Decision on access criteria for two COVID-19 treatments

Medicines COVID-19 Decision

What we’re doing

We're pleased to announce that casirivimab with imdevimab (brand name Ronapreve) and baricitinib (brand name Olumiant) will be listed on the on the Pharmaceutical Schedule from 1 February 2022 subject to access criteria. 

The mechanism that will be used to distribute COVID-19 treatments in the community hasn’t been finalised yet. The Ministry of Health is leading the plans for regional and local distribution of COVID-19 treatments in the community, and we are supporting them with that. We have structured the access criteria to allow for access in the community once systems are in place to support this. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 22 December 2021. This consultation included detail of the proposed access criteria for baricitinib and casirivimab with imdevimab and requested feedback on how distribution of casirivimab with imdevimab could be achieved in an equitable way, in the community. 

Consultation closed on 12 January 2022. We would like to take this opportunity to express our appreciation and thanks to the individuals, healthcare professionals, professional societies and wholesalers who took the time to provide us with their feedback. 

After reviewing and carefully considering the consultation feedback we have made some changes to access criteria for baricitinib and casirivimab with imdevimab. A summary of the changes made are detailed below:

Baricitinib 

  • We removed the requirement for patients to have significantly increased laboratory markers of systemic inflammation for access to baricitinib. The same changes will also be made to the access criteria for tocilizumab to ensure the access criteria for tocilizumab and baricitinib are aligned, since it is intended that baricitinib would be used if tocilizumab is not available.

Casirivimab with imdevimab 

  • The access requirements for immunocompromised patients in the community and hospital settings have been clarified
  • We amended the requirement for patients hospitalised with COVID-19 to be seronegative to access treatment with casirivimab with imdevimab.

Who we think will be most interested

  • People who have, or are at risk of developing, COVID-19 and their whānau
  • Healthcare professionals involved in the treatment of people with COVID-19
  • DHBs and other organisations involved in providing COVID-19 testing services
  • Organisations involved in developing the clinical guidelines for the treatment of COVID-19
  • The Ministry of Health and other organisations involved in the roll out of COVID-19 treatments in New Zealand.

Detail about this decision

Baricitinib (Olumiant) 

The Olumiant brand of baricitinib will be listed in Part II of Section H of the Pharmaceutical Schedule from 1 February 2022 for the treatment of moderate to severe COVID-19 in hospitalised patients as follows: 

Chemical Formulation Brand Pack size Price
Baricitinib Tab 2mg Olumiant 28 $0
Baricitinib Tab 4mg Olumiant 28 $0

The price and subsidy will be listed as $0 because stock has been purchased directly by Pharmac. COVID-19 treatments are funded from a dedicated budget allocated by the Government, which means that COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). 

We have secured an initial supply of enough baricitinib to treat 500 people, and this has been distributed to some DHBs around the country. In addition, Pharmac will be able to order additional stock from Onelink as required. DHBs will not be invoiced for supply because this stock has been purchased directly by Pharmac. 

Baricitinib will be listed in Part II Section H of the Pharmaceutical Schedule from 1 February 2022 subject to the following access criteria (differences from criteria consulted on shown by additions in bold and deletions in strikethrough):

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.

Tocilizumab (Actemra): 

To align the access criteria for tocilizumab and baricitinib for the treatment of moderate to severe COVID-19, the following changes will be made to the access criteria for tocilizumab in Part II Section H and Section B of the Pharmaceutical Schedule from 1 February 2022 (deletions in strikethrough, additions in bold):

Restricted

Indication – moderate to severe COVID-19*

Therapy limited to 1 dose

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, PCT or ferritin); and
  4. Patient is receiving adjunct systemic corticosteroids, or systemic corticosteroids are contraindicated; and
  5. Tocilizumab is to be administered at doses no greater than 8mg/kg IV for a maximum of one dose.
  6. Tocilizumab is not to be administered in combination with baricitinib.

Casirivimab with imdevimab (Ronapreve): 

Casirivimab with imdevimab (brand name Ronapreve) will be listed in Part II of Section H  and Section B of the Pharmaceutical Schedule from 1 February 2022 as follows: 

Chemical Formulation Brand Pack size Price
Casirivimab and imdevimab Inj 120 mg per ml casirivimab, 11.1 ml vial (1) and
inj 120 mg per ml imdevimab, 11.1 ml vial (1)		 Ronapreve 1 $0

The price and subsidy will 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). 

