AETNA BETTER HEALTH Prior Authorization guideline for Narcotic Analgesic Utilization Policy applies to all formulary and non-formulary schedules II V opioid narcotics, including tramadol and codeine, as either single or combination products. Policy applies to all formulations (e.g. oral, topical, and parenteral formulations). Members under the age of 18 with a diagnosis of active cancer, sickle cell anemia with crisis, neonatal abstinence syndrome or receiving palliative care/hospice will be exempt from prior authorization for formulary agents. Members 18 years of age or older with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care will be exempt from prior authorization for formulary agents. Preferred Opioid Analgesics Acetaminophen-Codeine #2 TABLET 300-15 MG Acetaminophen-Codeine #3 Tablet 300-30 MG Acetaminophen-Codeine #4 Tablet 300-60 MG Acetaminophen-Codeine SOLUTION 120-12 MG/5ML Butalbital-APAP-Caff-Cod CAPSULE 50-300-40-30 MG ORAL Butalbital-APAP-Caff-Cod CAPSULE 50-325-40-30 MG ORAL Butalbital-ASA-Caff-Codeine CAPSULE 50-325-40-30 MG ORAL Codeine Sulfate TABLET 15 MG ORAL Codeine Sulfate TABLET 30 MG ORAL Codeine Sulfate TABLET 60 MG ORAL FentaNYL Citrate Lozenge on a Handle 1200 MCG Buccal FentaNYL Citrate Lozenge on a Handle 1600 MCG Buccal FentaNYL Citrate Lozenge on a Handle 200 MCG Buccal FentaNYL Citrate Lozenge on a Handle 400 MCG Buccal Methadone HCl CONCENTRATE 10 MG/ML Methadone HCl SOLUTION 10 MG/5ML ORAL Methadone HCl SOLUTION 5 MG/5ML ORAL Methadone HCl Tablet 10 MG Methadone HCl Tablet 5 MG Methadone HCl TABLET SOLUBLE 40 MG ORAL Morphine Sulfate (Concentrate) Solution 10 MG/0.5ML Morphine Sulfate ER Tablet Extended Release 100 MG Morphine Sulfate ER Tablet Extended Release 15 MG Morphine Sulfate ER Tablet Extended Release 200 MG Morphine Sulfate ER Tablet Extended Release 30 MG Morphine Sulfate ER Tablet Extended Release 60 MG Morphine Sulfate SOLUTION 10 MG/5ML Morphine Sulfate SOLUTION 20 MG/5ML
FentaNYL Citrate Lozenge on a Handle 600 MCG Buccal FentaNYL Citrate Lozenge on a Handle 800 MCG Buccal FentaNYL Patch 72 Hour 100 MCG/HR Transdermal FentaNYL Patch 72 Hour 12 MCG/HR Transdermal FentaNYL Patch 72 Hour 25 MCG/HR Transdermal FentaNYL Patch 72 Hour 50 MCG/HR Transdermal FentaNYL Patch 72 Hour 75 MCG/HR Transdermal Hydrocodone-Acetaminophen SOLUTION 7.5-325 MG/15ML Hydrocodone-Acetaminophen Tablet 10-325 MG Hydrocodone-Acetaminophen Tablet 2.5-325 MG Hydrocodone-Acetaminophen Tablet 5-325 MG Hydrocodone-Acetaminophen Tablet 7.5-325 MG Hydrocodone-Homatropine SYRUP 5-1.5 MG/5ML Hydrocodone-Homatropine TABLET 5-1.5 MG Hydrocodone-Ibuprofen TABLET 10-200 MG Hydrocodone-Ibuprofen TABLET 5-200 MG Hydrocodone-Ibuprofen TABLET 7.5-200 MG Hydromet SYRUP 5-1.5 MG/5ML ORAL HYDROmorphone HCl PF Solution 10 MG/ML Injection HYDROmorphone HCl PF Solution 50 MG/5ML Injection HYDROmorphone HCl PF Solution 500 MG/50ML Injection HYDROmorphone HCl Solution 2 MG/ML Injection HYDROmorphone HCl SUPPOSITORY 3 MG Rectal HYDROmorphone HCl Tablet 2 MG Morphine Sulfate SUPPOSITORY 10 MG Rectal Morphine Sulfate SUPPOSITORY 20 MG Rectal Morphine Sulfate SUPPOSITORY 30 MG Rectal Morphine Sulfate SUPPOSITORY 5 MG Rectal Morphine Sulfate TABLET 15 MG ORAL Morphine Sulfate TABLET 30 MG ORAL OxyCODONE HCl SOLUTION 5 MG/5ML OxyCODONE HCl TABLET 10 MG OxyCODONE HCl TABLET 15 MG OxyCODONE HCl TABLET 20 MG OxyCODONE HCl Tablet 30 MG OxyCODONE HCl Tablet 5 MG Oxycodone-Acetaminophen Tablet 10-325 MG Oxycodone-Acetaminophen TABLET 2.5-325 MG Oxycodone-Acetaminophen Tablet 5-325 MG Oxycodone-Acetaminophen Tablet 7.5-325 MG Oxycodone-Aspirin TABLET 4.8355-325 MG Hour 10 MG Hour 15 MG Hour 20 MG Hour 30 MG Hour 40 MG Hour 5 MG Hour 7.5 MG 2
HYDROmorphone HCl Tablet 4 MG HYDROmorphone HCl TABLET 8 MG Pentazocine-Naloxone HCl TABLET 50-0.5 MG Promethazine VC/Codeine SYRUP 6.25-5-10 MG/5ML ORAL Promethazine-Codeine Syrup 6.25-10 MG/5ML TraMADol HCl Tablet 50 MG Tramadol-Acetaminophen Tablet 37.5-325 MG Coverage Policy Short-acting opiate containing medications (with and without acetaminophen, aspirin, and ibuprofen, pentazocine and tramadol) will be limited to a 5 day supply without prior authorization for members 21 years old or older and to a 3-day supply without prior authorization for members under age 21. Long-Acting opiate containing medications require prior authorization before the original fill. Prior authorization is always required for non-formulary opioids. Prior authorization is required for doses exceeding 50 MME per day (Morphine Milligram Equivalent). 3
