opioid immediate release and extended release new to …...one or 2 capsules every 4 hours as...

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© Copyright Prime Therapeutics LLC. 02/2019 All Rights Reserved

This program applies to Medicaid.

FDA APPROVED INDICATIONS AND DOSAGE3-23

Immediate Release Opioid Agents

Indication Dosing

butorphanol nasal spraya

nasal spray

Management of pain

severe enough to

require an opioid

analgesic and for which

alternative treatments

are inadequate.

The usual recommended initial dose is

1 mg (1 spray in one nostril). If

adequate pain relief is not achieved

within 60 to 90 minutes, an additional

1 mg dose may be given.

The initial dose sequence outlined

above may be repeated in 3 to 4

hours as required after the second

dose of the sequence.

Depending on the severity of the pain,

an initial dose of 2 mg (1 spray in

each nostril) may be used in patients

who will be able to remain recumbent

in the event drowsiness or dizziness

occurs. In such patients, single

additional 2 mg doses should not be

given for 3 to 4 hours.

codeinea

tablet

Management of mild to

moderate pain, where

treatment with an

opioid is appropriate

and for which


are inadequate.

15 mg to 60 mg repeated up to every

four hours as needed for pain. The

maximum 24 hour dose is 360 mg.

Dilaudida

(hydromorphone)

tablet,

liquid

Management of pain

severe enough to

require an opioid



are inadequate.

Every 4-6 hours

Levorphanola

tablet

management of pain

severe enough to

require an opioid



are inadequate.

Every 6-8 hours

Opioid Immediate Release

and Extended Release New To Therapy Program Summary



Immediate Release

Opioid Agents

Indication Dosing

Demerola

(meperidine) tablet,

solution

Management of pain,

severe enough to

require an opioid



are inadequate.

Every 3-4 hours

Dolophinea

Methadosea

(methadone)

tablet, soluble tablet, solution

Management of pain

severe enough to

require daily, around-

the-clock, long-term

opioid treatment and

for which alternative

treatment options are

inadequate

Every 8-12 hours

morphinea

tablet,

concentrate, solution

Management of

acute and chronic pain severe enough

to require an opioid analgesic and for which alternative

treatments are inadequate.

Every 4 hours

Oxaydo (oxycodone)

tablet

Management of acute

and chronic pain

severe enough to

require an opioid



are inadequate.

Every 4-6 hours

oxycodonea

tablet,

solution,

concentrate

Management of pain

severe enough to

require an opioid



are inadequate.

Every 4-6 hours

Roxicodonea

(oxycodone)

tablet

Management of pain

severe enough to

require an opioid



are inadequate.

Every 4-6 hours

Roxybond (oxycodone)

tablet

Management of pain

severe enough to

require an opioid



are inadequate.

Every 4-6 hours



Immediate Release

Opioid Agents

Indication Dosing

Opanaa

(oxymorphone) tablet

Management of acute

pain severe enough to

require an opioid



are inadequate.

Every 4-6 hours

Nucynta (tapentadol)

tablet

Management of acute

pain severe enough to

require an opioid



are inadequate.

Every 4-6 hours. Daily doses greater

than 700 mg on the first day of

therapy and 600 mg on subsequent

days have not been studied and are

not recommended.

Ultrama (tramadol)

tablet

Management of pain in

adults that is severe

enough to require an

opioid analgesic and for

which alternative

treatments are

inadequate.

Every 4 to 6 hours not to exceed 400

mg/day



Combination Opioid

Agents

Strength Dosage & Administration

Reprexain, Ibudone

(hydrocodone/ ibuprofen)

5 mg/200 mg tablet

10 mg/200 mg tablet

One tablet every 4 to 6 hours, as

necessary. Dosage should not exceed 5 tablets in a 24-hour period.

Vicoprofen (hydrocodone/

ibuprofen)

7.5 mg/200 mg tablet

One tablet every 4 to 6 hours, as necessary.

Dosage should not exceed 5 tablets in a 24-hour period.

Ultracet (tramadol/

acetaminophen)


2 tablets every 4 to 6 hours as needed for pain relief,

up to a maximum of 8 tablets per day for up to 5 days.

oxycodone/ aspirin


One tablet every 6 hours as needed for pain. The maximum daily dose of aspirin

should not exceed 4 grams or 12 tablets.

Apadaz

(benzhydrocodone/

acetaminophen)

4.08/325 mg tablet

6.12/325 mg tablet

8.16/325 mg tablet

1-2 tablets every 4-6 hours. Dosage

should not exceed 12 tablets in a 24

hour period.

Percocet, Endocet (oxycodone/

acetaminophen)


Maximum 12 tablets per day

Percocet, Endocet, Roxicet (oxycodone/

acetaminophen)

5 mg/325 mg tablet Maximum 12 tablets per day

Percocet, Endocet

(oxycodone/ acetaminophen)

7.5 mg/325 mg

tablet


Percocet, Endocet (oxycodone/

acetaminophen)


Primlev



Primlev (oxycodone/ acetaminophen)



Primlev (oxycodone/

acetaminophen)


Roxicet


5 mg/325 mg/5 mL

solution

Maximum 60 mLs per day



Combination Opioid

Agents


Capital and Codeine

(acetaminophen/ codeine)

120 mg/12 mg/5 mL

suspension

Pediatric: 5-10 mLs 3-4 times

daily. Adults: 15 mLs every 4 hours as

needed.

