- Email: [email protected]
WILLINGNESS TO PAY OF BLOOD SUGAR CONTROL IN DIABETES AND THE INFLUENCE FACTORS: AN EXPLORATORY SURVEY
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“communication with my healthcare provider,” and “my personal understanding of diabetes” as having the most positive impact in self-managing their disease. Least positively ranked items included “my language and culture” and “resources in my local community,” each receiving an average ranking below 5.7. Ratings and rankings were combined via a self-explicated method, yielding eight facilitators (p< .001) and no barriers. The lack of variance in the rating exercise led to an inability to detect barriers to self-management. Conclusions: The findings of this study call into question the validity of rating and ranking exercises as methods to identify factors with negative scores. Methods such as best-worst scaling may be better suited to identify both positive and negative weights. PDB64 THE TREATMENT-RELATED IMPACT MEASURE FOR ADULTS WITH GROWTH HORMONE DEFICIENCY (TRIM-AGHD): CALCULATING AND INTERPRETING THE MINIMALLY CLINICAL IMPORTANT DIFFERENCE Brod M 1, Wilkinson L 2, Hojbjerre L 2, Rasmussen M H 2 Brod Group, Mill Valley, CA, USA, 2Novo Nordisk A/S, Søborg, Denmark .
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Objectives: The Treatment Related Impact Measure for Adults with Growth Hormone Deficiency (TRIM-AGHD), a patient reported outcome (PRO) measure assessing the impact of growth hormone deficiency (GHD) in adults was developed in accordance with the FDA guidance on PRO measure development. Prior validation work determined that the TRIM-AGHD had adequate measurement properties, and was reliable and valid. However, for TRIM-AGHD scores to be interpretable, it is critical that the TRIM-AGHD be responsive to treatment benefit and the minimally clinical important difference in scores (MCID) quantified. Methods: A clinic based study, recruiting naïve-to-treatment adult GHD patients, was conducted. Assessments were at baseline visit (treatment start), weekly by telephone, and 8 week follow-up visit. Responsiveness was evaluated using the effect size of change scores from baseline to follow-up. The MCID estimates were derived from distribution-based [½ standard deviation (½SD), standard error of measurement (SEM)] and anchor-based methods [using the patient global rating of change (PGRC)] using change scores from baseline to initial report of minimal improvement in their GHD severity. Results were then triangulated to suggest an acceptable MCID. Results: Ninety-six patients completed the study, mean age 49.65 years (range 29–68), 65.62% female, 76.04% white, and the primary cause of GHD was head trauma (17.71%) [unknown cause 46.88%]. At follow-up, the TRIM-AGHD was shown to be highly responsive to treatment with the total score effect size being 1.38 (subdomains ranging between 1.22 and 1.36). For the total score, the ½SD was 8.09, the SEM was 2.66, and the anchor-based (PGRC) was 20.43. The suggested MCID based on averaging these methods is 10.40. Conclusions: The TRIM-AGHD is a highly responsive measure of the impact of adult growth hormone treatment. A change score of 10.40 points on the measure can be considered a clinically meaningful improvement in patient functioning and well-being. PDB65 PATIENT-REPORTED OUTCOMES CLAIMS IN ACROMEGALY: A REVIEW OF THE LABELS OF PRODUCTS APPROVED BY THE FDA AND THE EMA Perret C , Perrier L , Acquadro C Mapi Research Trust, Lyon, France .
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PDB66 VALUING INJECTION FREQUENCY: TYPE 2 DIABETES STUDY WILLINGNESS-TOPAY STUDY Fifer S 1, Rose J 2, Swain D 3 and Patient Preference Research, Sydney, Australia, 2Institute for Choice, North Sydney, Australia, 3AstraZeneca, North Ryde, Australia .
PDB67 LOW HEALTH-REALTED QUALITY OF LIFE AND POVERTY AMONG ADULTS WITH DIABETES Alenzi E O 1, Sambamoorthi U 2, Dwibedi N 2 1West Virginia University, School of Pharmacy, Morgantown, WV, USA, 2West Virginia University, Morgantown, WV, USA .
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Objectives: To assess the extent to which disparities in individual, environmental, social, and the bio-physiological characteristics explain the inequalities in healthrelated quality of life (HRQoL) between poor and non-poor adults with diabetes. Methods: We adopted a cross-sectional design using the Medical Expenditure Panel Survey of 9490 adults with diabetes. We categorized adults into: poor (family income < 199 % of Federal Poverty Line (FPL)) and non-poor (family income ≥ 200% of FPL). HRQOL was measured using the physical component summary (PCS) and mental component summary (MCS) scores from the Short Form Health Survey -12 version 2. Low physical and mental HRQoL was defined as having PCS and MCS scores lower than the norm based scores (PCS = 41.52 and MCS= 47.28) of general US individuals with diabetes. The adjusted association between low HRQoL and poverty was tested using logistic regressions controlling for the individual, environmental, social and the bio-physiological characteristics. To explain disparities in having low HRQoL between poor and non-poor, a post-regression non-linear multivariate decomposition technique (mvdcm) was used. Results: A significantly higher percent of poor adults with diabetes had low physical and mental HRQOL (61.9% and 50.5%) compared to non-poor adults (41% and 29.8%). Our results showed that, of the 20.85 percentage point difference in low HRQoL, 11.25 percentage point was explained by disparities in the individual, environmental, social and the bio-physiological characteristics between poor and non-poor adults with diabetes. Disparities in employment status, number of chronic conditions, and physical activity between poor and non-poor explained the differences in low HRQoL between poor and nonpoor adults with diabetes. Conclusions: To eliminate disparities in low HRQoL between poor and non-poor, investment in programs that promote employment, prevent chronic conditions and encourage physical activity are needed.
