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

Medicines

Consultation Closed

What we’re proposing

We are seeking feedback on proposals for widening access to medicines in the immunosuppressant, cardiovascular and antinausea therapeutic areas.

In summary, the proposals would result in the following changes from 1 October 2019:

Consultation closes at 5pm on Friday, 23 August 2019 and feedback can be emailed to consult@pharmac.govt.nz.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 23 August 2019.

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). 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.

Adalimumab (Humira) for hidradenitis suppurativa

What would the effect be?

Funded access to adalimumab would be widened from 1 October 2019 to include treatment of moderate to severe hidradenitis suppurativa (HS). This change would apply to both the community and hospital listings in the Pharmaceutical Schedule. Adalimumab is approved by Medsafe for the treatment of HS in people 12 years of age and older.

Adalimumab would be funded for people with moderate to severe disease (Hurley stage II and III) who have tried long-term systemic antibiotics (at least 90 days) and had an inadequate response, or who are intolerant or have a contraindication to antibiotics.

For some people, this treatment would result in improvements in skin nodules, abscesses and improved mobility, and could prevent disease progression. People who use adalimumab would be able to self-administer their treatment. We estimate that approximately 75 people each year would be eligible for treatment under the proposed criteria for funding.

Preventing disease progression would likely result in reduced healthcare costs. There may be a reduction in surgical costs for DHBs if people respond to adalimumab treatment and surgical treatment is reduced.

Who we think will be interested

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

About adalimumab and hidradenitis suppurativa

Adalimumab is a recombinant human tumour necrosis factor (TNF) inhibitor that reduces chronic inflammation and immune response activation. It is administered by subcutaneous injection. Adalimumab is currently funded to treat a number of autoimmune inflammatory conditions, which include both approved and unapproved (off-label) indications.

Hidradenitis suppurativa (HS) is a chronic skin disease characterised by inflammation of hair follicles (usually in areas such as underarms, under the breasts, inner thighs, groin and buttocks) and painful nodules or boils under the skin. Severity ranges from no symptoms to chronically inflamed abscesses and scarring. HS can be very painful and disabling, limiting mobility and quality of life. HS treatment is currently limited to antibiotics and surgical management.

The ‘the Hurley clinical staging system’ to describe HS severity:

  • Stage I – Abscess formation (single or multiple) without sinus tracts and cicatrisation/scarring
  • Stage II – Recurrent abscesses with sinus tracts and scarring, single or multiple widely separated lesions
  • Stage III – Diffuse or almost diffuse involvement, or multiple interconnected tracts and abscesses across the entire area.

Details about our proposal

Access to adalimumab (Humira) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML) from 1 October 2019 to include 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. 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) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Nicardipine hydrochloride injection for use in adults

What would the effect be?

Funded access to nicardipine hydrochloride injection in DHB hospitals would be widened from 1 October 2019 to include use as an anti-hypertensive/vasodilator in adults. This would mean nicardipine hydrochloride could be used for any person for specific conditions, removing the restriction for use only in children.

Who we think will be interested

  • Anaesthetists, Intensivists, Cardiologists
  • Hospital pharmacies
  • DHBs

About nicardipine hydrochloride injection

Nicardipine hydrochloride is a dihydropyridine calcium-channel blocker for the short-term treatment of hypertension.  It is fast acting and inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. This results in a rapid control of high blood pressure.

Nicardipine hydrochloride is given intravenously (ie straight into the vein) in situations where it is important to get blood pressure under control quickly.

Nicardipine hydrochloride injection has not been approved by Medsafe, so it would need to be supplied under Section 29 of the Medicines Act 1981.

Details regarding the use and supply of unapproved medicines is available from the Medsafe website(external link).

Why we're proposing this

Nicardipine hydrochloride injection (2.5 mg per ml, 10 ml vial) is currently funded in DHB hospitals for use as an antihypertensive/vasodilator for paediatric patients.

A funding application to widen access to adults was reviewed by the Cardiovascular Subcommittee of PTAC in September 2017 [PDF, 178 KB]. The Subcommittee recommended that access to intravenous (IV) nicardipine should be widened to the adult population for the same indications as children (ie as an antihypertensive/vasodilator), with a medium priority.

More information, including links to the Subcommittee minutes, can be found in the Application Tracker record for nicardipine hydrochloride for perioperative use as antihypertensive/vasodilator for adults(external link).

Details about our proposal

Access to nicardipine hydrochloride injection would be widened in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML) from 1 October 2019 to include adults as follows (deletions in strikethrough):

Restricted

Initiation

Anaesthetist, intensivist 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

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

What would the effect be?

Ondansetron dispersible tablets would be available for prescribers to order on a Practitioner’s Supply Order from 1 October 2019. This would mean that Prescribers could have a limited supply available to them for use in emergency situations, where it isn’t practical for a person to go to a pharmacy to have a prescription filled.

Who we think will be interested

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

About ondansetron

Ondansetron is a medicine that is used for the management of nausea and vomiting. It is particularly useful for the management of nausea and vomiting associated with certain cancer treatments, and after surgery.

There are tablets available that need to be swallowed with a glass of water, and dispersible tablets which dissolve on the tongue. The dispersible tablets are suitable for people who are not able to easily swallow a standard tablet. Both tablet types are currently funded for use in the hospital and community settings.

Why we're proposing this

There are some clinical scenarios where it is useful for ondansetron dispersible tablets to be given to a patient with nausea or vomiting in an emergency setting without the need to have a prescription filled by a pharmacist. A Practitioners Supply Order (PSO) allows this to happen.

The current options available on a PSO for the treatment of nausea and vomiting include metoclopramide injection, prochlorperazine tablets and prochlorperazine injection.  We have received a request from primary care to allow access to ondansetron dispersible tablets on a PSO as another option.

The clinical advice we received from our expert advisors was generally supportive of this approach. Allowing ondansetron dispersible tablets to be supplied on a PSO would increase the options available to prescribers who are managing nausea and vomiting in the emergency setting in the community. As the dispersible tablets dissolve on the tongue, they may replace the need for an injection in some circumstances.

Details about our proposal

Access to ondansetron dispersible tablets would be amended in Section B of the Pharmaceutical Schedule from 1 October 2019, as follows (changes in bold): 

Chemical

Formulation

Brand

Pack size

Price and Subsidy

Ondansetron

Tab disp 4 mg – up to 10 tab available on a PSO

Ondansetron
ODT-ORLA

10

$0.95

Ondansetron

Tab disp 8 mg – up to 10 tab available on a PSO

Ondansetron
ODT-ORLA

10

$1.43