Decision for funding in the neurology, immunosuppressants, diabetes and antithrombotic therapy areas

Medicines

Decision

We’re pleased to announce the approval of a decision relating to medicines in the neurology, immunosuppressant, diabetes and antithrombotic areas.

In summary, this will result in the following changes from 1 August 2019:

Rituximab for neuromyelitis optica spectrum disorders (NMOSD)

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

Who we think will be most interested

  • People with NMOSD and their whānau
  • Neurologists
  • Hospital pharmacies and DHBs

Detail about this decision

The following changes will occur from 1 August 2019:

Access to rituximab (Mabthera) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2019 to include NMOSD, as follows (new criteria only shown below):

Special Authority for Subsidy
Initial application – (Neuromyelitis Optica Spectrum Disorder (NMOSD)) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:
Both:

  1. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m2 administered weekly for four weeks; and
  2. Either:

2.1     The patient has experienced a severe episode or attack of NMOSD (rapidly progressing symptoms and clinical investigations supportive of a severe attack of NMOSD); or
2.2     All of the following:

2.2.1    The patient has experienced a breakthrough attack of NMOSD; and
2.2.2    The patient is receiving treatment with mycophenolate; and
2.2.3    The patient is receiving treatment with corticosteroids.

Renewal – (Neuromyelitis Optica Spectrum Disorder) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m2 administered weekly for four weeks; and
  2. The patient has responded to the most recent course of rituximab; and
  3. The patient has not received rituximab in the previous 6 months.

The same changes to the restrictions for rituximab (Mabthera) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback and our responses to the feedback received are set out below.

Theme

PHARMAC Comment

Supportive of widening access to this treatment and considered increased access would meet known clinical needs.

Noted.

Concerns about the impact on infusion services. 

PHARMAC consider the impact to infusion services as a result of this decision would be small, noting a number of patients throughout the country who would be eligible for funding have been funded in the past via NPPA. It is acknowledged that there would be a cost and resource impact to DHBs related to infusion services needed to administer rituximab.  However, it is likely that there would be an overall reduction in cost for DHBs associated with hospitalisations due to NMOSD attacks and subsequent disability.

Questions regarding the factors that influence the timeline from notification date to funding date.

Notification of a decision occurs as soon as possible following a decision.

If significant issues are raised during consultation then a delay in decision making, and subsequent notification can occur if additional time is required to consider the issues raised.

Similarly, a change to the funding date, different to what was originally proposed in a consultation, can occur as a result of consultation feedback.

Questions regarding how the cost of infusion services are calculated.

The cost of infusion services are generally informed by PHARMAC’s cost-resource manual. Information on the cost-resource manual and how this data is collected is available on our website.  

There is a long list of restrictions for rituximab funding within the Pharmaceutical Schedule.

Requested consideration be given to redefining the current restrictions to particular specialties and reducing the number of condition based restrictions.

Funding of rituximab is currently targeted to specific indications within different specialties.

Should rituximab be funded in the future for all indications within a particular specialty, then this would be something which could be considered.

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. 

Rituximab for severe refractory myasthenia gravis

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

Who we think will be most interested

  • People with severe myasthenia gravis and their whānau
  • Neurologists
  • Hospital pharmacies and DHBs

Detail about this decision

The following changes will occur from 1 August 2019:

Access to rituximab (Mabthera) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2019 to include severe refractory myasthenia gravis, as follows (new criteria only shown below):

Special Authority for Subsidy
Initial application – (Severe Refractory Myasthenia Gravis) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:
Both:

  1. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart; and
  2. Either:

2.1.    Treatment with corticosteroids and at least one other immunosuppressant for at least a period of 12 months has been ineffective; or
2.2.    Both:

2.2.1.  Treatment with at least one other immunosuppressant for a period of at least 12 months; and
2.2.2.  Corticosteroids have been trialed for at least 12 months and have been discontinued due to unacceptable side effects.

