Approval of funding for hepatitis C treatments

Medicines Decision

PHARMAC is pleased to announce that, from 1 July 2016:

  • Ledipasvir with sofosbuvir (Harvoni) will be funded in the community and DHB hospitals for the treatment of hepatitis C for patients with severe liver disease, subject to restrictions; and
  • Paritaprevir with ritonavir and ombitasvir copackaged with dasabuvir (Viekira Pak) and paritaprevir with ritonavir and ombitasvir copackaged with dasabuvir and ribavirin (Viekira Pak-RBV) will be funded in the community and DHB hospitals for the treatment of hepatitis C.

This decision was the subject of a consultation letter dated 4 May 2016 which can be found on PHARMAC’s website.

Changes made following consideration of consultation feedback

Paritaprevir with ritonavir and ombitasvir with dasabuvir with/without ribavirin (Viekira Pak / Viekira Pak-RBV)

A number of consultation responses said that, although they strongly supported the use of these treatments in the community, the proposals would result in one of the biggest changes for primary care prescribing in a number of years. To address these concerns the following change has been made:

  • From 1 July 2016 Viekira Pak and Viekira Pak-RBV will be listed with a restriction limiting access to funded treatment to infectious disease specialists, gastroenterologists and hepatologists.
  • This restriction will be lifted on 1 October 2016, meaning that any relevant prescriber will be able to access full funding for those products from that date.

PHARMAC will be working closely with clinicians, the Ministry of Health, suppliers and others in the health sector to ensure that the right materials, education and systems are in place to support primary care prescribing.

Importantly, although funding will be restricted to certain prescribers until 1 October 2016, we expect that most people who have an urgent clinical need for these treatments before 1 October could access funding.

Ledipasvir with sofosbuvir (Harvoni)

In addition we received feedback, regarding the proposed Special Authority criteria relating to cryoglobulinaemia for Harvoni. These amendments have been made to better reflect the intent of the criteria. We note that, with respect to Harvoni, access to funding will be via application to the Hepatitis C Treatments Panel (HepCTP), membership of which will include hepatitis C treatment specialists.

Details of the decision

Ledipasvir with sofosbuvir (Harvoni)

From 1 July 2016:

  • Ledipasvir with sofosbuvir (Harvoni) will be listed in Section B (the Community) and in Part II of Section H (the Hospital Medicines List, or HML) as follows:
Chemical Presentation Brand Pack size Price and subsidy
Ledipasvir with sofosbuvir Tab 90 mg with sofosbuvir 400 mg Harvoni 28 $24,363.46
  • Harvoni will be listed in Section B of the Pharmaceutical Schedule as Xpharm – meaning that pharmacies will not be able to claim subsidy as alternative distribution arrangements will be managed by PHARMAC. A summary of the proposed distribution arrangement is provided on page 4 below.
  • A confidential rebate will apply to Harvoni, reducing its net price to the Funder.
  • Harvoni will have subsidy and delisting protection until 30 June 2019.
  • Ledipasvir with sofosbuvir will be subject to the following access criteria in Section B and Section H of the Pharmaceutical Schedule:

Special Authority for Subsidy

By application to the Hepatitis C Treatment Panel (HepCTP). Applications will be considered by HepCTP and approved subject to confirmation of eligibility according to the Access criteria (below):

Notes: Application details may be obtained from PHARMAC’s website or:

The Co-ordinator, Hepatitis C Treatment Panel                          Phone: (04) 460 4990

PHARMAC, PO Box 10 254                                                               Email: hepcpanel@pharmac.govt.nz

Wellington                                                                        

Access Criteria

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 with a MELD score of 15 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

3.3.1       Cryoglobulinaemic glomerulonephritis; 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:
    1. Patient has decompensated cirrhosis with a MELD score of 15 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

3.3.1       Cryoglobulinaemic glomerulonephritis; or
3.3.2        Systemic vasculitis.

Paritaprevir with ritonavir and ombitasvir with dasabuvir with/without ribavirin (Viekira Pak / Viekira Pak-RBV)

From 1 July 2016:

  • Paritaprevir with ritonavir and ombitasvir co-packaged with dasabuvir (Viekira Pak) and paritaprevir with ritonavir and ombitasvir co-packaged with dasabuvir and ribavirin (Viekira Pak-RBV) will be listed in Section B (the Community) and in Part II of Section H (the Hospital Medicines List, or HML) as follows.

