Medical and Drug Policies

Asset Publisher

ph-1117

Opioids Immediate Release (IR) Quantity Limit Program Summary

Policy Number: PH-1117

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

Single Ingredient Agent(s)	Indication(s)	Dosage
butorphanol^a Nasal spray	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	The usual recommended initial dose is 1 mg (1 spray in one nostril). If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given. The initial dose sequence outlined above may be repeated in 3 to 4 hours as required after the second dose of the sequence. Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occurs. In such patients, single additional 2 mg doses should not be given for 3 to 4 hours.
Codeine^a Tablet	Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.	15 mg to 60 mg every four hours as needed for pain. The maximum 24 hour dose is 360 mg.
Dilaudid (hydromorphone)^a Tablet Liquid	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Oral solution: Initial dose of 2.5 mg to 10 mg every 3 to 6 hours as needed. Tablets: Initial dose of 2 mg to 4 mg every 4 to 6 hours.
Levorphanol^a Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Initial dose 1 to 2 mg every 6 to 8 hours as needed. If necessary, the dose may be increased up to 3 mg every 6 to 8 hours.
Meperidine^a Tablet Solution	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Adults: 50 mg to 150 mg every 3 to 4 hours as needed. Pediatric: 1.1 mg/kg to 1.8 mg/kg every 3 to 4 hours as needed. If adequate pain management cannot be achieved with a total daily dose of 600 mg or less, discontinue meperidine by tapering dose and selecting an alternative treatment
Dolophine, Methadose (methadone)^a Tablet Soluble tablet Solution Concentrate	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.	Initial dose of 2.5 mg every 8 to 12 hours
Morphine^a Tablet Concentrate Solution	Management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Tablets: 15 mg to 30 mg every 4 hours as needed Oral Solution: 10 mg to 20 mg every 4 hours as needed
Oxaydo, Roxybond, Roxicodone (oxycodone)^a Capsule Tablet Solution Concentrate	Management of acute and chronic pain in adults severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Initial dose of 5 mg to 15 mg every 4 to 6 hours
oxymorphone^a Tablet	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	10 mg to 20 mg every 4 to 6 hours
Nucynta (tapentadol) Tablet	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	50 mg to 100 mg every 4 to 6 hours. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
Qdolo, Tramadol Oral solution	Management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Initial dose: 25 mg/day and titrate in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times daily). After titration, may administer 50 mg to 100 mg every 4 to 6 hours. Max of 400 mg per day.
Ultram^a, Tramadol Tablet	Management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	50 mg to 100 mg every 4 to 6 hours as needed. Max dose of 400 mg per day.

Single Ingredient Agent(s)

Indication(s)

Dosage

butorphanol^a

Nasal spray

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The usual recommended initial dose is 1 mg (1 spray in one nostril). If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given.

The initial dose sequence outlined above may be repeated in 3 to 4 hours as required after the second dose of the sequence.

Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occurs. In such patients, single additional 2 mg doses should not be given for 3 to 4 hours.

Codeine^a

Tablet

Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

15 mg to 60 mg every four hours as needed for pain. The maximum 24 hour dose is 360 mg.

Dilaudid

(hydromorphone)^a

Tablet

Liquid

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Oral solution: Initial dose of 2.5 mg to 10 mg every 3 to 6 hours as needed.

Tablets: Initial dose of 2 mg to 4 mg every 4 to 6 hours.

Levorphanol^a

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Initial dose 1 to 2 mg every 6 to 8 hours as needed. If necessary, the dose may be increased up to 3 mg every 6 to 8 hours.

Meperidine^a

Tablet

Solution

Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Adults: 50 mg to 150 mg every 3 to 4 hours as needed.

Pediatric: 1.1 mg/kg to 1.8 mg/kg every 3 to 4 hours as needed.

