Proposal on access criteria for two COVID-19 treatments

Medicines COVID-19 Consultation Closed

What we’re proposing

We are seeking feedback on the proposed access criteria for: 

  • baricitinib (Oluminant) for the treatment of moderate to severe COVID-19 in hospitalised patients
  • casirivimab/imdevimab (Ronapreve) for the treatment of mild to moderate COVID-19. 

In addition, we are interested in feedback on how distribution of casirivimab/imdevimab could be achieved in an equitable way, should wider community access criteria be proposed in the future (further details below). 

Changes are proposed to be made to the Pharmaceutical Schedule from 1 February 2022. 

Consultation closes at 5 pm on Wednesday 12 January 2022 and feedback can be emailed to consult@pharmac.govt.nz

We acknowledge that it is not ideal to issue a consultation in the last week before the summer holiday period. We consider it is important to seek feedback on this proposal as soon as possible, given the rapidly evolving nature of the COVID-19 pandemic and the need to confirm access to treatments in a timely manner.

What would the effect be?

Baricitinib (Olumiant)

Baricitinib would be listed in Part II of Section H of the Pharmaceutical Schedule for the treatment of moderate to severe COVID-19 in hospitalised patients who meet the following access criteria:

Restricted

Initiation – moderate to severe COVID-19*

Any relevant practitioner

Limited to 14 days treatment

All of the following:

  1. Patient has confirmed (or probable) COVID-19*; and
  2. Oxygen saturation of <92% on room air, or requiring supplemental oxygen; and
  3. Patient has significantly increased laboratory markers of systemic inflammation (eg CRP, procalcitonin or ferritin); and
  4. Patient is receiving adjunct systemic corticosteroids, or systemic corticosteroids are contraindicated; and
  5. Baricitinib is to be administered at doses no greater than 4mg daily for up to 14 days; and
  6. Baricitinib is not to be administered in combination with tocilizumab. 

Note: Indications marked with * are unapproved indications.

Baricitinib tablets are not approved by Medsafe. This means that baricitinib would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981(external link). 

Our COVID-19 Treatments Advisory Group has advised us that baricitinib is an immune modulator that could be used to treat hospitalised patients with COVID-19 if stock of tocilizumab is unavailable. Full details of the advice we have received is available on the Pharmac website [PDF, 291 KB]. Guidance on its clinical use is given in the Ministry of Health’s Guideline for the Clinical Management of COVID-19 in Hospitalised Adults(external link). 

With current increased global use of tocilizumab for the treatment of COVID-19, there is a possibility of future supply constraints affecting New Zealand. Funding baricitinib means we can be prepared for potential disruptions to tocilizumab supply. Funding baricitinib would also, if necessary, allow remaining tocilizumab to be reserved for patients who are unable to use other funded treatments for conditions other than COVID-19. 

Pharmac continues to work closely with the supplier of tocilizumab (brand name Actemra), Roche New Zealand to manage supply. 

Baricitinib would be listed in Section H of the Pharmaceutical Schedule, subject to the restrictions listed above, from 1 February 2022 as follows

Chemical

Formulation

Brand

Pack size

Price

Baricitinib

Tab 2mg

Olumiant

28

$0

Baricitinib

Tab 4mg

Olumiant

28

$0

The price and subsidy would be listed as $0 as stock has been purchased directly by Pharmac. COVID-19 treatments are funded from a dedicated budget allocated by the Government. That means COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). DHBs would need to order stock from Onelink as required but would not be invoiced for supply. 

We have secured an initial supply of 500 courses of baricitinib and this has been distributed to some DHBs around the country. We expect more stock to be available for ordering from Onelink in early January 2022. 

Casirivimab/imdevimab (Ronapreve)

Casirivimab/imdevimab would be listed in Part II of Section H of the of the Pharmaceutical Schedule for the treatment of mild to moderate COVID-19 in patients who meet the following criteria:

Restricted

Initiation – mild to moderate COVID-19-hospitalised patients

Any relevant practitioner

All of the following: 

  1. Patient has confirmed (or probable) COVID-19; and
  2. Patient is an in-patient in hospital with mild to moderate disease severity*; and
  3. Patient’s symptoms started within the last 10 days; and
  4. Patient is not receiving high flow oxygen or assisted/mechanical ventilation; and
  5. Any of the following:
    1. Age > 50; or
    2. BMI >30; or
    3. Patient is Māori or Pacific ethnicity; or
    4. Patient is at increased risk of severe illness from COVID-19, excluding pregnancy, as described on the Ministry of Health website(external link); and
  6.  Either:
    1. Patient is unvaccinated; or
    2. Patient is seronegative
  7. Casirivimab and imdevimab is to be administered at a maximum dose of no greater than 2400 mg