Tylenol w/Codeine (acetaminophen/

codeine)


Tylenol w/Codeine

(acetaminophen/ codeine)


Tylenol w/Codeine (acetaminophen/ codeine)


Hycet (hydrocodone/

acetaminophen)

7.5 mg/325 mg/15 mL solution

Maximum 90 mLs per day

Hydrocodone/

Acetaminophen

2.5 mg/325 mg

tablet

One or two tablets every four to

six hours as needed for pain. The total daily dosage should not exceed 12 tablets.

Norco (hydrocodone/

acetaminophen)

5 mg/325 mg tablet One or two tablets every four to six hours as needed for pain.

The total daily dosage should not exceed 8 tablets.

Norco (hydrocodone/

acetaminophen)


One tablet every four to six hours as needed for pain.


Norco (hydrocodone/ acetaminophen)

10 mg/325 mg tablet One tablet every four to six hours as needed for pain. The total daily dosage should not

exceed 5 tablets.

Xodol

(hydrocodone/ acetaminophen)

5 mg/300 mg tablet One or two tablets every four to

six hours as needed for pain. The total daily dosage should not

exceed 8 tablets.

Xodol


7.5 mg/300 mg

tablet

One tablet every four to six hours

as needed for pain. The total daily dosage should not exceed 6 tablets.

Xodol (hydrocodone/

acetaminophen)

10 mg/300 mg tablet One tablet every four to six hours as needed for pain.




Combination Opioid

Agents


Zamicet


10 mg/325 mg/15

mL solution

One tablespoonful (15 mL) every

four to six hours as needed for pain. The total daily dosage should not

exceed 6 tablespoonfuls.

Zolvit/Lortab


10 mg/300 mg/15

mL solution

Maximum 67.5 mL per day

Trezix, Acetaminophen/

Caffeine/ Dihydrocodeine

320.5 mg/30 mg/16 mg capsule

Two capsules orally every four hours, as needed.

No more than two capsules should be taken in a 4-hour period. No more than five doses, or ten

capsules should be taken in a 24-hour period.

Allzital

(butalbital/

acetaminophen)

25 mg/325 mg tablet 1-2 tablets every four hours as

needed. Do not exceed 6 tablets per

day. Butalbital Compound

(butalbital/

aspirin/

caffeine)

50 mg/325 mg/40 mg

capsule One or 2 tablets every 4 hours as

needed. Total daily dosage should not

exceed 6 tablets.

butalbital/

acetaminophen 50 mg/325 mg tablet One or two tablets every four hours as

needed. Do not exceed not exceed 6

tablets per day. Vanatol LQ

(butalbital/

acetaminophen/

caffeine)

50 mg/325 mg/40

mg/15 mL solution One or two tablespoonfuls (15 mL or

30 mL) every four hours. Total daily

dosage should not exceed 6

tablespoonfuls. Esgic

(butalbital/

acetaminophen/

caffeine)

50 mg/325 mg/40 mg

capsule One or 2 tablets every 4 hours as


exceed 6 tablets.

Esgic

(butalbital/

acetaminophen/

caffeine)

50 mg/325 mg/40 mg

tablet

One or 2 tablets every 4 hours as


exceed 6 tablets.

butalbital/ acetaminophen/

caffeine/codeinea

50 mg/325 mg/40 mg/30 mg capsule

One or 2 tablets every 4 hours as needed.

Total daily dosage should not exceed 6 tablets.

Fioricet w/Codeine (butalbital/ acetaminophen/

caffeine/codeine)

50 mg/300 mg/40 mg/30 mg capsule

One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.



Combination Opioid

Agents


Fiorinal w/Codeine

(butalbital/ aspirin/ caffeine/

codeine)a

50 mg/325 mg/40

mg/30 mg capsule

One or 2 tablets every 4 hours as

needed. Total daily dosage should not exceed 6 tablets.

Orbivan

(butalbital/

acetaminophen/

caffeine)

50 mg/300 mg/40 mg

capsule One or 2 capsules every 4 hours as


exceed 6 capsules.

Bupap, Orbivan CF

(butalbital/

acetaminophen)

50 mg/300 mg tablet One or two tablets every four hours.

Total daily dosage should not exceed

6 tablets.

Pentazocine/naloxonea 50 mg/0.5 mg tablet One or two tablets every 3 to4 hours. Total daily dosage should not exceed 12 tablets

a – generic available

b – discontinued

Opioid Extended

Release Agents Dosing Frequency (Maximum Labeled

Dose)

Indication and Usage

Narcotics

Arymo ER™ (morphine sulfate ER)

15, 30, 60 mg

Two or three times

daily

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.