Renewal – (Severe Refractory Myasthenia Gravis) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart; and
  2. An initial response lasting at least 12 months was demonstrated; and
  3. Either:

3.1.    The patient has relapsed despite treatment with corticosteroids and at least one other immunosuppressant for a period of at least 12 months; or
3.2.    Both

3.2.1.  The patient’s myasthenia gravis has relapsed despite treatment with at least one immunosuppressant for a period of at least 12 months; and
3.2.2.  Corticosteroids have been trialed for at least 12 months and have been discontinued due to unacceptable side effects.

The same changes to the restrictions for rituximab (Mabthera) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback and our responses to the feedback received are set out below.

Theme

PHARMAC Comment

Supportive of widening access to this treatment and considered increased access would meet known clinical needs.

Noted.

Concerns about the impact on infusion services. 

PHARMAC considers the impact to infusion services as a result of this proposal would be small, noting a number of patients throughout the country who would be eligible for funding have been funded in the past via NPPA. It is acknowledged that there would be a cost and resource impact to DHBs related to infusion services needed to administer rituximab.  However, it is likely that there would be an overall reduction in cost for DHBs associated with hospitalisations due to myasthenia gravis attacks and subsequent disability.

Questions regarding the factors that influence the timeline from notification date to funding date.

Notification of a decision occurs as soon as possible following a decision.

If significant issues are raised during consultation then a delay in decision making, and subsequent notification can occur if additional time is required to consider the issues raised.

Similarly, a change to the funding date, different to what was originally proposed in a consultation, can occur as a result of consultation feedback.

Questions regarding how the cost of infusion services are calculated.

The cost of infusion services are generally informed by PHARMAC’s cost-resource manual. Information on the cost-resource manual and how this data is collected is available on our website.

There is a long list of restrictions for rituximab funding within the Pharmaceutical Schedule.

Requested consideration be given to redefining the current restrictions to particular specialties and reducing the number of condition based restrictions.

Funding of rituximab is currently targeted to specific indications within different specialities.

Should rituximab be funded in the future for all indications within a particular specialty, then this would be something which could be considered.

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.

Bevacizumab and HPV vaccine for recurrent respiratory papillomatosis (RRP)

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

Who we think will be most interested

  • People with recurrent respiratory papillomatosis (RRP) and their whānau
  • ENT surgeons, otolaryngologists, respiratory physicians
  • Hospital pharmacies and DHBs

Detail about this decision

The following changes will occur from 1 August 2019:

Access to bevacizumab and HPV vaccine (Gardasil 9) will be widened in Part II of Section H of the Pharmaceutical Schedule from 1 August 2019 to include recurrent respiratory papillomatosis, as follows (new criteria in bold):

Bevacizumab

Restricted
Initiation – Recurrent Respiratory Papillomatosis

Otolaryngologist.

Re-assessment required after 12 months

All of the following:

  1. Maximum of 6 doses; and
  2. The patient has recurrent respiratory papillomatosis; and
  3. The treatment is for intra-lesional administration

Continuation – Recurrent Respiratory Papillomatosis

Otolaryngologist.

Re-assessment required after 12 months

All of the following

  1. Maximum of 6 doses; and
  2. The treatment is for intra-lesional administration; and
  3. There has been a reduction in surgical treatments or disease regrowth as a result of treatment.

Initiation – ocular conditions

Either:

  1. Ocular neovascularisation; or
  2. Exudative ocular angiopathy.

Human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52 and 85) vaccine [HPV]

Restricted

Initiation – Recurrent Respiratory Papillomatosis

All of the following:

  1. Either:

1.1.    Maximum of two doses for children aged 14 years and under; or
1.2.    Maximum of three doses for people aged 15 years and over; and

  1. The patient has recurrent respiratory papillomatosis; and
  2. The patient has not previously had an HPV vaccine.


Initiation – Children aged 14 years and under

Therapy limited to 2 doses

Children aged 14 years and under.