If adequate pain management cannot be achieved with a total daily dose of 600 mg or less, discontinue meperidine by tapering dose and selecting an alternative treatment

Dolophine, Methadose

(methadone)^a

Tablet

Soluble tablet

Solution

Concentrate

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Initial dose of 2.5 mg every 8 to 12 hours

Morphine^a

Tablet

Concentrate

Solution

Management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Tablets: 15 mg to 30 mg every 4 hours as needed

Oral Solution: 10 mg to 20 mg every 4 hours as needed

Oxaydo, Roxybond, Roxicodone

(oxycodone)^a

Capsule

Tablet

Solution

Concentrate

Management of acute and chronic pain in adults severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Initial dose of 5 mg to 15 mg every 4 to 6 hours

oxymorphone^a

Tablet

Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

10 mg to 20 mg every 4 to 6 hours

Nucynta

(tapentadol)

Tablet

Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

50 mg to 100 mg every 4 to 6 hours. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.

Qdolo,

Tramadol

Oral solution

Management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Initial dose: 25 mg/day and titrate in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times daily). After titration, may administer 50 mg to 100 mg every 4 to 6 hours.

Max of 400 mg per day.

Ultram^a,

Tramadol

Tablet

Management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

50 mg to 100 mg every 4 to 6 hours as needed. Max dose of 400 mg per day.

a – generic available

Combination Ingredient Agent(s)	Indication(s)	Dosage
Apadaz, Benzhydrocodone/ acetaminophen Tablet	Short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	1-2 tablets every 4 to 6 hours. Dosage should not exceed 12 tablets in a 24 hour period.
Tylenol w/Codeine (acetaminophen/ codeine)^a Tablet Oral solution	Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.	Tablets: Based on codeine component 15 mg and 30 mg: one to two every 4 hours. 60 mg: one every 4 hours. Max of 360 mg of codeine per day. Oral solution: 15 mL every 4 hours.
Fioricet w/Codeine (butalbital/ acetaminophen/ caffeine/codeine)^a Capsule	Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.	One or two capsules every 4 hours. Total daily dosage should not exceed 6 capsules.
butalbital/aspirin/ caffeine/codeine^a Capsule	Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.	One or two capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules.
Trezix, Acetaminophen/ caffeine/ dihydrocodeine Capsule Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Two capsules/tablets every four hours, as needed. No more than five doses, or ten capsules/tablets should be taken in a 24-hour period.
Hydrocodone/ Acetaminophen^a Solution	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	15 mL every 4 to 6 hours. Maximum 90 mLs per day.
Lortab (hydrocodone/ acetaminophen) Solution	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	11.25 mL every 4 to 6 hours. Maximum 67.5 mL per day.
hydrocodone/ acetaminophen^a Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Initial dose depends on hydrocodone dose: 5 mg: one to two tablets every 4 to 6 hours. Max of 8 tablets per day. 7.5 mg and 10 mg: one tablet every 4 to 6 hours. Max of 6 tablets per day.
Hydrocodone/ Ibuprofen^a Tablet	Short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	One tablet every 4 to 6 hours, as needed. Dosage should not exceed 5 tablets in a 24-hour period.
Nalocet, Oxycodone/ Acetaminophen, Prolate Tablet Solution	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Tablet: One tablet every 6 hours as needed. Maximum dose based on oxycodone strength: 2.5 mg and 5 mg: 12 tablets daily. 7.5 mg: 8 tablets daily. 10 mg: 6 tablets daily. Oral solution: 5 mL every 6 hours as needed. Maximum dose based on oxycodone strength: 10 mg/300 mg: Max of 30 mL daily 5 mg/325 mg: Max of 60 mL daily
Percocet (oxycodone/ acetaminophen)^a Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	One tablet every 6 hours as needed. Maximum dose based on oxycodone strength: 2.5 mg and 5 mg: 12 tablets daily. 7.5 mg: 8 tablets daily. 10 mg: 6 tablets daily.
oxycodone/ aspirin^a Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	One tablet every 6 hours as needed for pain. The maximum daily dose of aspirin should not exceed 4 grams or 12 tablets.
pentazocine/ naloxone^a Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	One or two tablets every 3 to 4 hours. Total daily dosage should not exceed 12 tablets.
Seglentis (celecoxib/tramadol) Tablet	Management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate	Two tablets every 12 hours as needed for pain. Do not exceed recommended dose of Seglentis.
Ultracet (tramadol/ acetaminophen)^a Tablet	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.	Two tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day for up to 5 days.

Combination Ingredient Agent(s)

Indication(s)

Dosage

Apadaz, Benzhydrocodone/ acetaminophen

Tablet

Short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

1-2 tablets every 4 to 6 hours. Dosage should not exceed 12 tablets in a 24 hour period.

