and costs) of re-interventions.28 These studies clearly suggest that SET may play an important role as an adjuvant therapy after revascularisation in patients with IC. It may well be that a combination of therapies for IC may prove more effective in improving walking impairment compared with a single treatment approach. The ERASE trial showed that a combination of endovascular revascularisation followed by SET resulted in significantly greater improvement in walking distances and health related quality of life scores than SET only.27 However, an important condition to achieve this synergistic effect is to have a well established standardised and accessible SET program for patients to follow after the endovascular revascularisation procedure, which is not the case in most countries. Therefore, the results of the ERASE trial should not be interpreted as evidence supporting increases in rates of lower extremity revascularisation, but rather as an incentive for strategies required to ensure that effective SET programs are accessible for all patients with IC.29 Increasingly unaffordable healthcare costs necessitate economically viable and efficient healthcare plans.30 Although the present study demonstrates an estimated V415 reduction in healthcare costs per patient with IC, these savings are lower than one would expect based on the results of a previous study.12 When comparing the 2011 and 2009 data, physician based invoices increased in both groups, whereas physiotherapists based invoices did not significantly change or hardly contributed to the change in costs of IC treatment. Even in the INT group, physician based invoices increased despite a decreased secondary intervention rate. Consequently, the results of the present study call for SCM optimisation. In the future, further efforts should be made to stimulate a SET first approach for all patients with IC, restricting expensive imaging techniques and invasive treatments to those not responding to SET. Limitations This study has potential limitations. First, it may be argued that the insurance database was dated. However, as a standard such databases are completed retrospectively. A complete set of invoice data are only available after 2 years. Second, a more serious concern is the large number of patients in the REST group. Limitations of the insurance database do not allow for determining with certainty that a person suffers from PAD. As the focus is on cost registration, details of treatment are often unclear. For instance, when a person is referred to a vascular surgeon for evaluation of suspected IC, an “IC” invoice is registered. However, if PAD is ruled out following testing, this invoice is often not replaced by a “ruling out PAD” invoice. These faulty assignments may have contaminated the data sets. Third, a potential selection bias may be present as patients with aorto-iliac lesions or cardiopulmonary comorbidity may have been treated primarily by revascularisation, based on surgeon preferences.9,12 However, all included patients were diagnosed with IC and should have started SET
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according to contemporary guidelines.1e3 Fourth, a significant difference in age between groups was found. Unfortunately, it was impossible to adjust the analyses for this covariate because of limitations of the insurance database. Fifth, it was also impossible to differentiate between secondary ipsilateral and primary contralateral treatment. This is an important limitation because SET and revascularisation have different influences on the vascular branch. SET trains both legs, whereas revascularisation just repairs one leg. Therefore, the number of primary contralateral revascularisations in the INT group would be interesting to investigate as these may have been unnecessary in the SET group. Last, it would be of interest to take other important outcomes, such as walking distances, health related quality of life, and cost effectiveness, into consideration. However, this was impossible as data on these parameters were not included in the insurance database. CONCLUSION A 22% increase in adherence to SET as first treatment strategy in Dutch patients with IC was achieved between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system. CONFLICT OF INTEREST None. FUNDING None. REFERENCES 1 Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/ AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006;113(11):e463e654. 2 Layden J, Michaels J, Bermingham S, Higgins B. Diagnosis and management of lower limb peripheral arterial disease: summary of NICE guidance. BMJ 2012;345:e4947. 3 Conte MS, Pomposelli FB, Clair DG, Geraghty PJ, McKinsey JF, Mills JL, et al. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg 2015;61(3 Suppl.):2Se41S. 4 O’Brien-Irr MS, Harris LM, Dosluoglu HH, Dryjski ML. Endovascular intervention for treatment of claudication: is it costeffective? Ann Vasc Surg 2010;24(6):833e40.
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