Evidence-based analyses to look at cost-effectiveness, cost-benefit information  clinical data – Pubrica
                     EVIDENCE-BASED ANALYSES  
TO LOOK AT COST-  
EFFECTIVENESS, COST-
BENEFIT  INFORMATION & 
CLINICAL  DATA FROM RT – 
DEVICE  MANUFACTURERS
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, 
Pubrica  Group: www.pubrica.com
Email: [email protected]
Today's 
Discussion
Outlin In-Brief
e Introduction
Evidence-based Analyses to Look Cost-Effectiveness at the FDA 
Medical Devices  Current Economic Considerations in FDA’s Drug 
and Medical Device Approval  Processes
The Economic evaluation and Clinical Data from RT – Device 
Manufacturers  Treatment Planning Process
Conclusion
In-
Brief
Cost analysis of implementing evidence-based analysis has become 
important  within implementation science and is critical for bridging 
the research to  practice gap to improve access to quality healthcare 
services. Costing studies  in this area are rare but necessary since 
the cost can be a barrier to
implementing and sustaining evidence-based analysis.
Introductio To provide physicians with a foundational view of 
n health  economics studies, such as cost-benefit, cost-  effectiveness, and cost-utility analysis.
The procurement of services that yield the best 
patient  benefit at the lowest cost is a challenge 
in a healthcare  economy with occasional funding.
To make informed decisions in value-based care,  
information on benefits and costs is needed. Any 
cost-  benefit, cost-effectiveness, or cost-utility 
model relies  heavily on costs.
Estimating model costs is difficult and can vary 
greatly  based on the viewpoint of the 
stakeholder.
Contd...
First, the investigator must decide which costs should be included in 
the report.  In economic terms, an expense is any capital use.
Both prices must be in the same units for study, which is normally 
currency.
Time and materials are all categories of costs that must be valued 
and factored  into the decision-making process.
Evidence-based Analyses 
to  Look Cost-
Effectiveness at the  FDA 
Medical Devices
Mainly FDA’s Center for Devices and 
Radiological  Health (CDRH) is in charge of 
medical technology  premarket evaluation, 
strong manufacturing process  standards, and 
post-market surveillance.
However, the FDA’s premarket appraisal of most 
 medical devices is not as stringent as it is for  
medications until they are introduced to the 
market.
Contd...
While all new drugs must go through rigorous premarketing tests in  
randomized clinical trials before receiving FDA approval, only a 
few new  devices must go through the same process.
Instead, the FDA categorizes new devices into low risk, moderate 
risk, and  high risk.
Low-risk products (bandages, splints, and surgical drapes) account 
for half of  all medical devices sold each year, and they are exempt 
from all premarket  review criteria.
Current  
Economic  The FDA does not use economic conditions in its  medication and medical device approval  
Consideration procedures.
s  in FDA’s 
The Food, Medicine, and Cosmetic Act,
Drug  and tAhgeency’s principal legislative neith
Medical  jurisdiction,  authorizes nor er  
froerqbuiidrsemetnhtes in tuhse FDofA’s assessmfiennatn coif 
Device applicant  drugs and products. al
Approval  
Processes The legality of using cost efficacy to assist with  evaluating experimental medications 
and products  is yet to be determined.
Contd...

The Economic  
evaluation In the management and care of cancer, RT 
plays a  crucial part.
and  Clinical 
Data  from RT External beam (EBRT) and
innovati radiotherapy  its  cancer
– Device  cvaepabilities,a ndsuch as stetrreaottmacetnict body 
Manufacturer ablative  rlaodciaoltihzedrapy (SABR) and proton therapy, are the  subject of many studies.
s
Intern radiotherapy (IRT)employs
al  invasive  techniques and seed
(sburagcichythimerpalpeym),e nint awtiohnich nuclear seeds are 
adlirectly  inserted next to cancerous cells for 
invasive  procedures.
Contd...
The figure depicts the traditional EBRT pathway, which includes the 
following steps:
(1)immobilization and visualization of the patient using modalities such 
as  computed tomography (CT), magnetic resonance imaging (MRI), 
positron  emission tomography (PET), single-photon emission computed 
tomography  (SPECT), ultrasound, or plain x-ray radiographs;
(2), (3), then tumour segmentation, in which attending clinicians 
determine tumour  volume parameters (such as form and location) and 
margins when taking into  account essential structures before image 
validation procedures;
Contd...
(4) Physicians and physicists then use computerized treatment planning 
systems  (TPS) to digitally replicate the radiotherapy procedure, where 
dose beam  directions and intensities are optimized for improved 
patient treatment.
The optimization may be performed by the operator (planning), who 
chooses the  beam number, form, paths, and dosage contribution, or by 
a computer algorithm  (inverse treatment planning).
Once the treatment arrangements have been finalized and accepted, 
the actual  patient irradiation procedure begins, in which (5) the entire 
dose is separated into  small doses (fractions) and administered to the 
patient at predetermined times  (usually daily) to enable healthy tissues 
to recover between procedures.
Contd...

Treatmen TPS-based computer algorithms are used in the 
t  care  preparation process to assess the best 
treatment  parameters for the individual’s 
Planning  condition.
Process
aGloloacl a t ivoonl,u mdeo(sse),   f rdaocstieo-nliamtiotin,g   d omsec hdaenliisvmersy, , 
p daotiseent  positioning, therapy machine 
configurations, and  adjuvant therapies are 
among these criteria.
In addition, the device generates reference 
images and  other data that help in the patient’s 
set-up and location  verification of treatment 
fraction.
Contd...
Over several weeks, attending clinicians safely monitor the process’s 
final  performance.
Quality assurance (QA) is an important aspect of radiotherapy 
treatment because  of the heavy and extremely harmful doses of 
radiation administered to patients.
The value of high-quality delivery has been shown in many clinical 
research, with  scientific QA generally measuring both the dosage 
administered and the  geometric accuracy of the delivery.
Contd...
The confirmation of a procedure in a standardized phantom or the 
verification of dose  administered in a delivery series for a particular patient 
are two typical QA processes in  radiotherapy delivery.
The issue with both is that they almost all use a generic description of a 
human patient.
Conclusion
The medical device industry spends a lot of 
money on  emerging technologies, testing, 
product creation,  insurance, and patient access.
Near working partnerships with suppliers will 
help align  priorities by providing access to 
hospital management  and buying teams to 
inform them on the effect of  technological 
investments on cost-benefit analysis and  better 
patient outcomes.
Contd...
Hospitals and physicians should also take the lead in developing health 
performance  reporting and benchmarking procedures and disseminating 
the data needed for  evidence-based technology evaluations.
More sophisticated information systems that connect goods to cost, results 
and  protection are being established.
Still, widespread implementation would necessitate establishing criteria for 
 comprehensive data collection and specially trained personnel to perform 
evidence-  based research that includes cost-benefit and cost-effectiveness
 analysis.
Contact Us
UNITED KINGDOM
+44- 7424810299
INDIA
+91-9884350006
EMAIL
[email protected]