Performance Drug List Dispensing Limits
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2021 National Formulary 3Rd Quarter Edition
2021 National Formulary 3rd Quarter Edition Last Revised: 08/18/2021 Version 2021Q3c Table of Contents OVERVIEW 4 CARDIOVASCULAR (HEART) DRUGS 14 Alpha & Beta Blockers 14 COVERAGE LIMITATION 4 Antihypertensive Combinations 14 Calcium Channel Blockers (CCBs) 14 COMPOUNDED DRUGS 4 ACE Inhibitors without & with Diuretics 15 DRUG PLACEMENT DETERMINATION 4 ACE Inhibitors / CCB Combinations 15 ARBs without & with Diuretics 15 PREFERRED BRAND PRODUCTS 5 ARB Combinations 15 Naprilysin Inhibitors 15 GENERIC SUBSTITUTION 5 Diuretics 15 Renin Inhibtors 16 SINGLE & DUAL SOURCE GENERICS 5 Antiarrhythmics/Anti-Ischemic 16 Cardiac Glycosides 16 PRIOR AUTHORIZATIONS, STEP EDITS & QTY LIMITS 6 Vasodilators, Coronary, Nitrates/Vasodilators, Sympatholytics 16 EXCLUDED DRUGS 6 Other Drugs 16 NON-LISTED DRUGS & DRUG CATEGORIES 7 ANTIHYPERLIPIDEMIC (CHOLESTEROL) DRUGS 17 Statins & Statin/CCB Combinations 17 FORMULARY MODIFICATIONS & CHANGES 7 Bile Acid Sequestrants, Liver Drugs 17 Fibrates 17 BIOSIMILARS 7 ACL Inhibitors 17 Other Drugs 17 MAJOR CHANGES TO THE PDL 7 PANCREATIC DRUGS 18 ANTIBIOTICS 8 Penicillins & Cephalosporins 8 KIDNEY & URINARY / UROLOGICAL DRUGS 18 Tetracyclines 8 Benign Prostate Hyperplasia 18 Macrolides & Clindamycins 8 Urologic Drugs / Other Drugs 18 Sulfonamides, Sulfones & Ketolides 8 Erectile Dysfunction Drugs 18 Quinolones 8 Gout Drugs – Purine Inhibitors 19 Miscellaneous Antibiotics 8 Urinary Ph Modifiers 19 Potassium & Electrolytes 19 ANTI-VIRALS 9 Phosphorus/Calcium/Electrolyte Depleters 19 General Antivirals 9 HIV Antiviral Drugs 9 OSTEOPOROSIS (BONE) DRUGS 20 HIV Pre-Exposure Propylaxis Drugs 9 ANTI-INFLAMMATORY / ANALGESIC (PAIN) DRUGS 20 ANTI-INFECTIVES 10 Anti-Inflammatory Drugs (NSAIDS) 20 Anaerobic Anti-Infectives 10 COX-II Drugs 21 Antiparasitics 10 Analgesics, Narcotics (Opioids) 21 Antimalarials & Antiprotozoals 10 Analgesics, Salicylates, Non-Salicylates, Other 21 Antihelmintic Drugs 10 CENTRAL NERVOUS SYSTEM DRUGS 22 ANTIEMETICS 10 Anti-Anxiety Drugs (Benzodiazepines) 22 Sedative/Sleeping Drugs 22 NEUROLOGIC DRUGS 11 A.D.D. -
January 2021 Update
PUBLISHED JULY 08, 2021 OCTOBER/DECEMBER 2020; JANUARY 2021 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for January 2021. The formularies and pharmaceutical management procedures are updated on a bimonthly basis, and the following changes reflect the decisions made in October, December, and January by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary B. Changes to the Highmark Healthcare Reform Essential Formulary C. Changes to the Highmark Core Formulary D. Changes to the Highmark National Select Formulary E. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Formulary Program 4. Quantity Level Limit (QLL) Programs As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy Program/Formularies link from the menu on the left. Highmark Blue Cross Blue Shield Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides secure, web-based portal between providers and health insurance companies. IMPORTANT DRUG SAFETY UPDATES 03/31/2021 – Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. -
Gonadotropin Therapy in Assisted Reproduction: an Evolutionary Perspective from Biologics to Biotech
REVIEW Gonadotropin therapy in assisted reproduction: an evolutionary perspective from biologics to biotech Roge´rio de Barros F. Lea˜ o, Sandro C. Esteves Andrology & Human Reproduction Clinic (ANDROFERT), Referral Center for Male Reproduction, Campinas/SP, Brazil. Gonadotropin therapy plays an integral role in ovarian stimulation for infertility treatments. Efforts have been made over the last century to improve gonadotropin preparations. Undoubtedly, current gonadotropins have better quality and safety profiles as well as clinical efficacy than earlier ones. A major achievement has been introducing recombinant technology in the manufacturing processes for follicle-stimulating hormone, luteinizing hormone, and human chorionic gonadotropin. Recombinant gonadotropins are purer than urine- derived gonadotropins, and incorporating vial filling by mass virtually eliminated batch-to-batch variations and enabled accurate dosing. Recombinant and fill-by-mass technologies have been the driving forces for launching of prefilled pen devices for more patient-friendly ovarian stimulation. The most recent developments include the fixed combination of follitropin alfa + lutropin alfa, long-acting FSH gonadotropin, and a new family of prefilled pen injector devices for administration of recombinant gonadotropins. The next step would be the production of orally bioactive molecules with selective follicle-stimulating hormone and luteinizing hormone activity. KEYWORDS: Gonadotropins; Ovulation Induction; Assisted Reproductive Techniques; Systematic Review. -
