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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.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2024

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
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		6
butorphanol Nasal spray*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	7
Codeine Tablet*	Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate	* generic available	8
Meperidine Tablet Solution	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate		18
Dilaudid (hydromorphone) Tablet* Liquid*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	9
Methadose, Methadone 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	* generic available	19,20
Fioricet w/Codeine (butalbital/acetaminophen/caffeine/codeine) Capsule*	Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate	* generic available	11
butalbital/aspirin/caffeine/codeine Capsule*	Management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate	* generic available	12
Hydrocodone/Acetaminophen Solution*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	14
Hydrocodone/Ibuprofen Tablet*	Short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	15
levorphanol Tablet*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	16
Lortab (hydrocodone/acetaminophen) Solution	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate		17
Morphine Sulfate Tablet* Concentrate* Solution*	Management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	21
Nalocet, Oxycodone/Acetaminophen, Prolate Tablet Solution	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate		26,27,33
hydrocodone/acetaminophen Tablet*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	22
Nucynta (tapentadol) Tablet	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg.		23
Oxaydo, Roxybond™, Roxicodone (oxycodone) Capsule* Tablet* Solution* Concentrate*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	24,25,35,41
oxymorphone Tablet*	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	30
pentazocine/naloxone Tablet*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	31
Percocet (oxycodone/acetaminophen) Tablet*	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	32
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		34
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		36
Trezix, Acetaminophen/caffeine/dihydrocodeine Capsule Tablet	Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate		4,37
Tylenol w/Codeine, Acetaminophen/codeine Tablet* Oral solution	Management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate	* generic available	5,38
Ultracet (tramadol/acetaminophen) Tablet*	Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	39
Ultram (tramadol) Tablet*	Management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate	* generic available	40

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

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 palliative or 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

Number	Reference
1	Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. Accessed at: https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.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	Acetaminophen/caffeine/dihydrocodeine prescribing information. Xspire Pharma, LLC. January 2021.
5	Acetaminophen/codeine solution prescribing information. Akorn. November 2022.
6	Apadaz prescribing information. KVK Tech Inc. March 2021.
7	butorphanol tartrate nasal solution prescribing information. Apotex Corp. September 2023.
8	codeine prescribing information. Hikma Pharmaceuticals USA Inc. February 2023.
9	Dilaudid prescribing information. Rhodes Pharmaceuticals. January 2023
10	Reference no longer used.
11	Fioricet with Codeine prescribing information. Actavis Pharma, Inc. March 2021.
12	Butalbital, Aspirin, Caffeine, Codeine prescribing information. Breckenridge Pharmaceutical. April 2021.
13	Hydrocodone/Acetaminophen 300 mg prescribing information. Lupin Pharmaceuticals. December 2021.
14	Hydrocodone/Acetaminophen oral solution prescribing information. Eywa Pharma Inc. October 2022.
15	hydrocodone/ibuprofen prescribing information. Amneal Pharmaceuticals, LLC. November 2022.
16	levorphanol prescribing information. Lannett Company, Inc. January 2022.
17	Lortab prescribing information. Akorn, Inc. September 2022.
18	meperidine prescribing information. West-Ward Pharmaceuticals Corp. December 2022.
19	methadone prescribing information. VistaPharm, Inc. June 2021.
20	Methadose prescribing information. VistaPharm. July 2021.
21	morphine prescribing information. Hikma Pharmaceuticals USA Inc. April 2022.
22	Hydrocodone/Acetaminophen tablet prescribing information. Amneal Pharmaceuticals, LLC. November 2022.
23	Nucynta prescribing information. Collegium Pharm, Inc. July 2023.
24	Oxaydo prescribing information. Zyla Life Sciences US Inc. July 2023.
25	oxycodone prescribing information. ANI Pharmaceuticals Inc. August 2021.
26	Oxycodone/acetaminophen 300 mg prescribing information. FH2 Pharma LLC. April 2023.
27	Oxycodone/acetaminophen 5/325 solution prescribing information. Nostrum Laboratories, Inc. September 2021.
28	Reference no longer used.
29	Reference no longer used.
30	oxymorphone prescribing information. Hikma Pharmaceuticals. April 2023.
31	Pentazocine/naloxone prescribing information. Actavis Pharma, Inc. July 2020.
32	Percocet prescribing information. Endo Pharmaceuticals Inc. July 2022.
33	Prolate prescribing information. Forte Bio-Pharma LLC. September 2021.
34	Qdolo prescribing information. Athena Bioscience, LLC. September 2021.
35	Roxicodone prescribing information. Specgx LLC. January 2023.
36	Seglentis prescribing information. Kowa Pharmaceuticals America, Inc. October 2021.
37	Trezix prescribing information. Wraser Pharms LLC. February 2021.
38	Tylenol with codeine prescribing information. A-S Medication Solutions. April 2019.
39	Ultracet prescribing information. Jassen Pharma. February 2023.
40	Ultram prescribing information Janssen Pharms. February 2023.
41	Roxybond prescribing information. Protega Pharms. March 2021.

