Proposal involving treatments for multiple sclerosis, narcolepsy, and attention deficit and hyperactivity disorder

What we’re proposing

PHARMAC is seeking feedback on a proposal involving the following products through a provisional agreement with Teva Pharma New Zealand Limited (Teva):

• fund a new pack size of modafinil (Modavigil) for narcolepsy in conjunction with a price decrease, from 1 February 2019
• fund a new brand of methylphenidate extended-release tablets (Methylphenidate ER - Teva) for attention deficit and hyperactivity disorder (ADHD) subject to the same restrictions as the Concerta and Ritalin LA brands of methylphenidate extended-release, following Medsafe approval
• fund a new 40 mg formulation of glatiramer acetate (Copaxone), which would mean fewer injections for people taking this medicine, from 1 February 2019
• delist the current 20 mg formulation of glatiramer acetate from 1 July 2019.

We are also proposing to change the distribution arrangements for three multiple sclerosis (MS) treatments: interferon beta-1-alpha (Avonex); Interferon beta-1-beta (Betaferon); and glatiramer acetate (Copaxone), to align with the other funded MS treatments. This would mean that these treatments would need to be collected from a community pharmacy, in the same way as other funded medicines, rather than the current direct distribution arrangement to the patient’s nominated delivery point. This change would begin from February 2019 for glatiramer and from July 2019 for the interferons.

Consultation closes at 5 pm on Friday, 21 December 2018 and feedback can be emailed to Andrew Oliver, Therapeutic Group Manager via consult@pharmac.govt.nz.

What would the effect be?

For Patients

Modafinil (Modavigil)

There would be no change for patients as this product would continue to be fully funded subject to the same restrictions as it is now.

Methylphenidate extended-release tablets (Methylphenidate ER - Teva)

An additional funded brand would be available for patients who meet the Special Authority criteria for methylphenidate extended-release tablets/capsules, subject to Medsafe registration. The currently funded brands are Concerta and Ritalin LA. Methylphenidate ER – Teva is undergoing registration with Medsafe as a generic version of the Concerta formulation.

Glatiramer acetate (Copaxone)

Glatiramer 40 mg prefilled syringe, with three times per week dosing, would be funded from 1 February 2019. Glatiramer 20 mg prefilled syringe would continue to be funded until 30 June 2019, when it would be delisted.

In order to remain on funded glatiramer, patients currently using this treatment would need to change to the new 40 mg strength before the 20 mg strength was delisted. A change from glatiramer 20 mg to 40 mg would involve a change in dosing frequency, which patients will need to discuss with their prescribers.

Direct distribution of the 20 mg prefilled syringe would continue to the patient’s nominated collection point until the patient changed to the 40 mg strength. Patients would need to discuss this change with their usual neurology clinic or doctor to get a prescription for the new 40 mg strength.

Once patients have changed to the 40 mg prefilled syringes, they would need to collect their glatiramer from their usual community pharmacy and pay the standard prescription co-payment, in the same way as they do for most other funded medicines.

The 20 mg strength would not be available for new patients commencing treatment with glatiramer from 1 February 2019 onwards – these patients would need to get a prescription for glatiramer 40 mg to take to their community pharmacy.

Interferon beta-1-alpha (Avonex)

All patients who are taking interferon beta-1-alpha as at 5 June 2019 would receive an eight-week delivery of their medicine on 5 June 2019. From 1 July 2019 onwards, these existing patients would need to have prescriptions for interferon beta-1-alpha dispensed from their usual community pharmacy each month.

All new patients starting on interferon beta-1-alpha from 1 July 2019 would need to obtain a prescription from their neurologist to take to their community pharmacy for dispensing.

All patients would need to pay a prescription co-payment for these pharmaceuticals when dispensed from their community pharmacy.

Interferon beta-1-beta (Betaferon)

All patients who are taking interferon beta-1-beta as at 29 May 2019 would receive an eight-week delivery of their medicine on 29 May 2019. From 1 July 2019 onwards, these existing patients would need to have prescriptions for interferon beta-1-beta dispensed from their usual community pharmacy each month.

All new patients starting on interferon beta-1-beta from 1 July 2019 would need to obtain a prescription from their neurologist to take to their community pharmacy for dispensing.

All patients would need to pay a prescription co-payment for these pharmaceuticals when dispensed from their community pharmacy.