Infertility Therapy Reference Number: CP.CPA.261 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid – Medi-Cal Revision Log
Clinical Policy: Infertility Therapy Reference Number: CP.CPA.261 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid – Medi-Cal Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are gonadotropins requiring prior authorization: Menotropins (Menopur®), Follitropin alpha, recombinant (Gonal-F® RFF), Follitropin beta, recombinant (Follistim®-AQ), Urofollitropin (Bravelle®), Choriogonadotropin alfa (Ovidrel®), Human chorionic gonadotropin (Novarel®, Pregnyl®), Ganirelex acetate, Cetrorelix (Cetrotide®). FDA approved indication Menopur is indicated for development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Gonal-F RFF is indicated: • For induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure. • For development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Follistim AQ is indicated: • In women for: Induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. • In women for: Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle. • In men for: Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure. Bravelle is indicated: • For induction of ovulation in women who have previously received pituitary suppression. • For development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression. -
5.01.610 Pharmacologic Treatment of Infertility
PHARMACY / MEDICAL POLICY – 5.01.610 Pharmacologic Treatment of Infertility Effective Date: Feb. 1, 2021 RELATED MEDICAL POLICIES: Last Revised: Jan. 21, 2021 4.02.503 Infertility and Reproductive Services Replaces: N/A Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction Infertility is a problem or problems with the reproductive system that affects the ability to conceive. Different types of reproductive problems affect men and women, but the end result is the inability to conceive or complete a pregnancy. There are many reasons for infertility and drug options vary depending on the cause of infertility and type of infertility treatment required. Even though drug treatment exists, it does not mean it is covered; the member’s contract determines this. This policy describes when infertility drugs may be considered medically necessary if covered by the member’s contract. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage -
Rxoutlook® 1St Quarter 2019
® RxOutlook 1st Quarter 2020 optum.com/optumrx a RxOutlook 1st Quarter 2020 Orphan drugs continue to feature prominently in the drug development pipeline In 1983 the Orphan Drug Act was signed into law. Thirty seven years later, what was initially envisioned as a minor category of drugs has become a major part of the drug development pipeline. The Orphan Drug Act was passed by the United States Congress in 1983 in order to spur drug development for rare conditions with high unmet need. The legislation provided financial incentives to manufacturers if they could demonstrate that the target population for their drug consisted of fewer than 200,000 persons in the United States, or that there was no reasonable expectation that commercial sales would be sufficient to recoup the developmental costs associated with the drug. These “Orphan Drug” approvals have become increasingly common over the last two decades. In 2000, two of the 27 (7%) new drugs approved by the FDA had Orphan Designation, whereas in 2019, 20 of the 48 new drugs (42%) approved by the FDA had Orphan Designation. Since the passage of the Orphan Drug Act, 37 years ago, additional regulations and FDA designations have been implemented in an attempt to further expedite drug development for certain serious and life threatening conditions. Drugs with a Fast Track designation can use Phase 2 clinical trials to support FDA approval. Drugs with Breakthrough Therapy designation can use alternative clinical trial designs instead of the traditional randomized, double-blind, placebo-controlled trial. Additionally, drugs may be approved via the Accelerated Approval pathway using surrogate endpoints in clinical trials rather than clinical outcomes. -
Kaiser Permanente Bernard J. Tyson School of Medicine, Inc. Exclusive Provider Organization (EPO) Student Blanket Health Plan Drug Formulary
