Zhiyu Qiu, MSc, Government Affairs and Market Access Lead, Medtronic Singapore
Sang-Soo Lee, PhD, MBA, Sr. Director, Government Affairs and Market Access (GAMA), Medtronic Korea, Seoul, South Korea and Head of Center of Expertise (COE), GAMA, Medtronic Asia Pacific
Singapore’s Ministry of Health (MOH) announced introduction of a new Implant Subsidy List (ISL) with enhanced subsidies for citizens and permanent residents effective 1st December 2023 1.
The ISL includes implants that are assessed to be clinically effective, safe, and cost-effective by Agency for Care Effectiveness (ACE), the national Health Technology Assessment (HTA) agency. Implants are grouped according to a five-tier classification system by clinical function, clinical category, product category, product groups and products 2. There are currently 15 established implant categories covering commonly used implants such as cardiac implantable electronic devices, transcatheter aortic valve implantation devices, interventional cardiology implants as well as hip and knee implants. It is expected that the ISL will progressively expand to include 11 more categories in the next two years.
For the current version of ISL, having full regulatory approval is one of the prerequisites for listing. For new market entrants, there are three application windows open to manufacturers in April, August, and December each year. There are two assessment pathways: 1. Expedited pathway for products falling under existing product groups and with proposed prices deemed reasonable by MOH; 2. Full pathway for new product group creation. The full pathway entails a comprehensive assessment of clinical and economic evidence to be conducted over a timeline of approximately two years. Most ISL-listed products are accorded subsidy criteria in line with Health Science Authority (HSA)-registered indications while there are also a select group of products with more specific subsidy criteria determined by MOH.
The implementation of ISL is critical in addressing the lack of a nationally standardized implant subsidy list while bringing improved subsidies for eligible patients. Prior to the introduction ISL, implant subsidies in the public sector varied from hospital to hospital, with a maximum limit of 50% up to SGD 1,000 for citizens. The new subsidy framework allows subsidized patients (i.e. patients in class B2/C wards and day surgery settings) to have means-tested subsidies from 50% to 80% (for citizens) or 25% to 50% (for permanent residents) without a dollar cap. Means-testing is based on patients’ monthly per capita household income (PCHI) or annual rental value of their property.
One of the hallmarks of ISL is the employment of HTA principles in product assessment. ACE’s medical technology assessment criteria include clinical need, overall benefit, cost-effectiveness, annual budget impact, and organizational feasibility among other factors. With the rollout of ISL creating nationwide impact for subsidized patients, the use of HTA and HEOR in healthcare resource allocation and financing policy is becoming ever more prominent in Singapore.
References
- Ministry of Health. Enhanced subsidies for clinically- and cost-effective implants. Published November 29, 2023. Accessed February 8, 2024. https://www.moh.gov.sg/news-highlights/details/enhanced-subsidies-for-clinically--and-cost-effective-implants
- Agency for Care Effectiveness. Medical Technologies Evaluation Methods and Process Guide. Published online March 2022. https://www.ace-hta.gov.sg/docs/default-source/process-methods/ace-med-tech-evaluation-methods-and-process-guide-(mar-2022).pdf