Casirivimab with imdevimab will be listed in Part II Section H of the Pharmaceutical Schedule from 1 February 2022 subject to the following access criteria (differences from criteria consulted on shown by additions in bold and deletions in strikethrough):

Restricted

Initiation – Treatment of profoundly immunocompromised patients

Any relevant practitioner

Limited to 2 weeks

All of the following: 

  1. Patient has confirmed (or probable) COVID-19; and
  2. The patient is in the community (treated as an outpatient) 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 is profoundly immunocompromised** and is at risk of not having mounted an adequate response to vaccination against COVID-19 or is unvaccinated; and
  5. Patient’s symptoms started within the last 10 days; and
  6. Patient is not receiving high flow oxygen or assisted/mechanical ventilation; and
  7. Casirivimab and imdevimab is to be administered at a maximum dose of no greater than 2,400 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

Restricted

Initiation – mild to moderate COVID-19-hospitalised patients

Any relevant practitioner

Limited to 2 weeks

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 (see Notes); and
  6. Either:
    1. Patient is unvaccinated; or
    2. Patient is seronegative where serology testing is readily available or strongly suspected to be seronegative where serology testing is not readily available; and
  7. Casirivimab and imdevimab is to be administered at a maximum dose of no greater than 2,400 mg.

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

** (https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-information-specific-audiences/covid-19-advice-higher-risk-people(external link))

Casirivimab with imdevimab will also be funded for the treatment of profoundly immunocompromised people in the community:

Casirivimab with imdevimab will be listed in Section B of the Pharmaceutical Schedule from 1 February 2022 subject to the following access criteria (differences from criteria consulted on shown by additions in bold and deletions in strikethrough):

Restricted

Initiation – Treatment of profoundly immunocompromised patients

Any relevant practitioner

Initial application – (Treatment of profoundly immunocompromised patients) from any relevant practitioner. Approvals valid for 2 weeks for applications meeting the following criteria:

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 is profoundly immunocompromised** and is at risk of not having mounted an adequate response to vaccination against COVID-19 or is unvaccinated; and
  5. Patient’s symptoms started within the last 10 days; and
  6. Patient is not receiving high flow oxygen or assisted/mechanical ventilation
  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)

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

The Xpharm restriction will apply to the listing of casirivimab and imdevimab in Section B of the Pharmaceutical Schedule, meaning that pharmacies cannot claim subsidy because Pharmac has made alternative distribution arrangements.

About casirivimab with imdevimab

Casirivimab with imdevimab will be supplied as co-packaged 20 ml multidose vials containing 11.1 ml of casirivimab or 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 with imdevimab can be administered via IV infusion, or subcutaneous injection.

We have secured supply of a limited volume of casirivimab with imdevimab, which we estimate would be sufficient to treat a maximum of 12,800 people throughout 2022. 5,300 courses are currently available in New Zealand, with the rest of the stock to be delivered from April 2022.

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

Reports show that casirivimab with imdevimab is successful in treating people with the Delta variant of COVID-19. The evidence is less clear and still emerging for Omicron; however, based on available evidence it appears that casirivimab with imdevimab has reduced effectiveness against the Omicron variant of COVID-19.

Distribution considerations for DHB hospitals

Stock of casirivimab with imdevimab may be directly ordered from HealthCare Logistics by DHB hospitals as required. It is Pharmac’s preference that stock of casirivimab with imdevimab would be reserved for the DHB hospitals with the greatest need. We will be working with HCL to manage this.

Distribution considerations in the community

The distribution mechanism for COVID-19 treatments in the community hasn’t been finalised. We are supporting the Ministry of Health on their plans for regional and local distribution to make casirivimab with imdevimab available in the community where appropriate.

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, our responses to the feedback received, and changes we have made after listening to you are shown below.

Theme Pharmac Comment

Omicron variant of COVID-19
Emerging evidence suggests that casirivimab with imdevimab does not appear to be an effective treatment against the Omicron variant of COVID-19. We are aware of emerging evidence, which indicates that casirivimab with imdevimab does not appear to be effective against the Omicron variant of COVID-19. We understand that the Delta variant of COVID-19, which casirivimab with imdevimab is effective against remains in circulation in New Zealand. We are closely monitoring the ongoing outbreak of Omicron in New Zealand and will respond as needed to ensure casirivimab with imdevimab can be used effectively in the treatment COVID-19.

Seronegative status
The access criteria requiring patients to be seronegative to access casirivimab with imdevimab in DHB Hospitals should be removed We have amended the criteria for serology testing where this might not be available.  
Clarification regarding timing of serology testing and the definition of ‘seronegative’ It is anticipated that, where possible, a patient’s serostatus would be tested at the at the time they are hospitalised with COVID-19.   Anti-S(pike) antibodies were used to define seronegativity in the studies for casirivimab with imdevimab. We will work with the relevant teams at the Ministry of Health to ensure detail is provided in practice guidelines.

