CurrentBlue Cross Blue Shield - MassachusettsPolicy 113

113 Fentanyl, oral-transmucosal prn.pdf

Policy governs prior authorization and coverage criteria for oral-transmucosal and other short-acting fentanyl products (e.g., Abstral, Actiq, Fentora, Lazanda, Onsolis, Subsys) for treatment of breakthrough cancer pain in commercial members. Applies to outpatient retail pharmacy benefit; individual consideration process available for exceptions.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

Policy113 Fentanyl, oral-transmucosal prn.pdf

Policy CodePolicy 113

Change TypeReformats and product additions (historical)

Effective Date

Next Review Date

Key ActionSubmit prior authorization using the BCBSMA Prior Authorization/Formulary Exception form or call Pharmacy Operations; document diagnosis of breakthrough cancer pain and opioid tolerance at listed doses for ≥1 week.

POLICY UPDATE CHANGES

7/2023 - Reformatted Policy.

2/2020 - Updated to add Fentanyl Buccal to the policy.

1/2013 - Required use of generic fentanyl lozenges prior to brand name formulations.

4/2012 - Updated to include Lazanda and Subsys.

6Specific fentanyl products listed

1Required prior authorization

>=60 mg/dayOpioid morphine-equivalent threshold

Coverage summary

Scope: This policy (Policy Number: 113) governs prior authorization and coverage criteria for oral-transmucosal and other short-acting fentanyl products (examples: Abstral, Actiq, Fentora, Fentanyl Buccal, Lazanda, Onsolis, Subsys) for the treatment of breakthrough cancer pain. Applicability: outpatient retail pharmacy benefit for commercial members (HMO, POS, PPO, Indemnity, MEDEX with Rx, and related commercial plans).

Coverage stance and status: These short-acting transmucosal fentanyl products are covered with criteria (prior authorization required) for patients meeting the specified documentation requirements (diagnosis of breakthrough cancer pain and demonstrated opioid tolerance at listed thresholds). Status: CURRENT. Boxed warning: products carry a black box warning limiting use to breakthrough cancer pain in opioid-tolerant patients and contraindicating use for acute/postoperative pain; prior authorization and provider documentation are required.

Tolerance and threshold criteria

Opioid tolerance (badge)Taking ≥ 60 mg oral morphine/day, or ≥ 25 mcg transdermal fentanyl/hour, or equivalent for ≥ 1 week

Oral morphine threshold60 mg/day

Transdermal fentanyl threshold25 mcg/hour

Oxycodone threshold30 mg/day

Oral hydromorphone threshold8 mg/day

Provider actions and requirements

Prior Authorization

Prior authorization is required

Prior authorization is required for outpatient retail pharmacy requests for commercial members with pharmacy benefits. Submit the BCBSMA Prior Authorization/Formulary Exception form or call Pharmacy Operations for review.

Documentation Required

Document opioid tolerance and diagnosis

Document a diagnosis of breakthrough cancer pain and evidence of opioid tolerance at or above the listed doses for at least one week (e.g., oral morphine 60 mg/day, transdermal fentanyl 25 mcg/hour, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an equianalgesic dose of another opioid). For branded products also document prior treatment failure with or a contraindication to fentanyl lozenge.

Step Therapy

Step prior to branded products

Coverage for branded short-acting fentanyl products (Abstral, Actiq, Fentora, Fentanyl Buccal, Lazanda, Subsys) requires previous treatment failure with or a contraindication to fentanyl lozenge before coverage of the branded product will be approved.

Background and evidence

Short-acting transmucosal fentanyl products are potent Schedule II opioids indicated for the management of breakthrough cancer pain only in patients who are already receiving and are tolerant to opioid therapy. The policy emphasizes that these drugs are rapid-acting and highly potent and therefore carry a boxed warning.

Boxed warnings (exact policy emphasis): these products should be used only in breakthrough cancer pain; only in patients who are already receiving and tolerant to opioid therapy; and are contraindicated for acute or postoperative pain.

Definitions

Evidence

Revision history

7/2023reformattedLatest

Reformatted Policy. (Formatting changes only per history.)

2/2020revised

Updated to add Fentanyl Buccal to the policy. (Added product inclusion.)

1/2013revised

Required use of generic fentanyl lozenges prior to brand name formulations. (Step requirement to prefer generic lozenge prior to brand products.)

4/2012revised

Updated to include Lazanda and Subsys. (Added new FDA approved medications to policy.)