Chemical

Presentation

Brand

Pack size

Price and subsidy

Paritaprevir, ritonavir and ombitasvir with dasabuvir

Tab 75 mg with ritonavir 50 mg, and ombitasvir 12.5 mg (56), with dasabuvir tab 250 mg (56)

Viekira Pak

1 OP

$16,500

Paritaprevir, ritonavir and ombitasvir with dasabuvir and ribavirin

Tab 75 mg with ritonavir 50 mg, and ombitasvir 12.5 mg (56) with dasabuvir tab 250 mg (56) and ribavirin tab 200 mg (168)

Viekira Pak-RBV

1 OP

$16,500
  • From 1 July 2016 until 1 October 2016, PHARMAC will only process prescriptions for Viekira Pak and Viekira Pak-RBV that are received from an infectious disease specialist, a gastroenterologist or a hepatologist. On 1 October 2016, this restriction will be lifted and no prescriber restrictions will be in place. PHARMAC may receive prescriptions from other prescribers prior to 1 October 2016; however they will not be processed until this date. This restriction would take the form of the following note:

note from 1 July 2016 until 1 October 2016, PHARMAC will only process prescriptions received from an infectious disease specialist, a gastroenterologist or a hepatologist. PHARMAC may receive prescriptions from other prescribers prior to 1 October 2016; however they will not be processed until this date.

  • Viekira Pak and Viekira Pak-RBV will be listed in Section B of the Pharmaceutical Schedule as Xpharm – this means that pharmacies will not be able to claim subsidy as an alternative distribution arrangement will be put in place by PHARMAC.
  • A note will accompany the HML listing that will highlight that supply of treatment is via PHARMAC’s approved direct distribution supply.
  • A summary of the proposed distribution arrangement for Viekira Pak and Viekira Pak-RBV is provided on page 4 below.
  • Viekira Pak and Viekira Pak-RBV will have subsidy and delisting protection until 30 June 2019.
  • A confidential discount and expenditure cap will apply until 30 June 2019 for Viekira Pak and Viekira Pak-RBV, reducing the net price of these products to the Funder.

Applications, administration and distribution

Both Harvoni and Viekira Pak/Viekira Pak-RBV will be distributed through a non-standard mechanism.

Ledipasvir with sofosbuvir (Harvoni)

Applications forms for funding for Harvoni will be available from the PHARMAC website. Applications for Harvoni can be made by any relevant practitioner. Applications for Harvoni along with the original prescription will be sent to PHARMAC.

Upon receipt of an application PHARMAC’s Hepatitis C Panel Co-ordinator will organise for the application to be considered by the Hepatitis C Treatment Panel. Following a decision to approve funded access, the Hepatitis C Panel Co-ordinator will organise for the medicine to be dispensed from a central pharmacy and sent to the specified delivery address.

The applicant will be required to specify a delivery address for the medicine. This will need to be an address where someone is available to accept delivery as the courier will require a signature. We therefore suggest appropriate delivery addresses would include a clinic address, a GP address or some other destination where a signature is able to be obtained and the medicine can be correctly looked after until required.

Paritaprevir with ritonavir and ombitasvir with dasabuvir with/without ribavirin (Viekira Pak / Viekira Pak-RBV)

AbbVie Ltd is responsible for the distribution of Viekira Pak and Viekira Pak-RBV. However PHARMAC will be providing administrative support to ensure patient confidentiality is maintained. The distribution mechanism is still being finalised. However, PHARMAC understands that AbbVie Ltd is currently considering a community pharmacy model that would be known as the AbbVie Care Pharmacy Program. Under this program, a patient’s Viekira Pak/Viekira Pak-RBV would be sent to an AbbVie accredited pharmacy. These pharmacies would receive training and then be certified and registered by AbbVie Ltd.

A patient would receive their prescription from their doctor and take it to an AbbVie accredited pharmacy. Accredited pharmacies would receive the Viekira Pak/Viekira Pak-RBV from AbbVie’s distributor. The pharmacy would then dispense the medicine and counsel the patient in relation to the medicine.

AbbVie is initially identifying pharmacies that have experience with Viekira Pak/Viekira Pak-RBV, or would meet a specific need such as serving geographically remote patients. Following this initial accreditation intake, we understand AbbVie is intending to extend its accreditation programme to all pharmacies that are interested in providing this service. Funding for the services would be via an agreement between AbbVie and accredited pharmacies.

We also understand that an alternative model would be in place for patients who are unable to access an AbbVie accredited pharmacy. With this alternative model a suitable delivery address would need to be specified by the prescriber. This would need to be an address where someone is available to accept the delivery as the courier will require a signature. We therefore suggest appropriate delivery addresses would include a clinic address, a GP address or some other destination where a signature is able to be obtained and the medicine can be correctly looked after until required.

Once the distribution mechanism for Viekira Pak/Viekira Pak-RBV is finalised PHARMAC will provide further information on its website.

Feedback received

We know our decisions have flow-on impacts to other parts of the health system, so consultation feedback is vital to us making the best possible decisions to ensure the best possible health outcomes. We appreciate all of the feedback that we received and acknowledge the time people took to respond.

