PHARMAC Glecaprevir and Pibrentasvir (Maviret) Consultation

CONSULTATION

Proposal to fund a pangenotypic hepatitis C treatment - glecaprevir and pibrentasvir (Maviret) 20 July 2018

What we’re proposing We propose to fund a pangenotypic treatment for chronic hepatitis C infection, glecaprevir and pibrentasvir (Maviret), through a provisional agreement with AbbVie Ltd. We also seek feedback on the proposed distribution arrangements.

In summary, this proposal would result in the following changes at a date to be determined: 

Glecaprevir and pibrentasvir (Maviret) 100 mg/40 mg tablets would be funded in the community and DHB hospitals without restrictions for patients with chronic hepatitis C. Listing would be no earlier than 1 October 2018. The list date would be confirmed as soon as possible pending Medsafe approval of a Changed Medicine Notification for Maviret.

Maviret would replace Viekira Pak and Viekira Pak-RBV.

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Proposed distribution arrangements for Maviret: 

Maviret would be listed ‘XPHARM’ in the Schedule and only pharmacies registered as a ‘Maviret AbbVie Care Pharmacy’ could provide funded Maviret.

Patients would present a prescription for Maviret directly to the pharmacy.

Pharmacies would order stock through Healthcare Logistics and process the prescription through dispensing software (see below for details).

Pharmacies would be reimbursed for dispensing and professional services outside of normal subsidy and claiming arrangements.

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Consultation closes at 5 pm on Monday, 13 August 2018 and feedback can be emailed to Matthew Tyson, Therapeutic Group Manager, at: hepc@pharmac.govt.nz. Please share this information with other groups you think may be interested in providing feedback.

Who we think will be interested

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 People with chronic hepatitis C infection  Gastroenterologists, infectious disease specialists, general practitioners, nurses  Organisations that support people at risk of chronic hepatitis C infection Hospital and community pharmacists, DHBs, suppliers and wholesalers.

Pharmacy software vendors

What would the effect be?

For people starting treatment  All people with chronic hepatitis C would be able to access a funded treatment, regardless of disease genotype.

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People would not need to pay a co-payment for Maviret.

Those people not able to take Maviret may be eligible for funded ledipasvir with sofosbuvir (see below).

For people already on treatment People who are already on a treatment course of Viekira Pak or Harvoni would be able to complete their course and should not switch therapies.

For people with hepatic impairment Maviret is not recommended in those people with moderate hepatic impairment (Child-Pugh B) and is contraindicated in those with severe hepatic impairment (Child-Pugh C). Ledipasvir with sofosbuvir (Harvoni) would remain a funded treatment option for these people via current access criteria and distribution arrangements through the Hepatitis C Treatment Panel.

For community pharmacies We are proposing a purchase and claiming mechanism for Maviret that is different to the current system that is in place for Viekira Pak and Viekira PakRBV. This is to align distribution with standard pharmacy processes as much as possible and improve the claims data available for hepatitis C treatments. This would also reduce the administration burden from manually processing the supply of hepatitis C treatments through PHARMAC and the distributor. More details on this proposed mechanism are outlined in the ‘Details about our proposal’ section.

For hospital pharmacies Maviret would be listed on the HML subject to supply being sourced through PHARMAC’s approved distribution mechanism. Hospital pharmacies would need to process any usage through a pharmacy with access to community dispensing software and an ability to register with the Maviret AbbVie Care Pharmacy Programme for the provision of stock and reimbursement of service costs.

For prescribers  

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Prescribers would be able to prescribe Maviret for all appropriate people with chronic hepatitis C. For those with moderate to severe hepatic impairment, Harvoni would remain a funded treatment option.

Prescriptions for Maviret would be provided to the patient who would present it at a Maviret AbbVie Care registered pharmacy identified during the consultation with the patient. This differs from the current Viekira Pak arrangement where prescribers provide a distribution request direct to PHARMAC. Where a Maviret AbbVie Care pharmacy is not accessible, the prescribers requests an ‘alternative distribution form’ from PHARMAC to arrange medication counselling and delivery.

The ‘health pathways’ or a DHB’s equivalent clinical support platform would be updated by the Ministry of Health to reflect these changes.

We are interested in feedback regarding any additional educational needs for prescribers regarding these treatments to support this proposal.

For DHBs  

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Funding of this new treatment may lead to an increase in demand for related services such as fibro-scanning.

In the long term, it would reduce demand for services such as late stage liver care, hepatocellular carcinoma support and liver transplantation.

