MEDICAL DEVICE ASSESSMENT IN KAZAKHSTAN. by Alexander Kostyuk, MD, PhD BACKGROUND

Transcription

1 MEDICAL DEVICE ASSESSMENT IN by Alexander Kstyuk, MD, PhD BACKGROUND 1

2 BACKGROUND SPECIFICITIES FOR HTAS ON MEDICAL DEVICES Manufacturers / vendrs f new healthcare technlgy increasingly required t demnstrate value fr mney Early-stage decisins ften perfrmed under pressure Value t users and service prviders ften prly established Medical devices typically brught t market at high risk, ften by small cmpanies Risk: Technical, Clinical, Cmmercial... 2

3 HTAS ON MEDICAL DEVICES IN Natinal Center f Expertise f Drugs, Medical Devices and Medical Equipment Cnducts assessment f safety and quality f devices (required fr entry int the market) Sets reference pricing fr devices that are purchased thrugh public funds (state benefit package) Cnducts assessment f marketing materials fr devices Organizes the natinal nmenclature f devices harmnized with the Glbal Medical Device Nmenclature (in develpment) currently includes 9689 devices KEY ELEMENTS OF MARKET ACCESS FOR MEDICAL DEVICES IN Elements Cntext Kazakhstan Health system Mre than 70% expenditure n devices cmes frm public health system in the EU Variatins in Kazakhstan Mixt state benefit package & statutry health insurance prvided t all (17 millin patients) Hspital payment system Mechanism t supprt innvative devices? Heavy investments n medical devices are cncentrated in the hspitals Rather than rutine HTA prcesses, additinal rutes are available fr early access f innvative devices Public sectr: Capital and natinal budget distributed amngst reginal/municipal bdies N specific mechanisms available t supprt innvative high cst devices Hwever, greater adaptability in private sectr as hspital need t be cmpetitive (i.e., market mechanisms); greater resistance in public sectr n new/expensive device uptake 3

4 KEY ELEMENTS OF MARKET ACCESS FOR MEDICAL DEVICES IN Classificatin system Elements Cntext Kazakhstan Prcess f assessment fr lw risk devices (Classes I-II) Prcess f assessment fr high risk devices (Classes II-III fr EU) Devices are classified frm a regulatry level int different grades based n level f risk and invasiveness Nt all devices are assessed by HTA; generic and lw risk devices pass thrugh simpler rutes Devices are assessed by varius HTA bdies nly under given circumstances NCEDMDME registratin (Class I, II, III) Public sectr: des nt assess lwer risk devices (i.e., Class I/II); hwever, sme higher risk/ mre nvel Class I/II devices may still be subject t assessment Private sectr: mainly price rientated (i.e., will assess lwer risk/class I and II devices based n cmparative price) Public sectr: Higher risk devices (primarily Classes III and IV) are assessed Private sectr: Nvel/high risk devices assessed by individual hspitals KEY ELEMENTS OF MARKET ACCESS FOR MEDICAL DEVICES IN Elements Cntext Kazakhstan Assessment bdies (HTA) Different bdies are invlved in HTA assessment prcess f the devices Data requirements Data requirements are nt as transparent fr medical devices as they are fr pharmaceuticals Very basic guidance is prvided by HTA bdies Length f assessment Assessment perids vary acrss different cuntries and smetimes may be much lnger than given in the guidance Final decisin Final assessment decisin may be made at the natinal/ reginal level Public: NCEDMDDE r RCHD Private: hspitals Public: Technical, clinical, ecnmic data; QL data als cnsidered; n QALY limits but there are standards and sme health ecnmic evidence is expected; Private: ecnmic data, but less rbust and rigid prcess; shuld prvide technical and clinical data als Public: 2-3 mnths Private: as little as 1 mnths MH has 30 days t publish a final reimbursement deliberatin; Public: Ministry f Health (MH)/Health Insurance Fund Private: hspitals 4

5 KEY ELEMENTS OF MARKET ACCESS FOR MEDICAL DEVICES IN Elements Cntext Kazakhstan Budget hlders Budget hlders are respnsible fr final uptake f medical devices in hspitals Pricing (inpatient devices nly) Pricing cvered by varius bdies can be split int ambulatry and hspital sectr Public: Gvernment; MH will decide wh shuld pay fr the device E.g., very expensive nvel technlgies may be funded frm the natinal budget, while all thers funded by the state r municipality budgets Private: hspitals Gvernment (MH, regins, municipalities depending n wh pays fr it) Tendering/negtiating with manufacturer Early scientific advice Similar t pharmaceutical sectr, seeking early scientific advice is cnsidered beneficial in cuntries where the pssibility exists Templates Guidance templates are prvided by natinal and reginal bdies fr submitting the required infrmatin fr HTA assessment Nt available Yes (guidance) KEY ELEMENTS OF MARKET ACCESS FOR MEDICAL DEVICES IN Elements Cntext Kazakhstan Stakehlders Highly influential stakehlders in decisin-making (i.e., scred 5 and 4) Public: HTA, gvernment departments Private; hspitals Less influential stakehlders in decisin making (i.e., scred 1-3) Physicians in hspitals, ambulatry physicians, patients, nurses, and health ecnmists Pharmacists Purchasing grups r natinal/reginal prcurement Benefits Advantages f the current prcedures fr the device manufacturers If yu can demnstrate that the prduct is clinically and ecnmically effective, chances f successful reimbursement are high Prices fr medical devices are nt cntrlled 5

6 CHALLENGES IN HTAS ON MEDICAL DEVICES IN Prductin f rbust clinical and ecnmic evidence; a gd ecnmic analysis needs lcal data whereas clinical data des nt need t be lcal / freign studies in reliable centers anywhere in the wrld are acceptable Ecnmic evaluatin is very new in Kazakhstan, lcal data is scarce; Public health system is very ambitius; budget cnstraints are very imprtant TRENDS IN HTAS ON MEDICAL DEVICES IN Private segment will grw substantially - the ppulatin btaining private insurance is grwing, and with this the level f investment and access t new technlgies willals increase; MH will intrduce mre medical devices fr cverage; hwever, they will likely train medical scieties and nurses t develp a netwrk which will cntribute t the decisin making prcess; Cntinued investment in lcal prductin and incentives fr Kazakh cmpanies t prduce lcally; Rbustness f technlgy evaluatin will increase in private sectr; Increased patient pwer/imprtance f patient rganisatins 6