IQVIA CORE Diabetes Model Version 10

Dear CDM User,

We are very happy to announce the launch of version 10 of the IQVIA Core Diabetes Model.

This version of the model comes with several improvements:

• Time In Range is now available as an alternative to HbA1c changes
• The clinical data of CVD submodules (HF, MI, Stroke) has been updated with more recent evidence.
  • HF submodule now includes HF rehospitalizations
• An additional type 1 diabetes cardiovascular risk equation
• Additional options with new parameters for indirect cost calculations
• As changes in weight are appreciated differently around the globe, region specific BMI related disutility approaches are now available.

The many updates done to the model and its inputs obliged us to start with a new empty database. Please note that there are, at the moment no plans to decommission version 9.0 of the CDM.

With the kindest regards

Mark Lamotte
For the CDM team

IQVIA CORE Diabetes Model Version 9.5 Plus

Dear CDM User,

We are very happy to announce the launch of version 9.5 Plus of the IQVIA Core Diabetes Model.

This version of the model comes with several improvements:

• UKPDS 90 progression equations for several risk factors have been included
• A new eGFR progression option has been added
• Lipid parameters (TC, HDL, LDL, and triglycerides) will now follow the same progression option over time
• Asian risk equations have been adapted so that HbA1c changes influence outcomes
• The CDM Clinical Default includes new data on progression of blood pressure and lipids in type 1 diabetes patients
• EDIC risk of cardiovascular disease predictions after 26 years has been updated using extrapolation

The many updates done to the model and its inputs obliged us to start with a new empty database. Therefore, 9.5 settings are made available in version 9.5Plus, except the simulations to facilitate the start of the use of this new version.

Please note that there are, at the moment no plans to decommission version 9.0 of the CDM.

With the kindest regards

Mark Lamotte
For the CDM team

IQVIA CORE Diabetes Model Version 9.5

Dear Core Diabetes Model User,

We are very happy to announce the launch of version 9.5 of the IQVIA Core Diabetes Model.

This version of the model comes with several new features:

• An uploadable excel as an alternative to populating the different settings online, you may now complete the following modules in an excel template and upload it in a couple of seconds:
  • Cohort
  • Economics
  • Treatment
  • Management
  • Mortality tables
• Updated default values for Clinical settings, available to all users
• New cardiovascular risk equations:
  • Swedish National Diabetes Registry for type 1
  • Four Asian risk equations in type 2
  • An alternative Framingham equation
• Progression of physiological parameters based on Swedish National Diabetes Registry
• Simplified foot ulcer sub-model
• Updated renal disease progression parameters
• Replacement of lactic acidosis as adverse event by three placeholder treatment-specific adverse events
• Replacement of depression sub-model by a placeholder complication sub-model
• Possibility to relate hypoglycemic events to cardiovascular events and mortality
• An adherence module that links adherence to a drug below 100% with decreased treatment impact on HbA1c and BMI.
• BMI disutility applicable via static approach (with a single data input) or a polynomial function
• Relative risk reduction on cardiovascular and renal events, allowing model calibration for cardiovascular outcomes trials

The many updates done to the model and its inputs obliged us to start with a new empty database. Therefore, settings from version 9.0 cannot be migrated to version 9.5. However, with the uploadable excel this should not cause you any delays (to the contrary).

We hope you are as excited as we are about this new version of the IQVIA Core Diabetes Model, and we are happy to tell you more about all the changes and implications. For that, we are working on a reference manual for version 9.5 where all inputs will be documented.

Please note that there are at the moment no plans to decommission version 9.0 of the CDM. It should at least be available until the end of 2021.

With the kindest regards

Mark Lamotte
For the CDM team

IQVIA CORE Diabetes Model at ISPOR 2019 US

Dear IQVIA Core Diabetes Model User,

Since March 19 the IQVIA CDM has been available with a new user interface under the E360 platform. By the end of Q2 2019 we are also expecting to launch version 9.5 of the CDM. This new version will have several new features.
During the upcoming ISPOR conference in New Orleans (May 20-22 2019) the IQVIA CDM team will be present to provide demo presentations on the new platform and on the new features of version 9.5.
Please book your time with us by e-mailing Mafalda.ramos@iqvia.com or mark.lamotte@iqvia.com.
Don’t hesitate to forward this e-mail to your colleagues that are participating in the conference!

