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Health Technology Assessment on Continuous And Intermittent Renal Replacement Therapies For Acute Kidney Injury In Adult Patients
A684
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Peng X1, He X1, Liu D1, van Brunt K2, Balogh E2, Idris I3 1Eli Lilly and Company, Indianapolis, IN, USA, 2Eli Lilly & Company, Windlesham, UK, 3University of Nottingham, Nottingham, UK
Objectives: This study aims to assess the trend of insulin initiation among diabetes patients from 2009 to 2013, with a particular focus on patients who initiate high daily doses (> 200 units/day) of insulin. Methods: A retrospective analysis was conducted using UK general practice data from the clinical practice research datalink (CPRD). High dose insulin initiators (HDII) were defined based on total daily dose (TDD) > 200 units/day and TDD ≤ 200 units/day in 6 months prior. The trend of initiators’ demographics, insulin initiation dose, and clinical characteristics were analyzed from year 2009, 2011, and 2013. Results: From 2009 to 2013, 19631 patients with diabetes were prescribed insulin (type 1: 7620, 38.8%; type 2: 12011, 61.2%). In 5 years, incidence of HDII increased from 289 to 415 (type 1: 95 to 170; type 2: 194 to 245). In 2013, the average age of HDII was 51.7 years (Type 1: 35.5 years; Type 2: 62.9 years), 58.8% were males, 77.6% from England. The average initiation insulin TDD of HDII was 248.5 units (2.8 units/kg), and 378 (91.1%) were prescribed insulin analogue. In a year following high dose insulin initiation, 29.3% HDII achieved HbA1c< 7.5%, 33.1% of HDII reported HbA1c≥ 9%. Oral antidiabetic medication and GLP-1 were prescribed to 45.3% and 8.0% of HDII, respectively; concomitant antihypertension and lipid-lowering medications were prescribed to 79.8% and 65.1% of HDII, respectively. TDD of insulin at initiation of HDII was similar between 2009 and 2013, and less than 30% of patients achieved HbA1c< 7.5% in this time period. Conclusions: From 2009 to 2013, an increasing number of patients required high doses of insulin to control hyperglycemia. However, high concomitant non-insulin antidiabetic medication use and poor glycemic control in the follow-up year suggested that alternative intensive insulin therapy might be considered for this challenging population. PDB105 Polypharmacy and Medication Adherence in Elderly Patients with Diabetes in Pafos General Hospital, Cyprus Geitona M1, Latsou D2, Georgiou A3, Panayidis N3 1University of Peloponnese, Athens, Greece, 2University of Peloponnese, Athens, UK, 3Pafos General Hospital, Pafos, Cyprus
Objectives: The aim of this study was to identify the appropriateness of polypharmacy and medication adherence in elderly diabetic patients. Methods: This retrospective study was carried out at the diabetic outpatient department of Pafos General Hospital (PGH). A random sample of 173 patients was selected out of 311 patients followed up from March to April 2016. A questionnaire was prepared based on the EU SIMPATHY experience including questions on patients’ characteristics, medication use and adherence, comorbidities, adverse drug reactions (ADRs), and follow up. Medication assessment has been done by General Practitioners (GPs) based on the Clinical Practice Guidelines, of the Ministry of Health. The student’s t-test was performed to examine the associations between categorical and continuous variables; a two-sided P value ≤ 0.001 was considered significant. Data analysis was carried out using SPSS-20. Results: 137 outpatients filled out the questionnaire (RR= 79.2%) with a mean age of 67.8 (SD 7.8) years and disease duration of 10.5 (SD 7) years. 98.5% of respondents were followed up by GP and 81% reported that GP communicates with multidisciplinary teams. Also, 91.2% have comorbidities, although 73% stated no ADRs. Appropriate polypharmacy was assessed in 87.6% of patients, despite the fact that 46.7% received more than 12 medications (p≤ 0.001). As far as patients’ adherence, 39.1% did not receive medications according to GP instructions, due to many medications (p≤ 0.001). Moreover, 28.9% of patients often/very often missed taking their medications because they feel better and 22.7% increased drug dosage in order to feel better. Conclusions: Elderly diabetic patients’ awareness is necessary in order to improve medication adherence. Appropriate polypharmacy has been achieved by the involvement of multidisciplinary teams in PGH; however an integrated system needs to be further developed in Cyprus. PDB106 A Comparison of Insulin Degludec Clinical Evaluations and Recommendations Between an Independent HTA and National HTA Bodies Oehrlein EM1, Hanna ML2, Bjoernebo L3, Perfetto EM4 of Maryland, School of Pharmacy, Baltimore, MD, USA, 2School of Pharmacy, University of Maryland, Baltimore, MD, USA, 3Karolinska Institutet, Solna, Sweden, 4National Health Council, Washington, DC, USA
