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

This is an optional program for self-funded groups.

FDA APPROVED INDICATIONS AND DOSAGE^4-21

Agent(s)	Indication(s)	Dosage (Maximum Labeled Dose)
Belbuca® (buprenorphine) Buccal film	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily (1800 mcg daily)
Butrans® (buprenorphine) Transdermal patch	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	1 transdermal system weekly (20 mcg/hr)
Conzip®, Tramadol Sustained Release Capsule Extended Release Tablet	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Once daily (300 mg daily)
Duragesic® (fentanyl) Transdermal patch	Management of pain in opioid tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	One patch every 72 hours 15 patches per month
hydromorphone Extended-Releasea Tablet	Management of pain in opioid tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Once daily
fentanyl Transdermal patch	Management of pain in opioid tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	One patch every 72 hours 15 patches per month
Hysingla ER® (hydrocodone Extended-Release)a Tablet	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Once daily
Morphine Sulfate Extended-Release Capsule	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Once daily
MS Contin® (morphine sulfate Extended-Release)a Tablet	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Two to three times daily
Nucynta ER® (tapentadol Extended-Release) Tablet	Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tapentadol ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily (500 mg daily)
OxyContin®, Oxycodone Extended-Release Tablet	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily
Oxymorphone Extended-Release Tablet	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily
Xtampza ER® (oxycodone Extended-Release) Capsule	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily (288 mg daily)
Zohydro ER® Abuse Deterrent, Hydrocodone Extended-Release Capsulea	Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve product for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Product is not indicated as an as-needed (prn) analgesic.	Twice daily

a – generic available

CLINICAL RATIONALE

Chronic Pain

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 (≥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 MME, 41-90 MME should be considered moderate dose, and greater than 91 morphine milligram equivalents (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

Safety^4-21

The concurrent use of opioid agonists with buprenorphine or buprenorphine/naloxone should be avoided. Such concurrent use may reduce analgesic effect and/or may precipitate withdrawal symptoms.

All agents contain the following boxed warnings:

• Addiction, Abuse, and Misuse: Product exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing product and monitor all patients regularly for the development of these behaviors and conditions
• Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:
  • complete a REMS-compliant education program
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist
  • consider other tools to improve patient, household, and community safety.
• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of product. Monitor for respiratory depression, especially during initiation of product or following a dose increase
  • Oral products: Instruct patients to swallow product whole (for some capsules, contents may be sprinkled on applesauce and swallowed immediately without chewing); crushing, chewing, or dissolving product can cause rapid release and absorption of a potentially fatal dose of product
  • Belbuca, Butrans: Misuse or abuse of Belbuca by chewing, swallowing, snorting, or injecting buprenorphine extracted from the film/patch will result in uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death
  • Fentanyl transdermal patches: Due to risk of respiratory depression, patches are contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain
• Accidental Ingestion/Exposure: Accidental ingestion/exposure of even one dose of product, especially by children, can result in a fatal overdose of product
  • Fentanyl products also note deaths due to an overdose have occurred when children and adults were accidentally exposed. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure
• Neonatal Opioid Withdrawal Syndrome: Prolonged use of product during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
• Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death:
  • Reserve concomitant prescribing of product and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate
  • Limit dosages and durations to the minimum required
  • Follow patients for signs and symptoms of respiratory depression and sedation

Tramadol products contain the following additional boxed warnings:

• Ultra-Rapid Metabolism Of Tramadol And Other Risk Factors For Life-Threatening Respiratory Depression In Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. Tramadol is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol
• Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1

Fentanyl products contain the following additional boxed warnings:

• Cytochrome P450 3A4 Interaction: The concomitant use of fentanyl with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl and any CYP3A4 inhibitor or inducer
• Risk of Increased Fentanyl Absorption with Application of External Heat: Exposure of the fentanyl application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources

Oxycodone and hydrocodone products contain the following additional boxed warning:

• Cytochrome P450 3A4 Interaction: The concomitant use of oxycodone/hydrocodone with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone/hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone/hydrocodone plasma concentration. Monitor patients receiving oxycodone/hydrocodone and any CYP3A4 inhibitor or inducer

Oxymorphone, Morphine sulfate ER capsules,  Kadian, Nucynta contain the following additional boxed warning:

