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Policy
New reimbursement standards set for Kymriah·Zolgensma
by Kim, Jung-Ju Dec 22, 2022 05:52am
New reimbursement standards have been set for high-priced pharmaceuticals like Kymriah and Zolgensma, the so-called ‘one-shot treatments.’ Also, reimbursement standards will be newly established for the second CGRP-targeted therapy for migraine, Ajovy (fremanezumab), and the new tuberculosis drug Dovprela 200mg (pretomanid) that had been the first to be developed in half a century, as the drugs will be listed for reimbursement starting on January 1. The Ministry of Health and Welfare issued a pre-announcement of an administrative notice for the ’Proposed Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contain the details stated above, and will be collecting opinions until the 28th. First, a new standard will be established for the reimbursement management of high-priced pharmaceuticals. With ‘one-shot treatments’ Kymriah and Zolgensma being listed this year, a new reimbursement standard was needed for the management of such high-priced drugs. Thus, the government and the Health Insurance Review and Assessment Service established new reimbursement standards that specify those subject to reimbursement management and how they can prepare a medical care benefit expense statement. Under the new standards, the follow-up management period for Kymriah has been set to 1 year when administered for non-Hodgkin lymphoma, and Zolgensma to 5 years. Also, new reimbursement standards were set for the Ajovy autoinjector and Ajovy pre-filled syringe, the CGRP-targeted new therapies for migraine, as well as the new tuberculosis drug Dovprela tab, which are set to be listed on the 1st of next month. In the case of Ajovy, response evaluations with headache diaries and MIDAS should be performed within a month before administration and every 3 months thereafter. If the number of monthly migraine days is not reduced by over 50% from baseline at any response evaluation, administration will be discontinued. The administration period was set to 12 months, and switching between anti-CGRP migraine prevention drugs is not accepted for reimbursement. In the case of Dovprela 200mg, patients must first apply in advance and are granted reimbursement by the KDCA to receive reimbursement. The details for the KDCA’s approval including its procedure, method, and committee member composition will be determined by the KDCA commissioner. The Praluent pen inj 75mg (evolocumab) and other alirocumab injections will be extended reimbursement to patients confirmed with heterozygous familial hypercholesterolemia (heFH) as diagnosed by a score of 6 or higher on the Dutch (2004) diagnostic criteria or ‘definite heFH or possible heFH' under the Simon Broome (2006) standards. The government and HIRA explained that it had received an opinion from a relevant academic society that patients with a high LDL-C level (over 190mg/dL) with a family history should be regarded as heFH patients and be treated accordingly. Clinical literature (RUTHERFORD-2, 2015) showed studies were conducted with patients with definite heFH or possible heFH based on Simon Broome (2006) standards, and NICE had described heFH as “patients with a score of 6 or higher on the Dutch (2004) diagnostic criteria or definite heFH or possible heFH' under the Simon Broome (2006) standards.” Also, with Nuvorozet tab. 40/2.5/5/10mg being newly listed next month, the government and HIRA decided to add the combination to the list of oral fixed-dose combinations that have already been listed for reimbursement. The new combination added is ‘S-amlodipine+telmisartan+rosuvastatin+ezetimibe.’ Also, reimbursement standards for the 25mg strength of K-Cab 50mg (tegoprazan) will be extended with its listing next month. In addition to its already-reimbursed indications as ▲treatment of erosive and non-erosive gastroesophageal reflux disease, ▲ treatment of gastric ulcer, the drug will be additionally reimbursed as ‘maintenance therapy after the treatment of erosive GERD (only the 25mg strength).' 10mg strengths of Lucentis inj and Lucentis prefilled syringe (ranibizumab) are also set to be newly listed for reimbursement. Therefore, reimbursement standards for the ingredient will be modified, and in consideration of the differences in indication by product, a new phrase was added to allow the administration of the drug within the scope of each drug’s indication.