Proposal for new calcineurin inhibitor listings on the Pharmaceutical Schedule

Source: Pharmac

What we’re proposing

As the Tender process is still in progress, the brand names, pricing and timing for these products to be listed is still to be determined; however, PHARMAC is seeking your feedback on the proposed restrictions for these products:

• Pimecrolimus cream 1% for eczema (atopic dermatitis) on the eyelid
• Tacrolimus ointment 0.1% for eczema (atopic dermatitis) on the face

Consultation closes at 5pm Tuesday 25 August 2020 and feedback can be emailed to tender@pharmac.govt.nz.

What would the effect be?

For patients

Patients who meet the Special Authority criteria (or Hospital restrictions) would have access to a fully funded medicine. This would mean patients who have eczema on their face and/or eyelids but cannot use corticosteroids on their skin, would have access to a non-steroidal product. We currently receive Named Patient Pharmaceutical Assessment applications for these products, so funding pimecrolimus and tacrolimus would reduce the time it would take for patients to access funded treatment.

For prescribers, pharmacies and DHBs

Prescribers would have the option to prescribe a non-steroidal product for patients with eczema who have contraindications to topical corticosteroids. Any practitioner would be able to submit an application, on the recommendation of a dermatologist, paediatrician or ophthalmologist and there are no proposed renewal criteria to minimize the potential administrative burden on prescribers.

We currently receive Named Patient Pharmaceutical Assessment applications for pimecrolimus and tacrolimus for this indication, so funding these products would reduce the administrative burden on prescribers.

Funding these products is expected to decrease GP and specialist appointments and decrease the cost of complementary therapies, decrease hospitalisation due worsening/infected eczema. Funding pimecrolimus is also expected to decrease ophthalmology clinic presentations and referrals.

Who we think will be interested

• People with eczema on their face and/or eyelids who cannot use topical corticosteroids on their skin, and their whānau
• New Zealand Dermatological Society
• Paediatric Society of New Zealand
• Dermatologists
• Paediatricians
• Ophthalmologists
• General Practitioners
• Community and Hospital Pharmacists
• Pharmaceutical wholesalers and suppliers

About pimecrolimus and tacrolimus

Pimecrolimus and tacrolimus belong to the class of calcineurin inhibitors and therefore provide a steroid-sparing alternative for eczema (atopic dermatitis). There are currently no topical calcineurin inhibitors funded in New Zealand. As non-steroidal options, pimecrolimus and tacrolimus would provide an alternative to topical corticosteroids where topical corticosteroids are contraindicated. Tacrolimus is suitable for use on atopic dermatitis on the face and pimecrolimus is suitable for use on atopic dermatitis on the eyelids.

Why we’re proposing this

Pimecrolimus and tacrolimus were reviewed by the Dermatology Subcommittee of PTAC in 2017 and the Pharmacology and Therapeutics Advisory Committee (PTAC) in 2018, following a funding application. PTAC and the Dermatology Subcommittee have recommended that, subject to Special Authority criteria, tacrolimus be listed on the Pharmaceutical Schedule for patients with atopic dermatitis of the face and pimecrolimus be listed on the Pharmaceutical Schedule for patients with atopic dermatitis of the eyelid.

Pimecrolimus and tacrolimus were included in the 2019/20 Invitation to Tender, dated 1 November 2019, in order to secure supply of these products. This proposal supports PHARMAC’s goal to make more medicines available to more New Zealanders.

Details about our proposal

As part of PHARMAC’s annual multi-product Tender, PHARMAC sought proposals for the supply of a number of medicines that are not currently listed on the Pharmaceutical Schedule, including pimecrolimus and topical tacrolimus.

The listing of these products would be through the Tender, therefore the brands to be made available, the pricing of these products, and the dates of listing are still to be confirmed. Any products listed through the Tender would have Sole Supply Status and Hospital Supply Status until 30 June 2023.

PHARMAC is seeking feedback on the following proposed restrictions that would apply to the listings of these products in Section B and Part II of Section H of the Pharmaceutical Schedule if the tenders are progressed:

Pimecrolimus

Section B of the Pharmaceutical Schedule

Special Authority for Subsidy

Initial application from a dermatologist, paediatrician or ophthalmologist, or any practitioner on the recommendation of a dermatologist, paediatrician or ophthalmologist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. Patient has atopic dermatitis on the eyelid; and
2. Patient has at least one of the following contraindications to topical corticosteroids: periorificial dermatitis, rosacea, documented epidermal atrophy, documented allergy to topical corticosteroids, cataracts, glaucoma, or raised intraocular pressure.

The following note would also apply:

Note: a maximum of 15 g per prescription and no more than one prescription per 12 weeks.

Part II of Section H of the Pharmaceutical Schedule

Restricted

Initiation

Dermatologist, paediatrician or ophthalmologist

All of the following

1. Patient has atopic dermatitis on the eyelid; and
2. Patient has at least one of the following contraindications to topical corticosteroids: periorificial dermatitis, rosacea, documented epidermal atrophy, documented allergy to topical corticosteroids, cataracts, glaucoma, or raised intraocular pressure.

Tacrolimus

Section B of the Pharmaceutical Schedule

Special Authority for Subsidy

Initial application only from a dermatologist or paediatrician, or any practitioner on the recommendation of a dermatologist or paediatrician. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. Patient has atopic dermatitis on the face; and
2. Patient has at least one of the following contraindications to topical corticosteroids: periorificial dermatitis, rosacea, documented epidermal atrophy or documented allergy to topical corticosteroids.

The following note would also apply:

Note: a maximum of 30 g per prescription and no more than one prescription per 12 weeks.

Part II of Section H of the Pharmaceutical Schedule

Restricted

Initiation

Dermatologist or paediatrician

All of the following:

1. Patient has atopic dermatitis on the face; and
2. Patient has at least one of the following contraindications to topical corticosteroids: periorificial dermatitis, rosacea, documented epidermal atrophy or documented allergy to topical corticosteroids.

To provide feedback

Send us an email:  tender@pharmac.govt.nz by 5pm Tuesday 25 August 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.

MIL OSI