Kaiser Permanente Bernard J. Tyson School of Medicine, Inc. Exclusive Provider Organization (EPO) Student Blanket Health Plan Drug Formulary Effective September 1, 2021 Health Plan Products: Kaiser Permanente Bernard J. Tyson School of Medicine, EPO Student Blanket Health Plan offered by Kaiser Permanente Insurance Company For the most current list of covered medications or for help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit: Call 1-800-533-1833, TTY 711, Monday through Friday, 7 a.m. to 9 p.m. ET Visit kaiserpermanente.org to: • Find a participating retail pharmacy by ZIP code. • Look up possible lower-cost medication alternatives. • Compare medication pricing and options. • Find an electronic copy of the formulary here. • Get plan coverage information. For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit kp.org/kpic-websiteTBD The formulary is subject to change and all previous versions of the formulary are no longer in effect. Kaiser Permanente Last updated: September 1, 2021 Table of Contents Informational Section...........................................................................................................................................3 ANTIHISTAMINE DRUGS - Drugs for Allergy.....................................................................................................9 ANTI-INFECTIVE AGENTS - Drugs for Infections........................................................................................... -
Specialty Guideline Management
SPECIALTY GUIDELINE MANAGEMENT North Carolina State Health Plan: Fertility Agents PROGRAM RATIONALE Client Requested: The intent of the criteria is to ensure that patients follow selection elements established by North Carolina State Health Plan’s Commercial Prior Authorization Approval policy. PRIOR AUTHORIZATION CRITERIA1 • Coverage is provided for female infertility treatment and in males for non-infertility indications. • Coverage is NOT provided for patients using fertility medication in conjunction with any type of Artificial Reproductive Technology (ART) procedure. ART procedures include In Vitro Fertilization (IVF), Gamete Intrafallopian Transfer (GIFT), Zygote Intrafallopian Transfer (ZIFT) and Intrauterine or Artificial Insemination. COVERED FERTILITY AGENTS* Medication Generic Name Covered Indications Gonadotropins Follicle Stimulating Hormone (FSH) Bravelle† urofollitropin . Ovulation induction Follistim AQ follitropin beta . Ovulation induction . Hypogonadotropic hypogonadism in males Gonal-F†/ follitropin alfa . Ovulation induction Gonal-F RFF Pen† . Hypogonadotropic hypogonadism in males (Gonal-F only) Human Chorionic Gonadotropin (hCG) Novarel, Pregnyl, chorionic gonadotropin . Ovulation induction hcG (generic) . Selected cases of hypogonadotropic hypogonadism in males (ie, hypogonadism secondary to a pituitary deficiency) . Prepubertal cryptorchidism Ovidrel choriogonadotropin alfa . Ovulation induction Human Menopausal Gonadotropin (hMG) Menopur menotropin . Ovulation induction Gonadotropin Releasing Hormone (GnRH) Analogs -
ART Drugs Page: 1 of 8
Federal Employee Program® 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.02 Section: Prescription Drugs Effective Date: July 1, 2021 Subsection: Endocrine and Metabolic Drugs Original Policy Date: January 1, 2011 Subject: ART Drugs Page: 1 of 8 Last Review Date: June 17, 2021 ART Drugs Description Bravelle (urofollitropin) Cetrotide (cetrorelix) Clomid, Clomiphene Powder, Serophene (clomiphene citrate) Crinone, Endometrin, Progesterone in Oil, Progesterone Powder, Prometrium (progesterone) Follistim AQ (follitropin beta) Gonal-F, Gonal F RFF (follitropin alfa) Ganirelix (ganirelix) Menopur (menotropins) Milprosa (progesterone) Background Assisted Reproductive Technologies (ART) represent a group of non-coital manipulations and processes that manipulate ova and/or sperm to achieve a pregnancy. The most well-known examples are ovulation induction, intrauterine insemination and in-vitro fertilization. ART and infertility drugs used in conjunction with ART procedures or erectile or sexual dysfunction, weight loss, performance enhancement and anti-aging are not covered benefits. The diagnosis of hypogonadotropic hypogonadism is an off-label indication for these medications. A variety of drugs are used to manipulate the hypothalamic-pituitary-gonadal axis in order to induce ovulation in females known as controlled ovarian hyperstimulation (COH). Some of these pharmacologic agents are used for additional clinical care indications. Drugs Included in Infertility Drugs / ART Criteria • Antagon (ganirelix) – inhibition -
Appendiks Til Marte Myhre Reigstad, Inger Kristin Larsen, Ritsa Storeng