• Interaction with Alcohol: Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking product. The co-ingestion of alcohol with product may result in increased plasma levels and a potentially fatal overdose  

Morphine ER products have the following contraindications for use:

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to morphine

Buprenorphine products have the following contraindications for use:

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity (e.g., anaphylaxis) to buprenorphine

Tramadol products have the following contraindications for use:

• Hypersensitivity to tramadol
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• All children younger than 12 years of age
• Post-operative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

Fentanyl products have the following contraindications for use:

• Opioid non-tolerant patients
• Acute or intermittent pain, postoperative pain, mild pain
• Respiratory compromise, acute or severe asthma
• Known or suspected GI obstruction, including paralytic ileus
• Known hypersensitivity to fentanyl or any of the components of the transdermal system

Hydromorphone ER has the following contraindications for use:

• Opioid non-tolerant patients.
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction
• Hypersensitivity (e.g., anaphylaxis) to hydromorphone or sulfite-containing medications

Hydrocodone ER products have the following contraindications for use:

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known of suspected paralytic ileus or gastrointestinal obstruction
• Hypersensitivity to any component or hydrocodone bitartrate

Nucynta ER has the following contraindications for use:

• Acute or severe bronchial asthma
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to tapentadol or to any other ingredients of the product
• Concurrent use of monoamine oxidase inhibitors (MAOI) or use within the last 14 days

Oxycodone ER products have the following contraindications for use:

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment 
• Known or suspected gastrointestinal obstruction, including paralytic ileus 
• Hypersensitivity (e.g., anaphylaxis) to oxycodone

Oxymorphone ER products have the following contraindications for use:

• Acute or severe bronchial asthma or hypercarbia
• Known or suspected paralytic ileus and gastrointestinal obstruction
• Moderate and severe hepatic impairment
• Hypersensitivity (e.g., anaphylaxis) to oxymorphone, any other ingredients in oxymorphone ER, or to morphine analogs such as codeine

REFERENCES

1. 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: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
2. 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.

3. 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.
4. Belbuca prescribing information. Endo Pharmaceutical, Inc. June 2022.
5. Butrans prescribing information.  Purdue Pharma LP. June 2022.
6. Conzip prescribing information.  Vertical Pharmaceuticals Inc. September 2021.
7. Duragesic prescribing information. Janssen Pharmaceuticals. March 2021.
8. hydromorphone ER prescribing information.  Ascent Pharmaceuticals, Inc. September 2020.
9. Fentanyl patch prescribing information. Mylan Pharmaceuticals Inc. March 2021.
10. Hysingla ER prescribing information.  Purdue Pharma LP. March 2021.
11. Morphine sulfate ER capsule prescribing information.  Upsher-Smith Laboratories, LLC. April 2021.
12. morphine sulfate ER prescribing information. Actavis Pharma, Inc. August 2021.
13. MS Contin prescribing information.  Purdue Pharma LP. March 2021.
14. Nucynta ER prescribing information.  Janssen Pharmaceuticals Inc. March 2021.
15. OxyContin prescribing information. Purdue Pharma L.P. October 2021.
16. Oxymorphone prescribing information. Amneal Pharmaceuticals LLC. June 2022.
17. Tramadol ER prescribing information. Sun Pharmaceuticals Industries, Inc. June 2021.
18. Xtampza prescribing information. Collegium Pharmaceuticals, Inc. March 2021.
19. Zohydro ER prescribing information.  Zogenix Inc. March 2021.

Opioids ER Prior Authorization with Quantity Limit

TARGET AGENT(S)

Belbuca^® (buprenorphine buccal film)

Butrans^® (buprenorphine transdermal system)^a

Conzip^® (tramadol ER)

Duragesic^® (fentanyl transdermal patch)^a

fentanyl transdermal patch

Hydrocodone ER

hydromorphone ER^a

Hysingla ER^® (hydrocodone ER)^a

Morphine Sulfate ER

MS Contin^® (morphine sulfate ER)^a

Nucynta ER^® (tapentadol ER)

Oxycodone ER

OxyContin^® (oxycodone ER)

Oxymorphone SR

Tramadol ER^a

Xtampza ER^® (oxycodone ER)

