Decision to change the funded brand of epoetin alfa

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Novartis New Zealand Ltd for the supply of epoetin alfa.

The effect of the decision is that:

  • The funded brand of epoetin alfa will change from Eprex, supplied by Janssen, to Binocrit, supplied by Novartis.
  • Binocrit will be listed from 1 February 2019 and will become the only funded brand of epoetin alfa after a 5-month transition period.
  • Transition timeframes and further information are detailed below.

This decision results from a Request for Proposals (RFP) for the supply of epoetin.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 21 August 2018.

The proposed terms of listing were approved as consulted on without any changes.

We advised during consultation that the price and subsidy of Binocrit would be notified if the proposal was approved; accordingly, this information is included below.

Who we think will be most interested

People currently using epoetin alfa, pharmacists, clinicians involved in the management of chronic renal failure and/or myelodysplasia, DHBs and suppliers of epoetin injections.

Price and subsidy of Binocrit

From 1 February 2019, Novartis’ brand of epoetin alfa (Binocrit) 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

Epoetin alfa

Inj 1,000 iu in 0.5 ml, syringe

Binocrit

6

$250.00

Epoetin alfa

Inj 2,000 iu in 1 ml, syringe

Binocrit

6

$100.00

Epoetin alfa

Inj 3,000 iu in 0.3 ml, syringe

Binocrit

6

$150.00

Epoetin alfa

Inj 4,000 iu in 0.4 ml, syringe

Binocrit

6

$96.50

Epoetin alfa

Inj 5,000 iu in 0.5 ml, syringe

Binocrit

6

$125.00

Epoetin alfa

Inj 6,000 iu in 0.6 ml, syringe

Binocrit

6

$145.00

Epoetin alfa

Inj 8,000 iu in 0.8 ml, syringe

Binocrit

6

$175.00

Epoetin alfa

Inj 10,000 iu in 1 ml, syringe

Binocrit

6

$197.50

Epoetin alfa

Inj 40,000 iu in 1 ml, syringe

Binocrit

1

$250.00

A confidential rebate will apply that will reduce the net price to the Funder.

From 1 July 2019, all other brands of epoetin will be delisted from Section B of the Pharmaceutical Schedule and Binocrit will be the only funded brand of epoetin injections in the community until 30 June 2022.

Binocrit will be the Hospital Supply Status brand of epoetin injections in DHB hospitals from 1 April 2019 to 30 June 2022, with a 1% DV limit.

What will the effect of this decision be?

For patients

From 1 February 2019, eligible people will have funded access to a new brand of epoetin alfa, Binocrit.

  • During a transition period, from 1 February 2019 to 30 June 2019, all current patients receiving funded epoetin will need to switch to Binocrit to continue to receive a funded treatment.
  • Novartis will provide sharps containers and cooler bags for patients.

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

For prescribers

Between 1 February 2019 and 1 July 2019, treating clinicians will need to transition all existing patients receiving funded epoetin alfa to the new brand, Binocrit.

For community pharmacies

From 1 February 2019, community pharmacies dispensing epoetin alfa will need to liaise with treating clinicians and patients to support patients switching to Binocrit and manage stock of both products during the transition.

For hospital pharmacies

From 1 February 2019, Binocrit will be available for use in DHB hospitals for eligible patients.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All consultation responses received were considered in their entirety in making a decision on the proposed changes.

Common issues raised during consultation, and our comments on these, are summarised in the table below.

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.

Theme

PHARMAC Comment

Responders were supportive of the proposal, noting that there does not appear to be any issues regarding efficacy or toxicity.

Responders were also pleased to see that Binocrit syringes would be graduated and that Novartis would provide cooler bags, sharps containers and patient information materials.

Noted.

 

Responders hoped that Binocrit is associated with less pain at the administration site.

There is no published data available with regards to pain at the administration site compared with the Eprex brand. However, we have no reason to believe that there would be a difference in pain at the administration site between the two products.

A responder noted that they were pleased to see that Binocrit includes a needle guard.

We note that the Binocrit product that will be marketed in New Zealand does not have a retractable needle or guard. However, we consider that the product is suitable for use and note that it is similar to other subcutaneous syringes used in the community.

Responders questioned whether the new brand would allow clinicians to adjust doses. For example, if a patient is prescribed 9,000 IU can they use the 10,000 IU syringe and discard the remainder? It was noted that this is not possible with the retractable needles for the currently funded product.

One responder also noted that while the syringes are graduated there are no numbers on the side which could lead to dosing errors if less than a full syringe was required.

Brinocrit will be funded in the same range of strengths as Eprex. We consider that a sufficient range of strengths will be funded to meet clinical needs and there is no restriction on the number of syringes per patient. If a dose is required that is not able to be made up using a single full syringe, it will be a clinical decision to rely on the syringe graduations or to prescribe a combination of strengths.

A responder requested that a brand switch fee be applied to the change of brands from Eprex to Binocrit.

As this market has experienced a brand switch previously, this brand switch does not meet the eligibility criteria (as determined by the DHBs) for a brand switch fee.

Further, we consider that the focus of this brand switch will be in renal centres and that the majority of patients who are self-administering will receive their initial education on the new brand at hospital outpatient clinics. Novartis will also provide education material to healthcare professionals to support patients though the change.