Also note that we will present 5 posters talking about the new features of version 9.5 at this conference as outlined hereunder.

RESEARCH POSTER PRESENTATIONS – SESSION II
PDB: DIABETES/ENDOCRINE/METABOLIC DISORDERS
Monday, May 20, 2019
3:30 PM - 7:00 PM

Monteiro S, Ramos M, Altrabsheh E, Gurjar K, Olivieri A, Lamotte M. Contrasting Framingham Risk Equations in Type 2 Diabetes Using the IQVIA Core Diabetes Model. Submitted to ISPOR 24th Annual International Meeting New Orleans US, May 18-22 2019. PDB35

Olivieri A, Ramos M, Monteiro S, Altrabsheh E, Gurjar K, Lamotte M. CONTRASTING THREE TYPE 2 DIABETES CARDIOVASCULAR RISK EQUATIONS FOR EAST ASIA WITH UKPDS82 USING THE IQVIA CORE DIABETES MODEL. Submitted to ISPOR 24th Annual International Meeting New Orleans US, May 18-22 2019. PDB26

Ramos M, Olivieri A, Monteiro S, Altrabsheh E, Gurjar K, Lamotte M. BODY MASS INDEX ASSOCIATED UTILITY APPROACHES IN THE IQVIA CORE DIABETES MODEL. Submitted to ISPOR 24th Annual International Meeting New Orleans US, May 18-22 2019. PDB23

Gurjar K, Ramos M, Monteiro S, Altrabsheh E, Olivieri A, Lamotte M. Comparability of results using two alternative versions of the IQVIA CORE Diabetes Model. Submitted to ISPOR 24th Annual International Meeting New Orleans US, May 18-22 2019. PDB30

Altrabsheh E, Monteiro S, Ramos M, Gurjar K, Olivieri A, Lamotte M. Association Between Cardiovascular Disease Risk Factors and Hypoglycaemic events in Type 2 Diabetes Using the IQVIA Core Diabetes Model Submitted to ISPOR 24th Annual International Meeting New Orleans US, May 18-22 2019. PDB64

Looking forward to see you in New Orleans.

With the kindest regards

For the CDM team
Mark Lamotte

Update to Mount Hood Challenge website

The Mount Hood Challenge website has been further updated to include more information. These include

1. Tools and plans for developing diabetes simulation models including several studies that have been recently published.
2. Links to studies which report costs for complications in numerous countries that can be used in simulation models.
3. Link to studies which report utilities for major complication.
4. A list of 72 studies that use simulation models to study cost-effectiveness.

The enhanced website also has an archive with programs and material from all previous Mount Hood challenges dating back to 1999 as well as a database of diabetes computer simulation models. The website currently contains information that are obtained from modeling groups for various Mount Hood Challenge. The organisation would like to however become a comprehensive database consisting of all health economic related diabetes computer simulation models and supporting material. It is encouraged that if organisations have relevant published material , they must send these to this email (mthood2016@gmail.com).

The next Mound Hood Challenge will take place between 5th – 7th of October 2018 in Düsseldorf Germany. Further details will follow later in the year.

The Mount Hood Challenge

The notable town of St. Gallen in Switzerland hosted the 8th Mount Hood Diabetes Challenge, the only dedicated conference to diabetes health economic simulation modelling. Modelling groups from around the globe as well as health economics and market access responsible from the industry, and academics were present at the conference. The core diabetes model (CDM) team from IQVIA attended the meeting and presented the results of the different challenges obtained with the QI Core Diabetes Model and also contributed to the wrapping up of the conference that should result in guidelines for reporting on diabetic health economic modelling.

The challenge part of this meeting consisted of eight modelling teams trying to reproduce the results of two published papers as well as assessing how risk factors such as HbA1c, blood pressure and lipids influence the life expectancy and quality adjusted life expectancy of people with diabetes. The modellings teams were advised to produce comparable outcome tables using their own models for patients with Type 2 diabetes. Transparency of the comparisons was promoted by comparing models across a broad range of standardized patient simulations. These simulations for patients allowed users to understand what risk factors drove variations in model outcomes.

