- Policy
- Eye drops late to submit test results pass reivew
- by Lee, Hye-Kyung Apr 4, 2024 05:59am
- Amid the ongoing equivalence reevaluations being conducted on eye drops, products that received dispositions for failing to submit equivalence data in time received a final compliant decision. The Ministry of Food and Drug Safety (MFDS) released the results of the ‘2022 drug equivalence reevaluation’ that contained such results on the 3rd.
- Policy
- K-CAB is in talks to extend refund-type PVA
- by Lee, Tak-Sun Apr 4, 2024 05:59am
- HK inno.N is in talks with the National Health Insurance Service (NHIS) to extend the refund-type price-volume agreement (PVA) for K-CAB (tegoprazan), a drug developed in Korea for gastroesophageal reflux disease. K-CAB is the only drug under the refund-type price-volume agreement (PVA). Since its release in 2019, K-CAB’s claim amount
- Policy
- Novartis’ 'Ilaris' will be reconsidered for the DREC review
- by Lee, Tak-Sun Apr 3, 2024 05:50am
- The rare disease drug 'Ilaris Injection (canakinumab, Novartis Korea)' will be reconsidered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) after two months. Ilaris is a drug used to treat a rare disease called 'periodic fever syndromes (PFS)' for which there
- Policy
- 3 more successful Zolgensma treatment cases reported…
- by Lee, Tak-Sun Apr 2, 2024 05:54am
- Zolgensma, a one-shot treatment for spinal muscular atrophy (SMA), is demonstrating a high effect post-reimbursement. The government has been conducting a post-marketing performance evaluation on the drug since its reimbursement in August 2022, and so far, there has been only 1 case of failure reported after its use. The drug costs a
- Policy
- Oppo parties also promise 'drug price system reform'
- by Lee, Jeong-Hwan Apr 2, 2024 05:54am
- Following the ruling party’s pledge, the opposition parties also announced their general election pledges to promote Korea’s growth into a pharma-bio powerhouse, by investing in research and development (R&D) and preparing customized drug pricing systems for the global entry of Korea’s new drugs, heralding their intent to foster and devel
- Policy
- Price reduction dilemma for 'Forxiga' set for withdrawal
- by Lee, Tak-Sun Apr 2, 2024 05:53am
- 'Forxiga tab (dapagliflozin, AstraZeneca),' a diabetes treatment that was announced to be withdrawn from the Korean market in the second quarter of this year, has failed to reach an agreement in the price-volume agreement (PVA). Initial negotiations fell apart, so the company is likely to attempt renegotiation. The company hopes to maint
- Policy
- K-drugs’ approval in the Philippines to be expedited
- by Lee, Tak-Sun Apr 1, 2024 05:29am
- The Philippine Food and Drug Administration (PH-FDA) has newly listed Korea’s Ministry of Food and Drug Safety as a Reference Drug Regulatory Agency, which is expected to shorten the approval process of domestic drugs that are exported to the Philippines. The MFDS announced that it has been listed as a Reference Drug Regulatory Agency by
- Policy
- Prior approval not required for reimb of Strensiq in KOR
- by Lee, Tak-Sun Apr 1, 2024 05:29am
- Strensiq Inj (asfotase alfa, AstraZeneca), which was subject to prior review by the Health Insurance Review and Assessment Service since it was listed for reimbursement in June 2020, will be converted and be subject to post-review from next month. The drug is a long-term enzyme replacement therapy used to treat bone symptoms in patients w
- Policy
- The NHI Trade Union says, 'NHIS should join the DREC'...
- by Lee, Tak-Sun Mar 29, 2024 05:53am
- The National Health Insurance Trade Union has criticized the government’s ‘The Second Comprehensive Plan of National Health Insurance’ regarding measures to strengthen patients’ access to new drugs. The union argued that the government formulated the policy referencing the corporate civil complaint. And added, it would be more effect
- Policy
- "Seek social consensus, shift away from 2,000 quota"
- by Lee, Jeong-Hwan Mar 29, 2024 05:53am
- "How can we persuade and negotiate with the medical community after President Yoon Suk Yeol forced university assignments by pushing through with an excessive fixation on increasing the quota to 2,000? It's time to shift away from this fixation and instead establish a committee proposed by the Democratic Party to facilitate social discussi
