SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES TESTOSTERON. Generic Brand HICL GCN Exception/Other ROUTE MISCELL.
|
|
- Anissa Bryant
- 6 years ago
- Views:
Transcription
1 Generic Brand HICL GCN Exception/Other ANDRODERM ROUTE MISCELL. ANDROGEL AXIRON FORTESTA NATESTO STRIANT TESTIM VOGELXO DEPO ROUTE MISCELL. CYPIONATE TESTOSTERON E GCN DELATESTRYL ROUTE MISCELL. ENANTHATE METHYLTESTOSTERO NE GUIDELINES FOR USE TESTRED ANDROID METHITEST ROUTE MISCELL. 1. Is the request for a male patient with a diagnosis of primary or secondary hypogonadism (hypotestosteronism or low testosterone) who meets ONE of the following criteria? The patient has a previously approved prior authorization for testosterone or has been receiving any form of testosterone replacement therapy as indicated per physician attestation or claims history OR The patient has AT LEAST ONE of the following laboratory values confirming low testosterone levels: o Total serum testosterone level of less than 300 ng/dl (10.4 nmol/l) o Low total serum testosterone level as indicated by a lab result with a reference range obtained within the past 90 days o Free serum testosterone level of less than 5 pg/ml (0.17 nmol/l) If yes, continue to #2. If no, continue to #4. Revised: 09/29/2017 Page 1 of 13
2 GUIDELINES FOR USE (CONTINUED) 2. Is the request for Androderm, Fortesta, Natesto, Striant, Testim, Vogelxo, Testred, Android, or Methitest and has the following criteria been met? The patient has previously tried or has a contraindication to Androgel AND Axiron If yes, approve the requested agent for lifetime by GPID with the following quantity limits: Androderm (testosterone): (2mg, 2.5mg, 4mg or 5mg patches) 30 patches per 30 days. Fortesta (testosterone): up to 120 grams per 30 days (2 of the 60-gram pumps). Natesto (testosterone): up to grams (3 bottles) per 30 days. Striant (testosterone): 60 systems (tablets) per 30 days. Testim (testosterone): ([1%] 50mg per 5 gram gel tube) up to 2 tubes per day per 30 days. Vogelxo (testosterone): ([1%] 50mg per 5 gram gel tube) up to 2 tubes per day per 30 days; (50mg/5 gram gel packet) up to 2 packets per day per 30 days; (12.5mg/1.25 gram pump) up to 4 of the 75 gram pumps per 30 days. Testred (methyltestosterone): (10mg capsules) 5 capsules per day. Android (methyltestosterone): (10mg capsules) 5 capsules per day. Methitest (methyltestosterone): (10mg tablets) 5 tablets per day. If no, continue to #3. 3. Is the request for AndroGel 1%, AndroGel 1.62%, Axiron, Depo-Testosterone (testosterone cypionate), or testosterone enanthate (Delatestryl)? If yes, approve the requested agent for lifetime by GPID with the following quantity limits: AndroGel 1% (testosterone): (2.5 gram packet) up to 5 grams per day per 30 days; (5 gram packet) up to 10 grams per day per 30 days; or up to 4 of the 75 gram pumps. AndroGel 1.62% (testosterone): (1.25 gram packet) up to 1.25 grams per day per 30 days; (2.5 gram packet) up to 5 grams per day per 30 days; or up to 2 of the 75 gram pumps per 30 days. Axiron (testosterone): (30mg per pump, 60 pumps per container) up to 180mL per 30 days (2 of the 90mL metered-dose pumps). Depo-Testosterone (testosterone cypionate): (100mg/mL, 200mg/mL 10mL vial) up to 1 vial per 30 days. Depo-Testosterone (testosterone cypionate): (200mg/mL, 1mL vial) up to 10 vials per 30 days. Revised: 09/29/2017 Page 2 of 13
3 Testosterone enanthate (Delatestryl): (200mg/mL, 5mL vial) 1 vial per 30 days. If no, do not approve. DENIAL TEXT: See the denial text at the end of the guideline. Revised: 09/29/2017 Page 3 of 13
4 GUIDELINES FOR USE (CONTINUED) 4. Is the request for a male patient with a diagnosis of delayed puberty not secondary to a pathological disorder who meets ONE of the following criteria: The request is for testosterone enanthate (Delatestryl) The request is for methyltestosterone (Testred, Android, or Methitest) AND the patient had a previous trial of or contraindication to Delatestryl If yes, approve the requested agent for lifetime by GPID with the following quantity limits: Delatestryl (testosterone enanthate): (200mg/mL, 5mL vial) 1 vial per 30 days. Testred (methyltestosterone): (10mg capsules) 5 capsules per day. Android (methyltestosterone): (10mg capsules) 5 capsules per day. Methitest (methyltestosterone): (10mg tablets) 5 tablets per day. If no, continue to #5. 5. Is the request for testosterone cypionate (Depo-Testosterone) for a diagnosis of gender dysphoria and the patient is at least 18 years of age? If yes, approve the requested agent for 12 months by GPID with the following quantity limits: Testosterone cypionate (Depo-Testosterone) 100mg/mL, 200mg/mL 10mL vial: 1 vial per 30 days. Testosterone cypionate (Depo-Testosterone) 200mg/mL, 1mL vial: 10 vials per 30 days. If no, continue to #6. 6. Is the request for a female patient with a diagnosis of metastatic breast cancer who meets ONE of the following criteria? The request is for testosterone enanthate (Delatestryl) The request is for methyltestosterone (Testred, Android, or Methitest) AND the patient had a previous trial of or contraindication to Delatestryl If yes, approve for requested agent for lifetime by GPID with the following quantity limits: Delatestryl (testosterone enanthate): (200mg/mL, 5mL vial) 1 vial per 30 days. Testred (methyltestosterone): (10mg capsules) 20 capsules per day. Android (methyltestosterone): (10mg capsules) 20 capsules per day. Methitest (methyltestosterone): (10mg tablets) 20 tablets per day. If no, do not approve. DENIAL TEXT: See the denial text at the end of the guideline. Revised: 09/29/2017 Page 4 of 13