Belbuca™ (buprenorphine buccal

film)

75, 150, 300, 450, 600,

750, 900 mcg

Twice daily

(1800 mcg daily)

Butrans

Buprenorphine Transdermal

5, 7.5, 10, 15, 20

mcg/hour system

1 transdermal system weekly

(20 mcg/hr)

Duragesic

(fentanyl transdermal patch ER)

12, 25, 50, 75, 100 mcg/houra

15 patches per

month

Embeda (morphine/naltrexone ER)

Once or twice daily



Opioid Extended Release Agents

Dosing Frequency

(Maximum Labeled Dose)


20-0.8, 30-1.2, 50-2, 60-2.4,

80-3.2, 100-4 mg

Exalgo (hydromorphone ER)

8, 12, 16, 32 mg

Once daily

Fentanyl transdermal patch

37.5, 62.5, 87.5 mcg/hour

15 patches per

month

Hysingla ER (hydrocodone ER)

20, 30, 40, 60, 80, 100,

120 mg

Once daily

Kadian (morphine ER)a

10, 20, 30, 40, 50, 60,

70, 80, 100, 130, 150, 200 mg

Once or twice daily

Morphabond ER (morphine ER)

15, 30, 60, 100 mg

Twice daily

Morphine Sulfate ER

30, 45, 60, 75, 90, 120 mg

Once daily

(1600 mg daily)

MS Contin (morphine sulfate ER)a

15, 30, 60, 100, 200 mg

Twice daily with some patients

requiring three times daily

Opana ER crush-resistant (oxymorphone ER)

5, 7.5, 10, 15, 20, 30, 40 mg

Twice daily

OxyContin Twice daily




Dosing Frequency



(oxycodone ER)

Oxymorphone ER

5, 7.5, 10, 15, 20, 30, 40 mg

Twice daily

Xtampza ER (oxycodone ER)

9, 13.5, 18, 27, 36 mg

capsules

Twice daily

(288 mg)

Zohydro ER Abuse Deterrent (hydrocodone ER)

10, 15, 20, 30, 40, 50 mg capsules

Twice daily

Xartemis XR™

(oxycodone/acetaminophen ER)


Twice daily Management of acute pain

severe enough to require opioid treatment and for which

alternative treatment options are inadequate.

Limitations of Use: Because of the risks of addiction,

abuse, misuse, overdose, and death with opioids, even at

recommended doses, reserve oxycodone/acetaminophen ER

for use in patients for whom alternative treatment options

(e.g., non-opioid analgesics) are ineffective, not tolerated, or

would be otherwise inadequate

Tramadol, Tapentadol

Nucynta ER®

(tapentadol ER)

50, 100, 150, 200, 250 mg

Twice daily

(500 mg daily)

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




Dosing Frequency



(DPN) in adults severe enough

to require daily, around-the-clock, long-term opioid

treatment and for which alternative treatment options are

inadequate.

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.

Tapentadol ER is not indicated as an as-needed (prn) analgesic.

Conzip (tramadol SR biphasic)

100, 200, 300 mg

Once daily

(300 mg daily)

Management of moderate to

moderately severe chronic pain in adults who require around-

the-clock treatment of their pain for an extended period of time tramadol ERa

100, 200, 300 mg

Once daily

(300 mg daily)

Tramadol SR Biphasic

(tramadol SR biphasic)

150 mg

Once daily

(300 mg daily)

Ultram ER (tramadol ER)a

100, 200, 300 mg

Once daily

(300 mg daily)

a – generic available



CLINICAL RATIONALE

The Center for Disease Control and Prevention recommends that 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. Three days or less will often be sufficient; more

than seven days will rarely be needed.1

When starting opioid therapy for chronic pain, clinicians should prescribe immediate-

release opioids instead of extended-release/long-acting (ER/LA) opioids. 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.1

Use of tramadol or codeine containing products in pediatric patients has cause 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.2

REFERENCES

1. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.

Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

65(1);1–49. March 18, 2016

2. 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.

3. butorphanol tartrate nasal solution prescribing information. Apotex Corp. August

2018.

4. codeine prescribing information. Lannett Company, Inc. September 2018.

5. meperidine prescribing information. Sanofi-Aventis US. LLC. September 2018.

6. Dilaudid prescribing information. Purdue Pharma LP. September 2018.

7. Dolophine prescribing information. West-Ward Pharmaceuticals Corp. September

2018.

8. levorphanol prescribing information. Roxane Laboratories, Inc. September 2018.

9. methadone prescribing information. Cerbert Pharmaceuticals. May 2008.

10. Methadose prescribing information. Mallinkrodt, Inc. April 2018.

11. morphine prescribing information. West-Ward Pharmaceuticals Corp. April 2017.

12. oxycodone prescribing information. Amneal Pharmaceuticals LLC. June 2017.

