Proposal to Change Brand of Oral Flecainide Acetate

CONSULTATION

Proposal to change the funded brand of oral flecainide acetate 29 January 2019

What we’re proposing We propose the following changes to the funded brands of oral flecainide used in the prevention of supraventricular and ventricular arrhythmias:  the funded brand of flecainide acetate tab 50 mg would change from Tambocor (supplied by Radiant Health) to Flecainide BNM (supplied by Boucher) following a transition period starting on 1 September 2019; and 

the funded brand of flecainide acetate cap long-acting 100 mg and 200 mg would change from Tambocor CR (supplied by Radiant Health) to Flecainide Controlled Release Teva (supplied by Teva) following a transition period starting on 1 July 2019;



from the end of the transition periods, Flecainide BNM and Flecainide Controlled Release Teva would be the only funded brands in both the community and hospital settings.

No changes are proposed for the listing of flecainide inj 10 mg per ml, 15 ml ampoule (Tambocor). PHARMAC is aware of the importance of flecainide injections and would continue to ensure funding to this product is maintained.

Flecainide is used in patients with certain cardiac arrythmias so in addition to general feedback to the proposal, we would like your specific feedback to help us develop any implementation support that may be required.

1. What would help health professionals support patients with a change in brand of medicine?

2. Are there any other types of implementation support that would be useful for patients or health professionals?

Consultation closes at 4 pm on Monday 18 February 2019 and can be emailed to procurement@pharmac.govt.nz.

What would the effect be?

For patients From 1 September 2019, people would have funded access to a new brand of oral flecainide acetate tab 50 mg (Flecainide BNM). From 1 July 2019, people would have funded access to a new brand of oral flecainide acetate cap longacting 100 mg and 200 mg (Flecainide Controlled Release Teva).

During a three-month transition period, from 1 September 2019 to 30 November 2019 (cap long-acting 100 mg and 200 mg) and from 1 November 2019 till 31 January 2020 (tab 50 mg), the subsidy would be reduced for the other currently A1230474

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funded brands of oral flecainide (Tambocor and Tambocor CR, supplied by Radiant Health). If the supplier of these brands did not reduce its price, people using those brands would need to pay a manufacturer’s surcharge for their medicine or change to the fully funded brand (Flecainide BNM or Flecainide Controlled Release Teva).

From 1 December 2019 (cap long-acting 100 mg and 200 mg) and 1 February 2020 (tab 50 mg), the currently funded brands of oral flecainide acetate, Tambocor and Tambocor CR, would be delisted. People using these brands of oral flecainide acetate would need to change brands to keep accessing a funded treatment.

This proposal would not affect the currently listed flecainide acetate inj 10 mg per ml, 15 ml ampoule presentation which will remain listed and fully funded.

PHARMAC acknowledges the importance and value of flecainide injections and PHARMAC has no plans to delist or otherwise limit access to this product.

Prescribers, pharmacists and patients would be supported with information and implementation activities to manage any change.

For community pharmacies Following the listing of each strength of Flecainide BNM and Flecainide Controlled Release Teva on the Pharmaceutical Schedule, pharmacies could continue to dispense and claim for any listed brand of flecainide tab 50 mg and cap long-acting 100 mg and 200 mg for five months. After that, Flecainide BNM and Flecainide Controlled Release Teva would be the only funded brands of the relevant oral flecainide presentations.

A brand switch fee would apply to dispensings of oral flecainide for three months following the commencement of sole supply for each brand.

For hospital pharmacies Following the listing of Flecainide BNM and Flecainide Controlled Release Teva on the Pharmaceutical Schedule, pharmacies could continue to purchase any listed brand of the relevant oral flecainide presentations for two months. After that a discretionary variant (DV) limit of 1% would apply, meaning that only 1% of total purchases of the relevant presentation of oral flecainide could be a brand other than Flecainide BNM and Flecainide Controlled Release Teva.

For prescribers Prescribers would continue to be able to prescribe funded flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg, but the only funded brand from 1 December 2019 and 1 February 2020 would be Flecainide BNM and Flecainide Controlled Release Teva respectively.

For DHBs This proposal would allow the price of oral flecainide to be reduced in the Pharmaceutical Schedule which would allow savings to be achieved. These savings could be reinvested in new pharmaceutical funding to provide improved health outcomes for New Zealanders.

