DOCSLIB.ORG

The Histrelin Implant: a Novel Treatment for Central Precocious Puberty

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The Histrelin Implant: a Novel Treatment for Central Precocious Puberty The Histrelin Implant: A Novel Treatment for Central Precocious Puberty Harry J. Hirsch, MD*‡; David Gillis, MD§; David Strich, MD࿣; Boris Chertin, MD¶; Amicur Farkas, MD¶; Tzina Lindenberg, MA‡; Hadassa Gelber, BSc‡; and Irving M. Spitz, MD, DSc, FRCP‡ ؎ ABSTRACT. Objective. Standard treatment of central were 1.30 ؎ 1.34 vs 0.25 ؎ 0.08 and 1.68 ؎ 1.08 vs 1.13 precocious puberty (CPP) consists of intramuscular or 0.55 mIU/mL, respectively. Basal and stimulated gonad- subcutaneous administration of a gonadotropin-releas- otropin levels and E2 level remained suppressed in all 6 ing hormone (GnRH) agonist (GnRHa) at 3- to 4-week patients followed for 15 months after implant insertion. intervals. Although generally effective in suppressing Patients and parents reported less pain and discomfort clinical and laboratory parameters of puberty, GnRHa and less interference with school activity and work with injections are painful, and the need for monthly clinic the implant compared with standard monthly injections. visits may contribute to poor compliance. Recently, a Conclusions. The histrelin implant consistently sup- subcutaneous implant was developed that releases the presses clinical and laboratory parameters of puberty for GnRHa histrelin at an average rate of 65 ␮g/day. The 1 year and is a promising new technique for treating CPP aims of this study were to determine if a histrelin im- without the pain and inconvenience of monthly plant would suppress gonadotropin and estradiol (E2)in injections. Pediatrics 2005;116:e798–e802. URL: www. girls with CPP for 1 year and to compare the suppression pediatrics.org/cgi/doi/10.1542/peds.2005-0538; precocious to standard treatment. puberty, gonadotropins, estradiol, GnRH agonists, histre- Methods. We studied 11 girls with CPP to determine lin. if the histrelin implant can maintain long-term gonado- tropin suppression. Mean age at diagnosis was 61⁄2 years (range: 2–9 years). GnRH (100 ␮g intravenously) stimu- ABBREVIATIONS. CPP, central precocious puberty; LH, luteiniz- lation tests (GnRH-STs) showed peak luteinizing hor- ing hormone; FSH, follicle-stimulating hormone; E2, estradiol; mone and follicle-stimulating hormone responses of 23 GnRH, gonadotropin-releasing hormone; GnRHa, gonadotropin- mean ؎ SD) and 20 ؎ 25 mIU/mL, respectively. All releasing hormone agonist(s); GnRH-ST, gonadotropin-releasing) 28 ؎ hormone stimulation test; CBC, complete blood count; IM, intra- subjects were initially treated with depot intramuscular muscular(ly); SDS, standard deviation score. GnRHa triptorelin embonate. Implants were inserted subcutaneously under local anesthesia, and depot GnRHa treatment was discontinued. Six girls were fol- recocious puberty is defined as the onset of lowed for 15 months after insertion (group A). For the secondary sexual characteristics associated remaining 5 girls, the implant was removed after 9 with increased linear growth velocity and ac- months, and a new implant was inserted at the same P celerated bone maturation occurring before the age incision site (group B). GnRH-STs were performed be- 1,2 fore depot GnRHa treatment, immediately before im- of 7 to 8 years in girls and 9 years in boys. If plant insertion, at the 6- and 9-month visits for each untreated, precocious puberty results in early epiph- patient and the 12- and 15-month visit for those girls yseal closure and short final height.3 The most com- followed for 15 months. mon cause in girls is idiopathic central precocious Results. In all girls, breast development regressed, puberty (CPP) caused by the early onset of luteiniz- growth velocity decreased, and bone-age advancement ing hormone (LH), follicle-stimulating hormone was slowed. Basal gonadotropins and their responses to 4 (FSH), and estradiol (E2) secretion. GnRH-STs and E2 levels were suppressed. Peak lutein- Standard