Tylenol w/Codeine

(acetaminophen/

codeine)^a

Tablet

Oral solution

Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Tablets: Based on codeine component

15 mg and 30 mg: one to two every 4 hours.

60 mg: one every 4 hours.

Max of 360 mg of codeine per day.

Oral solution: 15 mL every 4 hours.

Fioricet w/Codeine

(butalbital/

acetaminophen/

caffeine/codeine)^a

Capsule

Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.

One or two capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

butalbital/aspirin/

caffeine/codeine^a

Capsule

Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.

One or two capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules.

Trezix,

Acetaminophen/

caffeine/

dihydrocodeine

Capsule

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Two capsules/tablets every four hours, as needed.

No more than five doses, or ten capsules/tablets should be taken in a 24-hour period.

Hydrocodone/

Acetaminophen^a

Solution

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

15 mL every 4 to 6 hours.

Maximum 90 mLs per day.

Lortab

(hydrocodone/

acetaminophen)

Solution

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

11.25 mL every 4 to 6 hours.

Maximum 67.5 mL per day.

hydrocodone/

acetaminophen^a

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Initial dose depends on hydrocodone dose:

5 mg: one to two tablets every 4 to 6 hours. Max of 8 tablets per day.

7.5 mg and 10 mg: one tablet every 4 to 6 hours. Max of 6 tablets per day.

Hydrocodone/

Ibuprofen^a

Tablet

Short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

One tablet every 4 to 6 hours, as needed. Dosage should not exceed 5 tablets in a 24-hour period.

Nalocet,

Oxycodone/

Acetaminophen, Prolate

Tablet

Solution

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Tablet: One tablet every 6 hours as needed.

Maximum dose based on oxycodone strength:

2.5 mg and 5 mg: 12 tablets daily.

7.5 mg: 8 tablets daily.

10 mg: 6 tablets daily.

Oral solution: 5 mL every 6 hours as needed.

Maximum dose based on oxycodone strength:

10 mg/300 mg: Max of 30 mL daily

5 mg/325 mg: Max of 60 mL daily

Percocet

(oxycodone/

acetaminophen)^a

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

One tablet every 6 hours as needed.

Maximum dose based on oxycodone strength:

2.5 mg and 5 mg: 12 tablets daily.

7.5 mg: 8 tablets daily.

10 mg: 6 tablets daily.

oxycodone/

aspirin^a

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

One tablet every 6 hours as needed for pain. The maximum daily dose of aspirin should not exceed 4 grams or 12 tablets.

pentazocine/

naloxone^a

Tablet

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

One or two tablets every 3 to 4 hours. Total daily dosage should not exceed 12 tablets.

Seglentis

(celecoxib/tramadol)

Tablet

Management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Two tablets every 12 hours as needed for pain. Do not exceed recommended dose of Seglentis.

Ultracet

(tramadol/

acetaminophen)^a

Tablet

Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Two tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day for up to 5 days.

a – generic available

CLINICAL RATIONALE

The Centers for Disease Control and Prevention (CDC) guidelines define acute pain as pain with abrupt onset and caused by an injury or other process that is not ongoing. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.¹

Use of tramadol or codeine containing products in pediatric patients has caused life-threatening respiratory depression, with some of the reported cases occurring post-tonsillectomy and/or adenoidectomy. Ultra-rapid metabolizers are at increased risk of life-threatening respiratory depression due to a CYP2D6 polymorphism. Use in children under 12 years of age is contraindicated for these products, and for those between the ages of 12 and 18 years when used for post-operative pain management following tonsillectomy and/or adenoidectomy.³

The CDC defines chronic pain as pain that continues or is expected to continue more than three months or past the time of normal tissue healing. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids. The FDA modified labeling of ER/LA opioids, indicating they should be reserved for management of severe, continuous pain requiring daily, around-the-clock, long term opioid treatment. The CDC indicates ER/LA opioids should be reserved for severe, continuous pain and should be considered only for patients who have received immediate-release opioids daily for at least 1 week. Assessment should be done to determine if continued opioid therapy is needed.¹