Zohydro ER^® Abuse Deterrent (hydrocodone ER)^a

a - generic available, and targeted by program

Brand (generic)	GPI	Multi-Source Code	Quantity Limit (per day or as listed)
Belbuca (buprenorphine)
75 mcg buccal film	65200010108210	M, N, O, Y	2 films
150 mcg buccal film	65200010108220	M, N, O, Y	2 films
300 mcg buccal film	65200010108230	M, N, O, Y	2 films
450 mcg buccal film	65200010108240	M, N, O, Y	2 films
600 mcg buccal film	65200010108250	M, N, O, Y	2 films
750 mcg buccal film	65200010108260	M, N, O, Y	2 films
900 mcg buccal film	65200010108270	M, N, O, Y	2 films
Butrans (buprenorphine)a
5 mcg/hour transdermal system	65200010008820	M, N, O, Y	1 system/week
7.5 mcg/hour transdermal system	65200010008825	M, N, O, Y	1 system/week
10 mcg/hour transdermal system	65200010008830	M, N, O, Y	1 system/week
15 mcg/hour transdermal system	65200010008835	M, N, O, Y	1 system/week
20 mcg/hour transdermal system	65200010008840	M, N, O, Y	1 system/week
ConZip, Tramadol ER
100 mg extended-release capsule	65100095107070	M, N, O, Y	1 capsule
200 mg extended-release capsule	65100095107080	M, N, O, Y	1 capsule
300 mg extended-release capsule	65100095107090	M, N, O, Y	1 capsule
Duragesic (fentanyl)a
12 mcg/hr transdermal patch	65100025008610	M, N, O, Y	15 patches/month
25 mcg/hr transdermal patch	65100025008620	M, N, O, Y	15 patches/month
50 mcg/hr transdermal patch	65100025008630	M, N, O, Y	15 patches/month
75 mcg/hr transdermal patch	65100025008640	M, N, O, Y	15 patches/month
100 mcg/hr transdermal patch	65100025008650	M, N, O, Y	15 patches/month
fentanyl transdermal patcha
37.5 mcg/hr transdermal patch	65100025008626	M, N, O, Y	15 patches/month
62.5 mcg/hr transdermal patch	65100025008635	M, N, O, Y	15 patches/month
87.5 mcg/hr transdermal patch	65100025008645	M, N, O, Y	15 patches/month
hydromorphone ERa
8 mg extended-release tablet	65100035107521	M, N, O, Y	1 tablet
12 mg extended-release tablet	65100035107531	M, N, O, Y	1 tablet
16 mg extended-release tablet	65100035107541	M, N, O, Y	1 tablet
32 mg extended-release tablet	65100035107556	M, N, O, Y	1 tablet
Hysingla ER (hydrocodone ER)a
20 mg extended-release tablet	6510003010A810	M, N, O, Y	1 tablet
30 mg extended-release tablet	6510003010A820	M, N, O, Y	1 tablet
40 mg extended-release tablet	6510003010A830	M, N, O, Y	1 tablet
60 mg extended-release tablet	6510003010A840	M, N, O, Y	1 tablet
80 mg extended-release tablet	6510003010A850	M, N, O, Y	1 tablet
100 mg extended-release tablet	6510003010A860	M, N, O, Y	1 tablet
120 mg extended-release tablet	6510003010A870	M, N, O, Y	1 tablet
Morphine sulfate ER
10 mg extended-release capsule	65100055107010	M, N, O, Y	2 capsules
20 mg extended-release capsule	65100055107020	M, N, O, Y	2 capsules
30 mg extended-release capsule	65100055107030	M, N, O, Y	2 capsules
40 mg extended-release capsule	65100055107035	M, N, O, Y	2 capsules
50 mg extended-release capsule	65100055107040	M, N, O, Y	2 capsules
60 mg extended-release capsule	65100055107045	M, N, O, Y	2 capsules
80 mg extended-release capsule	65100055107050	M, N, O, Y	2 capsules
100 mg extended-release capsule	65100055107060	M, N, O, Y	2 capsules
200 mg extended-release capsule	65100055107080	M, N, O, Y	2 capsules
Morphine Sulfate ER
