Risk sharing or risk shifting? On the development of patient access schemes in the process of updating the national list of health services in Israel.

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.

The ESMO-Magnitude of Clinical Benefit Scale for novel oncology drugs: correspondence with three years of reimbursement decisions in Israel.

BACKGROUND: The European Society for Medical Oncology published in 2015 its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for cancer medicines. Our objective was to evaluate the association between Israel's national reimbursement decisions regarding novel cancer drugs, prior to the availability of ESMO-MCBS, and the later published ESMO-MCBS scores. RESEARCH DESIGN AND METHODS: ESMO-MCBS scores were obtained retrospectively for the cancer drugs that were candidates for reimbursement in Israel in 2013-2015 and were categorized to 'highest benefit' (ESMO-MCBS 4-5 or A) 'medium benefit' (3 or B) and 'lowest benefit' (0-2 or C). The reimbursement decisions were accessed and compared with the categorized ESMO scores. RESULTS: ESMO-MCBS score was available for 19/22 drugs approved for reimbursement and 15/16 non-approved drugs. 58% of the approved drugs gained a 'highest benefit' score and 37% were 'medium benefit'. 87% of the non-approved drugs had 'lowest benefit' scores. Median score for approved drugs was 4 vs. 1 for the non-approved (p < 0.05). CONCLUSIONS: The Israeli decisions regarding reimbursement of novel cancer drugs, demonstrated concordance with ESMO-MCBS scores. Incorporation of ESMO-MCBS data in reimbursement deliberations could assist in framing the appropriate use of the limited resources to deliver effective and affordable cancer care.