13. Opana prescribing information. Endo Pharmaceuticals. September 2018.

14. Oxaydo prescribing information. Egalet US Inc. September 2018.

15. Nucynta prescribing information. Janssen Pharmaceuticals, Inc. September 2018.

16. Ultram prescribing information. Janssen Pharms. September 2018.

17. Roxybond prescribing information. Daiichi Sankyo Inc. September 2018.

18. Roxicodone prescribing information. Specgx LLC. September 2018.

19. Combunox prescribing information. Forest Pharmaceuticals, Inc. September 2010.

20. DailyMed. UN National Library of Medicine. Accessed 10/15/2018.

https://dailymed.nlm.nih.gov/dailymed/index.cfm

21. Ultracet prescribing information. Janssen Pharmaceuticals, Inc. August 2017.

22. Tylenol with codeine prescribing information. Janssen Pharmaceuticals, Inc. April

2018.

23. Apadaz prescribing information. KemPharm, Inc. September 2018.

https://dailymed.nlm.nih.gov/dailymed/index.cfm



Opioids IR and ER New To Therapy

OBJECTIVE

The intent of the program is to help direct appropriate use of opioids based on the CDC

guideline recommendation that acute use of these agents should rarely exceed 7 days of

therapy. The program will check if a patient is new to opioid therapy as defined as having

no prior opioid use in the past 120 days. If the patient is new to therapy, the patient will

be restricted to ≤7 days of therapy. The program will allow for uses beyond this limit if

the patient has a diagnosis of cancer pain due to an active malignancy, is taking an

oncology agent in the past 120 days, is eligible for hospice care, or has provided

documentation showing use beyond this limit is appropriate. Tramadol or codeine

containing agents will not be approved for pediatric patients less than 12 years of age,

nor for patients less than 18 years of age for post-operative pain management following

a tonsillectomy and/or adenoidectomy.

TARGET AGENTS FOR NEW TO THERAPYa

AGENT Strength GPI Brand,

Generic

Availability

Multi-

source

Code

butorphanol 10 mg/mL nasal

spray

65200020102050 G M,N,O,Y

Codeine 15 mg tablet 65100020200305 B M,N,O,Y

Codeine 30 mg tablet 65100020200310 BG M,N,O,Y

Codeine 60 mg tablet 65100020200315 B M,N,O,Y

Dilaudid

(hydromorphone

)

2 mg tablet 65100035100310 BG M,N,O,Y

Dilaudid

(hydromorphone

)

4 mg tablet 65100035100320 BG M,N,O,Y

Dilaudid

(hydromorphone

)

8 mg tablet 65100035100330 BG M,N,O,Y

Dilaudid

(hydromorphone

)

1 mg/mL liquid 65100035100920 BG M,N,O,Y

Levorphanol 2 mg tablet 65100040100305 G M,N,O,Y

Levorphanol 3 mg tablet 65100040100310 B M,N,O,Y

meperidine 50 mg tablet 65100045100305 BG M,N,O,Y

Demerol

(meperidine)

100 mg tablet 65100045100310 BG M,N,O,Y

Meperidine 50 mg/5 mL solution 65100045102060 B M,N,O,Y

Dolophine

(methadone)

5 mg tablet 65100050100305 BG M,N,O,Y

Dolophine

(methadone)

10 mg tablet 65100050100310 BG M,N,O,Y

Methadose

(methadone

40 mg soluble tablet 65100050107320 G M,N,O,Y

methadone 5 mg/5mL solution 65100050102010 BG M,N,O,Y

methadone 10 mg/5 mL solution 65100050102015 BG M,N,O,Y

methadone 10 mg/mL

concentrate

65100050101310 BG M,N,O,Y

Morphine 15 mg tablet 65100055100310 B M,N,O,Y




Generic

Availability

Multi-

source

Code

Morphine 30 mg tablet 65100055100315 B M,N,O,Y

Morphine 10 mg/5 mL solution 65100055102065 G M,N,O,Y

Morphine 20 mg/5 mL solution 65100055102070 G M,N,O,Y

Morphine 20 mg/mL

concentrate

65100055102090 G M,N,O,Y

oxycodone 5 mg capsule 65100075100110 G M,N,O,Y

Oxaydo,

Roxybond

(oxycodone)

5 mg tablet 6510007510A510 B M,N,O,Y

Oxaydo

(oxycodone)

7.5 mg tablet 6510007510A520 B M,N,O,Y

oxycodone 10 mg tablet 65100075100320 G M,N,O,Y

oxycodone 20 mg tablet 65100075100330 G M,N,O,Y

oxycodone 5 mg/5mL solution 65100075102005 G M,N,O,Y

oxycodone 20 mg/mL

concentrate

65100075101320 G M,N,O,Y

Roxicodone

(oxycodone)

5 mg tablet 65100075100310 BG M,N,O,Y

Roxicodone

(oxycodone)

15 mg tablet 65100075100325 BG M,N,O,Y

Roxybond

(oxycodone)

15 mg tablet 6510007510A540 B M,N,O,Y

Roxybond

(oxycodone)

30 mg tablet 6510007510A560 B M,N,O,Y

Roxicodone

(oxycodone)

30 mg tablet 65100075100340 BG M,N,O,Y

Opana

(oxymorphone)

5 mg tablet 65100080100305 BG M,N,O,Y

Opana

(oxymorphone)

10 mg tablet 65100080100310 BG M,N,O,Y

Nucynta

(tapentadol)

