Decision to change brands of oral flecainide

Medicines

Decision

PHARMAC has made a decision to approve agreements with Teva New Zealand Ltd (‘Teva’) and Boucher & Muir New Zealand (‘Boucher’) for the supply of two new brands of oral flecainide.

What we’re doing

PHARMAC has made a decision to approve agreements with Teva New Zealand Ltd (‘Teva’) and Boucher & Muir New Zealand (‘Boucher’) for the supply of two new brands of oral flecainide.

The effect of the decision is that:

  • the funded brand of flecainide acetate tab 50 mg will change from Tambocor (supplied by Radiant Health) to Flecainide BNM (supplied by Boucher) following a five-month transition period starting on 1 September 2019;
  • the funded brand of flecainide acetate cap long-acting 100 mg and 200 mg will change from Tambocor CR (supplied by Radiant Health) to Flecainide Controlled Release Teva (supplied by Teva) following a five-month transition period starting on 1 July 2019; and
  • from the end of the five-month transition periods, Flecainide BNM (from 1 December 2019) and Flecainide Controlled Release Teva (from 1 February 2020) will be the only funded brands of oral flecainide in both the community and hospital settings.

There are no changes to the listing of flecainide injection 10 mg per ml, 15 ml ampoule (Tambocor) as a result of this decision.

This decision results from a Request for Tenders (RFT) for the supply of flecainide.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 29 January 2019.

The only change to the proposal as consulted on is to amend the transition process. For each presentation there will be a five-month transition period, during which both the incumbent brand and the new brand will be fully funded. This change was made following consideration of consultation feedback asking the transition period to be made simpler and more supportive of patients’ needs.

Who we think will be most interested

People currently using oral flecainide acetate, pharmacists, clinicians involved in the management and prevention of cardiac arrhythmias, DHBs, wholesalers, and suppliers of oral flecainide acetate.

Detail about this decision

Long-acting capsules

From 1 July 2019, Teva’s brand of flecainide acetate cap long-acting 100 mg and 200 mg (Flecainide Controlled Release Teva) will 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

Price & Subsidy

Flecainide acetate

Cap long-acting 100 mg

Flecainide Controlled Release Teva

90

$39.51

Flecainide acetate

Cap long-acting 200 mg

Flecainide Controlled Release Teva

90

$61.06

From 1 December 2019, the currently listed brand of long-acting capsules, Tambocor CR, will be delisted both from Section B and from Part II of Section H of the Pharmaceutical Schedule. Tambocor CR will remain fully subsidised at its current price until delisting. After that, Flecainide Controlled Release Teva will be the only funded brand of flecainide long-acting capsules in the community until 30 June 2022. Flecainide Controlled Release Teva will be the Hospital Supply Status brand of flecainide long-acting capsules until 30 June 2022, with a 1% DV limit.
Short-acting tablets

From 1 September 2019, Boucher’s brand of flecainide acetate tab 50 mg (Flecainide BNM) will 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

Price & Subsidy

Flecainide acetate

Tab 50 mg

Flecainide BNM

60

$19.95

From 1 February 2020, the currently listed brand of flecainide tab 50 mg, Tambocor, will be delisted both from Section B and from Part II of Section H of the Pharmaceutical Schedule. Tambocor will remain fully subsidised at its current price until delisting. After that, Flecainide BNM will be the only funded brand of flecainide tab 50 mg tablets in the community until 30 June 2022. Flecainide BNM will be the Hospital Supply Status brand of flecainide tab 50 mg until 30 June 2022, with a 1% DV limit.
Injections

PHARMAC has decided not to award any bids for flecainide injections from the August 2018 Request for Tender. This means that there is no change to the listing of flecainide inj 10 mg per ml, 15 ml ampoule (Tambocor) as a result of this decision.

PHARMAC is aware of the importance of flecainide injections and will continue to ensure that funding of flecainide injections is maintained.

What will the effect of this decision be?

Long-acting capsules

For patients

From 1 July 2019, patients will have funded access to a new brand of oral flecainide acetate, Flecainide Controlled Release Teva.

During a transition period, from 1 July 2019 to 30 November 2019, all current patients receiving funded flecainide acetate long-acting capsules will need to change to Flecainide Controlled Release Teva to continue to receive a funded treatment.

