Gilead Sciences Korea’s hepatitis B treatment Vemlidy (ingredient: tenofovir ala fenamide, TAF) failed to achieve rapid sales growth last year. The drug made the market debut in late 2017 drawing the industry’s attention because of its improved renal and bone safety.
Vemlidy, which changed the base of Viread (tenofovir disoproxil fumarate, TDF), recorded less than 3.5 billion won ($3.1 million) worth of outpatient prescriptions last year. Besivo (besifovir dipivoxil maleate), Korea’s 28th novel drug and Ildong Pharmaceutical’s first self-developed medicine, also sold less than 300 million won.
To sum up, new hepatitis B treatments have failed to outrival conventional drugs last year.
According to UBIST data for the past two years, Gilead’s Vemlidy marked 3.49 billion won outpatient prescriptions in 2018.
Gilead won the license for Vemlidy in May 2017 and insurance coverage for the drug in November 2017. Patients who receive Vemlidy as the first treatment for hepatitis B and those resistant to existing treatments can benefit from insurance coverage when using Vemlidy.
Gilead emphasized that Vemlidy had stronger renal and bone safety and less drug tolerance risk compared to Viread, expecting not only Viread takers would switch to Vemlidy, but patients with renal and bone problems would take the new drug. However, limitations in the reimbursement dented Vemlidy sales.
The authorities give the insurance benefit to alternative hepatitis B treatments in the case of drug tolerance, insufficient or no response to the drug, pregnancy, and severe side effects that are objectively proven.
They also allow the insurance benefit partially for medical reasons such as the need for improvement of medication compliance and the improvement of cost-effectiveness.
Some physicians report reimbursement cuts after a switch to Vemlidy for patients with renal or bone diseases to the Korean Association for the Study of the Liver. However, the association said it was too early to raise its voice against reimbursement reductions.
Ildong’s Besivo, the locally developed new drug, sold 284 million won in 2018, failing to carve out a share out of the over 200 billion won worth local hepatitis B treatment market.
Compared to conventional hepatitis B drugs, Besivo is at a disadvantage in insurance coverage. The authorities ban the use of Besivo in patients with a glomerular filtration rate of less than 50. Plus, physicians should administrate Besivo with 660mg of L-carnitine, which is another demerit.
Hepatitis B drug industry leader Viread posted 153.6 billion won in outpatient prescriptions last year, down 7.4 percent from a year earlier.
Despite the sales decline since the rollouts of generic drugs in late 2017, Viread still kept its stable status as a blockbuster treatment with over 150 billion won sales.
Generic copies of Viread did not show impressive results. Chong Kun Dang’s Tenofobell sold 1.4 billion won, Dong-A ST’s Virreal, 1.3 billion won, Jeil Pharm’s Tecavir, 927 million won, and Hanmi Pharmaceutical’s Tefovir, 955 million won.
BMS Pharmaceutical Korea’s Baraclude (entecavir) recorded 72.3 billion won prescriptions last year, with its pace of sales decline slowing compared to 2015 or 2016 when it had to compete against new generics.