By Erfan Akbraian, Analyst
Email: [email protected]
Majority of orphan drug manufacturers do not currently view Israel as an early launch opportunity. However, universal reimbursed access to high quality healthcare which is at par with Western European countries, combined with the expansion of the prenatal and new-born screening programmes that have considerably improved diagnosis rates is increasingly making Israel an attractive market for orphan drug manufacturers.
Having a complete understanding of Israel’s structured reimbursement procedure, associated timelines and possible routes to market that enables quick reimbursed access after obtaining market authorisation is imperative to achieve commercial success.
The National Formulary or Healthcare Basket of reimbursed drugs is managed by the Ministries of Health and Finance. The health basket is updated annually. The manufacturer needs to submit an application form in conjunction with a reimbursement dossier before 25th February 2020 in order for a medicinal product to be considered for reimbursement in 2021. After the initial submission the manufacturer can submit any additional data or data updates at any given time. Having an Israeli marketing authorisation during or before submission of the dossier is not necessary. However, to be considered for reimbursement in 2021, it is crucial to obtain marketing authorisation by no later than September 2020.
The reimbursement dossier consists of 4 key sections, namely: general company and drug information, supporting clinical data, epidemiological data as well as an economic assessment. The economic assessment consists of calculations in relation to cost-effectiveness and budget impact. Israeli specific data must be included within the dossier such as any experience in Israel with the technology or treatment type, opinions of clinical experts in Israel, prevalence and incidence of the disease in Israel and budget impact information. All the information within the dossier must be in Hebrew, however supporting data from publications can be in English.
The reimbursement assessment process can occur simultaneously with the regulatory assessment therefore Israel has potential to be an early launch market for orphan drug manufacturers. However, manufacturers are encouraged to plan ahead and prepare for the deadlines imposed by the system. Missing these deadlines could result in the loss of a full year of revenue for manufacturers and stagnate patient access to essential orphan drugs.
- Zlotogora, J. (2014). Genetics and genomic medicine in Israel. Molecular Genetics & Genomic Medicine, 2(2), pp.85-94.
- Guidelines for the procedure for applying for inclusion (drug) in the health care basket (According to the National Health Insurance Law , D.- 1994)