For prescribers

Between 1 July 2019 and 30 November 2019, treating clinicians will need to transition all existing patients receiving funded flecainide acetate long-acting capsules to the new brand, Flecainide Controlled Release Teva.

We were advised by our Cardiovascular Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) that there would be no reason to recommend plasma monitoring if a brand change were to occur but it could be done if there was concern that a patient was not receiving optimal therapy. Plasma monitoring would be at the discretion of the clinician, depending on the patient’s clinical circumstances. Clinicians can apply to PHARMAC to cover the patient’s cost of any additional clinic visits needed for monitoring of plasma flecainide levels, if required.  

For community pharmacies

From 1 July 2019, community pharmacies dispensing flecainide long-acting capsules will need to support patients changing to the new brand and manage stock during the transition.

A Brand Switch Fee will apply from 1 December 2019 to 1 March 2020 for Flecainide Controlled Release Teva. The Brand Switch Fee recognises that community pharmacists may be required to provide more counselling to their patients to assist them with the transition.

For hospital pharmacies

From 1 July 2019, Flecainide Controlled Release Teva will be available for use in DHB hospitals for patients. From 1 December 2019 Flecainide Controlled Release Teva will be the Hospital Supply Status brand of flecainide acetate long-acting capsules subject to a 1% DV limit.

More information and resources will be available on PHARMAC’s website during the transition period for pharmacists, prescribers and clinicians.

Short-acting tablets

For patients

From 1 September 2019, patients will have funded access to a new brand of oral flecainide, Flecainide BNM.

During a transition period, from 1 September 2019 and 31 January 2020, all current patients receiving funded flecainide acetate tab 50 mg with need to change to Flecainide BNM to continue to receive a funded treatment.

For prescribers

Between 1 September 2019 and 31 January 2020, treating clinicians will need to transition all existing patients receiving funded flecainide acetate tab 50 mg to the new brand, Flecainide BNM.

We were advised by our Cardiovascular Subcommittee of PTAC that there would be no reason to recommend plasma monitoring if a brand change were to occur but it could be done if there was concern that a patient was not receiving optimal therapy. Plasma monitoring would be at the discretion of the clinician, depending on the patient’s clinical circumstances. Clinicians can apply to PHARMAC to cover the patient’s cost of any additional clinic visits needed for plasma monitoring, if required.  

For community pharmacies

From 1 September 2019, community pharmacies dispensing flecainide acetate tab 50 mg will need to support patients changing to the new brand and manage stock during the transition.

A Brand Switch Fee will apply from 1 February 2020 to 1 May 2020 for Flecainide BNM. The Brand Switch Fee recognises that community pharmacists may be required to provide more counselling to their patients to assist them with the transition.

For hospital pharmacies

From 1 September 2019, Flecainide BNM will be available for use in DHB hospitals for eligible patients. From 1 February 2020 Flecainide BNM will be the Hospital Supply Status brand of flecainide acetate short-acting tablets subject to a 1% DV limit.

More information and resources will be available during the transition period on PHARMAC's website for pharmacists, prescribers and clinicians. 

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Most consultation feedback was positive, generally supporting the brand change as long as there was proper support for patients and clinicians during the transition, recognising the clinical risks in managing patients who are taking flecainide. The table below summarises the main themes raised in feedback as well as our responses to the feedback received and changes we have made after listening to you. 

Theme

PHARMAC Comment

Differences between the incumbent and proposed brands

The new brand should be bioequivalent to the current product.

To be approved for distribution in New Zealand, a generic medicine must be bioequivalent to the New Zealand innovator medicine, or other appropriate reference medicine. The regulator, Medsafe, has approved both Flecainide BNM (supplied by Boucher) and Flecainide Controlled Release Teva (supplied by Teva) for distribution in New Zealand, using Tambocor and Tambocor CR (respectively) as the reference products.

Flecainide BNM needs to be physically and chemically stable in an extemporaneously compounded formulation. If not, the incumbent brand should be funded.

Flecainide BNM is an immediate release uncoated tablet that contains the same excipients as Tambocor except for the exclusion of hydrogenated vegetable oil.

The NZ standard formula for flecainide suspension does not call for any specific brand, nor does the evidence it is based on.