Note:* Mild to moderate disease severity as described on the Ministry of Health Website(external link)

Casirivimab/imdevimab would be listed in Section B and H of the of the Pharmaceutical Schedule for the treatment of mild to moderate COVID-19 in patients who meet the following criteria:

Restricted

Initiation – Treatment of profoundly immunocompromised patients

Any relevant practitioner

All of the following: 

  1. Patient has confirmed (or probable) COVID-19; and
  2. The patient is in the community with mild to moderate disease severity; and
  3. Either:
    1. Patient is profoundly immunocompromised** and is at risk of not having mounted an adequate response to vaccination against COVID-19, or
    2. Patient is profoundly immunocompromised** and is unvaccinated; and
  4. Patient’s symptoms started within the last 10 days; and
  5. Patient is not receiving high flow oxygen or assisted/mechanical ventilation
  6. Casirivimab and imdevimab is to be administered at a maximum dose of no greater than 2400 mg

Note:* Mild to moderate disease severity as described on the Ministry of Health Website(external link)

** Examples include B-cell depletive illnesses or patients receiving treatment that is B-Cell depleting.

Casirivimab and imdevimab would be listed in Section H of the Pharmaceutical Schedule, subject to the restrictions listed above, from 1 February 2022 as follows: 

Chemical

Formulation

Brand

Pack size

Price

Casirivimab with imdevimab

Inj 120 mg per ml casirivimab 20 ml vial and Inj 120 mg per ml imdevimab 20 ml vial

Ronapreve

1

$0

Casirivimab and imdevimab would also be listed in Section B of the Pharmaceutical Schedule, subject to the restrictions listed above, from 1 February 2022. The Xpharm restriction would apply meaning that pharmacies cannot claim subsidy because Pharmac has made alternative distribution arrangements. 

The price and subsidy for casirivimab and imdevimab would be $0 as stock has been purchased directly by Pharmac. These medicines are funded from a dedicated budget allocated by the Government. That means COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). It is anticipated that DHBs would need to order stock from a wholesaler as required but would not be invoiced for supply. 

We have secured supply of a limited volume of casirivimab and imdevimab, which we estimate would be sufficient to treat up to a maximum of 12,800 patients with mild to moderate COVID-19 throughout 2022. We expect 5,300 courses to be available in New Zealand from January 2022, with additional stock to be delivered from April 2022. 

Casirivimab and imdevimab will be supplied as individual 20 ml multidose vials of casirivimab and imdevimab. The recommended dose is 600 mg of casirivimab and 600 mg of imdevimab administered together as soon as possible following a positive viral test for COVID-19. Casirivimab and imdevimab can be administered via IV infusion, or subcutaneous injection. 

Casirivimab and imdevimab has been approved by Medsafe for the treatment of COVID-19. 

Reports show that casirivimab and imdevimab is successful in treating those with the Delta variant of COVID-19. The evidence is less clear and still emerging for Omicron. Pharmac is continuing to work as quickly as possible to assess the latest information as it becomes available and secure access to further treatments.

Why we’re proposing this

Pharmac and the supplier of casirivimab and imdevimab (Roche Products (New Zealand) Limited) have negotiated an agreement for supply of a limited volume of casirivimab and imdevimab for the treatment of COVID-19. The proposed criteria reflect the limited volume that would initially be available. 

Pharmac sought advice from its COVID-19 Therapeutics Advisory Group regarding the proposed access criteria for casirivimab and imdevimab in October 2021. [PDF, 291 KB]

This is an area of rapidly evolving evidence and knowledge. We understand that there may be additional groups in the community that could benefit from treatment with casirivimab and imdevimab who may fall outside the currently proposed criteria. In December 2021 we sought further advice from our COVID-19 Therapeutics Advisory Group regarding additional patient groups who may benefit from treatment with casirivimab and imdevimab in the community including Māori and Pacific peoples.  The proposed criteria will be reassessed once the record of the advice has been finalised. Any proposals for wider access criteria would be subject to more stock being available and a separate consultation process in 2022. 

The exact distribution mechanism that would be used to make casirivimab and imdevimab available to patients in the community has not been confirmed. We are working with the Ministry of Health to identify and consider available options, including the possible use of regional and local coordination hubs that are being established to support New Zealand’s response to COVID-19. We are particularly interested in receiving feedback on how equitable distribution in the community could be achieved.

To provide feedback

Please send us an email: consult@pharmac.govt.nz by 5pm on Wednesday 12 January 2022. 

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. 

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity. 

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