JUXTAPID (lomitapide) oral capsule

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1 JUXTAPID (lomitapide) oral capsule Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Juxtapid (lomitapide) is a microsomal triglyceride transfer protein (MTP) inhibitor indicated as an adjunct to a lowfat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-highdensity lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (HoFH). The disease is caused by a loss of function mutations in both alleles of the low-density lipoprotein receptor (LDLR) gene that encodes the LDLR protein. HoFH is a rare inherited disorder in which the body cannot remove low-density lipoprotein cholesterol (LDL-C). HoFH affects approximately 1 in 1,000,000 individuals. The safety and effectiveness of Juxtapid (lomitapide) have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of Juxtapid (lomitapide) on cardiovascular morbidity and mortality has not been determined. Safety and effectiveness in pediatric patients have not established. Page 1 of 8

2 Juxtapid (lomitapide) directly binds and inhibits MTP, which is found in the lumen of the endoplasmic reticulum. MTP is responsible for binding and shuttling individual lipid molecules between membranes. Juxtapid (lomitapide) prevents the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. The result is inhibition of the synthesis of chylomicrons and very-low density lipoproteins (VLDL). The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C. Juxtapid (lomitapide) is only available through a restricted program called JUXTAPID REMS PROGRAM and therefore, it is only available from certified pharmacies that are enrolled in the program. Providers must be enrolled in the program in order to prescribe Juxtapid (lomitapide). Definitions: Homozygous familial hypercholesterolemia: Loss of function mutations in both alleles of the LDLR gene Heterozygous familial hypercholesterolemia: Loss of function mutation in one allele of the LDLR gene The Child-Pugh classification system: Score: 1 point Score: 2 points Score: 3 points Serum Albumin (g/dl) > <3.0 Serum Bilirubin (mg/dl) < >3.0 Prothrombin time (seconds) >6 Ascites none moderate severe Encephalopathy none mild severe The three classes and their scores are: Class A is score 5 6: Well compensated Class B is score 7 9: Significant functional compromise Class C is score >9: Decompensated disease Inhibitors of Juxtapid metabolism; concurrent use is contraindicated (list is not all inclusive): 3A4 inhibitors: Strong inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole Moderate inhibitors: amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil Page 2 of 8

3 Drug related events: Ineffective / failure Use of a drug employing optimal doses (FDA-recommended doses) for optimal duration; where the condition being treated has not improved or worsened A request for branded agent due to generic drug failure or ineffectiveness will be assessed for potential approval with documentation of use of optimal dose / duration of the generic product and meeting other criteria within the coverage guideline. When the drug in question is a combination product, there must be documentation of failure / ineffectiveness of concurrent use (each ingredient used at the same time) of individual generic components. When the drug in question is a low dose formulation, there must be documentation of failure / ineffectiveness of low dose generic formulation. Adverse Drug Event: Allergic reaction / Hypersensitivity / Intolerance Use of a drug produced a significant reaction where continued use of the drug places the individual at risk for either lack of improvement or worsening of the condition being treated or at risk for harm and the concern is documented in medical record. A significant adverse drug event is when an individual s outcome is death, life-threatening, hospitalization (initial or prolonged), disability resulting in a significant, persistent, or permanent change, impairment, damage or disruption in the individuals body function/structure, physical activities or quality of life, or requires intervention to prevent permanent impairment or damage. Allergic reaction / hypersensitivity may or may not involve the active ingredient. When the active ingredient is involved, use of same or a chemically similar agent places the individual at risk for harm when the same or chemically similar agent is used. The subsequent reaction may be the same as the original reaction or a more exaggerated response may be seen, potentially placing the individual at even greater risk for harm. If the reaction occurred from the active/main generic ingredient; request for branded agent with same active ingredient will not be considered unless it is proven (documented) that active ingredient did not cause reaction and the request meets other criteria within the coverage guideline Intolerance these events represent circumstance(s) where use of a drug produced a significant reaction and continued use may result in non-adherence to proposed therapy and this concern is documented in medical record Contraindication Use of a drug that is not recommended by the manufacturer or FDA labelling Use of any drug in the face of a contraindication is outside of the FDA and manufacturer s labelled recommendation and is considered investigational or experimental Non-adherence Individual does not follow prescribe regimen that places the individual at risk for lack of improvement or worsening of the condition being treated and this concern is documented in medical record Precertification: Page 3 of 8