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Objectives: Acromegaly is a rare acquired disorder resulting from the excessive production of growth hormone by the anterior pituitary gland, and often diagnosed in middle-aged adults. It is characterized by progressive somatic disfigurement (e.g., broadened extremities, thickened soft tissue, and widened face) and systemic manifestations. The objectives of this study were 1) to identify patient-reported outcome (PRO) claims in products approved for the treatment of acromegaly by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and 2) to identify the endpoint positioning of the PROs when measured. Methods: The EMA and FDA websites were explored to identify all products approved for acromegaly. PROLabels was used to identify products with a PRO claim in label. All corresponding clinical reviews (FDA), and assessments reports (EMA) were reviewed to check for endpoint positioning. Results: Six products were approved (from 1978 to 2014) with the indication of acromegaly (representing five INN, i.e., pegvisomant, octreotide acetate, lanreotide, bromocriptine mesylate, and pasireotide). FDA has approved all products, and EMA only two of them (i.e., pegvisomant and pasireotide). For the products approved by both agencies, the same data were submitted. PRO claims were found in the label of pegvisomant (EMA/FDA), octreotide acetate (FDA) and pasireotide (EMA/FDA). For pegvisomant, claims were symptoms-related, with FDA providing much more detailed information in the label than the EMA. Claims were also symptoms-related for octreotide acetate. As for pasireotide, discrepancies were found between agencies. An HRQL claim was found in the European label (improvements measured by the AcroQoL), but not in the FDA label, while symptom claims were retrieved in the FDA label, but not in the EMA’s. For all products, PROs were considered secondary endpoints. Conclusions: The perspective of the patients with acromegaly is recognized by the FDA and the EMA, with still some discrepancies between agencies.
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the survey, patients were asked to trade off both injectable and oral treatments with different features to ascertain what is most important to them. Results: Main effects are estimated for both injectable and oral cohorts. Results suggest that patients in the injectable cohort are mainly concerned with injection frequency, weight change and nausea. Patients in the oral cohort are more concerned about weight change and are intuitively more likely to choose oral treatments. Conclusions: The results have been integrated into a dashboard, which enables stakeholders to perform scenario analysis. Scenarios are presented for the different cohorts, with outcomes measured as a change in consumer surplus. Analysis of the injectable cohort suggests that a once-weekly injection generates an additional benefit over a daily injection, equivalent to a weighted consumer surplus of AUD$22.35 per month. Notably, moving to once-weekly injections from a daily injection is more valuable to patients than a move from twice-daily to once-daily injections. Similar calculations are presented for the oral cohort. Patients on oral treatments forced to choose between daily or once-weekly injections strongly prefer the once-weekly injectable.
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PDB68 PATIENT PERCEPTIONS OF NON-INSULIN INJECTION DEVICES FOR TYPE 2 DIABETES Matza L S 1, Stewart K D 1, Paczkowski R 2, Murray L 1, Landrian A 1, Boye K S 2 1Evidera, Bethesda, MD, USA, 2Eli Lilly and Company, Indianapolis, IN, USA .
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Objectives: Injection devices are commonly used for administration of treatment for type 2 diabetes (T2D). These medications vary in their injection delivery systems, which could impact patient preference. This qualitative study was designed to understand patients’ experiences with non-insulin injection delivery systems. Methods: Concept elicitation interviews were conducted until reaching saturation in the US, UK, and Germany with patients with T2D who have experience with non-insulin injection treatment. Interviews focused on experiences with devices used to administer these medications. Results: Qualitative interviews were conducted with 32 patients. Participants reported liking and disliking a wide range of injection device features. Device characteristics mentioned as positives included injection preparation (n = 30), injection comfort (28), needle characteristics (28), confidence in dose delivery (28), injection frequency (25), dose selection (25), disposal (24), time requirements (24), device size (23), injection site (23), appearance (22), storage (22), portability (21), and dosing schedule (20). Negatively perceived features included needle characteristics (18), portability (16), lack of discreetness (15), storage (15), preparation (14), difficulty using device appropriately (12), size (11), comfort (11), multiple parts (10), confidence in dose delivery (9), dosing schedule (7), injection timing (7), and injection site (7). When asked what they would like to change about non-insulin injectable devices, the most common responses were characteristics of the needle (n= 8), requirements for injection preparation (n= 6), or the need for multiple device parts (n= 6). Conclusions: Patients reported a wide range of injection device features that influenced their perceptions of noninsulin injection devices. Several of these features are not captured by currently available measures of satisfaction with insulin and other diabetes treatment. A patient-reported measure focusing on features important to patients treated with non-insulin injectable medications would be a useful tool for assessing patients’ experiences with these treatments and associated injection devices.
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Objectives: This paper outlines a study designed to investigate the key drivers of choice for type 2 diabetes treatments. The key objective of the study was to explore patient willingness to pay for the different attributes of type 2 diabetes medicines, with a particular focus on valuing injection frequency. Methods: A sample of 171 patients including 58 twice daily injection patients (injectable cohort) and 113 orally treated patients (oral cohort) provided data in November 2014. Data was collected through an online survey and analyzed using state of the art discrete choice experiments. In
PDB69 WILLINGNESS TO PAY OF BLOOD SUGAR CONTROL IN DIABETES AND THE INFLUENCE FACTORS: AN EXPLORATORY SURVEY Long E 1, Chen J 2, Hu M 3, Zhou N 3, Yang N 3 1Sichuan Provincial People’ s Hospital, Chengdu, China, 2University of Maryland, College Park, MD, USA, 3Sichuan University, Chengdu, China .
