1.0 Product Summary
Suboxone Film
- 1.1 Suboxone Film (buprenorphine/naloxone) ("Suboxone Film") is indicated for substitution treatment in adults with opioid drug dependence.
- 1.2 Health Canada first issued a Notice of Compliance for Suboxone Film on July 17, 2020. Suboxone Film was first sold in Canada on August 15, 2018, through the Access to Drugs in Exceptional Circumstances regulatory pathway, namely, the List of Drugs for an Urgent Public Health Need (UPHN).
- 1.3 Suboxone Film is available as a soluble film. It is available in four strengths: 2/0.5 mg/film (DIN 02502313), 4/1 mg/film (DIN 02502321), 8/2 mg/film (DIN 02502348), and 12/3 mg/film (DIN 02502356).
- 1.4 The first reported patent pertaining was granted on July 18, 2017. The last reported patent pertaining is set to expire on August 5, 2030. Indivior UK Ltd. ("Indivior") is the rights holder for the purposes of the Patent Act and the Patented Medicine Prices Review Board (PMPRB).
Sublocade
- 1.5 Sublocade (buprenorphine) is indicated for the management of moderate to severe opioid use disorder in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product.
- 1.6 Health Canada first issued a Notice of Compliance for Sublocade on November 21, 2018. Sublocade was first sold in Canada on March 20, 2019, through the Access to Drugs in Exceptional Circumstances regulatory pathway, namely, the UPHN.
- 1.7 Sublocade is available as an extended-release solution for injection in a single-use, prefilled syringe. It is presented in strengths of 100 mg/syringe (DIN 02483084) and 300 mg/syringe (DIN 02483092).
- 1.8 The first reported patent pertaining was granted on August 7, 2018. The last reported patent pertaining is set to expire on November 6, 2035. Indivior is the rights holder for the purposes of the Patent Act and the PMPRB.
2.0 Application of the Guidelines
- 2.1 The Human Drug Advisory Panel (HDAP) recommended that Suboxone Film be classified as a Slight or No Improvement. In accordance with the Guidelines, a Reasonable Relationship (RR) test was conducted for each strength of Suboxone Film. The RR tests established the respective Maximum Average Potential Prices (MAPPs) for Suboxone Film 2/0.5 mg/film, Suboxone Film 4/1 mg/film, Suboxone Film 8/2 mg/film, and Suboxone Film 12/3 mg/film.
- 2.2 The introductory National Average Transaction Prices (N-ATPs) of Suboxone Film 2/0.5 mg/film, Suboxone Film 8/2 mg/film, and Suboxone Film 12/3 mg/film each exceeded their respective MAPPs by an amount which triggered the investigation criteria set out in the Guidelines. As of December 31, 2021, the cumulative excess revenues of Suboxone Film 2/0.5 mg/film, Suboxone Film 8/2 mg/film, and Suboxone Film 12/3 mg/film were respectively determined to be $98,704.70, $277,486.71, and $503,259.07, totaling $879,450.48.
- 2.3 The HDAP recommended that Sublocade be classified as a Moderate Improvement. In accordance with the Guidelines, a Midpoint test was conducted for Sublocade 300 mg/syringe and a Reasonable Relationship Test (RR) was conducted for Sublocade 100 mg/syringe. The Midpoint and RR tests established the respective MAPPs for Sublocade 300 mg/syringe and Sublocade 100 mg/syringe.
- 2.4 The introductory N-ATPs of Sublocade 100 mg/syringe and Sublocade 300 mg/syringe each exceeded their respective MAPPs by an amount which triggered the investigation criteria set out in the Guidelines. As of December 31, 2021, the cumulative excess revenues of Sublocade 100 mg/syringe and Sublocade 300 mg/syringe were respectively determined to be $35,537.52 and $33,366.84, totaling $68,904.36.
3.0 Position of the Rights Holder
- 3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Indivior that the prices of Suboxone Film or Sublocade are now, or were at any time since the date of first sale, excessive for the purposes of the Patent Act, nor is this VCU binding upon any panel of the Board for the purposes of the Patent Act.
- 3.2 Indivior asserts that it initially supplied these two products for sale in response to an urgent request from the government. Indivior established prices based on foreign pricing at that time. According to Indivior, sales made since the products were removed from the UPHN were and continue to be lower than those calculated under the PMPRB rules.
4.0 Terms of the Voluntary Compliance Undertaking
- 4.1 Pursuant to this VCU, Indivior will undertake:
- 4.1.1 To agree that the MAPPs and Non-Excessive Average Prices (NEAPs) for Suboxone Film are as follows:
MAPPs and Non-Excessive Average Prices
| Year |
2/0.5 mg/film |
4/1 mg/film |
8/2 mg/film |
12/3 mg/film |
|---|
| 2018 |
$2.6700 |
- |
$4.7300 |
$7.0950 |
| 2019 |
$2.7127 |
- |
$4.8057 |
$7.2085 |
| 2020 |
$2.7741 |
- |
$4.9145 |
$7.3717 |
| 2021 |
$2.8275 |
$3.6890 |
$5.0091 |
$7.5136 |
| 2022 |
$2.8132 |
$3.7148 |
$4.9228 |
$7.2474 |
- 4.1.2 To agree that the MAPPs and NEAPs for Sublocade are as follows:
the MAPPs and NEAPs
| Year |
100 mg/syringe |
300 mg/syringe |
|---|
| 2019 |
$1,085.3411 |
$1,085.3411 |
| 2020 |
$1,056.7777 |
$1,028.6839 |
| 2021 |
$566.5000 |
$566.5000 |
| 2022 |
$556.0500 |
$556.0500 |
- 4.1.3 To ensure that the 2022 N-ATPs of Suboxone Film and Sublocade do not exceed their respective 2022 N-NEAPs as stated in 4.1.1 and 4.1.2 above, and that the prices of Suboxone Film and Sublocade are within the thresholds set out in the Guidelines in each market where they are sold;
- 4.1.4 To offset the cumulative excess revenues accrued by Indivior in respect of Suboxone Film and Sublocade up to December 31, 2021, by ensuring that the 2022 N-ATPs for the DINs of both Suboxone Film and Sublocade which generated excess revenues are below their respective 2021 N-NEAPs. The resulting offset for both products will be applied to the cumulative excess revenues as between them, totaling $948,354.84;
- 4.1.5 To offset any remaining cumulative excess revenues received by Indivior in connection with Suboxone Film 2/0.5 mg/film, Suboxone Film 8/2 mg/film, Suboxone Film 12/3 mg/film, Sublocade 100 mg/syringe, and Sublocade 300 mg/syringe, by making a payment to His Majesty in right of Canada, within 30 days of receiving PMPRB Staff’s notification of remaining excess revenues calculated based on the semi-annual price and sales data filed by Indivior, as required by the Patented Medicines Regulations and the 2022 N-NEAPs set out in 4.1.1 and 4.1.2 above; and
- 4.1.6 To ensure that prices of Suboxone Film and Sublocade remain within the PMPRB’s Guidelines in all future periods in which they are under the PMPRB’s jurisdiction.
Name: Abigail Sheppard
Position: Director
Rights Holder: Indivior UK Ltd.
Date: 18 November 2022
