Notification of decision involving treatments for multiple sclerosis, narcolepsy, and attention deficit and hyperactivity disorder

Medicines

Decision

We’re pleased to announce the approval of a multiproduct agreement with Teva Pharma New Zealand Limited (Teva).

What we’re doing

We’re pleased to announce the approval of a multiproduct agreement with Teva Pharma New Zealand Limited (Teva).

This will result in the following:

  • funding a new pack size of modafinil (Modavigil), 60 tab pack, for narcolepsy in conjunction with a price decrease for the 30 tab pack, from 1 February 2019;
  • funding a new brand of methylphenidate hydrochloride 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 hydrochloride extended-release, following Medsafe approval;
  • funding a new 40 mg formulation of glatiramer acetate (Copaxone) prefilled syringes, which would mean fewer injections for people taking this medicine, from 1 February 2019;
  • delisting the current 20 mg formulation of glatiramer acetate (Copaxone) prefilled syringes from 1 July 2019.

Patient information

Copaxone [PDF, 81 KB]

Avonex and Betaferon [PDF, 139 KB]

We are also changing the distribution arrangements for three multiple sclerosis treatments: interferon beta-1-alpha (Avonex); interferon beta-1-beta (Betaferon); and glatiramer acetate (Copaxone), to align with the other funded multiple sclerosis treatments. This will mean that these treatments will 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 will begin from February 2019 for glatiramer and from July 2019 for the interferons.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 30 November 2018.

The proposed terms of listing, delisting and changing distribution arrangements were approved as consulted on without any changes except that a decision has been made to waive prescription co-payments for Copaxone, Avonex and Betaferon as these treatments transition from direct distribution to community pharmacy dispensing. This means that patients will not need to pay a co-payment during 2019.

Who we think will be most 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. 

What will the effect be?


For Patients

Modafinil (Modavigil)

There will be no change for patients as this product will 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 will be available for patients who meet the Special Authority criteria for methylphenidate hydrochloride extended-release tablets/capsules, subject to Medsafe registration of the Teva supplied brand. 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, will be funded from 1 February 2019. Glatiramer 20 mg prefilled syringe will continue to be funded until 30 June 2019, when it will no longer be available in New Zealand.

To continue using funded glatiramer, people currently using this treatment will need to change to the new 40 mg strength before 30 June 2019. This change in strength will mean a change in the number of times people need to inject each week. People taking glatiramer will need to discuss injection frequency with their neurology clinic or doctor.

At the moment, people receive their glatiramer delivered to an address of their choice. Once people change from the 20 mg dosing to the 40 mg dosing, this direct delivery will stop. This will mean that people will need to get a prescription from their usual neurology clinic or doctor and take this prescription to their community pharmacy.

There will be no pharmacy prescription co-payment (usually $5 per prescription item) for glatiramer 40 mg until 31 December 2019.

People taking glatiramer will need to talk with the person who usually prescribes their glatiramer to decide whether the prescriptions for their glatiramer will come from their neurology clinic or from their GP. It could be a specialist or GP, depending on the individual circumstances. As with many other medicines, a single prescription will provide three months’ supply, but this medicine will need to be collected monthly from a community pharmacy. All patients will still need an annual neurology review to assess their eligibility for ongoing treatment. Prescribers can issue repeat prescriptions without having to see a patient every three months, if they consider this to be clinically appropriate, so it is not expected that patients would incur significant extra costs for frequent GP visits.


Interferon beta-1-alpha (Avonex) and Interferon beta-1-beta (Betaferon)

  • All people taking interferon beta-1-alpha (Avonex) at 5 June 2019 will receive an eight-week delivery of their medicine on 5 June 2019.
  • All people taking interferon beta-1-beta (Betaferon) at 29 May 2019 will receive an eight-week delivery of their medicine on 29 May 2019.

From then on, people taking Avonex or Betaferon will need to get a prescription from their usual prescriber every three months and take this to their usual community pharmacy.  People will collect Avonex and Betaferon each month from their usual community pharmacy.

There will be no pharmacy prescription co-payment (usually $5 per prescription item) for interferon beta-1-alpha (Avonex) or interferon beta-1-beta (Betaferon) until 31 December 2019. 

People taking interferon beta-1-alpha (Avonex) or interferon beta-1-beta (Betaferon) will need to talk with the person who usually prescribes this for them to decide whether the prescriptions will come from their neurology clinic or from their GP. It could be a specialist or GP, depending on the individual circumstances. As with many other medicines, a single prescription will provide three month’s supply, but these medicines will need to be collected monthly from a community pharmacy. All patients will still need an annual neurology review to assess their eligibility for ongoing treatment. Prescribers can issue repeat prescriptions without having to see a patient every three months, if considered clinically appropriate, so it is not expected that patients would incur significant extra costs for frequent GP visits.