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About Hepatitis C & glecaprevir/pibrentasvir (Maviret) Hepatitis C The hepatitis C virus (HCV) causes both acute and chronic hepatitis. The acute process is self-limited, and rarely causes hepatic failure, but usually leads to chronic infection. Chronic HCV infection often follows a progressive course over many years and can ultimately result in liver cirrhosis, hepatocellular carcinoma, and the need for liver transplantation. Hepatitis C is now the most common reason for liver transplant in New Zealand; in 2013, 54% of all adult transplants were attributable to HCV. In New Zealand, there are approximately 20,000 people who are diagnosed with hepatitis C with an estimated 1,000 new cases each year. It is estimated that there are up to 30,000 individuals who are infected with HCV but are currently undiagnosed1. In New Zealand this is dominated by genotypes 1 (57%) and 3 (35%). Genotypes 2 (7%), 4 (0.5%) and 6 (0.5%) make up a small percentage overall, with genotype 5 essentially not occurring in New Zealand.

Given non-genotype 1 patients make up 43% of HCV infected individuals in New Zealand, there are approximately up to 21,000 people (both diagnosed and undiagnosed) who would benefit from this proposal who are not currently able to benefit from the currently funded treatments.

We note that there is uncertainty around the total number of people in New Zealand with hepatitis C this is in part due to the large pool of undiagnosed individuals. We are currently supporting primary care to identify people with hepatitis C currently enrolled in PHOs through the matching of laboratory data.

We are aware of other national level activities in development that would support identifying people with hepatitis C who are currently undiagnosed.

Glecaprevir and pibrentasvir (Maviret) Glecaprevir and pibrentasvir (Maviret) contains two direct acting antiviral agents (DAAs) with distinct mechanisms of action and non-overlapping resistance profiles. Detailed information about Maviret can be found in the Medsafe datasheet.

Maviret has been approved in New Zealand for treatment of chronic hepatitis C infection since June 2018. Medsafe is assessing the approval of a new manufacturing plant via a Changed Medicine Notification that would provide stock to the New Zealand market.

The Pharmacology and Therapeutics Advisory Committee (PTAC), at its August 2017 meeting, recommended that glecaprevir and pibrentasvir be funded for the treatment of chronic hepatitis C in adults with medium priority.

PTAC considered that in comparison with Viekira Pak, glecaprevir/pibrentasvir (Maviret) has better efficacy, no requirement for ribavirin, which reduces the number of side-effects and complexity of treatment, significantly less drug-drug interactions and has a reduced treatment duration. The Committee considered that these benefits, along with no requirement for pre-treatment genotype testing, should make prescribing by general practitioners straight forward.

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Gane et al. Impact of improved treatment on disease burden of chronic hepatitis C in New Zealand NZMJ; 2014; 127:1407: 61- 74. Available from NZMJ A1163955

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CONSULTATION More information, including a link to the PTAC minutes, can be found in the Application Tracker record for glecaprevir and pibrentasvir.

Differences between Maviret and Viekira Pak Maviret has a number of advantages over Viekira Pak2 and Viekira Pak-RBV3 as detailed below: Maviret

Viekira Pak

Genotypes

All genotypes

Genotype 1 only

Dose Frequency

Once per day

Twice per day

Drug-drug interactions

Few

Many

Treatment duration#

8 weeks (non-cirrhotic, treatment naïve patients)

8*-12 weeks (non-cirrhotic, treatment naïve)

12 weeks (cirrhotic treatment naïve patients)

12 weeks (cirrhotic treatment naïve patients)

Not required

Yes for some patients

Ribavirin required

* In genotype 1b: 8 weeks may be considered in previously untreated patients without advanced fibrosis or cirrhosis #

treatment experienced regimens vary, please refer the Medsafe datasheet

Why we’re proposing this In June 2016, PHARMAC notified of its decision to fund two new DAA treatments, Viekira Pak and Viekira Pak-RBV and Harvoni (ledipasvir with sofosbuvir).

Viekira Pak is indicated for genotype 1a and 1b and is listed with no funding restrictions. Harvoni is indicated for genotypes 1, 4, 5 or 6, and is currently restricted to patients with any genotype with severe liver disease. Funded access to Harvoni has been widened since the initial listing by refining the disease severity criteria. To date, over 3000 patients have been treated with DAA treatment for chronic hepatitis C. PHARMAC are aware that the majority of people with genotype 2-6 have no funded DAA treatment option. These people, if they chose to be on treatment, currently use interferon based therapies which are less effective and can be poorly tolerated.