5 Revised: 09/29/2017 Page 5 of 13
6 GUIDELINES FOR USE (CONTINUED) DENIAL TEXT: The guideline named requires a diagnosis of primary or secondary male hypogonadism (hypotestosteronism or low testosterone), delayed puberty in males not secondary to a pathological disorder, gender dysphoria, or metastatic breast cancer. For a diagnosis of metastatic female breast cancer or delayed puberty in males not secondary to a pathological disorder, only testosterone enanthate (Delatestryl) or methyltestosterone (Testred, Android, or Methitest) may be approved. For patients with gender dysphoria, only testosterone cypionate (Depo-Testosterone) may be approved. In addition, the following criteria must also be met. For male patients with a diagnosis of primary or secondary hypogonadism, approval requires that the following criteria must also be met. The patient has a previously approved prior authorization for testosterone or has been receiving any form of testosterone replacement therapy as indicated per physician attestation or claims history OR The patient has AT LEAST ONE of the following laboratory values confirming low testosterone levels: o Total serum testosterone level of less than 300ng/dL (10.4 nmol/l) o Low total serum testosterone level as indicated by a lab result with a reference range obtained within 90 days o Free serum testosterone level of less than 5 pg/ml (0.17 nmol/l). For requests of Androderm, Fortesta, Natesto, Striant, Testim, Vogelxo, Testred, Android, or Methitest, approval requires that the following criteria must also be met. The patient has previously tried or has a contraindication to Androgel and Axiron For patients with a diagnosis of gender dysphoria, approval requires: The patient is at least 18 years old. For male patients requesting methyltestosterone (Testred, Android or Methitest) for a diagnosis of delayed puberty not secondary to a pathological disorder, approval requires a previous trial of or contraindication to testosterone enanthate (Delatestryl). Please note that Delatestryl requires a prior authorization. For female patients requesting methyltestosterone (Testred, Android or Methitest) for a diagnosis metastatic breast cancer, approval requires a previous trial of or contraindication to testosterone enanthate (Delatestryl). Please note that Delatestryl requires a prior authorization. Revised: 09/29/2017 Page 6 of 13
7 RATIONALE Ensure appropriate diagnostic, utilization, and safety criteria. Normal testosterone level is defined for males as between 300-1,200ng/dL per the National Institute on Aging. Low free serum testosterone level is defined as less than 50ng/L per Adult Men with Androgen Deficiency Syndrome: An Endocrine Society Clinical Practice Guideline. Coverage for gender dysphoria is medically accepted for testosterone cypionate only as indicated in MicroMedex DrugDex. MicroMedex DrugDex has a therapeutic indication of female-to-male transsexual-gender identity disorder for testosterone cypionate. Other testosterone products do not have a medically accepted indicate for gender dysphoria or gender identity disorder. Testosterone Enanthate and methyltestosterone have an FDA indication of metastatic (skeletal) mammary cancer. The other testosterone products do not have a medically accepted indication for metastatic mammary cancer. FDA APPROVED INDICATIONS ANDRODERM (testosterone transdermal system) is indicated for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter s Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations accompanied by gonadotropins (FSH, LH) above the normal range. Secondary, i.e., hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations without associated elevation in gonadotropins. ANDROGEL, an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic Hypogonadism (Congenital or Acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. AXIRON, an androgen is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterones: Primary Revised: 09/29/2017 Page 7 of 13
8 hypogonadism (congenital or acquired); Hypogonadotropic hypogonadism (congenital or acquired). Not indicated in males <18 years of age. Revised: 09/29/2017 Page 8 of 13
9 FDA APPROVED INDICATIONS (CONTINUED) DEPO- INJECTION is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. DELATESTRYL (Testosterone Enanthate Injection, USP) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. May be used secondarily in woman with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. FORTESTA is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Important limitation of use: safety and efficacy of FORTESTA in males <18 years old have not been established. NATESTO is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) Hypogonadotropic hypogonadism (congenital or acquired) Limitations of use: safety and efficacy of Natesto in males less than 18 years old have not been established. STRIANT is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range. Revised: 09/29/2017 Page 9 of 13