The attempt to replicate the journal results emphasized the necessity for standardized reporting on inputs and characteristics (a minimum data set) to permit replicability of previously published data in presented models. The next meeting is planned in Germany in September 2018. More details of this conference is accessible online.

http://www.mthooddiabeteschallenge.com/

IQVIA CORE Diabetes Model update

Dear IQVIA CORE Diabetes model users,

IQVIA are pleased to inform all users that we will release the updated 64bit version of IQVIA CORE Diabetes Model (CDM) version 9.0 and version 8.5 by March 17 2017.

The transition to the updated 64 bit CDM infrastructure is part of a continued development programme to ensure that the CDM is hosted and processed on current state-of-the-art technology and software. This upgrade is associated with a number of benefits which are outlined below.

Simulation time � The number of simultaneous simulations that can be processed on the simulation severer system has been increased more than threefold which will considerably reduce the overall waiting time until simulation results can be accessed.

Stability � Recently an increasing number of simulation crashes have been observed (simulations being interrupted during execution and requiring restart) which contributed to the elongation of waiting time until outcomes can be accessed. With the upgrade to the new system it is expected that the stability of simulation processes will be substantially improved.

Security � The technologies used by 64bit CDM allow improvement to the security of the environment on which new CDM system is built. It will allow the development and deployment of resolutions to newly discovered threats as well as ensuring improved safety and integrity of data. SSL encryption of all communication between the user and web interface mean that all sensitive settings and simulation data will remain protected from outside interference and theft.

With this background information we kindly advise all CDM users to start using the new 64bit CDM versions as soon as possible.

The following URL link to the new 64bit CDM version can be used:

64bit CDM
CDM v9.0 and CDM v8.5: https://www.core-diabetes.com

The new versions will be fully equivalent to the current (32 bit) versions with the below exceptions:

• Due to the change to the 64bit infrastructure, the randomness of simulations has changed which means that simulations that are executed on the new system will present slight (random) deviations towards outcomes generated on the current versions. The magnitude of random variability is dependent on the simulation size (i.e. declines with increasing number of patients and/or bootstrap iterations included).
• The web interface appearance has changed slightly. Since the upgrade to 64 bit required a reimplementation of the web code, we took advantage of this update to change particular features which are explained in the attached update guide.

To access the 32bit versions, please use the following URL links:
32bit CDM
CDM v9.0: http://www.core-diabetes.com:8080/login.asp
CDM v8.5: http://www.core-diabetes.com:8080/CDM2012/login.asp

IQVIA CORE Diabetes Model User Group Forum

Dear CDM user,

The IQVIA Core Diabetes Model team will be at ISPOR in Milan in November, if you would like to attend a workshop on Sunday 8th November to find out more about the model please contact Mike Gains

Meeting Agenda

• Introduction to version 9.0 of the model
• Hypoglycaemic event module
• New type 2 risk equations
• Completely new Type 1 inputs based on new equations
• NICE comments on version 8.5 and how they are addressed in version 9
• Assessing the impact of BMI on cost-effectiveness
• FAQ�s on the CDM

If you already use the model and have any questions regarding the analyses you are running please send all your questions and remarks to mlamotte@be.imshealth.com

Mark Lamotte
Senior Principal - Cardiologist
Real-World Evidence Solutions & HEOR
IQVIA

CDM USER FORUM - ISPOR Milan 2015

Validation Study of the IQVIA CORE Diabetes Model is Published in Value in Health

We are pleased to announce that the results of a recent study validating the IQVIA CDM to contemporary outcomes data is published in September�s issue of Value In Health. A press release will also be published in Value In Health alongside the article and reads as follows:

�The IQVIA CORE Diabetes Model (CDM) is a simulation model that predicts the long-term health outcomes and costs associated with the management of type 1 and type 2 diabetes. The model is routinely used to inform reimbursement decisions, public health issues, clinical trial design and optimal patient management strategies. Validation is a key component of the continual development of any disease model and as the CDM has undergone a number of major updates since publication of its last validation exercise. The objective of this study was to validate the latest version of the model to results from contemporary major outcomes studies.

