DOCSLIB.ORG

Pharma Support Virtual Event Bag

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharma Support Virtual Event Bag #NANETSgoesVirtual PHARMA SUPPORT VIRTUAL EVENT BAG NANETS2020 MULTIDISCIPLINARY NET MEDICAL VIRTUAL SYMPOSIUM OCTOBER 2-3 2020 NANETS Multidisciplinary Net Medical Virtual Symposium - Pharma Support | 1 TABLE OF CONTENTS Diamond Supporters ................................................................... 3 Advanced Accelerator Applications Ipsen Platinum Supporter ..................................................................... 8 SunPharma Gold Supporter .......................................................................... 13 Curium Silver Supporters ....................................................................... 16 ITM Progenics TerSera Bronze Supporter ...................................................................... 34 Entrinsic 2 | 2020 NANETS Multidisciplinary Net Medical Virtual Symposium - Pharma Support DIAMOND SUPPORTERS 2020 NANETS Multidisciplinary Net Medical Virtual Symposium - Pharma Support | 3 The role of LUTATHERA® (lutetium Lu 177 dotatate) in patients with progressive GEP-NETs Presented by: Dr. Eric Liu, MD, FACS General Surgeon Neuroendocrine Specialist The Neuroendocrine Institute, Rocky Mountain Cancer Centers Denver, Colorado INDICATION: LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Click here to watch it online including foregut, midgut and hindgut neuroendocrine tumors in adults.1 IMPORTANT SAFETY INFORMATION1 WARNINGS AND PRECAUTIONS bronchoconstriction or other signs and symptoms of tumor-related hormonal Radiation Exposure: Treatment with LUTATHERA contributes to a patient’s overall release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and long-term cumulative radiation exposure and is associated with an increased risk electrolytes as indicated. for cancer. Radiation can be detected in the urine for up to 30 days following Embryo-Fetal Toxicity: LUTATHERA can cause fetal harm. Advise pregnant women LUTATHERA administration. Minimize radiation exposure to patients, medical of the potential risk to a fetus. Advise females of reproductive potential to use personnel, and household contacts during and after treatment with LUTATHERA effective contraception during treatment and for 7 months after the final dose. Advise consistent with institutional good radiation safety practices, patient management males with female partners of reproductive potential to use effective contraception procedures, Nuclear Regulatory Commission patient-release guidance, and during treatment and for 4 months after the final dose. Verify pregnancy status of instructions to the patient for follow-up radiation protection at home. females of reproductive potential prior to initiating LUTATHERA. Myelosuppression: In NETTER-1 clinical trial, myelosuppression occurred more Risk of Infertility: LUTATHERA may cause infertility in males and females. Radiation frequently in patients receiving LUTATHERA with long acting octreotide at the absorbed by testis and ovaries from the recommended cumulative LUTATHERA following rates (all grades/grade 3 or 4): anemia (81%/0), thrombocytopenia dose falls within the range in which temporary or permanent infertility can be (53%/1%), and neutropenia (26%/3%). Blood cell counts must be monitored prior expected following external beam radiotherapy. to, during, and after treatment. Withhold, reduce dose, or permanently discontinue based on severity of myelosuppression. ADVERSE REACTIONS The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence Secondary Myelodysplastic Syndrome and Leukemia: In NETTER-1, with in LUTATHERA arm) observed in NETTER-1 were lymphopenia (44%), increased a median follow-up time of 24 months, myelodysplastic syndrome (MDS) was GGT (20%), vomiting (7%), nausea (5%), elevated AST (5%), increased ALT (4%), reported in 2.7% of patients receiving LUTATHERA with long-acting octreotide. In hyperglycemia (4%), and hypokalemia (4%). ERASMUS, a Phase I/II clinical study, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to the development of MDS was In ERASMUS, the following serious adverse reactions have been observed with 28 months (9 to 41 months) and 55 months (32 to 155 months) for acute leukemia. a median follow-up time of more than 4 years after treatment with LUTATHERA: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension Renal Toxicity: Treatment with LUTATHERA will expose kidneys to radiation, which (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal may impair renal function. In ERASMUS <1% of patients developed renal failure crisis (1%). Patients should be counseled and monitored in accordance with the 3 to 36 months following LUTATHERA. Monitor serum creatinine and creatinine LUTATHERA Prescribing Information. clearance to assess changes in renal function. Advise patients to urinate frequently during and after administration of LUTATHERA. A concomitant intravenous infusion DRUG INTERACTIONS of amino acids before, during and after LUTATHERA administration is mandatory for Somatostatin and its analogs competitively bind to somatostatin receptors and may renal protection. Patients with baseline renal impairment may be at greater risk of interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each toxicity. Perform more frequent assessments of renal function in patients with mild LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA or moderate impairment. Withhold, reduce dose, or permanently discontinue based treatment as recommended. on severity of renal toxicity. Do not decrease the dose of amino acid solution if the dose of LUTATHERA is reduced. LUTATHERA has not been studied in patients with Corticosteroids can induce down-regulation of subtype 2 somatostatin receptors severe renal impairment (CrCL < 30 mL/min). (SST2). Avoid repeated administration of high doses of glucocorticosteroids during treatment with LUTATHERA. Hepatotoxicity: In ERASMUS, <1% of patients were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic SPECIFIC POPULATIONS congestion and cholestasis. Patients with hepatic metastasis may be at increased Lactation: Because of the potential risk for serious adverse reactions in breastfed risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, infants, advise women not to breastfeed during treatment with LUTATHERA and for and serum albumin during treatment. Withhold, reduce dose, or permanently 2.5 months after the final dose. discontinue based on severity of hepatic impairment. To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Neuroendocrine hormonal crisis: Manifesting with flushing, diarrhea, Applications USA, Inc. at 1-844-863-1930, or [email protected], bronchospasm and hypotension, neuroendocrine hormonal crisis occurred in <1% or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. of patients in ERASMUS and typically occurred during or within 24 hours following the initial LUTATHERA dose. Monitor patients for flushing, diarrhea, hypotension, Please see the full Prescribing Information. 1. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; May 2020. This symposium is organized and sponsored by Advanced Accelerator Applications (AAA), a Novartis company. AAA-Lu177-US-0254 September 2020 TESTED & DEMONSTRATED PREFERENCE IN PRESTO1 SEE WHY PRESTO: LONG-ACTING SSA SYRINGE PREFERENCE STUDY To learn more about Somatuline Depot: A randomized, multinational, multicenter, noninterventional, simulated-use study: MOST NURSES • Objective: The primary objective of this study was to assess the preferences of nurses between theSOMATULINE DEPOT syringe and the SANDOSTATIN LAR DEPOT syringe PREFERRED THE • Participants: Nurses (N=90) with experience administering SOMATULINE DEPOT and SANDOSTATIN LAR • Method: Nurses attended a single testing session, during which they injected injection pads with each type of SOMATULINE DEPOT syringe twice before reporting their preferences. Data were collected using an anonymous, self-administered, Visit SomatulineDepotHCP.com web-based questionnaire 1 • Limitations: Limitations of this study included the need for a change in injection pad after 10 injection sessions SYRINGE due to clogging issues which resulted in 2 separate cohorts, and that the injections performed were simulated. There were imbalances noted in the sociodemographics and the clinical settings of nurses that potentially introduced bias in the reporting of preferences. Another limitation was that IN A SIMULATED-USE STUDY some nurse respondents were from the Contract Research Organizations (CRO) network. No assessment of efficacy or safety should be made based on this study *The Somatuline Depot delivery system was updated in response to feedback, provided by acromegaly and NET patients, nurses, and caregivers, during 4 formative studies regarding the design and functionality of updated delivery device prototypes. The subsequent human factors validation study in 2017 reviewed the use of the updated delivery system by intended users in the intended use environment. Most common errors among HCPs (N=35) were failure to follow correct procedure if the syringe was dropped (34%) and failure to inspect the product before administration (34%); no