Authorization guidelines CRITERIA FOR SHORT-ACTING OPIOIDS Initial Review A. Documentation of one of the following exemptions: a) Request is for a formulary agent and b) Member is < 18 years old with a diagnosis of active cancer, sickle cell anemia with crisis, neonatal abstinence syndrome or receiving palliative care/hospice and drug not does not contain codeine or tramadol or c) Member is 18 years with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care OR B. Request is for either of the following: a) More than a 5-day supply for members 21 years old or a 3-day supply for members < 21 years old or b) Less than a 5-day supply for members 21 years old or a 3-day supply for members <21 years old at a dose of 50 MME/day or greater C. Documentation of moderate or severe pain and the associated diagnosis D. Documentation of rationale for use of a short acting opioid for more than 5 days for members 21 years old or for more than 3 days for members < 21 years old and the anticipated duration of therapy E. Member was recently assessed for use of an opioid (within the past 60 days) F. Documentation of therapeutic failure, contraindication, or intolerance to non-pharmacological and non-opioid therapies (e.g. acetaminophen, non-steroidal anti-inflammatory agents (NSAIDSs)) G. Member or parent/guardian has been educated on the potential adverse effects H. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary I. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database 4
J. Member has a pain management agreement on file K. If member is under 18 years of age, short acting opioid does not contain codeine or tramadol L. Prescriber has counseled member on the use of naloxone (or has already prescribed naloxone) for members with any of the following risk factors for opioid-related harm: a) opioid doses 50 MME per day b) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use M. Member has baseline urine drug screen (UDS)* that is consistent with prescribed controlled substances and will have ongoing UDS at the following frequency: a) UDS every 3-12 months for members on opioid doses < 50 MME per day b) UDS every 3-6 months for members on opioid doses 50 MME per day *Note: Includes testing for licit and illicit drugs with the potential for abuse; must include specific testing for oxycodone, fentanyl, tramadol, and carisoprodol N. If request is for 50 Morphine Milligram Equivalents (MME) per day, documentation of the following: a) Medication is prescribed by an appropriate specialist or in consultation with an appropriate specialist b) Pain is inadequately controlled at lower dosage O. If request is for a transmucosal fentanyl product, documentation of the all of following: a) Member has a diagnosis of cancer b) Member is opioid tolerant (defined as taking at least morphine 60 mg/day, transdermal fentanyl 25 mcg/h, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an equianalgesic dose of another opioid for one (1) week or longer) c) The prescriber is an American Board of Medical Specialties (ABMS) Certified Oncologist or Pain Specialist d) Trial and failure, contraindication or inadequate response to a preferred agent P. If request is for nasal butorphanol, documentation of all of the following: a) Member has a diagnosis of migraine b) Member is managed by a neurologist or pain medication specialist c) Trial and failure, contraindication or inadequate response to triptans for acute treatment of migraine attacks d) Trial and failure, contraindication or inadequate response to two (2) of the following preventative therapies: 1) Beta blockers 5
2) Calcium channel blockers 3) Anticonvulsants 4) Selective serotonin reuptake inhibitor (SSRI) Antidepressants 5) Tri-cyclic antidepressants 6) Non-steroidal anti-inflammatories (NSAIDs) Q. If member is on concurrent buprenorphine or naltrexone for extended-release injectable suspension (Vivitrol), documentation of all of the following: a) Both of the prescriptions are written by the same prescriber or, if written by different prescribers, all prescribers are aware of the other prescription(s) b) The member has an acute need for therapy with a short acting opioid and the other therapy will be suspended during the treatment for acute pain R. If there is therapeutic duplication with another short acting opioid, documentation of the following: a) The member is being titrated to, or tapered from, a drug in the same class or b) There is supporting peer-reviewed literature or national treatment guidelines for the concomitant use S. If request is for a non-preferred short acting opioid, there s documentation of trial and failure, contraindication, or inadequate response to a preferred agent Requests for Renewals A. Documentation of improvement in pain control and level of functioning while on the requested agent B. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary C. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database D. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for members with any of the following risk factors for opioid-related harm: a) opioid doses 50 MME per day b) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use E. Documentation of one of the following: 6
a) If member is taking <50 Morphine Milligram Equivalents (MME) per day: A urine drug screen (UDS)* is performed every 3-12 months and is consistent with prescribed controlled substances b) If member taking 50 MME per day: Member has a UDS every 3-6 months that is consistent with prescribed controlled substances *Note: Includes testing for licit and illicit drugs with the potential for abuse; must include specific testing for oxycodone, fentanyl, tramadol, and carisoprodol 7
CRITERIA FOR LONG-ACTING OPIOIDS Initiation of Therapy A. Documentation of one of the following exemptions: a) Request is for a formulary agent b) Member is < 18 years old with a diagnosis of active cancer, sickle cell anemia with crisis, neonatal abstinence syndrome or receiving palliative care/hospice or c) Member is 18 years with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care OR B. Documentation of moderate or severe pain and the associated diagnosis/rationale for use C. Documentation of anticipated duration of therapy D. Member or parent/guardian has been educated on the potential adverse effects E. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for members with any of the following risk factors for opioid-related harm: a) opioid doses 50 MME per day b) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use F. Member has baseline urine drug screen (UDS)* that is consistent with prescribed controlled substances and will have ongoing UDS at the following frequency: a) UDS every 3-12 months for members on opioid doses < 50 MME per day b) UDS every 3-6 months for members on opioid doses 50 MME per day *Note: Includes testing for licit and illicit drugs with the potential for abuse; must include specific testing for oxycodone, fentanyl, tramadol, and carisoprodol G. Documentation of therapeutic failure, contraindication, or intolerance to non-pharmacological and non-opioid analgesics (e.g. acetaminophen, non-steroidal anti-inflammatory agents (NSAIDSs)) H. Member is opioid tolerant* and previously received a trial of short-acting opioids Note: *opioid tolerance is defined as taking at least morphine 60 mg/day, transdermal fentanyl 25 mcg/hour, oxycodone 30 mg/day, oral hydromorphone 8 mg/day or an equi-analgesic dose of another opioid for one week or longer 8
I. Prescribed dosing regimen is FDA-approved or supported by nationally recognized compendia and standards of care J. Member was recently assessed for use of an opioid (within the past 60 days) K. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary L. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database M. Member has a pain management agreement on file N. In addition, a) if request is for Oxymorphone ER or for a non-preferred long-acting opioid: documentation of trial and failure, contraindication, or inadequate response to at least 2 weeks of TWO formulary long-acting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone) b) if request is for Nucynta ER for the treatment of diabetic peripheral neuropathy: 1) Trial and failure, contraindication or inadequate response to duloxetine tramadol at least ONE additional formulary medication (i.e., gabapentin, amitriptyline, nortriptyline, or topical capsaicin) 2) Trial of formulary agents were for at least 4 weeks and at maximum tolerated doses Requests for Renewals A. Documentation of improvement in pain control and level of functioning while on the requested agent B. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary C. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database D. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for members with any of the following risk factors for opioid-related harm: a) opioid doses 50 MME per day b) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use 9
