Evidence-based analyses to look at cost-effectiveness, cost-benefit information clinical data – Pubrica

1. EVIDENCE-BASED ANALYSES TO LOOK AT COST- EFFECTIVENESS, COST-BENEFIT INFORMATION&CLINICAL DATAFROMRT–DEVICE MANUFACTURERS AnAcademicpresentationby Dr.NancyAgnes,Head,TechnicalOperations,Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline In-Brief Introduction Evidence-basedAnalysestoLookCost-EffectivenessattheFDAMedicalDevices Current Economic Considerations in FDA’s Drug and Medical Device Approval Processes TheEconomicevaluationandClinicalDatafromRT–DeviceManufacturers TreatmentPlanningProcess Conclusion

3. In-Brief Costanalysisofimplementingevidence-basedanalysishasbecomeimportant within implementation science and is critical for bridging the research to practice gap to improve access to quality healthcare services. Costing studies inthisarea arerarebut necessarysincethe costcanbe abarrierto implementingandsustainingevidence-basedanalysis.

4. To provide physicians with a foundational view of health economicsstudies,suchascost-benefit,cost- effectiveness,andcost-utility analysis. Introduction The procurement of services that yield the best patient benefit at the lowest cost is a challenge in a healthcare economywith occasionalfunding. Tomakeinformeddecisionsinvalue-basedcare, information on benefits and costs is needed. Any cost- benefit,cost-effectiveness,orcost-utilitymodelrelies heavilyon costs. Estimating model costs is difficult and can vary greatly basedontheviewpoint ofthestakeholder. Contd...

5. First,theinvestigatormustdecidewhichcostsshouldbeincludedinthereport. Ineconomic terms,an expense isany capital use. Bothpricesmustbeinthesameunitsforstudy,whichisnormallycurrency. Timeandmaterialsareallcategoriesofcoststhatmustbevaluedandfactored intothe decision-making process.

6. Evidence-based Analyses to LookCost-Effectivenessatthe FDAMedicalDevices MainlyFDA’sCenterforDevicesandRadiological Health(CDRH)isinchargeofmedicaltechnology premarketevaluation,strongmanufacturingprocess standards,andpost-marketsurveillance. However,theFDA’spremarketappraisalofmost medicaldevicesisnotasstringent asitisfor medicationsuntiltheyareintroducedtothemarket. Contd...

7. Whileallnewdrugsmustgothroughrigorouspremarketingtestsin randomizedclinicaltrialsbeforereceivingFDAapproval,onlyafewnew devicesmust go throughthe same process. Instead, the FDA categorizes new devices into low risk, moderate risk, and highrisk. 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 reviewcriteria.

8. Current Economic Considerations in FDA’s Drug and Medical DeviceApproval Processes The FDA does not use economic conditions in its medicationandmedicaldeviceapproval procedures. The Food, Medicine, and Cosmetic Act, the Agency’s principal legislative jurisdiction, authorizes nor forbids the use of neither financial requirements in the FDA’s assessment of applicant drugsand products. Thelegalityofusingcostefficacytoassistwith evaluatingexperimentalmedicationsandproducts isyet tobe determined. Contd...

10. Inthemanagementandcareofcancer,RTplaysa crucialpart. The Economic evaluation and Clinical Data fromRT–Device Manufacturers External innovative beam radiotherapy and localized (EBRT) and its cancer treatment capabilities,suchasstereotacticbodyablative radiotherapy (SABR) and proton therapy, are the subjectof manystudies. Internal surgical radiotherapy (IRT) employs invasive techniques and seed implementation (brachytherapy), in which nuclear seeds are directly insertednexttocancerouscellsforinvasive procedures. Contd...

11. ThefiguredepictsthetraditionalEBRTpathway,whichincludesthefollowingsteps:ThefiguredepictsthetraditionalEBRTpathway,whichincludesthefollowingsteps: immobilizationandvisualizationofthepatientusingmodalitiessuchas computedtomography(CT),magneticresonanceimaging(MRI),positron emissiontomography(PET),single-photonemissioncomputedtomography (SPECT),ultrasound, orplain x-ray radiographs; , (3), then tumour segmentation, in which attending clinicians determine tumour volume parameters (such as form and location) and margins when taking into accountessentialstructures beforeimage validationprocedures; Contd...

12. (4) Physicians and physicists then use computerized treatment planning systems (TPS)todigitallyreplicatetheradiotherapyprocedure,wheredosebeam directionsandintensitiesareoptimized forimprovedpatienttreatment. The optimization may be performed by the operator (planning), who chooses the beam number, form, paths, and dosage contribution, or by a computer algorithm (inversetreatment 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 (usuallydaily)toenablehealthy tissuestorecoverbetweenprocedures. Contd...

14. TPS-based computer algorithms are used in the care preparationprocesstoassessthebesttreatment parametersfortheindividual’s condition. Goal volume(s), dose-limiting mechanisms, dose Treatment Planning Process allocation,dosefractionation,dosedelivery,patient positioning,therapymachineconfigurations,and adjuvanttherapiesareamongthesecriteria. In addition, the device generates reference images and other data that help in the patient’s set-up and location verificationof treatmentfraction. Contd...

15. Overseveralweeks,attendingclinicianssafelymonitortheprocess’sfinal performance. Quality assurance (QA) is an important aspect of radiotherapy treatment because oftheheavyandextremelyharmfuldosesofradiationadministeredtopatients. The value of high-quality delivery has been shown in many clinical research, with scientificQAgenerallymeasuringboththedosageadministeredandthe geometricaccuracy of thedelivery. Contd...

16. 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 radiotherapydelivery. Theissuewithbothisthattheyalmostalluseagenericdescriptionofahumanpatient.

17. Conclusion The medical device industry spends a lot of money on emergingtechnologies,testing,productcreation, insurance,and patientaccess. Near working partnerships with suppliers will help align priorities by providing access to hospital management andbuyingteamstoinformthemontheeffectof technological investments on cost-benefit analysis and betterpatient outcomes. Contd...

18. Hospitals and physicians should also take the lead in developing health performance reportingandbenchmarkingproceduresanddisseminatingthedataneededfor evidence-basedtechnology evaluations. Moresophisticatedinformationsystemsthatconnectgoodstocost,resultsand protectionare being established. Still,widespread implementationwouldnecessitateestablishingcriteriafor comprehensive data collection and specially trained personnel to perform evidence- basedresearch thatincludes cost-benefitand cost-effectiveness analysis.

19. ContactUs UNITEDKINGDOM +44-7424810299 INDIA +91-9884350006 EMAIL sales@pubrica.com