Pharmacy Policy Bulletin

Opioid Management - Commercial
Number: J-0672	Category: Managed Rx Coverage
Line(s) of Business: Commercial Healthcare Reform Medicare	Benefit(s): Commercial Plans (1., 2., or 3.): 1. Rx Mgmt Performance = Deterrent/Patent Extenders 2. Rx Mgmt Performance = Deterrent/Patent Extenders + Guideline 3. Rx Mgmt Performance = MRXC = Yes
Region(s): All Delaware New York Pennsylvania West Virginia	Additional Restriction(s): None

Opioid Management - Commercial

Number: J-0672

Category: Managed Rx Coverage

Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial Plans (1., 2., or 3.):

1. Rx Mgmt Performance = Deterrent/Patent Extenders

2. Rx Mgmt Performance = Deterrent/Patent Extenders + Guideline

3. Rx Mgmt Performance = MRXC = Yes

Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None

Approval Criteria
Approval Criteria I. Short‐Acting Opioid Analgesics A. Adults (18 years of age or older) When a benefit, coverage of a short‐acting opioid analgesic for greater than 7 days’ supply per fill or greater than 14 days’ supply per 30 days for a member 18 years of age or older may be approved when one (1) of the following criteria are met (1., 2., or 3.): 1. There is documentation of pain associated with one (1) of the following criteria (a., b., or c): a. Active cancer treatment or cancer not in remission (cancer diagnosis provided) b. Hospice program, end-of-life care, or palliative care c. Sickle cell anemia 2. The member is currently utilizing opioid therapy on a consistent basis for chronic pain (member currently receiving opioids on a consistent basis is defined as prescribed use for 90 out of the past 110 days). 3. There is documentation the medication is being used for the treatment of severe pain and all the following criteria are met (a., b., and c.): a. Non-opioid therapies (e.g., non-opioid medications [e.g., nonsteroidal anti-inflammatory drugs {NSAIDs}, acetaminophen, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors {SNRIs}, anticonvulsants]) have provided an inadequate response or are inappropriate according to the prescribing physician. b. The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP) according to the prescribing physician. c. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction. B. Pediatrics (17 years of age or younger) When a benefit, coverage of a short‐acting opioid analgesic for greater than 3 days’ supply per fill or greater than 6 days’ supply per 30 days for a pediatric member 17 years of age and younger may be approved when one (1) of the following criteria are met (1., 2., or 3.): 1. There is documentation of pain associated with one (1) of the following criteria (a., b., or c): a. Active cancer treatment or cancer not in remission (cancer diagnosis provided) b. Hospice program, end-of-life care, or palliative care c. Sickle cell anemia 2. The member is currently utilizing opioid therapy on a consistent basis for chronic pain (member currently receiving opioids on a consistent basis is defined as prescribed use for 90 out of the past 110 days). 3. There is documentation the medication is being used for the treatment of severe pain and all the following criteria are met (a., b., and c.): a. Non-opioid therapies (e.g., non-opioid medications [e.g., nonsteroidal anti-inflammatory drugs {NSAIDs}, acetaminophen, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors {SNRIs}, anticonvulsants]) have provided an inadequate response or are inappropriate according to the prescribing physician. b. The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP) according to the prescribing physician. c. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction. II. Extended Release Opioids When a benefit, coverage of an extended release opioid may be approved when one (1) of the following criteria are met (A. or B.): A. There is documentation of pain associated with one (1) of the following criteria (1., 2., or 3): 1. Active cancer treatment or cancer not in remission (cancer diagnosis provided) 2. Hospice program, end-of-life care, or palliative care 3. Sickle cell anemia B. There is documentation of all the following criteria (1. through 5.): 1. Pain is severe enough to require daily, around-the-clock, long-term opioid treatment. 2. The member is not opioid naïve. 3. At least one (1) of the following therapies have been evaluated (a. through e.): a. Non-opioid therapies (e.g., non-opioid medications [e.g., nonsteroidal anti-inflammatory drugs {NSAIDs}, acetaminophen, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors {SNRIs}, anticonvulsants]) b. Exercise therapy c. Physical therapy d. Weight loss e. Cognitive behavioral therapy 4. The member’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP), according to the prescribing physician. 5. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction. III. Morphine Equivalent Daily Dose (MEqD) When a benefit, cumulative opioids that exceeded 90 MEqD may be approved when one (1) of the following criteria are met (A. or B.): A. There is documentation of pain associated with one (1) of the following criteria (1., or 2., or 3): 1. Active cancer treatment or cancer not in remission (cancer diagnosis provided) 2. Hospice program, end-of-life care, or palliative care 3. Sickle cell anemia B. The prescriber states based on the patient’s clinical circumstances that the amount of opioid prescribed is warranted in order to adequately manage the patient’s pain IV. An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