50 mg tablet 65100091100320 B M,N,O,Y

Nucynta

(tapentadol)

75 mg tablet 65100091100330 B M,N,O,Y

Nucynta

(tapentadol)

100 mg tablet 65100091100340 B M,N,O,Y

Ultram

(tramadol)

50 mg tablet 65100095100320 BG M,N,O,Y

Combination Agents

Oxycodone/

Ibuprofen

5 mg/400 mg tablet 65990002260320 B M,N,O,Y

Reprexain

(hydrocodone/

ibuprofen)

2.5 mg/200 mg

tablet

65991702500310 DC M,N,O,Y

Reprexain,

Ibudone

(hydrocodone/

ibuprofen)

5 mg/200 mg tablet 65991702500315 BG M,N,O,Y




Generic

Availability

Multi-

source

Code

Reprexain,

Ibudone, Xylon

(hydrocodone/

ibuprofen)

10 mg/200 mg

tablet

65991702500330 BG M,N,O,Y

Vicoprofen

(hydrocodone/

ibuprofen)

7.5 mg/200 mg

tablet

65991702500320 G M,N,O,Y

Ultracet

(tramadol/

acetaminophen)

37.5 mg/325 mg

tablet

65995002200320 BG M,N,O,Y

Percodan,

Endodan

(oxycodone/

aspirin)

4.8355 mg/325 mg

tablet

65990002220340 G M,N,O,Y

Synalgos-DC,

Aspirin/Caffeine/

Dihydrocodeine

356.4 mg/30 mg/16

mg capsule

65991303100115 B M,N,O,Y

Apadaz

(benzhydrocodon

e/acetaminophen

4.08/325 mg tablet 65990002020310 B M,N,O,Y

Apadaz

(benzhydrocodon

e/acetaminophen

6.12/325 mg tablet 65990002020320 B M,N,O,Y

Apadaz

(benzhydrocodon

e/acetaminophen

8.16/325 mg tablet 65990002020330 B M,N,O,Y

Percocet,

Endocet

(oxycodone/

acetaminophen)

2.5 mg/325 mg

tablet

65990002200305 BG M,N,O,Y

Percocet,

Endocet, Roxicet

(oxycodone/

acetaminophen)


Percocet,

Endocet

(oxycodone/

acetaminophen)

7.5 mg/325 mg

tablet

65990002200327 BG M,N,O,Y

Percocet,

Endocet

(oxycodone/

acetaminophen)

10 mg/325 mg

tablet

65990002200335 BG M,N,O,Y

Nalocet

(oxycodone/

acetaminophen)

2.5 mg/300 mg

tablet

65990002200303 B M,N,O,Y

Primlev

(oxycodone/

acetaminophen)





Generic

Availability

Multi-

source

Code

Primlev

(oxycodone/

acetaminophen)

7.5 mg/300 mg

tablet

65990002200325 B M,N,O,Y

Primlev

(oxycodone/

acetaminophen)

10 mg/300 mg

tablet

65990002200333 B M,N,O,Y

Roxicet

(oxycodone/

acetaminophen)

5 mg/325 mg/5 mL

solution

65990002202005 B M,N,O,Y

Capital and

Codeine

(acetaminophen/

codeine)

120 mg/12 mg/5 mL

suspension

65991002051805 B M,N,O,Y

Acetaminophen/

codeine

120 mg/12 mg/5 mL

solution

65991002052020 G M,N,O,Y

Tylenol

w/Codeine

(acetaminophen/

codeine)

300 mg/15 mg

tablet

65991002050310 BG M,N,O,Y

Tylenol

w/Codeine

(acetaminophen/

codeine)

300 mg/30 mg

tablet

65991002050315 BG M,N,O,Y

Tylenol

w/Codeine

(acetaminophen/

codeine)

300 mg/60 mg

tablet

65991002050320 BG M,N,O,Y

Hycet

(hydrocodone/

acetaminophen)

7.5 mg/325 mg/15

mL solution

65991702102015 G M,N,O,Y

Hydrocodone/

acetaminophen

2.5 mg/325 mg

tablet

65991702100302 G M,N,O,Y

Norco

(hydrocodone/

acetaminophen)


Norco

(hydrocodone/

acetaminophen)

7.5 mg/325 mg

tablet

65991702100358 BG M,N,O,Y

Norco

(hydrocodone/

acetaminophen)

10 mg/325 mg

tablet

65991702100305 BG M,N,O,Y

Xodol

(hydrocodone/

acetaminophen)


Xodol

(hydrocodone/

acetaminophen)

7.5 mg/300 mg

tablet

65991702100322 BG M,N,O,Y

Xodol

(hydrocodone/

acetaminophen)

10 mg/300 mg

tablet

65991702100375 BG M,N,O,Y




Generic

Availability

Multi-

source

Code

hydrocodone/

acetaminophen

solution

10 mg/325 mg/15

mL solution

65991702102025 BG M,N,O,Y

Zolvit/Lortab

(hydrocodone/

acetaminophen)

