Decision to list new cardiovascular medications for use in DHB hospitals

12 June 2017

Medicines Decision

PHARMAC is pleased to announce the listing of ivabradine tablets and intravenous sildenafil on the Hospital Medicines List for use in DHB hospitals from 1 July 2017.

This was the subject of a consultation letter dated 21 April 2017.

The proposal was approved as consulted on with no changes.

In summary, the effect of the decision is that:

ivabradine tablets can be used by DHB hospitals, subject to restrictions, for premedication prior to CT coronary angiography (CTCA).
intravenous sildenafil can be used by DHB hospitals, subject to restrictions, for infants and children for pulmonary hypertension in paediatric intensive care units and neonatal intensive care units.

Details of the decision

Ivabradine (5 mg tab) and sildenafil (inj 0.8 mg per ml, 12.5 ml vial) will be listed in Part II of Section H (the Hospital Medicines List, HML) of the Pharmaceutical Schedule with no price, pack size or brand name from 1 July 2017.

Ivabradine 5 mg tablets will be listed with the following hospital restrictions:

Restricted

Initiation

Both:

Patient is indicated for computed tomography coronary angiography; and
Either:
1. Patient has a heart rate of greater than 70 beats per minute while taking a maximally tolerated dose of beta blocker; or
2. Patient is unable to tolerate beta blockers.

Ivabradine prior to CTCA may be used as a single dose, or a longer dosing regimen, prior to the procedure. As this medicine is listed on the HML only, DHB hospitals will need to determine an appropriate mechanism to provide the treatment to outpatients using a longer dosing regimen (Rule 8.1(b) of the HML rules would apply).

Sildenafil inj 0.8 mg per ml, 12.5 ml vial will be funded with the following hospital restrictions:

Restricted

Initiation - injection

Both:

For use in the treatment of pulmonary hypertension in infants or children being treated in paediatric intensive care units and neonatal intensive care units when the enteral route is not accessible; and
Any of the following:
1. For perioperative use following cardiac surgery; or
2. For use in persistent pulmonary hypertension of the newborn (PPHN); or
3. For use in congenital diaphragmatic hernia.

Ivabradine 5 mg tablet and sildenafil injection (0.8 mg per ml, 12.5 ml vial) are both unapproved medicines in New Zealand. These medicines are not approved by Medsafe under the Medicines Act 1981. Further information on the use of unapproved medicines is available on the Medsafe website(external link). We note these products are registered in other countries. Clinicians prescribing unapproved pharmaceuticals should be aware of, and comply with, their obligations under section 25 and/or section 29 of the Medicines Act 1981. We also note Rule 23 of the HML which states:

23 Unapproved Pharmaceuticals

Prescribers should, where possible, prescribe Hospital Pharmaceuticals that are approved under the Medicines Act 1981. However, the funding criteria (including Restrictions) under which a Hospital Pharmaceutical is listed in Section H of the Schedule may:

23.1 in some cases, explicitly permit a DHB to fund a Pharmaceutical that is not approved under the Medicines Act 1981 or for an Unapproved Indication; or
23.2 not explicitly prohibit a DHB from funding a Pharmaceutical for use for an Unapproved Indication;

Accordingly, if clinicians are planning on prescribing an unapproved Pharmaceutical or a Pharmaceutical for an Unapproved Indication, they should:

a. be aware of and comply with their obligations under sections 25 and/or 29 of the Medicines Act 1981, as applicable, and otherwise under that Act and the Medicines Regulations 1984;

b. be aware of and comply with their obligations under the Health and Disability Commissioner's Code of Consumer Rights, including the requirement to obtain informed consent from the patient (PHARMAC recommends that clinicians obtain written consent); and

c. exercise their own skill, judgment, expertise and discretion, and make their own prescribing decisions with respect to the use of an unapproved Pharmaceutical or a Pharmaceutical for an Unapproved Indication.

Clinicians should be aware that simply by listing a Pharmaceutical on the Pharmaceutical Schedule, PHARMAC makes no representations about whether that Pharmaceutical has any form of approval or consent under, or whether the supply or use of the Pharmaceutical otherwise complies with, the Medicines Act 1981. Further, the Pharmaceutical Schedule does not constitute an advertisement, advertising material or a medical advertisement as defined in the Medicines Act or otherwise.