10 FDA APPROVED INDICATIONS (CONTINUED) TESTIM is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. Testim has not been clinically evaluated in males less than 18 years of age. TESTRED, ANDROID, AND METHITEST are androgens, indicated for replacement therapy in the following patients: Males with conditions associated with a deficiency or absence of endogenous testosterone: o Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome: or orchidectomy. o Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary- hypothalamic injury from tumors, trauma or radiation. o Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously later. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. Females: may be used secondarily in woman with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. VOGELXO, an androgen, indicated for replacement therapy in males for conditions in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired). Hypogonadotropic hypogonadism (congenital or acquired). Revised: 09/29/2017 Page 10 of 13
11 REFERENCES Lilly USA, LLC. Axiron Package Insert. Indianapolis, IN. July, Auxilium Pharmaceuticals, Inc. Testim package insert. Malvern, PA. September Bartor Pharmacal Co.; Inc. Testopel package insert. Rye, NY. January Columbia Laboratories, Inc. Striant package insert. Livingston, NJ. February Conway AJ, Handelsman DJ, Lording DW, Stuckey B, Zajac JD. Use, misuse and abuse of androgens. MJA. 2000; 172: Endo Pharmaceuticals. Fortesta package insert. Chadds Ford, PA. April, Francis S. Greenspan and David G. Gardner eds. Lange Basic and Clinical Endocrinology. 7th ed. McGraw-Hill Companies, Inc.; Gould DC, Petty R, Jacobs HS. The male menopause: does it exist? BMJ. 2000; 320: Endo Pharmaceuticals, Inc. Delatestryl package insert. Chadds Ford, PA. June, Lui PY, Swerdloff RS, Wang C. Relative testosterone deficiency in older men: Clinical definition and presentation. Endocrinol Metab Clin N Am. 2005; 34: Miller KK. Special Articles: Hormones and Reproductive Health. J Clin Endocrinol Metab 2001; 86(6): National Institute on Aging. Scientific task force to examine usefulness of testosterone replacement therapy in older men [online]. NIH News Release. November 6, Available at: htm [Accessed July 21, 2009]. Valeant Pharmaceuticals. Testred package insert. Aliso Viejo, CA. June 2014 Petak SM. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients-2002 Update. Endocrine Practice. 2002; 8 (6): Pharmacia & Upjohn Company. Depo-Testosterone package insert. New York, NY. September Shalender B, Glenn, Cunningham, FJ, et al. Adult Men with Androgen Deficiency Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, June 2010, 95(6): Available at: [Accessed July 25, 2011]. The Formulary Monograph Service, Facts and Comparisons, St Louis, Missouri, Abbott Laboratories. Androgel 1% package insert. North Chicago, IL. November, Abbott Laboratories. Androgel 1.62% package insert. North Chicago, IL. April, Watson Pharma, Inc. Androderm package insert. Parsippany, NJ. October Upsher-Smith Laboratories, Inc. Vogelxo Package Insert. Maple Grove, MN. June, Revised: 09/29/2017 Page 11 of 13
12 UpToDate, Inc. Testosterone treatment of male hypogonadism. UpToDate [database online]. Waltham, MA. Available at: edtitle=1%7e50§ionrank=1&anchor=h #h1. Accessed on March 17, 2015 Revised: 09/29/2017 Page 12 of 13
13 REFERENCES (CONTINUED) Bhasin S, Cunningham GR, et al. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, June 2010, 95(6): Trimel Pharmaceuticals Press Release: Trimel Receives FDA Approval for Natesto Nasal Gel to Treat Men with Low Testosterone. May 28, Available at: Natesto-Nasal-Gel-to-Treat-Men-with-Low-Testosterone. Accessed on March 17, 2015 Sexson E, Knezevich J. Male Hypogonadism: A Review of the Disease and Its Treatment. US Pharm. 2010; 35(6):HS7-HS16. Available at: Accessed on March 17, 2015 Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract May; 64(6): Available at: Accessed on March 17, Food and Drug Administration. Background documents for the joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. September 17, Available at: ugs/reproductivehealthdrugsadvisorycommittee/ucm pdf. Accessed on November 4, 2014 Food and Drug Administration. Testosterone Products: Drug Safety Communication- FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke. March 3, Available at: alproducts/ucm htm. Accessed on March 17, Natesto [Prescribing Information]. Malvern, PA: Endo Pharmaceuticals Inc.; November Valeant Pharmaceuticals. Testred package insert. Bridgewater, NJ. April Commercial X Market Place X Created: 11/16 Effective : 1/1/18 Client Approval: P&T Approval: Revised: 09/29/2017 Page 13 of 13
HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
Generic Brand HICL GCN Exception/Other METHYL ANDROID METHITEST METHYL TESTRED 01404 ROUTE MISCELL. CYPIONATE ENANTHATE GUIDELINES FOR USE ANDRODERM ANDROGEL AXIRON FORTESTA NATESTO STRIANT TESTIM VOGELXO