Load more

Recommended publications
  • Summary of Drug Limitations Mary C
    RON DESANTIS GOVERNOR SUMMARY OF DRUG LIMITATIONS MARY C. MAYHEW SECRETARY **Medications listed in this document may or may not require a prior authorization. Please view the Preferred Drug List at: http://ahca.myflorida.com/Medicaid/Prescribed_Drug/pharm_thera/fmpdl.shtml** Summary of Drug Limitations Abilify (aripiprazole) 2mg, 5mg, 20mg, 30mg tablets Minimum age = 6; Maximum of 1 tablet per day Abilify (aripiprazole) 10mg, 15mg tablets Minimum age = 6; Maximum of 15mg per day for ages = 6 - 11; Maximum of 30mg per day for ages = 12-17 Maximum of 1 tablet per day Abilify (aripiprazole) Discmelt 10mg, 15mg tabs Minimum age = 6; Maximum of 15mg per day for ages = 6 - 11; Maximum of 30mg per day for ages = 12-17; Maximum of 2 tablets per day Abilify (aripiprazole) 1mg/ml solution Minimum age = 6; Maximum of 15ml per day for ages = 6 - 11; Maximum of 30ml per day for ages = 12-17; Maximum of 30ml per day for ages =/> 18 Abilify Maintena (aripiprazole) syringe/vial Minimum age = 18; Maximum of 1 syringe or vial every 28 days Absorica (isotretinoin) 10mg, 20mg, 25mg,30mg, 35mg, & Minimum age = 12 40mg capsules Abstral (fentanyl citrate) sublingual tablets Minimum age = 18; Maximum of 4 sublingual tablets per day Acanya (benzoyl peroxide/clindamycin)Gel, gel pump Minimum Age= 12 Accolate (zafirlukast) tablets Maximum of 3 tablets per day Aciphex (rabeprazole) 5mg, 10mg sprinkle capsules Minimum age = 1; Maximum age = 11; Maximum of 1 capsule per day Aciphex (rabeprazole) 20mg tablets Minimum age = 1; Maximum of 2 tablets per day Actemra (tocilizumab) 80mg/4ml, 200mg/10ml, Minimum age= 2 400mg/20ml Vials, & 162mg/0.9ml Syringe Actimmune (Interferon Gamma-1b) Maximum of 6ml every 28days Actiq (fentanyl citrate) Lozenges Minimum age = 18; Maximum of 4 lozenges per day Activella (estradiol/norethindrone) tablets Minimum age = 18 Updated 02/28/2019 1 RON DESANTIS GOVERNOR SUMMARY OF DRUG LIMITATIONS MARY C.
    [Show full text]
  • XERMELO™ (Telotristat Ethyl)
    PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 5/18/2017 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: XERMELO™ (telotristat ethyl) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as “Description” defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as “Criteria” defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans.
    [Show full text]
  • Somatostatin Analogues in the Treatment of Neuroendocrine Tumors: Past, Present and Future
    International Journal of Molecular Sciences Review Somatostatin Analogues in the Treatment of Neuroendocrine Tumors: Past, Present and Future Anna Kathrin Stueven 1, Antonin Kayser 1, Christoph Wetz 2, Holger Amthauer 2, Alexander Wree 1, Frank Tacke 1, Bertram Wiedenmann 1, Christoph Roderburg 1,* and Henning Jann 1 1 Charité, Campus Virchow Klinikum and Charité, Campus Mitte, Department of Hepatology and Gastroenterology, Universitätsmedizin Berlin, 10117 Berlin, Germany; [email protected] (A.K.S.); [email protected] (A.K.); [email protected] (A.W.); [email protected] (F.T.); [email protected] (B.W.); [email protected] (H.J.) 2 Charité, Campus Virchow Klinikum and Charité, Campus Mitte, Department of Nuclear Medicine, Universitätsmedizin Berlin, 10117 Berlin, Germany; [email protected] (C.W.); [email protected] (H.A.) * Correspondence: [email protected]; Tel.: +49-30-450-553022 Received: 3 May 2019; Accepted: 19 June 2019; Published: 22 June 2019 Abstract: In recent decades, the incidence of neuroendocrine tumors (NETs) has steadily increased. Due to the slow-growing nature of these tumors and the lack of early symptoms, most cases are diagnosed at advanced stages, when curative treatment options are no longer available. Prognosis and survival of patients with NETs are determined by the location of the primary lesion, biochemical functional status, differentiation, initial staging, and response to treatment. Somatostatin analogue (SSA) therapy has been a mainstay of antisecretory therapy in functioning neuroendocrine tumors, which cause various clinical symptoms depending on hormonal hypersecretion. Beyond symptomatic management, recent research demonstrates that SSAs exert antiproliferative effects and inhibit tumor growth via the somatostatin receptor 2 (SSTR2).
