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Outcry over patient death puts Hong Kong's drug reimbursement system into spotlight
Hong Kong's drug reimbursement process has come under renewed scrutiny following a public outcry over the death of a patient from a rare genetic disease, after the Hospital Authority (HA) refused to subsidise Afinitor, which could have saved her life. In particular, there is increasing public debate over whether Hong Kong's cash-rich government should give more public funding to rare rare-disease medicines.
Single mother Chi Yin-lan, 36, who died in April from tuberous sclerosis complex (TSC), spent months petitioning Hong Kong's public officials to subsidise Afinitor, which received marketing approval in the city-state late last year. Chi's emotional appeal in the Legislative Council - during which she pleaded "I don't want to die … Please give me a chance" - prompted some legislators to hold marches petitioning the HA to subsidise Afinitor. Tuberous sclerosis complex causes tumours in vital organs such as the kidneys and the brain. Chi leaves behind a 13-year-old daughter, who has also inherited the condition.
In Hong Kong, Afinitor costs approximately HKD20,000 (USD2,570) per month out-of-pocket. High-cost treatments for rare diseases such as tuberous sclerosis complex are rarely included in Hong Kong's formulary, or available under its safety net. Hong Kong authorities do not provide statistics on its number of patients with rare diseases. However, total drug expenditure by Hong Kong's public hospitals has soared, reaching HKD4.6 billion in 2015-16, compared to HKD2.2 billion in 2005-06. Still, critics argue that the Hong Kong government's considerable cash reserves should allow it to subsidise a larger number of treatments for rare diseases.
However, the HA refused to reimburse Afinitor for TSC, arguing that the decision to subsidise innovative medicines should be based on clinical effectiveness rather than cost. The HA argued that clinical effectiveness data was still being collected on Afinitor, which was only recently approved in Hong Kong, but not added to the formulary. Afinitor was originally approved as a cancer treatment, but has also been found effective against TSC.
Critics have long argued that Hong Kong's drug approval and reimbursement process is bureaucratic and its regulations outdated. For example, patients can wait as long as 18 to 24 months for innovative treatments to become available in Hong Kong, compared to only 60 days in Singapore, according to the South China Morning Post. Not only that: only 20 to 50 new drugs are registered every year in Hong Kong, compared to around 100 in Singapore, according to the Hong Kong Health Department.
Given Hong Kong's slow drug reimbursement process, Hong Kong's medical profession has lobbied pharmaceutical companies to share the cost of providing expensive treatments that target rare diseases. In 2015, a public campaign lobbied the HA to include Alexion Pharmaceuticals (US)'s orphan drug Soliris (eculizumab) in Hong Kong's drug formulary for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Soliris has yet to receive reimbursement approval from the HA's Drug Advisory Committee (DAC), which meets every three months to decide which drugs should be subsidised. While the DAC's meeting outcome notes are relatively non-transparent and give no detail on specific indications for which the drugs are being considered, or rationale behind decision-making, it appears that cost-effectiveness is an increasing concern.
Looking ahead, it remains to be seen whether Hong Kong plans to overhaul its drug approval and reimbursement regulations, and the effect this may have on pharmaceutical companies. So far, public opinion appears to have little sway on the HA's decisions-making process. It also looks unlikely that authorities will increase opportunities for more flexible market access processes such as managed entry agreements (MEAs) in order to accelerate patient access to treatment.
Still, Afinitor is expected to receive funding for some cancers in July under Hong Kong's Samaritan Fund, which was set up to make certain medications affordable for low-income families. The HA is expected to come under increasing pressure to expand access to affordable treatment for rare diseases. While it is now tragically now too late for Chi Yin-lan, hopefully her daughter will benefit from subsidised treatment.
Sophie Cairns is a Senior Life Science Analyst for the APAC region at IHS Markit
Posted 8 June 2017
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