The Pharmaceutical Benefits Committee has approved the chronic hepatitis B therapy Besivo Tab. (compound: besifovir), the first new drug developed by Ildong Pharmaceutical일동제약, to receive conditional health insurance benefits.
A conditional insurance coverage means the drug is clinically meaningful, but the proposed price is too high. If the drugmaker accepts the price below the adequacy of benefit, the drug can receive full insurance coverage.
Besivo Tab. has won the recognition for clinical usefulness but the committee judged the proposed price was too high.
According to results of the clinical trials of Besivo Tab., L-carnitin tended to fall, requiring the additional administering of L- carnitin substance (330mgx2) to make up for the deficiency. In the approval conditions, regulators made it obligatory to also give L- carnitin 660MG to patients.
In a news conference in May, Ildong also said it would push for receiving insurance benefits on the condition of taking three tablets (Besivo Tab. +L-Carn).
However, the price Ildong proposed was higher than the one the committee had assessed. Health Insurance Review & Assessment Service (HIRA)심평원 has notified the result to Ildong.
Ildong has to decide whether it receives the decision or not. If it accepts, HIRA has to report the drug as an insurance-covered item to the Ministry of Health and Welfare (MOHW) 보건복지부, which in turn will instruct National Health Insurance Service(NHIS) 건강보험공단 to negotiate the price.
Only, if Ildong accepts the price equivalent to the weighted average of 90-100 percent of alternative medicines, it can skip the negotiations for the price of Besivo with the NHIS.
It is rare new drugs pass the assessment of the committee at first attempts. This is because the optimal prices thought by the business and government officials are quite different. Accordingly, the conditional approval of Besivo Tab. can always occur in the course of new drugs trying to receive insurance benefits.
In the case of Korean new drugs, however, it is the industry’s position that a rational pricing system is needed if for no other reason than promoting the domestic pharmaceutical industry. New drugs have high added value, and the domestic drug prices can more easily knock on overseas markets when they are backed up by higher domestic prices.
Meanwhile, Besivo Tab. is the nucleotide chronic hepatitis B therapy with Besifovir Dipivoxil Maleate substance. And it is the 28th new drug made by Korean pharmaceutical companies and Ildong’s first
After LG Chemical LG화학 had developed and finished Phase 2 clinical trial, Ildong concluded a license contract in 2012 and had succeeded in development after completing Phase 3 trial.
In Phase 2 clinical trial, the company compared it with Baraclude Tab .(compound: entecavir) on 114 patients with chronic hepatitis B disease for 96 weeks and proved equivalent efficacy. And it also compared the drug with Viread (compound: tenofovir) for 197 patients for 48 weeks in Phase 3 trial to show the efficacy.
Also, the company confirmed it reduced side effects, such as bone mineral density and kidney toxicity, compared with the existing treatments.