The American Society of Interventional Pain Physicians (ASIPP) 2017 Guideline for Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain states that there is similar effectiveness for long and short-acting opioids, with increased adverse consequences of long-acting opioids. Long-acting agents should only be used in the management of severe, intractable pain. The guidelines recommend the following for the treatment of chronic non-cancer pain:²

Initiating therapy with an opioid:
- Complete a comprehensive assessment and document comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history
- Screen for opioid abuse, utilize prescription drug monitoring programs (PDMPs), and utilize urine drug testing (UDT) to identify opioid abusers, reduce opioid abuse, and potentially reduce doctor shopping. Utilize at initiation of therapy and to monitor adherence
- Establish appropriate physical and psychological diagnoses prior to initiating therapy
- Complete a pain management consultation, for non-pain physicians, if use of chronic opioids is planned or in patients where the total daily dose will exceed the recommended CDC morphine equivalent therapy
- Establish medical necessity prior to initiation or maintenance of opioid therapy based on average, moderate, or severe (greater than or equal to 4 on a scale of 0-10) pain and/or disability
- Establish treatment goals of opioid therapy with regard to pain relief and improvement in function
- Obtain a robust agreement prior to initiating and maintaining opioid therapy. Agreements reduce over-use, misuse, abuse, and diversion
Assessing improvement:
- Assess improvement based on analgesia, activity, aberrant behavior, and adverse effects. Clinicians should document at least a 30% improvement in pain or disability without adverse consequences
- Therapy must be started with short-acting opioids and should be maintained with lowest effective doses
- Evidence of effectiveness is similar for long-acting and short-acting opioids with increased prevalence of adverse consequences of long-acting opioids
- Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting opioids or moderate doses of long-acting opioids
- Low dose should be considered up to 40 morphine milligram equivalents (MME), 41-90 MME should be considered moderate dose, and greater than 91 MME as high dose
- Long-acting opioids should not be utilized for initial opioid therapy
- Monitor adherence via UDT and PDMP to identify patients who are non-compliant or abusing prescription or illicit drugs
- Chronic opioid therapy may be continued, with continuous adherence monitoring, and modified in conjunction with or after failure of other modalities of treatments.

The 2022 CDC guidelines for Prescribing Opioids for Pain recommend the following for prescribing opioids for acute, subacute, and chronic pain:¹

When to initiate or continue opioids for chronic pain:
- Clinicians should maximize use of non-pharmacologic and non-opioid pharmacologic therapies prior to initiating opioid therapy as appropriate for the specific condition and patient
- Clinicians should consider opioids only if expected benefits for both pain and function are anticipated to outweigh risks to the patients
- Clinicians should establish treatment goals with all patients prior to starting opioid therapy for chronic pain. Goals should include realistic goals for pain and function, and how to discontinue therapy if benefits do not outweigh the risks. Clinicians should only continue therapy with opioids if there is clinically meaningful improvement in pain and function that outweigh the risks to patient safety
- Clinicians should discuss the risks and realistic benefits of opioid therapy prior to starting and periodically during therapy
Opioid selection, dosage, duration, follow-up, and discontinuation:
- Clinicians should prescribe immediate release opioids instead of extended release/long acting opioids when starting opioid therapy for acute, subacute, or chronic pain
- The lowest effective dose should be prescribed when opioids are started. Clinicians should use caution when prescribing opioids, should reassess evidence of benefits and risks when increasing doses to greater than or equal to 50 MME/day, as many patients do not experience benefit in pain or function when doses are increased beyond 50 MME/day. Exposure to doses over 50 MME/day put patients at increased risk of harm, including opioid misuse
- Opioids for acute pain should be prescribed at the lowest effective dose of immediate release opioids and should be prescribed at a quantity no greater than necessary for the expected duration of pain. Benefits and risks should be evaluated at least every 2 weeks if patients after initiating opioid therapy, and if opioid use is required beyond 1 month, clinicians should ensure reversible causes of pain are addressed and that opioid prescribing for acute pain does not become long-term opioid therapy simply due to lack of appropriate reassessment
- Benefits and risks should be evaluated within 1 to 4 weeks after starting opioid therapy for subacute or chronic pain or of dose escalations. Benefits and risks of continued therapy should be evaluated every 3 months or more frequently
- Clinicians should re-evaluate patients at higher risk for opioid use disorder (e.g., patients with mental health conditions or depression, patients with a history of substance abuse, history of overdose, taking more than 50 MME/day, or taking other central nervous system depressants with opioids) more frequently than every 3 months
Assessing Risk and addressing Harms of Opioid use:
- Clinicians should incorporate into the management plan strategies to mitigate risk, including offering naloxone when there is increased risk of opioid overdose, such as history of overdose, history of substance abuse disorder, higher opioid dosages (greater than or equal to 50 MME/day), or concurrent benzodiazepine use
- When initiating opioid therapy for acute, subacute, or chronic pain, and periodically during opioid therapy for subacute or chronic pain, clinicians should review a patient’s history of controlled substance prescriptions using the states prescription drug monitoring program (PDMP) data to determine if the patient is receiving opioid dosages or dangerous combinations that put the patient at high risk for overdose.
- Clinicians should consider the benefits and risks of toxicology testing when prescribing opioids for subacute or chronic pain
- Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible

The CDC guideline for opioid prescribing note that patients with cancer, sickle cell disease, and patients receiving end of life care are exempt from these recommendations. The guideline also states that although identification of an opioid use disorder can alter the expected benefits and risks of opioid therapy for pain, patients with co-occurring pain and substance use disorder require ongoing pain management that maximizes benefits relative to risks. Clinicians should continue to use non-pharmacologic and non-opioid pharmacologic pain treatments as appropriate and consider consulting a pain specialist as needed to provide optimal pain management.¹

REFERENCES

Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1
Manchikanti L, Kaye AM, Knezevic NN, et al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician 2017;20:S3-S92.
FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. April 2017.
butorphanol tartrate nasal solution prescribing information. Apotex Corp. January 2021.
codeine prescribing information. Hikma Pharmaceuticals USA Inc. March 2021.
meperidine prescribing information. West-Ward Pharmaceuticals Corp. August 2022.
Dilaudid prescribing information. Purdue Pharma LP. March 2021.
levorphanol prescribing information. Lannett Company, Inc. December 2021.
methadone prescribing information. VistaPharm, Inc. January 2022.
Methadose prescribing information. SpecGX, LLC. May 2022.
morphine prescribing information. Hikma Pharmaceuticals USA Inc. June 2021.
oxycodone prescribing information. ANI Pharmaceuticals Inc. August 2021.
oxymorphone prescribing information. West-Ward Pharmaceuticals Corp. August 2020.
Oxaydo prescribing information. Zyla Life Sciences US Inc. March 2021.
Nucynta prescribing information. Collegium Pharm, Inc. March 2021.
Ultram prescribing information Janssen Pharms. September 2021.
Roxicodone prescribing information. Specgx LLC. March 2021.
hydrocodone/ibuprofen prescribing information. Amneal Pharmaceuticals, LLC. October 2021.
Ultracet prescribing information. Jassen Pharma. September 2021.
Oxycodone/aspirin prescribing information. Actavis Labs FL Inc. October 2019.
Apadaz prescribing information. KVK Tech Inc. March 2021.
Percocet prescribing information. Endo Pharmaceuticals Inc. July 2020.
Oxycodone/acetaminophen 300 mg prescribing information. FH2 Pharma LLC. June 2021.
Prolate prescribing information. Forte Bio-Pharma LLC. September 2021.
Tylenol with codeine prescribing information. Janssen Pharms. October 2019.
Lortab prescribing information. Akorn, Inc. May 2021.
Hydrocodone/Acetaminophen tablet prescribing information. Amneal Pharmaceuticals, LLC. September 2021.
Hydrocodone/Acetaminophen oral solution prescribing information. Eywa Pharma Inc. April 2021.
Hydrocodone/Acetaminophen 300 mg prescribing information. SpecGx, LLC. March 2021.
Trezix prescribing information. Wraser Pharms LLC. July 2017.
Butalbital, Aspirin, Caffeine, Codeine prescribing information. Activis Pharma, Inc. April 2021.
Fioricet with Codeine prescribing information. Actavis Pharma, Inc. March 2021.
Pentazocine/naloxone prescribing information. Actavis Pharma, Inc. July 2020.
Acetaminophen/codeine solution prescribing information. Akorn. May 2022.
Qdolo prescribing information. Athena Bioscience, LLC. September 2021.
Acetaminophen/caffeine/dihydrocodeine prescribing information. Xspire Pharma, LLC. January 2021.
Seglentis prescribing information. Kowa Pharmaceuticals America, Inc. October 2021.
Oxycodone/acetaminophen 5/325 solution prescribing information. Nostrum Laboratories, Inc. September 2021.
Roxybond prescribing information. Protega Pharms. March 2021.

