MANAGER, REGULATORY INTELLIGENCE
中東～北アフリカ地域では、治療行為の革新的な評価を通じたヘルスケアシステムの近代化を期待して医療技術評価（Health Technology Assessment）を導入する規制変革の動きがあります。その現状についてのレポートです。
Health Technology Assessment (HTA) has become one of the most anticipated regulatory advancements across the Middle East and North Africa (MENA) due to its potential to modernize healthcare systems through innovative evaluation of healthcare interventions. Stakeholders see HTA as a tool to optimize healthcare resource allocation through transparent decision making.
The current state of HTA in MENA
Currently, HTA is not used in MENA countries’ reimbursement systems since the region still relies heavily on External Reference Pricing (ERP). ERP is used as a cost minimization tool in MENA countries by simply benchmarking against the lowest list prices in reference countries.1 In an evaluation of ERP application in Europe, researchers found several limitations including lack of reliable sources for price information, price heterogeneity, exchange rate volatility and more.2 MENA regulators realize that there is a need to transition to a value-based assessment system to give patients access to innovative therapies through more efficient and fair pricing – especially for expensive lifesaving products.
Nevertheless, local regulators are making changes to legislation and policy across MENA to incorporate HTA and/or efficiency interests, either explicitly (i.e., Egypt) or implicitly (i.e., Saudi Arabia). In some countries, like Egypt and Lebanon, authorities recommended that drug developers submit an economic analysis (e.g., budget impact) to aid in negotiations with manufacturers. Currently, these requests are focused more on expensive innovative products. For example, the King Hussein Cancer Centre in Jordan uses HTA to evaluate the costs and benefits of costly cancer treatments.
In order to incorporate HTA into MENA countries quicker and more efficiently, independent or quasi-independent institutions in Arabic countries are conducting HTA for clinical cost-effectiveness and/or comparative clinical benefit assessment analysis. For example, Tunisia established an HTA agency in 2012, INEAS (Tunisian Authority of Assessment and Accreditation in Healthcare), and is the only representative of Arabic countries at the International Network of Agencies for Health Technology Assessment (INAHTA). However, Egypt and KSA have included the development of an HTA agency in their 2030 healthcare vision goals.3
HTA has the potential to modernize healthcare systems through innovative evaluation of healthcare interventions
Cost-effective treatments and biosimilars
During the DIA Middle East Regulatory Conference in October 2019, Ibrahim Al Juffali, the Advisor to the Minister of Health for Pharmaceutical Sector Development of Saudi Arabia, discussed what local experts – from a variety of pharma industry backgrounds – would expect from an HTA entity in Saudi Arabia.4 Regulatory experts believe that HTAs should consider the full scope of health technologies from drugs to medical procedures and other health interventions. Experts in Saudi Arabia also agreed that HTAs should not solely focus on new technologies but should also consider generics and biosimilars.
Biosimilar medicines are an ideal option to improve patients’ accessibility to cost-effective treatments for a wide variety of diseases and should be subject to HTA in MENA. Most Arabic countries regulators’ have published regulations or registration guidelines, but there are still some gaps. In countries where no local regulations exist (i.e., Iraq, Algeria and Morocco), authorities have adopted the EMA and ICH guidelines for their own local guidance. This means that only E.U. or U.S. approved biosimilars will be licensed in the MENA region. Ultimately, this could limit access to life saving therapies to those approved based on the demographics/needs of another region.
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- Pharmaceutical Pricing and Reimbursement in the Middle East and North Africa Region
- Overview of external reference pricing systems in Europe
- ISPOR Europe 2019 —The Professional Society for Health Economics and Outcomes Research
- Cortellis Regulatory Intelligence