10 mg/300 mg/15

mL solution

65991702102024 B M,N,O,Y

Trezix,

Acetaminophen/

Caffeine/

Dihydrocodeine

320.5 mg/30 mg/16

mg capsule

65991303050115 B M,N,O,Y

Panlor,

(acetaminophen/

caffeine/dihydroc

odeine)

325 mg/30 mg/16

mg tablet

65991303050320 G M,N,O,Y

Fioricet

w/Codeine

(butalbital/

acetaminophen/

caffeine/codeine)

50 mg/325 mg/40

mg/30 mg capsule

65991004100115 G M,N,O,Y

Fioricet

w/Codeine

(butalbital/

acetaminophen/

caffeine/codeine)

50 mg/300 mg/40

mg/30 mg capsule

65991004100113 BG M,N,O,Y

Fiorinal

w/Codeine

(butalbital/

aspirin/caffeine/

codeine)

50 mg/325 mg/40

mg/30 mg capsule

65991004300115 BG M,N,O,Y

Oxycodone/

Ibuprofen


Reprexain

(hydrocodone/

ibuprofen)

2.5 mg/200 mg

tablet

65991702500310 BG M,N,O,Y

Reprexain,

Ibudone

(hydrocodone/

ibuprofen)


pentazocine/nalo

xone

50 mg/0.5 mg tablet 65200040300310 G M,N,O,Y

Opioid ER Agents

Arymo ER

(morphine

sulfate)

15 mg extended

release tablet

6510005510A620 B M,N,O,Y

Arymo ER

(morphine

sulfate)

30 mg extended

release tablet

6510005510A630 B M,N,O,Y

Arymo ER

(morphine

sulfate)

60 mg extended

release tablet

6510005510A640 B M,N,O,Y




Generic

Availability

Multi-

source

Code

Belbuca

(buprenorphine

buccal film)

75 mcg buccal film 65200010108210 B M,N,O,Y

Belbuca

(buprenorphine

buccal film)


Belbuca

(buprenorphine

buccal film)


Belbuca

(buprenorphine

buccal film)


Belbuca

(buprenorphine

buccal film)


Belbuca

(buprenorphine

buccal film)


Belbuca

(buprenorphine

buccal film)


Butrans,

Buprenorphine

Transdermal

System

5 mcg/hour

transdermal system

65200010008820 BG M,N,O,Y

Butrans,

Buprenorphine

Transdermal

System

7.5 mcg/hour

transdermal system

65200010008825 BG M,N,O,Y

Butrans,

Buprenorphine

Transdermal

System

10 mcg/hour

transdermal system

65200010008830 BG M,N,O,Y

Butrans,

Buprenorphine

Transdermal

System

15 mcg/hour

transdermal system

65200010008835 BG M,N,O,Y

Butrans,

Buprenorphine

Transdermal

System

20 mcg/hour

transdermal system

65200010008840 BG M,N,O,Y

Duragesic

(fentanyl

transdermal

patch)

12 mcg/hr

transdermal patch

65100025008610 BG M,N,O,Y

Duragesic

(fentanyl

transdermal

patch)

25 mcg/hr

transdermal patch

65100025008620 BG M,N,O,Y




Generic

Availability

Multi-

source

Code

Duragesic

(fentanyl

transdermal

patch)

50 mcg/hr

transdermal patch

65100025008630 BG M,N,O,Y

Duragesic

(fentanyl

transdermal

patch)

75 mcg/hr

transdermal patch

65100025008640 BG M,N,O,Y

Duragesic

(fentanyl

transdermal

patch)

100 mcg/hr

transdermal patch

65100025008650 BG M,N,O,Y

Embeda

(morphine/naltre

xone)

20 mg/0.8 mg

controlled-release

capsule

65100055700220 B M,N,O,Y

Embeda

(morphine/naltre

xone)

30 mg/1.2 mg

controlled-release

capsule

65100055700230 B M,N,O,Y

Embeda

(morphine/naltre

xone)

50 mg/2 mg

controlled-release

capsule

65100055700240 B M,N,O,Y

Embeda

(morphine/naltre

xone)

60 mg/2.4 mg

controlled-release

capsule

65100055700250 B M,N,O,Y

Embeda

(morphine/naltre

xone)

80 mg/3.2 mg

controlled-release

capsule

65100055700260 B M,N,O,Y

Embeda

(morphine/naltre

xone)

100 mg/4 mg

controlled-release

capsule

65100055700270 B M,N,O,Y

Exalgo (hydromorphone)

8 mg extended-

release tablet

6510003510A820 BG M,N,O,Y


12 mg extended-

release tablet

6510003510A830 BG M,N,O,Y


16 mg extended-

release tablet

6510003510A840 BG M,N,O,Y


32 mg extended-

release tablet

6510003510A855 BG M,N,O,Y

Fentanyl

transdermal

patch

37.5 mcg/hr

transdermal patch

65100025008626 G M,N,O,Y

Fentanyl

transdermal

patch

62.5 mcg/hr

transdermal patch

65100025008635 G M,N,O,Y

Fentanyl

transdermal

patch

87.5 mcg/hr

transdermal patch

65100025008645 G M,N,O,Y

Hysingla ER

(hydrocodone)