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.

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

	Acetaminophen w/ Codeine Soln 120-12 MG/5ML	120-12 MG/5ML	2700	mLs	30	DAYS
	Acetaminophen w/ Codeine Tab 300-15 MG	300-15 MG	360	Tablets	30	DAYS
	Acetaminophen w/ Codeine Tab 300-30 MG	300-30 MG	360	Tablets	30	DAYS
	Acetaminophen w/ Codeine Tab 300-60 MG	300-60 MG	180	Tablets	30	DAYS
	Acetaminophen-Caffeine-Dihydrocodeine Tab 325-30-16 MG		300	Tablets	30	DAYS
	Butalbital-Acetaminophen-Caff w/ COD Cap 50-325-40-30 MG	50-325-40-30 MG	180	Capsules	30	DAYS
	Butorphanol Tartrate Nasal Soln 10 MG/ML	10 MG/ML	3	Bottles	30	DAYS
	Codeine Sulfate Tab 15 MG	15 MG	180	Tablets	30	DAYS
	Codeine Sulfate Tab 30 MG	30 MG	180	Tablets	30	DAYS
	Codeine Sulfate Tab 60 MG	60 MG	180	Tablets	30	DAYS
	Hydrocodone-Acetaminophen Soln 7.5-325 MG/15ML	2.5-108 MG/5ML ; 5-217 MG/10ML ; 7.5-325 MG/15ML	2700	mLs	30	DAYS
	Hydrocodone-Acetaminophen Tab 10-300 MG	10-300 MG	180	Tablets	30	DAYS
	Hydrocodone-Acetaminophen Tab 10-325 MG	10-325 MG	180		30	DAYS
	Hydrocodone-Acetaminophen Tab 5-325 MG	5-325 MG	240	Tablets	30	DAYS
	Hydrocodone-Acetaminophen Tab 7.5-300 MG	7.5-300 MG	180	Tablets	30	DAYS
	Hydrocodone-Acetaminophen Tab 7.5-325 MG	7.5-325 MG	180	Tablets	30	DAYS
	Hydrocodone-Ibuprofen Tab 10-200 MG	10-200 MG	150	Tablets	30	DAYS
	Hydrocodone-Ibuprofen Tab 5-200 MG	5-200 MG	150	Tablets	30	DAYS
	Hydrocodone-Ibuprofen Tab 7.5-200 MG	7.5-200 MG	150	Tablets	30	DAYS
	Levorphanol Tartrate Tab 2 MG	2 MG	120	Tablets	30	DAYS
	Levorphanol Tartrate Tab 3 MG	3 MG	120	Tablets	30	DAYS
	Meperidine HCl Oral Soln 50 MG/5ML	50 MG/5ML	1800	mLs	30	DAYS
	Meperidine HCl Tab 50 MG	50 MG	360	Tablet	30	DAYS
	Methadone HCl Soln 10 MG/5ML	10 MG/5ML	450	mLs	30	DAYS
	Methadone HCl Soln 5 MG/5ML	5 MG/5ML	900	mLs	30	DAYS
	Methadone HCl Tab 10 MG	10 MG	90	Tablets	30	DAYS
	Methadone HCl Tab 5 MG	5 MG	90	Tablets	30	DAYS
	Morphine Sulfate Oral Soln 10 MG/5ML	10 MG/5ML	2700	mLs	30	DAYS
	Morphine Sulfate Oral Soln 100 MG/5ML (20 MG/ML)	10 MG/0.5ML ; 100 MG/5ML ; 20 MG/ML	270	mLs	30	DAYS
	Morphine Sulfate Oral Soln 20 MG/5ML	20 MG/5ML	1350	mLs	30	DAYS
	Morphine Sulfate Tab 15 MG	15 MG	360	Tablets	30	DAYS
	Morphine Sulfate Tab 30 MG	30 MG	180	Tablets	30	DAYS
	Oxycodone HCl Cap 5 MG	5 MG	360	Capsules	30	DAYS
	Oxycodone HCl Conc 100 MG/5ML (20 MG/ML)	10 MG/0.5ML ; 100 MG/5ML	270	mLs	30	DAYS
	Oxycodone HCl Soln 5 MG/5ML	5 MG/5ML	5400	mLs	30	DAYS
	Oxycodone HCl Tab 10 MG	10 MG	180	Tablets	30	DAYS
	Oxycodone HCl Tab 20 MG	20 MG	180	Tablets	30	DAYS
	Oxycodone w/ Acetaminophen Soln 5-325 MG/5ML	5-325 MG/5ML	1800	mLs	30	DAYS
	Oxymorphone HCl Tab 10 MG	10 MG	180	Tablets	30	DAYS
	Oxymorphone HCl Tab 5 MG	5 MG	180	Tablets	30	DAYS
	Pentazocine w/ Naloxone Tab 50-0.5 MG	50-0.5 MG	360		30	DAYS
	tramadol hcl tab	25 MG	240	Tablets	30	DAYS
	Tramadol HCl Tab 100 MG	100 MG	120	Tablets	30	DAYS
