Immediate Release Opioid Quantity Limits – NC Standard

Rationale

National guidelines on the use of opioids in acute pain indicate that 3 days of medication or less is often sufficient for pain management. Furthermore, a supply greater than 7 days is rarely needed. * Several states, including North Carolina (Strengthen Opioid Misuse Prevention Act), have implemented legal restrictions on the prescribing of opioids for more than 7 day on initial evaluation. Therefore, the following limitation encourages members to seek follow up evaluation for the use of opioids beyond the initial 7 days of treatment.

Prescriptions for more than a 7-day supply for members who have no prescription history of opioids in the past 180 days will reject at the pharmacy for payment. These prescriptions can be resubmitted for 7 days or less to receive a paid claim. Subsequent prescriptions will not have this same limitation. Should a member have a prescription reject for an opioid prescription that is NOT their initial fill of the medication, the prescriber can attest to a member’s medication history.

Quantity limits have been added to ensure safe and effective use following the first time use of the pain medication.

Benefit limitation

1. Members that are filling an immediate release opioid for the first time within 180 days are limited to a maximum of a 7-day supply.

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed); AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

• Benefit limit: 30 days 
• Quantity limit: 6 months

References

All information referenced is from FDA package insert unless otherwise noted below.

*Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016; 65 (No. RR-1):1–49.

Strengthen Opioid Misuse Prevention (STOP) Act, NC, House Bill 243 / S.L. 2017-74.

Policy Implementation/Update Information

February 2021: Criteria update: Added Seglentis to policy

March 2021: Criteria update: Annual Criteria review. Removal of discontinued products: Synlagos-DC, hydrocodone/ibuprofen 2.5/200mg tablet, Roxicet 5/325mg per 5mL solution, Hydrocodone/APAP 2.5/325mg.
Jan 2021: Criteria change: Added Prolate 10mg/300mg solution to the policy.
Nov 2020: Criteria update: Added Qdolo to the policy.
Oct 2020: Criteria change: Removed Roxybond from policy (discontinued product). Corrected levorphanol dosing and QL.
Sept 2020: Criteria change: Changed Oxaydo 5mg quantity limit to 12 tabs per day.
June 2020: Criteria update: Added Prolate to the policy.
Feb 2020: Criteria update: Added Dvorah brand name to the policy, generic already listed.
Feb 2020: Criteria update: Added new to market Tramadol 100mg tablet to the policy.
January 2019: Added benefit limitation language to criteria.
January 2019: Original utilization management criteria issued.