    [Show full text]
  • Multi-Discipline Review(S)
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210828Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-Disciplinary Review and Evaluation (NDA 210828) 505(b)(2) (Ga-68-DOTATOC) NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NME & 505 (b)(2) Application Number(s) NDA 210828 Priority or Standard Standard Submit Date(s) May 23, 2018 Received Date(s) May 23, 2018 PDUFA Goal Date August 23, 2019 Division/Office Office of Drug Evaluation IV/Division of Medical Imaging Products (DMIP/ODEIV) Review Completion Date TBD Established/Proper Name Ga-68-DOTATOC injection (Proposed) Trade Name Not applicable Pharmacologic Class Radioactive diagnostic agent Code name IC2000 Applicant University of Iowa Health Care/P.E.T. Imaging Center Dosage Form Injection: Clear, colorless solution containing 18.5 to 148 MBq/mL (0.5 to 4 mCi/mL) of Ga-68-DOTATOC injection at end of synthesis (EOS) (approximately 14 mL volume) in a 30 mL multiple-dose vial. Applicant proposed Dosing For adults: 148 MBq (4 mCi); for pediatric patients: 1.59 Regimen MBq/kg (0.043 mCi/kg) with a range of 11.1 MBq (0.3 mCi) to 111 MBq (3 mCi) Applicant Proposed For localization of somatostatin receptor positive (b) (4) Indication(s)/Population(s) neuroendocrine tumors (NETs) in (b) (4) adult and pediatric patients. Applicant Proposed Indicated for use with positron emission tomography (PET) for SNOMED CT Indication localization of somatostatin receptor positive neuroendocrine (b) (4) Disease Term for Each tumors (NETs) in adult and pediatric (b) (4) Proposed Indication patients.
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [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]
  • Mississippi Division of Medicaid Universal Preferred Drug List
    MISSISSIPPI DIVISION OF MEDICAID EFFECTIVE 01/01/2021 UNIVERSAL PREFERRED DRUG LIST Version 2021.13a Updated: 8-30-2021 (For All Medicaid, MSCAN and CHIP Beneficiaries) Conduent’s SmartPA Pharmacy Application (SmartPA) is a proprietary electronic prior authorization system used for Medicaid fee for service claims. MSCAN plans may/may not -have electronic PA functionality. However, they must adhere to Medicaid’s PA criteria. THERAPEUTIC PREFERRED AGENTS NON-PREFERRED AGENTS PA CRITERIA DRUG CLASS ACNE AGENTS ANTI-INFECTIVE clindamycin gel (generic Cleocin-T) ACZONE (dapsone) Maximum Age Limit clindamycin lotion AKNE-MYCIN (erythromycin) • 21 years – all agents except clindamycin solution azelaic acid isotretinoins AMZEEQ FOAM (minocycline) AZELEX (azelaic acid) CLEOCIN-T (clindamycin) CLINDAMYCIN PAC (clindamycin) CLINDAGEL (clindamycin) clindamycin foam clindamycin gel daily (generic Clindagel) dapsone ERY (erythromycin) ERYGEL (erythromycin) erythromycin gel, swabs, solution EVOCLIN (clindamycin) KLARON (sulfacetamide) sulfacetamide RETINOIDS RETIN-A (tretinoin) adapalene tretinoin cream AKLIEF (trifarotene) ALTRENO (tretinoin) ARAZLO (tazarotene) ATRALIN (tretinoin) AVITA (tretinoin) DIFFERIN (adapalene) FABIOR (tazarotene) PLIXDA (adapalene) 1 Drug coverage subject to the rules and regulations set forth in Sec. 1927 of Social Security Act.This is not an all-inclusive list of available covered drugs and includes only managed categories. Unless otherwise stated, the listing of a particular brand or generic name includes all dosage forms of that drug. NR indicates a new drug that has not yet been reviewed by the P&T Committee. PREFERRED BRANDS will not count toward the two brand monthly Rx limit. Drugs highlighted in yellow denote a change in PDL status. An * denotes existing users will be grandfathered; grandfathering is defined as approving a Non-Preferred agent for an existing user; all other changes will not qualify for grandfathering.