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Objectives: To investigate the willingness to pay of controlling blood sugar in diabetic patients and analyze the influences factors of WTP. Methods: Face-to-Face
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interview of diabetic patients in a provincial hospital was conducted based on a pre-tested questionnaire. The basic demographic data, disease economic data and WTP for recovery of different diabetic indicators were collected. SPSS17.0 was used to conducted multiple linear regression and step-wise regression to analyze the influence factors of WTP. Results: 120 questionnaires were sent out and 106 were effectively responded The average age of respondents was 59.92 ±13.89. The median value of the WTP for full-recovery of HbA1C, FPG, 2hPG were all $151.5 per month, and the median value of WTP for recovered 10% of HbA1C, FPG, 2hPG’s were $75.75, $87.1 and $77.27, respectively. Multiple linear regression and step-wise regression of factors showed among 6 different recovery statuses, some related factors of WTP value were common, such as the serious complications; and some factors were different. Conclusions: Diabetic patients, particularly with mental derangement changes or diabetic foot were willing to pay higher WTP, and it showed that mental burden and disease burden of them was heavier than others. Patients recovered 10% of HbA1C, FPG, 2hPG’s WTP was closer to actual treatment state. In term of average monthly cost of diabetes, depressed patients and patients with a family history of diabetes spent more money than the others; and patients who had hospitalized experience had higher WTP.
DIABETES/ENDOCRINE DISORDERS – Health Care Use & Policy Studies PDB70 TREND IN ORAL ANTIDIABETICS USE AMONG MOROCCAN PATIENTS Mousannif S , Belaiche A , Cherrah Y , Ahid S Mohammed V University, Rabat, Morocco .
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Objectives: In this study, we analyzed the consumption trends of oral antidiabetics in Morocco in the private sector, during the 1997-2014 period and the impact of generics’ penetration and the Medical Insurance System launch since 2004. Methods: We used sales data in volume from the ATC system : the consumption volumes were converted in defined daily doses (DDD). Results: between 1997 and 2014, outpatients consumption of oral antidiabetics (OAD) in Morocco went from 1,9 to 14 DDD/1000 inhabitants/day habitants/jour (7,8 time more). The consumption increased significantly since 2005 due to the launch of Public Medical Insurance System (called “AMO”), inducing a significant increase in OAD consumption growth : from (+8,8%) during the 1997-2004 period to (+13,7%) during the 2005-2014 period. This evolution is mainly due to the : - Increase of sulfonylureas consumption (multiplied by 4) during this period, with the launch of « Amaryl® » in 1999 and its generics since 2006 and medical guidelines supporting sulfa drugs use. - Increase of Metformin (biguanides’ class) consumption (multiplied by 10), supported by medical guidelines recommending Metformin as preferred initial therapy. - The consumption of innovating therapies marketed in Morocco since 2008 in monotherapy or biotherapy (DPPIV inhibitors) increased dramatically : as an example, Janumet® reached 11% of total OADs’ consumption in 6 years. Conclusions: The consumption of oral antidiabetics increased significantly in Morocco during the 1997-2014 period due medical guidelines in favor of some OADs (sulfonylureas, biguanides..), generics’ penetration, and the launch of innovative therapies, like DPPIV inhibitors, in Morocco. PDB71 A COMPARISON OF ANTI-TYPE 2 DIABETES MELLITUS DRUGS IN CANADA, UNITED STATES, AND UNITED KINGDOM BETWEEN 1958–2015 Alqahtani M 1, Seoane-Vazquez E 2, Rodriguez-Monguio R 3, Szeinbach S 4, Heath N 5, Eguale T 2 1Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA, 2MCPHS University, Boston, MA, USA, 3University of Massachusetts, Amherst, MA, USA, 4Ohio State University, Columbus, OH, USA, 5Takeda Pharmaceuticals International Co., Cambridge, MA, USA .
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Objectives: New drugs for treatment of Type 2 Diabetes mellitus (T2DM) are been approved, however, studies comparing the availability and characteristics of these drugs in different countries are lacking. The objective of this study was to examine the availability and characteristics of T2DM drugs approved in Canada, the US, and the UK in the period (1958-2015). Methods: Regulatory data, including approvals, indications, contraindications, strengths, formulations, and approval dates of T2DM drugs were collected from US Food and Drug Administration (FDA), Health Canada (HC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) websites. Descriptive statistics and t-tests were used in the analysis. Results: In total, 29 drugs included in the study period. The FDA approved 27 (93.1%) T2DM drugs, HC 26 (89.7%) and UK 23 (79.3%). There were 7 (24.1%) T2DM drugs discontinued by the FDA, HC or MHRA. The comparative analysis included 18 T2DM drugs approved by the three agencies. T2DM drugs were first approved by the FDA (61,1%), MHRA (33.3%), and HC (5.65%). There was no significant difference between the average number of indications per T2DM drug approved by HC (1.81 ± 0.40), the FDA (1.19 ± 0.40) and MHRA (1.75 ± 0.58). The average number of contraindications was higher for T2DM drugs approved by MHRA (3.44 ± 3.14), followed by HC (3.22 +/- 1.86) and the FDA (2.16 ± 1.04). More strengths per drug were available for T2DM drugs approved in the US (mean, 2.72) than in the UK (mean, 2.27) and Canada (mean, 2.11). Conclusions: This study found significant differences in the availability and characteristics of T2DM drugs approved by HC, the FDA and MHA. More studies assessing the reasons and effects in clinical practice of differences in availability and characteristics of T2DM drugs in Canada, the US, and the UK three countries are needed. PDB72 INTERNATIONAL DIFFERENCES IN THE ROLE OF PAYER AND ADMINISTRATIVE CONTROLS IN PRESCRIBING DECISIONS IN TYPE 2 DIABETES Silvey M 1, Higgins V 2, Leith A 2, Benford M 2, Graham A 3, Piercy J 3 1Adelphi Real World, Bollington, UK, 2Adelphi Real World, Bollington, UK, 3Adelphi Real World, Manchester, UK .
