On average, it takes about a year for a new orphan drug to enter the NHI Benefit Scheme. The Taiwan Foundation for Rare Diseases (TFRD) held a press conference today, trying to find a solution for patients with rare diseases who are eagerly waiting for their life-saving drugs. In the press conference, the TFRD put forward 5 appeals: 1. to shorten the review time of orphan drugs; 2. to implement a global budget for orphan drugs; 3. to diversify the approaches to drug effectiveness evaluation; 4. to expand patient participation; and 5. to campaign for gene therapies. The BNHI expressed that most of the waiting time was spent in the price negotiation with drug companies. The BNHI is committed to improving the price negotiation efficiency, and urges drug companies to engage in performance-based risk sharing arrangements.
Dr Lee Po-Chang, the Director General of the BNHI, stressed that it is the government’s responsibility to care for the public. This year, the NHI spent about NT$8.7 billion on drugs for rare diseases, and it is expected to spend NT$1.1 billion more next year. The BNHI will do its best to provide as many orphan drugs as possible. However, the BNHI calls on drug companies to help patients by lowering drug prices. Under a budget constraint, if the NHI spends too much on orphan drugs, it will have to cut other medical services.
According to the BNHI’s data, since June 2018, the BNHI has listed 25 new orphan drugs with an average review time of 12 months. The longest case took 25 months, while about 50% of the cases were under 9 months. From June 17, 2014, drugs granted with the orphan drug designation can apply for NHI listing before obtaining a drug license. It reduces the review time by 6-8 months. The BNHI said that most of the delays were due to the price negotiation process with drug companies. The BNHI will strive to improve the price negotiation efficiency.
With patients’ best interests in mind, the BNHI has set a special fund for orphan drugs since 2005. This fund grew by NT$1.174 billion this year to cover the increases in drug fees, the patient population, the new reimbursement scopes and the new listed drugs. So far, there are still 14 new orphan drugs in the review process of NHI listing.
In reply to a recent study done by the Economist, the BNHI pointed out that, for the 8 orphan drugs in that study, 3 of them have not yet obtained the orphan drug designation in Taiwan, 2 of them are already listed by the NHI, 1 of them is still under review, 1 of them is already approved by the NHI but the drug company has no intention to supply, and the last one has not yet applied for NHI listing.
The BNHI expressed that the special fund for orphan drugs will continue to grow as the number of patients increases. However the amount of the growth will be determined based on the consensus among the representatives of fee payers and hospitals.
The BNHI attaches great importance to the opinions of patients. In addition to giving 2 seats to patient groups in the NHI Drug Dispensing Items and Fee Schedule Joint Establishment Meeting, the BNHI also commissions the CDE to assist patient groups in preparing supporting data.
At the moment, the BNHI is reviewing 14 orphan drugs, including a gene therapy product. Those who pass the review will be forwarded to the NHI Drug Dispensing Items and Fee Schedule Joint Establishment Meeting for discussion. The BNHI hopes that drug companies would share the treatment and financial risks with BNHI through risk-sharing agreements.
Dr Lee Po-Chang urges patient groups to understand the dilemma faced by the BNHI and to support the BNHI in bargaining with drug companies for better prices. Once again, Dr Lee appeals to drug companies to take on their social responsibilities and look after patients with rare diseases.
【2022-10-05 / United Daily】