More informationTestosterone Topical/Buccal/Nasal
BENEFIT APPLICATION Testosterone Topical/Buccal/Nasal DRUG POLICY Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.CPA.291 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Androgens and Anabolic Steroids Page 1 of 57 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Androgens and Anabolic Steroids Prime Therapeutics will review Prior
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Androgens and Anabolic Steroids Page 1 of 53 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Androgens and Anabolic Steroids Prime Therapeutics will review Prior
More informationAndrogens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent
Androgens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent Androgens/Anabolic Steroids Prior Authorization with Quantity Limit Through Preferred
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2018-9 Program Prior Authorization/Medical Necessity Topical Androgens Medication Axiron*, Androderm, Androgel*, Fortesta*, Natesto*,
More informationTestosterone Hormone Replacement Drug Class Prior Authorization Protocol
Line of business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Testosterone Hormone Replacement Drug Class Prior Authorization Protocol This policy has been developed through
More informationMedication Policy Manual
Independent licensees of the Blue Cross and Blue Shield Association Medication Policy Manual Topic: Non-preferred, non-transdermal testosterone replacement therapy products (Android, Aveed, Androxy, Methitest,
More informationDrug Class Monograph
Drug Class Monograph Class: Testosterone Hormone Replacement Drug: Androderm (testosterone transdermal system), Androgel (testosterone topical gel), Axiron (testosterone topical solution), Aveed (testosterone
More informationClinical Policy: Testosterone Reference Number: AZ.CP.PHAR.02 Effective Date: Last Review Date: Line of Business: Arizona Medicaid
Clinical Policy: Reference Number: AZ.CP.PHAR.02 Effective Date: 11.16.16 Last Review Date: 09.12.18 Line of Business: Arizona Medicaid Revision Log See Important Reminder at the end of this policy for
More informationTestosterone Hormone Replacement Drug Class Prior Authorization Protocol
Testosterone Hormone Replacement Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective date: April 1, 2018 This policy has been developed through
More informationPolicy. covered: bilateral. alcohol or. Approve. 3. Palliative enanthate injection in. women for. 6 months if. can also sponsive tumor.
Injectablee Testosterone Products Prior Authorization Policy Number: 5.01.597 Origination: 07/2014 Last Review: 07/2014 Next Review: 07/2015 Policy BCBSKC will provide coverage for injectable testosterone
More informationMALE HORMONE THERAPY OPTIONS
MALE HORMONE THERAPY OPTIONS The following tables have been compiled by Women s staff pharmacists to represent some of the more frequently prescribed regimens for men. The Women s logo is placed throughout
More informationAndrogens and Anabolic Steroids Prior Authorization with Quantity Limit Through Preferred Topical Androgen Criteria Program Summary
OBJECTIVE The intent of the Androgens and Anabolic Steroids Prior Authorization with Quantity Limit (PA) program is to appropriately select patients for therapy according to product labeling and/or clinical
More informationMALE HORMONE THERAPY OPTIONS
MALE HORMONE THERAPY OPTIONS The following tables have been compiled by Women s International Pharmacy staff pharmacists to represent some of the more frequently prescribed regimens for men. The Women
More informationAndrogens and Anabolic Steroids Prior Authorization and Quantity Limit Program Summary
Androgens and Anabolic Steroids Prior Authorization and Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1-11,27,28,32,33,37-39,41,42,46,50 Topical Androgen Agents Agent Indication Dosage
More informationSeptember 17, FDA background documents for the discussion of two major issues in testosterone replacement therapy (TRT):
JOINT MEETING FOR BONE, REPRODUCTIVE AND UROLOGIC DRUGS ADVISORY COMMITTEE (BRUDAC) AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE (DSARM AC) September 17, 2014 FDA background documents for
More informationIssues. What is a low testosterone? Who needs testosterone therapy? Benefits/adverse effects of testosterone replacement Treatment options
Male Hypogonadism Jauch Symposium Waterloo, IA May 17, 2013 Janet A. Schlechte, M.D. Disclosure of Financial Relationships Janet A. Schlechte, M.D. has no relationships with any proprietary entity producing
More informationMI Androgen Deficiency Hypogonadism
MI Androgen Deficiency Hypogonadism WADA TUE Expert Group John A Lombardo, MD October 2014, Columbus, Ohio USA Hypothalamic-Pituitary-Gonadal Axis / 2 Hypogonadism/Androgen Deficiency Clinical syndrome:
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Implantable Hormone Pellets Table of Contents Coverage Policy... 1 General Background... 3 Coding/Billing Information... 5 References... 6 Effective Date...
