This is the text extract for Proposal to list buprenorphine with naloxone (Suboxone); Closing Date: Closed; Contact: Sue Anne Yee, browse documents here.

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23 April 2012

Proposal to list buprenorphine with naloxone (Suboxone)

PHARMAC is seeking feedback on a proposal to fund buprenorphine with naloxone (Suboxone) sublingual tablets through a provisional agreement with Reckitt Benckiser Pharmaceuticals. In summary, this proposal would result in the controlled drug, buprenorphine with naloxone (Suboxone) sublingual tablets being fully funded from 1 July 2012 for detoxification and maintenance treatment in opiate dependent patients.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday, 8 May 2012 to: Sue Anne Yee Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: sueanne.yee@pharmac.govt.nz Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

Details of the proposal  Buprenorphine with naloxone (Suboxone) sublingual tablets would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2012 as follows:

Chemical Buprenorphine with naloxone Buprenorphine with naloxone Presentation Tab sublingual 2 mg with naloxone 0.5 mg Tab sublingual 8 mg with naloxone 2 mg Brand Suboxone Pack size 28 Price and subsidy $57.40

Suboxone

28

$166.00

 

The subsidy paid for Suboxone would be subject to confidential rebates; and, Buprenorphine with naloxone (Suboxone) would be funded subject to the following Special Authority restriction:

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Initial application - (Detoxification) from any medical practitioner. Approvals valid for 1 month for applications meeting the following criteria: All of the following: 1 Patient is opioid dependent; and 2 Patient is currently enrolled in an opioid substitution treatment program in a service approved by the Ministry of Health; and 3 Applicant works in an opioid substitution treatment service approved by the Ministry of Health. Initial application - (Maintenance treatment) from any medical practitioner. Approvals valid for 12 months for applications meeting the following criteria: All of the following: 1 Patient is opioid dependent; and 2 Patient will not be receiving methadone; and 3 Patient is currently enrolled in an opioid substitution treatment program in a service approved by the Ministry of Health; and 4 Applicant works in an opioid substitution treatment service approved by the Ministry of Health. Renewal – (Detoxification) from any medical practitioner. Approvals valid for 1 month for applications meeting the following criteria: All of the following: 1 Patient is opioid dependent; and 2 Patient has previously trialled but failed detoxification with buprenorphine with naloxone and another attempt is planned; and 3 Patient is currently enrolled in an opioid substitution treatment program in a service approved by the Ministry of Health; and 4 Applicant works in an opioid substitution treatment service approved by the Ministry of Health. Renewal - (Maintenance treatment) from any medical practitioner. Approvals valid for 12 months for applications meeting the following criteria: All of the following: 1 Patient is receiving maintenance therapy with buprenorphine with naloxone (and is not receiving methadone); and 2 Any of the following: 2.1 Patient is still unstable and requires further treatment; or 2.2 Patient achieved significant improvement but requires further treatment; or 2.3 Patient is well controlled but requires further treatment; and 3 Patient is currently enrolled in an opioid substitution program in a service approved by the Ministry of Health; and 4 Applicant works in an opioid substitution treatment service approved by the Ministry of Health. Renewal - (Maintenance treatment where the patient has previously had an initial application for detoxification) from any medical practitioner. Approvals valid for 12 months for applications meeting the following criteria: All of the following: 1 Patient received but failed detoxification with buprenorphine with naloxone; and 2 Maintenance therapy with buprenorphine with naloxone is planned (and patient will not be receiving methadone); and 3 Patient is currently enrolled in an opioid substitution program in a service approved by the Ministry of Health; and 4 Applicant works in an opioid substitution treatment service approved by the Ministry of Health.

A494652T07-058

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Background Buprenorphine with naloxone (Suboxone) is a controlled drug. It is indicated for the treatment of opiate dependence within a framework of medical, social and psychological treatment. The buprenorphine component suppresses withdrawal and cravings associated with opiate dependence. The naloxone component deters intravenous misuse of the product because it is an opioid antagonist which is poorly absorbed sublingually or orally but well absorbed intravenously so patients injecting buprenorphine with naloxone would experience withdrawal symptoms. PTAC recommended that buprenorphine with naloxone be funded with low priority for both detoxification and maintenance treatment for opiate dependence at its meeting in February 2008. The relevant PTAC minutes can be found at: http://www.pharmac.govt.nz/2008/02/01. Methadone is currently the only funded opiate dependence treatment and it requires close monitoring due to its abuse potential. This proposal to fund buprenorphine with naloxone would provide an alternative opiate dependence treatment and would reduce inpatient stays for detoxification as patients would be able to be treated as outpatients.

A494652T07-058

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