Proposals to list hepatitis C treatments

The proposals are as a result of two separate provisional agreements one with Gilead Sciences (NZ) Ltd and another with AbbVie Ltd. In summary, the proposals would result in, from 1 July 2016:

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

On August 10 2015, PHARMAC released a Request for Information (RFI) on hepatitis C treatments and received feedback from suppliers, clinicians, advocacy groups and patients. Feedback to the RFI helped to inform our analysis and development of these proposals.

Details of the proposals and some background information is set out on the following pages.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Wednesday, 25 May 2016 to:

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 (Harvoni)

From 1 July 2016:

• Ledipasvir with sofosbuvir (Harvoni) would 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	Tablet	Harvoni	28	$24,363.46

• It would be listed in Section B of the Pharmaceutical Schedule as Xpharm – meaning that pharmacies would not be able to claim subsidy as alternative distribution arrangements would be put in place by PHARMAC. A summary of the proposed distribution arrangement is provided below.
• A confidential rebate would apply to Harvoni, reducing its net price to the Funder.
• Harvoni would have subsidy and delisting protection until 30 June 2019.
• Ledipasvir with sofosbuvir would be subject to the following access criteria in Section B and Section H of the Pharmaceutical Schedule:

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) would be listed in Section B (the Community) as follows.

  Chemical	Presentation	Brand	Pack size	Price and subsidy
  Paritaprevir, ritonavir and ombitasvir with dasabuvir	Paritaprevir/ritonavir/ombitasvir (56 tablets) with dasabuvir (56 tablets)	Viekira Pak	1 OP	$16,500
  Paritaprevir, ritonavir and ombitasvir with dasabuvir and ribavirin	Paritaprevir/ritonavir/ombitasvir (56 tablets) with dasabuvir (56 tablets) and ribavirin (168 tablets)	Viekira Pak-RBV	1 OP	$16,500

• There would be no access criteria or restrictions for funded access to Viekira Pak and Viekira Pak-RBV.
• These products would be listed in Section B of the Pharmaceutical Schedule as Xpharm – this means that pharmacies would not be able to claim subsidy as alternative distribution arrangement would be put in place by PHARMAC. A summary of the proposed distribution arrangement is provided below.
• Viekira Pak and Viekira Pak-RBV would have subsidy and delisting protection until 30 June 2019.
• A confidential discount and expenditure cap would apply until 30 June 2019 for Viekira Pak and Viekira Pak-RBV, reducing the net price of these products to the Funder.

Distribution

It is proposed that an alternative distribution mechanism for each of Harvoni, Viekira Pak and Viekira Pak-RBV would be put in place. These distribution arrangements would be similar to a number of other high cost funded medicines that are managed by PHARMAC, for example imatinib mesilate, glatiramer acetate, interferon beta-1-alpha etc.

Harvoni

A Hepatitis C Treatment Panel (HepCTP), would be established and managed by PHARMAC. The HepCTP would consider applications for funded access to Harvoni, assessing whether or not patients meet the criteria determined by PHARMAC. It is anticipated that the Panel would meet with a frequency determined based on the number of applications received and severity of clinical circumstances of the patients’ named in the applications; initially meetings would likely be monthly. Following confirmation by the HepCTP that the patient meets the funded access criteria the application would be approved.

Applicants would send a prescription, along with an application for funded access to Harvoni, to the HepCTP via PHARMAC. Should the application be approved, a PHARMAC employed Hep C Co-ordinator would organise for the product to be dispensed from a central pharmacy and sent to a destination nominated by the applicant.

Viekira Pak and Viekira Pak-RBV

In the case of Viekira Pak/Viekira Pak-RBV, it is proposed that a direct distribution mechanism would be funded and managed by AbbVie Ltd and that the dispensing and distribution of Viekira Pak/Viekira Pak-RBV would be as follows:

• In order to access funded treatment, in both the Community and in DHB Hospitals, a request form specifying, amongst other matters, an address for delivery, along with a prescription would be sent to PHARMAC’s Hep C Coordinator for processing.
• The Hep C Coordinator would then pass on the prescription and delivery address to the distributor (and dispensing pharmacy) arranged by AbbVie Ltd. Patient information would remain confidential between PHARMAC, the pharmacy and the distributor to ensure that patient information is not disclosed to AbbVie Ltd.
• Viekira Pak/Viekira Pak-RBV would be delivered to the patient at the address specified in the request form.
• AbbVie Ltd, would be required to ensure that patient counselling is offered by a health professional to patients requiring advice and support on taking their Viekira Pak/Viekira Pak-RBV.

Background

In New Zealand, there are approximately 20,000 people who have been diagnosed with chronic hepatitis C. There are thought to be a further 30,000 people who have chronic hepatitis C who aren’t yet diagnosed with the disease[1]. Current data also suggests that Māori are over represented in the population of people living with chronic hepatitis C.