treatment of CPP consists of depot par- izing hormone and follicle-stimulating hormone re- enteral preparations of gonadotropin-releasing hor- sponses to GnRH-STs at preinsertion versus 9 months mone agonists (GnRHa), usually at 4-week inter- vals.5 GnRHa are generally effective in retarding From the *Pediatric Day Hospital, ¶Department of Urology, and ‡Institute progression of secondary sexual characteristics, pre- of Hormone Research, Shaare Zedek Medical Center and the Faculty of venting menses, slowing bone-age advancement, Health Sciences, Ben Gurion University of the Negev, Jerusalem, Israel; and improving final height. Injections are painful, §Department of Pediatrics and Pediatric Endocrinology Clinic, Hadassah however, and the need for monthly clinic visits may University Hospital, Ein-Kerem, Jerusalem, Israel; and ࿣Specialty Pediatric Clinics, Endocrinology and Diabetes, Clalit Health Service, Jerusalem, Is- contribute to poor compliance. 6 rael. Chertin et al observed that insertion of a subcu- Accepted for publication Jun 13, 2005. taneous hydrogel implant containing the potent doi:10.1542/peds.2005-0538 GnRHa histrelin suppresses LH and testosterone in Presented in part at the 86th annual meeting of the Endocrine Society; June 16–19, 2004; New Orleans. metastatic prostate cancer for at least 1 year. The Conflict of interest: Dr Spitz is a consultant for Valera Pharmaceuticals Inc, same investigators then proposed to the manufac- manufacturer of the histrelin implant. turer that they assess a revised implant (that releases Reprint requests to (I.M.S.) Institute of Hormone Research, Shaare Zedek more drug on a daily basis) for children with CPP. If Medical Center, POB 3235, Jerusalem 91031, Israel. E-mail: irving@spitz. com effective, this implant could be more convenient and PEDIATRICS (ISSN 0031 4005). Copyright © 2005 by the American Acad- less painful than monthly injections. The aims of the emy of Pediatrics. present study were to determine if a histrelin im- e798 PEDIATRICS Vol.Downloaded 116 No. 6 from December www.aappublications.org/news 2005 www.pediatrics.org/cgi/doi/10.1542/peds.2005-0538 by guest on September 27, 2021 plant would suppress gonadotropin and E2 in girls or painful?”; and “To what extent is your child’s current treatment with CPP for 12 months and to compare the suppres- regimen inconvenient or disruptive to school, work, or other activities?” sion to standard treatment. This investigator-initiated study was approved by the human investigation committee of each participating institution. Written METHODS informed consent was obtained from the parents before enroll- Subjects ment. The study was designed and the data were analyzed by the academic investigators. Eleven girls with CPP referred to pediatric endocrinologists (H.J.H., D.G., or D.S.) were studied. Inclusion criteria were age of Ͻ Auxological Data 11 years at initial enrollment, advanced bone age, serum E2 level of Ͼ20 pg/mL (73 pmol/L), and pubertal gonadotropin responses Height was measured with a wall-mounted stadiometer. to a standard GnRH stimulation test (GnRH-ST).7–9 Patients with Growth velocity, calculated by comparing height measurements at gonadotropin-independent precocious puberty, children in whom 6-month intervals, was converted to a standard deviation score treatment would be needed for Ͻ1 year, those with other illnesses (GV Ϫ SDS) by using Tanner’s reference data.12 Bone age was that would interfere with follow-up, and those with a history of determined from radiographs of the left hand and wrist by using noncompliance were excluded. the method of Greulich and Pyle.13 BMI (weight [kg]/height 2 Mean age was 61⁄2 years (range: 2–9 years) at initial diagnosis [meters ]) percentiles were determined by using the Centers for 14 and 81⁄2 years (range: 3.75–11 years) at implant insertion. BMI Disease Control and Prevention 2000 growth charts. exceeded the 50th percentile in 9 girls and exceeded the 95th percentile in 4 girls. Pelvic ultrasound showed no ovarian pathol- Hormonal Assays ogy. Routine