More informationInappropriate Testosterone Billings
Inappropriate Testosterone Billings Carla Patrick-Fagan March 30, 2015 Truven Health Analytics Inc. All Rights Reserved. 1 Agenda Proposed in the 2015 analytic plan Steroid prescriptions Code of Federal
More informationMedical Policy Testosterone Therapy
Medical Policy Testosterone Therapy Subject: Testosterone Therapy Effective Date: April 2015 Overview: Testosterone cypionate, testosterone enanthate, testosterone undecanoate, and testosterone pellet
More informationCurrent Data and Considerations Novel Testosterone Formulations
Current Data and Considerations Novel Testosterone Formulations 1 Current and Novel Therapeutic Options Module 4 2 Objectives Identify desirable characteristics of ideal testosterone formulations Review
More informationAll About T Testosterone for FTMs. Presented by John Otto, MLIS
All About T Testosterone for FTMs Presented by John Otto, MLIS Who? Anyone thinking about transitioning Those who have transitioned, but want to know more Empowerment from self-managing transition Allies
More informationComparison of Testosterone Replacement Therapy Medications in the Treatment of Hypogonadism
Brigham Young University BYU ScholarsArchive All Student Publications 2016-07-27 Comparison of Testosterone Replacement Therapy Medications in the Treatment of Hypogonadism Christopher M. Williams Brigham
More informationJeremiah Murphy, MD Mercy Urology Clinic. October 21, 2017
Jeremiah Murphy, MD Mercy Urology Clinic October 21, 2017 Describe an appropriate strategy for the evaluation and diagnosis of male hypogonadism Endocrine Society Clinical Practice Guideline-2010 Review
More informationMonth/Year of Review: September 2013 Date of Last Review: December 2009
Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Copyright 2013 Oregon State University. All Rights
More informationDEPO-Testosterone Injection is available in two strengths, 100 mg/ml and 200 mg/ml testosterone cypionate.
Depo -Testosterone testosterone cypionate injection, USP CIII DESCRIPTION DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate
More informationThe Testosterone Quandary. Beth Crowder, PhD, APRN
The Testosterone Quandary Beth Crowder, PhD, APRN Objectives Define testosterone, the hypothalamic-pituitary-gonadotrophic axis, and normal blood levels List functions of testosterone and symptoms of low
More informationAffirming Care of the Transgender Patient
Mountain West AIDS Education and Training Center Affirming Care of the Transgender Patient Jessica Rongitsch, MD, FACP This presentation is intended for educational use only, and does not in any way constitute
More informationSUMMARY and OBJECTIVES. LOW T- I m half the man I used to be. Prevalence of Low-T. Definition of Hypogonadism 9/19/ Million men in the US
SUMMARY and OBJECTIVES LOW T- I m half the man I used to be A discussion of male hypogonadism David Doriguzzi, PA-C Valley Endocrine & Diabetes Consultants Definition Prevalence Causes Signs & Symptoms
More informationTestosterone Replacement Therapy
30 Bond Street, Toronto ON, M5B 1W8 www.odprn.ca info@odprn.ca Testosterone Replacement Therapy Environmental Scan and Local/Historical Context December 1, 2014 2 Executive Summary Part A: Pharmacy Benefit
More informationCase ILN/1:14-cv Document 1 Filed 04/30/14 Page 1 of 10 BEFORE THE JUDICIAL PANEL ON MULTIDISTRICT LITIGATION ) ) ) ) ) )
Case ILN/1:14-cv-02934 Document 1 Filed 04/30/14 Page 1 of 10 BEFORE THE JUDICIAL PANEL ON MULTIDISTRICT LITIGATION IN RE: ANDROGEL PRODUCTS LIABILITY LITIGATION MDL DOCKET NO. 2545 OPPOSITION OF DEFENDANTS
More informationThe ICL Insider. Lab Testing: Testosterone. In This Issue. The Debate
The ICL Insider February 2017 Volume 2, Issue 2 Lab Testing: Testosterone In This Issue Testosterone shashtilak@iclabs.ca Next Issue: Expected Release April 2017 The Debate Aging is accompanied by various
More informationIcd 10 hormone replacement therapy male
Icd 10 hormone replacement therapy male 2018 ICD - 10 code for Hormone replacement therapy is Z79.890. Lookup the complete ICD 10 Code details for Z79.890. The ICD - 10 system requires that. TEENren who
More informationHypogonadism and Testosterone Replacement Therapy
Testosterone Replacement Therapy Hypogonadism and Testosterone Replacement Therapy a report by Adrian S Dobs, MD, MHS and Anjana Myneni, MD Professor of Medicine and Oncology, Department of Medicine, Johns
More informationTESTIM (testosterone gel) for topical use, CIII Initial U.S. Approval: 1953
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TESTIM safely and effectively. See full prescribing information for TESTIM. TESTIM (testosterone
More informationNatural Hair Transplant Medical Center, Inc Dove Street, Suite #250, Newport Beach, CA Phone
Natural Hair Transplant Medical Center, Inc. 1000 Dove Street, Suite #250, Newport Beach, CA 92660 Phone-949-622-6969 Finasteride (PROPECIA ) Acknowledgement Finasteride is an oral medication, manufactured
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Human, Recombinant) Reference Number: CP.CPA.76 Effective Date: 11.16.16 Last Review Date: 08.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of
More informationInsight into male menopause'
Insight into male menopause' Dr Mark Vanderpump MD FRCP Consultant Endocrinologist Clinics: Tuesday PM Mark Vanderpump Consultant Physician and Endocrinologist Introduction Serum total and free testosterone
More informationAndroGel. (testosterone gel) 1% H 3 C
1 AndroGel (testosterone gel) 1% 500122/500127 Rev Dec 2004 DESCRIPTION AndroGel (testosterone gel) is a clear, colorless hydroalcoholic gel containing 1% testosterone. AndroGel provides continuous transdermal