30 mg extended-release capsule	65100055207020	M, N, O, Y	1 capsule
45 mg extended-release capsule	65100055207025	M, N, O, Y	1 capsule
60 mg extended-release capsule	65100055207030	M, N, O, Y	1 capsule
75 mg extended-release capsule	65100055207035	M, N, O, Y	1 capsule
90 mg extended-release capsule	65100055207040	M, N, O, Y	1 capsule
120 mg extended-release capsule	65100055207050	M, N, O, Y	1 capsule
MS Contin (morphine sulfate ER)a
15 mg extended-release tablet	65100055100415	M, N, O, Y	3 tablets
30 mg extended-release tablet	65100055100432	M, N, O, Y	3 tablets
60 mg extended-release tablet	65100055100445	M, N, O, Y	3 tablets
100 mg extended-release tablet	65100055100460	M, N, O, Y	3 tablets
200 mg extended-release tablet	65100055100480	M, N, O, Y	3 tablets
Nucynta ER (tapentadol ER)
50 mg extended-release tablet	65100091107420	M, N, O, Y	2 tablets
100 mg extended-release tablet	65100091107430	M, N, O, Y	2 tablets
150 mg extended-release tablet	65100091107440	M, N, O, Y	2 tablets
200 mg extended-release tablet	65100091107450	M, N, O, Y	2 tablets
250 mg extended-release tablet	65100091107460	M, N, O, Y	2 tablets
OxyContin, Oxycodone ER
10 mg extended-release tablet	6510007510A710	M, N, O, Y	2 tablets
15 mg extended-release tablet	6510007510A715	M, N, O, Y	2 tablets
20 mg extended-release tablet	6510007510A720	M, N, O, Y	2 tablets
30 mg extended-release tablet	6510007510A730	M, N, O, Y	2 tablets
40 mg extended-release tablet	6510007510A740	M, N, O, Y	2 tablets
60 mg extended-release tablet	6510007510A760	M, N, O, Y	4 tablets
80 mg extended-release tablet	6510007510A780	M, N, O, Y	4 tablets
Oxymorphone SR
5 mg extended-release tablet	65100080107405	M, N, O, Y	2 tablets
7.5 mg extended-release tablet	65100080107407	M, N, O, Y	2 tablets
10 mg extended-release tablet	65100080107410	M, N, O, Y	2 tablets
15 mg extended-release tablet	65100080107415	M, N, O, Y	2 tablets
20 mg extended-release tablet	65100080107420	M, N, O, Y	2 tablets
30 mg extended-release tablet	65100080107430	M, N, O, Y	2 tablets
40 mg extended-release tablet	65100080107440	M, N, O, Y	2 tablets
Tramadol ERa
100 mg extended-release tablet	65100095107520	M, N, O, Y	1 tablet
100 mg sustained-release tabletb	65100095107560	M, N, O, Y	1 tablet
200 mg extended-release tablet	65100095107530	M, N, O, Y	1 tablet
200 mg sustained-release tabletb	65100095107570	M, N, O, Y	1 tablet
300 mg extended-release tablet	65100095107540	M, N, O, Y	1 tablet
300 mg sustained-release tabletb	65100095107580	M, N, O, Y	1 tablet
Xtampza ER (oxycodone ER)
9 mg capsule	6510007500A310	M, N, O, Y	2 capsules
13.5 mg capsule	6510007500A315	M, N, O, Y	2 capsules
18 mg capsule	6510007500A320	M, N, O, Y	2 capsules
27 mg capsule	6510007500A330	M, N, O, Y	2 capsules
36 mg capsule	6510007500A340	M, N, O, Y	8 capsules
Zohydro ER Abuse Deterrent, Hydrocodone ER
10 mg sustained-release capsulea	65100030106910	M, N, O, Y	2 capsules
15 mg sustained-release capsulea	65100030106915	M, N, O, Y	2 capsules
20 mg sustained-release capsule	65100030106920	M, N, O, Y	2 capsules
30 mg sustained-release capsulea	65100030106930	M, N, O, Y	2 capsules
40 mg sustained-release capsulea	65100030106940	M, N, O, Y	2 capsules
50 mg sustained-release capsulea	65100030106950	M, N, O, Y	2 capsules

