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TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

Pre - PA Allowance Age 12 years of age or older Quantity

Immediate-release Formulation Ultracet 720 dosage units per 90 days OR Ultram 720 dosage units per 90 days

Extended-release Formulations Ultram ER 90 dosage units per 90 days OR Conzip 90 dosage units per 90 days OR Tramadol ER 90 dosage units per 90 days Maximum daily limit of any combination: 300mg

*Utilizing the highest strengths available to achieve the dosage is recommended to minimize dosing errors and improve compliance ______

Prior-Approval Requirements

Diagnosis

Ultram (tramadol)

Age 16 years of age or older

Patient must have the following:

Moderate to severe

AND ALL of the following: 1. NO dual therapy with other immediate release (s) 2. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy 3. Prescriber agrees to assess patient for syndrome 4. NO dual therapy with opioid treatment or 5. NO dual therapy with an anti-anxiety benzodiazepine(s) a. Alprazolam (Xanax) b. Clonazepam (Klonopin) c. Diazepam (Valium) d. Lorazepam (Ativan)

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

e. Oxazepam (Serax) f. Chlordiazepoxide (Librium) g. Clorazepate dipotassium (Tranxene)

AND the following: 1. Physician agrees to taper patient’s dose to the maximum FDA allowable dose based on their daily dose a. Patients taking over 600mg daily will be required to taper to 600mg daily b. Patients at 600mg or less daily will be required to taper to 400mg daily

Ultram ER and Conzip (tramadol ER)

Age 18 years of age or older

Patient must have the following:

Moderate to severe pain requiring daily, around-the-clock long term opioid treatment

AND ALL of the following: 1. NO dual therapy with other long acting opioid analgesic(s) 2. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain i. These include: non-opioid and immediate release analgesics 3. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy 4. Prescriber agrees to assess patient for 5. NO dual therapy with opioid addiction treatment or methadone 6. NO dual therapy with an anti-anxiety benzodiazepine(s) a. Alprazolam (Xanax) b. Clonazepam (Klonopin) c. Diazepam (Valium) d. Lorazepam (Ativan) e. Oxazepam (Serax) f. Chlordiazepoxide (Librium) g. Clorazepate dipotassium (Tranxene)

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

AND the following: 1. Physician agrees to taper patient’s dose to the maximum FDA allowable dose based on their daily dose a. Patients taking over 600mg daily will be required to taper to 500mg daily b. Patients at 600mg or less daily will be required to taper to 300mg daily

Prior - Approval Limits Quantity

Immediate-release Formulation Above 600mg daily dose Ultram 1440 dosage units per 90 days

600mg or less daily dose Ultram 1080 dosage units per 90 days OR Extended-release Formulations Above 600mg daily dose Conzip / Tramadol ER / Ultram ER 100mg 540 dosage units per 90 days OR Tramadol ER 150mg 360 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 200mg 270 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 300mg 180 dosage units per 90 days Maximum daily limit of any combination: 600mg

600mg or less daily dose Conzip / Tramadol ER / Ultram ER 100mg 360 dosage units per 90 days OR Tramadol ER 150mg 180 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 200mg 180 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 300mg 135 dosage units per 90 days Maximum daily limit of any combination: 400mg

Duration 6 months ______

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

Prior – Approval Renewal Requirements Diagnosis

Ultram (tramadol)

Age 16 years of age or older

Patient must have the following:

Moderate to severe pain

AND ALL of the following: 1. NO dual therapy with other immediate release opioid analgesic(s) 2. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy 3. Prescriber agrees to assess patient for serotonin syndrome 4. NO dual therapy with opioid addiction treatment or methadone 5. NO dual therapy with an anti-anxiety benzodiazepine(s) a. Alprazolam (Xanax) b. Clonazepam (Klonopin) c. Diazepam (Valium) d. Lorazepam (Ativan) e. Oxazepam (Serax) f. Chlordiazepoxide (Librium) g. Clorazepate dipotassium (Tranxene)

AND the following: 1. Physician agrees to taper patient’s dose to the maximum FDA allowable dose of 400mg daily

Ultram ER and Conzip (tramadol ER)

Age 18 years of age or older

Patient must have the following:

Moderate to severe pain requiring daily, around-the-clock long term opioid treatment

AND ALL of the following:

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

1. NO dual therapy with other long acting opioid analgesic(s) 2. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy 3. Prescriber agrees to assess patient for serotonin syndrome 4. NO dual therapy with opioid addiction treatment or methadone 5. NO dual therapy with an anti-anxiety benzodiazepine(s) a. Alprazolam (Xanax) b. Clonazepam (Klonopin) c. Diazepam (Valium) d. Lorazepam (Ativan) e. Oxazepam (Serax) f. Chlordiazepoxide (Librium) g. Clorazepate dipotassium (Tranxene)

AND the following: 1. Physician agrees to taper patient’s dose to the maximum FDA allowable dose of 300mg daily

Prior - Approval Renewal Limits Quantity

Immediate-release Formulation Ultram 1080 dosage units per 90 days OR Extended-release Formulations Conzip / Tramadol ER / Ultram ER 100mg 360 dosage units per 90 days OR Tramadol ER 150mg 180 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 200mg 180 dosage units per 90 days OR Conzip / Tramadol ER / Ultram ER 300mg 135 dosage units per 90 days Maximum daily limit of any combination: 400mg

Duration 6 months - One renewal only for patients with an initial daily dose above 600mg

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

Appendix 1 - List of

Selective Serotonin Reuptake Inhibitors (SSRIs) Paxil, Paxil CR, Pexeva, Brisdelle Luvox, Luvox CR Prozac, Prozac Weekly, Sarafem, Selfemra, Symbyax Zoloft Celexa Lexapro

Serotonin- Reuptake Inhibitors (SNRIs) Effexor XR Pristiq, Khedezla Cymbalta Savella

Tricyclic (TCAs) No brand name currently marketed Norpramin Anafranil Tofranil, Tofranil PM Pamelor, Aventyl Vivactil Zonalon, Silenor Surmontil

Monoamine Oxidase Inhibitors (MAOIs) isocarboxazid Marplan phenelzine Nardil Emsam, Eldepryl, Zelapar tranylcypromine Parnate

Other Psychiatric Medicines No brand name currently marketed No brand name currently marketed No brand name currently marketed Oleptro No brand name currently marketed Viibryd Remeron, Remeron Soltab llthium Lithobid

Tramadol FEP Clinical Criteria

TRAMADOL Ultram (tramadol), Ultram ER (tramadol extended-release tablets); Conzip (tramadol extended-release capsules)

Migraine Medicines Axert Frova Amerge Maxalt, Maxalt-MLT Imitrex, Imitrex Statdose, Alsuma, Sumavel Dosepro, Zecuity, Treximet Zomig, Zomig-ZMT

Antiemetics Zofran, Zofran ODT, Zuplenz Kytril, Sancuso Anzemet Aloxi

Other Serotonergic Medicines Bromfed-DM, Delsym, Mucinex DM, Nuedexta linezolid Zyvox Amrix St. John’s wort

Tramadol FEP Clinical Criteria