Proposal to list a new presentation of raltegravir and amend arrangements for raltegravir and posaconazole

What we’re proposing

PHARMAC is seeking your feedback on a multiproduct proposal with Merck Sharpe & Dohme (MSD). The proposal would list a new, once-daily presentation of raltegravir for the treatment of HIV, as well as make changes to the contractual arrangements for the currently funded presentation of raltegravir and for posaconazole.

Consultation closes at 5 pm on Friday, 21 December 2018 and feedback can be emailed to alexander.rodgers@pharmac.govt.nz.

What would the effect be?

Raltegravir

A new 600 mg tablet formulation of raltegravir would be funded (brand name Isentress HD) once it has received Medsafe registration. The currently funded 400 mg tablet formulation of raltegravir (Isentress) is taken twice a day, while the 600 mg tablet formulation is taken once a day. Both the current and new formulations would be funded subject to the restrictions that currently apply to the 400 mg formulation; there would be no change to the funding criteria for raltegravir.

Raltegravir (Isentress and Isentress HD) would have protection from subsidy reduction and delisting until 30 June 2022.

Posaconazole

The proposal would amend the confidential rebates that apply to posaconazole tablets and liquid (Noxafil). The effect of this would be to reduce the net price of posaconazole.

Posaconazole (Noxafil) would have protection from subsidy reduction and delisting until 30 June 2022.

There would not be any changes to the funding restrictions for posaconazole.

For Patients

Patients would have a choice of raltegravir regimens if their clinician considers it appropriate, either twice a day or once a day at their preference. We understand that both regimens are similarly effective, so the decision would be between a clinician and their patient. Patients currently on the twice-daily regimen would not be required to switch.

The funding restrictions for raltegravir and posaconazole would not change.

For Prescribers

Prescribers would have two options for raltegravir regimens. Otherwise no change is expected.

For DHBs

The new rebate on posaconazole would lead to a lower net price than the current rebate. This proposal would therefore provide savings which can be reinvested in other medicines.

Who we think will be interested

• Clinicians who prescribe HIV treatments.
• Patients with HIV.
• Suppliers of HIV treatments or of other anti-infective agents.
• Hospital and community pharmacists, and wholesalers.
• DHBs. 

About posaconazole and raltegravir

Posaconazole is an antifungal drug used to treat or prevent invasive aspergillosis and candidiasis. It is funded specifically for patients who either have acute myeloid leukaemia and are to be treated with high dose remission induction, re-induction or consolidation chemotherapy; or who have received a stem cell transplant and has graft versus host disease and is on significant immunosuppressive therapy. The Community Special Authority for posaconazole(external link) can be viewed here.

Raltegravir is an HIV treatment. It is an integrase inhibitor and is funded under the same criteria as other HIV treatments. The community Special Authority criteria for raltegravir can be viewed here(external link). The currently funded presentation (Isentress) is formulated to be taken one tablet per dose, two doses per day. The proposed new presentation (Isentress HD) would be taken two tablets per dose, one dose per day.

Why we’re proposing this

PHARMAC runs an annual tender each year for medicine that are off-patent. Before this we invite suppliers to submit alternative commercial proposals.

Merck Sharp & Dohme (MSD) presented us with such a proposal, which included changes to the arrangements for posaconazole and raltegravir as described in this consultation letter.

We consider that the proposal offers an opportunity to list a new form of raltegravir as part of a commercially acceptable arrangement.

Details about our proposal

Posaconazole (Noxafil)

The confidential rebates that apply to both Noxafil presentations (tab modified-release 100 mg and oral liq 40 mg per ml) would be changed from 1 February 2019. The effect of this would be to reduce the net cost of posaconazole.

The Noxafil brand of posaconazole would have subsidy and delisting protection until 30 June 2022.

There would be no changes to the list price, or to the funding restrictions.

Raltegravir potassium tab 400 mg (Isentress)

The currently listed form of raltegravir potassium tab 400 mg, Isentress, would have subsidy and delisting protection until 30 June 2022.

There would be no other changes to the listing: the list price, confidential rebate and funding restrictions would all remain the same as they are now.

Raltegravir potassium tab 600 mg (Isentress HD)

A new, once-daily 600 mg tablet presentation of raltegravir potassium, Isentress HD, would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule after it has received Medsafe approval. An application is currently being considered by Medsafe.

The 600 mg tablet presentation would be listed at a price and subsidy of $1,090.00 per pack of 60 tablets (ex-manufacturer, excluding GST), which is the same list price per tablet as the 400 mg tablet presentation.

The 600 mg tablet presentation would be funded subject to the same funding restrictions as the 400 mg tablet.

A confidential rebate would apply to Isentress HD, which would reduce the cost of the medicine to the funder.

Isentress HD would have subsidy and delisting protection until 30 June 2022.

To provide feedback

Send us an email: alexander.rodgers@pharmac.govt.nz by 5pm on Friday 21 December 2018.

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.