More informationArthi Thirumalai 1, Kathryn E. Berkseth 1, John K. Amory 2
REVIEW Treatment of Hypogonadism: Current and Future Therapies [version 1; referees: 2 approved] Arthi Thirumalai 1, Kathryn E. Berkseth 1, John K. Amory 2 1Division of Metabolism, Endocrinology, and Nutrition,
More informationCLINICAL PHARMACOLOGY
TESTOPEL- testosterone pellet Slate Pharma ---------- DESCRIPTION TESTOPEL Pellets (testosterone) are cylindrically shaped pellets 3.2mm (1/8 inch) in diameter and approximately 9mm in length. Each sterile
More informationIcd-10 low levels of testosterone
Icd-10 low levels of testosterone The Borg System is 100 % Icd-10 low levels of testosterone 1-10-2017 if your hormone levels are too high or too low, you may have a hormone disorder. Hormone diseases
More informationOriginal Research Declining testicular function in aging men
(2003) 15, Suppl 4, S3 S8 & 2003 Nature Publishing Group All rights reserved 0955-9930/03 $25.00 www.nature.com/ijir Original Research 1 * 1 Wesley Woods Health Center, Atlanta, Georgia, USA Age-related
More informationFemale testosterone level chart
Female testosterone level chart The Borg System is 100 % Female testosterone level chart Mar 23, 2015. Male, Female. Age: T Level (ng/dl):, Age: T Level (ng/dl):. 0-5 mo. 75-400, 0-5 mo. 20-80. 6 mos.-9
More informationTESTOVIRON 300 TESTOCYP 200 INJECTABLE PRODUCTS
Platinum Biotech has a commitment to all people, a commitment of improving the quality of life for each and every person worldwide, through which we constantly strive to innovate, improve and increase
More informationMale Hormone Replacement Therapy. Punita Dhindsa D.O PGY 2
Male Hormone Replacement Therapy Punita Dhindsa D.O PGY 2 Physiology of Testosterone & Causes of Hypogonadism in Males The use of testosterone therapy is very common in the US, with an estimated 2.3 million
More informationTESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE
More informationCinryze. Cinryze (C1 esterase inhibitor [human]) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.05 Subject: Cinryze Page: 1 of 5 Last Review Date: September 20, 2018 Cinryze Description Cinryze
More informationTransgender 201: Case Discussion Group
Transgender 201: Case Discussion Group Melissa Davis, MD Maria Barnett, DO October 19, 2017 Maria Barnett, DO, Date Welcome! Disclosures Introductions Discussion The total time of this workshop will depend
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET 1. PRODUCT NAME DEPO-TESTOSTERONE 100mg/mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml solution for injection contains 100 mg/ml testosterone cypionate.
More informationInitial trial of slow-release testosterone microspheres in hypogonadal men*
FERTILITY AND STERILITY Copyright c 1988 The American Fertility Society Printed in U.S.A. Initial trial of slow-release testosterone microspheres in hypogonadal men* Allen S. Burris, M.D. t Larry L. Ewing,
More informationDilution Sequence Protocol
Dilution Sequence Protocol ATS Short Quadrupling Doses 0.0625 0.25 1 4 16 Provocholine 1600 mg/vial (US NDC 64281-016-01) 1 Provocholine (methacholine chloride USP) powder for solution, for inhalation,
More informationDilution Sequence Protocol
Dilution Sequence Protocol ATS Short Quadrupling Doses 0.0625 0.25 1 4 16 Provocholine 100 mg/vial (US NDC 64281-100-06) 1 Provocholine (methacholine chloride USP) powder for solution, for inhalation,
More informationTreatment of androgen deficiency in the aging male
Treatment of androgen deficiency in the aging male The Practice Committee of the American Society for Reproductive Medicine Birmingham, Alabama Although guidelines for androgen replacement therapy for
More informationPRODUCT INFORMATION TESTOVIRON DEPOT. (testosterone enanthate)
PRODUCT INFORMATION TESTOVIRON DEPOT (testosterone enanthate) NAME OF THE MEDICINE Testosterone enanthate is designated chemically as 17 beta-heptanoyloxy-4-androstene-3- one. The empirical formula of
More informationTestosterone Effects in Transmen
Transmen Testosterone Effects in Transmen EFFECT Skin oiliness/acne Facial/body hair growth Scalp hair loss Increased muscle mass/strength Fat redistribution Cessation of menses Clitoral enlargement Vaginal
More informationHIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use testosterone gel safely and effectively. See full prescribing information for testosterone gel. Testosterone
More informationMale hypogonadism is a clinical syndrome that
Journal of Andrology, Vol. 33, No. 4, July/August 2012 Copyright E American Society of Andrology A Novel Testosterone 2% Gel for the Treatment of Hypogonadal Males ADRIAN S. DOBS,* JOHN MCGETTIGAN,{ PAUL
More informationDonald W. Morrish, MD, PhD, FRCPC Presented at Mountain Man: Men's Health Conference, May Terry s Testosterone
Focus on CME at University of Alberta ADAM: Dealing with the Decline Donald W. Morrish, MD, PhD, FRCPC Presented at Mountain Man: Men's Health Conference, May 2005 We now know there is a decline in total
More informationXYOSTED (testosterone enanthate) injection, for subcutaneous use CIII Initial US approval: 1953 IMPORTANT SAFETY INFORMATION
ANTARES PHARMA ANNOUNCES THE COMMERCIAL AVAILABILITY OF XYOSTED (TESTOSTERONE ENANTHATE) INJECTION A NEW TREATMENT FOR ADULT MEN DIAGNOSED WITH TESTOSTERONE DEFICIENCY XYOSTED - A Novel Subcutaneous Testosterone
More informationAppendix A: State-Level Survey Results
Appendix A: State-Level Survey Results Table A1: Reimbursement for LARCs Post Labor and Delivery States Hospital Reimbursement Other Provider Reimbursement Device Insertion Device (n=39) Insertion (n=40)
More informationpump. a metered-dose pump that delivers 30 mg of testosterone per twist. Each metered-dose pump is supplied with an applicator.
