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Kynamro Mipomersen MCP156

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Kynamro Mipomersen MCP156 Subject: Kynamro (mipomersen) Original Effective Date: 10/30/2013 Policy Number: MCP-156 Revision Date(s): Review Date(s): 12/16/15; 6/15/2016; 3/21/2017 DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage Policy (MCP) document and provide the directive for all Medicare members. SUMMARY OF EVIDENCE/POSITION This policy addresses the use of Kynamro (mipomersen) for the treatment of homozygous familial hypercholesterolemia (HoFH). ∑ The covered FDA-approved indications are conditions that are considered medically necessary; however it is not inclusive of all conditions which may be approved by the Medical Reviewer. At the discretion of the Medical Director and on a case-by-case basis, Molina Healthcare may consider authorization of the biologic therapies addressed in this Policy for members with exceptional circumstances and for members with severe disease who may fall outside of the defined criteria. ∑ Molina Healthcare reserves the right to update this Policy and revise coverage criteria to include or omit any off-label condition(s) as necessary based on medical literature and clinical studies that may become available. ∑ The intent of this Policy is to ensure the safe, clinically appropriate and cost-effective use of Kynamro (mipomersen) while maintaining optimal therapeutic outcomes. ∑ The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH. ∑ The effects of mipomersen on cardiovascular outcomes (cardiovascular morbidity and mortality) in patients with HoFH have not been established. ∑ Kynamro (mipomersen) for patients with hypercholesterolemia who do not have homozygous familial hypercholesterolemia (HoFH) will not be authorized. Page 1 of 21 ∑ Kynamro (mipomersen) as an adjunct to LDL apheresis or within 8 weeks after receiving LDL apheresis will not be authorized.2,3,4 ‹ The safety and efficacy of use as an adjunct to LDL apheresis have not been established; therefore, its use as an adjunct to LDL apheresis is not recommended. ∑ There are no head-to-head trials comparing Kynamro (mipomersen) to other treatments. Therefore, there is no evidence that Kynamro (mipomersen) is safer or more effective than other treatments for homozygous familial hypercholesterolemia. ∑ Mipomersen may also be an option for patients who are unable to use lomitapide (Juxtapid) due to its contraindications, including pregnancy category X status, drug interactions with strong and moderate CYP3A4 inhibitors, and additional warnings. Lomitapide (Juxtapid) also carries a black box warning for hepatotoxicity. FDA INDICATIONS � ∑ Kynamro (mipomersen) is indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein- cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). Limitations of Use • The safety and effectiveness of Kynamro (mipomersen) Injection Solution for Subcutaneous Injection have not been established in patients with hypercholesterolemia who do not have HoFH. • The effect of Kynamro (mipomersen) Injection Solution for Subcutaneous Injection on cardiovascular morbidity and mortality has not been determined. • The use of Kynamro (mipomersen) Injection Solution for Subcutaneous Injection as an adjunct to LDL apheresis is not recommended. Available as: 200 mg/mL (1 mL) solution for injection Approved by the FDA: January 2013 RECOMMENDATIONS/COVERAGE CRITERIA Initiation of therapy with Kynamro (mipomersen) may be authorized for members who meet ALL of the following criteria [ALL] 1. � Prescriber specialty [BOTH] ß Board-certified clinical lipidologist (achieved certification from the American Board of Clinical Lipidology); specialist in Endocrinology, Diabetes and Metabolism; cardiologist; or hematologist ‹ According to the National Lipid Association (NLA), homozygous FH patients should always be managed by a lipid specialist.B ß Prescribed by a certified REMS provider demonstrated with supporting documentation (signed attestation) ‹ For more information and Provider enrollment, refer to: http://www.kynamrorems.com/ Page 2 of 21 2. � Diagnosis/Indication [ALL] ß Diagnosis of definite homozygous familial hypercholesterolemia confirmed by ONE of the following genetic testing [ONE] û Genetic testing demonstrating mutations in both alleles for LDLR (LDL receptors) û Genetic testing demonstrating gain-of-function mutations in both alleles for PCSK9 û Genetic testing demonstrating mutations in both alleles for apoB (apoprotein B) û Cellular testing demonstrating reduced LDL receptor activity in fibroblasts / lymphocytes equaling 20% or less of the normal activity NOTE: Molina Healthcare will not authorize coverage for members who do not have homozygous familial hypercholesterolemia (HoFH), such as heterozygous familial hypercholesterolemia ß Documented diagnosis of definite FH according to the Simon Broome criteria:C [ONE] û Adult: Cholesterol above 7.5mmol/l or LDL cholesterol above 4.9 mmol/l, or Child under 16: Cholesterol above 6.7mmol/l or LDL cholesterol above 4 mmol/l AND Tendon xanthomas in patient or a 1st degree relative (parent, sibling, child), or in a 2nd degree relative (grandparent, uncle, aunt). û DNA-based evidence of an LDL receptor mutation, familial defective apoB-100, or a PCSK9 mutation. ß Laboratory or clinically determined presence of homozygous familial hypercholesterolemia defined by the presence of at least one of the following clinical criteria:2 [ONE] û History of genetic testing confirming two mutated alleles at the LDL receptor gene locus, or û Documented history of untreated LDL-C > 500 mg/dL, and at least ONE of the following criteria [ONE] o Tendinous and/or cutaneous xanthoma prior to age 10 years o Documentation of elevated LDL-C > 190 mg/dL prior to lipid-lowering therapy consistent with heterozygous familial hypercholesterolemia (HeFH) in both parents. In case a parent is not available, a history of coronary artery disease in a first degree male relative of the parent younger than 55 years old or first degree female relative of the parent younger than 60 years old was acceptable. 3. � Age/Gender/Other restrictions [ONE] ß 12 years of age or older2 ‹ The safety and efficacy of Kynamro (mipomersen) have not been established in pediatric patients.a,b Page 3 of 21 4. Step/Conservative Therapy/Other condition Requirements [ONE] � ß Documentation in the medical record that prior to the initiation of therapy, the member has been and will continue to follow a low-fat diet supplying < 20% of energy from fat AND other lipid-lowering therapies including: [ALL] û Low-fat diet2: Prior to the initiation of Kynamro (mipomersen) therapy, the member has been and will continue to follow a low-fat diet supplying less than 20% of energy from fat a,b û HMG CoA reductase inhibitor (statin)2: Inadequate clinical response (defined as failure to reach target LDL), intolerance (refer to next criterion) or contraindication to TWO of the following HMG CoA reductase inhibitor (statin) therapy after an adherent trial at maximum therapeutic dose for at least 90 days of consecutive therapy in the past 12 months: [TWO] o pravastatin (Pravachol) 80mg daily o simvastatin (Zocor) 40mg daily o atorvastatin (Lipitor) 80mg daily o rosuvastatin (Crestor) 40mg daily OR For members intolerant to statins: Failure to reach target LDL on fenofibrate, colestipol, or other approved non-formulary LDL lowering medication o Fibrates [Gemfibrozil (Lopid), Tricor, Lofibra] o nicotinic acidD o ezetimibe o bile acid sequestrants (Cholestyramine, Light) ‹ Refer to Appendix 1 for a list of FDA-approved lipid lowering agents ¶ Kynamro (mipomersen) will be used in combination with a standard lipid lowering regimen containing a high potency statin ¶ Kynamro (mipomersen) will not be used concomitantly with Juxtapid (lomitapide) ‹ The safety and effectiveness of mipomersen have not been studied in combination with lomitapide. ¶ Member has not had LDL apheresis within 8 weeks2,3 5. � Contraindications/Exclusions to Kynamro (mipomersen) therapya,b [ANY] Authorization will not be granted if ANY of the following conditions
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