Opioids IR Quantity Limit

OBJECTIVE

The intent of the Opioids IR quantity limit is to encourage FDA approved dosing regimen. Requests for larger quantities will be approved upon review. The program will also check for appropriate age for requests for products containing tramadol, dihydrocodeine, and codeine. Requests for these agents will be limited to patients 12 years of age and older, and patients 12 years to 18 years will be restricted from use for post-operative pain management following a tonsillectomy and/or adenoidectomy.

QUANTITY LIMIT TARGET AGENT(S) – RECOMMENDED LIMITS

Brand (generic)	GPI	Daily Quantity Limit	Age Limit
SINGLE INGREDIENT AGENT(S)
butorphanol^a
10 mg/mL nasal spray	65200020102050	0.25 mL	NA
Codeine
15 mg tablet	65100020200305	6 tablets	≥18 years
30 mg tablet^a	65100020200310	6 tablets	≥18 years
60 mg tablet	65100020200315	6 tablets	≥18 years
Dilaudid (hydromorphone)^a
2 mg tablet	65100035100310	6 tablets	NA
4 mg tablet	65100035100320	6 tablets	NA
8 mg tablet	65100035100330	6 tablets	NA
1 mg/mL liquid	65100035100920	48 mL	NA
Levorphanol^a
2 mg tablet	65100040100305	4 tablets	NA
3 mg tablet	65100040100310	4 tablets	NA
Meperidine
50 mg tablet	65100045100305	12 tablets	NA
50 mg/5 mL solution	65100045102060	60 mL	NA
Dolophine (methadone)^a
5 mg tablet	65100050100305	3 tablets	NA
10 mg tablet	65100050100310	3 tablets	NA
Methadose, Methadone^a
40 mg soluble tablet	65100050107320	3 tablets	NA
5 mg/5 mL solution	65100050102010	30 mL	NA
10 mg/5 mL solution	65100050102015	15 mL	NA
10 mg/mL concentrate	65100050101310	3 mL	NA
Morphine sulfate^a
15 mg tablet	65100055100310	12 tablets	NA
30 mg tablet	65100055100315	6 tablets	NA
10 mg/5 mL solution	65100055102065	90 mL	NA
20 mg/5 mL solution	65100055102070	45 mL	NA
20 mg/mL concentrate	65100055102090	9 mL	NA
Oxaydo, Roxybond, Roxicodone (oxycodone)
5 mg capsule^a	65100075100110	12 capsules	NA
5 mg tablet^a	65100075100310	12 tablets	NA
5 mg tablet	6510007510A530	12 tablets	NA
7.5 mg tablet	65100075100315	6 tablets	NA
10 mg tablet^a	65100075100320	6 tablets	NA
15 mg tablet^a	65100075100325	6 tablets	NA
15 mg tablet	6510007510A540	6 tablets	NA
20 mg tablet^a	65100075100330	6 tablets	NA
30 mg tablet^a	65100075100340	6 tablets	NA
30 mg tablet	6510007510A560	6 tablets	NA
5 mg/5 mL solution^a	65100075102005	180 mL	NA
20 mg/mL concentrate^a	65100075101320	9 mL	NA
oxymorphone^a
5 mg tablet	65100080100305	6 tablets	NA
10 mg tablet	65100080100310	6 tablets	NA
Nucynta (tapentadol)
50 mg tablet	65100091100320	6 tablets	NA
75 mg tablet	65100091100330	6 tablets	NA
100 mg tablet	65100091100340	6 tablets	NA
Qdolo, Ultram, Tramadol
50 mg tablet^a	65100095100320	8 tablets	≥18 years
100 mg tablet^a	65100095100340	4 tablets	≥18 years
5 mg/mL solution	65100095102005	80 mL	≥18 years
COMBINATION INGREDIENT AGENT(S)
Apadaz, Benzhydrocodone/acetaminophen
