Injections for severe asthma patients who are not controlled by ICS-LABA+LAMA administration
Nizatidine’s seven drugs are released from coverage suspension due to set free on the suspensionof sale
Novartis’ new coverage standard for Xolair, severe asthma treatment, is going to establish.
Seven products of Nizatidine, which had been temporarily suspended of sales due to the detection of carcinogens in last year, are returned to the coverage list with the cancellation of suspension.
On the 25th, the Ministry of Health and Welfare (Secretary Park NeungHoo) announced an administrative amendment (Ministry of Health and Welfare announcement No. 2020-470) to the ‘details of treatment benefit,’ which contains a new standard for drug coverage of Xolair, and said that they would gather opinions by 6:00 pm today (26th) to implement the plan on the 1st.
According to the amendment, the coverage is determined when Omalizumab injections, such as Xolair injections, are not properly controlled for adults and adolescents (at least 12 years of age) with high dose of inhaled corticosteroid of long-acting Beta2 agonists and long-acting muscarinic antagonist, and children (ages 6 to 12 years) who do not benefit from ICS-LABA administration.
Moreover, when ▲ the level of immune globulin E is above 76IU/mL prior to treatment, ▲in vitro or skin reaction is positive for allergens compared to age, and▲acute exacerbation of asthma requiring systemic corticosteroid occurred more than twice within 12 months before starting treatment.
In addition, it is required to confirm the overall asthma control through a reaction-evaluation for 16 weeks after the initial administration and concede a future continuous administration. Afterward, the reaction should be continuously evaluated every three to six months to determine whether the administration lasts.
The reaction-evaluation refers to peak expiratory flow, use of rescue medication, spirometry, and exacerbations.
Although Xolair has indications in chronic idiopathic urticaria besides severe asthma, in the draft, patients were required to pay the entire drug cost, except for the specified criteria.
Meanwhile, the Ministry of Health and Welfare announced that Nizatidine’s seven products are now available in coverage determination after the Ministry of Food and Drug Safety let them free from the suspension of sale.
The targeted products are Nizant Cap. (Aprogen-Pharm), Nizixid Cap. (Daewoo-Pharm), Wezatidine Tab. 150mg (Wooridul-Pharm), Zanitidine Tab. 75mg (Alvogenkorea), andZanitin Cap. 150mg etc.