Fasenra·Idelvion, Ajovy·Emgality receive reimb in KOR

Fasenra·Idelvion newly listed, Ajovy·Emgality granted reimbursement extensions

MOHW issues pre-announcement of administrative notice on the amendment of the drug reimbursement benefit application standards

AstraZeneca's severe eosinophilic asthma treatment Fasenra (benralizumab) and CSL Behring's hemophilia B drug Idelvion (albutrepenonacog alfa) will be reimbursed by the national health insurance starting on the 1st of next month.

 

Also, the anti-malignant tumor agent rituximab (original brand name: MabThera) and the migraine drug Ajovy (fremanezumab) and Emgality(galcanezumab) will receive expanded reimbursement coverage.

 

In addition, the reimbursement standards for psoriasis and macular degeneration treatments will be improved.

 

The Ministry of Health and Welfare recently issued a pre-announcement of an administrative notice on the ’Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contained the details stated above.

 

The MOHW plans to collect opinions until the 25th and implement the amended standards from the 1st of next month.

 

New reimbursement standards set for Fasenra·Idelvion Fasenra, a severe eosinophilic asthma drug that contains benralizumab, and Idelvion, a hemophilia B treatment that contains albutrepenonacog alfa, will be newly granted reimbursement in July.

 

Fasenra will be granted reimbursement for use in adult patients with severe eosinophilic asthma who are not adequately controlled despite the use of high-dose inhaled corticosteroids-long-acting inhaled beta2-agonists (ICS-LABAs) and long-acting muscarinic antagonists (LAMA).

 

More specifically, ▲ patients with a baseline blood eosinophil count of 300 cells/μL or greater and have experienced four or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to treatment initiation, or received continuous use of oral corticosteroids at a dose equivalent to prednisolone 5 mg/day or greater for 6 months prior to starting treatment; or ▲patients with a blood eosinophil counts of 400 cells/㎕ or greater who have experienced 3 or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to starting treatment, will be eligible for reimbursement.

 

Patients will be evaluated every year before and after Fasenra’s use, and those who showed overall asthma control, such as ▲ those who showed a 50% or greater reduction in the frequency of acute asthma exacerbations from baseline, and ▲those requiring ongoing oral corticosteroid therapy who showed a 50% or greater reduction in the oral corticosteroid dose from baseline while improving or maintaining asthma symptom control, that submit a doctor’s note will be eligible for continued use of Fasenra with reimbursement.

 

However, in patients for whom the drug’s effect is deemed insufficient based on clinical symptoms, the effectiveness of the treatment can be evaluated before one year.

 

Patients who co-administer biological agents for severe asthma will not be granted reimbursement.

 

Also, reimbursement will not be granted for patients switching between Nucala, Fasenra, and Cinqair, or switching from Fasenra to Xolair.

 

However, patients switching to Fasenra after Xolair may be reimbursed on a case-by-case basis if the patient has been on Xolair for at least 3-6 months and is unable to continue taking Xolair due to inadequate efficacy, side effects, or the need to improve adherence.

 

Such patients would need to submit a doctor’s note and satisfy the Fasenra reimbursement eligibility standards to receive reimbursement.  Idelvion will be granted reimbursement as a routine prophylactic therapy for the control and prevention of bleeding, pre-and post-operative management, and reduction in the frequency of bleeding episodes in patients with hemophilia B, at 23 IU/kg (30 IU/kg in children) per dose.

 

However, for patients with moderate or severe bleeding, up to 39 IU/kg (up to 50 IU/kg for children) may be reimbursable, based on the physician's medical judgment.

 

For patients who need to be hospitalized but receive outpatient treatment and require dose escalation, their use of the increased dose can be reimbursed with the submission of a doctor’s note.

 

In terms of dosing interval, up to 2 doses at the first visit and 1 dose (2 doses for severe patients) at the second visit every 4 weeks will be granted reimbursement, which totals to 3 doses every 4 weeks (up to 4 doses for severe patients with a coagulation factor activity of less than 1%).

 

If the patient's condition is stable, up to a total of 3 doses per visit every 4 weeks (4 doses for severe patients) may be reimbursed at the doctor’s discretion, and if bleeding occurs after being administered 3 doses every 4 weeks (4 doses for severe patients), up to 1 dose per visit is granted reimbursement, and a doctor's note must be attached.

 

If the dose is administered in the hospital, the administered dose is included in the calculation of the allowable number of reimbursed doses.

 

Reimbursement expanded for Ajovy-Emgality Reimbursement for the migraine drugs Ajovy and Emgality had been previously limited to patients who had failed treatment with three or more migraine prevention drugs within one year, but the period limit has been lifted, expanding coverage.

 

The anti-malignant tumor agent rituximab will additionally be reimbursable as maintenance therapy for patients with severe refractory pemphigus vulgaris and pemphigus foliaceus.

 

Two doses of 500 mg/day every 6 months, 12 months after initiation will be granted reimbursement.

 

In addition, the reimbursement exclusion phrase for macular degeneration treatments such as abatacept (original brand name: Eylea), brolucizumab (original brand name: Beovu), faricimab (original brand name: Vabysmo), and ranibizumab (original brand name: Lucentis) has been clarified.

 

Also, the expected adverse events in the psoriasis-specific reimbursement standards for dimethyl fumarate (original brand name: Skilarence), guselkumab (original brand name: Tremfya), ixekizumab (original brand name: Taltz), Risankizumab (original brand name: Skyrizi), secukinumab (original brand name: Cosentyx), ustekinumab (original brand name: Stelara), adalimumab(original brand name: Humira), etanercept (original brand name: Enbrel), Infliximab (original brand name: Remicade) have been further specified.