Access Criteria  
The proposed criteria for baricitinib are appropriate and should be aligned with the criteria for tocilizumab. We have ensured the criteria for tocilizumab and baracitinib are aligned.
Information such as contraindications and age restrictions should be included in the access criteria for baricitinib and casirivimab with imdevimab. The access criteria for baricitinib and casirivimab with imdevimab are intended to target treatment to those people who would benefit the most and have the highest health need. The access criteria are not designed to provide a clinical guideline. We understand that the Ministry of Health is producing guidance for clinicians regarding treatments for COVID-19.
A definitive list of relevant conditions for a person to be identified as immunocompromised for access to casirivimab with imdevimab would be helpful. We have not proposed a list of conditions for a person to be identified as immunocompromised for access to casirivimab with imdevimab; however, based on clinical advice we have received the access criteria notes that profoundly immunocompromised patients could include those with B-cell depletive illnesses or patients receiving treatment that is B-Cell depleting. We understand that the Ministry of Health has recently published eligibility criteria for access to a third primary dose of the Pfizer COVID-19 vaccine, which includes severely immunocompromised people. This document may provide useful guidance for identifying profoundly immunocompromised people for access to casirivimab with imdevimab.
The criteria for significantly increased laboratory markers of systemic inflammation should be removed for access to baricitinib.   The criteria for significantly increased laboratory markers of systemic inflammation from the access criteria for baricitinib and tocilizumab has been removed
Access to funded baricitinib and casirivimab with imdevimab should be restricted to only those people who have been vaccinated against COVID-19 or targeted to groups such as frontline workers.  

The proposed access criteria for baricitinib and casirivimab with imdevimab have been developed to target the limited volume of COVID-19 treatments to those patients most likely to benefit from treatment, and those with the greatest health need. Our expert clinical advisors [PDF, 291 KB] have recommended that profoundly immunocompromised people and people hospitalised with mild to moderate COVID-19, at risk of progressing to severe disease should be eligible to access these treatments. These groups could include people who have been vaccinated and unvaccinated people.
Requests for access criteria for casirivimab with imdevimab to be widened for additional patient groups.    We intend to seek further clinical advice from the COVID-19 Treatments Advisory Group on additional patient groups in 2022. 
Baricitinib should be able to be used alongside tocilizumab for some patients to preserve remaining stock Based on the clinical evidence currently available, we have been advised that tocilizumab is the preferred treatment for patients hospitalised with severe COVID-19. We are continuing to work with the supplier of tocilizumab to manage ongoing supply.
Access to treatment with casirivimab with imdevimab should not be delayed due to Special Authority processes. The proposed XPharm listing enables flexibility to determine the most appropriate mechanism for distribution. Special Authority approvals are regularly used to provide funded access to treatments required urgently in the community and there are mechanisms in place to ensure this can happen in a timely manner. As stock of casirivimab with imdevimab has already been purchased by Pharmac, an Application for Subsidy by Special Authority form would not need to be completed for the purposes of claiming. We would likely require a Special Authority approval to be completed for community access to effectively monitor usage.

Equity of access to treatments 
Support for the inclusion of pro equity criteria for Māori to access casirivimab with imdevimab, noting that Māori and Pacific Peoples are at higher risk of severe disease at a younger age than other ethnic groups in New Zealand. We are pleased that inclusion of criteria to prioritise access for Māori and Pacific people with COVID-19 to casirivimab with imdevimab is supported
Discrepancies in the proposed access criteria for casirivimab with imdevimab in hospital compared to community settings could lead to inequitable access for those with the least access to the health system (Māori, other ethnic minorities and rural people).   It is our intention that all DHB hospitals in New Zealand including Level 1 Hospitals (rural clinics/health centres) would be able to access casirivimab with imdevimab for the treatment of COVID-19. We are working with the Ministry of Health and the supplier (Roche) to successfully implement this treatment. We understand that there may be additional patient groups that may benefit from treatment with casirivimab with imdevimab, who are not covered by the proposed criteria, including Māori people and other groups in the community at risk of severe COVID-19. We sought advice on these groups from our COVID-19 Treatments Advisory Group in December 2021. Records of this meeting have not yet been published. We expect to consult on a proposal to widen access to casirivimab with imdevimab in the near future.

Community distribution
There will be substantial challenges to overcome to administer casirivimab with imdevimab at scale within community settings. It will be important to determine the best model of efficient and equitable administration systems without compromising existing and essential activities that will be undertaken in primary care during COVID-19 outbreaks. The distribution mechanism for COVID-19 treatments in the community hasn’t been finalised. The Ministry of Health is leading the plans for regional and local distribution of COVID-19 treatments in the community, and we are supporting them with that. We’ll be making sure the access criteria for funded COVID-19 treatments reflect how the Ministry is expecting distribution in the community to work.

Other requests
Multiple pharmaceutical wholesalers should be engaged to store and distribute baricitinib to DHB Hospitals, and the usual wholesale channel should be used to distribute casirivimab with imdevimab     Due to a number of constraints, we have engaged Onelink to manage the storage and distribution of the small volume of baricitinib we have secured. Ongoing storage and distribution arrangements for casirivimab with imdevimab are still being worked through.

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.