1University
Objectives: In the US, HTA bodies not responsible for reimbursement decisionmaking are making coverage and pricing recommendations. As a result, biopharmaceutical manufacturers must anticipate reimbursement decision-making a decade into the future and not just among national insurers or managed care companies, but based upon reviews by third parties. To discern how these third-party organizations’ reviews compare to national HTAs, ICER’s report on insulin degludec was compared to evaluations by national HTA bodies. Methods: ICER, IQWiG, NICE, and Swedish Health/Welfare reports/guidelines examining insulin degludec for Types I and II DM were compared by (1) comparators; (2) clinical outcomes examined; (3) data sources; (4) final recommendations. Results: (1) Comparators: Decisionmakers exhibited variability in selecting comparators: ICER examined insulin glargine or detemir; NICE also allowed sitagliptin; IQWiG deemed human insulin or human insulin plus metformin as comparators. (2) Clinical outcomes: Change in HbA1c and nocturnal hypoglycemia were the outcomes of interest for all reviews. (3) Data sources: Based on published data-alone, ICER provided a recommendation of added benefit for Type II DM. However, other HTAs declined to provide any recommendation based on both published or unpublished data due to inappropriate and/or missing data. (4) Final recommendations: None recommend insulin degludec for patients with Type I DM; while ICER and NICE found added benefit or non-inferiority in patients with Type II DM. Conclusions: This study found that substantial differences exist between approaches used by ICER and traditional HTA
bodies. Traditional HTAs have been subject to heavy criticism and do not necessarily represent a “gold standard.” ICER decisions are based on a systematic review of the peer-reviewed literature, which differs from the traditional method of a systematic review in addition to manufacturers submitting both published and un-published materials. Timely publication of trial data is becoming increasingly important to successful evaluations by traditional HTAs and emerging independent evaluators alike.
PDB107 A UK Observational Cohort Study of Insulin Treatment Patterns and Characterisation of Insulin Users in Type 1 And Type 2 Diabetes Mellitus Fernandes G1, Alemayehu B1, Liu J1, Paul E2, Das R2 1Merck, North Wales, PA, USA, 2Merck Sharp & Dohme Limited, Hoddesdon, UK
Objectives: To evaluate insulin treatment patterns for new insulin users in the UK and to identify factors associated with patients initiating insulin glargine. Methods: A retrospective cohort study using Clinical Practice Research Datalink (CPRD) was conducted. Patients with type 2 diabetes mellitus (T2DM) (age ≥ 18 years) and type 1 diabetes mellitus (T1DM) (age ≥ 6 years) were included. The index period was the first insulin prescription from 2009-2013 and patients were followed for up to five year after insulin initiation. Logistic regressions were performed to identify factors associated with initiation of insulin glargine. Results: Of the 3030 T1DM patients identified, 37% initiated their insulin therapy with glargine, 21% with determir and 13% with NPH ; 88% had a prescription for rapid acting (prandial) insulin. At baseline, T1DM patients initiating insulin glargine had a mean age of 28 years, 60% male, mean body mass index (BMI) of 24.3 and mean haemoglobin A1c (HbA1c) at 10.9%. Of the 15,863 T2DM patients identified, 32% patients initiated their insulin therapy with glargine, 27% with insulin isophane (NPH) and 15% on determir ; 33% had a prescription for rapid acting (prandial) insulin. At baseline, T2DM patients initiating insulin glargine had a mean age of 65 years, 56% male, mean BMI of 30.7 and mean HbA1c at 9.7%. The anti-hyperglyacemic drugs commonly prescribed were metformin (78.5%), Sulfonylureas (81.6%), DPP-4 inhibitors (30.0%) and Thiazolidinediones (25.5%). Factors associated with glargine initiation among patients with T2DM included increased age, other anti-hyperglycaemic drugs and microvascular complications. Conclusions: Among patients identified as new users of insulin in the UK between 2009 and 2013, 32% and 37% of patients with T2DM and T1DM, respectively, initiated their insulin therapy with glargine. Age, comorbidities and other anti-hyperglycaemic drugs, were among factors associated with glargine initiation in patients with T2DM.