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Objectives: To assess the extent to which prescribing decisions for T2DM are influenced by payer-implemented controls. Methods: Data were drawn from the Adelphi Diabetes Disease Specific Programme (DSP) conducted across France, Germany, Italy, Spain, UK, US and Japan in Q2 2015. The diabetes DSP is a realworld, cross-sectional survey involving 390 endocrinologists and 560 primary care physicians (PCPs) who complete physician-reported forms for their next 10 consulting T2DM patients. In addition to clinical considerations, physicians were asked to record the impact of administrative controls on their prescribing and the processes they followed. We evaluated 16,209 T2DM prescribing decisions in this analysis. Results: Administrative controls were identified as influencing > 70% of prescribing decisions in Germany, UK and US; 40-60% in France; Spain and Italy; and just over 30% in Japan, all differences were statistically significant (p< 0.0001) except between France and Spain. However, physicians perceived controls led to a non-ideal prescription in < 1 in 100 cases, other than in UK (1 in 50; different from all except US and France p< 0.01) and US (1 in 33; different from all except UK p< 0.0001). Also, physicians did not perceive their decisions to be influenced by administrative controls as often as was detected by their behavior, with international variations observed. Conclusions: This analysis shows physician prescribing behavior is strongly influenced by administrative controls in most countries. However, the mismatch between actual and perceived influence and limited reporting of nonpreferred prescribing may suggest good alignment between payers and physicians, or simply that the controls facilitate appropriate access to medicine while restricting use of some products to selected patients. Further research will characterize the features of controls that are effective, accepted and allow appropriate patient access, with the potential to inform discussions between physicians and payers about economic use of medicines and patients’ access to medicines. PDB73 GENERIC DRUG DISCOUNT PROGRAMS AND THEIR POTENTIAL IMPACT ON BARRIERS TO ACCESS IN PATIENTS WITH DIABETES OR HYPERTENSION Thompson J A , Heaton P , Kelton C , Lin A , Luder H R , Winstanley E L University of Cincinnati, Cincinnati, OH, USA .
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Objectives: Generic Drug Discount Programs (GDDPs) offer commonly used medications at low out-of-pocket cost, potentially reducing the cost barrier to access for many patients. The objectives of this study were to determine the national share of antidiabetic and antihypertensive prescriptions filled through a GDDP and to estimate the effects of various demographic and socioeconomic patient characteristics on GDDP use. Methods: Data were taken from the Medical Expenditure Panel Survey (MEPS). Patients who filled at least one prescription, over a two-year period, for an oral antidiabetic or antihypertensive medication were identified from the annual prescribed medicines files (2010-2013) and longitudinal panel files (20102011, 2011-2012, 2012-2013). Claims for these patients were considered GDDP-filled if the only recorded price paid was out-of-pocket, and the drug quantity dispensed and price matched those on published retail-chain GDDP lists. A logistic regression model was developed and estimated to explain whether a patient filled at least one of his or her prescriptions through a GDDP. Covariates included age, race, income, insurance type, geographic region, and number of medications. Results: GDDP-filled prescriptions accounted for 15.1% of the 1,632,508,663 prescriptions filled between 2010 and 2013. Of the 193.2 million patients with any antidiabetic or antihypertensive claim over these same years, 38.3% (N= 74,078,714) used a GDDP. Significant predictors of GDDP use were patients from the Midwest (OR= 1.31; 95%CI 1.07-1.60) or South (OR= 1.30; 95%CI 1.08-1.58) compared to the West; patients aged 40-49 (OR= 1.40; 95%CI 1.15-1.71) or 50-64 (OR= 1.40; 95%CI 1.21-1.60) compared to those 65 and older; and, uninsured patients (OR= 2.88; 95%CI 2.30-3.60) or privately insured patients (OR= 1.44; 95%CI 1.25-1.67) compared to those with public insurance. Conclusions: The fact that uninsured patients were nearly 3 times more likely to use a GDDP than publicly insured patients suggests that the availability of low-cost medications via a GDDP may help to reduce the cost barrier to medication access. PDB74 ANALYSIS OF TRENDS IN UTILIZATION AND COST OF INSULIN IN THE UNITED STATES AND CANADA DiMario S , Seoane-Vazquez E , Eguale T , Tyrrell B MCPHS University, Boston, MA, USA .
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Objectives: As the prevalence of diabetes increased, new diabetes medications have been approved which impact the utilization and cost of insulin. This analysis evaluates differences in insulin utilization and ex-manufacturer sales between the US and Canada by comparing data from the third quarter (Q3) of 2008 through Q3 of 2014. Methods: Data were derived from the IMS Dataview database to assess insulin utilization measured by volume sold in international units (IU) and exmanufacturer sales in US dollars in the US and Canada. Information was gathered at the country level, and then segmented by retail versus hospital and pens versus vials. Cross-sections of volume and sales for Q3 of 2008 through Q3 of 2014 were evaluated. Descriptive statistics were used to analyze trends in utilization and exmanufacturer prices. Results: The volume of insulin sold increased from 24.8 billion IU to 30.0 billion IU in the US and from 2.2 billion IU to 3.2 billion IU in Canada in the study period. Insulin ex-manufacturer sales increased from $1.9 billion to $5.54 billion in the US and from $78 million to $140 million in Canada. The average cost per unit of insulin sold in the retail and hospital settings increased from $0.068 to $0.184 in the US and from $0.036 to $0.044 in Canada. Beginning in 2011, utilization of insulin in the US began to plateau and the cost per unit of insulin increased at a faster rate, lending to increased total ex-manufacturer sales despite the small change in units sold during the same period. Conclusions: Although utilization of insulin increased in both countries, utilization has slowed in the US. Ex-manufacturer insulin prices increased at substantially faster rates in the US than in Canada. These differences may partially be explained by variations in pricing regulations and the time to “insulinization” in clinical practice.