20 mg extended-

release tablet

6510003010A810 B M,N,O,Y




Generic

Availability

Multi-

source

Code

Hysingla ER

(hydrocodone)

30 mg extended-

release tablet

6510003010A820 B M,N,O,Y

Hysingla ER

(hydrocodone)

40 mg extended-

release tablet

6510003010A830 B M,N,O,Y

Hysingla ER

(hydrocodone)

60 mg extended-

release tablet

6510003010A840 B M,N,O,Y

Hysingla ER

(hydrocodone)

80 mg extended-

release tablet

6510003010A850 B M,N,O,Y

Hysingla ER

(hydrocodone)

100 mg extended-

release tablet

6510003010A860 B M,N,O,Y

Hysingla ER

(hydrocodone)

120 mg extended-

release tablet

6510003010A870 B M,N,O,Y

Kadian

(morphine

sulfate)

10 mg sustained-

release capsule

65100055107010 BG M,N,O,Y

Kadian

(morphine

sulfate)

20 mg sustained-

release capsule

65100055107020 BG M,N,O,Y

Kadian

(morphine

sulfate)

30 mg sustained-

release capsule

65100055107030 BG M,N,O,Y

Kadian

(morphine

sulfate)

40 mg sustained-

release capsule

65100055107035 BG M,N,O,Y

Kadian

(morphine

sulfate)

50 mg sustained-

release capsule

65100055107040 BG M,N,O,Y

Kadian

(morphine

sulfate)

60 mg sustained-

release capsule

65100055107045 BG M,N,O,Y

Kadian

(morphine

sulfate)

70 mg sustained-

release capsule

65100055107047 DC M,N,O,Y

Kadian

(morphine

sulfate)

80 mg sustained-

release capsule

65100055107050 BG M,N,O,Y

Kadian

(morphine

sulfate)

100 mg sustained-

release capsule

65100055107060 BG M,N,O,Y

Kadian

(morphine

sulfate)

130 mg sustained-

release capsule

65100055107070 DC M,N,O,Y

Kadian

(morphine

sulfate)

150 mg sustained-

release capsule

65100055107074 DC M,N,O,Y

Kadian

(morphine

sulfate)

200 mg sustained-

release capsule

65100055107080 B M,N,O,Y

Morphabond ER

(morphine ER)

15 mg ER tablet 6510005510A720 B M,N,O,Y




Generic

Availability

Multi-

source

Code

Morphabond ER

(morphine ER)


Morphabond ER

(morphine ER)


Morphabond ER

(morphine ER)


morphine sulfate

ER

30 mg sustained-

release capsule

65100055207020 B M,N,O,Y

morphine sulfate

ER

45 mg sustained-

release capsule

65100055207025 B M,N,O,Y

morphine sulfate

ER

60 mg sustained-

release capsule

65100055207030 B M,N,O,Y

morphine sulfate

ER

75 mg sustained-

release capsule

65100055207035 B M,N,O,Y

morphine sulfate

ER

90 mg sustained-

release capsule

65100055207040 B M,N,O,Y

morphine sulfate

ER

120 mg sustained-

release capsule

65100055207050 B M,N,O,Y

MS Contin

(morphine

sulfate)

15 mg sustained-

release tablet

65100055100415 BG M,N,O,Y

MS Contin

(morphine

sulfate)

30 mg sustained-

release tablet

65100055100432 BG M,N,O,Y

MS Contin

(morphine

sulfate)

60 mg sustained-

release tablet

65100055100445 BG M,N,O,Y

MS Contin

(morphine

sulfate)

100 mg sustained-

release tablet

65100055100460 BG M,N,O,Y

MS Contin

(morphine

sulfate)

200 mg sustained-

release tablet

65100055100480 BG M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

5 mg sustained-

release tablet

6510008010A705 B M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

7.5 mg sustained-

release tablet

6510008010A707 B M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

10 mg sustained-

release tablet

6510008010A710 B M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

15 mg sustained-

release tablet

6510008010A715 B M,N,O,Y




Generic

Availability

Multi-

source

Code

Opana ER

(oxymorphone

SR, crush

resistant)

20 mg sustained-

release tablet

6510008010A720 B M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

30 mg sustained-

release tablet

6510008010A730 B M,N,O,Y

Opana ER

(oxymorphone

SR, crush

resistant)

40 mg sustained-

release tablet

6510008010A740 B M,N,O,Y

OxyContin

(oxycodone ER)

10 mg tablet 6510007510A710 B M,N,O,Y

OxyContin

(oxycodone ER)

15 mg tablet 6510007510A715 B M,N,O,Y

OxyContin

(oxycodone ER)

20 mg tablet 6510007510A720 B M,N,O,Y

OxyContin

(oxycodone ER)

30 mg tablet 6510007510A730 B M,N,O,Y

OxyContin

(oxycodone ER)

40 mg tablet 6510007510A740 B M,N,O,Y

OxyContin

(oxycodone ER)

60 mg tablet 6510007510A760 B M,N,O,Y

OxyContin

(oxycodone ER)