For Community Pharmacies

Modafinil (Modavigil)

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


Methylphenidate extended-release tablets (Methylphenidate ER - Teva)

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


Multiple sclerosis treatments

Community pharmacies will access glatiramer 40 mg, interferon beta-1-alpha and interferon beta-1-beta through their usual supply channels. Any community pharmacy dispensing these products can claim reimbursement for it for patients with a valid Special Authority approval. There will be no patient pharmacy co-payments required for people picking up their dispensing of glatiramer 40 mg, interferon beta-1-alpha and interferon beta-1-beta until 31 December 2019.

Special Authority (panel approval) numbers will be issued for patients and provided to nominated pharmacies in advance of the proposed changes.


For Prescribers

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

Funded access to all multiple sclerosis treatments will continue to be via application to the Multiple Sclerosis Treatment Assessment Committee (MSTAC) through the MSTAC panel coordinator. Patients will still require an annual neurology review.

The MSTAC panel coordinator will no longer be able to remind prescribers that new prescriptions and renewal applications are due, so prescribers and patients will be responsible for ensuring that patients are seen and prescriptions are issued in a timely manner, as they already do for other funded multiple sclerosis treatments. Neurologists may wish to consider whether they would prefer to continue prescribing these multiple sclerosis treatments for their patients or delegate prescribing to the patient’s GP.

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

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

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


For DHBs

The changes will incur pharmacy 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 savings, there would likely be longer-term savings to the health sector as a result of this proposal.

Detail about this decision

Modafinil (Modavigil) for the treatment of narcolepsy

  • Modafinil (Modavigil) will 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):
Chemical Presentation Brand Pack size Current price and subsidy New price and subsidy
Modafinil Tab 100 mg Modavigil 30 $72.50 $32.00*
Modafinil Tab 100 mg Modavigil 60 N/A $64.00
* Modavigil tab 100 mg, 30 tab pack size, will have a price and subsidy decrease from 1 February 2019.
  • A confidential rebate will apply to Modavigil that would further reduce its net price to the Funder.
  • There will be no change to the Special Authority criteria for modafinil. The current criteria can be found here.
  • Modafinil (Modavigil) 30 tablet pack will be delisted from the Pharmaceutical Schedule from 1 September 2019.
  • Modafinil (Modavigil) 60 tablet pack will 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) will 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 between 1 June and 1 November 2019, at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Methylphenidate hydrochloride extended-release

Tab extended-release 18 mg

Methylphenidate ER - Teva

30

$18.20

Methylphenidate hydrochloride extended-release

Tab extended-release 27 mg

Methylphenidate ER - Teva

30

$22.00

Methylphenidate hydrochloride extended-release

Tab extended-release 36 mg

Methylphenidate ER - Teva

30

$22.40

Methylphenidate hydrochloride extended-release

Tab extended-release 54 mg

Methylphenidate ER - Teva

30

$26.40

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


Glatiramer acetate (Copaxone) for relapsing remitting multiple sclerosis

  • Glatiramer acetate (Copaxone) 40 mg prefilled syringes will 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):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Glatiramer acetate

Inj 40 mg prefilled syringe

Copaxone

12

$2,275.00

  • A confidential rebate will apply to both strengths of Copaxone that will reduce its net price to the Funder.
  • Copaxone 40 mg will have protection from delisting and subsidy reduction until 1 October 2020.
  • The Xpharm rule will continue to apply to glatiramer acetate inj 20 mg prefilled syringe but will not be applied to glatiramer inj 40 mg prefilled syringe.
  • There will be no change to the Special Authority criteria for glatiramer acetate as a result of this proposal, however there will be a small amendment to the note included within the criteria.
  • All applications for treatment with glatiramer acetate will continue to be assessed by the Multiple Sclerosis Treatments Assessment Committee (MSTAC).
  • Glatiramer acetate 20 mg will be delisted from the Pharmaceutical Schedule on 1 July 2019, when all patients using the 20 mg strength would have switched to glatiramer acetate 40 mg or stock is exhausted.
  • Patients using glatiramer acetate 20 mg will need to transition to the 40 mg strength to remain on funded glatiramer treatment.
  • Glatiramer acetate 20 mg will continue to be provided by direct distribution until it is delisted.
  • Direct distribution will not be available for glatiramer acetate 40 mg. Patients will need to take their prescription to a community pharmacy for dispensing, as with their other funded medicines.
  • There will be no prescription co-payment payable for glatiramer acetate 40 mg from 1 February 2019 until 31 December 2019.