a – generic available

b – branded generic available

PRIOR AUTHORIZATION AND QUANTITY LIMIT CRITERIA FOR APPROVAL

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:
      1. Information has been provided that the patient has been treated with the requested agent within the past 90 days

OR

1. 1. 2. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

OR

1. 2. ONE of the following:
      1. The patient has a diagnosis of chronic cancer pain due to an active malignancy

OR

1. 1. 2. The patient is eligible for hospice OR palliative care

OR

1. 1. 3. The patient has a diagnosis of sickle cell disease

OR

1. 1. 4. The patient is undergoing treatment of chronic non-cancer pain and ALL of the following:
         1. A formal, consultative evaluation which includes ALL of the following has been conducted:
            1. Diagnosis

AND

1. 1. 1. 1. 2. A complete medical history which includes previous and current pharmacological and non-pharmacological therapy

AND

1. 1. 1. 1. 3. The need for continued opioid therapy has been assessed

AND

1. 1. 1. 2. The requested agent is not prescribed as an as-needed (prn) analgesic

AND

1. 1. 1. 3. ONE of the following:
            1. The patient’s medication history includes a trial of at least 7 days of an immediate-acting opioid

OR

1. 1. 1. 1. 2. The patient has an intolerance or hypersensitivity to therapy with immediate-acting opioids that is not expected to occur with the requested agent

OR

1. 1. 1. 1. 3. The patient has an FDA labeled contraindication to ALL immediate-acting opioids that is not expected to occur with the requested agent

AND

1. 1. 1. 4. A patient-specific pain management plan is on file for the patient

AND

1. 1. 1. 5. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP) AND has determined that the 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

2. ONE of the following:
   1. The patient is not concurrently using buprenorphine or buprenorphine/naloxone for opioid dependence treatment

OR

1. 2. The prescriber has provided information in support of use of concurrent use of opioids with buprenorphine or buprenorphine/naloxone for opioid dependence treatment due to one of the following:
      1. Dental procedure with dates
      2. Surgery with dates
      3. Acute injury with dates

AND

3. If the request is for one of the following brand agents with an available generic equivalent (listed below), then ONE of the following:
   1. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent

OR

1. 2. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent

OR

1. 3. The prescriber has provided information to support the use of the requested brand agent over the generic equivalent

Brand	Generic Equivalent
Butrans	Buprenorphine patch
Duragesic	Fentanyl patch
Hysingla	Hydrocodone ER tabs
MS Contin	Morphine sulfate ER tabs
Zohydro	Hydrocodone ER caps

AND

4. 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 agent will NOT be used for post-operative pain management following a tonsillectomy and/or adenoidectomy

OR

1. 2. The patient is 18 years of age or over

AND

5. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

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

OR

1. 1. 2. The prescriber has provided rationale as to why the patient cannot tolerate a reduction in MED

AND

7. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

1. 2. The requested quantity (dose) is greater than the program quantity limit AND BOTH of the following:
      1. The requested quantity (dose) cannot be achieved with a lower  quantity of a higher strength that does not exceed the program quantity limit

AND  

1. 1. 2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  6 months

Opioids Extended Release (ER) Quantity Limit

OBJECTIVE

The intent of the Opioids ER 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 DRUGS - RECOMMENDED LIMITS

