Reimb standards will be newly established for Coagadex

Also, eperisone’s reimb standards will reflect reevaluation results

MOHW to apply changes from December 1... Esomeprazole 10mg oral tablet to be newly listed

Reimbursement standards for the hemophilia treatment Coagadex (Human coagulation factor X) that had been granted urgent introduction in Korea have been newly established.

 

Also, oral eperisone hydrochloride as well as oral and ophthalmic solutions that include syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy will be applied new reimbursement standards according to their reevaluation results.

 

The Ministry of Health and Welfare announced its partial amendment to the ‘Details on the standards and methods for application and method (pharmaceuticals)‘ and is opinion inquiry until the 24th.

 

The new reimbursement standards are set to be applied on December 1st.

 

First, the MOHW recognized the need for reimbursement for the hemophilia treatment Coagadex (Human coagulation factor X) in patients confirmed with hereditary Factor X deficiency and willy newly establish reimbursement standards.

 

Patients with hereditary Factor X deficiency will be allowed the administration of Coagadex.

 

In terms of a single administration (single dose), 40 IU/kg in patients aged less than 12 years, 25 IU/kg in patients aged 12 years or older will be allowed, with up to 4 courses recognized per visit.

 

Under the doctor’s discretion, such as when the patient's condition is stable, up to 8 courses of administration will be reimbursable if a patient visits once every 4 weeks.

 

If Coagadex is administered in the hospital, those administered in hospitals are also counted.

 

However, if bleeding occurs in the patient even after administering 8 courses for 4 weeks, an additional 2 courses per visit may be covered, but the doctors’ medical opinion in the medical record needs to be attached.

 

Also, oral eperisone hydrochloride, oral, and ophthalmic solutions including syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy this year will be applied new reimbursement standards according to their reevaluation results.

 

Eperisone hydrochloride drugs including CHodang Pharm’s Mulex Tab will be reimbursed for painful muscle spasms associated with musculoskeletal disorders such as cervicobrachial syndrome, periarthritis, and lower back pain.

 

Sodium alginate preparations including Taejoon Pharm’s Lamina-G solution etc will be granted reimbursement for improving subjective symptoms of reflux esophagitis.

 

For ophthalmic solutions including syrup and oral suspension forms, a new reimbursement standard will be set under oral sodium alginate products according to the reimbursement reassessment results, and be deleted under general principles for ophthalmic solutions.

 

The restrictions set on the number of administrations for Hanmi Pharmaceutical’s Maqaid Inj (triamcinolone acetonide) will be deleted based on approvals in Korea and abroad, textbooks, clinical practice guidelines, clinical literature, and opinion from related societies, but readministration will only be applied reimbursement when administered in intervals that exceed 3 months.

 

Also, Hanmi Pharmaceutical’s Esomezol Cap 10mg (oral esomeprazole 10mg) will be newly listed next month and be added to the list of proton pump inhibitors.

 

Reimbrusement standards for oral proton pump inhibitors include omeprazoles like Yuhan Losec Cap, lansoprazoles like Lanston Cap, pantoprazole like Pantoloc Tab, rabeprazoles like Pariet Tab, and esomeprazoles like Nexium Tab.

 

However, as Esomezole DR Cap 10mg was not approved for the treatment of H.pylori infections, this indication is off-label and excluded from reimbursement.

 

Reimbursement for Kyowa Kirin Korea’s Romiplate Inj 250μg (Romiplostim) will be extended to the treatment of refractory or relapsed aplastic anemia following immunosuppressive therapy based on approvals in Korea and abroad, textbook, clinical practice guidelines, and clinical literature.

 

Reimbursement standards for vedolizumab injections that are applied to Takeda Pharmaceuticals Korea’s Kynteles Inj (vedolizumab) will newly include Kynteles refilled Pen Inj to account for its new listing.

 

However, in consideration of the differences between existing formulations and the approvals (dose and usage), the evaluation method for ulcerative colitis will be changed and new standards for self-injection and long-term prescription will be set.

 

According to the new details, considering how Kynteles Prefilled Pen Inj is a self-injection formulation, the patient should fill out a 'patient dosing diary' to monitor the administration period of the drug for the management of medical care institutions.

 

Also, for long-term prescriptions of Kynteles Prefilled Pen Inj, a single prescription period shall be up to 2 weeks upon discharge from the hospital and up to 3 weeks for outpatient prescriptions and shall be prescribed in hospitals in principle.

 

Patients who show no side effects and stable disease activity 24 weeks since initial administration.