Changes to distribution arrangements for other multiple sclerosis treatments

Interferon beta-1-alpha (Avonex)

Chemical

Presentation

Brand

Pack size

Price and subsidy

Interferon beta-1-alpha

Inj 6 million iu prefilled syringe

Avonex

4

$1,170.00

Interferon beta-1-alpha

Injection 6 million iu per 0.5 ml pen injector

Avonex Pen

4

$1,170.00

  • The Xpharm rule will be removed from interferon beta-1-alpha (Avonex and Avonex Pen) with effect from 1 July 2019, meaning that it will need to be dispensed from a community pharmacy.
  • There will 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 will receive an eight-week delivery of their medicine on 5 June 2019.  From 1 July 2019 onwards, patients will need to have prescriptions for interferon beta-1-alpha dispensed from their usual community pharmacy.
  • There will be no prescription co-payment payable for interferon beta-1-alpha from 1 July 2019 until 31 December 2019.

Interferon beta-1-beta (Betaferon)

Chemical

Presentation

Brand

Pack size

Price and subsidy

Interferon beta-1-beta

Inj 8 million iu per 1 ml

Betaferon

15

$1,322.89

  • The Xpharm rule will be removed from interferon beta-1-beta (Betaferon) with effect from 1 July 2019, meaning that it will need to be dispensed from a community pharmacy.
  • There will 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 will receive an eight-week delivery of their medicine on 29 May 2019.  From 1 July 2019 onwards, patients will need to have their prescription for interferon beta-1-beta dispensed from their usual community pharmacy.
  • There will be no prescription co-payment payable for interferon beta-1-beta from 1 July 2019 until 31 December 2019.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All of the consultation responses received by 21 December 2018 were considered in their entirety in making a decision on the proposed changes. Responses were supportive of various aspects of the proposal.

The table below summarises issues raised by responders in relation to specific aspects of the proposal (note that no concerns were raised in relation to modafinil):

Theme

PHARMAC response

Methylphenidate extended-release

Clarification was sought about the tablet composition and sustained release profile of Methylphenidate ER - Teva

Methylphenidate ER – Teva is currently undergoing Medsafe evaluation with Concerta as the reference product, so Medsafe will evaluate the pharmacokinetic release profile against Concerta. We understand that Methylphenidate ER – Teva uses similar extended-release technology to Concerta to provide a similar pharmacokinetic release profile and reduce the potential for substance abuse.

Responders questioned whether the currently funded extended-release methylphenidate brands would still be funded

The decision does not include any changes to the availability or funding of Concerta or Ritalin LA, so these brands will continue to be available for patients.

Multiple sclerosis

Some responders would prefer to remain on Copaxone 20 mg rather than switching to the 40 mg strength

The supplier has advised it will be discontinuing the 20 mg strength so this will not be available in the longer term.

If patients do not want to switch to Copaxone 40 mg, there are a number of other funded multiple sclerosis treatments. We suggest that patients discuss treatment options with their prescribers.

Some responders questioned whether generic glatiramer acetate 20 mg could be funded in the future

There is nothing in this decision that would prevent the future listing of a generic glatiramer acetate 20 mg if one should obtain Medsafe registration.

Some respondents had concerns or questions about possible side effects from increasing the dose of Copaxone

PHARMAC received clinical advice from our expert clinical advisors that indicated increase side effects from the increased dose were unlikely. We would encourage patients to discuss any concerns regarding side effects of their medicine with their prescribers.

Responders had questions about the new processes for the prescribing and dispensing of multiple sclerosis treatments

As with most other prescriptions, patients will need to contact their prescriber (hospital clinic or GP) to request another prescription.

All current patients who are affected by these changes will be sent individual communication to clarify what is required for their individual situation.

Patients should contact their preferred pharmacy to make arrangements. Pharmacies are likely to only order in these treatments when they know a prescription is due to be presented.

Some responders raised concerns about additional costs for GP visits and pharmacy dispensing

We note that costs for GP visits and pharmacy dispensing would be the same as those for most other medicines, including the range of other funded multiple sclerosis treatments.

Prescriptions will generally be written every three months, but dispensed monthly by the pharmacy, in the same way as many other medicines. The prescriber may not need to see the patient every three months, depending on the individual situation. Many people taking an multiple sclerosis treatments are also taking other medicines that are prescribed by a GP.  Their multiple sclerosis treatment could be added to their usual script which would mean that an extra visit to their GP may not be needed.

To assist patients with the transition to community pharmacy dispensing, a pharmacy prescription co-payment waiver will apply for Avonex, Betaferon and Copaxone prescriptions until 31 December 2019.

Some responders would prefer that the current direct distribution model remains in place

These changes will ensure that the prescribing and dispensing of all multiple sclerosis treatments are managed in the same way, through community pharmacy.

We consider that community pharmacists are best placed to have an overview of a patient’s medicines.

Some responders asked how they would obtain replacement injector devices or needle cutters in the future

Currently, PHARMAC passes requests for injector devices or needle cutters onto the supplier. In the future, it is expected that patients will request these items from their neurology nurse who could obtain them from the supplier, or patients could request these direct from the supplier.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.