Entecavir and Tenofovir Disproxil

CONSULTATION

Proposal to widen access and change the funded brand of tenofovir disoproxil and entecavir 9 March 2018

What we’re proposing PHARMAC is delighted to propose the widening of access to tenofovir disoproxil and entecavir, antiviral medicines used for the treatment of hepatitis B and HIV. These changes would have impacts that we would like your feedback on: • From 1 June 2018 the Special Authority and Hospital Restrictions for both chemicals would be removed.

• The funded brand of tenofovir disoproxil would change from Viread (supplied

by Gilead) to Tenofovir Disoproxil Teva (supplied by Teva). Tenofovir Disoproxil Teva would be the only funded brand of tenofovir disoproxil in both the community and hospital setting. A transition period would start 1 June 2018.

• Teva’s brand of tenofovir disoproxil is a different salt and strength to the currently funded brand of tenofovir disoproxil (Viread). From 1 June 2018 prescriptions should be written for the base chemical tenofovir disoproxil 245 mg. Note, the base chemical (tenofovir disoproxil) of these two brands are the same strength (245 mg) and considered clinically equivalent.

• The funded brand of entecavir would change from Baraclude (supplied by BMS) to Entecavir Sandoz (supplied by Novartis). Entecavir Sandoz would be the only funded brand of entecavir in both the community and hospital setting. A transition period would occur as soon as practical after Entecavir Sandoz is Medsafe registered.

• Transition timeframes and further information is detailed below including sole supply, reference pricing, additional repeat funding and brand switch fees.

Consultation closes at 5 pm on Monday, 26 March 2018 and can be emailed to: procurement@pharmac.govt.nz. Please share this information with other groups you think may be interested in provided feedback.

What would the effect be?

For Patients • • •

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Patients with Hepatitis B would be able to access funded entecavir or tenofovir disoproxil without restriction in consultation with their doctor.

Patients with HIV would have no access change, for tenofovir disoproxil, this would continue to be included in the count of up to four subsidised antiretrovirals.

All patients on treatment with tenofovir disoproxil or entecavir would experience a brand change.

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CONSULTATION •

Some patients could require a new prescription due to a change in the salt of tenofovir disoproxil.

More information would be available during the transition period from pharmacists, prescribers and PHARMAC’s website.

For Community Pharmacies • •

•

Pharmacies would need to start transitioning patients to the new brands of tenofovir disoproxil and entecavir after they are listed. Incumbent brands would be referenced priced two months after the new listing.

There would be impacts on repeat prescriptions for tenofovir disoproxil fumerate during the transition due to the change of salt and strength.

PHARMAC are investigating options to allow repeat prescriptions for the Viread brand of tenofovir disoproxil started prior to reference pricing to be fully subsidised up until the start of the sole supply period. o For example, a valid prescription written for tenofovir disoproxil fumerate 300 mg first dispensed on 30th July 2018, would have both repeats issued with the Viread brand fully funded if collected prior to 1st November 2018.

A brand switch fee would apply to both chemicals to aid in this transition.

For Hospital Pharmacies • • •

From 1 June 2018 hospital pharmacies would start transitioning from the incumbent brand of Tenofovir Disoproxil (Viread) to Tenofovir Disoproxil Teva.

From 1 September 2018 only 1% of total purchases of tenofovir disoproxil tablets could be a brand other than Tenofovir Disoproxil Teva. The DV limit would apply to any salt of tenofovir disoproxil tablets.

After Entecavir Sandoz is listed, Hospital Pharmacies would commence transitioning from the incumbent brand of entecavir (Baraclude) to Entecavir Sandoz. Three months from this date only 1% of total purchases of entecavir tablets could be a brand other than Entecavir Sandoz.

For Prescribers •

• • •

From 1 June 2018 prescribers would be able to choose for their patients tenofovir disoproxil or entecavir and have these funded without restrictions.

We are interested in feedback regarding any additional educational needs for prescribers regarding these treatments to support the proposed widened access.

From 1 June 2018 new prescriptions should be written as the base chemical tenofovir disoproxil 245 mg.

Tenofovir disoproxil would continue to be included in the count of up to four subsidised antiretrovirals when co-prescribed with other antiretrovirals for the treatment of HIV. No endorsement would be required on the prescription.