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“communication with my healthcare provider,” and “my personal understanding of diabetes” as having the most positive impact in self-managing their disease. Least positively ranked items included “my language and culture” and “resources in my local community,” each receiving an average ranking below 5.7. Ratings and rankings were combined via a self-explicated method, yielding eight facilitators (p< .001) and no barriers. The lack of variance in the rating exercise led to an inability to detect barriers to self-management. Conclusions: The findings of this study call into question the validity of rating and ranking exercises as methods to identify factors with negative scores. Methods such as best-worst scaling may be better suited to identify both positive and negative weights. PDB64 THE TREATMENT-RELATED IMPACT MEASURE FOR ADULTS WITH GROWTH HORMONE DEFICIENCY (TRIM-AGHD): CALCULATING AND INTERPRETING THE MINIMALLY CLINICAL IMPORTANT DIFFERENCE Brod M 1, Wilkinson L 2, Hojbjerre L 2, Rasmussen M H 2 Brod Group, Mill Valley, CA, USA, 2Novo Nordisk A/S, Søborg, Denmark .
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Objectives: The Treatment Related Impact Measure for Adults with Growth Hormone Deficiency (TRIM-AGHD), a patient reported outcome (PRO) measure assessing the impact of growth hormone deficiency (GHD) in adults was developed in accordance with the FDA guidance on PRO measure development. Prior validation work determined that the TRIM-AGHD had adequate measurement properties, and was reliable and valid. However, for TRIM-AGHD scores to be interpretable, it is critical that the TRIM-AGHD be responsive to treatment benefit and the minimally clinical important difference in scores (MCID) quantified. Methods: A clinic based study, recruiting naïve-to-treatment adult GHD patients, was conducted. Assessments were at baseline visit (treatment start), weekly by telephone, and 8 week follow-up visit. Responsiveness was evaluated using the effect size of change scores from baseline to follow-up. The MCID estimates were derived from distribution-based [½ standard deviation (½SD), standard error of measurement (SEM)] and anchor-based methods [using the patient global rating of change (PGRC)] using change scores from baseline to initial report of minimal improvement in their GHD severity. Results were then triangulated to suggest an acceptable MCID. Results: Ninety-six patients completed the study, mean age 49.65 years (range 29–68), 65.62% female, 76.04% white, and the primary cause of GHD was head trauma (17.71%) [unknown cause 46.88%]. At follow-up, the TRIM-AGHD was shown to be highly responsive to treatment with the total score effect size being 1.38 (subdomains ranging between 1.22 and 1.36). For the total score, the ½SD was 8.09, the SEM was 2.66, and the anchor-based (PGRC) was 20.43. The suggested MCID based on averaging these methods is 10.40. Conclusions: The TRIM-AGHD is a highly responsive measure of the impact of adult growth hormone treatment. A change score of 10.40 points on the measure can be considered a clinically meaningful improvement in patient functioning and well-being. PDB65 PATIENT-REPORTED OUTCOMES CLAIMS IN ACROMEGALY: A REVIEW OF THE LABELS OF PRODUCTS APPROVED BY THE FDA AND THE EMA Perret C , Perrier L , Acquadro C Mapi Research Trust, Lyon, France .
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PDB66 VALUING INJECTION FREQUENCY: TYPE 2 DIABETES STUDY WILLINGNESS-TOPAY STUDY Fifer S 1, Rose J 2, Swain D 3 and Patient Preference Research, Sydney, Australia, 2Institute for Choice, North Sydney, Australia, 3AstraZeneca, North Ryde, Australia .
PDB67 LOW HEALTH-REALTED QUALITY OF LIFE AND POVERTY AMONG ADULTS WITH DIABETES Alenzi E O 1, Sambamoorthi U 2, Dwibedi N 2 1West Virginia University, School of Pharmacy, Morgantown, WV, USA, 2West Virginia University, Morgantown, WV, USA .
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Objectives: To assess the extent to which disparities in individual, environmental, social, and the bio-physiological characteristics explain the inequalities in healthrelated quality of life (HRQoL) between poor and non-poor adults with diabetes. Methods: We adopted a cross-sectional design using the Medical Expenditure Panel Survey of 9490 adults with diabetes. We categorized adults into: poor (family income < 199 % of Federal Poverty Line (FPL)) and non-poor (family income ≥ 200% of FPL). HRQOL was measured using the physical component summary (PCS) and mental component summary (MCS) scores from the Short Form Health Survey -12 version 2. Low physical and mental HRQoL was defined as having PCS and MCS scores lower than the norm based scores (PCS = 41.52 and MCS= 47.28) of general US individuals with diabetes. The adjusted association between low HRQoL and poverty was tested using logistic regressions controlling for the individual, environmental, social and the bio-physiological characteristics. To explain disparities in having low HRQoL between poor and non-poor, a post-regression non-linear multivariate decomposition technique (mvdcm) was used. Results: A significantly higher percent of poor adults with diabetes had low physical and mental HRQOL (61.9% and 50.5%) compared to non-poor adults (41% and 29.8%). Our results showed that, of the 20.85 percentage point difference in low HRQoL, 11.25 percentage point was explained by disparities in the individual, environmental, social and the bio-physiological characteristics between poor and non-poor adults with diabetes. Disparities in employment status, number of chronic conditions, and physical activity between poor and non-poor explained the differences in low HRQoL between poor and nonpoor adults with diabetes. Conclusions: To eliminate disparities in low HRQoL between poor and non-poor, investment in programs that promote employment, prevent chronic conditions and encourage physical activity are needed.
