Hysingla ER. Hysingla ER (hydrocodone bitartrate) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Hysingla ER Page: 1 of 9 Last Review Date: September 15, 2017 Hysingla ER Description Hysingla ER (hydrocodone bitartrate) Background Hysingla ER is a long acting hydrocodone to treat pain severe enough to require around-theclock, long term treatment. Hysingla ER is not approved for as-needed pain relief. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Hysingla ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain (1). Hysingla ER is a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. This should be considered when prescribing or dispensing Hysingla ER in a situation where misuse, abuse, or diversion are a concern. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (1). Regulatory Status FDA-approved indication: Hysingla ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate (1). 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 Hysingla ER for use in patients for whom alternative treatment options

2 Subject: Hysingla ER Page: 2 of 9 (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hysingla ER is not indicated as an as-needed analgesic (1). Initiate treatment with Hysingla ER with a 20mg capsule every 24 hours. Discontinue all other around-the-clock opioid drugs when Hysingla ER therapy is initiated. Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression. Total daily dose greater than or equal to 80mg are only for patients in whom tolerance to an opioid of comparable potency is established (1). Hysingla ER carries several boxed warnings regarding addiction, abuse, and misuse; lifethreatening respiratory depression; accidental exposure; neonatal opioid withdrawal syndrome; and interaction with alcohol (1). Hysingla ER is contraindicated in patients who have significant respiratory depression, acute or severe bronchial asthma, and in patients who have or are suspected of having paralytic ileus and gastrointestinal obstruction (1). CDC guidelines find that concurrent use of benzodiazepines and opioids might put patients at greater risk for potentially fatal overdose. Three studies of fatal overdose deaths found evidence of concurrent benzodiazepine use in 31% 61% of decedents (2). CDC guidelines finds that given uncertain benefits and substantial risks that opioids should not be considered first-line or routine therapy for chronic pain (i.e., pain continuing or expected to continue longer than 3 months or past the time of normal tissue healing) outside of active cancer, palliative, and end-of-life care (2). FDA warns that opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity (see Appendix 1 for list of drugs) (3). The safety and effectiveness of Hysingla ER in pediatric patients below the age of 18 years have not been established (1). Related policies Belbuca, Butrans, Duragesic, Embeda, Methadone, Meperidine, Morphine Drug Class, Nucynta, Oxycodone, Subsys, Tramadol, Xartemis ER, Zohydro ER

3 Subject: Hysingla ER Page: 3 of 9 Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Hysingla ER may be considered medically necessary in patients that are 18 years of age and older with pain severe enough to require daily, around-the-clock long term opioid treatment and if the conditions below are met. Hysingla ER is considered investigational in patients below 18 years of age and for all other indications. Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist. Age 18 years of age or older Diagnosis Patient must have the following: 1. Pain, severe enough to require daily, around-the clock long term opioid treatment AND ALL of the following: a. NO dual therapy with other long acting opioid analgesic(s) b. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain a. These include non-opioid analgesic and immediate release opioids c. The prescriber is knowledgeable in the use of potent opioids for the management of chronic pain d. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy e. Prescriber agrees to assess patient for serotonin syndrome f. NO dual therapy with opioid addiction treatment or methadone g. NO dual therapy with an anti-anxiety benzodiazepine(s) i. Alprazolam (Xanax) ii. Clonazepam (Klonopin)

4 Subject: Hysingla ER Page: 4 of 9 iii. Diazepam (Valium) iv. Lorazepam (Ativan) v. Oxazepam (Serax) vi. Chlordiazepoxide (Librium) vii. Clorazepate dipotassium (Tranxene) AND ONE of the following: 1. Opioid naïve patient and opioid non-tolerant patient initiation therapy MUST start at 20mg once daily AND for no less than 7 days before changing to a higher dose. OR 2. Opioid tolerant patient patients are considered opioid tolerant if they have been receiving, for one week or longer, at least one of the following: a. 60 mg oral morphine per day b. 25 mcg transdermal fentanyl per hour c. 30 mg oral oxycodone per day d. 8 mg oral hydromorphone per day e. 25 mg oral oxymorphone per day f. Or an equianalgesic dose of another opioid Prior Approval Renewal Requirements Age 18 years of age or older Diagnosis Patient must have the following: 1. Pain severe enough to require daily, around-the clock long term opioid treatment AND ALL of the following: a. NO dual therapy with other long acting opioid analgesic(s) b. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy c. Prescriber agrees to assess patient for serotonin syndrome d. NO dual therapy with opioid addiction treatment or methadone e. NO dual therapy with an anti-anxiety benzodiazepine(s)