We have listed these unapproved medicines on the Hospital Medicines List due to the high unmet health need of patients with these niche indications, short duration of treatment, and the lack of suitable funded alternatives.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 12 May 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Ivabradine

Theme	Comment
Some respondents considered that the proposed criteria could be less restrictive and that trialling beta blockers meant additional resource was required, and in certain patients’ such as those with AV nodal conduction disease or lung disease, beta blockers were not appropriate.	The criteria consulted on were recommended by PTAC at its August 2016 meeting [PDF, 348 KB]. We consider that the health need of patients who need a CTCA and can tolerate a beta blocker is met with a currently funded medication, metoprolol tartrate. We consider that the wording of the criteria allows patients who cannot tolerate, or should not be trialed on, beta blocker therapy to access ivabradine if the clinician considers it to be appropriate.
Responders were supportive of the proposal. Some respondents considered that that widening of access to ivabradine for other indications such as inappropriate sinus tachycardia, heart failure and angina would be useful.	PHARMAC received a funding application of ivabradine for inappropriate sinus tachycardia (IST) in 2012. Clinical advice at the time considered PTAC should assess this application once an ivabradine product is approved for use in New Zealand. PHARMAC considers a Medsafe approved product would be required if long term indications were to be funded. PHARMAC continues to investigate possible suppliers for this product and we would welcome further evidence on the health need and benefit for ivabradine for IST. We have not received an application for funding of ivabradine for heart failure or angina. Should this product become registered in New Zealand, we would welcome a funding application for these indications.

Theme

Comment

Some respondents considered that the proposed criteria could be less restrictive and that trialling beta blockers meant additional resource was required, and in certain patients’ such as those with AV nodal conduction disease or lung disease, beta blockers were not appropriate.

The criteria consulted on were recommended by PTAC at its August 2016 meeting [PDF, 348 KB]. We consider that the health need of patients who need a CTCA and can tolerate a beta blocker is met with a currently funded medication, metoprolol tartrate. We consider that the wording of the criteria allows patients who cannot tolerate, or should not be trialed on, beta blocker therapy to access ivabradine if the clinician considers it to be appropriate.

Responders were supportive of the proposal.

Some respondents considered that that widening of access to ivabradine for other indications such as inappropriate sinus tachycardia, heart failure and angina would
be useful.

PHARMAC received a funding application of ivabradine for inappropriate sinus tachycardia (IST) in 2012. Clinical advice at the time considered PTAC should assess this application once an ivabradine product is approved for use in New Zealand. PHARMAC considers a Medsafe approved product would be required if long term indications were to be funded. PHARMAC continues to investigate possible suppliers for this product and we would welcome further evidence on the health need and benefit for ivabradine for IST.

We have not received an application for funding of ivabradine for heart failure or angina. Should this product become registered in New Zealand, we would welcome a funding application for these indications.

Sildenafil

Theme	Comment
One responder considered listing sildenafil injection would reduce the quantity of oral sildenafil liquid manufactured and that it would also reduce the use of tadalafil if its restriction was widened to include adults.	PHARMAC considers that it is unlikely listing this treatment would change the manufactured quantity of compounded oral sildenafil liquid; we note the intravenous formulation is restricted to infants and children when the enteral route is not accessible. Tadalafil is not currently listed in the HML. We note that, except where permitted in accordance with HML rules 11-17, DHBs must not give any pharmaceutical that is not listed in the HML to a patient.

Theme

Comment

One responder considered listing sildenafil injection would reduce the quantity of oral
sildenafil liquid manufactured and that it would also reduce the use of tadalafil if its restriction was widened to include adults.

PHARMAC considers that it is unlikely listing this treatment would change the manufactured quantity of compounded oral sildenafil liquid; we note the intravenous formulation is restricted to infants and children when the enteral route is not accessible.

Tadalafil is not currently listed in the HML. We note that, except where permitted in accordance with HML rules 11-17, DHBs must not give any pharmaceutical that is not listed in the HML to a patient.

More information

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.