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Objectives: Acromegaly is a rare acquired disorder resulting from the excessive production of growth hormone by the anterior pituitary gland, and often diagnosed in middle-aged adults. It is characterized by progressive somatic disfigurement (e.g., broadened extremities, thickened soft tissue, and widened face) and systemic manifestations. The objectives of this study were 1) to identify patient-reported outcome (PRO) claims in products approved for the treatment of acromegaly by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and 2) to identify the endpoint positioning of the PROs when measured. Methods: The EMA and FDA websites were explored to identify all products approved for acromegaly. PROLabels was used to identify products with a PRO claim in label. All corresponding clinical reviews (FDA), and assessments reports (EMA) were reviewed to check for endpoint positioning. Results: Six products were approved (from 1978 to 2014) with the indication of acromegaly (representing five INN, i.e., pegvisomant, octreotide acetate, lanreotide, bromocriptine mesylate, and pasireotide). FDA has approved all products, and EMA only two of them (i.e., pegvisomant and pasireotide). For the products approved by both agencies, the same data were submitted. PRO claims were found in the label of pegvisomant (EMA/FDA), octreotide acetate (FDA) and pasireotide (EMA/FDA). For pegvisomant, claims were symptoms-related, with FDA providing much more detailed information in the label than the EMA. Claims were also symptoms-related for octreotide acetate. As for pasireotide, discrepancies were found between agencies. An HRQL claim was found in the European label (improvements measured by the AcroQoL), but not in the FDA label, while symptom claims were retrieved in the FDA label, but not in the EMA’s. For all products, PROs were considered secondary endpoints. Conclusions: The perspective of the patients with acromegaly is recognized by the FDA and the EMA, with still some discrepancies between agencies.
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the survey, patients were asked to trade off both injectable and oral treatments with different features to ascertain what is most important to them. Results: Main effects are estimated for both injectable and oral cohorts. Results suggest that patients in the injectable cohort are mainly concerned with injection frequency, weight change and nausea. Patients in the oral cohort are more concerned about weight change and are intuitively more likely to choose oral treatments. Conclusions: The results have been integrated into a dashboard, which enables stakeholders to perform scenario analysis. Scenarios are presented for the different cohorts, with outcomes measured as a change in consumer surplus. Analysis of the injectable cohort suggests that a once-weekly injection generates an additional benefit over a daily injection, equivalent to a weighted consumer surplus of AUD$22.35 per month. Notably, moving to once-weekly injections from a daily injection is more valuable to patients than a move from twice-daily to once-daily injections. Similar calculations are presented for the oral cohort. Patients on oral treatments forced to choose between daily or once-weekly injections strongly prefer the once-weekly injectable.
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PDB68 PATIENT PERCEPTIONS OF NON-INSULIN INJECTION DEVICES FOR TYPE 2 DIABETES Matza L S 1, Stewart K D 1, Paczkowski R 2, Murray L 1, Landrian A 1, Boye K S 2 1Evidera, Bethesda, MD, USA, 2Eli Lilly and Company, Indianapolis, IN, USA .
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Objectives: Injection devices are commonly used for administration of treatment for type 2 diabetes (T2D). These medications vary in their injection delivery systems, which could impact patient preference. This qualitative study was designed to understand patients’ experiences with non-insulin injection delivery systems. Methods: Concept elicitation interviews were conducted until reaching saturation in the US, UK, and Germany with patients with T2D who have experience with non-insulin injection treatment. Interviews focused on experiences with devices used to administer these medications. Results: Qualitative interviews were conducted with 32 patients. Participants reported liking and disliking a wide range of injection device features. Device characteristics mentioned as positives included injection preparation (n = 30), injection comfort (28), needle characteristics (28), confidence in dose delivery (28), injection frequency (25), dose selection (25), disposal (24), time requirements (24), device size (23), injection site (23), appearance (22), storage (22), portability (21), and dosing schedule (20). Negatively perceived features included needle characteristics (18), portability (16), lack of discreetness (15), storage (15), preparation (14), difficulty using device appropriately (12), size (11), comfort (11), multiple parts (10), confidence in dose delivery (9), dosing schedule (7), injection timing (7), and injection site (7). When asked what they would like to change about non-insulin injectable devices, the most common responses were characteristics of the needle (n= 8), requirements for injection preparation (n= 6), or the need for multiple device parts (n= 6). Conclusions: Patients reported a wide range of injection device features that influenced their perceptions of noninsulin injection devices. Several of these features are not captured by currently available measures of satisfaction with insulin and other diabetes treatment. A patient-reported measure focusing on features important to patients treated with non-insulin injectable medications would be a useful tool for assessing patients’ experiences with these treatments and associated injection devices.
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Objectives: This paper outlines a study designed to investigate the key drivers of choice for type 2 diabetes treatments. The key objective of the study was to explore patient willingness to pay for the different attributes of type 2 diabetes medicines, with a particular focus on valuing injection frequency. Methods: A sample of 171 patients including 58 twice daily injection patients (injectable cohort) and 113 orally treated patients (oral cohort) provided data in November 2014. Data was collected through an online survey and analyzed using state of the art discrete choice experiments. In
PDB69 WILLINGNESS TO PAY OF BLOOD SUGAR CONTROL IN DIABETES AND THE INFLUENCE FACTORS: AN EXPLORATORY SURVEY Long E 1, Chen J 2, Hu M 3, Zhou N 3, Yang N 3 1Sichuan Provincial People’ s Hospital, Chengdu, China, 2University of Maryland, College Park, MD, USA, 3Sichuan University, Chengdu, China .