4 Precertification (Prior Authorization) is required for members with a Blue Cross Blue Shield of Arizona (BCBSAZ) pharmacy benefit for medication(s) or product(s) indicated in this guideline. This Pharmacy Coverage Guideline does not apply to FEP or other states Blues Plans. Information about medications that require precertification is available at Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Criteria: See Resources section for FDA-approved dosage. Precertification for Juxtapid requires completion of the specific request form in its entirety. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) or ed to Incomplete forms will be returned. FDA-approved product labeling (indication, age, dosage, testing, contraindications, exclusions, etc.) of Juxtapid is considered medically necessary as adjunctive treatment of homozygous familial hypercholesterolemia (HoFH) when ALL of the following criteria are met: 1. Age is 18 years or older 2. Medical record documentation of: Homozygous mutation of LDLR gene Concurrent use of other lipid lowering treatment Concurrent use of a low-fat diet Concurrent supplementation use of 400 IU vitamin E, 200 mg linoleic acid, 210 mg alphalinoleic acid, 110 mg eicosapentaenoic acid, and 80 mg docosahexaenoic acid 3. ALL of the following baseline tests have been obtained before initiation of treatment: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin Negative pregnancy test, in females of reproductive potential 4. Absence of ALL of the following contraindications: Pregnancy Simultaneous use of strong to moderate CYP3A4 inhibitors Moderate or severe hepatic impairment (Child-Pugh Class B or C) Active liver disease Page 4 of 8

5 5. Absence of ALL of the following exclusions for use: Use of inadequate contraception during therapy in women of reproductive potential Woman that is breast feeding an infant or child Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucosegalactose malabsorption Concurrent use of drugs, fruits, or fruit juices known to significantly alter the blood concentration of Juxtapid have been discontinued if clinically safe and appropriate to do so or their doses have been adjusted or the dose of Juxtapid has been appropriately adjusted (concurrent use of moderate to strong inhibitors of Juxtapid metabolism are contraindicated) Juxtapid for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. This includes but is not limited to the following: Individuals who do not have a diagnosis of homozygous familial hypercholesterolemia Concurrent use with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors History: Date: Activity: Pharmacy and Therapeutics review Approved Director Pharmacy Mgmt. review Criteria revisions. Removed Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or Glucose-galactose malabsorption from experimental/ investigational section. Pharmacy and Therapeutics review Approved Director Pharmacy Mgmt. review Added as adjunctive treatment to initial criteria statement, item #6 rewritten, item #7 deleted, item #8 rewritten, added item to experimental/investigational Pharmacy and Therapeutics review Approved Annual Review Added to Definitions section the Child-Pugh classification and a limited list of contraindicated drug-drug interactions Pharmacy and Therapeutics review Approved guideline Director Pharmacy Mgmt. review Development oversight Criteria Revisions: Date: Criteria: Revisions: Absence of ALL of the following contraindications: 4. Absence of ALL of the following contraindications: Moderate or severe hepatic Pregnancy Page 5 of 8

