Singapore: Key Insights Into One of the World’s Most Efficient Healthcare Systems
By Xcenda
HTA QUARTERLY | WINTER 2016
Singapore: Key Insights Into One of the World’s Most Efficient Healthcare Systems
By David Campbell, PharmD, MS and Chelsey Campbell, PharmD, MBA, MS
Structure and Design of the Singapore Healthcare System
Product Registration, Pricing, and Reimbursement in Singapore
Pharmaceutical Registration
The Therapeutic Products Branch (TPB) of the Health Sciences Authority (HAS) under the purview of the Singapore government is responsible for the registration of medicines and the continual review of previously approved technologies. Similar to other markets, Singapore requires manufacturers to submit a New Drug Application (NDA) in order to receive market authorization. There are 3 different types of NDAs. NDA-1 is for the first strength of an innovator product, NDA-2 is for a new combination dosage form of previously approved entities, and NDA-3 is for lesser changes such as new indications, dosing regimens, patient groups, or legal changes such as change of name of license holder. Manufacturers have the opportunity to submit their application among 3 application-evaluation pathways with varying timelines. Applications can be submitted through either full, abridged, or verification routes, which take approximately 270, 180, and 60 working days, respectively. To qualify for the abridged pathway, the technology must be previously approved by one reference agency. To qualify for the verification pathway, the technology must have been previously approved by 2 or more reference agencies. The health authorities that qualify as reference agencies by the HAS include the Therapeutic Goods Administration (TGA) of Australia, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). In addition to the alternative NDA routes, Singapore offers abridged dossier and verification dossier regulatory submission options to optimize time to market and efficiently utilize HAS resources. The availability of alternative application-evaluation pathways reflects the country’s commitment to efficiency.
Product Registration, Pricing, and Reimbursement in Singapore
Pricing and Reimbursement
Compared to the registration process, the policies and procedures for the pricing and reimbursement of pharmaceuticals are less transparent. The Singapore MOH has created the Standard Drug List 1 (SDL-1), which contains medicines that it has deemed essential and cost-effective. Medicines contained in the SDL-1 often treat common diseases and are heavily subsidized by the government to promote access. To ensure access to more costly treatments in areas like oncology, the government established a second formulary called the Standard Drug List 2 (SDL-2). Medications contained in the SDL-2 are also heavily subsidized, as patients are required to pay just 50% of product costs. Any medicine that is considered for inclusion in the SDL formularies must be evaluated for cost-effectiveness by the Pharmacoeconomic Evaluation and Drug Utilization (PEDU) unit within the Center for Drug Administration. However, specifics of the pharmacoeconomic evaluation process are unclear. To address transparency concerns, 2 significant changes were implemented by the MOH in 2005. First, the MOH has allocated a budget for the maintenance and improvement of the SDL formularies to ensure that they are current with technological advances. Second, medical boards of public institutions are now included in the SDL formulary decision making and ranking process. Before this change, physicians of public institutions would make ad-hoc requests for medicines, and appraisal criteria were less consistently applied to products under consideration.
Pharmaceutical Market Outlook
Similar to other countries of the region, such as Japan , Singapore has an aging population that will require increasing healthcare resources in the coming years. In an environment of an aging population and strong healthcare funding programs, the pharmaceutical sector should experience continued growth. However, to establish a place in Singapore’s highly efficient healthcare system, manufacturers should be prepared to demonstrate the value of their products, including comparative cost-effectiveness data. The transparency of the drug appraisal process, including pharmacoeconomic assessments, remains limited, but recent changes to the process are promoting clarity. Additionally, the pricing of innovative therapies may be challenging. Due to the healthcare financing structure in which individuals self-finance their healthcare, the affordability of high-cost medicines is problematic. Despite pricing concerns, the overall healthcare and pharmaceutical markets of Singapore are poised for continued growth, and the country has established its position as a key market of Asia.
The article should be referenced as follows:
Campbell D, Campbell C. Singapore: Key insights into one of the world’s most efficient healthcare systems. HTA Quarterly. Fall 2016. Oct. 13, 2016.
Further Reading
- Singapore government. Pharmaceuticals and biotechnology. https://www.edb.gov.sg/content/edb/en/industries/industries/pharma-biotech.html. Accessed June 20, 2016.
- Singapore government. Department of Statistics Singapore. http://www.singstat.gov.sg/. Accessed June 20, 2016.
- Bloomberg. Singapore beats Hong Kong in health efficiency: Southeast Asia. http://www.bloomberg.com/news/articles/2014-09-18/singapore-beats-hong-kong-in-health-efficiency-southeast-asia. Accessed June 20, 2016.
- Singapore Ministry of Health. https://www.moh.gov.sg/content/moh_web/home.html. Accessed June 24, 2016.
- Prudential Singapore. PRUshield. http://www.prudential.com.sg/corp/prudential_en_sg/solutions/protect/PRUshield.html. Accessed June 24, 2016.
- Singapore Ministry of Health. Medifund. https://www.moh.gov.sg/content/moh_web/home/costs_and_financing/schemes_subsidies/Medifund.html. Accessed June 20, 2016.
- Singapore Ministry of Health. Medifund continues to ensure accessible and affordable healthcare for all Singaporeans. https://www.moh.gov.sg/content/moh_web/home/pressRoom/pressRoomItemRelease/2015/Medifund-continues-to-ensure-accessible-and-affordable-healthcare-for-all-singaporeans.html. Accessed June 24, 2016.
- Singapore Ministry of Health. ElderShield.
- https://www.moh.gov.sg/content/moh_web/home/costs_and_financing/schemes_subsidies/ElderShield.html Accessed June 20, 2016.
- Health Sciences Authority. Health product registration. http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Western_Medicines/Overview.html. Accessed June 20, 2016.
- Kudrin A. Challenges in the clinical development requirements for the marketing authorization of new medicines in Southeast Asia. J Clin Pharmacol. 2009 Mar;49(3):268-280.
- Khokal D. Medicinal products regulation in Singapore. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/singapore/medicinal-products-regulation-in-singapore.pdf?sfvrsn=6. Accessed June 20, 2016.
- Li SH. Health care system and public sector drug formulary in Singapore. http://www.ispor.org/news/articles/oct07/hcs.asp. Accessed June 24, 2016.
- Tarn YH. Health-care systems and pharmacoeconomic research in Asia-Pacific region. Value Health. 2008 Mar;11 Suppl 1:S137-155.