Proposal to fund mepolizumab for the treatment of severe refractory eosinophilic asthma

18 December 2019

Medicines Consultation Closed

We are seeking feedback on a proposal to fund mepolizumab (Nucala), a new treatment for severe refractory eosinophilic asthma, from 1 April 2020 through a provisional agreement with GlaxoSmithKline NZ Limited (GSK).

A decision has been made

Read the notification of PHARMAC's decision – published 12 March 2020

Read the media release – published 12 March 2020

What we’re proposing

The agreement with GSK would also include amendments to the contractual arrangements for warfarin sodium (Marevan) and for lamotrigine (Lamictal) 2mg and 5mg tablets. There would be no changes to the funding of these products, but the price would change.

Consultation closes at 5 pm on Friday 24 January 2020 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

People with severe refractory eosinophilic asthma would have funded access to mepolizumab. Evidence suggests that treatment with mepolizumab reduces the number of severe exacerbations and hospitalisations for this patient group.

Funding is proposed for patients with severe eosinophilic asthma that have a blood eosinophil count of over 500 cells/microliters in the previous 12 months. We estimate that 500 patients would be eligible for treatment under the proposed criteria.

Who we think will be interested

People with severe eosinophilic asthma and their whānau
Respiratory physicians, respiratory nurses, immunologists and other clinicians involved in the management of severe eosinophilic asthma.
Hospital pharmacists
Pharmaceutical suppliers

About mepolizumab

Mepolizumab is a monoclonal antibody against interleukin-5 and is used as an add on treatment to manage symptoms in patients aged 12 years and older that have severe eosinophilic asthma.

Mepolizumab is available as lyophilised powder and is administered by subcutaneous injection once every 4 weeks; treatment is ongoing.

Why we’re proposing this

A funding application for mepolizumab for the treatment of patients with severe refractory eosinophilic asthma was considered by the Respiratory Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2017 and by PTAC in May 2018. Both PTAC and the Respiratory Subcommittee recommended that mepolizumab be funded with a high priority for patients with severe refractory eosinophilic asthma, subject to Special Authority criteria.

More information, including links to the PTAC and Subcommittee minutes, can be found in the Application Tracker record for mepolizumab.

Details about our proposal

Mepolizumab (Nucala) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2020 at the following price (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Proposed price and subsidy
Mepolizumab	Inj 100 mg vial	Nucala	1	$1,638.00

A confidential rebate would apply to Nucala that would reduce the net price to the Funder.

Mepolizumab would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application – (Severe eosinophilic asthma) only from a respiratory physician. 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 > 500 cells/microlitres in the last 12 months; and
Patient must be adherent to optimised asthma therapy including inhaled corticosteroids (equivalent to at least 1,000 mcg per day of fluticasone propionate) plus long acting beta-2 agonist, unless contraindicated or not tolerated; and
Either:

6.1. 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 steroids; or
6.2. Patient has received continuous oral corticosteroids of at least the equivalent of 10 mg per day over the previous 3 months; and

7. 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.

Renewal – (Severe eosinophilic asthma) only from a respiratory physician. Approvals valid for 2 years for applications meeting the following criteria:

Both:

An increase in the Asthma Control Test (ACT) score of at least 5 from baseline; and
Either:

2.1. Exacerbations have been reduced from baseline by 50% as a result of treatment with mepolizumab; or
2.2. Reduction in continuous oral corticosteroid use by 50% or by 10 mg/day while maintaining or improving asthma control.

The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Nucala would have protection from delisting and subsidy reduction until 31 March 2023.

As part of this agreement, a prefilled syringe form and an autoinjector form of Nucala 100 mg would also be listed in the Pharmaceutical Schedule at the same price and subsidy at a later date, subject to Medsafe approval.

Other changes associated with this proposal

As part of this proposal, protection from delisting and subsidy reduction until 31 March 2023 would also be provided for the following treatments that are currently supplied by GSK:

warfarin sodium (Marevan) 1 mg, 3 mg and 5 mg tablets
lamotrigine (Lamictal) 2 mg and 5 mg dispersible tablets

Marevan would continue to be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule with a change in price and subsidy from 1 April 2020 as follows (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Current price and subsidy	Proposed price and subsidy
Warfarin sodium	Tab 1 mg	Marevan	100	$7.60	$6.46
Warfarin sodium	Tab 3 mg	Marevan	100	$11.80	$10.03
Warfarin sodium	Tab 5 mg	Marevan	100	$13.50	$11.48

Lamictal 2 mg and 5 mg dispersible tablets would continue to be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule with a change in price and subsidy from 1 September 2020 as follows (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Current price and subsidy	Proposed price and subsidy
Lamotrigine	Tab dispersible 2 mg	Lamictal	30	$6.74	$55.00
Lamotrigine	Tab dispersible 5 mg	Lamictal	30	$9.64	$50.00

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on Friday 24 January 2020.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.