laboratory tests (urinalysis, complete blood count LH and FSH were measured by a chemiluminescent micropar- [CBC], biochemical screening, thyroid function) were normal. ticle 2-step immunoassay (Abbott Laboratories, Abbott Park, IL). The lower limits of sensitivity of the LH and FSH assays were 0.07 Prior GnRHa Treatment and 0.05 mIU/mL, respectively. In the low range of gonadotropin Treatment with the GnRHa triptorelin embonate (Decapeptyl; levels, intraassay and interassay variations were 2.1% and 3.4% for Ferring, Kiel, Germany) 3.75 mg given intramuscularly (IM) at 3- LH and 2.8% and 3.6% for FSH. E2 was measured by using a to 4-week intervals was begun in all children before study enroll- radioimmunoassay-coated kit (CIS Bio International-Schering, Gif ment. Ten girls were treated from 1 to 26 months and 1 for 39 sur Yvette, France). The reported lower limit of sensitivity was 1.4 Ͻ months. pg/mL. Serum E2 levels in prepubertal girls are typically 20 11,15 pg/mL (73 pmol/L). At this range of E2 levels, the intraassay Histrelin Implant and interassay variations were 13.3% and 17.6%, respectively. The subdermal implant (length: 30 mm; diameter: 3.5 mm; wall thickness: 0.5 mm) consists of a microporous hydrogel containing Statistics 50 mg of histrelin.10 Histrelin diffuses through the implant wall at The statistical analysis was performed by using the nonpara- an average rate of 65 ␮g/day. This version of the implant releases metric Wilcoxon paired sign-rank test. more histrelin than the one used for prostate cancer.10 Before insertion of the implant, a topical preparation of lido- RESULTS caine and prilocaine (EMLA; AstraZeneca, Wilmington, DE) was applied to the medial aspect of the upper arm, after which the skin No menstrual bleeding occurred during the im- was infiltrated with ϳ5 mL of 2% lidocaine. Pediatric surgeons plant treatment. Mean breast development was Tan- (B.C. and A.F.) performed the implant insertions. In 2 patients, ner stage 3.3 (range: 2–4) at implant insertion and 2.7 mild sedation was achieved by oral midazolam hydrochloride (range: 1–3) at 9 months.
Load more

Recommended publications
  • A Comparison of the Costs for Treating Central Precocious Puberty During the First Year with Monthly Leuprolide Acetate Injectable and Histrelin Acetate Implant
    A Comparison Of The Costs For Treating Central Precocious Puberty During The First Year With Monthly Leuprolide Acetate Injectable And Histrelin Acetate Implant B F Banahan III1, Mayo K2, Summers KH2 1 Center for Pharmaceutical Marketing and Management and Department of Pharmacy Administration, University of Mississippi, University, MS 2 Health Outcomes & PharmacoEconomics, Endo Pharmaceuticals, Inc., Chadds Ford, PA Estimated Annual Cost of Treatment if all PTs Treated With . BACKGROUND METHODS MEDICAID MODEL Lupron SUPPRELIN LA Product costs $ 1,770,201 $ 1,515,188 Two retrospective cohort studies were conducted using datasets derived from the Office visit costs $ 79,896 $ 14,000 Puberty results when secretion of gonadotropin releasing hormone (GnRH) is initiated 100% compliance with Lupron treatment 1 Implant procedures $ 91,400 and the hypothalamic-pituitary-gonadal axis is activated. During puberty, the brain Thomas Reuter’s MarketScan© Multi-State Medicaid Database (2003-2007) and the (All patients receive 13+ treatments in year) MarketScan© Commercial Database (2005-2009). A probabilistic patient flow model Lab/xray for monitoring $ 53,900 $ 37,500 produces GnRH through a complex process. GnRH causes increases in other TOTAL COST TO PAYER $ 1,903,997 $ 1,658,088 hormones like luteinizing hormone (LH) and follicle stimulating hormone (FSH). It is was developed using estimates for treatment patterns and costs for products, office Normal Compliance with Lupron: Lupron SUPPRELIN LA these hormones that cause the ovaries to produce estrogen and the testicles to visits, and monitoring therapy. Patients with < 13 treatments per year Product costs $ 1,572,921 $ 1,515,188 Quality of Care ofCare Quality % of TXd PTs: 53% Aver.
