Sunflower Health Plan APOKYN, Apomorphine Hydrochloride Form

Apomorphine (Apokyn®, Kynmobi™) is a non-ergoline dopamine agonist. FDA Approved Indication(s) Apokyn is indicated for acute, intermittent treatment of hypomobility, “off`” episodes (“end-of- dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. Kynmobi is indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation® that Apokyn and Kynmobi are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Parkinson’s Disease (must meet all): 1. Diagnosis of Parkinson’s disease; 2. Prescribed by or in consultation with neurologist; 3. Prescribed concurrently with an anti-Parkinson agent (e.g., levodopa/carbidopa, dopamine agonists [e.g., ropinirole], catechol-O-methyl transferase [COMT] inhibitors [e.g., tolcapone], monoamine oxidase type B [MAO-B] inhibitors [e.g., rasagiline]); 4. Member is experiencing hypomobility episodes at the end of the dosing interval or is experiencing unpredictable hypomobility (“on/off”) episodes (see Appendix D); 5. Dose does not exceed the following (a or b): a. Apokyn: 0.6 mL (6 mg) per injection, 5 injections per day, and 2 mL (20 mg) per day; b. Kynmobi: 30 mg (1 film) per dose and 5 films per day. Approval duration: Medicaid/HIM – 6 months Commercial – 6 months (Kynmobi), 6 months or to the member’s renewal date, whichever is longer (Apokyn) Page 1 of 7 CLINICAL POLICY Apomorphine B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Parkinson’s Disease (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed the following (a or b): a. Apokyn: 0.6 mL (6 mg) per injection, 5 injections per day, and 2 mL (20 mg) per day; b. Kynmobi: 30 mg (1 film) per dose and 5 films per day. Approval duration: Medicaid/HIM – 12 months Commercial – 12 months (Kynmobi), 6 months or to the member’s renewal date, whichever is longer (Apokyn) B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 7 CLINICAL POLICY Apomorphine CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key COMT: catechol-O-methyl transferase FDA: Food and Drug Administration MAO-B: monoamine oxidase type B Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Concomitant use with 5HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron. o Hypersensitivity/allergic reaction to apomorphine or to any of the excipients, including a sulfite (i.e., sodium metabisulfite); angioedema or anaphylaxis may occur. • Boxed warning(s): none reported Appendix D: General Information • Based on reports of profound hypotension and loss of consciousness when apomorphine was given to patients receiving ondansetron, the concomitant use of apomorphine with drugs of the 5-HT3 antagonist class is contraindicated. These drugs should not be used to prevent or treat apomorphine-induced nausea and vomiting. • Apomorphine induces nausea and vomiting. Patients should be pretreated with trimethobenzamide 300 mg orally three times a day for three days prior to beginning apomorphine therapy. The manufacturer recommends continuing trimethobenzamide as long as necessary to control nausea and vomiting, and generally no longer than two months. However, the length of concomitant therapy in trials varied. • Off time/episodes represent a return of Parkinson’s disease symptoms (bradykinesia, rest tremor or rigidity) when the L-dopa treatment effect wears off after each dosing interval. • Parkinson’s disease symptoms, resulting from too little levodopa (L-dopa), are in contrast with dyskinesia which typically results from too much L-dopa. The alterations between Page 3 of 7 CLINICAL POLICY Apomorphine “on” time (the time when Parkinson’s disease symptoms are successfully suppressed by L-dopa) and “off” time is known as “motor fluctuations”. • The addition of carbidopa to L-dopa prevents conversion of L-dopa to dopamine in the systemic circulation and liver. V. Dosage and Administration Drug Name Dosing Regimen Apomorphine (Apokyn) 0.2 mL (2 mg) SC initial test dose. If patient tolerates and responds, starting dose should be 0.2 mL (2 mg) used on an as needed basis to treat “off” episodes. If needed, may increase dose by 0.1 mL (1 mg) increments every few days; Doses must be separated by at least 2 hours 10 to 30 mg per dose sublingually as needed; separated by at least 2 hours Maximum Dose 0.6 mL (6 mg)/dose, 5 injections/day, max of 2 mL(20 mg)/day 30 mg/dose, max of 5 doses/day Apomorphine (Kynmobi) VI. Product Availability Drug Name Apomorphine (Apokyn) Apomorphine (Kynmobi) Availability Multi-dose glass cartridge solution for injection: 30 mg/3 mL (10 mg/mL) with a multiple-dose pen injector Sublingual film: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg VII.