There would be a reduction in administration workload involved in applying for Special Authorities for these patients.

For DHBs Significant savings would be achieved through this proposal and more patients would have access to funded tenofovir disoproxil and entecavir tablets.

Who we think will be interested • •

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Patients currently taking entecavir or tenofovir disoproxil tablets Patients with Chronic Hepatitis B or HIV

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CONSULTATION • •

Gastroenterologists, infectious disease specialists, named HIV specialists and general practitioners Hospital and community pharmacists, DHBs, suppliers and wholesalers.

About tenofovir disoproxil and entecavir Tenofovir disoproxil fumarate is a salt of an oral prodrug of tenofovir with activity against HBV polymerase and human immunodeficiency virus (HIV) reverse transcriptase. Tenofovir disoproxil fumarate has been approved in New Zealand for treatment of HIV infection since November 2005 and chronic Hepatitis B infection since April 2008.

The Anti-infective Subcommittee of PTAC at its October 2016 meeting advised that once alternative salts of tenofovir disoproxil were approved by Medsafe with tenofovir disoproxil fumerate as the reference product, they would be considered clinically equivalent. Proposals received for this RFP included tenofovir disoproxil fumerate, tenofovir disoproxil maleate, tenofovir disoproxil succinate. Teva’s tenofovir disoproxil succinate product is approved by Medsafe with tenofovir disoproxil succinate as the reference product.

Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV) polymerase. Entecavir has been approved for treatment of chronic Hepatitis B (CHB) infection in New Zealand since September 2006.

Why we’re proposing this PHARMAC released a Request for Proposals (RFP) for the supply of entecavir and tenofovir disoproxil to community pharmacies and DHB hospitals on 19 July 2017 to obtain the best possible pricing from suppliers of entecavir and tenofovir disoproxil tablets to enable to reduced expenditure with wider access to both treatments.

As a result of the RFP, PHARMAC has entered into provisional agreements with Novartis New Zealand Limited and Teva Pharma (New Zealand) Limited and feedback to this consultation will help us decide if these agreements should be confirmed.

Benefits to patients Currently, entecavir can be used as a first line treatment option whereas tenofovir disoproxil is only available after previous treatments have resulted in viral resistance or where patients are meeting other funding restriction criteria.

As part of the agreements with Novartis and Teva, PHARMAC proposes to remove the funding restrictions on entecavir and tenofovir disoproxil achieving the RFPs clinical goals of widened access.

Benefits to pharmaceutical expenditure Substantial savings to the Combined Pharmaceutical Budget and DHB hospital pharmaceutical spend would result from this proposal enabling PHARMAC to fund more medicines for more New Zealanders.

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CONSULTATION

Details about our proposal Listing of Tenofovir Disoproxil Teva and Entecavir Sandoz On 1 June 2018, PHARMAC propose that Teva’s brand of tenofovir disoproxil (Tenofovir Disoproxil Teva), and following Medsafe approval, Novartis’ brand of entecavir (Entecavir Sandoz) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

•

Base chemical

Dose form and strength of base chemical

Tenofovir disoproxil

Tab 245 mg

Entecavir

Tab 0.5 mg

Pack size

Proposed price and subsidy

Tenofovir Disoproxil Teva

30

$38.10

Entecavir Sandoz

30

$52.00

Brand

The Special Authority restrictions applying to Baraclude and Viread in Section B would be removed from 1 June 2018.

Tenofovir Disoproxil •

From 1 June 2018 there would be no Special Authority, endorsement restrictions or hospital restrictions applying to Tenofovir Disoproxil Teva.

•

When tenofovir disoproxil is co-prescribed with other antiretrovirals for the treatment of HIV it would continue to be included in the count of up to 4 subsidised antiretrovirals for the purposes of Special Authority SA1651.