    [Show full text]
  • Hormones and Breeding
    IN-DEPTH: REPRODUCTIVE ENDOCRINOLOGY Hormones and Breeding Carlos R.F. Pinto, MedVet, PhD, Diplomate ACT Author’s address: Theriogenology and Reproductive Medicine, Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, OH 43210; e-mail: [email protected]. © 2013 AAEP. 1. Introduction affected by PGF treatment to induce estrus. In The administration of hormones to mares during other words, once luteolysis takes place, whether breeding management is an essential tool for equine induced by PGF treatment or occurring naturally, practitioners. Proper and timely administration of the events that follow (estrus behavior, ovulation specific hormones to broodmares may be targeted to and fertility) are essentially similar or minimally prevent reproductive disorders, to serve as an aid to affected (eg, decreased signs of behavioral estrus). treating reproductive disorders or hormonal imbal- Duration of diestrus and interovulatory intervals ances, and to optimize reproductive efficiency, for are shortened after PGF administration.1 The example, through induction of estrus or ovulation. equine corpus luteum (CL) is responsive to PGF These hormones, when administered exogenously, luteolytic effects any day after ovulation; however, act to control the duration and onset of the different only CL Ͼ5 days are responsive to one bolus injec- stages of the estrous cycle, specifically by affecting tion of PGF.2,3 Luteolysis or antiluteogenesis can duration of luteal function, hastening ovulation es- be reliably achieved in CL Ͻ5 days only if multiple pecially for timed artificial insemination and stimu- PGF treatments are administered. For that rea- lating myometrial activity in mares susceptible to or son, it became a widespread practice to administer showing delayed uterine clearance.
    [Show full text]
  • DESCRIPTION Vantas™ (Histrelin Implant) Is a Sterile Non-Biodegradable, Diffusion-Controlled Reservoir Drug Delivery System De
    Vantas™ (histrelin implant) PACKAGE INSERT DESCRIPTION Vantas™ (histrelin implant) is a sterile non-biodegradable, diffusion-controlled reservoir drug delivery system designed to deliver histrelin continuously for 12 months upon subcutaneous implantation. The Vantas implant contains 50 mg of histrelin acetate. Histrelin acetate is a synthetic nonapeptide analogue of the naturally occurring gonadotropin releasing hormone (GnRH) or luteinizing hormone releasing hormone (LH-RH). The sterile Vantas implantation device (provided with the implant) is used to insert the implant subcutaneously in the inner aspect of the upper arm. After 12 months, the implant must be removed. At the time the implant is removed, another implant may be inserted to continue therapy. The sterile Vantas ™ implant consists of a 50-mg histrelin acetate drug core inside a non- biodegradable, 3 cm by 3.5 mm cylindrically shaped hydrogel reservoir (Figure A). The drug core also contains the inactive ingredient stearic acid NF. The hydrogel reservoir is a hydrophilic polymer cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. The hydrated implant is packaged in a glass vial containing 2.0 mL of 1.8% NaCl solution. The implant is primed for release of the drug upon insertion. Figure A. Vantas Histrelin Implant diagram (not to scale) Hydrogel Reservoir Drug Formulation Histrelin acetate is chemically described as 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L- tyrosyl-Nt-benzyl-D-histidyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) [C66H86N18O12. (1.7-2.8 moles) CH3COOH, (0.6-7.0 moles) H2O], with the molecular weight of 1443.70 (or 1323.50 as histrelin base.
    [Show full text]
  • PE2572 Puberty Blockers
    Puberty Blockers What are puberty Puberty blockers are medicines that block puberty-related hormones that blockers? make your body go through puberty. Starting puberty blockers is a decision that is different for everyone. To make the most informed decision, this handout is meant to help you understand: • What is puberty? • What do puberty blockers do? • What are the changes that will happen to my body? • What are the benefits, risks and costs involved? We will work with you to support the decision that is best for you. You can view a video about puberty blockers at seattlechildrens.org/gender. How does puberty Puberty is the process the body goes through to become capable of begin? making a baby (reproduction), as well as reach adult size and brain development. Puberty starts when your brain tells your pituitary gland to start releasing puberty-related hormones. This happens at different ages for different people. During this time, your body starts to increase the amount of certain puberty-related hormones (Luteinizing Hormone (LH) and Follicle- Stimulating Hormone (FSH). This causes your testicles to start producing testosterone or your ovaries start producing estrogen. These hormones do not cause acne, pubic or armpit hair – those are caused by other hormones. Body changes in • Testicle growth (this improves the body’s ability to make testosterone) people with testicles • Penis growth (without puberty • Pubic hair blockers) • Increased acne, increased armpit and facial hair • Rapid growth (growth spurt) • Voice changes (deepens) Body changes in • Breast changes people with ovaries • Changes in body shape, including fuller hips (without puberty • Menstrual periods start (usually more than 2 years after breast changes blockers) begin) 1 of 6 To Learn More Free Interpreter Services • Adolescent Medicine • In the hospital, ask your nurse.