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AXIRON safely and effectively. See full prescribing information for AXIRON. AXIRON (testosterone)
More informationScreening and Monitoring in Men Prescribed Testosterone Therapy in the U.S.,
Research Articles Screening and Monitoring in Men Prescribed Testosterone Therapy in the U.S., 2001 2010 Jacques Baillargeon, PhD a,b Randall J. Urban, MD b,c Yong-Fang Kuo, PhD a,b,c Holly M. Holmes,
More informationAssociate Professor Geoff Braatvedt
Associate Professor Geoff Braatvedt Endocrinologist Diabetologist and Physician Green Lane and Auckland City Hospitals Auckland 14:00-14:55 WS #145: Approach to Low Testosterone Values 15:05-16:00 WS #157:
More informationscr.zacks.com 10 S. Riverside Plaza, Suite 1600, Chicago, IL (LPCN - NASDAQ) INITIATION ZACKS ESTIMATES
Small-Cap Research August 18, 2014 Jason Napodano, CFA David Bautz, PhD 312-265-9421 / jnapodano@zacks.com scr.zacks.com 10 S. Riverside Plaza, Suite 1600, Chicago, IL 60606 Lipocine, Inc. (LPCN - NASDAQ)
More informationNew long-acting androgens
World J Urol (2003) 21: 306 310 DOI 10.1007/s00345-003-0364-x TOPIC PAPER Louis J. Gooren New long-acting androgens Received: 16 September 2003 / Accepted: 17 September 2003 / Published online: 9 October
More informationDilution Sequence Protocol
Dilution Sequence Protocol US Package Insert Multi-Patient (2-5 patients; requires 2 vials of Provocholine) 0.025 0.25 2.5 10 25 Provocholine 100 mg/vial (US NDC 64281-100-06) 1 Provocholine (methacholine
More informationChapter 5. General discussion
Chapter 5. General discussion 127 Chapter 5 In 2003, two review papers concluded that endogenous androgens do not show any consistent association with cardiovascular disease (CVD) risk 1,2. Apparently,
More informationTREATMENT OPTIONS FOR MALE HYPOGONADISM
TREATMENT OPTIONS FOR MALE HYPOGONADISM Bruce Biundo, RPh, FACA PCCA Pharmacy Consulting Department Updated July 2012 Hypogonadism in men is primarily a state involving lower than expected levels of testosterone,
More informationMens Health Post Puberty. Nayan Patel PharmD
Mens Health Post Puberty Nayan Patel PharmD Definition of Androgen Deficiency * Consistently low testosterone * Associated signs/symptoms * Evidence based review of literature * Data is weak at best Definition
More informationAndrogenes and Antiandrogenes
Androgenes and Antiandrogenes Androgens The androgens are a group of steroids that have anabolic and/or masculinizing effects in both males and females. Testosterone [tess-toss-terone], the most important
More informationCHEMILUMINESCENCE ENZYME IMMUNOASSAY (CLIA) TESTOSTERONE. Testosterone. Cat #
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationCpt code for testosterone cypionate injection
Cpt code for testosterone cypionate injection As the number of people taking injections. Number: 0007. Policy. Aetna considers the diagnosis and treatment of erectile dysfunction (impotence) medically
More informationM0BCore Safety Profile. Pharmaceutical form(s)/strength: 5 mg SE/H/PSUR/0002/006 Date of FAR:
M0BCore Safety Profile Active substance: Finasteride Pharmaceutical form(s)/strength: 5 mg P-RMS: SE/H/PSUR/0002/006 Date of FAR: 16.05.2014 4.3 Contraindications Finasteride is not indicated for use in
More informationThe physiology of normal androgen production in
Mayo Clin Proc, April 2004, Vol 79 (Supplement) Formulations and Use of Androgens S3 Supplement Article Formulations and Use of Androgens in Women MICHELINE C. CHU, MD, AND ROGERIO A. LOBO, MD The physiology
More informationAndrogen deficiency in the aging male
Androgen deficiency in the aging male Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Male Reproduction and Urology The American Society for Reproductive
More informationPersistent depression? Low libido?