•

Listing the Teva brand of tenofovir disoproxil would result in a change of salt of this chemical. From 1 August 2018, new prescriptions would need to be presented as the base chemical (tenofovir disoproxil 245mg) or the new salt (tenofovir disoproxil succinate 300.6 mg) to get full subsidy. The strength of the proposed salt is different from the current product however both are equivalent to 245 mg of the base chemical tenofovir disoproxil, as follows: Base Chemical and strength

Salt and Strength

Current

tenofovir disoproxil 245 mg

Proposed

tenofovir disoproxil 245 mg

Brand

Colour/shape/dose form

tenofovir disoproxil fumerate 300 mg

Viread

Light blue/ almond shape/ tablet

tenofovir disoproxil succinate 300.6 mg

Tenofovir Disoproxil Teva

Light blue/ almond shape/ tablet

We are interested in any specific feedback about the implications for patients, pharmacists and prescribers, software vendors in the proposed change from tenofovir disoproxil fumerate 300 mg to tenofovir disoproxil succinate 300.6 mg.

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CONSULTATION Entecavir •

There would be no Special Authority restrictions or hospital restrictions applying to Entecavir Sandoz.

•

Entecavir Sandoz would be listed as soon as practicable following Medsafe approval.

•

There are no salt changes to entecavir. New and incumbent presentations are listed below: Base Chemical and strength

Salt

Brand

Colour/shape/ dose form

Current

entecavir 0.5 mg

entecavir monohydrate

Baraclude

White to off-white, triangular shaped/ tablet

Proposed

entecavir 0.5 mg

entecavir monohydrate

Entecavir Sandoz

White, round shaped/ tablet

Timeline In the Community Two months after listing of Tenofovir Disoproxil Teva/Entecavir Sandoz Two months after the proposed listings, the subsidies for the incumbent brands would be reduced, via the application of reference pricing, to the new proposed subsidy relating to Tenofovir Disoproxil Teva and Entecavir Sandoz, as follows:

Chemical and presentation

Current Brand

Pack size

Current subsidy and price

Proposed subsidy (price)

Viread

30

$531.00

$38.10 ($531.00)

Baraclude

30

$400.00

$52.20 ($400.00)

tenofovir disoproxil fumerate tab 300 mg ** (equivalent to tenofovir disoproxil 245 mg) entecavir tab 0.5 mg

** Reference pricing for the Viread brand would be from 1 August 2018.

• If the supplier of Viread tablets decides not to reduce the price of Viread to match the new proposed subsidy, a manufacturer’s surcharge would apply when Viread is prescribed (Please note due to the salt change and to support transition, we are investigating options to fully fund repeats of Viread up until the start of the sole supply period).

• If the supplier of Baraclude tablets decides not to reduce the price of Baraclude to match the new proposed subsidy, a manufacturer’s surcharge would apply when Baraclude is prescribed.

Five months after listing of Tenofovir Disoproxil Teva/Entecavir Sandoz Five months after Tenofovir Disoproxil Teva is listed, the Viread brand would be delisted from Section B of the Pharmaceutical Schedule from 1 November 2018.

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CONSULTATION From this date, Tenofovir Disoproxil Teva would have Sole Subsidised Supply (SSS) until 30 June 2021.

Five months after Entecavir Sandoz is listed, the Baraclude brand would be delisted from Section B of the Pharmaceutical Schedule. From this date, Entecavir Sandoz would have SSS until 30 June 2021.

In DHB Hospitals Three months after listing of Tenofovir Disoproxil Teva/Entecavir Sandoz Three months after Tenofovir Disoproxil Teva is listed in the Hospital Medicines List (HML), the Viread brand would be delisted from 1 September 2018. Hospital Supply Status (HSS) with a 1% Discretionary Variance (DV) limit would then apply in DHB hospitals for Tenofovir Disoproxil Teva. HSS would apply until 30 June 2021.

Three months after Entecavir Sandoz is listed in the HML following Medsafe approval, the Baraclude brand would be delisted. HSS with a 1% DV limit would then apply in DHB hospitals for Entecavir Sandoz. HSS would apply until 30 June 2021.

To provide feedback PHARMAC welcomes feedback on this proposal.

Consultation closes at 5 pm on Monday, 26 March 2018 and can be emailed to: procurement@pharmac.govt.nz. Please share this information with other groups you think may be interested in provided feedback.

Specific areas of feedback to consider: 1. Additional educational support needed for healthcare professionals around the appropriate use of these medicines? If so, what would be helpful?

2. Any implications for patients, pharmacists and prescribers, vendors regarding the proposed change in salt and strength from tenofovir disoproxil fumerate 300 mg to tenofovir disoproxil succinate 300.6 mg?

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.

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