For Community Pharmacies

A new 60 tablet pack size of modafinil (Modavigil) 100 mg tablets would be funded from 1 February 2019. The currently funded 30 tablet pack size would be delisted when stocks are exhausted, which is expected to be no later than 31 August 2019.

There would be an additional brand of methylphenidate hydrochloride extended release tablets funded for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) from a future date to be determined, following Medsafe approval.

Community pharmacies would access glatiramer 40 mg, interferon beta-1-alpha and interferon beta-1-beta through their usual supply channels. Any community pharmacy dispensing these products could claim reimbursement for it for patients with a valid Special Authority approval.

Special Authority (panel approval) numbers would be issued for patients in advance of the proposed changes.

For Prescribers

There would be no significant impacts for prescribers from the modafinil or methylphenidate extended-release components of the proposal.

Funded access to all multiple sclerosis treatments would continue to be via application to the Multiple Sclerosis Treatment Assessment Committee (MSTAC) through the MSTAC panel coordinator. The MSTAC panel coordinator would no longer be able to remind prescribers that new prescriptions are due, so the prescriber would be responsible for ensuring that patients are seen and prescriptions are issued in a timely manner.

A change from glatiramer 20 mg to 40 mg would involve a change in dosing frequency, which patients would need to be educated about. We have been advised by the Neurological Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) that neurology nurses would be likely to conduct most of the patient education about the dosing change in main centres, but general physicians may manage the patients in provincial centres.

Direct distribution to patients would cease so there would no longer be a requirement to submit prescriptions to PHARMAC for dispensing and direct distribution. Patients would need to request the prescriptions themselves through their usual MS healthcare professional (neurologist, nurse specialist, general physician or GP), and then present the script to their community pharmacy for dispensing.

There would be no changes to the access criteria (Special Authority criteria) for multiple sclerosis treatments as a result of this proposal.

For DHBs

The proposal would incur distribution costs for glatiramer, interferon beta-1-alpha and interferon beta-1-beta that are not currently payable due to the direct distribution arranged by PHARMAC. However, due to the proposed price reduction for modafinil, which would provide significant savings, there would likely be longer-term savings to the health sector as a result of this proposal.

Who we think will be interested

• People with multiple sclerosis, ADHD or narcolepsy.
• Multiple sclerosis, ADHD and narcolepsy consumer interest groups.
• Healthcare practitioners involved in the management of patients with multiple sclerosis, ADHD or narcolepsy.
• Hospital and community pharmacists, DHBs, suppliers and wholesalers.
• Ministry of Health Sector Operations and pharmacy software vendors.

Why we’re proposing this

PHARMAC has entered into a provisional agreement with Teva for the supply of the three pharmaceuticals in this proposal. Teva already supplies two of the pharmaceuticals (glatiramer 20 mg prefilled syringe and modafinil 100 mg tablets) and would be an additional supplier of methylphenidate extended-release tablets.

The modafinil and methylphenidate extended-release tablets components of the proposal would provide savings that could be used to fund other pharmaceuticals.

Teva has notified discontinuation of glatiramer 20 mg injections, so the proposal to fund glatiramer 40 mg is to ensure that patients would continue to have access to funded glatiramer.

PHARMAC received clinical advice from the Neurology Subcommittee of PTAC, which noted that switching from glatiramer 20 mg to 40 mg would involve a change in dosing frequency, which the patient would need to be educated about. The Subcommittee considered that neurology nurses would be likely to conduct most of the patient education about the dosing change in main centres, but general physicians may manage the patients in provincial centres.

Change in distribution arrangements

We think that people’s medicine supply is best managed by their community pharmacists, and we have been working over the last few years to return the dispensing of medicines such as this to community pharmacies. Most (if not all) people taking interferons or glatiramer will have an existing relationship with their community pharmacy. Having these medicines supplied through the pharmacy would enable the pharmacist to have an overview of each person’s medicines.  Other funded treatments for multiple sclerosis, such as fingolimod and dimethyl fumarate, are already dispensed through community pharmacy.

Details about our proposal

Modafinil (Modavigil) for the treatment of narcolepsy

• Modafinil (Modavigil) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2019 at the following prices and subsidies (ex-manufacturer, excluding GST):

* Modavigil tab 100 mg, 30 tab pack size, would have a price and subsidy decrease from 1 February 2019.