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 4.08-325 MG	4.08-325 MG	360	Tablets	30	DAYS
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 6.12-325 MG	6.12-325 MG	360	Tablets	30	DAYS
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 8.16-325 MG	8.16-325 MG	360	Tablets	30	DAYS
Ascomp/codeine	Butalbital-Aspirin-Caff w/ Codeine Cap 50-325-40-30 MG	50-325-40-30 MG	180	Capsules	30	DAYS
Dilaudid	Hydromorphone HCl Liqd 1 MG/ML	1 MG/ML	1440	mLs	30	DAYS
Dilaudid	Hydromorphone HCl Tab 2 MG	2 MG	180	Tablets	30	DAYS
Dilaudid	Hydromorphone HCl Tab 4 MG	4 MG	180	Tablets	30	DAYS
Dilaudid	Hydromorphone HCl Tab 8 MG	8 MG	180	Tablets	30	DAYS
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 10-325 MG	10-325 MG	180	Tablets	30	DAYS
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 2.5-325 MG	2.5-325 MG	360	Tablets	30	DAYS
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 5-325 MG	5-325 MG	360	Tablets	30	DAYS
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 7.5-325 MG	7.5-325 MG	240	Tablets	30	DAYS
Fioricet/codeine	Butalbital-Acetaminophen-Caff w/ COD Cap 50-300-40-30 MG	50-300-40-30 MG	180	Capsules	30	DAYS
Lortab	Hydrocodone-Acetaminophen Soln 10-300 MG/15ML	10-300 MG/15ML	2025	mLs	30	DAYS
Methadone hydrochloride i ; Methadose ; Methadose sugar-free	Methadone HCl Conc 10 MG/ML	10 MG/ML ; 5 MG/0.5ML	90	mLs	30	DAYS
Methadose	Methadone HCl Tab For Oral Susp 40 MG	40 MG	90	Tablets	30	DAYS
Nalocet	Oxycodone w/ Acetaminophen Tab 2.5-300 MG	2.5-300 MG	360	Tablets	30	DAYS
Nucynta	Tapentadol HCl Tab 100 MG	100 MG	180	Tablets	30	DAYS
Nucynta	Tapentadol HCl Tab 50 MG	50 MG	180	Tablets	30	DAYS
Nucynta	Tapentadol HCl Tab 75 MG	75 MG	180	Tablets	30	DAYS
Oxaydo	Oxycodone HCl Tab	7.5 MG	180	Tablets	30	DAYS
Oxaydo ; Roxicodone	Oxycodone HCl Tab 5 MG	5 MG	360	Tablets	30	DAYS
Prolate	Oxycodone w/ Acetaminophen Soln	10-300 MG/5ML	900	mLs	30	DAYS
Prolate	Oxycodone w/ Acetaminophen Tab 10-300 MG	10-300 MG	180	Tablets	30	DAYS
Prolate	Oxycodone w/ Acetaminophen Tab 5-300 MG	5-300 MG	360	Tablets	30	DAYS
Prolate	Oxycodone w/ Acetaminophen Tab 7.5-300 MG	7.5-300 MG	240	Tablets	30	DAYS
Qdolo	Tramadol HCl Oral Soln	5 MG/ML	2400	mLs	30	DAYS
Roxicodone	Oxycodone HCl Tab 15 MG	15 MG	180	Tablets	30	DAYS
Roxicodone	Oxycodone HCl Tab 30 MG	30 MG	180	Tablets	30	DAYS
Roxybond	Oxycodone HCl Tab Abuse Deter	5 MG	360	Tablets	30	DAYS
Roxybond	Oxycodone HCl Tab Abuse Deter	15 MG	180	Tablets	30	DAYS
Roxybond	Oxycodone HCl Tab Abuse Deter	30 MG	180	Tablets	30	DAYS
Seglentis	Celecoxib-Tramadol HCl Tab	56-44 MG	120	Tablets	30	DAYS
Trezix	Acetaminophen-Caffeine-Dihydrocodeine Cap 320.5-30-16 MG	320.5-30-16 MG	300	Capsules	30	DAYS
Ultracet	Tramadol-Acetaminophen Tab 37.5-325 MG	37.5-325 MG	240	Tablets	30	DAYS
Ultram	Tramadol HCl Tab 50 MG	50 ; 50 MG	240	Tablets	30	DAYS
Xodol	Hydrocodone-Acetaminophen Tab 5-300 MG	5-300 MG	240	Tablets	30	DAYS

