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Proposal for changes to funded haemophilia treatments

By   /  January 29, 2019  /  Comments Off on Proposal for changes to funded haemophilia treatments

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Source: Pharmac

We are proposing to make changes to the funding of haemophilia treatments from 1 May 2019, including funding of new extended half-life treatments. These changes would mean that most people with haemophilia would need to change brands, but there would be an increase in the range of funded treatment options available with extended-half-life treatments becoming funded for the first time.

If the proposal is approved, the following changes would occur:

Haemophilia A

  • The preferred funded brand of short-half-life recombinant Factor VIII would change from Xyntha to Advate, following a six-month transition period starting on 1 May 2019.
  • A new, extended-half-life, recombinant Factor VIII treatment (Adynovate) would be funded from 1 May 2019 for any patients requiring prophylaxis.
  • Xyntha would remain available for patients not able to be effectively or safely treated with Advate or Adynovate.
  • Kogenate FS would remain available for patients who currently have an approval for Kogenate FS.
  • FIEBA NF and NovoSeven RT would continue to be funded for patients with inhibitors to Factor VIII requiring bypassing agents, although FIEBA NF would be the preferred funded brand for longer-term use.

Haemophilia B

  • The funded brand of short-half-life recombinant Factor IX would change from BeneFIX to RIXUBIS, following a six-month transition period starting on 1 May 2019.
  • A new, extended-half-life recombinant Factor IX treatment (Alprolix) would be funded from 1 May 2019 for any patients requiring prophylaxis.

The arrangements outlined above would apply until at least 30 June 2022.

In addition, PHARMAC’s Haemophilia Treatments Panel would be disestablished and its function of determining named patient eligibility for funded access to the rare clinical circumstances brands (applying PHARMAC specified criteria) would shift to the Haemophilia Treaters Group.

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 4pm on 18 February 2019 to:

Andrew Park, Senior Therapeutic Group Manager, PHARMAC.  

Email: andrew.park@pharmac.govt.nz.

Details about our proposal

New listings

Extended half-life rFVIII

Rurioctocog alfa pegol [recombinant factor VIII] (Adynovate) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2019 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price

Rurioctocog alfa pegol

Inj 250 iu vial

Adynovate

1

$300.00

Rurioctocog alfa pegol

Inj 500 iu vial

Adynovate

1

$600.00

Rurioctocog alfa pegol

Inj 1,000 iu vial

Adynovate

1

$1,200.00

Rurioctocog alfa pegol

Inj 2,000 iu vial

Adynovate

1

$2,400.00

  • A confidential rebate would apply to Adynovate that would reduce its net price to the funder.

  • Adynovate would be listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of NHMG claiming only) subject to the ‘Xpharm’ rule and the following eligibility criteria until at least 30 June 2022:

For patients with haemophilia A receiving prophylaxis treatment. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

A funding application for Adynovate was reviewed by our Haematology Subcommittee in October 2017. The Subcommittee recommended that Adynovate be considered as clinically equivalent to rFVIIIFc (which had previously been assessed by PTAC) and that an extended half-life rFVIII be funded for haemophilia A, with a low priority. Detailed information about Adynovate dosing and administration can be found in the Medsafe datasheet(external link).


Extended half-life rFIX

Efmoroctocog [recombinant factor IX] (Alprolix) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2019 at the following prices (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Proposed price
efmoroctocog Inj 250 iu vial Alprolix 1 $612.50
efmoroctocog Inj 500 iu vial Alprolix 1 $1,225.00
efmoroctocog Inj 1,000 iu vial Alprolix 1 $2,450.00
efmoroctocog Inj 2,000 iu vial Alprolix 1 $4,900.00
efmoroctocog Inj ,3000 iu vial Alprolix 1 $7,350.00
  • A confidential rebate would apply to Alprolix that would reduce its net price to the Funder.

  • Alprolix would be listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of NHMG claiming only) subject to the ‘Xpharm’ rule and the following eligibility criteria until at least 30 June 2022:

For patients with haemophilia B receiving prophylaxis treatment. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

A funding application for Alprolix was reviewed by our Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2016. The Committee recommended that Alprolix be funded only if cost-neutral to the currently listed brands of short-acting rFIX. The Haematology Subcommittee in October 2017 recommended that an extended half-life rFIX be funded for haemophilia B, with a medium-high priority.

Detailed information about Alprolix dosing and administration can be found in the Medsafe datasheet(external link).