Brand (generic)	GPI	Multi-Source Code	Quantity Limit (per day or as listed)	Age Limit
Belbuca (buprenorphine)
75 mcg buccal film	65200010108210	M, N, O, Y	2 films	NA
150 mcg buccal film	65200010108220	M, N, O, Y	2 films	NA
300 mcg buccal film	65200010108230	M, N, O, Y	2 films	NA
450 mcg buccal film	65200010108240	M, N, O, Y	2 films	NA
600 mcg buccal film	65200010108250	M, N, O, Y	2 films	NA
750 mcg buccal film	65200010108260	M, N, O, Y	2 films	NA
900 mcg buccal film	65200010108270	M, N, O, Y	2 films	NA
Butrans (buprenorphine)a
5 mcg/hour transdermal system	65200010008820	M, N, O, Y	1 system/week	NA
7.5 mcg/hour transdermal system	65200010008825	M, N, O, Y	1 system/week	NA
10 mcg/hour transdermal system	65200010008830	M, N, O, Y	1 system/week	NA
15 mcg/hour transdermal system	65200010008835	M, N, O, Y	1 system/week	NA
20 mcg/hour transdermal system	65200010008840	M, N, O, Y	1 system/week	NA
ConZip, Tramadol ER
100 mg extended-release capsule	65100095107070	M, N, O, Y	1 capsule	≥ 18 years
200 mg extended-release capsule	65100095107080	M, N, O, Y	1 capsule	≥ 18 years
300 mg extended-release capsule	65100095107090	M, N, O, Y	1 capsule	≥ 18 years
Duragesic (fentanyl)a
12 mcg/hr transdermal patch	65100025008610	M, N, O, Y	15 patches/month	NA
25 mcg/hr transdermal patch	65100025008620	M, N, O, Y	15 patches/month	NA
50 mcg/hr transdermal patch	65100025008630	M, N, O, Y	15 patches/month	NA
75 mcg/hr transdermal patch	65100025008640	M, N, O, Y	15 patches/month	NA
100 mcg/hr transdermal patch	65100025008650	M, N, O, Y	15 patches/month	NA
fentanyl transdermal patcha
37.5 mcg/hr transdermal patch	65100025008626	M, N, O, Y	15 patches/month	NA
62.5 mcg/hr transdermal patch	65100025008635	M, N, O, Y	15 patches/month	NA
87.5 mcg/hr transdermal patch	65100025008645	M, N, O, Y	15 patches/month	NA
hydromorphone ERa
8 mg extended-release tablet	65100035107521	M, N, O, Y	1 tablet	NA
12 mg extended-release tablet	65100035107531	M, N, O, Y	1 tablet	NA
16 mg extended-release tablet	65100035107541	M, N, O, Y	1 tablet	NA
32 mg extended-release tablet	65100035107556	M, N, O, Y	1 tablet	NA
Hysingla ER (hydrocodone ER)a
20 mg extended-release tablet	6510003010A810	M, N, O, Y	1 tablet	NA
30 mg extended-release tablet	6510003010A820	M, N, O, Y	1 tablet	NA
40 mg extended-release tablet	6510003010A830	M, N, O, Y	1 tablet	NA
60 mg extended-release tablet	6510003010A840	M, N, O, Y	1 tablet	NA
80 mg extended-release tablet	6510003010A850	M, N, O, Y	1 tablet	NA
100 mg extended-release tablet	6510003010A860	M, N, O, Y	1 tablet	NA
120 mg extended-release tablet	6510003010A870	M, N, O, Y	1 tablet	NA
Morphine sulfate ER
10 mg extended-release capsule	65100055107010	M, N, O, Y	2 capsules	NA
20 mg extended-release capsule	65100055107020	M, N, O, Y	2 capsules	NA
30 mg extended-release capsule	65100055107030	M, N, O, Y	2 capsules	NA
40 mg extended-release capsule	65100055107035	M, N, O, Y	2 capsules	NA
50 mg extended-release capsule	65100055107040	M, N, O, Y	2 capsules	NA
60 mg extended-release capsule	65100055107045	M, N, O, Y	2 capsules	NA
80 mg extended-release capsule	65100055107050	M, N, O, Y	2 capsules	NA
100 mg extended-release capsule	65100055107060	M, N, O, Y	2 capsules	NA
200 mg extended-release capsule	65100055107080	M, N, O, Y	2 capsules	NA
Morphine Sulfate ER
30 mg extended-release capsule	65100055207020	M, N, O, Y	1 capsule	NA
45 mg extended-release capsule	65100055207025	M, N, O, Y	1 capsule	NA
60 mg extended-release capsule	65100055207030	M, N, O, Y	1 capsule	NA
75 mg extended-release capsule	65100055207035	M, N, O, Y	1 capsule	NA
90 mg extended-release capsule	65100055207040	M, N, O, Y	1 capsule	NA
120 mg extended-release capsule	65100055207050	M, N, O, Y	1 capsule	NA
MS Contin (morphine sulfate ER)a
15 mg extended-release tablet	65100055100415	M, N, O, Y	3 tablets	NA
30 mg extended-release tablet	65100055100432	M, N, O, Y	3 tablets	NA
60 mg extended-release tablet	65100055100445	M, N, O, Y	3 tablets	NA
100 mg extended-release tablet	65100055100460	M, N, O, Y	3 tablets	NA
200 mg extended-release tablet	65100055100480	M, N, O, Y	3 tablets	NA
Nucynta ER (tapentadol ER)
50 mg extended-release tablet	65100091107420	M, N, O, Y	2 tablets	NA
100 mg extended-release tablet	65100091107430	M, N, O, Y	2 tablets	NA
150 mg extended-release tablet	65100091107440	M, N, O, Y	2 tablets	NA