Appendiks til Marte Myhre Reigstad, Inger Kristin Larsen, Ritsa Storeng. Kreftrisiko hos mor og barn etter fertilitetsbehandling. Tidsskr Nor Legeforen 2018; 138. doi: 10.4045/tidsskr.17.1098. Dette appendikset er et tillegg til artikkelen og er ikke bearbeidet redaksjonelt. Ramme 1 Beskrivelse av søkestrengen Søket består av 3 deler; fertilitetsbehandling, risiko, kreft som er kombinert med AND. Det er søkt med kontrollerte emneord (MeSH eller EMTREE), ord i tittel/abstakt /forfatters nøkkelord, kombinert med OR, innenfor de tre delene. EMBASE: artificial insemination/ or embryo disposition/ or exp embryo transfer/ or fertilization in vitro/ or in vitro oocyte maturation/ or intracytoplasmic sperm injection/ or ovulation induction/ or in vitro oocyte maturation/ or intracytoplasmic sperm injection/ or ovulation induction/ or superovulation/ or chorionic gonadotropin/ or clomifene/ or clomifene citrate/ or corifollitropin alfa/ or follitropin/ or gonadotropin/ or human menopausal gonadotropin/ or recombinant chorionic gonadotropin/ or recombinant follitropin/ or recombinant follitropin plus recombinant luteinizing hormone/ or recombinant luteinizing hormone/ or urofollitropin/ or gonadorelin/ or (gonadotropin* or clomifene or clomiphene or corifollitropin* or follitropin* or recombinant luteinizing hormone or urofollitropin* or gonadorelin* or buserelin* or leuprolide or menotropin* or nafarelin* or (fertilization* adj3 vitro) or (fertilisation* adj3 vitro) or (fertilization* adj3 invitro) or (fertilisation* adj3 invitro) or ivf or intracytoplasmic -
Pharmacy Prior Authorization Guideline
Harvard Pilgrim Health Care – Pharmacy Prior Authorization Guideline Guideline Name Gonadotropins and Antigonadotropins: Bravelle (urofollitropin), Cetrotide (cetrorelix), chorionic gonadotropin, Ganirelix, Gonal-F (follitropin alfa), Follistim AQ (follitropin beta), Menopur (menotropin), Novarel (chorionic gonadotropin), Ovidrel (choriogonadotropin alfa), and Pregnyl (chorionic gonadotropin) 1 . Criteria Product Name: Bravelle, Cetrotide, generic chorionic gonadotropin, Ganirelix, Gonal-F, Gonal- F RFF, Menopur, Novarel, Ovidrel, Pregnyl Diagnosis Gonadotropin therapy for females with infertility** Approval Length As requested up to 7 Month(s)* Guideline Type Prior Authorization Approval Criteria 1 - Patient has been approved for infertility services through a Harvard Pilgrim Health Care (HPHC) medical authorization^ Notes ^ The approval duration for formulary infertility medications (authorized by HPHC Pharmacy Benefit) will be approved 1 month prior to the date of the medical infertility services authorization (authorized by HPHC Medical Benefit) plus an additional 6 months unless specified otherwise on PA request (for a total of up to 7 months). *For approvals: Please approve at GPI List Name HPHCMEDIVF. **Some plans EXCLUDE gonadotropin products for infertility and claims will reject as Plan Exclusion: Plan excludes meds for infertility. Product Name: Follistim AQ Diagnosis Gonadotropin therapy for females with infertility** Approval Length As requested up to 7 Month(s) Guideline Type Non-Formulary Approval Criteria 1 - Patient has -
ART Drugs Page: 1 of 6
Federal Employee Program® 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.02 Section: Prescription Drugs Effective Date: January 1, 2020 Subsection: Endocrine and Metabolic Drugs Original Policy Date: January 1, 2011 Subject: ART Drugs Page: 1 of 6 Last Review Date: December 6, 2019 ART Drugs Description Bravelle (urofollitropin), Cetrotide (cetrorelix), Clomid, Clomiphene Powder, Serophene (clomiphene citrate), Crinone, Endometrin, Progesterone in Oil, Progesterone Powder, Prometrium (progesterone), Follistim AQ (follitropin beta), Gonal-F, Gonal F RFF (follitropin alfa), Ganirelix (ganirelix), Eligard, Lupron Depot (leuprolide), Menopur (menotropins) Background Assisted Reproductive Technologies (ART) represent a group of non-coital manipulations and processes that manipulate ova and/or sperm to achieve a pregnancy. The most well-known examples are ovulation induction, intrauterine insemination and in-vitro fertilization. ART and infertility drugs used in conjunction with ART procedures or erectile or sexual dysfunction, weight loss, performance enhancement and anti-aging are not covered benefits. The diagnosis of hypogonadotropic hypogonadism is an off label indication for these medications. A variety of drugs are used to manipulate the hypothalamic-pituitary-gonadal axis in order to induce ovulation in females known as controlled ovarian hyperstimulation (COH). Some of these pharmacologic agents are used for additional clinical care indications. Drugs Included in Infertility Drugs / ART Criteria Antagon