Independent researchers with unrestricted access to the CDM and its source code worked with IQVIA to externally validate and verify the model to both short and long term outcomes studies in diabetes. A number of statistical measures of goodness of fit were used and the impact of choice of cardiovascular risk equations was evaluated, including use of the new UKPDS 82 outcomes model equations. At conventional levels of statistical significance the study found that the CDM fitted the contemporary validation data well.

Professor Phil McEwan of Swansea University, the lead researcher of the study said: " Those organisations developing policy and implementing decisions informed by CDM require the reassurance that the model and its results are current and validated. This study helps demonstrate the CDM is a validated tool for predicting major diabetes outcomes and consequently is potentially suitable for supporting policy decisions relating to disease management in diabetes." The full study " Validation of the IMS CORE Diabetes Model," is published in Value in Health.�

The full citation is: Validation of the IQVIA CORE Diabetes Model. Phil McEwan, PhD, Volker Foos, MSc, James L. Palmer, MSc, Mark Lamotte, MD, Adam Lloyd, MPhil, David Grant, MBA. Value in Health. 2014, 17 (6), 714�724. The paper has been published with open access and can be downloaded at no charge from this page:
http://authors.elsevier.com/sd/article/S1098301514019287

Any questions can be directed to the IQVIA CDM team through the email address info_CDM@imshealth.com.

The IQVIA Core Diabetes Model team participates in the 7th Mount Hood Challenge at Stanford University.

From June 17 to 19 four members of the CDM team (David Grant, Volker Foos, Mark Lamotte and external expert Phil McEwan), as well as Julie Munakata, Leader of the US RWES team, participated in the seventh Mount Hood Challenge at Stanford University in Palo Alto, CA, following the American Diabetes Association Conference in June 2014.

The major focus of the Mount Hood meetings, which take place every two years, is on economic aspects of diabetes and its complications and in particular a comparison of health economic diabetes models, both in terms of their structure and performance. The 80 attendees included the leading diabetes modelling groups, as well as academics, industry representatives and payers with an interest in the economics of diabetes.

A particular theme of the 2014 challenge was how to generalise diabetes simulation models for different populations and over time in order to address the question: to what degree are existing models able to adjust for differences risk due to ethnic and socio-economic differences as well as any secular improvements in diabetes care?

The conference consisted of three �challenges�, to which the participating modelling groups responded, as well as a number of open sessions covering all aspects of the economics of diabetes and its management. The purpose of the challenges was to compare model projections to real world or clinical trial outcomes and to discuss differences observed between the model and the real world results, as well as possible explanations for the observed differences. The objective of this exercise is to advance the science of economic modelling in diabetes, making it more valid and relevant to real world decision making. There is, contrary to popular belief, no attempt to crown a particular model the �winner� of the challenges. This year eleven diabetes modelling groups responded to three challenges set by the conference organisers:

1. Replication of key endpoints from the Action for Health Diabetes (Look AHEAD) study, a trial comparing an intensive lifestyle-intervention program aimed at achieving and maintaining weight loss and fitness in patients with type 2 diabetes.
2. Predicting mortality following first myocardial infarction (MI) or stroke.
3. Variation in event rates due to ethnicity.

In addition the CDM team participated in a session on �Advances in Type 1 diabetes simulation modelling� and also demonstrated the capabilities of the CDM in type 1 diabetes.

The organisers of the conference will co-ordinate the development of a manuscript detailing the results of the challenges for all the participating models. A condition of participation is not to share or discuss any results prior to their publication. Nevertheless, we can affirm that the IMS CDM performed well across the range of challenges.

In the open sessions, Volker and Phil presented two talks each:

• Validating the UKPDS 68 and 82 risk equations to contemporary outcomes studies in type 2 diabetes.
• Comparing simulation run time requirements to achieve stabilized absolute and incremental costs effectiveness results in probabilistic vs. deterministic modeling analysis.
• Quantifying nonlinear effects in stochastic Markov simulation using UKPDS 68 and UKPDS 82 equations in type 2 diabetes modelling.
• Analysis with the IQVIA CORE Diabetes Model: All cause mortality validation of the CORE diabetes model against predictions of the Charlson comorbidity index.