    [Show full text]
  • Third Quarter 2017 Update
    JULY 2017 THIRD QUARTER 2017 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the Third Quarter 2017 update to the Highmark Drug Formularies and pharmaceutical management procedures. The formularies and pharmaceutical management procedures are updated on a quarterly basis, and the following changes reflect the decisions made in May 2017 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 Progressive Formulary and the Highmark Progressive Healthcare Reform Formulary C. Changes to the Highmark Healthcare Reform Essential Formulary D. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Programs Section II. Highmark Medicare Part D Formularies A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary C. Additions to the Specialty Tier D. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Program 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/Formulary Information link from the menu on the left Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association.
    [Show full text]
  • 2016 Medicines in Development for Rare Diseases a LIST of ORPHAN DRUGS in the PIPELINE
    2016 Medicines in Development for Rare Diseases A LIST OF ORPHAN DRUGS IN THE PIPELINE Autoimmune Diseases Product Name Sponsor Official FDA Designation* Development Status Actemra® Genentech treatment of systemic sclerosis Phase III tocilizumab South San Francisco, CA www.gene.com Adempas® Bayer HealthCare Pharmaceuticals treatment of systemic sclerosis Phase II riociguat Whippany, NJ www.pharma.bayer.com ARA 290 Araim Pharmaceuticals treatment of neuropathic pain in patients Phase II Tarrytown, NY with sarcoidosis www.ariampharma.com ARG201 arGentis Pharmaceuticals treatment of diffuse systemic sclerosis Phase II (type 1 native bovine skin Collierville, TN www.argentisrx.com collagen) BYM338 Novartis Pharmaceuticals treatment of inclusion body myositis Phase III (bimagrumab) East Hanover, NJ www.novartis.com CCX168 ChemoCentryx treatment of anti-neutrophil cytoplasmic Phase II (5a receptor antagonist) Mountain View, CA auto-antibodies associated vasculitides www.chemocentryx.com (granulomatosis with polyangitis or Wegener's granulomatosis), microscopic polyangitis, and Churg-Strauss syndrome * This designation is issued by the FDA's Office of Orphan Products Development while the drug is still in development. The designation makes the sponsor of the drug eligible for entitlements under the Orphan Drug Act of 1983. The entitlements include seven years of marketing exclusivity following FDA approval of the drug for the designated use. Medicines in Development: Rare Diseases | 2016 1 Autoimmune Diseases Product Name Sponsor Official FDA
    [Show full text]
  • First Patient in Phase III Clinical Trial COMPETE with N.C.A.177Lu-Edotreotide (Solucin®) in Cancer Patients with GEP-NET
    Garching, Germany, April 18, 2017 First Patient in Phase III Clinical Trial COMPETE with n.c.a.177Lu-Edotreotide (Solucin®) in Cancer Patients with GEP-NET Solucin® (n.c.a. 177Lu-Edotreotide) to be shown as a highly precise and effective Targeted Radionuclide Therapy Agent Promising data of Solucin® expected to be confirmed in phase III clinical trial COMPETE Solucin® to demonstrate prolonged PFS compared to mTOR inhibitor Everolimus ITM Isotopen Technologien München AG (ITM), a specialized radiopharmaceutical company, today announced the enrollment of the first patient recruited in the COMPETE study, an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of n.c.a.177Lu-Edotreotide (Solucin®) compared to Everolimus in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary endpoint is progression-free survival (PFS). With Solucin® a retrospective phase II efficacy and safety study of Targeted Radionuclide Therapy in patients with advanced neuroendocrine tumors (NET) with encouraging results has been performed. The results suggest and demonstrate a significant benefit, a substantially improved progression-free survival (PFS).1 Therefore Solucin® received an Orphan Designation (EMA/OD/196/13). Due to these favorable data and the long-term experience with n.c.a. 177Lu-Edotreotide under compassionate use, ITM is positive to verify the results in the clinical phase III trial, known as COMPETE. The study will be conducted predominantly in Europe, North America, South Africa and Australia. The first patient has been enrolled and will be treated in Australia. Solucin® is injected into the patient´s body where it specifically accumulates at the tumor.