Approval Criteria

Approval Criteria

I. Short‐Acting Opioid Analgesics

A. Adults (18 years of age or older)

When a benefit, coverage of a short‐acting opioid analgesic for greater than 7 days’ supply per fill or greater than 14 days’ supply per 30 days for a member 18 years of age or older may be approved when one (1) of the following criteria are met (1., 2., or 3.):

1. There is documentation of pain associated with one (1) of the following criteria (a., b., or c):

a. Active cancer treatment or cancer not in remission (cancer diagnosis provided)

b. Hospice program, end-of-life care, or palliative care

c. Sickle cell anemia

2. The member is currently utilizing opioid therapy on a consistent basis for chronic pain (member currently receiving opioids on a consistent basis is defined as prescribed use for 90 out of the past 110 days).

3. There is documentation the medication is being used for the treatment of severe pain and all the following criteria are met (a., b., and c.):

a. Non-opioid therapies (e.g., non-opioid medications [e.g., nonsteroidal anti-inflammatory drugs {NSAIDs}, acetaminophen, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors {SNRIs}, anticonvulsants]) have provided an inadequate response or are inappropriate according to the prescribing physician.

b. The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP) according to the prescribing physician.

c. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction.

B. Pediatrics (17 years of age or younger)

When a benefit, coverage of a short‐acting opioid analgesic for greater than 3 days’ supply per fill or greater than 6 days’ supply per 30 days for a pediatric member 17 years of age and younger may be approved when one (1) of the following criteria are met (1., 2., or 3.):

1. There is documentation of pain associated with one (1) of the following criteria (a., b., or c):

a. Active cancer treatment or cancer not in remission (cancer diagnosis provided)

b. Hospice program, end-of-life care, or palliative care

c. Sickle cell anemia

3. There is documentation the medication is being used for the treatment of severe pain and all the following criteria are met (a., b., and c.):

b. The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP) according to the prescribing physician.

c. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction.

II. Extended Release Opioids

When a benefit, coverage of an extended release opioid may be approved when one (1) of the following criteria are met (A. or B.):

A. There is documentation of pain associated with one (1) of the following criteria (1., 2., or 3):

1. Active cancer treatment or cancer not in remission (cancer diagnosis provided)

2. Hospice program, end-of-life care, or palliative care

3. Sickle cell anemia

B. There is documentation of all the following criteria (1. through 5.):

1. Pain is severe enough to require daily, around-the-clock, long-term opioid treatment.

2. The member is not opioid naïve.

3. At least one (1) of the following therapies have been evaluated (a. through e.):

b. Exercise therapy

c. Physical therapy

d. Weight loss

e. Cognitive behavioral therapy

4. The member’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP), according to the prescribing physician.

5. Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction.

III. Morphine Equivalent Daily Dose (MEqD)

When a benefit, cumulative opioids that exceeded 90 MEqD may be approved when one (1) of the following criteria are met (A. or B.):

A. There is documentation of pain associated with one (1) of the following criteria (1., or 2., or 3):

1. Active cancer treatment or cancer not in remission (cancer diagnosis provided)

2. Hospice program, end-of-life care, or palliative care

3. Sickle cell anemia

B. The prescriber states based on the patient’s clinical circumstances that the amount of opioid prescribed is warranted in order to adequately manage the patient’s pain

IV. An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

Limitations of Coverage
I. Coverage of opioids for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions. II. For Commercial members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

Limitations of Coverage

I. Coverage of opioids for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II. For Commercial members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

Authorization Duration
Short‐Acting Opioid Analgesics and Extended Release Opioids Commercial Plans: If approved, up to a 6 month authorization may be granted base on patient treatment plan for short‐acting opioid analgesics and extended release opioids. Morphine Equivalent Daily Dose Commercial Plans: If approved, up to a 12 month authorization may be granted base on patient treatment plan for morphine equivalent daily dose.

Authorization Duration

Short‐Acting Opioid Analgesics and Extended Release Opioids

Commercial Plans: If approved, up to a 6 month authorization may be granted base on patient treatment plan for short‐acting opioid analgesics and extended release opioids.

Morphine Equivalent Daily Dose

Commercial Plans: If approved, up to a 12 month authorization may be granted base on patient treatment plan for morphine equivalent daily dose.

Automatic Approval Criteria
None

Automatic Approval Criteria

None