ABSTRACT #55053 PRESENTATION CODE PHP187
THE PILLARS OF COST-EFFECTIVENESS A PRACTICAL GUIDELINE FOR NEW TECHNOLOGY COST-EFFECTIVE DECISION-MAKING Mario-Ricardo CalderĂłn, Alejandro Salvatierra & Roel Roording Novartis Pharma AG, Central America & Caribbean
INTRODUCTION The critical importance and use of health technology assessment in health care decisions towards improved health is practically nonexistent in many Central American and Caribbean countries. A culture with a health economics mindset that enhances access to new technologies is needed; one that increases the knowledge and application of economic evaluation among health stakeholders to make cost-effective decisions that improve health. Health care progress depends on the effective use of resources including knowledge of what drugs or interventions work, how much they cost and how they are administered or implemented. Patients, providers, policy makers and payers share universal goals in terms of drugs and technology use and acquisition --best quality, lowest cost and reasonable access. This has resulted in (1) greater focus on healthcare spending, cost-containment, prescribing behavior control and smaller perceived drug differentiation within the healthcare industry, and (2) increased need for differentiated products, compelling value propositions and better support and patient access strategies in the pharmaceutical industry. The rising costs of healthcare and limited resources have spurred the need for evaluating the economic viability of any drug or intervention. However, evaluation of health technologies and economic evaluations represent only one of the components of a comprehensive strategy to make technologies more accessible to patients.
OBJECTIVES r *O HFOFSBM UP Ă OE OFX XBZT UP NBLF OFX ESVHT BOE UFDIOPMPHJFT BWBJMBCMF UP patients, healthcare providers, governments and society as a whole. r 4QFDJĂ DBMMZ UP EFWFMPQ B HVJEFMJOF GPS UIF QIBSNBDFVUJDBM BOE IFBMUIDBSF industries to make new technologies more cost-effective and available to patients in resource-limited settings.
METHODS AND DISCUSSION A needs assessment was conducted among key internal (pharmaceutical JOEVTUSZ BOE FYUFSOBM TUBLFIPMEFST QVCMJD QSJWBUF BOE OPO QSPĂ U JO $FOUSBM "NFSJDB and the Caribbean to gain insight about their behaviors, patterns and practices regarding new technology acquisition. Health stakeholders were interviewed at TDJFOUJĂ D BOE QIBSNBDFVUJDBM NFFUJOHT JO (VBUFNBMB &M 4BMWBEPS $PTUB 3JDB Panama and the Dominican Republic during 2014. A literature review of lessons learned and best practices around the world complemented information collected from local stakeholders. No standardized way to make budget allocations or procurement decisions was GPVOE .BOZ QVCMJD QSJWBUF BOE OPO QSPĂ U IFBMUI PSHBOJ[BUJPOT QVSDIBTF ESVHT based on empiric estimates, previous year consumption, earmarked budgets, EFNBOE PS OFFET BOE MFHBM PSEFST 4DJFOUJĂ D FWJEFODF BCPVU DMJOJDBM FGĂ DBDZ PG drugs is critically important but, due to limited budgets and lack of cost-effectiveness evidence or knowhow, the key driver behind most decisions is price, the lowest price
possible. Stakeholders acknowledge that inexpensive drugs may turn out expensive at the end in terms of increased tangible (direct and indirect) and intangible costs and poor health outcomes. A simple, useable, read-do Checklist could guide stakeholders to select cost-effective health technologies, particularly new, innovative high cost drugs. The Checklist concept has been used effectively for over 75 years by the aeronautical JOEVTUSZ J F 1SF 'MJHIU 4BGFUZ $IFDLMJTU UP SFEVDF BJS USBGà D BDDJEFOUT 6 4 "SNZ BOE Boeing Corporation, October 1935). The World Health Organization translated this concept intuitively to the operating room to reduce the number of surgical deaths around the world in conjunction with the Harvard School of Public Health (WHO Surgical Safety Checklist, 2008). A basic organization tool –the simple Checklist—when properly conceived has proven effective in a wide range of TJUVBUJPOT J F &NFSHFODZ .FEJDBM 4FSWJDFT $IFDLMJTU UP EFUFDU QPTTJCMF &CPMB cases, protect personnel and respond appropriately (U.S. Centers for Disease 1SFWFOUJPO BOE $POUSPM &NFSHFODZ 1SFQBSFEOFTT $IFDLMJTU UP QSPUFDU JOEJWJEVBMT save lives and cope with extreme weather conditions and disasters (American Red Cross), etc. In pharmacoeconomics, as in aviation, medicine and public health, checklists can help ensure consistency and completeness in carrying out complex tasks. Hence, a practical Checklist with all knowledge domains needed to select new drugs and technologies could improve the decision makers´ communication and consistency of information and data, facilitate the decision-making process and determine the most cost-effective options for the health system.