Initiation – other conditions

Either:

  1. Up to 3 doses for people aged 15 to 26 years inclusive; or
  2. Both:

2.1   People aged 9 to 26 years inclusive; and
2.2   Any of the following:

2.2.1         Up to 3 doses for confirmed HIV infection; or
2.2.2         Up to 3 doses for transplant (including stem cell) patients; or
2.2.3         Up to 4 doses for Post chemotherapy.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were supportive of the proposal. A summary of the main themes raised in feedback and our responses to the feedback are set out below.

Theme

PHARMAC Comment

Supportive of widening access to this treatment.

Noted.

Vaccination is typically a service of primary care rather than DHBs.

It is expected that the majority of people with RRP who require treatment with bevacizumab would have received or be eligible for HPV vaccination in primary care.

However, a small number of patients may not already be vaccinated. For these patients, the vaccine can be administered while the patient is in hospital for their treatment with bevacizumab. This will remove the need to make a separate visit to primary care and ensure patients receive the vaccination.

Request for clarification regarding whether the treating physician needs to make an application to PHARMAC each time treatment is indicated.

No. The treating physician will need to complete any necessary requirements of their DHB pharmacy department to demonstrate that the continuation criteria are met every 12 months.

General concern regarding ongoing availability of cidofovir.

Access and availability of cidofovir will not be changed by this decision. It will continue to be listed in Section H of the Pharmaceutical Schedule as it has a number of therapeutic indications.

Proposal for different restrictions for HPV vaccine, noting all patients under the age of 26 years are already eligible for funding.

There is a chance that some patients outside of the age restrictions may not have already received a vaccine. Based on this, PHARMAC consider the proposed restrictions remain necessary in order to enable access to treatment for these patients.

The proposed restrictions ensure the maximum number of doses are targeted to the appropriate age groups.

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.

Adalimumab for Behçet's disease

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

No consultation feedback was received for this proposal.  

Who we think will be most interested

  • People with Behçet’s disease and their whānau
  • Ophthalmologists, dermatologists, rheumatologists, paediatricians
  • Community and hospital pharmacies
  • DHBs

Detail about this decision

The following changes will occur from 1 August 2019.

Access to adalimumab (Humira) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2019 to include Behçet’s disease as follows (new criteria only shown below):

Special Authority for Subsidy
Initial application – (severe Behcet's disease) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. The patient has severe Behcet's disease that is significantly impacting the patient’s quality of life (see Notes); and
  2. Either:

2.1   The patient has severe ocular, neurological, gastrointestinal, rheumatological, mucocutaneous and/or vasculitic symptoms and has not responded adequately to treatment with infliximab (see Notes); or
2.2   The patient has severe ocular, neurological, gastrointestinal, rheumatological, mucocutaneous and/or vasculitic symptoms and has experienced intolerable side effects from treatment with infliximab; and

  1. The patient is experiencing significant loss of quality of life; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

Notes: Behcet's disease diagnosed according to the International Study Group for Behcet's disease. Lancet 1990;335(8697):1078-80. Quality of life measured using an appropriate quality of life scale such as that published in Gilworth et al, J Rheumatol. 2004;31:931-7

Renewal – (severe Behcet's disease) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Patient has had a good clinical response to initial treatment with measurably improved quality of life; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

The same changes to the restrictions for adalimumab (Humira) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Quantity of funded insulin needles

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

Who we think will be most interested

  • People with diabetes who use insulin and their whānau
  • Community pharmacies
  • Diabetes specialists, diabetes nurse specialists, GPs, nurses
  • DHBs
  • Suppliers of insulin and insulin needles and syringes

Detail about this decision

The following changes will occur from 1 August 2019:

The maximum quantity of insulin syringes with attached needles and insulin pen needles will be amended in Section B of the Pharmaceutical Schedule from 1 August 2019 as follows (additions in bold and deletions in strikethrough):

INSULIN PEN NEEDLES – Maximum of 100 dev per prescription

a)      Maximum of 200 dev per prescription

b)      Maximum of 100 dev per dispensing

INSULIN SYRINGES, DISPOSABLE WITH ATTACHED NEEDLE– Maximum of 100 dev per prescription

a)      Maximum of 200 dev per prescription

b)      Maximum of 100 dev per dispensing

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback and our responses to the feedback are set out below.

