Reimbursement of Oncology Drugs in Saudi Arabia

Transcription

1 Reimbursement of Oncology Drugs in Saudi Arabia Abdulaziz Al-Saggabi, B.Sc., M.Sc., Pharm.D. Director, Drug Policy & Economics Center Ministry of National Guard Health Affairs Chairman, ISPOR Arabic Network & President ISPOR Saudi Arabia Chapter Presentation Outline General Saudi Health Care System Indicators Decision-Makers & Influencers Reimbursement Decision-Making & Approval Process Saudi Arabia 2020 Transformational Program Saudi Arabia Reimbursement Drug Submission/HTA Guidelines Project Reimbursement/HTA Guidelines for Oncology drugs Risk Sharing Agreements

2 Saudi Health Care System Indicators Population Population 65 Years Old & Above Gross National Income Per Capita (PPP Int. $) Total Expenditure on Health as a Percentage of Gross Domestic Product General Government Expenditure on Health as a Percentage of Total Expenditure on Health Private Expenditure on Health as a Percentage of Total Expenditure on Health Private Prepaid Plans as a Percentage of Private Expenditure on Health Percentage of government budget allocated to Health Service Out-of-pocket Expenditure as a Percentage of Private Expenditure on Health Governmental Insured Population Population Insured by Private Health Insurance (%) (%) 31.07(%) 19.37(%) 6.84(%) 58.06(%) 71% 29% 3 5/22/2017 Decision-Makers & Influencers Pricing of pharmaceuticals is regulated by Saudi Food & Drug Authority( Saudi FDA) Reimbursements Decision-Makers: National Guard Health Affairs Ministry of Health Ministry of Defense Ministry of Interior Ministry of Higher Education (University Hospitals) Private Sector / Health Insurance Company

3 Reimbursement Decision-Making & Approval Process Registration & pricing of drugs by SFDA does not guarantee reimbursement by different health care sectors. Pharmaceuticals are fully reimbursed if they are listed in the formularies of governmental health care sectors. Decision-making on formulary listing, and therefore, reimbursement is made by Pharmacy & Therapeutics Committees in the different health care sectors Reimbursement Decision-Making & Approval Process Factors influencing decisions include clinical efficacy and safety data, availability of alternatives, comparative effectiveness, and cost effectiveness. Reimbursement of pharmaceuticals differs from one health care sector to the other. For example, a drug reimbursed in MOH might not be reimbursed in NGHA. Patients can opt to pay for drugs that are not reimbursed by the governmental health care sectors privately.

4 Reimbursement of Oncology Drugs The increasing cost of oncology drugs represents a major problem for payers and health care systems in Saudi Arabia & the region. Balancing access to innovative oncology drugs with existing budget constraints in many health care sectors represents a major challenge for decision-makers in Saudi Arabia. After the decrease in oil prices, the Saudi government developed 2030 vision to decrease dependence on oil. The budget for many health care organizations was reduced. Saudi Arabia 2020 Transformational Program The kingdom s 2020 national transformational program was developed to help fulfill the country s 2030 Vision and to identify the challenges faced by government bodies in the economic and development sector. An important strategic objective for 2020 transformation plan is to increase the efficient utilization of available resources and achieve efficiency of government spending. The program establishes strategic objectives that are based on the vision and addresses its challenges through 2020 in accordance with specific targets.

5 Saudi Arabia 2020 Transformational Program It identifies, each year, the initiatives necessary for achieving such goals and devises detailed plans on the basis of interim indicators that measure and monitor performance. the Bureau of Capital and Operational Spending Rationalization was established as an independent unit under the Council of Economic Affairs and Development to strengthen the government capabilities in managing expenditure. The council of Economic and Development Affairs has also established the National Center of Performance Measurement. Reimbursement of Oncology Drugs in Saudi Arabia Decision-makers in Saudi Arabia are looking for more stringent scientifically sound decision-making rules to ensure costeffectiveness of oncology drugs and improve access to innovative oncology drugs in the country.

6 Saudi Arabia Reimbursement /HTA Guidelines A national working is currently working on establishing National Reimbursement Drug Submission / HTA/ PE Guidelines for Payers. There will be a special section for value assessment of oncology Drugs to inform reimbursement decision-making. A Study is currently underway to: Set health state values based on EQ5D instrument for the Saudi General Population Estimate population norms for EQ-5D-5L for Saudi Arabia using a large randomly selected community sample and the new scoring algorithm to inform economic evaluations. Examine the relationship between socio-demographic factors and HrQOL measures using E5-5D-5L utility and VAS scores. Saudi Oncology Reimbursement/HTA Guidelines Several value assessment methods have been considered including: HTA based Multi-Criteria Decision-Making that use cost/qaly Incremental Cost Effectiveness Ratio (ICER) and other criteria (e.g., NICE End of Life Rule) European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale. American Society of Clinical Oncology (ASCO) Value Framework National Comprehensive Cancer Network (NCCN) Evidence Blocks

7 HTA based Multi-Criteria Decision Making Comprehensive HTA studies Cost/QALY incremental cost effectiveness ratio NICE End of Life Rule for Drugs that result in extension of life for 3 months or more in patients with life of expectancy of 2 years or less, higher ICERs will be accepted and considered cost-effective. ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) Overall survival or cure has more weight compared with surrogates, such as progression-free survival or response rate. Disease free survival (DFS) in curative disease is considered more valid surrogate in curative disease compared with PFS in incurable disease. Comparative or cohort study. Pre-specified endpoints of OS and DFS are given higher scores, whereas PFS is given lower scores. HR or absolute improvement in the pre-specified endpoint.

8 ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) Curative Disease: Scores are given based on achieving threshold HRs and absolute time difference compared with the control and A,B or C grades are given. A & B grades are deemed clinically meaningful to justify consideration by a HTA agency. Adjuvant setting: Magnitude of difference in HR and median OS or DFS is weighed against toxicity and impact on Quality of Life if measured. The highest scores (A & B) are considered of meaningful benefits. ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) Advanced Disease: 1-5 scores Higher scores (4 & 5) are given for meaningful improvement in important endpoints, such as OS Lower scores for surrogate endpoints such as PFS. Cost is not considered ESMO-MCBS might be useful for prioritizing HTA and costeffectiveness studies for drugs that achieve higher scores.

9 NCCN Evidence Block Evidence blocks were incorporated into NCCN guidelines. The domains include effectiveness, safety, quality of evidence, consistency of evidence and affordability. Each domain is scored 1 (least favorable) to 5 (most favorable). However, the scoring is subjective as it is based on expert opinion and lacks clear definition and cutoff thresholds for each scoring grade. Risk Sharing Agreements Risk sharing agreement that helps decrease uncertainty of innovative cancer therapy is needed when cost-effectiveness could not be achieved with listing prices. Many manufacturers have already started to provide risk and cost sharing agreement proposals to payers in Saudi Arabia. Risk Sharing Agreements are important tools that should be part of oncology drugs reimbursement system.

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