    [Show full text]
  • Quantity Limits/Daily Dose Limits
    Effective 07/20/21 Alphabetical by Brand Name (when applicable) PA Medical Assistance Fee-for-Service Quantity Limits & Daily Dose Limits Maximum Therapy Class Brand Name Generic Name Daily Dose Limit Antipsychotics, Atypical ABILIFY 1 MG/ML SOLUTION ARIPIPRAZOLE 25 Antipsychotics, Atypical ABILIFY 10 MG DISCMELT ARIPIPRAZOLE 2 Antipsychotics, Atypical ABILIFY 10 MG TABLET ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY 15 MG DISCMELT ARIPIPRAZOLE 2 Antipsychotics, Atypical ABILIFY 15 MG TABLET ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY 2 MG TABLET ARIPIPRAZOLE 2 Antipsychotics, Atypical ABILIFY 20 MG TABLET ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY 30 MG TABLET ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY 5 MG TABLET ARIPIPRAZOLE 1.5 Antipsychotics, Atypical ABILIFY 9.75 MG/1.3 ML INJECTION VIAL ARIPIPRAZOLE 3.9 Antipsychotics, Atypical ABILIFY MAINTENA ER 300 MG SYRINGE ARIPIPRAZOLE 0.04 Antipsychotics, Atypical ABILIFY MAINTENA ER 300 MG VIAL ARIPIPRAZOLE 0.04 Antipsychotics, Atypical ABILIFY MAINTENA ER 400 MG SYRINGE ARIPIPRAZOLE 0.04 Antipsychotics, Atypical ABILIFY MAINTENA ER 400 MG VIAL ARIPIPRAZOLE 0.04 Antipsychotics, Atypical ABILIFY MYCITE 10 MG KIT ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY MYCITE 15 MG KIT ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY MYCITE 2 MG KIT ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY MYCITE 20 MG KIT ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY MYCITE 30 MG KIT ARIPIPRAZOLE 1 Antipsychotics, Atypical ABILIFY MYCITE 5 MG KIT ARIPIPRAZOLE 1 Antivirals, Herpes ABREVA 10%
    [Show full text]
  • DEAR PHYSICIAN: This Letter Is Being Provided As a Sample to Help You with Your Payor Interactions Concerning Reimbursement
    DEAR PHYSICIAN: This letter is being provided as a sample to help you with your payor interactions concerning reimbursement for the administration of SUPPRELIN® LA (histrelin acetate) subcutaneous implant. Use of this document does not guarantee coverage or reimbursement. As a healthcare professional, you are solely responsible for providing accurate information to third-party payors. If there is any information in this document that does not accurately reflect your practices, it should be modified to appropriately represent your particular circumstances. INDICATION • SUPPRELIN® LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). • Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. • Prior to initiation of treatment, a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. IMPORTANT SAFETY INFORMATION ABOUT SUPPRELIN® LA • SUPPRELIN® LA is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs and in females who are or may become pregnant while receiving the drug.