Amended listings

Short half-life rFVIII

The listing subsidy and price of octocog alfa [recombinant factor VIII] (Advate) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2019 to reflect the following new prices (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Current price

Proposed price

octocog alfa

Inj 250 iu vial

Advate

1

$287.50

$210.50

octocog alfa

Inj 500 iu vial

Advate

1

$575.00

$420.00

octocog alfa

Inj 1,000 iu vial

Advate

1

$1,150.00

$840.00

octocog alfa

Inj 1,500 iu vial

Advate

1

$1,725.00

$1,260.00

octocog alfa

Inj 2,000 iu vial

Advate

1

$2,300.00

$1,680.00

octocog alfa

Inj 3,000 iu vial

Advate

1

$3,450.00

$2,520.00

  • A confidential rebate would apply to Advate that would reduce its net price to the Funder.

  • Advate would be listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of claiming) subject to the following eligibility criteria:

from 1 May 2019 until 31 October 2019:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

from 1 November 2019 until 30 June 2022:

For patients with haemophilia. Preferred Brand of short half-life recombinant factor VIII. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

The listing subsidy and price of moroctocog alfa [recombinant factor VIII] (Xyntha) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2019 to reflect the following new prices (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Current price* Proposed price
moroctocog alfa Inj 250 iu vial Xyntha 1 $210.00 $287.50
moroctocog alfa Inj 500 iu vial Xyntha 1 $420.00 $575.00
moroctocog alfa Inj 1,000 iu vial Xyntha 1 $840.00 $1,150.00
moroctocog alfa Inj 2,000 iu vial Xyntha 1 $1,680.00 $2,300.00
moroctocog alfa Inj 3,000 iu vial Xyntha 1 $2,520.00 $3,450.00
* Subject to a confidential rebate

Xyntha and Kogenate FS would be listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of claiming) subject to the following eligibility criteria:

from 1 May 2019 until 31 October 2019:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

from 1 November 2019 until 30 June 2022:

For patients with haemophilia. Rare Clinical Circumstances Brand of short half-life recombinant factor VIII. Access to funded treatment is by named patient application to the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group, subject to criteria.


Short half-life rFIX

The listing subsidy and price of nonacog gamma [recombinant factor IX] (RIXUBIS) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2019 to reflect the following new prices (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Current price* Proposed price
nonacog gamma Inj 500 iu vial RIXUBIS 1 $575.00 $435.00
nonacog gamma Inj 1,000 iu vial RIXUBIS 1 $1,150.00 $870.00
nonacog gamma Inj 2,000 iu vial RIXUBIS 1 $2,300.00 $1,740.00
nonacog gamma Inj 3,000 iu vial RIXUBIS 1 $3,450.00 $2,610.00
* Subject to a confidential rebate
  • A confidential rebate would apply to RIXUBIS that would reduce its net price to the Funder.

  • The 250 iu strength would be delisted from 1 May 2019 due to low use.

  • RIXUBIS would be listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of claiming) subject to the following eligibility criteria:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

All strengths of nonacog alfa [recombinant factor IX] (BeneFIX) would be delisted from the Pharmaceutical Schedule on 1 November 2019.


Bypassing agents

The listing subsidy and price of factor eight inhibitor bypassing fraction (FEIBA NF) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2019 to reflect the following new prices (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Current price Proposed price
Factor eight inhibitor bypassing fraction Inj 500 U vial FEIBA NF 1 $1,450.00 $1,315.50
Factor eight inhibitor bypassing fraction Inj 1,000 U vial FEIBA NF 1 $2,900.00 $2,630.00
Factor eight inhibitor bypassing fraction Inj 2,500 U vial FEIBA NF 1 $7,250.00 $6,575.00
  • A confidential rebate would apply to FEIBA NF that would reduce its net price to the Funder.

  • FEIBA NF would remain listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of claiming) subject to the following eligibility criteria:

from 1 May 2019 until 31 October 2019:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

from 1 November 2019 until 30 June 2022:

For patients with haemophilia. Preferred Brand of bypassing agent for >14 days predicted use. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

NovoSeven RT would remain listed in Part II of Section H of the Pharmaceutical Schedule and Section B (for the purposes of claiming) subject to the following eligibility criteria:

from 1 May 2019 until 31 October 2019:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.

from 1 November 2019 until 30 June 2022:

For patients with haemophilia. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group. Rare Clinical Circumstances Brand of bypassing agent for >14 days predicted use. Access to funded treatment for >14 days predicted use is by named patient application to the Haemophilia Treaters Group, subject to access criteria. 

To provide feedback

Send us an email to andrew.park@pharmac.govt.nz by 4pm on Monday, 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.

Last updated: 29 January 2019

MIL OSI

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