Proposal to widen access to various anti-infectives

Medicines Consultation Closed

PHARMAC is seeking feedback on three proposals to widen funded access, from 1 January 2018, to various pharmaceuticals in the anti-infectives therapeutic group.

These are:

  • ledipasvir with sofosbuvir (Harvoni) for patients with chronic hepatitis C who have decompensated cirrhosis (Child-Pugh B or C), by removing a minimum MELD score requirement;
  • tenofovir disoproxil fumarate (Viread) for hepatitis B in women of childbearing age; and
  • paromomycin (Humatin) for Entamoeba histolytica intestinal colonisation.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 28 November 2017 to:

Dr Lindsay Ancelet
Therapeutic Group Manager
PHARMAC

Email: consult@pharmac.govt.nz

Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

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.

Details of the proposals

Ledipasvir with sofosbuvir – removal of MELD score restriction

  • Funding criteria for ledipasvir with sofosbuvir (tab 90 mg with sofosbuvir 400 mg, Harvoni) would be widened in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 January 2018 by removing the requirement for patients with decompensated cirrhosis to meet a minimum MELD score.
  • This would change the Special Authority restriction (and the similar restriction in Part II of Section H of the Pharmaceutical Schedule) as shown below (deletions in strikethrough):

Special Authority for Subsidy

Chronic hepatitis C – Advanced disease - ribavirin is not contraindicated

Applications from any relevant practitioner. Approvals valid for 12 weeks for applications meeting the following criteria:

All of the following:

  1. Patient has chronic hepatitis C (any genotype); and
  2. Ribavirin treatment is not contraindicated; and
  3. Any of the following:
    1. Patient has decompensated cirrhosis (Child-Pugh B or C) with a MELD score of 12 or greater; or
    2. Patient has been accepted onto a list for a liver transplant or has received a liver transplant; or
    3. Patient has essential mixed cryoglobulinaemia with associated purpuric skin rash and; either
      1. Cryoglobulinaemic glomerulonephritis; or
      2. Systemic vasculitis.

Chronic hepatitis C – Advanced disease - ribavirin is contraindicated

Applications from any relevant practitioner. Approvals valid for 24 weeks for applications meeting the following criteria:

All of the following:

  1. Patient has chronic hepatitis C (any genotype); and
  2. Ribavirin treatment is contraindicated; and
  3. Any of the following:
    1. Patient has decompensated cirrhosis (Child-Pugh B or C) with a MELD score of 12 or greater; or
    2. Patient has been accepted onto a list for a liver transplant or has received a liver transplant; or
    3. Patient has essential mixed cryoglobulinaemia with associated purpuric skin rash and; either:
      1. Cryoglobulinaemic glomerulonephritis; or
      2. Systemic vasculitis.

Ledipasvir with sofosbuvir background

Ledipasvir and sofosbuvir (Harvoni) is a combination treatment of two antiviral agents that is active against all genotypes (1-6) of the hepatitis C virus.

In May 2015, PTAC reviewed the funding application for Harvoni and recommended it should be funded for all patients with decompensated cirrhosis with a high priority.

Ledipasvir with sofosbuvir (Harvoni) has been funded for patients with chronic hepatitis C with advanced disease who meet the Special Authority criteria (as detailed above without the marked-up changes) on application to the Hepatitis C Treatment Panel since 1 July 2016.  Another similar combination treatment, paritaprevir, ritonavir and ombitasvir with dasabuvir (Viekira Pak) is active against genotype 1 of the hepatitis C virus and it has also been funded since 1 July 2016 without any restrictions or access criteria.

On 12 June 2017, when PHARMAC announced our decision to reduce the MELD score requirement for Harvoni from 15 to 12, we noted that we had received feedback requesting that funded access to Harvoni be widened even further via reduction of the end-stage liver disease (MELD) score and we advised that we would consider this option. The notification letter for this can be found on PHARMAC's website. 

We now propose that the MELD score requirement be removed entirely so that Harvoni would be funded for all patients with chronic hepatitis C who have decompensated cirrhosis (Child-Pugh B or C).

Removing the requirement for a MELD score would allow earlier and simpler access for patients with decompensated cirrhosis. We estimate this proposal would result in an additional 20 to 40 people each year being able to access treatment with ledipasvir with sofosbuvir (Harvoni) earlier in the course of their disease.