    [Show full text]
  • Erleada (Apalutamide)
    Market Applicability Market GA KY MD NJ NY WA Applicable X X X X X X Erleada (apalutamide) Override(s) Approval Duration Prior Authorization 1 year Quantity Limit Medications Quantity Limit Erleada (apalutamide) May be subject to quantity limit APPROVAL CRITERIA Requests for Erleada (apalutamide) may be approved if the following criteria are met: I. Individual is diagnosed with one of the following: A. Individual has a diagnosis of non-metastatic castration-resistant* prostate cancer (nmCRPC); OR B. Individual has a diagnosis of metastatic castration-sensitive prostate cancer (mCSPC) AND II. One of the following: A. Individual is concomitantly receiving a gonadotropin-releasing hormone (GnRH) analog (e.g. Lupron (leuprolide, Zoladex (goserelin), Trelstar (triptorelin), Vantas (histrelin), Firmagon (degarelix); OR B. Individual has had a bilateral orchiectomy. *Castration-resistant refers to either surgical or medically induced methods. Medically induced methods include luteinizing hormone-releasing hormone (LHRH) agonists (such as leuprolide, goserelin) or LHRH antagonists (such as degarelix). Key References: 1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2020. URL: http://www.clinicalpharmacology.com. Updated periodically. 2. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: April 19, 2020. PAGE 1 of 2 09/11/2020 CRX-ALL-0595-20 New Program Date 04/09/2018 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. Market Applicability Market GA KY MD NJ NY WA Applicable X X X X X X 3.
    [Show full text]
  • Prior Authorization Gonadotropin-Releasing Hormone Agonists Implant - Zoladex® (Goserelin Acetate Subcutaneous Implant)
    Cigna National Formulary Coverage Policy Prior Authorization Gonadotropin-Releasing Hormone Agonists Implant - Zoladex® (goserelin acetate subcutaneous implant) Table of Contents Product Identifer(s) National Formulary Medical Necessity ................ 1 66292 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • Vantas (Histrelin Implant)
    Vantas™ (histrelin implant) DESCRIPTION Vantas™ (histrelin implant) is a sterile non-biodegradable, diffusion-controlled reservoir drug delivery system designed to deliver histrelin continuously for 12 months upon subcutaneous implantation. The Vantas implant contains 50 mg of histrelin acetate. Histrelin acetate is a synthetic nonapeptide analogue of the naturally occurring gonadotropin releasing hormone (GnRH) or luteinizing hormone releasing hormone (LH-RH). The sterile Vantas implantation device (provided with the implant) is used to insert the implant subcutaneously in the inner aspect of the upper arm. After 12 months, the implant must be removed. At the time the implant is removed, another implant may be inserted to continue therapy. The sterile Vantas ™ implant consists of a 50-mg histrelin acetate drug core inside a nonbiodegradable,3 cm by 3.5 mm cylindrically shaped hydrogel reservoir (Figure A). The drug core also contains the inactive ingredient stearic acid NF. The hydrogel reservoir is a hydrophilic polymer cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. The hydrated implant is packaged in a glass vial containing 2.0 mL of 1.8% NaCl solution. The implant is primed for release of the drug upon insertion. Figure A. Vantas Histrelin Implant diagram (not to scale) Histrelin acetate is chemically described as 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl­ Ltyrosyl-Nt-benzyl-D-histidyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) [C66H86N18O12. (1.7-2.8 moles) CH3COOH, (0.6-7.0 moles) H2O], with the molecular weight of 1443.70 (or 1323.50 as histrelin base.
    [Show full text]
  • D Rug U Tilization R Eview B Oard
    Wednesday, January 13, 2021 No live meeting scheduled for January. January 2021 will be a packet only meeting. Review Board Review Oklahoma Health Care Authority (OHCA) 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 Drug Utilization The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – January 13, 2021 NOTE: No live January meeting. January 2021 is a packet only meeting. Enclosed are the following items related to the January meeting. Material is arranged in order of the agenda. Approval of DUR Board Meeting Minutes – Appendix A Update on Medication Coverage Authorization Unit/SoonerCare Opioid Initiative Update – Appendix B Annual Review of Gonadotropin Releasing Hormone (GnRH) Medications and 30-Day Notice to Prior Authorize Fensolvi® (Leuprolide Acetate) and Oriahnn™ (Elagolix/Estradiol/Norethindrone and Elagolix) – Appendix C Annual Review of Antihyperlipidemics and 30-Day Notice to Prior Authorize Nexletol® (Bempedoic Acid) and Nexlizet™ (Bempedoic Acid/Ezetimibe) – Appendix D Annual Review of Glaucoma Medications and 30-Day Notice to Prior Authorize Durysta™ (Bimatoprost Implant) – Appendix E Annual Review of Antiviral Medications – Appendix F Annual Review of Korlym® (Mifepristone) – Appendix G Annual Review of Turalio® (Pexidartinib) – Appendix H Annual Review of Inrebic® (Fedratinib) and Elzonris® (Tagraxofusp-erzs) – Appendix I 30-Day Notice to Prior Authorize Imcivree™ (Setmelanotide) – Appendix J U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) Updates – Appendix K Future Business ORI-4403 • P.O. BOX 26901 • OKLAHOMA CITY, OKLAHOMA 73126-0901 • (405) 271-9039 • FAX: (405) 271-2615 Oklahoma Health Care Authority Drug Utilization Review Board (DUR Board) Packet – January 13, 2021 No live January meeting.
