Decision to fund upadacitinib for rheumatoid arthritis to support the management of the tocilizumab stock shortage

Medicines Decision

What we’re doing

We're pleased to announce a decision to fund upadacitinib for people with rheumatoid arthritis who have tried the funded alternatives available. Upadacitinib will be listed, subject to funding criteria, from 1 October 2021. We will continue to fund upadacitinib with the same criteria once tocilizumab supply resumes.

This decision is in response to the supply issue for tocilizumab. This decision will allow us to preserve the remaining tocilizumab stock for priority patients and ensure people have continued access to treatment. You can read about the tocilizumab supply issue on the Pharmac website here [link removed - page archived]. 

Given the urgency to mitigate the shortage of tocilizumab, we did not consult publicly on this decision. We sought clinical advice about potential alternative treatments for people currently receiving tocilizumab. Our clinical advisors indicated a janus kinase (JAK) inhibitor would be a suitable funded alternative. This is a class of medicines which work by modifying the immune system. 

Upadacitinib is one of several JAK inhibitors available worldwide for the treatment of rheumatoid arthritis. It has Medsafe-approval for use in the treatment of adults with moderately to severely active rheumatoid arthritis and was considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in February 2021 for use in rheumatoid arthritis as part of our standard funding application assessment process. 

You can find more information on upadacitinib on the Medsafe datasheet here(external link). 

You can read the relevant record of the clinical advice from PTAC on the Pharmac application tracker(external link). 

What this means for people with rheumatoid arthritis

We understand that supply issues for your medicine can cause concern. We’ve decided to fund upadacitinib to make sure patients can continue to have access to a funded treatment during the tocilizumab disruption. You will receive communication from your prescriber if they want to discuss with you whether you could start on upadacitinib treatment. They know your clinical circumstances best and can discuss suitable treatment options with you. 

Who we think will be most interested

  • People with rheumatoid arthritis and their family, whānau, and caregivers
  • People currently receiving tocilizumab
  • Rheumatologists and healthcare professionals involved in the management of rheumatoid arthritis
  • Consumer support groups for people living with rheumatoid arthritis
  • Hospital and community pharmacists
  • DHBs
  • Wholesalers and suppliers 

Details about this decision

Upadacitinib is an oral treatment. The recommended dose is a single 15 mg tablet taken once a day. We will continue to fund upadacitinib once tocilizumab supply resumes. People who would like to continue using upadacitinib once supply of tocilizumab resumes, will be able to do so.  

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule. 

Upadacitinib tab 15 mg (RINVOQ) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2021 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical

Formulation

Brand
(Supplier)

Pack size

Price and subsidy

Upadacitinib

Tab 15 mg

RINVOQ (AbbVie Limited)

28

$1,271.00

A confidential rebate will apply to RINVOQ that will reduce the net price to the Funder. RINVOQ will have protection from delisting and subsidy reduction until 1 October 2023. 

Upadacitinib will be listed in Section B of the Pharmaceutical Schedule subject to the following funding criteria:

Special Authority for Subsidy

Initial application – (Rheumatoid Arthritis (patients previously treated with adalimumab or etanercept)) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. The patient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
  2. Either:
    1. The patient has experienced intolerable side effects from adalimumab and/or etanercept; or
    2. The patient has received insufficient benefit from at least a three-month trial of adalimumab and/or etanercept such that they do not meet the renewal criteria for rheumatoid arthritis; and
  3. Either:
    1. The patient is seronegative for both anti-cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor; or
    2. Both:
      1. The patient has been started on rituximab for rheumatoid arthritis in a DHB hospital in accordance with the Section H rules; and
      2. Either:
        1. The patient has experienced intolerable side effects from rituximab; or
        2. At four months following the initial course of rituximab the patient has received insufficient benefit such that they do not meet the renewal criteria for rheumatoid arthritis. 

Renewal – (Rheumatoid arthritis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

  1. Following 6 months’ initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
  2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.

Similar criteria will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List). Note that for patients to receive funded upadacitinib treatment a new Special Authority approval is needed. 

AbbVie has indicated it will offer direct supply, for free, for people with rheumatoid arthritis who are receiving tocilizumab and need an alternative treatment between now and 1 October 2021. From 1 October 2021, upadacitinib will be fully funded via the Pharmaceutical Schedule. 

Upadacitinib is supplied in a 28-tablet carton pack. We ask that pharmacies dispense in 28 day lots. 

Information for prescribers

Upadacitinib will be listed in the Pharmaceutical Schedule, subject to funding criteria from 1 October 2021. 

AbbVie has indicated it will offer direct supply, for free, for people with rheumatoid arthritis who are receiving tocilizumab and need an alternative treatment between now and 1 October 2021.

Patients will need to meet the funding criteria and upadacitinib will need to be prescribed. Applications will need to be made by the prescriber, directly to AbbVie and direct supply would be provided to the nominated pharmacy. If you have a patient who is receiving tocilizumab and has no other funded alternatives, you can contact AbbVie at CustomerServiceANZ@abbvie.com. Please copy the nominated pharmacy into the request so it has the correct information to dispense the script. 

In order to preserve the remaining tocilizumab stock for patients at highest risk, we are asking prescribers to transition their patients with rheumatoid arthritis from tocilizumab to upadacitinib and other funded alternatives where appropriate. Clinical advice from PTAC specific to upadacitinib for moderate to severe rheumatoid arthritis is available here [PDF, 553 KB]. We acknowledge the impact this will have on prescribers, particularly rheumatologists. We are grateful for the engagement and support we have had on this issue. 

For patients to receive funded upadacitinib treatment a new Special Authority application will need to be approved. Special Authority approvals for tocilizumab are not transferrable to upadacitinib. Special Authority applications for upadacitinib will be available for processing by the Ministry of Health on 1 October 2021 onwards. 

If your patient is currently receiving tocilizumab, does not have a suitable funded alternative and does not meet the eligibility criteria for upadacitinib, you can apply for a Special Authority waiver. We will be working to process waivers as quickly as possible. 

Read more about our waiver process here

The New Zealand Rheumatology Association (NZRA) has sent out guidance to its members to support the management of rheumatology patients on tocilizumab. Pharmac and the NZRA are working together to continue to support healthcare professionals during this time.

Herpes Zoster vaccine update

Clinical advice received indicated a preference for a funded recombinant Herpes Zoster vaccine for patients starting on a JAK inhibitor. Our clinical advisors have indicated however that this would not be an absolute clinical requirement before starting treatment with a JAK inhibitor. At this stage, Pharmac has not made a decision regarding the funding of a recombinant Herpes Zoster vaccine. We will continue to consider the funding of a recombinant Herpes Zoster vaccine via our standard funding application assessment process. 

Information for pharmacists

Upadacitinib is supplied in a 28-tablet carton pack. We ask that pharmacies dispense in 28 day lots.

AbbVie has indicated it will offer direct supply, for free, for people with rheumatoid arthritis who are receiving tocilizumab and need an alternative treatment between now and 1 October 2021. Patients will still require upadacitinib to be prescribed. You may be copied into a request for direct supply. This stock would be sent directly to the nominated pharmacy for dispensing. 

From 1 October 2021, upadacitinib will be funded via the Pharmaceutical Schedule subject to funding criteria. This will follow the usual prescribing, dispensing, and claiming processes.

Details about the tocilizumab stock shortage

Roche has advised of an out-of-stock for tocilizumab from October 2021. Roche is the global supplier of tocilizumab. 

We continue to explore options to minimise the impact of this stock shortage. 

You can read more information about the supply issue and the other actions we are taking here. [link removed - page archived]

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.