Theme

PHARMAC Comment

Supportive of the change.

Noted.

Queries regarding funding of lancets for blood glucose monitoring.

Funding for lancets for blood glucose monitoring was not considered as part of this proposal.

We note that dispensing costs to DHBs and co-payments to patients would be greater than the cost of purchasing these devices over the counter from a pharmacy.

Request for funding of new oral treatments and glucose monitoring systems for people with diabetes.

Vildagliptin (a DPP-4 inhibitor), a new oral treatment for diabetes was funded from 1 October 2018. Other new oral treatments for diabetes, such as the SGLT-2 inhibitors and GLP-1 agonists are currently under assessment.

Similarly, the Freestyle Libre monitor is also under assessment.

Further information on applications currently under assessment can be found on PHARMAC’s application tracker(external link)(external link).

Concern that many patients do not need to change needles more frequently, with a request for funding of other diabetes products, including the Freestyle Libre monitor.  

The proposal is in line with the clinical advice that PHARMAC has received.

Repeat prescriptions will allow patients who need more than 100 needles to access these without needing an additional prescription, whilst managing the risk of stockpiling in patients who do not need 200 needles at one time. Based on this, overall costs are estimated to be minimal with patients no longer having to pay to access additional prescriptions.

Note an application for funding of the Freestyle Libre monitor is under assessment. Further information on this application can be found on PHARMAC’s application tracker.(external link)

Consider funding should be extended to include short insulin needles

PHARMAC has received a commercial proposal to list shorter needle lengths for syringes with attached needles. This proposal is currently under assessment and will be considered at a future time.

General concern that the quantity funded may not be sufficient for some patients who require multiple injections a day and are prone to developing lipohypertrophy.

The proposal is in line with the clinical advice PHARMAC has received.

Patients requiring more than 200 needles over a three-month period would need an additional prescription to have this quantity funded but will now require fewer prescriptions compared to the current arrangement.

PHARMAC will continue monitoring use and requirement for needles and may seek advice on increasing the quantities again in the future. 

General concern that increasing the quantity of funded insulin needles through a repeat prescription may present a barrier to treatment for some patients due to the requirement to go back to their community pharmacy.

PHARMAC acknowledges that patients will still need to return to their community pharmacy for additional needles.

This proposal will remove the requirement of an additional script and its associated co-payment for patients who need a quantity of needles greater than 100 per prescription, whilst managing the risk of stock piling in patients who do not need 200 needles at one time.

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.

Intravenous aspirin for acute interventional cardiology and neuro-radiology procedures

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 30 May 2019.

Who we think will be most interested

  • Cardiologists, interventional neuro-radiologists, neurologists, neurosurgeons and stroke physicians
  • Hospital pharmacies and DHBs

Detail about this decision

The following changes will occur from 1 August 2019:

Lysine acetylsalicylate 500 mg injection (intravenous aspirin) will be listed in Part II of Section H of the Pharmaceutical Schedule from 1 August 2019, with no brand name, pack size or price specified. An example brand name has been included (Aspegic), but hospitals will be able to purchase any brand of intravenous aspirin, in any pack size.

Lysine acetylsalicylate 500 mg injection (intravenous aspirin) will be listed subject to the following Hospital Restriction:

Restricted
Initiation

Both:

  1. For use when an immediate antiplatelet effect is required prior to an urgent interventional neuro-radiology or interventional cardiology procedure; and
  2. Administration of oral aspirin would delay the procedure.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback and our responses to the feedback received are set out below.

Theme

PHARMAC Comment

Considered funding of an IV preparation should be extended to include situations where patients (e.g. stroke patients) are nil by mouth and unable to use aspirin rectally.  

PHARMAC would welcome a funding application for this indication. Alternatively, the NPPA pathway may be appropriate to consider in this circumstance.

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.