PHARMAC is working with Boucher and the New Zealand compounding working group to ensure that Flecainide BNM can be compounded.

What are the excipients of Flecainide BNM compared to Tambocor? How guaranteed are these excipients?

 

The excipients of Tambocor and both new brands are detailed in their Medsafe datasheets and on the Medsafe website(external link). Suppliers are required to ensure that the excipients do not deviate from the datasheet.

Risks of a brand change

Flecainide is considered to be a narrow therapeutic index medicine and therefore there is a risk to patient safety of changing these patients to another brand.

We acknowledge there are risks with a brand change, which we have carefully considered. We have received advice from the Cardiovascular Subcommittee of PTAC that a brand change would be appropriate. We will be providing implementation resources to support the brand change.

Flecainide should be supplied by reliable companies, as it treats a life-threatening condition.

PHARMAC takes into account a company’s supply record when deciding whether to list its brand. Where out of stocks would cause greater harm, we place more weight on a supplier’s reliability.

PHARMAC assessed the supply record of all bidders, including Teva and Boucher, and considered this in our decision.

Suppliers also have continuity of supply obligations under the terms of their contracts with PHARMAC. In exchange for market exclusivity, we require suppliers to agree to rigorous conditions to prevent and manage potential out-of-stocks. This includes significant stock-holding, frequent stock reporting to PHARMAC and a commitment to source a suitable alternative to prevent a potential out-of-stock occurring.

The transition period may require extension. It is also complex.

We have amended the transition period from the one proposed in the consultation. There will instead be five months of fully funded dual supply before delisting the Tambocor/Tambocor CR brands. This will be the same in both community and hospital.

Patients should be managed through their transition by their specialist, not their GP.

We consider that in most cases GPs will be able to provide sufficient education and support for patients changing brands. Patient information leaflets will be available for GPs and other healthcare professionals to provide to their patieists as they change their brand of flecainide. GPs can refer their patients to a specialist if they consider this to be appropriate for the particular patient.

Education required to conduct a brand change

Patients would rely on clinicians to provide them with reassurance that the alternative agent has similar pharmacokinetic profile to Tambocor.

The new brands have been assessed by Medsafe as being bioequivalent to Tambocor/Tambocor CR (as revelant). PHARMAC will provide clinicians with information for patients about the active ingredient and appearance of their new brand of flecainide.

All healthcare professionals, including GPs, should receive adequate communication on the brand change.

PHARMAC will provide clinicians with information on PHARMAC's website for their patients, to support the transition. 

Should plasma levels be monitored in all patients before and after the brand change?

Advice from the Cardiovascular Subcommittee of PTAC is that there would be no reason to recommend plasma monitoring if a brand change were to occur but it could be done if there was concern that a patient was not receiving optimal therapy. Plasma monitoring would be at the discretion of the clinician, depending on the patient’s clinical circumstances. Clinicians can apply to PHARMAC to cover the patient’s cost of any additional clinic visits needed for plasma monitoring, if required.  

There would be potential time costs for clinicians and support services to manage this change.

We acknowledge that patients may require a greater level of support and contact with healthcare professionals during this brand change. A Brand Switch Fee will apply, in recognition that community pharmacists may be required to provide more counselling to their patients to assist them with the transition. In addition, as noted above, clinicians can apply to PHARMAC to cover the cost to patients of additional clinic visits if these are required for plasma monitoring.

Injections and other presentations

No objections to changing oral presentations as long as it does not jeopardise supply of flecainide injections.

 

There is no change to the listing of flecainide inj 10 mg per ml, 15 ml ampoule (Tambocor) as a result of this decision.

PHARMAC is aware of the importance of flecainide injections and will continue to ensure that funding of flecainide injections is maintained.

There should be a commercially prepared flecainide suspension (currently flecainide needs to be compounded).

This product would be used by children with paroxysmal supraventricular tachycardia which is a small but unaddressed issue.

This RFT did not seek presentations other than the currently funded ones, although this is something we could consider for future tender processes.

We note that access to oral liquid preparations of flecainide have only ever been available via compounding from a solid oral dose form. PHARMAC staff will work with the New Zealand compounding working group ensure the ongoing availability of an oral liquid preparation.

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.