Decision to widen access to various anti-infectives

Medicines Decision

What we’re doing

We’re pleased to announce our decision to widen funded access to three treatments:

  • Ledipasvir with sofosbuvir
  • Tenofovir disoproxil fumarate
  • Paromomycin

All changes will take effect from 1 January 2018.

Any changes to the original proposal?

This was the subject of a consultation letter dated 14 November 2017.   The final decision differs from the original proposal in the following way:

  • Ledipasvir with sofosbuvir: the funding requirement for patients with mixed cryoglobulinaemia with an associated purpuric skin rash to have cryoglobulinaemic glomerulonephritis has been amended to remove the cryoglobulins requirement for glomerulonephritis.
  • Tenofovir: separate to the issue of women of childbearing potential, the current funding criteria for tenofovir for severe hepatitis B required a “Mayo score” greater than 20. We were advised that Mayo scores are not used in practice anymore, so we have removed this requirement entirely.
  • Tenofovir: earlier this year, PHARMAC had widened funded access to HIV treatments to remove severity requirements. This was done to tenofovir in Section B but not in Section H. This was an oversight, and as part of this decision this has been corrected.
  • Tenofovir: During updating the restrictions we identified a number of typos in the current criteria. These have been fixed.
  • Paromomycin: We have amended the criteria so that gastroenterologists may apply for funded paromomycin. This change was made both in Section B and Section H. 

Who we think will be most interested

Among other groups, this decision will be of interest to:

  • community and hospital prescribers, particularly Infectious Disease specialists and general practitioners,
  • hospital and community pharmacists, DHBs, suppliers and wholesalers, and
  • patients with hepatitis B or C and consumer advocacy groups.

What will the effect of our decision be?

From 1 January 2018

Ledipasvir with sofosbuvir: Patients with chronic hepatitis C and decompensated cirrhosis will no longer need to meet a minimum MELD score (a measure of severity) to be eligible for funded treatment.

Tenofovir disoproxil fumarate: Women of childbearing age with hepatitis B will be eligible for funded tenofovir. Tenofovir provides the same benefit against the virus as other funded treatments such as entecavir, but has a lower risk of causing harm to an unborn child.

Paromomycin: will be funded for eradication of Entamoeba histolytica carriage. 

Detail about this decision

Ledipasvir with sofosbuvir (Harvoni)

From 1 January 2018, the Special Authority criteria for ledipasvir with sofosbuvir (Harvoni) tab 90 mg with sofosbuvir 400 mg will be amended as follows (additions in bold, 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:

3.1     Patient has decompensated cirrhosis (Child-Pugh B or C) with a MELD score of 12 or greater; or
3.2     Patient has been accepted onto a list for a liver transplant or has received a liver transplant; or
3.3     Patient has essential mixed cryoglobulinaemia with associated purpuric skin rash and; either

3.3.1       Cryoglobulinaemic gGlomerulonephritis; or
3.3.2       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:

3.1     Patient has decompensated cirrhosis (Child-Pugh B or C) with a MELD score of 12 or greater; or
3.2     Patient has been accepted onto a list for a liver transplant or has received a liver transplant; or
3.3     Patient has essential mixed cryoglobulinaemia with associated purpuric skin rash and; either:

3.3.1       Cryoglobulinaemic gGlomerulonephritis; or
3.3.2       Systemic vasculitis.

Tenofovir disoproxil fumarate (Viread)

From 1 January 2018, the Special Authority criteria for tenofovir disoproxil fumarate (Viread) tab 300 mg will be amended as follows (additions in bold, deletions in strikethrough):

TENOFOVIR DISOPROXIL FUMARATE – Subsidy by endorsement; can be waived by Special Authority see SA1362QQQQ

Endorsement for treatment of HIV: Prescription is deemed to be endorsed if tenofovir disoproxil fumarate is co-prescribed with another anti-retroviral antiretroviral subsidised under Special Authority SA1651 and the prescription is annotated accordingly by the Pharmacist or endorsed by the prescriber.

Note:

Tenofovir disoproxil fumarate prescribed under endorsement for the treatment of HIV is included in the count of up to 4 subsidised antiretrovirals for the purposes of Special Authority SA1651

Tab 300 mg ..............................................................531.00              30                      ✔ Viread

➽SA1362QQQQ Special Authority for Waiver of Rule

Initial application — (Chronic Hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Any of the following: Both:

1 All of the following:

1.1     Patient has confirmed Hepatitis B infection (HBsAg positive for more than 6 months); and
1.2     Patient has had previous lamivudine, adefovir or entecavir therapy; and
1.3     HBV DNA greater than 20,000 IU/mL or increased 10 fold or higher over nadir; and
1.4     Any of the following:

1.4.1       Lamivudine resistance - detection of M204I/V mutation; or
1.4.2       Adefovir resistance - detection of A181T/V or N236T mutation; or
1.4.3       Entecavir resistance - detection of relevant mutations including I169T, L180M T184S/A/I/L/G/C/M, S202C/G/I, M204V or M250I/V mutation; or

2 Patient is either listed or has undergone liver transplantation for HBV; or

3 Patient has decompensated cirrhosis with a Mayoscore > 20.

Initial application — (Pregnant, Women of child bearing age with 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:

2.1     HBV DNA > 20,000 IU/mL and ALT > ULN; or
2.2     HBV DNA > 20 million IU/mL and ALT normal; and

3 Either:

3.1     Patient is of child bearing potential and has not yet completed a family; or
3.2     Patient is pregnant; or
3.3     Patient is breastfeeding.

Renewal — (Confirmed Hepatitis B following funded tenofovir treatment for pregnancy within the previous two years) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Either:

1 All of the following:

1.1     Patient has confirmed Hepatitis B infection (HBsAg positive for more than 6 months); and
1.2     Patient has had previous lamivudine, adefovir or entecavir therapy; and
1.3     HBV DNA greater than 20,000 IU/mL or increased 10 fold or higher over nadir; and
1.4     Any of the following:

1.4.1      Lamivudine resistance - detection of M204I/V mutation; or
1.4.2      Adefovir resistance - detection of A181T/V or N236T mutation; or
1.4.3      Entecavir resistance - detection of relevant mutations including I169T, L180M T184S/A/I/L/G/C/M, S202C/G/I, M204V or M250I/V mutation; or

2 Patient is either listed or has undergone liver transplantation for HBV.

Renewal — (Subsequent pregnancy or Breastfeeding, Women of child bearing age with 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:

2.1     HBV DNA > 20,000 IU/mL and ALT > ULN; or
2.2     HBV DNA > 20 million IU/mL and ALT normal; and

3 Any of the following:

3.1     Patient is of child bearing potential and has not yet completed a family; or
3.2     Patient is pregnant; or
3.3     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 nor