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Objectives: To investigate the willingness to pay of controlling blood sugar in diabetic patients and analyze the influences factors of WTP. Methods: Face-to-Face
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interview of diabetic patients in a provincial hospital was conducted based on a pre-tested questionnaire. The basic demographic data, disease economic data and WTP for recovery of different diabetic indicators were collected. SPSS17.0 was used to conducted multiple linear regression and step-wise regression to analyze the influence factors of WTP. Results: 120 questionnaires were sent out and 106 were effectively responded The average age of respondents was 59.92 ±13.89. The median value of the WTP for full-recovery of HbA1C, FPG, 2hPG were all $151.5 per month, and the median value of WTP for recovered 10% of HbA1C, FPG, 2hPG’s were $75.75, $87.1 and $77.27, respectively. Multiple linear regression and step-wise regression of factors showed among 6 different recovery statuses, some related factors of WTP value were common, such as the serious complications; and some factors were different. Conclusions: Diabetic patients, particularly with mental derangement changes or diabetic foot were willing to pay higher WTP, and it showed that mental burden and disease burden of them was heavier than others. Patients recovered 10% of HbA1C, FPG, 2hPG’s WTP was closer to actual treatment state. In term of average monthly cost of diabetes, depressed patients and patients with a family history of diabetes spent more money than the others; and patients who had hospitalized experience had higher WTP.
DIABETES/ENDOCRINE DISORDERS – Health Care Use & Policy Studies PDB70 TREND IN ORAL ANTIDIABETICS USE AMONG MOROCCAN PATIENTS Mousannif S , Belaiche A , Cherrah Y , Ahid S Mohammed V University, Rabat, Morocco .
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Objectives: In this study, we analyzed the consumption trends of oral antidiabetics in Morocco in the private sector, during the 1997-2014 period and the impact of generics’ penetration and the Medical Insurance System launch since 2004. Methods: We used sales data in volume from the ATC system : the consumption volumes were converted in defined daily doses (DDD). Results: between 1997 and 2014, outpatients consumption of oral antidiabetics (OAD) in Morocco went from 1,9 to 14 DDD/1000 inhabitants/day habitants/jour (7,8 time more). The consumption increased significantly since 2005 due to the launch of Public Medical Insurance System (called “AMO”), inducing a significant increase in OAD consumption growth : from (+8,8%) during the 1997-2004 period to (+13,7%) during the 2005-2014 period. This evolution is mainly due to the : - Increase of sulfonylureas consumption (multiplied by 4) during this period, with the launch of « Amaryl® » in 1999 and its generics since 2006 and medical guidelines supporting sulfa drugs use. - Increase of Metformin (biguanides’ class) consumption (multiplied by 10), supported by medical guidelines recommending Metformin as preferred initial therapy. - The consumption of innovating therapies marketed in Morocco since 2008 in monotherapy or biotherapy (DPPIV inhibitors) increased dramatically : as an example, Janumet® reached 11% of total OADs’ consumption in 6 years. Conclusions: The consumption of oral antidiabetics increased significantly in Morocco during the 1997-2014 period due medical guidelines in favor of some OADs (sulfonylureas, biguanides..), generics’ penetration, and the launch of innovative therapies, like DPPIV inhibitors, in Morocco. PDB71 A COMPARISON OF ANTI-TYPE 2 DIABETES MELLITUS DRUGS IN CANADA, UNITED STATES, AND UNITED KINGDOM BETWEEN 1958–2015 Alqahtani M 1, Seoane-Vazquez E 2, Rodriguez-Monguio R 3, Szeinbach S 4, Heath N 5, Eguale T 2 1Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA, 2MCPHS University, Boston, MA, USA, 3University of Massachusetts, Amherst, MA, USA, 4Ohio State University, Columbus, OH, USA, 5Takeda Pharmaceuticals International Co., Cambridge, MA, USA .
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Objectives: New drugs for treatment of Type 2 Diabetes mellitus (T2DM) are been approved, however, studies comparing the availability and characteristics of these drugs in different countries are lacking. The objective of this study was to examine the availability and characteristics of T2DM drugs approved in Canada, the US, and the UK in the period (1958-2015). Methods: Regulatory data, including approvals, indications, contraindications, strengths, formulations, and approval dates of T2DM drugs were collected from US Food and Drug Administration (FDA), Health Canada (HC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) websites. Descriptive statistics and t-tests were used in the analysis. Results: In total, 29 drugs included in the study period. The FDA approved 27 (93.1%) T2DM drugs, HC 26 (89.7%) and UK 23 (79.3%). There were 7 (24.1%) T2DM drugs discontinued by the FDA, HC or MHRA. The comparative analysis included 18 T2DM drugs approved by the three agencies. T2DM drugs were first approved by the FDA (61,1%), MHRA (33.3%), and HC (5.65%). There was no significant difference between the average number of indications per T2DM drug approved by HC (1.81 ± 0.40), the FDA (1.19 ± 0.40) and MHRA (1.75 ± 0.58). The average number of contraindications was higher for T2DM drugs approved by MHRA (3.44 ± 3.14), followed by HC (3.22 +/- 1.86) and the FDA (2.16 ± 1.04). More strengths per drug were available for T2DM drugs approved in the US (mean, 2.72) than in the UK (mean, 2.27) and Canada (mean, 2.11). Conclusions: This study found significant differences in the availability and characteristics of T2DM drugs approved by HC, the FDA and MHA. More studies assessing the reasons and effects in clinical practice of differences in availability and characteristics of T2DM drugs in Canada, the US, and the UK three countries are needed. PDB72 INTERNATIONAL DIFFERENCES IN THE ROLE OF PAYER AND ADMINISTRATIVE CONTROLS IN PRESCRIBING DECISIONS IN TYPE 2 DIABETES Silvey M 1, Higgins V 2, Leith A 2, Benford M 2, Graham A 3, Piercy J 3 1Adelphi Real World, Bollington, UK, 2Adelphi Real World, Bollington, UK, 3Adelphi Real World, Manchester, UK .