RESEARCH POSTER PRESENTATIONS - SESSION V
HEALTH CARE TREATMENT STUDIES MEDICAL DEVICE/DIAGNOSTICS – Clinical Outcomes Studies PMD1 Health Technology Assessment on Continuous And Intermittent Renal Replacement Therapies For Acute Kidney Injury In Adult Patients Schoenfelder T, Chen X, Bleß H IGES Institut GmbH, Berlin, Germany
Objectives: Dialysis-dependent acute kidney injury (AKI) can be treated using continuous (CRRT) or intermittent renal replacement therapies (IRRT). Although some studies suggest that CRRT may have advantages over IRRT, study findings are inconsistent. This study aims to assess differences between CRRT and IRRT regarding important clinical outcomes and cost-effectiveness. Methods: Systematic searches in MEDLINE, EMBASE, and Cochrane Library including RCTs, observational studies, and cost-effectiveness-studies were performed (search date: December 2014). Results were pooled using a random effects-model. Results: Forty-nine studies were included. Findings show a higher rate of renal recovery among survivors who initially received CRRT as compared with IRRT. This advantage applies to the analysis of all studies with different observation periods (Relative Risk (RR) 1,10; 95%-Confidence Interval (CI) [1,05-1,16]) and to a selection of studies with observation periods until 90 days (RR 1,09; 95%-CI [1,04-1,15]). Regarding observation periods beyond there are no differences when only two identified studies were analyzed. Patients initially receiving CRRT have higher mortality as compared to IRRT (RR 1,17; 95%-CI [1,06-1,28]). This difference is attributable to observational studies and may have been caused by allocation bias since seriously ill patients more often initially receive CRRT instead of IRRT. CRRT do not significantly differ from IRRT with respect to change of mean arterial pressure, hypotensive episodes, and hemodynamic instability. Data on cost-effectiveness is inconsistent. Recent analyzes indicate that initial CRRT is cost-effective compared to initial IRRT due to a reduction of the rate of long-term dialysis dependence. As regards a short time horizon this cost benefit has not been shown. Conclusions: Initial CRRT is associated with higher rates of renal recovery. Potential long-term effects on clinical outcomes for more than three month could not be analyzed and should be investigated in further studies. Economical analyzes indicate that initial CRRT is cost-effective when costs of long-term dialysis dependence are considered.
PMD2 Implementation of One Stop Diagnosis In Patients with Thyroid Nodules: Impact on Cost And Surgery Kandel M1, Schlumberger M2, Benhamou E2, Leboulleux S2, Berdelou A2, Pottier E2,
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Peng X1, He X1, Liu D1, van Brunt K2, Balogh E2, Idris I3 1Eli Lilly and Company, Indianapolis, IN, USA, 2Eli Lilly & Company, Windlesham, UK, 3University of Nottingham, Nottingham, UK
Objectives: This study aims to assess the trend of insulin initiation among diabetes patients from 2009 to 2013, with a particular focus on patients who initiate high daily doses (> 200 units/day) of insulin. Methods: A retrospective analysis was conducted using UK general practice data from the clinical practice research datalink (CPRD). High dose insulin initiators (HDII) were defined based on total daily dose (TDD) > 200 units/day and TDD ≤ 200 units/day in 6 months prior. The trend of initiators’ demographics, insulin initiation dose, and clinical characteristics were analyzed from year 2009, 2011, and 2013. Results: From 2009 to 2013, 19631 patients with diabetes were prescribed insulin (type 1: 7620, 38.8%; type 2: 12011, 61.2%). In 5 years, incidence of HDII increased from 289 to 415 (type 1: 95 to 170; type 2: 194 to 245). In 2013, the average age of HDII was 51.7 years (Type 1: 35.5 years; Type 2: 62.9 years), 58.8% were males, 77.6% from England. The average initiation insulin TDD of HDII was 248.5 units (2.8 units/kg), and 378 (91.1%) were prescribed insulin analogue. In a year following high dose insulin initiation, 29.3% HDII achieved HbA1c< 7.5%, 33.1% of HDII reported HbA1c≥ 9%. Oral antidiabetic medication and GLP-1 were prescribed to 45.3% and 8.0% of HDII, respectively; concomitant antihypertension and lipid-lowering medications were prescribed to 79.8% and 65.1% of HDII, respectively. TDD of insulin at initiation of HDII was similar between 2009 and 2013, and less than 30% of patients achieved HbA1c< 7.5% in this time period. Conclusions: From 2009 to 2013, an increasing number of patients required high doses of insulin to control hyperglycemia. However, high concomitant non-insulin antidiabetic medication use and poor glycemic control in the follow-up year suggested that alternative intensive insulin therapy might be considered for this challenging population. PDB105 Polypharmacy and Medication Adherence in Elderly Patients with Diabetes in Pafos General Hospital, Cyprus Geitona M1, Latsou D2, Georgiou A3, Panayidis N3 1University of Peloponnese, Athens, Greece, 2University of Peloponnese, Athens, UK, 3Pafos General Hospital, Pafos, Cyprus
