Cancer, Rare Disease Drugs To Be Covered As China Expands Reimbursement
Executive Summary
China's national reimbursement drug list will undergo a much anticipated expansion in 2019, and therapies for cancer, pediatric and rare conditions from international firms including Roche and Actellion are likely to receive long-awaited coverage.
Pharmaceuticals that have gained approvals before Dec. 31, 2018 will be subject to consideration for a new expansion of China's National Reimbursement Drug List (NRDL), with priority to be given to national essential drugs, cancer and rare disease medicines, treatments for chronic disorders, pediatric medications and urgent care products.
Outlined in the 2019 National Healthcare Product coverage adjustment work plans, released by the country's Medical Insurance and Support Administration (MISA), the reimbursement of the products will be divided into two categories under the list.
One is direct inclusion, comprising regular products priced lower or similarly to currently listed drugs, meaning that the inclusion will not impact the bottom line of the existing medical insurance funding pool.
The other category will be high-priced products, which must go through the national price negotiation system to have their prices lowered before they can be included in the NRDL.
Large Expert Pool
To ensure a fair process, the NRDL inclusion procedure will involve tens of thousands of experts in roles ranging from consultants to selection committee members, health technical assessment experts and other negotiators.
Among these, 300 will serve as consultants to compile a comprehensive list of the drugs for the initial selection process. After that, 20,000 experts from different provinces and local hospitals will vote to select which final products to include in the NRDL.
Also, the state medical insurance agency plans to involve 30 insurance experts and health technology assessment (HTA) analysts to evaluate the cost-effectiveness of the products and impact on insurance funding. Especially for the high-priced drugs, past price negotiations have seen price reductions on average exceeding 50%.
For the drug price negotiation rounds, an unspecified number of negotiators selected from the local and central medical reimbursement agencies and outside experts will work to oversee the negotiation process with the drug makers.
Tight Time Frame
Despite the large expert pool required for the NRDL expansion process, the time-frame is quite tight. The whole procedure will be divided into five phases -preparation, evaluation and voting, release of direct inclusion products, negotiations, and release of the inclusion of high-priced drugs.
The preparation period will be the first three months in 2019, requiring the selection of the experts and setup of product databases. From April to May, the consulting experts will compile candidate products, and the 20,000 selection experts brought together from different levels of hospitals in two-thirds of China's 31 provinces.
Meanwhile, the consulting experts will finalize the products to be included in the direct inclusion list and release the list in June. Also, consulting experts will decide on high-priced products that are subject to price negotiations, and send negotiation requests to manufacturers.
These discussions then kick off in July and the final list will be released in August.
Expanding patient access to innovative new drugs has been a top priority for the reimbursement agency, as well as one of the top catalysts for the development of the healthcare sector in China in the years to come.
Who Will Benefit?
Since many newer oncology and rare diseases treatments are imported by multinationals, many see the NRDL coverage expansion as opening market access for such firms.
Some oncology products that are likely to be included are: Roche's lung cancer drug Alecensa (alectinib; licensed from Chugai Pharmaceutical Co. Ltd.), for anaplastic lymphoma kinase-positive disease, Hutchison MediPharma Ltd.'s Elunate (fruquintinib) for colorectal cancer, and Eisai Co. Ltd.’s Lenvima (lenvatinib) for patients with inoperable hepatocellular carcinoma who have not received any prior systemic therapy.
Domestic maker Jiangsu Hengrui Medicine Co. Ltd. has its TKI inhibitor Iruini (pyrotinib), indicated for breast cancer patients with HER2 and EGFR mutations, and Tianqing Chiatai Pharma’s Fukewei (anlotinib) is for lung cancer.
Rare disease treatments could include: Roche's Hemlibra (emicizumab; licensed from Chugai) for hemophilia, and Alexion Pharmaceuticals Inc.'s Soliris (eculizumab) for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as Actelion Pharmaceuticals Ltd.'s Uptravi (selexipag) for pulmonary hypertension.
From the editors of PharmAsia News.