In summary, the 7th Mount Hood Challenge conference was an excellent opportunity to understand the performance of the IQVIA CDM against a series of external validation challenges and to discuss many of the technical challenges in modelling this complex disease with the leading experts in the field. It was reassuring that the IMS CDM performed well in all of the challenges set and the ensuing discussions will certainly benefit and strengthen the model as we continue to develop and enhance its functionalities.

Press release - "Review of utility values for economic modeling in type-2 diabetes"

Basel, Switzerland - Many new products for type 2 diabetes mellitus (T2DM) will be launched in the coming years as a response to this ever-increasing world epidemic. Health technology assessment (HTA) agencies require cost-effectiveness studies of these agents, but no consistent set of utility data exists to act as a basis for these evaluations.

Researchers from IQVIA and Swansea University aimed to report a set of utility values for T2DM and its complications to illustrate challenges in creating such a utility set. In the study �Review of utility values for economic modeling in type-2 diabetes,� published in Value in Health, the researchers reported a set of values that might act as a common benchmark for assessing new diabetes treatments. Several limitations were observed in selecting values for inclusion in economic evaluations including the use of different instruments to measure preferences, the variability in patient recruitment, heterogeneity in statistical analysis, large variability around some point estimates and lack of recent data. This highlights the need for further research and guidance for the selection of utilities for use in cost-effectiveness analyses.

Adam Lloyd, one of the authors of the paper, said: �Evaluations of new diabetes therapy are inconsistent, because many estimates of patient outcomes are incomplete or do not meet the requirements of HTA agencies. Understanding long-term benefits is crucial to establishing whether new diabetes treatments offer good value for money. The use of a common set of inputs for different technologies might lead to greater consistency in evaluation of new therapies.�

Link to the full document

Keywords: systematic review, diabetes, utility, quality of life, EQ-5D

Incorporation of UKPDS 82 Risk Equations into the IQVIA CORE Diabetes Model

In 2013 the UKPDS group published the long awaited updated UKPDS risk equations in Diabetologia. We are pleased to inform all users that we will release version 8.5+ of the IMS CDM, including the updated UKPDS 82 risk equations on 17th of February 2014. The new version will produce consistent outcomes to the current CDM version 8.5 and provide the additional option to apply the new set of equations.

Prior to the release of V8.5+, IQVIA has undertaken a validation program to ensure that the new equations are coded correctly and has conducted a series of internal and external validations to compare event rate predictions from UKPDS 82 and UKPDS 68 risk equations with the CDM. The first results of this comparison were presented in Dublin at the CDM User Forum 2013 and a summary of this presentation can be found here:

UKPDS 82 equations inside the CDM.pdf

Earlier CDM validation studies with UKPDS 68 equations have demonstrated the model�s validity to predict event rates consistent with those reported in contemporary T2DM outcome studies. Please see the attached presentation for further details:

CDM Validation 2012.pdf

In addition, IQVIA has conducted a series of validation exercises using the new UKPDS 82 risk equations, including a comparison to recent outcomes study trial data. Initial findings using the updated equations have shown an improved fit in internal validations compared with UKPDS data but less precise external validity when compared to contemporary outcome studies. These findings are not unexpected as the new set of equations is still based on the same data set. Reasons for the lower predicted external validity may be due to necessary assumptions that were applied regarding the modifiable risk factor trajectories for newly included parameters such as estimated glomerular filtration rate (eGFR), haemoglobin count, white blood cell count and heart rate, but further research is required to assess the robustness of these new equations.

In light of these findings we recommend that users continue to use the UKPDS 68 risk equations as they represent the most extensively validated set of equations.

With release of CDM v8.5+, the new UKPDS 82 equations can be optionally applied to the formerly available sets of equations. For this please tick the option �Apply UKPDS 82 equations� in the CDM simulation input interface. Please note that if this box is selected, the selection of alternative regression methods in the upper dropdown section of the interface will be ignored (Figure 1).

Figure 1 � CDM simulation input interface with new option to select UKPDS 82 equations