Proposal to amend the contractual arrangements for the supply of rivaroxaban

What we’re proposing

PHARMAC is seeking feedback on a proposal to reduce the net price and extend the ‘subsidy and delisting protection period’ for all strengths of the currently listed brand of rivaroxaban (Xarelto) through a provisional agreement with Bayer New Zealand Limited (Bayer).

The reduction in net price would take effect from 1 January 2021 and this proposal would mean there would be no brand change for people taking rivaroxaban.

Consultation closes at 4 pm on Friday 27 November 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 January 2021:

• The net price would reduce for all currently funded rivaroxaban strengths; and
• Bayer’s brand of rivaroxaban, Xarelto, would have subsidy and delisting protection until 30 June 2023.

There would be no changes to:

• the price of, and subsidy for, Xarelto listed in the Pharmaceutical Schedule;
• the funded strengths, presentations, or brand of rivaroxaban; or
• the funding restrictions that apply to rivaroxaban.

Patients currently using Xarelto would not need to change brands and, with less money spent on rivaroxaban, PHARMAC would have more capacity to invest in other medicines.

Extension of the subsidy and delisting protection period for rivaroxaban (Xarelto) would not prevent the listing of another brand of rivaroxaban between 1 January 2021 and 30 June 2023.

Who we think will be interested

• People who need anticoagulation treatment with rivaroxaban and their family, whānau or caregivers
• Cardiologists, haematologists, surgeons, specialist nurses, general practitioners, and any other clinicians prescribing or involved in the care of patients taking anticoagulants
• Hospital and community pharmacists, DHBs, suppliers and wholesalers
• Suppliers of rivaroxaban or other anticoagulation therapy

About rivaroxaban

Rivaroxaban is an oral anticoagulant (direct factor Xa inhibitor) approved by Medsafe for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and the treatment and prevention of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

Three strengths of rivaroxaban are currently funded (10, 15 and 20 mg) for clinicians to prescribe for patients whom they consider it clinically appropriate to receive treatment.

Details and why we’re proposing this

In response to PHARMAC’s consultation on the draft 2020/21 Invitation to Tender (ITT) product list, Bayer submitted an alternative commercial proposal (ACP) involving its brand of rivaroxaban (Xarelto) which is the only currently listed brand of rivaroxaban on the Pharmaceutical Schedule.

The ACP formed the basis of PHARMAC’s provisional agreement with Bayer and, if approved, would result in Xarelto remaining fully funded subject to the provisional agreement’s terms, until at least 30 June 2023. We consider this proposal offers considerable benefit towards getting the best health outcomes within the funding provided.

This proposal would not prevent the listing of another brand of rivaroxaban during the subsidy and delisting protection period.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4 pm on Friday 27 November 2020.

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.