Omalizumab ========== Injection 75 mg in 0.5 mL single dose pre-filled pen SavePublic hospital PBS item code15543CMaximum quantity1 units Repeats5 More detailsProgramHB AdministrationINJECTION Benefit typeS Brands - Omlyclo Dispensed price for maximum quantity (DPMQ)2 pricesOmlyclo · s90-cp-s100$120.96 Omlyclo · s94-public-s100$102.99 Restrictions & indications ------------------------------ Streamline authority code19214 Asthma (Uncontrolled severe) - Continuing treatment Show full PBS criteriaHide full PBS criteriaUncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must be aged 12 years or older. An adequate response to omalizumab treatment is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction). For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient's medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated. The following information must be documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5) score; and (b) If applicable, maintenance oral corticosteroid dose; and (c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced. The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application. Notes (4)For copies of the ACQ and the calculation sheets please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday). Pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL syringe and pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL pen device are equivalent for the purposes of substitution. **TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE ASTHMA** The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for uncontrolled severe asthma. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of 'uncontrolled severe asthma'. A patient is eligible for PBS-subsidised treatment with only 1 biological medicine for uncontrolled severe asthma at any one time. A patient receiving PBS-subsidised treatment for uncontrolled severe asthma is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle. Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy. A patient currently receiving PBS-subsidised treatment as of 1 April 2021 is considered to have started a cycle of treatment. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment. Once a patient has either failed to achieve or sustain a response to treatment with each of the biological medicines they are eligible for, they are deemed to have completed a single treatment cycle. They must have at least a 12-month break in PBS-subsidised biological medicine therapy before they are eligible to recommence another new treatment cycle \[further details are under 'Recommencement of treatment after a treatment break in PBS-subsidised therapy' below\]. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine is ceased until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. How to prescribe PBS-subsidised biological medicine treatment for uncontrolled severe asthma. (1) Initial treatment: Applications for initial treatment should be made where: (i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 restriction); or (ii) a patient has received prior PBS-subsidised treatment with a biological medicine and wishes to recommence a new treatment cycle with this biological medicine following a treatment break in PBS-subsidised therapy (Initial 1 restriction); or (iii) a patient has received prior PBS-subsidised biological medicine therapy and wishes to trial an alternate biological medicine within the same treatment cycle (Initial 2 restriction) - \[further details are under 'Swapping therapy' below\]. All applications for initial treatment will be limited to provide for a maximum of up to 32 weeks of therapy of a biological medicine. It is recommended that a patient be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply. (2) Continuing treatment: Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply. (3) Baseline measurements to determine response: Baseline measurements of the Asthma Control Questionnaire (ACQ; 5 item version) or oral corticosteroid dose submitted with the Initial authority application for a biological medicine must be used to determine whether an adequate response to treatment has been achieved or sustained. For patients transitioned from the paediatric to the adolescent/adult restriction, the exacerbation history may also be used to determine response. However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and these new baseline measurements may be used to assess response. (4) Swapping therapy within the same treatment cycle. Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine at any time by qualifying under an Initial 2 restriction. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle. Within the same treatment cycle a patient may alternate between therapy with any biological medicine of their choice (1 at a time) providing: (i) they have not received PBS-subsidised treatment with that particular biological medicine previously; or (ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and (iii) they have not previously failed to respond to treatment with all eligible biological medicines in this treatment cycle. (5) Re-commencement of a new treatment cycle after a treatment break in PBS-subsidised therapy: A patient who wishes to trial a second or subsequent new treatment cycle, following a break in PBS-subsidised therapy of at least 12 months, must re-qualify through an Initial 1 restriction. (6) Monitoring of patients: Omalizumab only: Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medications for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur. Prescribing notes (4)For copies of the ACQ and the calculation sheets please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday). Pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL syringe and pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL pen device are equivalent for the purposes of substitution. TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE ASTHMA The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for uncontrolled severe asthma. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of 'uncontrolled severe asthma'. A patient is eligible for PBS-subsidised treatment with only 1 biological medicine for uncontrolled severe asthma at any one time. A patient receiving PBS-subsidised treatment for uncontrolled severe asthma is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle. Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy. A patient currently receiving PBS-subsidised treatment as of 1 April 2021 is considered to have started a cycle of treatment. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment. Once a patient has either failed to achieve or sustain a response to treatment with each of the biological medicines they are eligible for, they are deemed to have completed a single treatment cycle. They must have at least a 12-month break in PBS-subsidised biological medicine therapy before they are eligible to recommence another new treatment cycle [further details are under 'Recommencement of treatment after a treatment break in PBS-subsidised therapy' below]. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine is ceased until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. How to prescribe PBS-subsidised biological medicine treatment for uncontrolled severe asthma. (1) Initial treatment: Applications for initial treatment should be made where: (i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 restriction); or (ii) a patient has received prior PBS-subsidised treatment with a biological medicine and wishes to recommence a new treatment cycle with this biological medicine following a treatment break in PBS-subsidised therapy (Initial 1 restriction); or (iii) a patient has received prior PBS-subsidised biological medicine therapy and wishes to trial an alternate biological medicine within the same treatment cycle (Initial 2 restriction) - [further details are under 'Swapping therapy' below]. All applications for initial treatment will be limited to provide for a maximum of up to 32 weeks of therapy of a biological medicine. It is recommended that a patient be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply. (2) Continuing treatment: Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply. (3) Baseline measurements to determine response: Baseline measurements of the Asthma Control Questionnaire (ACQ; 5 item version) or oral corticosteroid dose submitted with the Initial authority application for a biological medicine must be used to determine whether an adequate response to treatment has been achieved or sustained. For patients transitioned from the paediatric to the adolescent/adult restriction, the exacerbation history may also be used to determine response. However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and these new baseline measurements may be used to assess response. (4) Swapping therapy within the same treatment cycle. Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine at any time by qualifying under an Initial 2 restriction. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle. Within the same treatment cycle a patient may alternate between therapy with any biological medicine of their choice (1 at a time) providing: (i) they have not received PBS-subsidised treatment with that particular biological medicine previously; or (ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and (iii) they have not previously failed to respond to treatment with all eligible biological medicines in this treatment cycle. (5) Re-commencement of a new treatment cycle after a treatment break in PBS-subsidised therapy: A patient who wishes to trial a second or subsequent new treatment cycle, following a break in PBS-subsidised therapy of at least 12 months, must re-qualify through an Initial 1 restriction. (6) Monitoring of patients: Omalizumab only: Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medications for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur. Other listings for Omalizumab Injection 75 mg in 0.5 mL single dose pre-filled pen ---------------------------------------------------------------------------------- [Public14905LMaximum 1 units · 0 repeats - Asthma (Uncontrolled severe) - Balance of supply](/p/14905L)[Public14950WMaximum 1 units · 5 repeats - Asthma (Uncontrolled severe) - Continuing treatment](/p/14950W)[Public14949TMaximum 1 units · 7 repeats - Asthma (Uncontrolled severe) - Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) - Asthma (Uncontrolled severe) - Initial treatment - Initial 2 (Change of treatment)](/p/14949T) Data source: [Australian Government PBS Schedule](https://www.pbs.gov.au/info/browse/download) · Record updated 30 September 2026. Verify current listing and prescribing requirements on the [official PBS website](https://www.pbs.gov.au/).