Persistent depression? Low libido? 24 Androgen decline may be to blame Cyril decommarque / Photonica Low serum testosterone can often be corrected without using hormones, such as by changing or supplementing
More informationSee 17 for PATIENT COUNSELING INFORMATION and Medication o 50 mg/0.5 ml. Revised: 09/2018 o 100 mg/0.5 ml
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XYOSTED safely and effectively. See full prescribing information for XYOSTED. XYOSTED (testosterone
More informationHormone management of trans men
Blog Managing trans people within a health service Join the discussion: www./blog Hormone management of trans men Jonny Coxon, GP and Clinical Assistant, Endocrinology; Leighton Seal, Consultant Endocrinologist,
More informationRunning head: Extremely low testosterone due to RED-S
AACE Clinical Case Reports Rapid Electronic Articles in Press Rapid Electronic Articles in Press are preprinted manuscripts that have been reviewed and accepted for publication, but have yet to be edited,
More informationSecrets of Abang Sado : Effects of testosterone therapy. Azraai Nasruddin
+ Secrets of Abang Sado : Effects of testosterone therapy Azraai Nasruddin + Testosterone Testosterone : Steroid hormone - Made primarily by the testicles in males - Small amounts produced by the adrenal
More informationAlthough women produce only
For mass reproduction, content licensing and permissions contact Dowden Health Media. Mary Lake Polan, MD, PhD, MPH Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Chair Emeritus,
More informationSubject: Hereditary Angioedema Drug Therapy
09-J1000-08 Original Effective Date: 07/15/09 Reviewed: 01/09/18 Revised: 02/15/19 Subject: Hereditary Angioedema Drug Therapy THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION
More informationAdverse effects of anabolic androgenic steroids abuse on gonadal function, glucose homeostasis and cardiovascular function
Adverse effects of anabolic androgenic steroids abuse on gonadal function, glucose homeostasis and cardiovascular function Associate Professor Caroline Kistorp, Ph.D Department of Internal Medicine, Herlev
More informationMixing Methacholine Dilutions for Bronchoprovocation Challenge Testing
powder for solution, for inhalation Mixing Methacholine Dilutions for Bronchoprovocation Challenge Testing Provocholine is a registered trademark of Methapharm Inc. Copyright Methapharm Inc. 2016. All
More informationw w w. o p t i m a l h e a l t h m d. c o m Optimal Health & Rejuvenation Center, LLC 2007
Optimize your life. LONGEVITY GUIDE TO 2 0 0 7 w w w. o p t i m a l h e a l t h m d. c o m Optimize your life. INTRODUCTION..................................I DO YOU NEED THERAPY?.........................1
More informationCHEMILUMINESCENCE IMMUNOASSAY (CLIA) Testosterone
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationGynaecomastia. Benign breast conditions information provided by Breast Cancer Care
Gynaecomastia This booklet tells you about gynaecomastia. It explains what gynaecomastia is, what causes it, how it s diagnosed and what will happen if it needs to be treated or followed up. Benign breast
More informationUpdates on Anti-doping and TUE Management in Paralympic Sport
International Paralympic Committee Updates on Anti-doping and TUE Management in Paralympic Sport Matthew Fedoruk, Ph.D. March 15, 2018 PyeongChang 2018 IPC Medical / Sports Science Committee Workshops
More informationFINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM
750 West Broadway Street Suite 905 Vancouver, BC M5Z 1K1 FAX: (604) 648-9003 vancouveroffice@donovanmedical.com FINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM What is finasteride? Finasteride
More informationPRODUCT INFORMATION PRIMOTESTON DEPOT. (testosterone enantate)
PRODUCT INFORMATION PRIMOTESTON DEPOT (testosterone enantate) NAME OF THE MEDICINE Testosterone enantate is designated chemically as 17 beta-heptanoyloxy-4-androstene-3- one. The empirical formula of testosterone
More information(12) United States Patent (10) Patent No.: US 8,338,395 B2
USOO8338395 B2 (12) United States Patent () Patent No.: Hubler et al. () Date of Patent: Dec., 2012 (54) METHODS AND PHARMACEUTICAL 4.212,863. A 7, 1980 Cornelius COMPOSITIONS FOR RELIABLE 5,364,632 A
More informationHealth Products Regulatory Authority
1 NAME OF THE VETERINARY MEDICINAL PRODUCT Myodine 25 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Nandrodine laurate 25
More informationPsychology. Psychology & Performance Enhancing Substances. The Ideal Performance State. Relationship Between Confidence and Athletic Performance
Psychology & Performance Enhancing Substances Psychology The Ideal Performance State Absence of fear no fear of failure No thinking about or analysis of performance Narrow focus of attention concentrated
More informationTestosterone for Sale
Testosterone for Sale Testosterone (C 19 H 28 O 2 ) is the male hormone. The brain, the pituitary gland, and the testes must work in perfect harmony to produce adequate amounts of it. If you want to know
More informationPublic Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended
Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Andriol Testocaps, Sustanon and Testosterone Implants [] NL/W/0026/pdWS/001
More informationPackage Leaflet: Information for the patient. Sustanon 250, 250 mg/ml, solution for injection (testosterone esters)
Package Leaflet: Information for the patient Sustanon 250, 250 mg/ml, solution for injection (testosterone esters) Read all of this leaflet carefully before you start using this medicine because it contains
More information