Co-payments retained for non-reimb drug+reimb drug comb

To yield favorable treatment effect by reducing patient co-payment burden…effective next month

Ofev, newly reimbursed for chronic fibrosing interstitial lung disease

The Ministry of Health and Welfare (MOHW) has decided that, even if an additional or combination anticancer drug is added to a chemotherapy regimen already covered by health insurance, the initial chemotherapy will continue to be subject to the patient’s existing co-payment.

 

Boehringer Ingelheim’s idiopathic pulmonary fibrosis and fibrosing interstitial lung disease treatment Ofev (nintedanib) will have new reimbursement criteria established, while the reimbursement standards for donepezil oral tablets and patches, such as Aricept tablets and Donerion patches, will be revised.

 

The reimbursement criteria for rituximab injections (such as MabThera), ceftazidime (such as vancomycin), and ganciclovir injections (such as Cytovene IV) will also be updated.

 

On April 17, the MOHW issued an administrative notice proposing partial revisions to the 'Detailed Criteria and Methods for Applying Reimbursement (Drugs).' The revision is aimed to take effect on May 1, and a public comment submission will run through April 21.

 

Previously, if a non‑reimbursed drug was added to a regimen already covered by reimbursement, even the previously reimbursed drugs would lose their coverage, increasing patients' out‑of‑pocket costs.

 

Under the revisions, adding a non‑reimbursed anticancer drug to an already reimbursed regimen will not change the co-payment rate for the reimbursed drugs.

 

In detail, a new clause states, 'When combining a reimbursed chemotherapy regimen with another anticancer drug, the existing co-payment for the previously initiated chemotherapy shall continue to apply to that regimen.' The MFDS approved Ofev's new reimbursement coverage for chronic fibrosing interstitial lung disease among the indications.

 

The coverage will be provided to patients with chronic fibrosing interstitial lung disease confirmed by high‑resolution chest CT (HRCT), excluding idiopathic pulmonary fibrosis.

 

The reimbursement criteria include cases where ▲predicted forced vital capacity (FVC) ≥ 45% ▲ predicted diffusing capacity for carbon monoxide (DLco) ≥ 30% and < 80% ▲despite prior treatment (steroids, immunosuppressants), within the past 24 months one of the following: a relative decline in predicted FVC ≥ 10%; a relative decline of greater than 5% or less than 10% with worsening respiratory symptoms; or a relative decline of greater than 5% or less than 10% with HRCT documented fibrosis progression.

 

Patients must be re‑evaluated every 12 months after treatment initiation (HRCT and pulmonary function tests), and if disease progression is confirmed (predicted FVC decline ≥ 10% within 12 months with HRCT worsening), administration must be discontinued.

 

The reimbursement criteria for donepezil formulations state the dosage and duration for 3 mg oral tablets.

 

The reimbursement criteria for 3 mg tablets indicate that ▲an initial dose of 3 mg once daily may be started to reduce adverse gastrointestinal reactions if needed, but use should not exceed 1–2 weeks ▲in underweight women (BMI < 18.5 kg/m²) aged ≥ 85 years who require ongoing 3 mg once‑daily dosing, reassessment should determine continuation based on evaluation methods.

 

Moreover, if dosing at 3 mg once daily must continue beyond 6–8 weeks, a dosing justification form must be submitted.

 

Reimbursement criteria for rituximab injections have been expanded to include myasthenia gravis.

 

Eligible patients are those who are MuSK antibody–positive because they are refractory to at least one prior therapy (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, etc.) or unable to receive such therapies due to ▲serious adverse effects, and who have either moderate to severe myasthenia gravis (MGFA class IIa or higher) or ▲at least two myasthenic crises within the past year.

 

Reimbursement is covered for rituximab at 375 mg/m² weekly for four doses or 1 g every two weeks for two doses, with retreatment permitted upon relapse.

 

For vancomycin and ceftazidime, reimbursement has been expanded beyond their approved indications to include adult bacterial endophthalmitis.

 

Vancomycin is reimbursed for intravitreal injection of 1 mg/0.1 mL administered at intervals of 3 days or more based on clinical findings (inflammation and infection control), and ceftazidime is reimbursed for intravitreal injection of 2 mg/0.1 mL or 2.25 mg/0.1 mL at intervals of 2 days or more.

 

If combination use is clinically required, each drug's reimbursement criteria apply.

 

For ganciclovir, reimbursement criteria have been added for acute retinal necrosis syndrome (ARN) and CMV retinitis (CMVR), expanding the reimbursement scope.

 

Eligible patients are those ▲who are nonresponsive or intolerant to systemic antiviral therapy or ▲who have rapidly progressive, vision‑threatening retinal lesions; dosage is 2 mg/0.1 mL intravitreally once to three times weekly, with dose reductions permitted based on patient status.