RESULTS " QJWPUBM DPODFQU XBT DSFBUFE UIF 1JMMBST PG $PTU &GGFDUJWFOFTT 1$& 5IF DPNQMFY BDUJWJUZ PG TFMFDUJOH UIF NPTU DPTU FGGFDUJWF ESVH PS UFDIOPMPHZ GPS B IFBMUI TZTUFN JT EJWJEFE JOUP i,OPXMFEHF %PNBJOTu DPNQSJTJOH &TTFOUJBM $PNQPOFOUT DMVTUFSFE JOUP i5ZQFT PG &GGFDUJWFOFTTu DSFBUJOH UIF GPMMPXJOH i/FX 5FDIOPMPHZ $PTU &GGFDUJWFOFTT $IFDLMJTUu
NEW TECHNOLOGY COST-EFFECTIVENESS CHECKLIST *
Table 1
(FIRST EDITION)
CLINICAL EFFECTIVENESS 1. EFFICACY Symptoms Relief Survival Quality of Life 2. SAFETY Frequency of Adverse Events Serious Adverse Events Risk Management Plan 3. QUALITY Good Manufacturing Practices Bioavailability Bioequivalency
MEDICAL ACCESS EFFECTIVENESS 4. VALUE-ADDED SERVICES Training Programs Diagnostic Tools Patient or Provider Services 5. MANAGED-ENTRY AGREEMENTS Performace-Based Agreements Financial-Based Agreements Risk-Sharing Arrangements 6. IMPACT INFORMATION Epidemiological Burden Evidence-Based Clinical Research Real World Evidence Research
ECONOMIC EFFECTIVENESS 7. COST OF ILLNESS Direct Costs Indirect Costs Intangible Costs 8. COST-EFFECTIVENESS EVIDENCE Cost-Utility Analysis Cost-Benefit Analysis Cost-Effectiveness Analysis 9. BUDGET IMPACT ANALYSIS Current Technology Mix Cost New Technology Mix Cost Comorbidity Related Costs
(&/&3*$ $)&$,-*45 */5&/%&% 50 #& .0%*'*&% "4 /&&%&% 50 '*5 -0$"- 3&26*3&.&/54 "/% &/7*30/.&/54
CONCLUSIONS r )FBMUIDBSF EFDJTJPOT UPXBSET JNQSPWFE IFBMUI NVTU DPOTJEFS UIF DMJOJDBM FGGFDUJWFOFTT NFEJDBM BDDFTT FGGFDUJWFOFTT BOE FDPOPNJD FGGFDUJWFOFTT PG BOZ ESVH PS UFDIOPMPHZ r 5IF 1JMMBST PG $PTU &GGFDUJWFOFTT $PODFQU NBZ TFSWF BT UIF OFX HVJEFMJOF UP NBLF FWJEFODF CBTFE EFDJTJPOT JO SFTPVSDF MJNJUFE TFUUJOHT BOE BDIJFWF UIF CFTU IFBMUI PVUDPNFT possible. r 5IF /FX 5FDIOPMPHZ $PTU &GGFDUJWFOFTT $IFDLMJTU NBZ CFDPNF B VTFGVM UPPM UP OFHPUJBUF WBMVF BEEFE TFSWJDFT BOE NBOBHFE FOUSZ BOE SJTL TIBSJOH BHSFFNFOUT UP NBLF IJHI cost drugs and technologies more cost-effective. r 5IF JUFN $IFDLMJTU NBZ JNQSPWF UIF EFDJTJPO NBLFST{ DPNNVOJDBUJPO BOE DPOTJTUFODZ PG LOPXMFEHF EPNBJOT SFRVJSFE UP NBLF DPTU FGGFDUJWF EFDJTJPOT r *O QIBSNBDPFDPOPNJDT BT JO BWJBUJPO NFEJDJOF BOE QVCMJD IFBMUI DIFDLMJTUT DBO IFMQ FOTVSF DPOTJTUFODZ BOE DPNQMFUFOFTT JO DBSSZJOH PVU UIF DPNQMFY UBTLT PG OFX ESVH BOE technology selection and acquisition. r *O UVSO UIF 1JMMBST PG $PTU &GGFDUJWFOFTT BOE JUT /FX 5FDIOPMPHZ $PTU &GGFDUJWFOFTT $IFDLMJTU NBZ CFDPNF UIF OPSN UP FOTVSF UIF VOJWFSTBM HPBMT PG QBUJFOUT QSPWJEFST policy-makers and payers to (1) get the best drug and technology quality at the lowest cost with reasonable access, and (2) enhance healthcare partnerships and solutions towards improved individual and population health outcomes.
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Presented at ISPOR 20th Annual International Meeting, 16 – 20 May, 2015, Philadelphia, USA.