Public basic healthcare is provided for free in Malaysia, with 84.7% of brand name medicine requests substituted with generics. While categorised as an upper middle income country based on World Bank GNI classification, average household income is USD$1334 per month, with populations we serve earning a fraction of this. Malaysia has a population of around 30 million people. First line HIV medications, including tenofovir, are fully subsidised by the government. Other medications like dolutegravir, are not subsidised whatsoever, and remain out of reach by Malaysian patients.
Dolutegravir was launched at the price of USD$290 per month in October 2014 and it remains at this price to this day. This price is prohibitively high, and at present there are only 9 adult patients nationwide accessing dolutegravir. GSK has said that due to a Brazilian tender, this price may go down to $176 per month, but it remains to be seen when this could be.
While Malaysia is included in MPPs voluntary license in terms of paediatric dolutegravir, there is a discrepancy between what the licence terms set out and actual practice on the ground in terms of procurement of these medications for paediatric use. That is, to this day there is no paediatric use of dolutegravir in Malaysia, and this is likely to international and domestic regulatory barriers. Dolutegravir for adult use is not on the government radar for a compulsory licence, and in such a case we think that a voluntary licence would be a step forward, but not the end game for access.
In terms of HCV, it is estimated that 425,000 Malaysians live with HCV, however an upcoming cohort study may show more accurate figures on prevalence and this may be slightly lower. Malaysia is predominantly genotype 3 with genotype 1 as the second most occurring genotype. Treatment regimens in public healthcare facilities are composited of pegylated interferon-ribavirin, i.e. direct-acting antivirals are not available in these facilities as of yet. However, sofosbuvir, sofosbuvir/ledipasvir, dasabuvir, daclatasvir, boceprevir, and Abbvie’s Viekirax drug (ombitasvir, paritaprevir, and ritonavir) have all been registered and are available at innovator prices in private facilities. Malaysia does not presently have a national hepatitis strategy, but it is in draft stage.
It should be noted that there is a very important trial for a pan-genotypic regimen underway in Malaysia and Thailand, driven by Drugs for Neglected Diseases initiative (DNDi), for sofosbuvir + ravidasvir with a target cost price of under USD$300 per cure. The decision of the government to treat with DAAs is likely to be hinged on the results of this study. At present, certain influential government officials are partial to a compulsory licence.
It should be noted that Malaysia has signed the Trans-Pacific Partnership Agreement, and is modifying its patent law to include longer market exclusivity periods. These could potentially keep medicines out of HCV patients hands for longer. I’m very keen on discussing the way forward today, whether in terms of VLs or CLs, and how we streamline the mechanism better so that we see patients accessing these medicines.