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	Acetaminophen w/ Codeine Soln 120-12 MG/5ML	120-12 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Acetaminophen w/ Codeine Tab 300-15 MG	300-15 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Acetaminophen w/ Codeine Tab 300-30 MG	300-30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Acetaminophen w/ Codeine Tab 300-60 MG	300-60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Acetaminophen-Caffeine-Dihydrocodeine Tab 325-30-16 MG		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Butalbital-Acetaminophen-Caff w/ COD Cap 50-325-40-30 MG	50-325-40-30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Butorphanol Tartrate Nasal Soln 10 MG/ML	10 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Codeine Sulfate Tab 15 MG	15 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Codeine Sulfate Tab 30 MG	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Codeine Sulfate Tab 60 MG	60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Soln 7.5-325 MG/15ML	2.5-108 MG/5ML ; 5-217 MG/10ML ; 7.5-325 MG/15ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Tab 10-300 MG	10-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Tab 10-325 MG	10-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Tab 5-325 MG	5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Tab 7.5-300 MG	7.5-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Acetaminophen Tab 7.5-325 MG	7.5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Ibuprofen Tab 10-200 MG	10-200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Ibuprofen Tab 5-200 MG	5-200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocodone-Ibuprofen Tab 7.5-200 MG	7.5-200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Levorphanol Tartrate Tab 2 MG	2 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Levorphanol Tartrate Tab 3 MG	3 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Meperidine HCl Oral Soln 50 MG/5ML	50 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Meperidine HCl Tab 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Methadone HCl Soln 10 MG/5ML	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Methadone HCl Soln 5 MG/5ML	5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Methadone HCl Tab 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Methadone HCl Tab 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Morphine Sulfate Oral Soln 10 MG/5ML	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Morphine Sulfate Oral Soln 100 MG/5ML (20 MG/ML)	10 MG/0.5ML ; 100 MG/5ML ; 20 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Morphine Sulfate Oral Soln 20 MG/5ML	20 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Morphine Sulfate Tab 15 MG	15 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Morphine Sulfate Tab 30 MG	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone HCl Cap 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone HCl Conc 100 MG/5ML (20 MG/ML)	10 MG/0.5ML ; 100 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone HCl Soln 5 MG/5ML	5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone HCl Tab 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone HCl Tab 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxycodone w/ Acetaminophen Soln 5-325 MG/5ML	5-325 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxymorphone HCl Tab 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Oxymorphone HCl Tab 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Pentazocine w/ Naloxone Tab 50-0.5 MG	50-0.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	tramadol hcl tab	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Tramadol HCl Tab 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 4.08-325 MG	4.08-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 6.12-325 MG	6.12-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Apadaz	Benzhydrocodone HCl-Acetaminophen Tab 8.16-325 MG	8.16-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Ascomp/codeine	Butalbital-Aspirin-Caff w/ Codeine Cap 50-325-40-30 MG	50-325-40-30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dilaudid	Hydromorphone HCl Liqd 1 MG/ML	1 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dilaudid	Hydromorphone HCl Tab 2 MG	2 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dilaudid	Hydromorphone HCl Tab 4 MG	4 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dilaudid	Hydromorphone HCl Tab 8 MG	8 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 10-325 MG	10-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 2.5-325 MG	2.5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 5-325 MG	5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Endocet ; Percocet	Oxycodone w/ Acetaminophen Tab 7.5-325 MG	7.5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fioricet/codeine	Butalbital-Acetaminophen-Caff w/ COD Cap 50-300-40-30 MG	50-300-40-30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lortab	Hydrocodone-Acetaminophen Soln 10-300 MG/15ML	10-300 MG/15ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Methadone hydrochloride i ; Methadose ; Methadose sugar-free	Methadone HCl Conc 10 MG/ML	10 MG/ML ; 5 MG/0.5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Methadose	Methadone HCl Tab For Oral Susp 40 MG	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nalocet	Oxycodone w/ Acetaminophen Tab 2.5-300 MG	2.5-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nucynta	Tapentadol HCl Tab 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nucynta	Tapentadol HCl Tab 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nucynta	Tapentadol HCl Tab 75 MG	75 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Oxaydo	Oxycodone HCl Tab	7.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Oxaydo ; Roxicodone	Oxycodone HCl Tab 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prolate	Oxycodone w/ Acetaminophen Soln	10-300 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prolate	Oxycodone w/ Acetaminophen Tab 10-300 MG	10-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prolate	Oxycodone w/ Acetaminophen Tab 5-300 MG	5-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prolate	Oxycodone w/ Acetaminophen Tab 7.5-300 MG	7.5-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qdolo	Tramadol HCl Oral Soln	5 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Roxicodone	Oxycodone HCl Tab 15 MG	15 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Roxicodone	Oxycodone HCl Tab 30 MG	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Roxybond	Oxycodone HCl Tab Abuse Deter	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Roxybond	Oxycodone HCl Tab Abuse Deter	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Roxybond	Oxycodone HCl Tab Abuse Deter	15 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Seglentis	Celecoxib-Tramadol HCl Tab	56-44 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trezix	Acetaminophen-Caffeine-Dihydrocodeine Cap 320.5-30-16 MG	320.5-30-16 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Ultracet	Tramadol-Acetaminophen Tab 37.5-325 MG	37.5-325 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Ultram	Tramadol HCl Tab 50 MG	50 ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Xodol	Hydrocodone-Acetaminophen Tab 5-300 MG	5-300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Program Maximum Daily Doses