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Objectives: To assess the extent to which prescribing decisions for T2DM are influenced by payer-implemented controls. Methods: Data were drawn from the Adelphi Diabetes Disease Specific Programme (DSP) conducted across France, Germany, Italy, Spain, UK, US and Japan in Q2 2015. The diabetes DSP is a realworld, cross-sectional survey involving 390 endocrinologists and 560 primary care physicians (PCPs) who complete physician-reported forms for their next 10 consulting T2DM patients. In addition to clinical considerations, physicians were asked to record the impact of administrative controls on their prescribing and the processes they followed. We evaluated 16,209 T2DM prescribing decisions in this analysis. Results: Administrative controls were identified as influencing > 70% of prescribing decisions in Germany, UK and US; 40-60% in France; Spain and Italy; and just over 30% in Japan, all differences were statistically significant (p< 0.0001) except between France and Spain. However, physicians perceived controls led to a non-ideal prescription in < 1 in 100 cases, other than in UK (1 in 50; different from all except US and France p< 0.01) and US (1 in 33; different from all except UK p< 0.0001). Also, physicians did not perceive their decisions to be influenced by administrative controls as often as was detected by their behavior, with international variations observed. Conclusions: This analysis shows physician prescribing behavior is strongly influenced by administrative controls in most countries. However, the mismatch between actual and perceived influence and limited reporting of nonpreferred prescribing may suggest good alignment between payers and physicians, or simply that the controls facilitate appropriate access to medicine while restricting use of some products to selected patients. Further research will characterize the features of controls that are effective, accepted and allow appropriate patient access, with the potential to inform discussions between physicians and payers about economic use of medicines and patients’ access to medicines. PDB73 GENERIC DRUG DISCOUNT PROGRAMS AND THEIR POTENTIAL IMPACT ON BARRIERS TO ACCESS IN PATIENTS WITH DIABETES OR HYPERTENSION Thompson J A , Heaton P , Kelton C , Lin A , Luder H R , Winstanley E L University of Cincinnati, Cincinnati, OH, USA .
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Objectives: Generic Drug Discount Programs (GDDPs) offer commonly used medications at low out-of-pocket cost, potentially reducing the cost barrier to access for many patients. The objectives of this study were to determine the national share of antidiabetic and antihypertensive prescriptions filled through a GDDP and to estimate the effects of various demographic and socioeconomic patient characteristics on GDDP use. Methods: Data were taken from the Medical Expenditure Panel Survey (MEPS). Patients who filled at least one prescription, over a two-year period, for an oral antidiabetic or antihypertensive medication were identified from the annual prescribed medicines files (2010-2013) and longitudinal panel files (20102011, 2011-2012, 2012-2013). Claims for these patients were considered GDDP-filled if the only recorded price paid was out-of-pocket, and the drug quantity dispensed and price matched those on published retail-chain GDDP lists. A logistic regression model was developed and estimated to explain whether a patient filled at least one of his or her prescriptions through a GDDP. Covariates included age, race, income, insurance type, geographic region, and number of medications. Results: GDDP-filled prescriptions accounted for 15.1% of the 1,632,508,663 prescriptions filled between 2010 and 2013. Of the 193.2 million patients with any antidiabetic or antihypertensive claim over these same years, 38.3% (N= 74,078,714) used a GDDP. Significant predictors of GDDP use were patients from the Midwest (OR= 1.31; 95%CI 1.07-1.60) or South (OR= 1.30; 95%CI 1.08-1.58) compared to the West; patients aged 40-49 (OR= 1.40; 95%CI 1.15-1.71) or 50-64 (OR= 1.40; 95%CI 1.21-1.60) compared to those 65 and older; and, uninsured patients (OR= 2.88; 95%CI 2.30-3.60) or privately insured patients (OR= 1.44; 95%CI 1.25-1.67) compared to those with public insurance. Conclusions: The fact that uninsured patients were nearly 3 times more likely to use a GDDP than publicly insured patients suggests that the availability of low-cost medications via a GDDP may help to reduce the cost barrier to medication access. PDB74 ANALYSIS OF TRENDS IN UTILIZATION AND COST OF INSULIN IN THE UNITED STATES AND CANADA DiMario S , Seoane-Vazquez E , Eguale T , Tyrrell B MCPHS University, Boston, MA, USA .
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Objectives: As the prevalence of diabetes increased, new diabetes medications have been approved which impact the utilization and cost of insulin. This analysis evaluates differences in insulin utilization and ex-manufacturer sales between the US and Canada by comparing data from the third quarter (Q3) of 2008 through Q3 of 2014. Methods: Data were derived from the IMS Dataview database to assess insulin utilization measured by volume sold in international units (IU) and exmanufacturer sales in US dollars in the US and Canada. Information was gathered at the country level, and then segmented by retail versus hospital and pens versus vials. Cross-sections of volume and sales for Q3 of 2008 through Q3 of 2014 were evaluated. Descriptive statistics were used to analyze trends in utilization and exmanufacturer prices. Results: The volume of insulin sold increased from 24.8 billion IU to 30.0 billion IU in the US and from 2.2 billion IU to 3.2 billion IU in Canada in the study period. Insulin ex-manufacturer sales increased from $1.9 billion to $5.54 billion in the US and from $78 million to $140 million in Canada. The average cost per unit of insulin sold in the retail and hospital settings increased from $0.068 to $0.184 in the US and from $0.036 to $0.044 in Canada. Beginning in 2011, utilization of insulin in the US began to plateau and the cost per unit of insulin increased at a faster rate, lending to increased total ex-manufacturer sales despite the small change in units sold during the same period. Conclusions: Although utilization of insulin increased in both countries, utilization has slowed in the US. Ex-manufacturer insulin prices increased at substantially faster rates in the US than in Canada. These differences may partially be explained by variations in pricing regulations and the time to “insulinization” in clinical practice.