[Newsmp] The reimbursement standard for BMS’ ulcerative colitis treatment Zeposia (ingredient: ozanimod), Kolon Pharma’s triple combination in a single inhaler for the treatment of chronic obstructive pulmonary disease (COPD) Trimbow (ingredient: beclometasone/formoterol/glycopyrrolate), and AstraZeneca's neurofibromatosis treatment Koselugo (ingredient: selumetinib) will be newly established.

Loxoprofen formulation Dongwha LOXONIN (Dong Wha Pharm) and limaprost α-cyclodextrin formulation Dong-A Opalmon (Dong-A ST) have also established new reimbursement in accordance with the results of the reassessment of quality of reimbursement, and epinastine formulation such as Argi (Pharvis Korea) have changed the reimbursement standard for the same reason.

Among existing products, Greenmono (GC Biopharma)'s plasma-derived factor VIII formulation has been expanded in range of insurance benefits.

The Ministry of Health and Welfare announced Monday an administrative notice of ‘Notice of the Review Results of a Healthcare Service Claim’ and began collecting opinions by 27 for its implementation on the 1st of the next month.

Zeposia will be covered for patients with moderate to severe ulcerative colitis who have not shown an adequate response or are intolerant to conventional treatment agents such as corticosteroids, 6-mercaptopurine, or azathioprine, or for whom the above agents are contraindicated.

If the Mayo score decreases by at least 30% and 3 points from the initial administration point after 10-20 weeks of administration, and the rectal bleeding score decreases by at least 1 point or is 0 or 1, the continued administration of Zeposia will be permitted.

For long-term prescriptions, reimbursement is granted for up to 30 days when not admitted, and up to 60-90 days may be approved if the disease shows stable activity beyond 24 weeks with no observed side effects.

Trimbow inhaler will be covered by insurance for COPD and asthma under the new standard.

Trimbow will be approved for reimbursement in adults (aged 18 years or older) with COPD who have inadequately controlled symptoms with long-acting β2 agonists and inhaled corticosteroids, or long-acting β2 agonists and sustained-release muscarinic receptor antagonists. Moreover, patients must meet one of the following criteria: ▲FEV1 values less than 50% of predicted normal values ▲Two or more acute exacerbations per year ▲One or more exacerbations that resulted in hospitalization.

Asthma patients who are 18 years of age or older and have had at least one severe exacerbation within the past 12 months, despite maintenance therapy with medium- or high-dose inhaled corticosteroids and long-acting β2 agonists, are eligible for reimbursement for maintenance therapy.

Koselugo will be applied for reimbursement for children with neurofibromatosis type 1 (NF1) who are at least 3 years old and under 18 years old and have plexiform neurofibroma (PN) that is inoperable due to the following reasons: the lesion is highly invasive, it is close to major organs, or the vascular structure is complex and completely unresectable.

Eligible for reimbursement are following patients: ▲with a risk of airway obstruction or damage to major blood vessels near the head or neck ▲with nerve compression and dysfunction near or on a major nerve (such as the brachial or lumbosacral plexus) ▲encirclement of a major blood vessel or major organ (such as the aorta, abdominal artery, hepatic portal vein, or spinal cord), with dysfunction of a major organ ▲caused significant physical deformity (such as in the limbs or around the eyes), with motor or sensory dysfunction ▲severe pain that interferes with daily life, even after taking neuropathic pain medication ▲in cases where it is judged that the administration of Koselugo is absolutely necessary

Response assessment must be performed at the start of Koselugo administration (within 4 weeks of administration) and every 6 months after administration. At the time of the first administration, objective data on the target of administration (such as medical records related to multidisciplinary integrated care, MRI reading reports, etc.) and reaction assessment (MRI reading reports, medical records, etc.) at the time of continued administration must be submitted.

To assess response, 3D MRI volumetric analysis is used to measure the overall volume of a single target lesion, and if the volume decreases by 20% or more from baseline, continued administration is approved.

In the case of patients with contraindications for MRI, 3D CT can be used for assessment if a medical opinion letter from the attending physician is attached.

Insurance coverage for Koselugo will be discontinued for adult patients ▲who have become 19 years old during continued administration (If the attending physician judges that continued administration after 19 years of age is absolutely necessary, insurance coverage may be continued if objective reasons and a prescription opinion are attached.) ▲after starting treatment, the results of the response evaluation conducted every 6 months show that a new lesion has developed ▲ if it is judged that other administration should be discontinued due to the occurrence of side effects that require permanent discontinuation.

For long-term prescriptions, the maximum amount that can be prescribed at once is 30 days. Patients must complete a 'patient diary' to confirm the duration of drug administration and other management, and the medical institution must keep the diary.

Koselugo must be administered by a relevant specialist who has experience in treating neurofibromatosis, in accordance with the approved indications by the Ministry of Food and Drug Safety. At the initial administration, the drug must be prescribed by a specialist from at least three medical specialties (one of pediatrics or neurology, plastic surgery, or neurosurgery related to the selection of target lesions, and radiology) through multidisciplinary care.

Multidisciplinary care establishes the treatment cost for multidisciplinary care fees, and reimbursement standards adhere to the 'Multidisciplinary Care Benefit Standard.'

In the meantime, according to the results of the reimbursement quality evaluation, the reimbursement standard for loxoprofen preparations will be covered for the following indications: ▲Symptoms and inflammation/pain of chronic rheumatoid arthritis, osteoarthritis (degenerative arthritis), low back pain, shoulder periarthritis, and shoulder-hand syndrome ▲Inflammation/pain after surgery, trauma, and tooth extraction.

Limaprost α-cyclodextrin will be reimbursed for the improvement of subjective symptoms (leg pain and numbness) and walking ability in patients with bilateral intermittent claudication who have a normal SLR test.

Moreover, epinastine-based medications will be covered by insurance for the treatment of allergic rhinitis, hives, eczema, dermatitis, pruritus, pruritic rash, and psoriasis vulgaris with pruritus after initial treatment with cheaper antihistamines, but which caused side effects such as drowsiness.

Plasma-derived factor VIII is typically administered within a hospital setting; however, insurance coverage extends to outpatient use under specific circumstances: ▲where treatment is necessitated by clinical symptoms and test results ▲coverage applies when the minimum coagulation factor activity remains below 1% 48 hours post-administration, as determined through pharmacokinetic testing ▲the inclusion of a doctor's opinion is a prerequisite for outpatient coverage.