6 impairment (Child-Pugh Class B or C) Active liver disease Concurrent use of drugs known to significantly alter the blood concentration of Juxtapid have been discontinued if clinically safe and appropriate to do so or their doses have been adjusted or the dose of Juxtapid has been appropriately adjusted (concurrent use of moderate to strong inhibitors of Juxtapid metabolism are contraindicated) Use of inadequate contraception during therapy in women of reproductive potential Woman that is breast feeding an infant or child Simultaneous use of strong to moderate CYP3A4 inhibitors Moderate or severe hepatic impairment (Child-Pugh Class B or C) Active liver disease 5. Absence of ALL of the following exclusions for use: Use of inadequate contraception during therapy in women of reproductive potential Woman that is breast feeding an infant or child Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption Concurrent use of drugs, fruits, or fruit juices known to significantly alter the blood concentration of Juxtapid have been discontinued if clinically safe and appropriate to do so or their doses have been adjusted or the dose of Juxtapid has been appropriately adjusted (concurrent use of moderate to strong inhibitors of Juxtapid metabolism are contraindicated) FDA-approved dosage of Juxtapid is considered medically necessary for treatment of homozygous familial hypercholesterolemia (HoFH) when ALL OF THE FOLLOWING criteria are met: Alkaline phosphatase, total bilirubin, alanine aminotransferase, and aspartate aminotransferase have been obtained before initiation and monthly or more often as clinically indicated to detect liver related toxicity Individual and provider are enrolled in the Juxtapid REMS Program The following conditions and/or circumstances have been ruled out and/or assessed: Negative pregnancy test, in females FDA-approved dosage of Juxtapid is considered medically necessary as adjunctive treatment of homozygous familial hypercholesterolemia (HoFH) when ALL of the following criteria are met: ALL of the following baseline tests have been obtained before initiation of treatment: Deleted Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin Negative pregnancy test, in females of reproductive potential Absence of ALL of the following contraindications: Moderate or severe hepatic impairment (Child-Pugh Class B or C) Page 6 of 8

7 of reproductive potential, prior to initiation of therapy Use of adequate contraception during therapy in females of reproductive potential Breast feeding an infant or child Moderate or severe hepatic impairment (Child-Pugh Class B or C; a contraindication) Active liver disease (a contraindication) Concurrent use of drugs known to significantly alter the blood concentration of Juxtapid have been discontinued if clinically safe and appropriate to do so or their doses have been adjusted or the dose of Juxtapid has been appropriately adjusted (concurrent use of moderate to strong inhibitors of Juxtapid metabolism are contraindicated) Active liver disease Concurrent use of drugs known to significantly alter the blood concentration of Juxtapid have been discontinued if clinically safe and appropriate to do so or their doses have been adjusted or the dose of Juxtapid has been appropriately adjusted (concurrent use of moderate to strong inhibitors of Juxtapid metabolism are contraindicated) Use of inadequate contraception during therapy in women of reproductive potential Woman that is breast feeding an infant or child Juxtapid for all other indications not previously listed or if above criteria not met is considered experimental or investigational: This includes but is not limited to the following: Individuals who do not have a diagnosis of homozygous familial hypercholesterolemia Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or Glucose-galactose malabsorption Juxtapid for all other indications not previously listed or if above criteria not met is considered experimental or investigational: This includes but is not limited to the following: Individuals who do not have a diagnosis of homozygous familial hypercholesterolemia Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or Glucose-galactose malabsorption Concurrent use with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors Resources: Juxtapid package insert, revised by manufacturer 05/2016, reviewed on Juxtapid package insert, revised by manufacturer 04/2015, reviewed on 06/13/2015 Juxtapid package insert, revised by manufacturer 05/2014, reviewed on 08/13/2014 Page 7 of 8

8 Juxtapid package insert, revised by manufacturer 12/2012, reviewed on 01/09/2013 Refer to package insert for complete dosing information. Indication JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL- C), total cholesterol (TC), apolipoprotein B (apo B), and nonhigh-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (HoFH). Limitations of Use The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. Recommended Dose Before treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin; obtain a negative pregnancy test in females of reproductive potential; and initiate a low-fat diet supplying <20% of energy from fat Initiate treatment at 5 mg once daily. Titrate dose based on acceptable safety/tolerability: increase to 10 mg daily after at least 2 weeks; and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and up to the maximum recommended dose of 60 mg daily. Due to reduced absorption of fat-soluble vitamins/fatty acids: Take daily vitamin E, linoleic acid, alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) supplements Take once daily, whole, with water and without food, at least 2 hours after evening meal Patients with end-stage renal disease on dialysis or with baseline mild hepatic impairment should not exceed 40 mg daily Page 8 of 8

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