More information, including links to advisory committee minutes and previous consultation and notification letters, can be found in the Application Tracker for ledipasvir with sofosbuvir at: https://www.pharmac.govt.nz/ApplicationTracker?ProposalId=1456 [link no longer available]

Tenofovir disoproxil fumarate – Hepatitis B, women of childbearing potential

  • Funding criteria for tenofovir disoproxil fumarate tab 300 mg (Viread) would be widened, in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 January 2018, to include women of childbearing age.
  • Proposed changes to the relevant parts of the Special Authority 1 and hospital restrictions are shown below (additions in bold, deletions in strikethrough):

➽SAQQQQ Special Authority for Waiver of Rule

Initial application — (Pregnant Child bearing age, active hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 12 months 2 years for applications meeting the following criteria:

Both: All of the following:

  1. Patient is HBsAg positive and pregnant; and
  2. Either:
    1. HBV DNA > 20,000 IU/mL and ALT > ULN; or
    2. HBV DNA > 20 million IU/mL and ALT normal; and
  3. Either:
    1. Patient is of child bearing potential and has not yet completed a family; or
    2. Patient is pregnant.

Renewal — (Subsequent pregnancy or Breastfeeding, Child bearing age, active hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 12 months 2 years for applications meeting the following criteria:

Both: All of the following:

  1. Patient is HBsAg positive and pregnant or breastfeeding; and
  2. Either:
    1. HBV DNA > 20,000 IU/mL and ALT > ULN; or
    2. HBV DNA > 20 million IU/mL and ALT normal; and
  3. Any of the following:
    1. Patient is of child bearing potential and has not yet completed a family; or
    2. Patient is pregnant; or
    3. Patient is breastfeeding.

Initial application (Pregnant, prevention of vertical transmission) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1 Patient is HBsAg positive and pregnant; and

2 HBV DNA > 20 million IU/mL and ALT normal.

Renewal — (Subsequent pregnancy, prevention of vertical transmission) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1 Patient is HBsAg positive and pregnant; and

2 HBV DNA > 20 million IU/mL and ALT normal.

1 Note, this proposal would not change the criteria for use in HIV, nor the current Initial and Renewal special authority criteria for ‘chronic hepatitis B’.

Tenofovir disoproxil fumarate background

Tenofovir disoproxil fumarate (Viread) is an anti-infective used to treat hepatitis B and HIV.

Tenofovir is currently funded for, among other patient groups, patients with hepatitis B who are pregnant because it has better safety data for an unborn child than the alternative hepatitis B treatment, entecavir. However, tenofovir is not currently funded for women who intend to get pregnant or who may become pregnant, meaning a woman with hepatitis B who is using entecavir may be pregnant for some time before switching to tenofovir, introducing early foetal risk.

To address this discrepancy, PTAC recommended that PHARMAC fund tenofovir for all women of childbearing age with a high priority to reduce any risk to unborn children. Tenofovir and entecavir have equivalent efficacy for the treatment of hepatitis B.

More information, including links to advisory committee minutes and previous consultation and notification letters, can be found in the Application Tracker record for tenofovir at: https://www.pharmac.govt.nz/ApplicationTracker?ProposalId=1210 [link no longer available]

Paromomycin – Eradication of Entamoeba histolytica intestinal colonisation

  • Funding criteria for paromomycin cap 250 mg (Humatin) would be widened in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 January 2018 to allow treatment of E. histolyica carriage.
  • This would involve a change the Special Authority criteria as shown below (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application only from an infectious disease specialist or clinical microbiologist. Approvals valid for 1 month for applications meeting the following criteria:

Either:

  1. where the pPatient has confirmed cryptosporidium infection; or
  2. For the eradication of E. histolyica carriage.

Renewal only from an infectious disease specialist or clinical microbiologist. Approvals valid for 1 month for applications meeting the following criteria:

Either:

  1. where the pPatient has confirmed cryptosporidium infection; or
  2. For the eradication of E. histolyica carriage.

Paromomycin background

Paromomycin is an antibiotic which has been listed on the Pharmaceutical Schedule since 2013. It is an unregistered medicine, meaning that use must be in accordance with section 29 of the Medicines Act.

The Anti-Infective Subcommittee of PTAC recommended widening funded access to paromomycin for the eradication of Entamoeba histolytica carriage with a high priority.

No change would be made to the hospital restrictions, as there are no indication restrictions on paromomycin in Section H of the Schedule.

More information, including links to advisory committee minutes and previous consultation and notification letters, can be found in the Application Tracker record for primaquine phosphate at: https://www.pharmac.govt.nz/ApplicationTracker?ProposalId=756 [link no longer available]