80 mg tablet 6510007510A780 B M,N,O,Y

Oxymorphone SR

5 mg sustained-

release tablet

65100080107405 B M,N,O,Y

Oxymorphone SR 7.5 mg sustained-

release tablet

65100080107407 B M,N,O,Y

Oxymorphone SR 10 mg sustained-

release tablet

65100080107410 B M,N,O,Y


release tablet

65100080107415 B M,N,O,Y


release tablet

65100080107420 B M,N,O,Y


release tablet

65100080107430 B M,N,O,Y


release tablet

65100080107440 B M,N,O,Y

Xartemis XR

(oxycodone/acet

aminophen)

7.5/325 mg tablet 65990002200430 B M,N,O,Y

Xtampza ER

(oxycodone ER)

9 mg capsule 6510007500A310 B M,N,O,Y

Xtampza ER

(oxycodone ER)

13.5 mg capsule 6510007500A315 B M,N,O,Y

Xtampza ER

(oxycodone ER)





Generic

Availability

Multi-

source

Code

Xtampza ER

(oxycodone ER)


Xtampza ER

(oxycodone ER)


Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

10 mg sustained-

release capsule

6510003010A310 B M,N,O,Y

Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

15 mg sustained-

release capsule

6510003010A315 B M,N,O,Y

Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

20 mg sustained-

release capsule

6510003010A320 B M,N,O,Y

Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

30 mg sustained-

release capsule

6510003010A330 B M,N,O,Y

Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

40 mg sustained-

release capsule

6510003010A340 B M,N,O,Y

Zohydro ER

Abuse Deterrent

(hydrocodone

ER)

50 mg sustained-

release capsule

6510003010A350 B M,N,O,Y

ConZip

(tramadol SR

biphasic)

100 mg sustained-

release capsule

65100095107070 B M,N,O,Y

ConZip

(tramadol SR

biphasic)

200 mg sustained-

release capsule

65100095107080 B M,N,O,Y

ConZip

(tramadol SR

biphasic)

300 mg sustained-

release capsule

65100095107090 B M,N,O,Y

Nucynta ER

(tapentadol SR)

50 mg extended-

release tablet

65100091107420 B M,N,O,Y

Nucynta ER

(tapentadol SR)

100 mg extended-

release tablet

65100091107430 B M,N,O,Y

Nucynta ER

(tapentadol SR)

150 mg extended-

release tablet

65100091107440 B M,N,O,Y

Nucynta ER

(tapentadol SR)

200 mg extended-

release tablet

65100091107450 B M,N,O,Y

Nucynta ER

(tapentadol SR)

250 mg extended-

release tablet

65100091107460 B M,N,O,Y

tramadol 100 mg sustained-

release tablet

65100095107560 G M,N,O,Y




Generic

Availability

Multi-

source

Code


release tablet

65100095107570 G M,N,O,Y


release tablet

65100095107580 G M,N,O,Y

Tramadol ER

(tramadol SR

biphasic)

150 mg sustained-

release capsule

65100095107075 B M,N,O,Y

Ultram ER

(tramadol)

100 mg sustained-

release tablet

65100095107520 G M,N,O,Y

Ultram ER

(tramadol)

200 mg sustained-

release tablet

65100095107530 G M,N,O,Y

Ultram ER

(tramadol)

300 mg sustained-

release tablet

65100095107540 G M,N,O,Y

a – all target agents are subject to a ≤ 7 days of therapy if no prior opioid or oncology claims are found in the past 120 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

TARGETED AGENT(S) will be approved for above the 7 days supply limit when BOTH of

the following are met:

1. ONE of the following:

a. There is documentation that the patient is not new to opioid therapy in the

past 120 days

OR

b. There is documentation that the patient has taken an oncology agent in

the past 120 days

OR

c. The prescriber states the patient is NOT new to opioids therapy AND is at

risk if therapy is changed

OR

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

malignancy

OR

e. The patient is eligible for hospice care

OR

f. ALL of the following

i. The prescriber has provided documentation in support of use of

opioids for an extended duration (>7 days)

AND

ii. The prescriber provides documentation of a formal, consultative

evaluation including:

1. Diagnosis

AND

2. A complete medical history which includes previous and

current pharmacological and non-pharmacological therapy

AND

iii. The prescriber has confirmed that a patient-specific pain

management plan is on file for the patient

AND



iv. The prescriber has confirmed that the patient is not diverting the

requested medication, according to the patient’s records in the

state’s prescription drug monitoring program (PDMP), if applicable

AND

2. ONE of the following:

a. The requested agent does not contain tramadol or codeine

OR

b. The requested agent contains tramadol or codeine AND ONE of the

following:

i. The patient is 18 years of age or older

OR

ii. The patient is between 12 and 18 years of age AND the requested

agent will NOT be used for post-operative pain management

following a tonsillectomy and/or adenoidectomy

Length of approval: 1 month

NOTE: If other programs (e.g. Quantity Limits, Step Therapy) also applies, please refer

to program specific documents.

opioid immediate release and extended release new to …...one or 2 capsules every 4 hours as...

Documents