Decision relating to widening funding criteria for ledipasvir with sofosbuvir (Harvoni)

Medicines

Decision

PHARMAC is pleased to announce the approval of the proposal to widen the funding criteria for Harvoni for the treatment of hepatitis C.

This was the subject of a consultation letter dated 8 May 2017.

The proposal was approved as consulted on with no changes to the criteria, however it will take effect from 12 June 2017 not 1 July as originally proposed.

In summary, the effect of the decision is that:

  • Funded access to ledipasvir with sofosbuvir (Harvoni) for the treatment of hepatitis C will be widened to include patients with a lower end-stage liver disease (MELD) score of 12 or greater, effective immediately.
  • As PHARMAC directly manages the distribution of Harvoni, we can implement this change prior to 1 July 2017.
  • Applicants with patients with a lower end-stage liver disease (MELD) score of 12 or greater can apply to the Hepatitis C Treatments Panel for access to Harvoni immediately by completing this form [PDF, 343 KB].
  • For consideration and a decision prior to 1 July 2017, applications, along with an original prescription, should be submitted by 21 June 2017.

Details of the decision

Ledipasvir with sofosbuvir – reduction in MELD score requirement

  • Funding criteria for ledipasvir with sofosbuvir (Harvoni) tab 90 mg with sofosbuvir 400 mg will be amended from 12 June 2017 as follows (additions in bold, deletions in strikethrough):

Access criteria:

Chronic hepatitis C – Advanced disease– where 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 with a MELD score of 15 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 glomerulonephritis; or
3.3.2 Systemic vasculitis.

Chronic hepatitis C – Advanced disease where 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 with a MELD score of 15 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 glomerulonephritis; or
3.3.2 Systemic vasculitis.

No restriction change is required for Part II of Section H of the Pharmaceutical Schedule as hospital access requires patients to have a valid Special Authority approval according to the criteria set out in Section B of the Schedule.

Feedback received

We appreciate the feedback we received and acknowledge the time people took to respond. All consultation responses received by 26 May 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Requests that PHARMAC widen funded access to all hepatitis C patients independent of genotype or degree of liver function. PHARMAC will continue to assess potential options for expansion of funded access to DAA hepatitis C treatments. We are aware that a number of suppliers are developing DAA hepatitis C treatments to treat all genotypes. We continue to explore the options for widening funded access to DAAs within the available budget
Widening of funded access to Harvoni to patients with a MELD score of 12 or above will not be enough to impact HCV prevalence, incidence or meet WHO targets. PHARMAC notes that 50-60% of HCV infected individuals in NZ are currently undiagnosed. The identification and treatment of these individuals will be critical for reducing the incidence of and reinfection rates of HCV. PHARMAC understands the Ministry of Health and other relevant stakeholder groups are working hard to improve the diagnosis and treatment of undiagnosed and high risk individuals.
Request funding for patients coinfected with HIV or hepatitis B and contraindicated for Viekira Pak earlier in their disease course as well as patients unable to be treated with Viekira Pak due to drug interactions. Noted. PHARMAC has received clinical advice regarding the funding of Harvoni for patients co-infected with HIV and Hepatitis C and will continue to assess potential options for expansion of funded access to DAA hepatitis C treatments.
The efficacy of Harvoni (with/without ribavirin) is lower in patients infected with HCV genotype 3 (SVR12 of 65%). Noted that EPCLUSA is a pangenotypic regiment with improved efficacy for HCV genotype 3 infection. While the efficacy of Harvoni is reduced in Genotype 3 HCV patients, Harvoni represents an improvement on treatment options available for this high need sub-population of patients.
Current drug company pricing prevents treatment of the Hepatitis C epidemic in NZ. Suggests that PHARMAC fund cheaper generic drugs for large-scale treatment of Hepatitis C. Noted.
One responder requested that PHARMAC change the distribution process for Harvoni to involve community pharmacy. Noted. PHARMAC note the distribution of Harvoni was thoroughly considered at the time of the initial listing in 2016 and PHARMAC considers the current direct distribution approach remains appropriate for now. We note the distribution mechanisms for Harvoni and Viekira Pak are different for several reasons, including differences in access criteria, cost and patient numbers.

One responder noted that access to Harvoni from primary care rather than secondary care specialist services would provide a logical extension for Hepatitis C management.

All prescribers, including general practitioners, can apply to the Hepatitis C Treatment Panel for funded Harvoni for eligible people. The application form can be found on PHARMAC’s website [PDF, 343 KB].

General practitioners are resistant to prescribe, treat and monitor due to drug interactions and administrative burden.

Extra information and prevention campaigns in prisons may help prevent reinfections.

PHARMAC is working closely with the Ministry of Health and clinicians to understand any barriers and improve diagnosis and prescribing of hepatitis C treatments in primary care and the treatment of high risk individuals with hepatitis C, including individuals in prisons.

More information

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 66 00 50.