NHIA to dedicate office to adding drugs to NHI faster – 台北時報 Feedzy

COVERAGE:
Hopefully the office would launch in January and work in parallel with the FDA to reduce the process of reviewing drugs to one year, the head of the NHIA said

By Lee I-chia / Staff reporter

The National Health Insurance Administration (NHIA) plans to set up a specialized office to speed up the process of adding new drugs to National Health Insurance (NHI) coverage, administration Director-General Shih Chung-liang (石崇良) said yesterday.

As new drugs are being developed that are relatively expensive, several medical welfare groups and patients’ associations, including the Formosa Cancer Foundation and Taiwan Young Patient Association, have urged the government to set up a special fund to help cover medical expenses for the new drugs and speed up the NHI coverage review process.

The groups have said it takes about two years for new cancer drugs to be assessed and included in the list of drugs covered by the NHI.

New drugs currently need to pass a review and obtain a drug license from the Food and Drug Administration (FDA) before applying to the administration for NHI coverage.

Shi said the specialized office would speed up the review of new drugs — especially those for unmet medical needs, breakthrough therapies, or which have a longer-lasting effect and can replace current drugs.

Hopefully the office would start operating in January next year, he said, adding that its main functions would be to conduct health technology assessments of new drugs, gather clinical data on new drugs that are temporarily covered by the NHI for future assessment, database management and training personnel to assist drug companies in providing the correct information in their report.

The proposed budget for the office is NT$100 million (US$3.14 million) for the first year, and the number of office personnel would be expanded from eight administrative personnel at present to about 100, including specialists in health economics, statistics and database management, Shi said.

With the FDA and the office reviewing the drugs simultaneously, the goal is to reduce the process to one year, he said.

As the office would be handling sensitive personal information when gathering clinical data, the next phase should be to establish an administrative agency, similar to the British National Institute for Health and Care Excellence, but legislation would be required for that, which would take about three to four years, Shi said,

As the UK has the Cancer Drugs Fund and the Innovative Medicines Fund, which provide interim funding for patients to gain access to promising new drugs faster, the administration also hopes to set up a new fund for drugs that is separate from the NHI global budget, Shi said

He said about 80 percent of the new drugs funded by the Innovative Medicines Fund later passed review and were covered by the British National Health Service, so the new drugs fund could cover new drugs where some uncertainties remain regarding their therapeutic effects, and further data and assessment is required.