SUBLOCADE (buprenorphine ER)
OFFICE ADMINISTRATION, PHARMACIST ADMINISTRATION - INJ
Indications for Prior Authorization:
- Treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days
Patients must meet the following criteria for the indication(s) above:
- Diagnosis of opioid use disorder
- Member is at least 18 years of age
- Member has been treated with a transmucosal buprenorphine-containing product delivering the equivalent of 8-24mg of buprenorphine daily for at least 7 days
- Medical justification supports inability to continue to use oral (e.g. sublingual, buccal) formulations of buprenorphine
- Not to exceed 300mg per month
For Reauthorization:
- Member is responding positively to therapy
- The member has not received an opioid analgesic since the last approval (or prescriber submits documentation that the use of an opioid since the last approval was due to a diagnosis of acute pain)
Dosing:
- For abdominal subcutaneous injection only
- Only healthcare providers should prepare and administer Sublocade
- Initial: 300mg monthly for the first two months
- Maintenance: 100mg monthly
- The maintenance dose may be increased to 300mg monthly for patients who tolerate the 100mg dose, but do not demonstrate a satisfactory clinical response, as evidenced by self-reported illicit opioid use or urine drug screens positive for illicit opioid use
- A patient who misses a dose should receive the next dose as soon as possible, with the following dose given no less than 26 days later. Occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect
Approval:
- 6 months
Last review date: April 22, 2019