Decision for funding in the immunosuppressant, cardiovascular and antinausea therapeutic areas

Source: Pharmac

Adalimumab (Humira) for hidradenitis suppurativa


Any changes to the original proposal?

As a result of consultation feedback, the Special Authority Criteria and restrictions for adalimumab were amended to allow for loading doses during the initial treatment of moderate to severe hidradenitis suppurativa.

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

This decision was subject to a consultation letter dated 6 August 2019.

Who we think will be most interested

  • People with hidradenitis suppurativa and their whānau
  • Dermatologists, general practitioners
  • Community and hospital pharmacies
  • DHBs

Details about this decision

The following changes will occur from 1 October 2019:

Access to adalimumab (Humira) will be widened in Section B of the Pharmaceutical Schedule to include moderate to severe hidradenitis suppurativa, as follows (new criteria only shown below).

Special Authority for Subsidy
Initial application — (hidradenitis suppurativa) only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

  1. Patient has hidradenitis suppurativa Hurley Stage II or Hurley Stage III lesions in distinct anatomic areas; and
  2. Patient has tried, but had an inadequate response to at least a 90 day trial of systemic antibiotics or patient has demonstrated intolerance to or has contraindications for systemic antibiotics; and
  3. The patient has 3 or more active lesions (e.g. inflammatory nodules, abscesses, draining fistulae); and
  4. The patient has a Dermatology Quality of Life Index of 10 or more and the assessment is no more than 1 month old at time of application; and
  5. Following the initial loading doses, adalimumab is to be administered at doses no greater than 40mg every 7 days.

Renewal — (hidradenitis suppurativa) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. The patient has a reduction in active lesions (e.g. inflammatory nodules, abscesses, draining fistulae) of 25% or more from baseline; and
  2. The patient has a Dermatology Quality of Life Index improvement of 4 or more from baseline; and
  3. Adalimumab is to be administered at doses no greater than 40mg every 7 days. Fortnightly dosing has been considered.

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

Further information regarding adalimumab and hidradenitis suppurativa can be found in the consultation letter dated 6 August 2019.

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 response to the feedback received is set out below. 

Theme

PHARMAC Comment

Even more effective options may be available in future.

PHARMAC would welcome a funding application for other treatment options for this patient group.

Request for provision in the funding criteria to allow loading dose as per the adalimumab Data Sheet (Data Sheet).(external link)

The funding criteria have been amended to allow for loading doses during the initial approval period.

Concern that restriction to dermatologists for treatment initiation may be an unnecessary barrier and cost to treatment, given regional variation in service availability. There may be an impact to clinical services related to clinical assessment, administration and education.

The criteria are consistent with all other funded dermatological indications of adalimumab and our clinical advice indicates that the criteria are appropriate in the context of current dermatology services in New Zealand.

The criteria allow renewal by a Practitioner on the recommendation of a dermatologist. PHARMAC will continue to review the criteria with consideration to access equity.

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.


Nicardipine hydrochloride injection for use in adults

Who we think will be most interested

  • Anaesthetists, intensivists, cardiologists
  • Hospital pharmacies
  • DHBs

Details about this decision

The following changes will occur from 1 October 2019:

The restrictions for nicardipine hydrochloride injection in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML) will be amended to include adults as follows (deletions in strikethrough, additions in bold):

Initiation

Anaesthetist, intensivist, cardiologist or paediatric cardiologist

Both:

  1. Patient is a Paediatric Patient; and
  2. Any of the following:

2.1.    1. Patient has hypertension requiring urgent treatment with an intravenous agent; or

2.2.    2. Patient has excessive ventricular afterload; or

2.3.    3. Patient is awaiting or undergoing cardiac surgery using cardiopulmonary bypass

Further information about nicardipine hydrochloride injection and its uses can be found in the consultation letter dated 6 August 2019.

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.

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.


Ondansetron dispersible tablets for supply on a Practitioner’s Supply Order (PSO)



Who we think will be most interested

  • People who need urgent treatment for nausea and vomiting and their whānau  
  • General practitioners
  • Community pharmacists
  • Pharmaceutical suppliers

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 is set out below. 

Theme

PHARMAC Comment

Considered there is a need for a higher quantity to be made available on a PSO.

We sought clinical advice on the appropriate quantities to be made available via PSO. This advice indicated that a maximum quantity of 10 tablets per strength would likely be sufficient in most circumstances.  We will continue to review usage of this medicine via PSO and may consider a change to the maximum quantity at a future 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.

Last updated: 11 September 2019