Proposal to widen access to valganciclovir for transplant patients

Medicines Consultation Closed

We are seeking feedback on a proposal to widen access to valganciclovir.

What we’re proposing

We are seeking feedback on a proposal to widen access to valganciclovir for use after lung transplant and for patients who require further cytomegalovirus (CMV) prophylaxis following pulse methylprednisolone treatment following transplant.

Consultation closes at 5 pm Wednesday 25 November 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that funded access to valganciclovir would be widened for:

  • An additional six months of initial CMV prophylaxis for lung transplant patients with a high risk of CMV disease (12 months total from time of transplant)
  • All transplant patients receiving pulse methylprednisolone for acute rejection after the initial course of CMV prophylaxis that require a further 90 days of valganciclovir for CMV prophylaxis.

We estimate that around 65 patients would benefit from this proposal in the first year, increasing to 80 in five years.

Who we think will be interested

  • Patients undergoing lung transplant and their whānau
  • Patients receiving pulse methylprednisolone after a transplant and their whānau
  • Clinical staff working in transplant services
  • Community and hospital pharmacies
  • DHBs
  • Pharmaceutical suppliers and wholesalers

About valganciclovir and its use following transplant

Valganciclovir is used to prevent and treat CMV infections in immune compromised patients. Valganciclovir is currently funded for a range of situations requiring CMV prophylaxis, including three months prophylaxis post-transplant for any solid organ transplant, six months prophylaxis post-lung transplant, and an additional three months prophylaxis for patients receiving anti-thymocyte globulin who received valganciclovir more than two years prior. Valganciclovir is also funded for the treatment of CMV disease in immunocompromised patients.

Lung transplantation carries a high risk of CMV infection which can result in severe health outcomes. While most CMV disease occurs one to four months following a transplant, it may be recognised later – once prophylactic valganciclovir treatment has been stopped. Therefore, it is proposed that these patients receive valganciclovir for CMV prophylaxis for a longer period of time.

Why we’re proposing this

The Transplant Immunosuppressant Subcommittee considered the widening of access of valganciclovir in October 2017. The Transplant Immunosuppressant Subcommittee recommended that funding for valganciclovir be widened to include CMV prophylaxis for all transplant patients receiving pulse methylprednisolone for acute rejection after the initial course of CMV prophylaxis (which would be variable depending on the organ) that require a further 90 days of valganciclovir for CMV prophylaxis with a high priority. The Subcommittee also recommended with high priority that funding of valganciclovir be widened to include an additional six months of initial CMV prophylaxis for lung transplant patients (12 months total from time of transplant) if the QuantiFERON CMV-approach is used to determine prophylaxis requirement.

Prior to this in 2015, the Anti-Infective Subcommittee assessed the widening of access to valganciclovir, it considered that although some guidelines supported consideration of valganciclovir in lung transplant recipients who require prophylaxis to prevent CMV reactivation during steroid pulse therapy, there was no data to support valganciclovir prophylaxis in this setting, and therefore the Anti-Infective Subcommittee recommended that the application be declined. Following this recommendation, the Pharmacology and Therapeutics Advisory Committee (PTAC) deferred making a recommendation and requested that the Transplant Immunosuppressant Subcommittee review additional evidence.

PTAC, having considered both meeting records of the Transplant Immunosuppressant and Anti-infective Subcommittees, then recommended that access be widened to valganciclovir with a high priority.

More information, including links to the Subcommittee records, can be found in the Application Tracker record for Valganciclovir – extended use after lung transplant and methylprednisolone(external link).

We understand that QuantiFERON CMV testing is not currently available consistently in New Zealand and therefore to avoid any inequities in access to valganciclovir, we have not included the requirement for QuantiFERON CMV testing to be used to determine prophylaxis requirement for patients to access treatment – instead we have proposed criteria that the patient must have a high risk of CMV disease, noting that relevant specialists are best placed to make this assessment.

Details about our proposal

Access to valganciclovir would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2021 to include people who require further CMV prophylaxis after lung transplantation and for all transplant patients receiving pulse methylprednisolone for acute rejection as follows (additions in bold, deletions in strikethrough):

Initial application — (Lung transplant cytomegalovirus prophylaxis) only from a relevant specialist. Approvals valid for 6 12 months for applications meeting the following criteria:

Both All of the following:

  1. Patient has undergone a lung transplant; and
  2. Either:
    1. The donor was cytomegalovirus positive and the patient is cytomegalovirus negative; or
    2. The recipient is cytomegalovirus positive; and
  3. Patient has a high risk of CMV disease.

Initial application — (transplant cytomegalovirus prophylaxis) only from a relevant specialist. Approvals valid for 3 months where the patient has undergone a solid organ transplant and requires valganciclovir for CMV prophylaxis.

Renewal — (transplant cytomegalovirus prophylaxis) only from a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Either:

  1. Both:
    1. 1 Patient has undergone a solid organ transplant and received anti-thymocyte globulin and requires valganciclovir therapy for CMV prophylaxis; and
    2. 2 Patient is to receive a maximum of 90 days of valganciclovir prophylaxis following anti-thymocyte globulin; or
  2. Both:
    1. Patient has received pulse methylprednisolone for acute rejection and requires further valganciclovir therapy for CMV prophylaxis; and
    2. Patient is to receive a maximum of 90 days of valganciclovir prophylaxis following pulse methylprednisolone.

There are no proposed changes to other existing Special Authority criteria for valganciclovir.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 25 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.