Proposal to list new cardiovascular medicines for use in DHB hospitals
PHARMAC is seeking feedback on a proposal to list two new cardiovascular medicines, ivabradine tablets and sildenafil injection, on the Hospital Medicines List (HML) for use in DHB hospitals from 1 July 2017.
- Ivabradine tablets would be funded in hospitals for use prior to computed tomography coronary angiography.
- Sildenafil injection would be funded in hospitals for pulmonary hypertension in paediatrics.
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 12 May 2017 to:
Attn: Cardiovascular Hospital Consult
Fax: 04 460 4995
Post: PO Box 10 254, Wellington 6143
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) and we will consider any request to have information withheld in accordance with our obligations under the 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.
Details of the proposals
- Ivabradine 5 mg tablets would be listed in Part II of Section H of the Pharmaceutical Schedule (the HML) from 1 July 2017 with no brand name, pack size or price specified.
- Ivabradine tablets would be listed subject to the following Hospital Restrictions:
- Patient is indicated for computed tomography coronary angiography; and
- Patient has a heart rate of greater than 70 beats per minute while taking a maximally tolerated dose of beta blocker; or
- Patient is unable to tolerate beta blockers.
Ivabradine tablets background
Ivabradine is an oral heart rate lowering agent that selectively inhibits the cardiac pacemaker cells If current at the sinoatrial node. Ivabradine tablets are registered internationally for the treatment of chronic stable angina and chronic heart failure. Ivabradine tablets are not registered for use in New Zealand.
A clinician funding application for ivabradine tablets, for use as a premedication prior to computed tomography coronary angiography (CTCA) in patients who still have a heart rate greater than 65 beats per minute after taking metoprolol or in whom metoprolol is contraindicated, was reviewed by PTAC at its meeting in August 2016. The Committee recommended that ivabradine tablets be funded in hospitals only, for use prior to CTCA in patients who have a heart rate greater than 70 beats per minute while taking a maximally tolerated dose of beta blocker or who are unable to tolerate beta blockers, with a high priority.
We estimate that approximately 400-1,000 people per year would be eligible for treatment under the proposed criteria.
If the proposal is approved, DHB hospitals would be able to purchase any brand of ivabradine 5 mg tablets, in any pack size at the best price they can negotiate. PHARMAC would monitor usage and would be amenable to pursuing a national contract should a registered product become available.
More information, including links to PTAC minutes, can be found in the Application Tracker record for ivabradine tablets at: https://connect.pharmac.govt.nz/apptracker/s/global-search/ivabradine(external link)
- Sildenafil inj 0.8 mg per ml, 12.5 ml vial would be listed in Part II of Section H of the Pharmaceutical Schedule (the HML) from 1 July 2017 with no brand name, pack size or price specified.
- Sildenafil injection would be listed subject to the following Hospital Restrictions:
- 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:
- For perioperative use following cardiac surgery; or
- For use in persistent pulmonary hypertension of the newborn (PPHN); or
- For use in congenital diaphragmatic hernia.
Sildenafil injection background
Sildenafil is a phosphodiesterase type 5 inhibitor. Sildenafil is registered for use in New Zealand for the treatment of erectile dysfunction in adults. Sildenafil injection is not registered for use in New Zealand.
Sildenafil tablets are currently funded for community and hospital use for Raynaud’s phenomenon and pulmonary arterial hypertension. The tablets are also funded in hospitals for persistent pulmonary hypertension of the newborn, for use in weaning patients from inhaled nitric oxide, for perioperative use in cardiac surgery patients, for use in intensive care as an alternative to nitric oxide and for in-hospital stabilisation in emergency situations.
A funding application for intravenous sildenafil for the treatment of pulmonary hypertension in paediatric patients who are pre or post cardiac surgery, and the treatment of paediatric patients with pulmonary hypertension from other causes (e.g. congenital diaphragmatic hernia, persistent pulmonary hypertension of the newborn), was reviewed by the Cardiovascular Subcommittee of our Pharmacology and Therapeutics Advisory Committee (PTAC) at its meeting in February 2016. The Subcommittee recommended that intravenous sildenafil be funded in these indications with a high priority, recommending their use be restricted to paediatric intensive care units and neonatal intensive care units. This recommendation was endorsed by PTAC at its August 2016 meeting.
We estimate that approximately 50 infants and children per year would be eligible for treatment under the proposed criteria.
If the proposal is approved, DHB hospitals would be able to purchase any brand of sildenafil inj 0.8 mg per ml, 12.5 ml vial, in any pack size at the best price they can negotiate. PHARMAC would monitor usage and would be amenable to pursuing a national contract should a registered product become available.
More information, including links to Subcommittee minutes, can be found in the Application Tracker record for intravenous sildenafil at: https://connect.pharmac.govt.nz/apptracker/s/global-search/intravenous%20sildenafil(external link)