Could the introduction of quality biosimilars to rheumatoid arthritis patients in Hong Kong improve treatment accessibility?

Abstract

INTRODUCTION: This study aimed at scoping for the public health impacts of introducing biosimilars to Rheumatoid Arthritis (RA) patients in Hong Kong, to assess their effect on treatment accessibility. Biosimilars are not just ‘cheaper biologics’: they hold the capacity to make biotherapeutic treatment competitive to mainstream disease- modifying antirheumatic drugs used in remission. This is important due to the disproportionate expenditure on RA in Hong Kong: direct management for patients (<1% of the total population) cost ~1.4% of the healthcare budget in 2002, burdening the economy. Despite being a lucrative sector, Hong Kong (unlike Europe) has no biosimilars for RA currently. Current registration protocol is also confusing, and a plan is still in the works. METHODS: A scoping review was performed, involving a literature search to look for information pertaining to several public health aspects; such as accessibility, cost effectiveness Research PICOS were identified, and a search strategy was devised based on a concept map using a ‘fill-in- the-blanks’ approach with public health principles. Findings were looked up online by strategic keyword searches on Google (for general information, news, other analyses and country guidelines), and PubMed (for journal articles and editorials). FINDINGS: Biosimilars potentially affects Hong Kong’s health system by: 1) enhancing health economics as a cost-effective option, 2) improving access to medicines in terms of affordability, acceptability, availability, distance and convenience, 3) guaranteeing short-term safety (with long-term unclear), 4) increasing choices for the patient and the responsiveness of the system to patient needs, 5) propagating ethical principles (Utilitarianism, The Helsinki Declaration, The Harm Principle, Kantian Deontology) despite being limited by practical considerations, and 6) benefitting other invested stakeholders—pharmaceutical firms (further concentrating the market favouring the Big Pharma) and the academic sector (which emerge as a leader for biosimilar-related publications).

DISCUSSION: Findings were framed as a SWOT Analysis. Strengths included: cheaper prices, enhanced cost-effectiveness, increased choice, guaranteed short-term safety, calculable development time, and greater accessibility. Weaknesses were: unclear long-term safety, lack of feasibility, and insufficient knowledge. Opportunities were: emergence of concepts likes health care financing and patient-centred care, the prospects for multinational pharmaceutical firms as producers, few competitive manufacturers, and the growing market for biopharmaceuticals. Threats included: lack of registration regulations, absence of financing policy, inadequate patient representation, innovative marketing protection, and other ethical- practical issues. Limitations included: 1) uncertainty of analysis due to lack of long- term studies, 2) reliability of findings due to no search restrictions, and 3) lacking external validity due to absence of local studies. Nonetheless, if given training, education, and patient representation, biosimilars are likely to succeed. CONCLUSION: Hong Kong may not be mature enough to implement biosimilars: guidelines are rough, the Hospital Authority (HA) is far from transparent, and there will be demands on regulatory expertise in order to properly manage biosimilars. The SWOT Analysis suggests that biosimilars are a potential niche market for Hong Kong’s health care regardless of how obtuse they are to comprehend, and are vital and essential. Provided clear leadership and direction, implementing them is almost sure to bring success. Hence, there is a strong basis to explore their introduction further.