[Newsmp] The benefit standards for Teva-Handok’s migraine treatment Ajovy (ingredient: fremanezumab) and Viatris’ extensively drug-resistant tuberculosis treatment Dovprela (ingredient: pretomanid) will be newly established.
Among the existing listed drugs, the PCSK9 inhibitor Praluent (ingredient: alirocumab, Sanofi) and Repatha (ingredient: evolocumab, Amgen) and Potassium Competitive Acid Blocker (P-CAB) K-CAB (ingredient: tegoprazan) will receive an extended range of benefits.
In addition, insurance coverage standards will be set for expensive drugs that are one-shot treatments but cost hundreds of millions to billions of dollars in administration.
The Ministry of Health and Welfare announced an administrative notice on the 20th of ‘Notice of the Review Results of a Healthcare Service Claim’ and began collecting opinions by 6 p.m. on the 28th to implement next month (1 Jan. 2023).
In this amendment, Kymriah (ingredient: tisagenlecleucel) and Zolgensma (ingredient: onasemnogene abeparvovec) were listed as drugs subject to management.
Kymriah’s management period is set to one year when administered to non-Hodgkin’s lymphoma, and Zolgensma to five years.
In the meantime, Fremanezumab injection (Ajovy) was newly established in the reimbursement standards for central nervous system drugs.
The reimbursement standard for Ajovy includes a prophylactic treatment for chronic migraine patients aged 18 years or older who meet the diagnostic criteria of the International Classification of Headache Disorders (ICHD-3), and targets are patients who have a history of migraine for at least one year with 15 or more days of headaches per month for at least six months or more before administration while having suffered migraine-type headache on at least eight days per month with a score of 21 or higher in the Migraine Disability Assessment (MIDAS) or 60 or more on the Headache Impact Test (HIT-6) before starting administration while having failed treatment with three or more migraine medications within the last one year.
More than three types of migraine prophylaxis refer to three or more of topiramate, divalproex, amitriptyline, flunarizine and beta-blocker (Propranolol or nadolol).
Treatment failure refers to a case in which the number of migraine per month does not decrease by more than 50% even after at least 8 weeks of administration at the maximum tolerated dose of each drug, or when it cannot be used due to side effects or contraindications.
Response evaluation (headache diary, MIDAS, etc.) should be performed before administration (within the last month) and every three months after administration, and if the number of experiencing migraine per month does not decrease by 50% or more compared to the baseline before administration starts, the patients should stop the administration.
The administration period is up to 12 months, and replacement administration between Anti-CGRP (Calcitonin Gene-Related Peptide, CGRP) migraine prophylaxis is not accepted.
In principle, in-hospital administration is required, but self-administration is permitted up to two injections only when patients who show stable disease activity and have no side effects under the doctor's judgment after 6 months from the first administration date and are properly educated on the administration method.
Moreover, the patient should write a ‘patient medication log’ to confirm the duration of administration, and the nursing institution should manage it, and submit objective data on the subject of administration at the time of initial administration and objective data (drug administration history, medical record, headache diary, MIDAS, etc.) on response evaluation every three months.
In the reimbursement standards for anti-tuberculosis drugs, a new item for pretomanid (Dovprela) will be added. The range of benefits includes a combination of Bedaquiline and Linezolid for extensive drug-resistant pulmonary tuberculosis and treatment-resistant or non-responsive multidrug-resistant pulmonary tuberculosis in adults.
Extensive drug-resistant pulmonary tuberculosis refers to patients who are resistant to injections such as isoniazid, rifampicin, fluoroquinolone and amikacin.
However, medical care benefits for pretomanid preparations are recognized only when they have been previously applied for and approved by the Korea Centers for Disease Control and Prevention Agency (KCDC), and the details of the procedures and methods for prior approval and the composition of the committee are determined by the commissioner of the KCDC.
Among the atherosclerotic disease agents, the reimbursement criteria for PCSK9 inhibitors alirocumab (Praluent) and evolocumab (Repatha) amended and expanded the range of benefits from ‘Simon Broome (2006) or Dutch (2004) Definite heFH’ criteria among Heterozygous Familial Hypercholesterolemia (HeFH) to from ‘Simon Broome (2006) to possible or from Dutch (2004) criteria to probable of six or more.
Maintenance therapy after treatment of erosive gastroesophageal reflux disease is added to the benefit standard for tegoprazan (K-CAB) among peptic ulcer drugs.
However, as only 25mg, which is scheduled to be newly registered, has a related indication, the benefit standard for this indication was also limited to 25mg.
In the treatment and diagnosis of other tissue cells, the reimbursement criteria for items related to ranibizumab injections have been changed within the range of the existing approval requirements to the approval requirements for each drug.
Diseases eligible for reimbursement within the range of approval for each drug include Neovascular Age-related Macular Degeneration (nAMD), diabetic macular edema, branch retinal vein occlusion with macular edema and choroidal neovascularization due to pathologic myopia.
Chong Kun Dang Pharmaceutical’s Lucen-BS and Samsung Bioepis’ Ameliebou will gain insurance benefits, but the approval requirements for each drug are different, so it is said that they will be administered within the range of each drug’s permission.