opioids (extended-release formulations) — Blue Cross Blue Shield of Montana

Preferred products

• Xtampza

Initial criteria

• A. Treatment of stage four advanced metastatic cancer or associated condition (chart notes required) AND use consistent with best practices supported by peer-reviewed, evidence-based literature and FDA-approved indication OR
• 2. Patient is currently treated and stable on requested agent (chart notes required) OR
• 3. Patient has tried and had inadequate response to Xtampza (chart notes required) OR
• 4. Xtampza was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event (chart notes required) OR
• 5. Patient has intolerance or hypersensitivity to Xtampza not expected with requested agent (chart notes required) OR
• 6. Patient has FDA labeled contraindication to Xtampza not expected with requested agent (chart notes required) OR
• 7. Xtampza is expected to be ineffective, cause adherence barrier, worsen comorbidity, impair function, cause adverse reaction, or harm (chart notes required) OR
• 8. Xtampza is not in best interest of patient based on medical necessity (chart notes required) OR
• 9. Patient has tried another drug in same class or with same mechanism as Xtampza discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event (chart notes required) AND
• B. Formal consultative evaluation including diagnosis, complete medical history (including pharmacologic and non‑pharmacologic therapy), and assessment of continued opioid need (chart notes required) AND
• C. Prescriber has reviewed patient’s controlled substance records in state PDMP AND
• D. Patient is routinely (at least every 3 months) assessed for function, pain status, and opioid dose AND
• E. ONE of the following: patient is not concurrently using a benzodiazepine OR concurrent use is supported; AND
• For Ohio fully insured or HIM Shop members: patient has no FDA labeled contraindications AND has another FDA-labeled or compendia-supported indication OR two peer‑reviewed journal articles supporting safety and efficacy (articles required)

Approval duration

12 months