This proposal would mean that all people with chronic hepatitis C could access a new generation funded DAA treatment, regardless of disease genotype.

PHARMAC has negotiated a provisional agreement with AbbVie New Zealand Limited and feedback to this consultation will help us decide if this agreement should be confirmed.

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paritaprevir with ritonavir and ombitasvir co-packaged with dasabuvir paritaprevir with ritonavir and ombitasvir co-packaged with dasabuvir and ribavirin A1163955

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Details about our proposal Listing of glecaprevir and pibrentasvir (Maviret) PHARMAC propose that Maviret would be listed with no restrictions in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

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Chemical

Presentation

Brand

Pack size

Price and subsidy

glecaprevir and pibrentasvir

Tab 100 mg with pibrentasvir 40 mg (84 tablets)

Maviret

84 OP

$24,750

Listing would be no earlier than 1 October 2018. The date of listing would be determined in the future, and is dependent on regulatory approval of an additional manufacturing site via a Changed Medicine Notification.

Maviret would have subsidy and delisting protection for three years from the date of listing.

A confidential risk sharing agreement would apply for Maviret, reducing the net price to the Funder. There is no cap to the number of patients that can be treated.

The HML listing would direct hospital pharmacies to use the community based claiming and distribution process described below.

Distribution It is proposed that an alternative distribution mechanism for Maviret would be put in place. This is similar to the mechanism for Viekira Pak or Viekira Pak-RBV, with some differences to align distribution with standard pharmacy processes as much as possible and improve the claims data available for hepatitis C treatments. This would also reduce the administration burden from manually processing the supply of hepatitis C treatments through PHARMAC and the distributor.

The process and its impacts are detailed below:   

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Maviret would be listed in the Pharmaceutical Schedule as ‘XPHARM’.

Only pharmacies registered as a Maviret AbbVie Care Pharmacy could provide funded Maviret.

Pharmacies would need to complete the ‘Maviret online Quality Use of Medicines training module’, even if they are an existing Viekira Pak AbbVie Care pharmacy’, and agree to the terms and conditions for the Maviret AbbVie Care Pharmacy Programme to be registered. Current Viekira Pak AbbVie Care Pharmacies can be found here.

Pharmacies would need a current Healthcare Logistics trading account to order stock via their dispensing software. This functionality would only be activated once their registration as a Maviret AbbVie Care pharmacy is complete.

A prescriber would provide a prescription for Maviret direct to the patient who would present it at a Maviret AbbVie Care registered pharmacy, identified during the consultation with the patient.

Where a Maviret AbbVie Care pharmacy is not accessible, the prescriber requests an ‘alternative distribution form’ from PHARMAC to arrange medication counselling and delivery.

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Pharmacies would dispense the prescription with an ‘NS’ patient code. In this case this would mean prescription information is provided to the Ministry of Health and PHARMAC through claims data (this is specific for Maviret).

Software vendors (Toniq and Rx One) have made necessary changes and tested their systems to enable dispensing data capture with the proposed mechanism of dispensing using the NS patient code.

Stock to be ordered from Healthcare Logistics through dispensing software.

Maviret would be provided to Maviret AbbVie Care Pharmacies free of charge. This means pharmacies would not be left with the liability of expensive stock.

Pharmacies would be reimbursed for the professional services related to dispensing and counselling for Maviret at $100 per patient (excluding GST).

Pharmacies would receive stock for the complete course of treatment per order and dispense to the patient monthly.

Delisting of Viekira Pak and Viekira Pak-RBV We propose that on the date of listing Maviret, Viekira Pak and Viekira Pak-RBV would be delisted in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule.

We note that pharmacies with people who have already commenced on Viekira Pak or Viekira Pak-RBV therapy would have received the full subsidised treatment course. The delisting would not affect these people currently taking Viekira Pak or Viekira Pak-RBV and pharmacies would be expected to provide these people with the complete treatment course as per the prescribed regimen.

We are interested in feedback regarding any issues that should be considered with this proposed transition.

To provide feedback Consultation closes at 5 pm on 13 August 2018 and can be emailed to: hepc@pharmac.govt.nz.

Please share this information with other groups interested in providing feedback.

We particularly seek your feedback on the following areas: 1. What additional educational support or implementation activities would be needed for healthcare professionals around the appropriate use of Maviret?

If so, what would be helpful?

2. We note that on the date of Maviret being listed, Viekira Pak and Viekira Pak-RBV would be delisted. Are there any issues that should be considered with this transition?

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 A1163955

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CONSULTATION 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.

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