Agent(s)	Program Maximum Daily Dose
butorphanol	0.25 mL
Codeine	360 mg
Dilaudid (hydromorphone)	48 mg
Levorphanol	12 mg
Meperidine	600 mg
Methadose (methadone) Tablet, solution, concentrate	30 mg
Methadose (methadone) Soluble tablet	120 mg
Morphine	180 mg
Oxaydo, Roxybond, Roxicodone (oxycodone)	180 mg
Opana (oxymorphone)	60 mg
Nucynta (tapentadol)	600 mg
Qdolo, Ultram, Tramadol	400 mg

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 OR
2. 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
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 Single Ingredient Opioids IR Agent(s) which exceed 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:
1. The patient has a diagnosis of active cancer pain due to an active malignancy OR
2. The patient is eligible for hospice OR palliative care OR
3. The patient has sickle cell disease OR
4. The patient is undergoing treatment of chronic non-cancer pain and ALL of the following are met:
  1. A formal, consultative evaluation which includes BOTH of the following has been conducted:
    1. Diagnosis AND
    2. A complete medical history which includes previous and current pharmacological and non-pharmacological therapy AND
  2. A patient-specific pain management plan is on file for the patient AND
  3. 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 OR
2. 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
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 Combination Ingredient Opioids IR Agent(s) which exceed 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 OR
2. 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
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.

ALBP _ Commercial _ CS _ Opioids_IR_QL _ProgSum_ 10-01-2024 _