ph-1017
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Opioid ER Summary

Policy Number: PH-1017

Opioids IR

Quantity Limit Program Summary

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

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.

QUANTITY LIMIT TARGET AGENTS – RECOMMENDED LIMITS

Agent

Strength

GPI

Brand (B)/

Generic (G)

Availability

Daily

Quantity Limit

butorphanol

10 mg/mL nasal spray

65200020102050

G

2.9167 mL

Codeine

15 mg tablet

65100020200305

B

6 tablets

Codeine

30 mg tablet

65100020200310

BG

6 tablets

Codeine

60 mg tablet

65100020200315

B

6 tablets

Dilaudid (hydromorphone)

2 mg tablet

65100035100310

BG

6 tablets

Dilaudid (hydromorphone)

4 mg tablet

65100035100320

BG

6 tablets

Dilaudid (hydromorphone)

8 mg tablet

65100035100330

BG

6 tablets

Dilaudid (hydromorphone)

1 mg/mL liquid

65100035100920

BG

48 mL

Levorphanol

2 mg tablet

65100040100305

G

4 tablets

Levorphanol

3 mg tablet

65100040100310

B

4 tablets

meperidine

50 mg tablet

65100045100305

G

8 tablets

Demerol (meperidine)

100 mg tablet

65100045100310

BG

8 tablets

Meperidine

50 mg/5 mL solution

65100045102060

B

80 mL

Dolophine (methadone)

5 mg tablet

65100050100305

BG

3 tablets

Dolophine (methadone)

10 mg tablet

65100050100310

BG

3 tablets

Methadose (methadone

40 mg soluble tablet

65100050107320

G

3 tablets

methadone

5 mg/5mL solution

65100050102010

BG

30 mL

methadone

10 mg/5 mL solution

65100050102015

BG

15 mL

methadone

10 mg/mL concentrate

65100050101310

BG

3 mL

Morphine

15 mg tablet

65100055100310

B

8 tablets

Morphine

30 mg tablet

65100055100315

B

6 tablets

Morphine

10 mg/5 mL solution

65100055102065

G

90 mL

Morphine

20 mg/5 mL solution

65100055102070

G

45 mL

Morphine

20 mg/mL concentrate

65100055102090

G

9 mL

oxycodone

5 mg capsule

65100075100110

G

12 capsules

Oxaydo, Roxybond (oxycodone)

5 mg tablet

6510007510A510

B

6 tablets

Oxaydo (oxycodone)

7.5 mg tablet

6510007510A520

B

6 tablets

oxycodone

10 mg tablet

65100075100320

G

6 tablets

oxycodone

20 mg tablet

65100075100330

G

6 tablets

oxycodone

5 mg/5mL solution

65100075102005

G

180 mL

oxycodone

20 mg/mL concentrate

65100075101320

G

9 mL

Roxicodone (oxycodone)

5 mg tablet

65100075100310

BG

12 tablets

Roxyicodone (oxycodone)

15 mg tablet

65100075100325

BG

6 tablets

Roxybond (oxycodone)

15 mg tablet

6510007510A540

B

6 tablets

Roxybond (oxycodone)

30 mg tablet

6510007510A560

B

6 tablets

Roxicodone (oxycodone)

30 mg tablet

65100075100340

BG

6 tablets

Opana (oxymorphone)

5 mg tablet

65100080100305

BG

6 tablets

Opana (oxymorphone)

10 mg tablet

65100080100310

BG

6 tablets

Nucynta (tapentadol)

50 mg tablet

65100091100320

B

6 tablets

Nucynta (tapentadol)

75 mg tablet

65100091100330

B

6 tablets

Nucynta (tapentadol)

100 mg tablet

65100091100340

B

6 tablets

Ultram (tramadol)

50 mg tablet

65100095100320

BG

8 tablets

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Quantities of Opioid IR agents above the program set limit but less than or equal to the Program Maximum Daily Dose (maximum mg allowed with highest dosage strength) will be approved when ALL of the following are met:

  1. The quantity (dose) requested cannot be achieved using a lesser quantity of a higher strength

AND

  1. The prescriber has submitted documentation in support of therapy with a higher dose (quantity) for the intended diagnosis

