Decision to widen access to valganciclovir for transplant patients

Medicines Decision

We're pleased to announce a decision to widen access to valganciclovir.

What we’re doing

We're pleased to announce a decision 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 from 1 February 2021.

Read the Application Tracker record for widening access to valganciclovir(external link) 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 12 November 2020

No changes have been made as a result of consultation feedback. 

Who we think will be most interested

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

Detail about this decision

Funded access to valganciclovir will be amended in Section B of the Pharmaceutical Schedule from 1 February 2021 for CMV prophylaxis post lung transplant and for transplant patients receiving pulse methylprednisolone for acute rejection subject to the following criteria (see below - additions in bold, deletions in strikethrough). Equivalent changes will also be made in Part II of Section H of the Pharmaceutical Schedule. No changes were made to the criteria for any of the other funded uses of this treatments.

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. 

Our response to what you told us

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

THEME

PHARMAC COMMENT

Although supportive of the proposal to widen access to valganciclovir for patients who require extended CMV prophylaxis after lung transplantation and for all patients receiving methylprednisolone treatment after rejection, one respondent raised some concerns regarding the process followed. They noted that, following the Transplant Immunosuppressant Subcommittee advice in 2017, no further specialist infectious disease input was sought. Nor did PTAC contain ID membership to provide that expertise.

 

 

PHARMAC staff note the concern raised regarding the process for obtaining clinical advice for this proposal. PHARMAC staff noted that the Anti-infective Subcommittee recommendation for decline (November 2015) was considered by PTAC (February 2016). PTAC reviewed the meeting record and recommend that, in light of the Anti-Infective Subcommittee recommendation, the proposal be reconsidered by the Transplant Immunisation Subcommittee. The Transplant Immunosupressant Subcommittee then reconsidered this at its meeting in October 2017, and recommended that valganciclovir be funded for these indications with a high priority. PTAC noted and accepted these recommendations at its meeting in August 2018.

Read the November 2015 Anti-infective subcommittee minute [PDF, 48 KB]

Read the February 2016 PTAC meeting record [PDF, 1.2 MB]

Read the October 2017 Transplant Immunosuppressant Subcommittee minute [PDF, 171 KB] 

Read the August 2018 PTAC meeting record [PDF, 665 KB]

PTAC considers funding proposals across all therapeutic areas and may seek specialist advice from Subcommittees. PTAC has a broad membership and has an expertise in critical appraisal of evidence. With regards to this proposal, PTAC noted and accepted the recommendations of the Transplant Immunisation Subcommittee.

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.