E. Documentation of one of the following: a) If member is taking <50 Morphine Milligram Equivalents (MME) per day: A urine drug screen (UDS)* is performed every 3-12 months and is consistent with prescribed controlled substances b) If member taking 50 MME per day: Member has a UDS every 3-6 months that is consistent with prescribed controlled substances *Note: Includes testing for licit and illicit drugs with the potential for abuse; must include specific testing for oxycodone, fentanyl, tramadol, and carisoprodol Authorization and Limitations Members with a diagnosis of active cancer, sickle cell with crisis or neonatal abstinence syndrome, or is receiving palliative care or hospice services will be granted one year authorizations. Initial Length: Lesser of the duration requested or 6 months. Extended Approval: Lesser of the duration requested or 1 year. A partial approval may be considered when there is documentation of the following: a. Member has no current valid authorization b. Information available indicates that the member has been chronically taking opioids (covered by Aetna or another payer) and would be at risk for withdrawal if treatment were abruptly discontinued/interrupted c. The requested opioid treatment is determined to be not medically necessary or inappropriate and would otherwise be denied, but a tapering regimen should be undertaken to safely discontinue opioid treatment. d. The member is currently expected to be without or have less than 7 days supply of medication on hand based on claim history or provider supplied information e. The requested prior authorization request does not meet the criteria outlined in this guideline for full Initial Approval or Extend Approval (outlined below) due to missing or incomplete information. f. Duration of the partial approval is at the discretion of the medical director based on the information supplied, not to exceed 3 months. Medically Necessary A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. 10
The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Determination of Medical Necessity for covered care and services, whether made on a Prior Authorization, Concurrent Review, Retrospective Review, or exception basis, must be documented in writing. The determination is based on medical information provided by the Member, the Member s family/caretaker and the Primary Care Practitioner, as well as any other Providers, programs, agencies that have evaluated the Member. All such determinations must be made by qualified and trained Health Care Providers. A Health Care Provider who makes such determinations of Medical Necessity is not considered to be providing a health care service under this Agreement. References: 1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2013. 2. National Institute for Health and Care Excellence (NICE). Neuropathic pain - pharmacological management. The pharmacological management of neuropathic pain in adults in non-specialist settings. London (UK): National Institute for Health and Care Excellence (NICE);. (Clinical guideline; no. 173). Updated February 2017 3. Xtampza ER (oxycodone hydrochloride) extended-release capsule package insert. Cincinnati OH: Patheon Pharmaceuticals. April 2016 4. Butrans (buprenorphine transdermal system) package insert. Stamford, CT: Purdue Pharma L.P Updated June 2014 5. Nucynta (tapentadol extended-release oral tablets) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc. Updated December 2016 6. Xartemis XR (acetaminophen; oxycodone) extended-release tablets. Hazelwood MO: Mallinckrodt Brand Pharmaceuticals, Inc. Updated March 2014 7. Kirschner N, Ginsburg J, Sulmasy LS for the Health and Public Policy Committee of the American College of Physicians. Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians. Annals of Internal Medicine 2014;160(3):198-200. 8. FDA News Release: FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics; September 10, 2013. Available at http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm367726.htm. 9. Belbuca (buprenorphine) buccal film package insert. Endo Pharmaceuticals Inc Updated October 2015 10. Embeda (morphine; naltrexone) package insert. New York, NY: Pfizer, Inc June 2009 11
11. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1 49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 12. Pennsylvania Guidelines on the Use of Opioids to Treat Chronic Noncancer Pain. Accessed January 31, 2017,http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/MP/opioids/Do cuments/paguidelinesonopioids.pdf 12