AND

  1. ONE of the following:
    1. The requested opioid does not contain tramadol or codeine

OR

    1. The requested opioid contains tramadol or codeine AND ONE of the following:
      1. The patient is between 12 and 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. The patient is 18 years of age or older

AND

  1. If the patient’s total morphine equivalent dose (MED) exceeds 300 mg per day BOTH of the following:
    1. The prescriber acknowledges that patient is using opioids (total daily dose of all opioids) that are at or over 300 mg MED and the associated risks

AND

    1. ONE of the following:
      1. The prescriber has provided a treatment plan to reduce the MED to less than 300 mg

OR

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

Length of Approval: 1 month for dose titration requests and

Up to 6 months for all other requests

Quantities of Opioids IR agents which are greater than the Program Maximum Daily Dose (maximum mg allowed with highest dosage strength) will be approved when ALL of the following are met:

  1. The quantity (dose) requested cannot be achieved using a lesser quantity of a higher strength

AND

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

OR

    1. The member is eligible for hospice care

OR

    1. The member is undergoing treatment of pain and ALL of the following are met:
      1. The prescriber provides documentation of a formal, consultative evaluation including:
        1. Diagnosis

AND

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

AND

        1. The need for continued opioid therapy has been assessed

AND

      1. The prescriber has confirmed that a patient-specific pain management plan is on file for the patient

AND

      1. 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

  1. The prescriber has submitted documentation in support of therapy with a higher dose (quantity) for the intended diagnosis which has been reviewed and approved by the Clinical Review pharmacist.  

AND

  1. ONE of the following:
    1. The requested opioid does not contain tramadol or codeine

OR

    1. The requested opioid contains tramadol or codeine AND ONE of the following:
      1. The patient is between 12 and 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. The patient is 18 years of age or older

AND

  1. If the patient’s total morphine equivalent dose (MED) exceeds 300 mg per day BOTH of the following:
  1. The prescriber acknowledges that patient is using opioids (total daily dose of all opioids) that are at or over 300 mg MED and the associated risks

AND

  1. ONE of the following:
  1. The prescriber has provided a treatment plan to reduce the MED to less than 300 mg

OR

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

Length of Approval:  1 month for dose titration requests

   Up to 6 months for all other requests

FDA APPROVED INDICATIONS:1-14, 16-17

Agent

Strength

Dosing

butorphanol

nasal spraya

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 alternative treatments 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 analgesic and for which alternative treatments are inadequate.

Every 4-6 hours

Levorphanola

tablet

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

Every 6-8 hours

Demerola

(meperidine)

tablet,

solution

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

Every 4-6 hours

oxycodonea

tablet,

solution,

concentrate

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

Every 4-6 hours

Roxicodonea

(oxyc odone)

tablet

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

Every 4-6 hours

Roxybond

(oxycodone)

tablet

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

Every 4-6 hours

Opanaa

(oxymorphone)

tablet

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

Every 4-6 hours

Nucynta

(tapentadol)

tablet

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

a – generic available

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.15

REFERENCES

  1. butorphanol tartrate nasal solution prescribing information. Apotex Corp. August 2018.
  2. codeine prescribing information. Lannett Company, Inc. September 2018.
  3. meperidine prescribing information. Sanofi-Aventis US. LLC. September 2018.
  4. Dilaudid prescribing information. Purdue Pharma LP. September 2018.
  5. Dolophine prescribing information. West-Ward Pharmaceuticals Corp. September 2018.
  6. levorphanol prescribing information. Roxane Laboratories, Inc. September 2018.
  7. methadone prescribing information. Cerbert Pharmaceuticals. May 2008.
  8. Methadose prescribing information. Mallinkrodt, Inc. April 2018.
  9. morphine prescribing information. West-Ward Pharmaceuticals Corp. April 2017.
  10. oxycodone prescribing information. Amneal Pharmaceuticals LLC. June 2017.
  11. Opana prescribing information. Endo Pharmaceuticals. September 2018.
  12. Oxaydo prescribing information. Egalet US Inc. September 2018.
  13. Nucynta prescribing information. Janssen Pharmaceuticals, Inc. September 2018.
  14. Ultram prescribing information Janssen Pharms. September 2018.
  15. 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.
  16. Roxybond prescribing information. Daiichi Sankyo Inc. September 2018.
  17. Roxicodone prescribing information. Specgx LLC. September 2018.

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 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.

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