5 Subject: Hysingla ER Page: 5 of 9 i. Alprazolam (Xanax) ii. Clonazepam (Klonopin) iii. Diazepam (Valium) iv. Lorazepam (Ativan) v. Oxazepam (Serax) vi. Chlordiazepoxide (Librium) vii. Clorazepate dipotassium (Tranxene) Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Opioid naïve / opioid non-tolerant Quantity 20 mg 90 tablets per 90 days Duration 180 days Opioid tolerant Quantity Duration 20 mg 90 tablets per 90 days OR 30mg 90 tablets per 90 days OR 40mg 90 tablets per 90 days OR 60mg 90 tablets per 90 days OR 80mg 90 tablets per 90 days OR 100mg 90 tablets per 90 days OR 120mg 90 tablets per 90 days 180 days Prior Approval Renewal Limits Quantity 20 mg 90 tablets per 90 days OR 30mg 90 tablets per 90 days OR 40mg 90 tablets per 90 days OR 60mg 90 tablets per 90 days OR

6 Subject: Hysingla ER Page: 6 of 9 80mg 100mg 120mg 90 tablets per 90 days OR 90 tablets per 90 days OR 90 tablets per 90 days Duration 180 days Rationale Summary Hysingla ER is an opioid used in the treatment severe pain. It should not be used for as needed pain relief. The potential for developing substance abuse and addiction is extreme. Patients should be thoroughly assessed for their risk of developing severe respiratory depression, as well as substance abuse prior to being prescribed Hysingla ER and should be routinely monitored for signs of misuse, abuse and addiction during therapy (1). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Hysingla ER while maintaining optimal therapeutic outcomes. References 1. Hysingla ER [package insert]. Stamford, CT: Purdue Pharma L.P..; February Dowell D, Haegerich T, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain. CDC Guidelines FDA Safety Release. FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. March 22, Policy History Date January 2015 March 2015 June 2015 March 2016 Action New addition to PA Annual review and reference update Annual review Annual editorial review and reference update Addition of no dual therapy with other long acting opioid analgesic(s) in renewal section Policy number changed from to

7 Subject: Hysingla ER Page: 7 of 9 September 2016 March 2017 June 2017 September 2017 Keywords Annual review Addition of prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy; prescriber agrees to assess patient for serotonin syndrome; no dual therapy with opioid addiction treatment; no dual therapy with an antianxiety benzodiazepine(s): alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), oxazepam (Serax), chlordiazepoxide (Librium), clorazepate dipotassium (Tranxene) Annual editorial review Addition of no dual therapy with Methadone Annual review This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 15, 2017 and is effective on October 1, 2017.

8 Subject: Hysingla ER Page: 8 of 9 Appendix 1 - List of Serotonergic Medications Selective Serotonin Reuptake Inhibitors (SSRIs) paroxetine Paxil, Paxil CR, Pexeva, Brisdelle fluvoxamine Luvox, Luvox CR fluoxetine Prozac, Prozac Weekly, Sarafem, Selfemra, Symbyax sertraline Zoloft citalopram Celexa escitalopram Lexapro Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) venlafaxine Effexor XR desvenlafaxine Pristiq, Khedezla duloxetine Cymbalta milnacipran Savella Tricyclic Antidepressants (TCAs) amitriptyline No brand name currently marketed desipramine Norpramin clomipramine Anafranil imipramine Tofranil, Tofranil PM nortriptyline Pamelor, Aventyl protriptyline Vivactil doxepin Zonalon, Silenor trimipramine Surmontil Monoamine Oxidase Inhibitors (MAOIs) isocarboxazid Marplan phenelzine Nardil selegiline Emsam, Eldepryl, Zelapar tranylcypromine Parnate

9 Subject: Hysingla ER Page: 9 of 9 Other Psychiatric Medicines amoxapine No brand name currently marketed maprotiline No brand name currently marketed nefazodone No brand name currently marketed trazodone Oleptro buspirone No brand name currently marketed vilazodone Viibryd mirtazapine Remeron, Remeron Soltab llthium Lithobid Migraine Medicines almotriptan Axert frovatriptan Frova naratriptan Amerge rizatriptan Maxalt, Maxalt-MLT sumatriptan Imitrex, Imitrex Statdose, Alsuma, Sumavel Dosepro, Zecuity, Treximet zolmitriptan Zomig, Zomig-ZMT Antiemetics ondansetron granisetron dolasetron palonosetron Zofran, Zofran ODT, Zuplenz Kytril, Sancuso Anzemet Aloxi Other Serotonergic Medicines dextromethorphan Bromfed-DM, Delsym, Mucinex DM, Nuedexta linezolid Zyvox cyclobenzaprine Amrix methylene blue St. John s wort tryptophan

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