Funding of benralizumab (Fasenra) prefilled pen for severe eosinophilic asthma from 1 September 2022
Pharmac is funding the benralizumab (Fasenra) prefilled pen for people with severe eosinophilic asthma.
What we’re doing
We're pleased to announce that from 1 September 2022 benralizumab (Fasenra) prefilled pen will be funded for people with severe eosinophilic asthma. Benralizumab will be subject to eligibility criteria.
Benralizumab is a medicine that targets your immune system. It belongs to a class of medicines that are sometimes called anti-IL 5 therapies.
We will also be amending the eligibility criteria for mepolizumab (Nucala) to align with the criteria for benralizumab. Mepolizumab is another anti-IL5 therapy for severe eosinophilic asthma.
This decision will provide an additional treatment option for people with severe eosinophilic asthma, including for people who cannot take mepolizumab or where mepolizumab hasn’t worked for them.
Who we think will be most interested
- People with severe eosinophilic asthma and their whānau and caregivers
- Respiratory physicians, respiratory nurses, clinical immunologists, and other clinicians involved in the management of severe eosinophilic asthma
- Hospital and community pharmacists and wholesalers
- Pharmaceutical suppliers
- Other organisations/groups with an interest in the treatment of asthma
Any changes to the original proposal?
We made a decision earlier this year to fund benralizumab prefilled pen once it had received Medsafe approval. This followed an earlier consultation on a proposal to fund benralizumab. Now that Medsafe approval has been granted, benralizumab will be funded for people with severe eosinophilic asthma from 1 September.
Following consultation feedback, we decided to make changes to the proposed eligibility criteria to extend the timeframe to confirm intolerance or lack of response to prior anti-IL5 therapy. We consider that this aligns better with clinical practice and the approval period for the other funded anti-IL5 therapy.
All consultation feedback received was summarised in the notification letter dated 16 March 2022.
Detail about this decision
Benralizumab (Fasenra) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2022 at the following prices and subsidies (ex-manufacturer, excluding GST):
Price and subsidy
Inj 30 mg per ml, 1 ml prefilled pen
A confidential rebate will apply to benralizumab (Fasenra) that will reduce the net price to the Funder. Fasenra will have protection from delisting and subsidy reduction until 31 March 2025.
Fasenra will be listed in Section B and Part II of Section H subject to the following eligibility criteria (changes made in response to consultation feedback are shown with additions in bold and deletions in strikethrough):
Special Authority for Subsidy
Initial application — (Severe eosinophilic asthma) only from a respiratory physician or clinical immunologist. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
- Patient must be aged 12 years or older; and
- Patient must have a diagnosis of severe eosinophilic asthma documented by a respiratory physician or clinical immunologist; and
- Conditions that mimic asthma eg. vocal cord dysfunction, central airway obstruction, bronchiolitis etc. have been excluded; and
- Patient has a blood eosinophil count of greater than 0.5 × 10ˆ9 cells/L in the last 12 months; and
- Patient must be adherent to optimised asthma therapy including inhaled corticosteroids (equivalent to at least 1000 mcg per day of fluticasone propionate) plus long-acting beta-2 agonist, or budesonide/formoterol as part of the anti-inflammatory reliever therapy plus maintenance regimen, unless contraindicated or not tolerated; and
- Patient has had at least 4 exacerbations needing systemic corticosteroids in the previous 12 months, where an exacerbation is defined as either documented use of oral corticosteroids for at least 3 days or parenteral corticosteroids; or
- Patient has received continuous oral corticosteroids of at least the equivalent of 10 mg per day over the previous 3 months; and
- Treatment is not to be used in combination with subsidised mepolizumab; and
- Patient has an Asthma Control Test (ACT) score of 10 or less. Baseline measurements of the patient’s asthma control using the ACT and oral corticosteroid dose must be made at the time of application, and again at around 52 weeks after the first dose to assess response to treatment; and
9.1 Patient has not previously received an anti-IL5 biological therapy for their severe eosinophilic asthma; or
9.2.1 Patient was refractory or intolerant to previous anti-IL5 biological therapy; and
9.2.2 Discontinued within 3 months of commencing treatment with previous anti-IL5 biological therapy
9.2.2 Patient was not eligible to continue treatment with previous anti-IL5 biological therapy and discontinued within 12 months of commencing treatment
Renewal — (Severe eosinophilic asthma) only from a respiratory physician or clinical immunologist. Approvals valid for 2 years for applications meeting the following criteria:
- An increase in the Asthma Control Test (ACT) score of at least 5 from baseline; and
- Exacerbations have been reduced from baseline by 50% as a result of treatment with benralizumab; or
- Reduction in continuous oral corticosteroid use by 50% or by 10 mg/day while maintaining or improving asthma control.
We will also be amending the eligibility criteria for mepolizumab (Nucala) for severe eosinophilic asthma to align with the criteria detailed above, from 1 September 2022.
Benralizumab comes in a prefilled pen presentation that can be self-administered. The first three doses are administered every four weeks. After that, doses are administered every eight weeks.
Detailed information about benralizumab dosing and administration can be found in the Medsafe datasheet.(external link)
Our response to what you told us
We’re really grateful for the time people took to respond to this consultation.
A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are available in the notification letter dated 16 March 2022.
If you have any questions about this decision, you can email us at firstname.lastname@example.org; or call our toll-free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.