All consultation responses received by 26 May 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal noting the potential for curative treatment in a substantial number of the population with hepatitis C. This was considered to help address disease burden, ongoing impact to the health system and impact on people with hepatitis C. In addition the following issues were raised in relation to specific aspects of the proposal:

Theme

PHARMAC comment

Respondents suggested that PHARMAC needs to investigate additional treatment options for Hep C patients with genotypes 2-6.

Noted. Other new hepatitis C treatments are still an option for investment and PHARMAC would pursue these should the opportunity arise.

We note that Harvoni is available for patients of all genotypes, who meet the clinical access criteria.

Respondents supported community access for these treatments. However they noted that in order to prescribe the new treatments, clinicians should receive specialised education/training/support. This is particularly important for GPs prescribing Viekira Pak. The majority of GPs would not have had previous experience with these classes of treatment and there won’t be oversight by a clinical panel in this situation.

Following consideration of this feedback, funded access to Viekira Pak for prescribers other than infectious disease specialists, gastroenterologists and hepatologists will be delayed to 1 October 2016.

This delay aims to allow sufficient time for health sector parties to work together to develop and distribute materials and deliver education that will enable other prescribers to become familiar with these treatments.

Respondents considered that funding should be provided for the additional GP consultations required for patients to receive the new proposed treatments.

They considered that funding for resources will be required in the community for implementation activities, patient counselling and in DHBs for additional diagnoses burden (laboratory tests etc.).

PHARMAC has raised these concerns with relevant health sector agents who are involved in service funding. Such costs were included in our analysis, where they are costs that would be incurred by DHBs.

PHARMAC notes that service impact costs would be short term, as, given there is a high cure rate, these would be offset by a significant reduction of costs for ongoing management of the disease (e.g. clinic visits, monitoring for cirrhosis, blood tests, transplants etc.) in the long term.

Respondents expressed concerns regarding the proposed direct distribution model of Viekira Pak. Respondents considered that a secondary check for drug-drug interactions may be missing and highlighted the need for ongoing patient monitoring and keeping patients’ GPs informed.

Noted. AbbVie Ltd is responsible for distribution of Viekira Pak and contractually obliged to ensure that appropriate patient counselling takes place. In addition to patient counselling PHARMAC understands that the supplier intends to ensure that appropriate arrangements are in place to assess drug interactions and engage with the prescribing clinician. For further details – please see the distribution section on page 4 – 5.

Respondents expressed concerns regarding the possibility of inequitable national roll out of hepatitis C services.

PHARMAC has been working closely with the Ministry of Health and understands that the four regional DHBs have been supported to develop integrated hepatitis C assessment and treatment services across primary and secondary care.

The Ministry informs us that from 2016/17 these services will be implemented to provide early quality identification through primarily community based testing and diagnosis; assessment; triage; and management, including monitoring, support and education to people with hepatitis C.

Respondents requested that the proposed funding criteria for Harvoni are widened. This included a lower MELD score, the inclusion of patients where Viekira Pak is not a treatment option or where treatment with Viekira Pak fails.

Noted. PHARMAC will continue to consider the possibility of wider access.

Respondents requested that amendments should be considered for the cryoglobulinaemia criteria. It was noted that the proposed criteria would very seldom occur in conjunction with each other in a clinical situation.

The criteria have been amended following consideration of this feedback.

Respondents indicated that assessment of liver fibrosis should be performed before treatment commences.

Noted. PHARMAC is working with other health sector parties and suppliers to ensure that information in relation to appropriate assessment is available to prescribers of these treatments.

One respondent expressed that ribavirin (in relation to the supply of Harvoni) should be provided in a form where it is not co-packaged with pegylated interferon.

Noted. PHARMAC is looking at options in relation to the funding of ribavirin and hopes to make a decision on this in the near future.

Respondents requested that access to Harvoni should be widened to patients with HIV and/or hepatitis B coinfection.

The clinical advice we have received indicates that being co-infected with HCV and HIV is not, in itself, a reason to prioritise funding with a new hepatitis C treatment. PHARMAC is willing to seek further clinical advice should further information be submitted that supports earlier access to Harvoni for these patients. In the meantime, patients who are co-infected with HCV and HIV may access Harvoni and Viekira Pak/Viekira Pak-RBV if they meet the funding restrictions.

Respondents indicated that children with chronic hepatitis C should only receive treatment under the care of a specialist.

Noted. PHARMAC will be working closely with other health sector parties to develop and distribute materials and deliver education that will enable other prescribers to become familiar with these treatments.

 

One respondent was unsupportive of the Gilead (Harvoni) proposal for clinical, ethical and fiscal reasons. The respondent considered the supplier’s behaviour has been profiteering and that, in letting patients become cirrhotic before treatment, they create incurring ongoing costs to the health system.

Noted.

Concern that the commercial terms of listing would provide a barrier to entry to other products prior to July 2019.

PHARMAC staff note that all potential suppliers of hepatitis C treatments were approached and given equal opportunity to submit proposals for the supply of their products.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.