Objectives: The aim of this study was to identify the appropriateness of polypharmacy and medication adherence in elderly diabetic patients. Methods: This retrospective study was carried out at the diabetic outpatient department of Pafos General Hospital (PGH). A random sample of 173 patients was selected out of 311 patients followed up from March to April 2016. A questionnaire was prepared based on the EU SIMPATHY experience including questions on patients’ characteristics, medication use and adherence, comorbidities, adverse drug reactions (ADRs), and follow up. Medication assessment has been done by General Practitioners (GPs) based on the Clinical Practice Guidelines, of the Ministry of Health. The student’s t-test was performed to examine the associations between categorical and continuous variables; a two-sided P value ≤ 0.001 was considered significant. Data analysis was carried out using SPSS-20. Results: 137 outpatients filled out the questionnaire (RR= 79.2%) with a mean age of 67.8 (SD 7.8) years and disease duration of 10.5 (SD 7) years. 98.5% of respondents were followed up by GP and 81% reported that GP communicates with multidisciplinary teams. Also, 91.2% have comorbidities, although 73% stated no ADRs. Appropriate polypharmacy was assessed in 87.6% of patients, despite the fact that 46.7% received more than 12 medications (p≤ 0.001). As far as patients’ adherence, 39.1% did not receive medications according to GP instructions, due to many medications (p≤ 0.001). Moreover, 28.9% of patients often/very often missed taking their medications because they feel better and 22.7% increased drug dosage in order to feel better. Conclusions: Elderly diabetic patients’ awareness is necessary in order to improve medication adherence. Appropriate polypharmacy has been achieved by the involvement of multidisciplinary teams in PGH; however an integrated system needs to be further developed in Cyprus. PDB106 A Comparison of Insulin Degludec Clinical Evaluations and Recommendations Between an Independent HTA and National HTA Bodies Oehrlein EM1, Hanna ML2, Bjoernebo L3, Perfetto EM4 of Maryland, School of Pharmacy, Baltimore, MD, USA, 2School of Pharmacy, University of Maryland, Baltimore, MD, USA, 3Karolinska Institutet, Solna, Sweden, 4National Health Council, Washington, DC, USA
1University
Objectives: In the US, HTA bodies not responsible for reimbursement decisionmaking are making coverage and pricing recommendations. As a result, biopharmaceutical manufacturers must anticipate reimbursement decision-making a decade into the future and not just among national insurers or managed care companies, but based upon reviews by third parties. To discern how these third-party organizations’ reviews compare to national HTAs, ICER’s report on insulin degludec was compared to evaluations by national HTA bodies. Methods: ICER, IQWiG, NICE, and Swedish Health/Welfare reports/guidelines examining insulin degludec for Types I and II DM were compared by (1) comparators; (2) clinical outcomes examined; (3) data sources; (4) final recommendations. Results: (1) Comparators: Decisionmakers exhibited variability in selecting comparators: ICER examined insulin glargine or detemir; NICE also allowed sitagliptin; IQWiG deemed human insulin or human insulin plus metformin as comparators. (2) Clinical outcomes: Change in HbA1c and nocturnal hypoglycemia were the outcomes of interest for all reviews. (3) Data sources: Based on published data-alone, ICER provided a recommendation of added benefit for Type II DM. However, other HTAs declined to provide any recommendation based on both published or unpublished data due to inappropriate and/or missing data. (4) Final recommendations: None recommend insulin degludec for patients with Type I DM; while ICER and NICE found added benefit or non-inferiority in patients with Type II DM. Conclusions: This study found that substantial differences exist between approaches used by ICER and traditional HTA
bodies. Traditional HTAs have been subject to heavy criticism and do not necessarily represent a “gold standard.” ICER decisions are based on a systematic review of the peer-reviewed literature, which differs from the traditional method of a systematic review in addition to manufacturers submitting both published and un-published materials. Timely publication of trial data is becoming increasingly important to successful evaluations by traditional HTAs and emerging independent evaluators alike.
