ACME Devices Company Outline ACME Devices Company Implantable Artificial Pancreas CMS Gap Analysis RWE Applications ACME Devices Company Diabetes is prevalent and leads to heart disease stroke and other serious disability ID: 909280
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Slide1
Implanted Artificial Pancreas
ACME
Devices Company
Slide2Outline
ACME Devices Company: Implantable Artificial Pancreas
CMS Gap Analysis
RWE Applications
Slide3ACME
Devices Company
Slide4Diabetes is prevalent and leads to heart disease, stroke and other serious disability
Approximately 1.6 million Americans with Type 1 Diabetes
Intensive diabetes therapy has clear benefits
Reducing risk of hypo- and hyperglycemia
Reducing glycemic variability
Improving quality of life
Existing approaches to intensive therapy
Require significant patient effort
Increase risk of hypoglycemia
May result in weight gain that undermines patient adherence
May cost 3x more than conventional therapy
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide5Implanted artificial pancreas represents a major advance in diabetes management and quality of lifeKey Features:Fully implanted system with expected 10-year device lifespanTranscutaneous inductive chargingMultiport system with full week insulin and glucagon reservoirsSmart-phone based app with photographic, AI-driven carbohydrate assessmentData synchronization with EHR module
Current Treatment Options
Implanted Artificial PancreasThe company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future. Images:
http://www.pharmatimes.com/magazine/2019/januaryfebruary_2019/ and https://www.jdrf.ca/resources/learn/research-news/what-is-an-artificial-pancreas/
Slide6Implanted artificial pancreas addresses lifestyle factors, improves care, and simplifies insulin managementThe company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide7Findings from the multicenter SWEET Relief trial
Multi-center RCT with enrollment from US, Canada.
24 months of data.
Two comparison groups: Self-administered insulin, Implanted
Bihormonal
Artificial Pancreas.
Primary outcomes:
Serious hyperglycemic episodes requiring hospitalization
Serious hypoglycemic episodes (BS < 70)
Average glucose values
HA1C % values
Secondary outcomes:
Surgical complications
Device failures requiring revision / extraction
Device or port infections
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide8Findings from the SWEET Relief trial
Manual Insulin (n=100)Artificial Pancreas (n=100)P ValueAge – yr
33 + 2533 + 25Female sex (%)43
47Median duration of DM (IQR) - yr18 (8 - 22)18 (9 – 24)Mean BMI at enrollment (IQR)24 (23 – 29)24 (22 – 28)HA1C Baseline (%)7.6 + 17.6 + 1% Time Glucose 70 – 18059 + 1480 + 10< 0.001% Time Glucose > 18038 + 1518 + 10< 0.001Glucose level170 + 25150 + 15< 0.001HA1C% 1 year7.39 + 0.927.02 + 0.60.001Any adverse event*250.15*Adverse Events: Severe hypoglycemia; Diabetic ketoacidosis; Serious adverse events related to device; hyperglycemia or ketosis without diabetic ketoacidosis. The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide9Findings from the SWEET Relief trialArtificial Pancreas (n=100)Major complications (Any)
5Surgical complication1
Pump failure0Port failure / revision2Infection
2Minor complications (Any)10Software failure (reboot, reprogram)5CGM miscalibration (> 5%)5The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide10The CRUSH Diabetes trial
Multi-center RCT with enrollment from US, Canada, and Germany.
Two comparison groups: Self-administered insulin, Implanted
Bihormonal
Artificial Pancreas.
Primary outcomes:
% time glucose in range 70 – 180
% time glucose > 180
HBA1C at 1 year
Secondary outcomes:
Composite adverse event rate
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide11Findings from the multicenter CRUSH Diabetes trial
Manual Insulin (n=100)Artificial Pancreas (n=100)P ValueAge – yr
42 + 2543 + 25Age > 65 (%)4
5Female sex (%)4544Median duration of DM (IQR) - yr23 (8 - 28)20 (11 – 24)Mean BMI at enrollment (IQR)25 (23 – 29)24 (22 – 28)HA1C% Baseline7.6 + 17.6 + 1% Time Glucose 70 – 18059 + 1476 + 10< 0.001% Time Glucose > 18038 + 1522 + 10< 0.001Glucose level170 + 25156 + 19< 0.001HA1C% 1 year7.39 + 0.927.06 + 0.790.001Any adverse event*2170.05*Adverse Events: Severe hypoglycemia; Diabetic ketoacidosis; Serious adverse events related to device; hyperglycemia or ketosis without diabetic ketoacidosis. The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide12FDA Labelling
The Artificial Pancreas is intended for continuous delivery of basal and bolus insulin for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The Artificial Pancreas can be programmed to automatically suspend insulin and deliver glucagon when the sensor glucose value falls below a predefined threshold value.
The Artificial Pancreas System consists of the following devices that can be used individually or in combination:
Artificial Pancreas
Subcutaneous inductive charger
Insulin Port Plus
NextGen Diabetes software suite
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide13Outline
ACME Devices Company: Implantable Artificial Pancreas
CMS Gap Analysis
RWE Applications
Slide14CMS Considerations
Is there an applicable Benefit Category?
After thorough review of the available evidence, does the item or service meet the “reasonable and necessary” definition?
If the item or service is promising but does not yet meet the “reasonable and necessary” definition, what evidence gaps remain?
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide15Reasonable and Necessary Definition
Reasonable and necessary means an item or service is (1) safe and effective, (2) not experimental or investigational, (3) appropriate for Medicare patients
Appropriate for Medicare Patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:
Furnished in accordance with
accepted standards of medical practice
for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member
Furnished in a
setting
appropriate to the patient's medical needs and condition
Ordered and furnished by
qualified personnel
One that
meets, but does not exceed, the patient's medical need
At least as beneficial
as an existing and available medically appropriate alternative
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide16Environmental Scan: Artificial Pancreas
Two pivotal clinical trials: SWEET Relief & CRUSH Diabetes
Other Published Evidence: CGM and insulin pumps generally
Studies demonstrated a meaningful improvement in glucose control; but neither study examined hard outcomes or patient preferences.
The longest of the two trials followed patients only for 24 months.
Data are poorly generalizable to Medicare beneficiaries.
Few older patients included;
Racial / ethnic breakdown not presented.
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide17CMS Gap Analysis
Demonstrate hard outcomes and patient preferences
Reduction in cardiovascular events and renal failure
Reduction in ED visits / hospitalizations
Improved patient self-efficacy and/or quality of life
The longest of the two trials followed patients for only 24 months
Demonstrate device durability and health outcomes over longer time periods (~ 5 years)
Data are poorly generalizable to Medicare beneficiaries
Older patients
Multiple comorbidities
Racial / ethnic minorities
The company, device, technologies, services, and clinical trials in this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide18Outline
ACME Devices Company: Implantable Artificial Pancreas
CMS Gap Analysis
RWE Applications
Slide19How might RWE be used to “close the gap”?
Slide20The company, device, technologies, services, and clinical trials n this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.
Slide21The company, device, technologies, services, and clinical trials n this case study are hypothetical and are presented to facilitate a discussion of real world evidence development. The gap analysis is focused on major issues. This presentation in no way represents a finding by CMS that an applicable benefit category exists nor does it represent a commitment to a specific coverage determination should an implantable artificial pancreas be developed in the future.