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Who we think will be interested People currently using oral flecainide acetate, pharmacists, clinicians involved in the management and prevention of supraventricular and ventricular arrhythmias, DHBs, wholesalers, and suppliers of oral flecainide acetate.

About flecainide acetate Flecainide is used in patients without structural heart disease and without myocardial infarction for the prevention of supraventricular arrhythmias and ventricular arrhythmias.

Why we’re proposing this PHARMAC released a Request for Tenders (RFT) for the supply of flecainide acetate in New Zealand on 6 August 2018. This was based on advice we received from the Cardiovascular Subcommittee (one of our expert clinical advisory groups). You can read details of the advice we received here.

As a result of the RFT, PHARMAC is proposing to enter into agreements with Teva New Zealand and Boucher & Muir for the supply of flecainide acetate and feedback to this consultation will help us to decide whether to enter into these agreements.

Details about our proposal Listing From 1 July 2019, Teva’s brand of flecainide acetate cap long-acting 100 mg and 200 mg (Flecainide Controlled Release Teva) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows: Chemical

Presentation

Brand

Pack size

Flecainide acetate

Cap long-acting 100 mg

Flecainide Controlled Release Teva

90

Cap long-acting 200 mg

Flecainide Controlled Release Teva

90

Flecainide acetate

From 1 September 2019 Boucher’s brand of flecainide acetate tab 50 mg (Flecainide BNM) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows: Chemical

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Presentation

Brand

Pack size

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Flecainide acetate

Tab 50 mg

Flecainide BNM

60

The price and subsidy would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.

Reference pricing of other listed brands of flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg in the community From 1 September 2019 (cap long-acting 100 mg and 200 mg) and 1 November 2019 (tab 50 mg), the subsidies for other currently listed brands of flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg (Tambocor and Tambocor CR) in the Pharmaceutical Schedule would be reduced, via the application of reference pricing, to the subsidy for the new brands.

If the supplier of Tambocor and Tambocor CR decided not to reduce the price of these brands to match the new proposed subsidy, a manufacturer’s surcharge would apply when these brands are dispensed and patients would be required to make a part payment for their prescription.

Flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg Sole Supply In DHB hospitals From 1 September (cap long-acting 100 mg and 200 mg) and 1 November 2019 (tab 50 mg) until 30 June 2022, Flecainide Controlled Release Teva and Flecainide BNM would be awarded Hospital Supply Status (HSS) for flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg in DHB hospitals.

This would result in these brands being the only available brands of flecainide acetate tab 50 mg and cap long-acting 100 mg and 200 mg in DHB hospitals, subject to a 1% DV limit (i.e. 99% of total volume of these presentations of flecainide purchased by DHB hospitals would be required to be Flecainide Controlled Release Teva and Flecainide BNM).

From 1 September and 1 November 2019, all other brands of flecainide cap longacting 100 mg and 200 mg and tab 50 mg would be delisted from Part II of Section H of the Pharmaceutical Schedule.

In the community From 1 December 2019 (cap long-acting 100 mg and 200 mg) and 1 February 2020 ( tab 50 mg) until 30 June 2022, Flecainide Controlled Release Teva and Flecainide BNM would be awarded Sole Subsidised Supply status for these presentations of flecainide acetate in the community.

From 1 December 2019 (cap long-acting 100 mg and 200 mg) and 1 February 2020 (tab 50 mg), all other brands of these presentations of flecainide acetate would be delisted from Section B of the Pharmaceutical Schedule.

Community pharmacies would be eligible to claim a Brand Switch Fee on the first dispensing of the relevant brand of oral flecainide during the 3-month period from A1230474

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1 December 2019 to 29 February 2020 (cap long-acting 100 mg and 200 mg) and 1 February 2020 to 30 April 2020 (tab 50 mg), (i.e. after the delisting of the other brands of flecainide acetate).

Flecainide Inj 10 mg per ml, 15 ml ampoule No changes are proposed for the listing of flecainide inj 10 mg per ml, 15 ml ampoule (Tambocor). PHARMAC is aware of the importance of flecainide injections and would continue to ensure funding to this product is maintained.

To provide feedback Send us an email: procurement@pharmac.govt.nz, by 5pm on 18 February 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) 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.

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