• A confidential rebate would apply to Modavigil that would further reduce its net price to the Funder.
• There would be no change to the Special Authority criteria for modafinil as a result of this proposal. The current criteria can be found here.
• Modafinil (Modavigil) 30 tablet pack would be delisted from the Pharmaceutical Schedule on or before 31 August 2019, or when stocks are exhausted.
• Modafinil (Modavigil) 60 tablet pack would have protection from delisting and subsidy reduction until 1 August 2020.

Methylphenidate hydrochloride extended-release (Methylphenidate ER – Teva) for the treatment of ADHD

• Methylphenidate hydrochloride extended-release tablets (Methylphenidate ER - Teva) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from a future date to be determined following Medsafe approval, but on between 1 June and 1 November 2019, at the following prices and subsidies (ex-manufacturer, excluding GST):

• The funding of Methylphenidate ER – Teva would be subject to it gaining Medsafe approval.
• There would be no change to the Special Authority criteria (SA1151) for methylphenidate hydrochloride extended-release as a result of this proposal. The current criteria can be found here.
• Methylphenidate hydrochloride extended-release (Methylphenidate ER – Teva) would have protection from delisting and subsidy reduction until 1 July 2020.

Glatiramer acetate (Copaxone) for relapsing remitting multiple sclerosis

• Glatiramer acetate (Copaxone) 40 mg injections would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2019 at the following prices and subsidies (ex-manufacturer, excluding GST):

• A confidential rebate would apply to both strengths of Copaxone that would reduce its net price to the Funder.
• Copaxone 40 mg would have protection from delisting and subsidy reduction until 1 October 2020.
• The Xpharm rule would continue to apply to glatiramer inj 20 mg prefilled syringe but would not be applied to glatiramer inj 40 mg prefilled syringe.
• There would be no change to the Special Authority criteria for glatiramer as a result of this proposal
• All applications for treatment with glatiramer would continue to be assessed by the Multiple Sclerosis Treatments Assessment Committee (MSTAC).
• Glatiramer 20 mg would be delisted from the Pharmaceutical Schedule by no later 30 June 2019, when all patients using the 20 mg strength would have switched to glatiramer 40 mg or stock is exhausted.
• Patients using glatiramer 20 mg would need to transition to the 40 mg strength to remain on funded glatiramer treatment.
• Glatiramer 20 mg would continue to be provided by direct distribution until it is delisted.
• Direct distribution would not be available for glatiramer 40 mg. Patients would need to take their prescription to a community pharmacy for dispensing, as with other funded medicines. A prescription co-payment would apply to dispensings of glatiramer 40 mg.

Patients currently using glatiramer 20 mg daily injection:

• Patients would need to visit their neurology clinic or MS healthcare professional between 1 February 2019 and 30 June 2019 to be changed to the glatiramer 40 mg.
• PHARMAC would already have provided the prescriber with an updated Special Authority approval number to write on the prescription for each patient.
• Patients would take the prescription for glatiramer 40 to their usual community pharmacy to be dispensed, and a prescription co-payment would apply.
• Glatiramer 20 mg and 40 mg can both be used with the same injector device.

Changes to distribution arrangements for other multiple sclerosis treatments

Interferon beta-1-alpha (Avonex)

• The Xpharm rule would be removed from interferon beta-1-alpha (Avonex and Avonex Pen) with effect from 1 July 2019, meaning that it would need to be dispensed from a community pharmacy.
• There would be no change to the price and subsidy of interferon beta-1-alpha.
• All patients taking interferon beta-1-alpha as at 5 June 2019 would receive an eight-week delivery of their medicine on 5 June 2019. From 1 July 2019 onwards, patients would need to have prescriptions for interferon beta-1-alpha dispensed from their usual community pharmacy and a prescription co-payment would apply.

Interferon beta-1-beta (Betaferon)

• The Xpharm rule would be removed from interferon beta-1-beta (Betaferon) with effect from 1 July 2019, meaning that it would need to be dispensed from a community pharmacy.
• There would be no change to the price and subsidy of interferon beta-1-beta.
• All patients taking interferon beta-1-beta as at 29 May 2019 would receive an eight-week delivery of their medicine on 29 May 2019. From 1 July 2019 onwards, patients would need to have their prescription for interferon beta-1-beta dispensed from their usual community pharmacy and a prescription co-payment would apply.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm on 21 December 2018.

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.