    [Show full text]
  • Xermelo (Telotristat Ethyl)
    Prior Authorization Criteria Xermelo (telotristat ethyl) Policy Number: C16325-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 7/2019 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J8499 (NOC) RxPA Q1 2021 20210127C16325-A PRODUCTS AFFECTED: Xermelo (telotristat ethyl) DRUG CLASS: Tryptophan hydroxylase inhibitor ROUTE OF ADMINISTRATION: oral PLACE OF SERVICE: Retail Pharmacy AVAILABLE DOSAGE FORMS: 250mg tablets FDA-APPROVED USES: for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Carcinoid syndrome diarrhea REQUIRED MEDICAL INFORMATION: A. CARCINOID SYNDROME DIARRHEA: 1. Documentation of member has a carcinoid/neuroendocrine tumor and has a diagnosis of carcinoid syndrome AND 2. Member has been receiving therapy with the FDA-approved maximum (or highest tolerated) dose of a somatostatin analog therapy (SSA) (i.e., octreotide solution/depot or lanreotide depot) for at least 3 months AND 3. Member will continue to receive this SSA therapy in combination with Xermelo; AND 4. Member has had an inadequate response to antidiarrheals (e.g., loperamide); Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission
    [Show full text]
  • Ongoing and Future Clinical Investigation in GEP Nens
    ESMO PRECEPTORSHIP PROGRAMME Multidisciplinary management, standards of care and future perspectives Lugano, Switzerland 13-14 April 2018 CHAIR: Nicola Fazio, Italy SPEAKERS: Pier Luigi Filosso, Italy George Pentheroudakis, Greece Andrea Frilling, United Kingdom Rocio Garcia-Carbonero, Spain Massimo Milione, Italy Marianne Pavel, Germany Aviral Singh, Germany Anders Sundin, Sweden Christos Toumpanakis, United Kingdom LEARNING OBJECTIVES Ongoing• Toand learn about future best clinical practice clinical in the multid isciplinary management of gastroenteropancreatic (GEP) and thoracic neuroendocrine neoplasms (NEN) patients Oncology investigation in GEP NENs of • To learn about the biological and clinical principles of diagnostic and therapeutic strategy Institute • To understand the importance of terminology, pathological and clinical classification, morphological and functional characterization of disease European Nicola Fazio, M.D., Ph. D. • To learn how to manage the integration of several different therapies in patients with advanced disease • To learn how to apply into clinical practice information coming from medical literature, guidelines and recommendations Division of Gastrointestinal Medical Oncology and ACCREDITATION Neuroendocrine Tumors EuropeanThe programme Institute of this event of has Oncology been accredited with 10 ESMO-MORA category 1 points. RecertificationMilan, is necessary Italy for medical oncologists to remain professionally certified by ESMO. Recertification guarantees that a certified medical oncologist has continued
    [Show full text]