    [Show full text]
  • Supprelin LA Histrelin Prior Authorization Criteria
    Prior Authorization Approval Criteria Supprelin (histrelin) Generic Name: Histrelin Brand Name: Supprelin LA®, Vantas™ Medication Class: Gonadotropin Releasing Hormone Agonist FDA Approved Uses: Vantas™ for palliative treatment of advanced prostate cancer in men Supprelin LA® for the treatment of children with central precocious puberty Available Dosage Forms: Vantas TM implantation kit 50 mg (release 50-60 mcg/day over 12 months) Supprelin ® LA implantation kit 50 mg (release~ 65 mcg/day over 12 months) Usual Dose: 50 mg implant surgically inserted every 12 months Duration of Therapy: (Vantas TM) Indefinitely (Supprelin ® LA) Until the onset of puberty (Girls ~ age 11; boys ~ age 12) Approximate monthly cost (based on ASP+6% as of 4/1/ 2008): Vantas TM has an ASP+6% of $1,508 for one implant (1 year) Supprelin® has an ASP+6% of $14,656 for one implant (1 year) Criteria for Use: (bullet points below are all inclusive unless otherwise noted) For Vantas TM for men only diagnosed with advanced prostate cancer not for children under 18 years of age For Supprelin® children age ≥ 2 years old clinically diagnosed with central precocious puberty. Diagnosis should be confirmed by the following: measurement of blood concentrations of total sex steroids (estrogens/testosterone) measurement of LH and FSH after stimulation with a GnRH analog assessment of bone age vs. chronological age Baseline evaluation should also include height and weight; diagnostic imaging of the brain, pelvic/testicular/adrenal ultrasound, HCG levels, and adrenal
    [Show full text]
  • Clinical Policy: Histrelin Acetate (Vantas, Supprelin LA) Reference Number: ERX.SPMN.96 Effective Date: 07/16 Last Review Date: 06/16 Revision Log
    Clinical Policy: Histrelin Acetate (Vantas, Supprelin LA) Reference Number: ERX.SPMN.96 Effective Date: 07/16 Last Review Date: 06/16 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions® that histrelin acetate (Vantas® and Supprelin LA®) are medically necessary for members meeting the following criteria: I. Initial Approval Criteria A. Prostate Cancer (must meet all): 1. Age ≥ 18 years; 2. Diagnosis of advanced prostate cancer (stage T3 through T4 or high risk through nodal/metastatic disease); 3. Treatment intent is palliative; 4. Prescription is for Vantas; 5. Prescribed dose does not exceed 50 mg administered as one 12-month implant; 6. Member has a contraindication to or has failed a trial of leuprolide acetate generic injection, Lupron Depot, or Zoladex. Approval Duration: 12 months B. Central Precocious Puberty (CPP) (must meet all): 1. Females, age ≥ 2 and ≤11 years, or males, age ≥ 2 and ≤12 years; 2. Diagnosis of CPP confirmed by a through c: a. Elevated basal LH level and/or elevated leuprolide stimulated LH level >5 IU/I; b. Assessment shows significantly advanced bone age versus chronological age; c. Age at onset of secondary sex characteristics is < 8 years if female, or < 9 years if male; 3. The following conditions have been ruled out: a. Intracranial tumor with diagnostic brain imaging; b. Steroid secreting tumors with pelvic/testicular/adrenal ultrasound; c. Chorionic gonadotropin secreting tumor via measurement of human chorionic gonadotropin levels; d. Congenital adrenal hyperplasia via measurement of adrenal steroids; 4.
    [Show full text]