Decision to amend the contractual arrangements for the supply of rivaroxaban

Medicines

Decision

PHARMAC is pleased to announce a decision to accept an alternative commercial proposal for rivaroxaban.

What we’re doing

PHARMAC is pleased to announce a decision to accept an alternative commercial proposal for rivaroxaban. This will result in a reduction in the net price and extension of the subsidy and delisting protection period for all strengths of the currently listed brand of rivaroxaban (Xarelto) through an agreement with Bayer New Zealand Limited (Bayer).

The reduction in net price will take effect from 1 January 2021 and means that there will be no brand change for people taking rivaroxaban.

What does this mean for people?

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

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

We consider that this decision will provide considerable benefit towards getting the best health outcomes within the funding provided.

Details about the decision

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.

PHARMAC’s agreement with Bayer will result in:

From 1 January 2021:

  • the net price for all currently funded rivaroxaban strengths (tab 10, 15 and 20 mg) will reduce; and
  • Bayer’s brand of rivaroxaban, Xarelto, will have subsidy and delisting protection and remain fully funded until 30 June 2023.

No changes to:

  • the list 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.

PHARMAC’s agreement with Bayer will result in Xarelto remaining fully funded until at least 30 June 2023.

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

Any changes to the original proposal?

This decision was subject to a consultation letter dated 13 November 2020.

There have been no changes as a result of the consultation feedback.

Who we think will be most 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

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback and our responses to the feedback received are set out below.  

Theme

Comment

Supportive of this amendment to the contractual arrangement for rivaroxaban

Noted

Indicated that there remains interest in apixaban and highlighted the importance of patent considerations for these commitments

PHARMAC staff note that apixaban has received a cost-neutral recommendation from PTAC for stroke prevention in atrial fibrillation (here) [PDF, 286 KB] and the positive recommendation for another oral anticoagulant in addition to dabigatran (of which apixaban was one) for the prevention of venous thromboembolic events following major orthopaedic surgery (here). [PDF, 178 KB]

PHARMAC staff recently consulted to decline these funding applications, however in response to the feedback that was received during this consultation, we intend to obtain further advice from the Cardiovascular Subcommittee on the need for apixaban.

PHARMAC staff do consider the patent status of these products prior to progression of any proposal.

Noted that recently there have been supply issues with rivaroxaban with limited allocation and considered that a price change will require pharmacy to keep very low stock at a time when there will be high demand with people going on holiday.

PHARMAC staff note the recent issues with the supply of rivaroxaban and understand that this issue has been resolved. PHARMAC staff also acknowledge the good supply history of Xarelto (10, 15 and 20 mg) prior to this.

PHARMAC staff note that there will be no change to the list price of this medicine and therefore, this should not impact wholesalers or pharmacies.

Supplier interest in the rivaroxaban market

Noted and appreciate the interest in this market. PHARMAC staff note that during the subsidy and delisting protection period, another Medsafe approved rivaroxaban product could be listed alongside Xarelto in the Pharmaceutical Schedule.

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 660 050.