Pharmaceutical News
NHIA plans to set up an independent fund to accelerate new drug listing

The NHI new drug listing has long been criticised for its slow pace.  In response to this issue, Dr Shih Chung-Liang, Director-General of the NHIA, said on the 30th that the NHIA is going to create a special unit in charge of health technology assessment (HTA), and the NHIA is going to allocate NT$10 billion from its official budget to set up a new drug fund which will be independent of the NHI global budget.  The waiting for the NHI listing of a licensed new drug could be reduced to within one year, said Dr Shih.

As new drugs are getting more and more expensive, the NHI is short of the funds to include every new drug in the NHI Benefit Scheme.  As a result, it is not uncommon for patients to pay for innovative treatments out of pocket.  Many patient groups, including Taiwan Cancer Foundation and Taiwan Young Patient Association, have been campaigning for a new drug fund independent of the NHI global budget so as to accelerate the access to new drugs under the NHI.

Dr Shih pointed out that the HTA is required to support the NHI’s decision of listing a new drug or a new technology, especially for those whose clinical effectiveness is still uncertain.  The delay in NHI new drug listing is mainly due to a lack of funding and human resources.

The NHIA is planning to establish an HTA unit based on the model of the UK’s National Institute for Health and Care Excellence (NICE).  The unit, which could be established as soon as January next year, will initially be entrusted to the NHIA.   This Taiwanese version of NICE will be responsible for the assessment of NHI new drug listing.  New drugs whose efficacy is highly uncertain could be eligible for a temporary reimbursement scheme.

According to Shih, South Korea also has a similar new drug assessment model which is supported by more than one thousand staff.  In Taiwan, the task is currently carried out by just 8 employees.  He expects that the new unit will increase the manpower to more than one hundred, including specialists in statistics, health economics, etc.   After the establishment of the HTA unit, the NHIA will be committed to the construction of a new drug fund. Ultimately, a relevant set of regulations could be developed within three to four years

The Taiwanese version of NICE will accommodate the TFDA’s parallel assessment pathway.   For new drugs addressing unmet medical needs, the assessment period hopefully could be shorten to within 1 year.  This year, the NHIA offered 3 new drugs the temporary reimbursement at a total annual cost of NT$1 billion.  The NHIA expects to allocate at least NT$10 billion to the new drug fund, of which NT$200 million will be administrative expenses.

Currently, the temporary reimbursement scheme remains funded by the Global Budget.  In the future, the new drug fund would be separated from the Global Budget, expressed Dr Shih.  According to the UK’s experience, about 80% of drugs eligible for temporary reimbursement later receive a full HNS coverage.  Separating new drug fund from the Global budget will protect the NHI point-value from being affected by the huge new drug cost. 

Dr Shi further explained that funding for new drugs will come from the NHIA's official budget, and financial risks will be shared with pharmaceutical companies. This means that if the actual payments exceed the budget, the budget deficit will be covered by drug companies according to their market share.   By sharing some of the financial risk, drug companies benefit from better product access and potentially a comprehensive coverage backed by favourable real-world evidence.

【2023-08-30 / Central News Agency 】