PDB107 A UK Observational Cohort Study of Insulin Treatment Patterns and Characterisation of Insulin Users in Type 1 And Type 2 Diabetes Mellitus Fernandes G1, Alemayehu B1, Liu J1, Paul E2, Das R2 1Merck, North Wales, PA, USA, 2Merck Sharp & Dohme Limited, Hoddesdon, UK
Objectives: To evaluate insulin treatment patterns for new insulin users in the UK and to identify factors associated with patients initiating insulin glargine. Methods: A retrospective cohort study using Clinical Practice Research Datalink (CPRD) was conducted. Patients with type 2 diabetes mellitus (T2DM) (age ≥ 18 years) and type 1 diabetes mellitus (T1DM) (age ≥ 6 years) were included. The index period was the first insulin prescription from 2009-2013 and patients were followed for up to five year after insulin initiation. Logistic regressions were performed to identify factors associated with initiation of insulin glargine. Results: Of the 3030 T1DM patients identified, 37% initiated their insulin therapy with glargine, 21% with determir and 13% with NPH ; 88% had a prescription for rapid acting (prandial) insulin. At baseline, T1DM patients initiating insulin glargine had a mean age of 28 years, 60% male, mean body mass index (BMI) of 24.3 and mean haemoglobin A1c (HbA1c) at 10.9%. Of the 15,863 T2DM patients identified, 32% patients initiated their insulin therapy with glargine, 27% with insulin isophane (NPH) and 15% on determir ; 33% had a prescription for rapid acting (prandial) insulin. At baseline, T2DM patients initiating insulin glargine had a mean age of 65 years, 56% male, mean BMI of 30.7 and mean HbA1c at 9.7%. The anti-hyperglyacemic drugs commonly prescribed were metformin (78.5%), Sulfonylureas (81.6%), DPP-4 inhibitors (30.0%) and Thiazolidinediones (25.5%). Factors associated with glargine initiation among patients with T2DM included increased age, other anti-hyperglycaemic drugs and microvascular complications. Conclusions: Among patients identified as new users of insulin in the UK between 2009 and 2013, 32% and 37% of patients with T2DM and T1DM, respectively, initiated their insulin therapy with glargine. Age, comorbidities and other anti-hyperglycaemic drugs, were among factors associated with glargine initiation in patients with T2DM.
RESEARCH POSTER PRESENTATIONS - SESSION V
HEALTH CARE TREATMENT STUDIES MEDICAL DEVICE/DIAGNOSTICS – Clinical Outcomes Studies PMD1 Health Technology Assessment on Continuous And Intermittent Renal Replacement Therapies For Acute Kidney Injury In Adult Patients Schoenfelder T, Chen X, Bleß H IGES Institut GmbH, Berlin, Germany
Objectives: Dialysis-dependent acute kidney injury (AKI) can be treated using continuous (CRRT) or intermittent renal replacement therapies (IRRT). Although some studies suggest that CRRT may have advantages over IRRT, study findings are inconsistent. This study aims to assess differences between CRRT and IRRT regarding important clinical outcomes and cost-effectiveness. Methods: Systematic searches in MEDLINE, EMBASE, and Cochrane Library including RCTs, observational studies, and cost-effectiveness-studies were performed (search date: December 2014). Results were pooled using a random effects-model. Results: Forty-nine studies were included. Findings show a higher rate of renal recovery among survivors who initially received CRRT as compared with IRRT. This advantage applies to the analysis of all studies with different observation periods (Relative Risk (RR) 1,10; 95%-Confidence Interval (CI) [1,05-1,16]) and to a selection of studies with observation periods until 90 days (RR 1,09; 95%-CI [1,04-1,15]). Regarding observation periods beyond there are no differences when only two identified studies were analyzed. Patients initially receiving CRRT have higher mortality as compared to IRRT (RR 1,17; 95%-CI [1,06-1,28]). This difference is attributable to observational studies and may have been caused by allocation bias since seriously ill patients more often initially receive CRRT instead of IRRT. CRRT do not significantly differ from IRRT with respect to change of mean arterial pressure, hypotensive episodes, and hemodynamic instability. Data on cost-effectiveness is inconsistent. Recent analyzes indicate that initial CRRT is cost-effective compared to initial IRRT due to a reduction of the rate of long-term dialysis dependence. As regards a short time horizon this cost benefit has not been shown. Conclusions: Initial CRRT is associated with higher rates of renal recovery. Potential long-term effects on clinical outcomes for more than three month could not be analyzed and should be investigated in further studies. Economical analyzes indicate that initial CRRT is cost-effective when costs of long-term dialysis dependence are considered.
PMD2 Implementation of One Stop Diagnosis In Patients with Thyroid Nodules: Impact on Cost And Surgery Kandel M1, Schlumberger M2, Benhamou E2, Leboulleux S2, Berdelou A2, Pottier E2,