4.08/325 mg tablet	65990002020310	12 tablets	NA
6.12/325 mg tablet	65990002020320	12 tablets	NA
8.16/325 mg tablet	65990002020330	12 tablets	NA
Tylenol w/Codeine (acetaminophen/codeine)^a
120 mg/12 mg/5 mL solution	65991002052020	90 mL	≥18 years
300 mg/15 mg tablet	65991002050310	12 tablets	≥18 years
300 mg/30 mg tablet	65991002050315	12 tablets	≥18 years
300 mg/60 mg tablet	65991002050320	6 tablets	≥18 years
Fioricet w/Codeine (butalbital/acetaminophen/caffeine/codeine)^a
50 mg/300 mg/40 mg/30 mg capsule	65991004100113	6 capsules	≥18 years
50 mg/325 mg/40 mg/30 mg capsule	65991004100115	6 capsules	≥18 years
butalbital/aspirin/caffeine/codeine^a
50 mg/325 mg/40 mg/30 mg capsule	65991004300115	6 capsules	≥18 years
Trezix, Acetaminophen/caffeine/dihydrocodeine
320.5 mg/30 mg/16 mg capsule	65991303050115	10 capsules	≥18 years
325 mg/30 mg/16 mg tablet	65991303050320	10 tablets	≥18 years
Lortab, Hydrocodone/acetaminophen
5 mg/300 mg tablet^a	65991702100309	8 tablets	NA
5 mg/325 mg tablet^a	65991702100356	8 tablets	NA
7.5 mg/300 mg tablet^a	65991702100322	6 tablets	NA
7.5 mg/325 mg tablet^a	65991702100358	6 tablets	NA
10 mg/300 mg tablet^a	65991702100375	6 tablets	NA
10 mg/325 mg tablet^a	65991702100305	6 tablets	NA
7.5 mg/325 mg/15 mL solution^a	65991702102015	90 mL	NA
10 mg/300 mg/15 mL solution	65991702102024	67.5 mL	NA
10 mg/325 mg/15 mL solution	65991702102025	90 mL	NA
Hydrocodone/Ibuprofen
5 mg/200 mg tablet	65991702500315	5 tablets	NA
7.5 mg/200 mg tablet^a	65991702500320	5 tablets	NA
10 mg/200 mg tablet	65991702500330	5 tablets	NA
Percocet, Prolate, Oxycodone/acetaminophen, Nalocet, Primlev
2.5 mg/300 mg tablet	65990002200303	12 tablets	NA
2.5 mg/325 mg tablet^a	65990002200305	12 tablets	NA
5 mg/300 mg tablet	65990002200308	12 tablets	NA
5 mg/325 mg tablet^a	65990002200310	12 tablets	NA
7.5 mg/300 mg tablet	65990002200325	8 tablets	NA
7.5 mg/325 mg tablet^a	65990002200327	8 tablets	NA
10 mg/300 mg tablet	65990002200333	6 tablets	NA
10 mg/325 mg tablet^a	65990002200335	6 tablets	NA
5 mg/325 mg/5 mL solution	65990002202005	60 mL	NA
10 mg/300 mg/5 mL solution	65990002202020	30 mL	NA
Oxycodone/Aspirin
4.8355 mg/325 mg tablet	65990002220340	12 tablets	NA
pentazocine/naloxone^a
50 mg/0.5 mg tablet	65200040300310	12 tablets	NA
Seglentis (celecoxib/tramadol)
56 mg/44 mg tablet	65995002100320	4 tablets	≥18 years
Ultracet (tramadol/acetaminophen)^a
37.5 mg/325 mg tablet	65995002200320	8 tablets	≥18 years

generic available

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Quantities of Single Ingredient Opioid IR Agent(s) above the program quantity limit but less than or equal to the Program Maximum Daily Dose (maximum mg allowed with highest dosage strength) or for patients under the age of 18 years (products containing tramadol, dihydrocodeine, and codeine any quantities) will be approved when ALL of the following are met:

The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

AND

The prescriber has provided information in support of therapy with a higher dose for the requested indication

AND

If the requested agent is tramadol, dihydrocodeine, OR codeine, then ONE of the following:
1. The patient is 12 to less than 18 years of age AND the requested opioid will NOT be used for post-operative pain management following a tonsillectomy and/or adenoidectomy

1. The patient is 18 years of age or over

AND

If the patient’s total morphine equivalent dose (MED) exceeds 210 mg per day, then BOTH of the following:
1. The prescriber acknowledges that the patient is using opioids (total daily dose of all opioids) that are at or over 210 mg MED and the associated risks

AND

1. ONE of the following:
  1. The prescriber has provided a treatment plan to reduce the MED to less than 210 mg

1. 1. The prescriber has provided rationale as to why the patient cannot tolerate a reduction in MED

Length of Approval: 1 month for dose titration requests and

up to 6 months for all other requests

Quantities of Single Ingredient Opioids IR Agent(s) which are greater than the Program Maximum Daily Dose (maximum mg allowed with highest dosage strength) or for patients under the age of 18 years (products containing tramadol, dihydrocodeine, and codeine any quantities) will be approved when ALL of the following are met:

The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

AND

ONE of the following:

The patient has a diagnosis of active cancer pain due to an active malignancy

The patient is eligible for hospice OR palliative care

The patient has sickle cell disease

The patient is undergoing treatment of chronic non-cancer pain and ALL of the following are met:
1. 1. A formal, consultative evaluation which includes BOTH of the following has been conducted:
    1. Diagnosis

AND

1. 1. 1. A complete medical history which includes previous and current pharmacological and non-pharmacological therapy

AND

1. 1. A patient-specific pain management plan is on file for the patient

AND

1. 1. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP) AND has determined that opioid dosages and combinations of opioids and other controlled substances within the patient’s records do NOT indicate the patient is at high risk for overdose

AND

The prescriber has provided information in support of therapy with a higher dose for the requested indication

AND

If the requested agent is tramadol, dihydrocodeine, OR codeine, then ONE of the following:
1. The patient is 12 to less than 18 years of age AND the requested opioid will NOT be used for post-operative pain management following a tonsillectomy and/or adenoidectomy

1. The patient is 18 years of age or over

AND

If the patient’s total morphine equivalent dose (MED) exceeds 210 mg per day, then BOTH of the following:

The prescriber acknowledges that the patient is using opioids (total daily dose of all opioids) that are at or over 210 mg MED and the associated risks

AND

ONE of the following:

The prescriber has provided a treatment plan to reduce the MED to less than 210 mg

The prescriber has provided rationale as to why the patient cannot tolerate a reduction in MED

Length of Approval: 1 month for dose titration requests and

up to 6 months for all other requests

Quantities of Combination Ingredient Opioids IR Agent(s) which are greater than the Daily Quantity Limit or for patients under the age of 18 years (products containing tramadol, dihydrocodeine, and codeine any quantities) will be approved when ALL of the following are met:

The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

AND

The prescriber has provided information in support of therapy with a higher dose for the requested indication

AND

If the requested agent contains tramadol, dihydrocodeine, OR codeine, then ONE of the following:
1. The patient is 12 to less than 18 years of age AND the requested opioid will NOT be used for post-operative pain management following a tonsillectomy and/or adenoidectomy

1. The patient is 18 years of age or over

AND

If the requested agent contains acetaminophen, then the requested dose of acetaminophen does NOT exceed 4 grams per day

AND

If the patient’s total morphine equivalent dose (MED) exceeds 210 mg per day, then BOTH of the following:
1. The prescriber acknowledges that the patient is using opioids (total daily dose of all opioids) that are at or over 210 mg MED and the associated risks

AND

1. ONE of the following:
  1. The prescriber has provided a treatment plan to reduce the MED to less than 210 mg

1. 1. The prescriber has provided rationale as to why the patient cannot tolerate a reduction in MED

Length of Approval: 1 month for dose titration requests and

up to 6 months for all other requests

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

CS_Opioids_IR_QL_ProgSum_07-01-23

Category Filter

Asset Publisher

Opioids Immediate Release (IR) Quantity Limit Program Summary

Policy Number: PH-1117