Chronic hepatitis C is a disease which is caused by a virus. There are different types of virus, known as genotypes. Six different hepatitis C genotypes have been identified. In New Zealand the genotype distribution for hepatitis C is thought to be:

Genotype	NZ prevalence
1	57%
2	7%
3	35%
4	0.5%
5	0%
6	1%

The virus causes inflammation in the liver. Over time, usually several years, this inflammation can result in scarring of the liver, known as fibrosis. As fibrosis develops, liver cirrhosis may develop which means the liver stops working properly.

The damage inflicted on the liver as a result of the virus can lead to serious health outcomes such as liver failure, liver cancer and potentially death.

The proposals detailed in this consultation are for the funding of two medicines, Harvoni and Viekira Pak/ Viekira Pak – RBV, both of which can be used to treat chronic hepatitis C. They show the willingness of these two suppliers to find a solution for people with hepatitis C in New Zealand.

The proposals would not result in access to a registered funded treatment for patients with hepatitis C of genotypes 2-6 who are early in their infection. Under the proposals, patients with genotypes 2-6 would have access to a registered funded treatment should they develop severe liver disease. We note that more treatments for patients with chronic hepatitis C are in development, including treatments that would be suitable and registered for patients with genotypes 2-6. PHARMAC continues to explore more options to widen treatment coverage for those with hepatitis C.

Harvoni

The medicine ledipasvir with sofosbuvir, which is also known under the brand name Harvoni, is a medicine which is used for the treatment of chronic hepatitis C (all genotypes). It is supplied by Gilead Sciences (NZ) Ltd.

The clinical advice we have received indicates that more than 90% of people who take Harvoni for their chronic hepatitis C will be free of the virus 12 weeks after their treatment has stopped. This result is independent of the person’s hepatitis C genotype, the state of their disease and the treatment they have previously received.

The Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed an application for Harvoni at its May 2015 meeting. The Committee recommended that ledipasvir with sofosbuvir should be funded with a high priority for the following subpopulations:

• HCV patients with decompensated cirrhosis (all genotypes)
• HCV patients pre/post liver transplant (all genotypes)
• HCV patients with essential mixed cryoglobulinaemia (with associated purpuric skin rash, cryoglobulinaemic glomerulonephritis and systemic vasculitis).

PHARMAC estimates that, each year, there are approximately 250 people with hepatitis C and severe liver disease who would be eligible for treatment via this proposal.

PHARMAC is proposing that for patients with decompensated cirrhosis, patients would have to have a MELD score of 15 or greater in order to access treatment with Harvoni. PHARMAC is proposing this due to the financial impact of funding Harvoni. PHARMAC notes that, once further information is obtained in relation to uptake and use of Harvoni, the requirement to have a MELD score of 15 or greater may be reviewed.

The gross treatment cost per patient for a 12 week course of Harvoni would be $73,090.38.

PTAC also recommended that ledipasvir with sofosbuvir be funded for all other subpopulations of patients with chronic hepatitis C with a low priority, based solely on fiscal risk. Funding of all other subpopulations is not part of this proposal. If this proposal to fund Harvoni for patients with severe liver disease is progressed, the application for funding Harvoni for other subpopulations would remain open.

A link to the relevant PTAC minutes [PDF, 378 KB] can be found on the PHARMAC website.

We are aware that a number of patients would require access to ribavirin as part of their treatment with Harvoni. Ribavirin is currently subsidised, co-packaged with pegylated interferon alfa, via Special Authority. PHARMAC is looking at options in relation to the funding of ribavirin and is developing a proposal around that which will be consulted on in the near future.

Viekira Pak and Viekira Pak-RBV

The medicine paritaprevir with ritonavir and ombitasvir with dasabuvir, which is also known under the brand name Viekira Pak, and paritaprevir with ritonavir and ombitasvir with dasabuvir and also with ribavirin, with the brand name Viekira Pak-RBV, are medicines used for the treatment of chronic hepatitis C.

Viekira Pak and Viekira Pak-RBV are both indicated for the treatment of people who have hepatitis C genotype 1. Using the genotype distribution information provided above this would equate to approximately 11,400 people who are currently diagnosed with chronic hepatitis C in NZ.

The clinical advice we have received indicates that more than 90% of people who take Viekira Pak or Viekira Pak-RBV for their chronic hepatitis C will be free of the virus 12 weeks after their treatment has stopped. This was the case in treatment naïve and treatment experienced people, and in non-cirrhotic and cirrhotic people.

PTAC reviewed an application for Viekira Pak and Viekira Pak-RBV at its August 2015 meeting. In summary, the Committee recommended that it should be funded for the treatment of chronic hepatitis C genotype 1 infection in adults with a low priority based solely on fiscal risk.

The gross treatment cost per patient (ie cost at list prices) for a 12 week course of Viekira Pak or Viekira Pak-RBV would be $49,500.

A link to the relevant PTAC minutes [PDF, 378 KB] can be found on the PHARMAC website.

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