With new, revolutionary, drugs available, why isn’t everyone getting the cure?
An estimated 454,000 people are living with hepatitis C (HCV) in Malaysia. This is a prevalence of 2.5% among the population. Of people living with the virus, between 55-85% will develop chronic HCV infection, despite it being a curable disease. Our partner, MTAAG+, has been lobbying government and raising awareness in communities, to tackle the epidemic in Malaysia.
Until recently, hepatitis C treatment was based on therapy with interferon and ribavirin, which required weekly injections for 48 weeks. This therapy cured some patients, but frequently caused adverse reactions. The recent launch of oral direct-acting antivirals (DAAs) has revolutionized HCV treatment, resulting in improved efficacy, much shorter treatment duration of just 8 to 24 weeks, and limited side effects. However, these new antivirals are exorbitantly priced.
Sofosbuvir, is the base DAA for the newly recommended treatment regimens. Gilead Sciences is the patent holder. The original price proposed by Gilead for Malaysia was USD $12,000 for 12 weeks of treatment. Due to the price, on top of Malaysia’s already shrinking health budget, MTAAG+ has been lobbying government to invoke a ‘government use’ compulsory license. Any country has the right to do so to protect public health when essential medicines are priced out of reach. MTAAG+ believes that civil society was close to achieving this aim when Gilead announced, via twitter, on 23 August 2017 that Malaysia would be included in voluntary licenses given to several Indian manufacturers.
Malaysia had been excluded from the previous voluntary license agreements (2014), and so this move by Gilead could be interpreted as bowing to pressure while protecting profits. If only a voluntary license is in place, it leaves Gilead with more control over pricing, so while it may lead to an increase in people accessing a cure, it does not go far enough, and we foresee many of the 454,000 people affected being left behind.
The prices for the same 12-week dosage of sofosbuvir are as follows:
- Initial price proposed by Gilead for Malaysia: USD $12,000
- Price achievable with generics purchased under a compulsory license: As low as USD $171
- We expect the price obtainable under the voluntary license to fall somewhere in between. We will have to wait for the Indian voluntary license holders to register the products in Malaysia first to set what price will be set. MTAAG+ understands that the Ministry of Health is aiming to pay a maximum of USD $300 in order to treat more patients, which will be an increase in people reached, but still not as many if a compulsory license was put in place.
MTAAG+’s director, Edward Low, argues: “Given the international recognition of the public health importance of combating hepatitis C; the previous systematic exclusion of Malaysia from voluntary license deals until pressure was felt; and the needs of the Malaysian population, it is perfectly reasonable for the Ministry of Health to issue a compulsory license for sofosbuvir.”
Sofosbuvir is used in combination with other DAAs. MTAAG+ is also opposing a patent on velpatasvir, which is marketed by Gilead in combination with sofosbuvir. This is priced at a staggering USD $52,233 for 12 weeks of treatment.
Malaysians will still have to wait for the Indian voluntary license holders to decide to register their product and then set a price. Although the voluntary licence covers sofosbuvir, sofosbuvir/ledipasvir and sofosbuvir/velpatasvir, there is also uncertainty as to which product will be registered by the license holders. With a compulsory license, Malaysia will have more regimen options with sofosbuvir as the backbone.
Meanwhile the Ministry of Health has rejected Bristol-Myers-Squibbs’ application for data exclusivity on another key DAA, daclatasvir. If it had been given, it would have delayed registration of generic daclatasvir until after December 2018, even though there is no patent on this drug. More decisions like this are needed, which prevent market monopoly and put public health first.
Community outreach goes hand-in-hand with MTAAG’s advocacy work. By increasing knowledge, of prevention as well as treatment, and of both patients’ and the government’s rights, then more patient and community groups are aware of the barriers and can engage in advocacy.
An informational leaflet has been published in Malay, and community talks have taken place across the country, along with rapid testing for HCV. As a result, treatment literacy is increasing, among both patients and parliamentarians. MTAAG+ will continue to lobby for a CL and also oppose additional, unmerited, patents on the drugs which extend the monopoly period.
At the Edge of a Miracle is a report published by the Malaysian AIDS Council (MAC), with the latest stats and situational analysis of the HCV epidemic in Malaysia.