200 mg extended-release tablet	65100091107450	M, N, O, Y	2 tablets	NA
250 mg extended-release tablet	65100091107460	M, N, O, Y	2 tablets	NA
OxyContin, Oxycodone ER
10 mg extended-release tablet	6510007510A710	M, N, O, Y	2 tablets	NA
15 mg extended-release tablet	6510007510A715	M, N, O, Y	2 tablets	NA
20 mg extended-release tablet	6510007510A720	M, N, O, Y	2 tablets	NA
30 mg extended-release tablet	6510007510A730	M, N, O, Y	2 tablets	NA
40 mg extended-release tablet	6510007510A740	M, N, O, Y	2 tablets	NA
60 mg extended-release tablet	6510007510A760	M, N, O, Y	4 tablets	NA
80 mg extended-release tablet	6510007510A780	M, N, O, Y	4 tablets	NA
Oxymorphone SR
5 mg extended-release tablet	65100080107405	M, N, O, Y	2 tablets	NA
7.5 mg extended-release tablet	65100080107407	M, N, O, Y	2 tablets	NA
10 mg extended-release tablet	65100080107410	M, N, O, Y	2 tablets	NA
15 mg extended-release tablet	65100080107415	M, N, O, Y	2 tablets	NA
20 mg extended-release tablet	65100080107420	M, N, O, Y	2 tablets	NA
30 mg extended-release tablet	65100080107430	M, N, O, Y	2 tablets	NA
40 mg extended-release tablet	65100080107440	M, N, O, Y	2 tablets	NA
Tramadol ERa
100 mg extended-release tablet	65100095107520	M, N, O, Y	1 tablet	≥ 18 years
100 mg sustained-release tabletb	65100095107560	M, N, O, Y	1 tablet	≥ 18 years
200 mg extended-release tablet	65100095107530	M, N, O, Y	1 tablet	≥ 18 years
200 mg sustained-release tabletb	65100095107570	M, N, O, Y	1 tablet	≥ 18 years
300 mg extended-release tablet	65100095107540	M, N, O, Y	1 tablet	≥ 18 years
300 mg sustained-release tabletb	65100095107580	M, N, O, Y	1 tablet	≥ 18 years
Xtampza ER (oxycodone ER)
9 mg capsule	6510007500A310	M, N, O, Y	2 capsules	NA
13.5 mg capsule	6510007500A315	M, N, O, Y	2 capsules	NA
18 mg capsule	6510007500A320	M, N, O, Y	2 capsules	NA
27 mg capsule	6510007500A330	M, N, O, Y	2 capsules	NA
36 mg capsule	6510007500A340	M, N, O, Y	8 capsules	NA
Zohydro ER Abuse Deterrent, Hydrocodone ER
10 mg sustained-release capsulea	65100030106910	M, N, O, Y	2 capsules	NA
15 mg sustained-release capsulea	65100030106915	M, N, O, Y	2 capsules	NA
20 mg sustained-release capsule	65100030106920	M, N, O, Y	2 capsules	NA
30 mg sustained-release capsulea	65100030106930	M, N, O, Y	2 capsules	NA
40 mg sustained-release capsulea	65100030106940	M, N, O, Y	2 capsules	NA
50 mg sustained-release capsulea	65100030106950	M, N, O, Y	2 capsules	NA

a – generic available

b – branded generic available

 

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Quantities of Opioids ER which are above the program set 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:

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

AND

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

AND

3. 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

OR

1. 2. The patient is 18 years of age or over

AND

4. 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

2. ONE of the following:

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

OR

2. 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 Opioids ER 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:

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

AND

2. ONE of the following:

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

OR

2. The patient is eligible for hospice OR palliative care

OR

3. The patient has a diagnosis of sickle cell disease

OR

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

AND

1. 1. 1. 2. A complete medical history which includes previous and current pharmacological and non-pharmacological therapy

AND

1. 1. 1. 3. The need for continued opioid therapy has been assessed

AND

1. 1. 2. A patient-specific pain management plan is on file for the patient

AND

1. 1. 3. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP) AND has determined that the 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

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

AND

4. 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

OR

1. 2. The patient is 18 years of age or over

AND

5. 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

2. ONE of the following:

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

OR

2. 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_ER_PAQL_QL_ProgSum_07-01-23