Table 1 Comparison of the NHF omalizumab (OMA) treatment program regulations with the drug indications

Age

≥12 years

≥6 years

tIgE in serum

30–1500 IU/ml

30–1500 IU/ml

Severe allergic asthma with sensitization to whole-year allergens

Yes

Yes

Uncontrolled asthma despite high-dose ICS plus an additional control drug

ACQ score > 1.5 points (1/6)^a >1000 mcg BDP-CFC/day + LABA or LTRA or theophylline

Symptomatic High ICS dose + LABA

Necessity of using OCS continuously or in bursts

Yes minimum of 5 mg of prednisone/day

No

Multiple exacerbations

≥3/year (1/6)^a

Yes

Hospitalizations due to exacerbations

Yes (1/6)^a

Not required

Life-threatening asthma attack in medical history

Yes (1/6)^a

Not required

With airflow limitation

FEV1 < 60 % predicted (1/6)^a

FEV1 < 80 % predicted

Additional criteria

AQLQ score < 5.0 points (1/6)^a

Not required

Contraindications

Hypersensitivity to the drug

Hypersensitivity to the drug

Co-morbidities inducing severe course of asthma

Yes^b

Not contraindicated

Tobacco

Non-smokers – obligatory condition

Not contraindicated

Pregnancy

Absolutely contraindicated

Should not be used during pregnancy unless clearly necessary

Contraindications: simultaneous therapy with immunosuppressive drugs (e.g. methotrexate or cyclosporine), anticancer drugs, immunoglobulin infusions or other biological drugs

Yes

Lack of studies