Reimbursement for Pharmaceuticals in Asia

Our regulatory experts will help you procure a competitive reimbursement price for your pharmaceutical product in Asia.

Reimbursement for Pharmaceuticals in AsiaObtaining reimbursement status from the local Asian government and procuring a high reimbursement price is essential for your sales in the Asian markets.

With our extensive knowledge and experience with the reimbursement regulations and procedures in each Asian country, Pacific Bridge Medical can help you acquire a profitable reimbursement price for your drug product in Asia.

How difficult is the process for obtaining reimbursement for pharmaceutical products in Asia?

  • In the most developed Asian countries, the government will provide reimbursement for purchased pharmaceutical products.
  • In the less advanced countries in Asia, the government generally provides little or no reimbursement. In these cases, some of the burden of payment may fall to the patient or to local charities. However, it is expected that these countries will further develop their reimbursement policies in time.
  • If you are unfamiliar with the reimbursement policies and procedures in the Asian countries, the government may attempt to reimburse your drug product at the same price as they reimburse other similar products, even if your product includes additional features or enhanced safety/efficacy. In order to procure a reasonable price, expertise in communicating and negotiating with the local Asian government agencies is essential.

To learn more about how we can assist you with reimbursement issues in Asia, contact us now to discuss your specific needs.

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Reimbursement for Pharmaceuticals in China

China partially reimburses the cost of many drugs. To be reimbursed, a drug must be put on China’s National Reimbursement Drug List (NRDL), which guides the drug reimbursement scheme and development of provincial price lists. NRDL inclusion can greatly expand the potential market of a drug in China by making it more accessible to middle to lower income consumers.

However, inclusion in the NRDL is difficult. It is theoretically revised every two years, but the scheduled revision timeframe is not always exact. Success usually requires strong support from Chinese Key Opinion Leaders (KOLs), whom the government taps to make recommendations for reimbursement.

The NRDL has become more specific over the last few years. The first version of the list was created in 1999 and published in 2000. Today, there are two lists where one list consists of more basic drugs that are reimbursed according to Basic Medical Insurance Fund (BMIF) regulations while the other list consists of drugs that receive relatively higher prices.

Five government departments influence the development of the NRDL. The Ministry of Human Resources and Social Security (MOHRSS) develops the listing strategy and implements the usage of funding. The National Development and Reform Commission (NDRC) controls the prices of the listed medicines. The Ministry of Health (MOH) ensures the implementation of the policy developed by the MOLSS. The China Food and Drug Administration (CFDA) ensures the efficacy and safety of the drugs, while the Ministry of Finance (MOF) ensures that sound accounting principles are applied to public medical care funding.

Reimbursement for Pharmaceuticals in Japan

In Japan, it is illegal in most cases for the Japanese to purchase pharmaceutical products that have not been granted reimbursement status by the Japanese government. Nearly all drugs sold in Japan are eventually paid for by Japan’s National Health Insurance (NHI) system.

Reimbursement levels for drugs are recommended by the Central Social Insurance Medical Council (Chuikyo), and enacted based on that recommendation by the Ministry of Health, Labor, and Welfare (MHLW). Chuikyo is a consultative group consisting of representatives of the government, the public, the medical profession, and various other specializations. Prices for all drugs are reviewed and adjusted every few years, while the procedure for an initial price for a newly marketed drug is separate.

Getting the best reimbursement for your drugs is a key factor in increasing sales in Japan.

Reimbursement for Pharmaceuticals in Korea

Korea’s National Health Insurance (NHI) system reimburses many drugs bought in Korea. In most cases, receiving official reimbursement status for your pharmaceutical product is essential, although some drugs are able to be sold in Korea without reimbursement.

The Health Insurance Review Agency (HIRA) is the main government entity that determines drug reimbursement in Korea. HIRA will determine if reimbursement is possible for a particular drug, as well as the final price.

Since 2007, HIRA has required applicants to submit a pharmacoeconomic evaluations (PE) report as part of the reimbursement application.

Reimbursement for Pharmaceuticals in Taiwan

The Bureau of National Health Insurance (BNHI) is responsible for reimbursement of pharmaceuticals in Taiwan. Drugs can only be reimbursed if they are listed in the Pharmaceutical Benefit Scheme (PBS) for National Health Insurance.

For new drugs, the BNHI will determine the reimbursement price. For other types of drugs, the prices will be determined based on price surveys. BNHI’s main goal for price adjustment is to narrow down price differences among drugs with identical active ingredients, volume, dosage form, etc.

Drugs that can apply for reimbursement include prescription drugs, orphan drugs, drugs only used by dentists, and certain Chinese traditional medicines requiring prescriptions. All of these drugs must be approved and registered by the Department of Health (DOH) beforehand. Medical products that generally do not receive reimbursement include vaccines for disease prevention, contraceptives, and nicotine patches.

Reimbursement for Pharmaceuticals in the Other Asian Countries

Hong Kong, Indonesia, India, Malaysia, the Philippines, Singapore, Thailand, and Vietnam

Pharmaceutical reimbursement is common in India, Singapore, Hong Kong, Thailand, Malaysia, Vietnam, the Philippines, and Indonesia. However, each country will treat pharmaceutical reimbursement somewhat differently and vary the reimbursement scheme according to whether the product is a locally-made generic, imported generic, or brand-name product.

The wealthier countries like Hong Kong and Singapore have well-defined drug reimbursement systems, and pharmaceutical products are generally reimbursed at higher prices. In contrast, the other Asian countries oftentimes have low or no reimbursement at all.

Pacific Bridge Medical can help you develop a strategy to acquire the highest possible reimbursement price for your medical device in the Asian countries. Contact us now to discuss your specific needs in a free consultation with our reimbursement experts.

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