Pre-Certification Requirements for Procedures, Programs & Drugs

Total Page:16

File Type:pdf, Size:1020Kb

Pre-Certification Requirements for Procedures, Programs & Drugs Procedures, programs and drugs that require precertification Participating provider precertification list Starting August 1, 2020 Applies to the following plans (also see General information section #1-#4, #9-#10): Aetna® plans, except Traditional Choice® plans All health benefits and insurance plans offered and/or underwritten by Innovation Health plans, Inc., and Innovation Health Insurance Company, except indemnity plans, Foreign Service Benefit Plan, MHBP and Rural Carrier Benefit Plan All health benefits and health insurance plans offered, underwritten and/or administered by the following: Banner Health and Aetna Health Insurance Company and/or Banner Health and Aetna Health Plan Inc. (Banner|Aetna), Texas Health +Aetna Health Insurance Company and/or Texas Health+Aetna Health Plan Inc. (Texas Health Aetna), Allina Health and Aetna Health Insurance Company (Allina Health| Aetna), Sutter Health and Aetna Administrative Services LLC (Sutter Health | Aetna) aetna.com 23.03.882.1 I (8/20) Proprietary For additional information, read all general precertification information Providers may submit most precertification requests electronically through the secure provider website or using your Electronic Medical Record (EMR) system portal (See #1 in the General Information section for more information on precertification). Services that require precertification: 1. Inpatient confinements (except hospice) 18. Nonparticipating freestanding ambulatory For example, surgical and nonsurgical stays, surgical facility services, when referred stays in a skilled nursing facility or rehabilitation by a participating provider facility, and maternity and newborn stays that 19. Orthognathic surgery procedures, bone grafts, osteotomies and surgical exceed the standard length of stay (LOS) (See #5 management of the temporomandibular in the General Information section). joint 2. Ambulance 20. Osseointegrated implant Precertification required for transportation by 21. Osteochondral allograft/knee fixed- wing aircraft (plane) 22. Private duty nursing 3. Autologous chondrocyte implantation 23. Proton beam radiotherapy 4. Chiari malformation decompression surgery Also see Special Programs; Radiation Oncology 5. Cochlear device and/or implantation 24. Reconstructive or other 6. Coverage at an in-network benefit level procedures that maybe for out-of-network provider or facility considered cosmetic, such as: unless services are emergent. • Blepharoplasty/canthoplasty Some plans have limited or no out-of­network • Breast reconstruction/breast enlargement benefits. • Breast reduction/mammoplasty 7. Dental implants • Excision of excessive skin due to weight loss 8. Dialysis visits • Gastroplasty/gastric bypass When a participating provider initiates a • Lipectomy or excess fat removal request and dialysis is to be performed at a • Surgery for varicose veins, except stab phlebectomy nonparticipating facility, call 1-866-752-7021 25. Shoulder Arthroplasty including revision for precertification. Or fax applicable request procedures — precertification required for revision forms to 1-888-267-3277. procedures effective 7/1/2020 26. Spinal procedures, such as: 9. Dorsal column (lumbar) • Artificial intervertebral disc surgery (cervical spine) neurostimulators: trial or implantation • Arthrodesis for spine deformity — precertification 10. Electric or motorized wheelchairs and required effective 7/1/2020 scooters • Cervical laminoplasty 11. Endoscopic nasal balloon dilation procedures 12. Functional endoscopic sinus surgery (FESS) — • Cervical, lumbar and thoracic laminectomy precertification required effective 7/1/2020 and\or laminotomy procedures 13. Gender reassignment surgery • Kyphectomy — precertification required effective 14. Hip surgery to repair impingement syndrome 7/1/2020 15. Hyperbaric oxygen therapy • Laminectomy with rhizotomy 16. Infertility services and pre-implantation • Spinal fusion surgery genetic testing 27. Uvulopalatopharyngoplasty, 17. Lower limb prosthetics, such as including laser- assisted procedures microprocessor-controlled lower limb 28. Ventricular assist devices prosthetics 29. Video electroencephalograph (EEG) 30. Whole exome sequencing Proprietary Drugs and medical injectables Blood-clotting factors (precertification for outpatient infusion of this drug class is required) For the following services, providers should call 1-855-888-9046 for precertification with the following exceptions: • Precertification of pharmacy-covered specialty drugs − For the Foreign Service Benefit Plan, please call Express Scripts at 1-800-922-8279 − For MHBP and the Rural Carrier Benefit Plan, please call CVS/Caremark at 1-800-237-2767 Advate (antihemophilic factor, human recombinant) Ixinity (coagulation factor IX [recombinant]) Adynovate (antihemophilic factor [recombinant], Jivi [antihemophilic factor (recombinant), PEGylated) PEGylated-aucl] Afstyla (antihemophilic factor [recombinant], Koate, Koate-DVI (antihemophilic factor [human]) single chain) Alphanate (antihemophilic factor/von Willebrand Kogenate FS (antihemophilic factor [recombinant]) factor complex [human]) Kovaltry (antihemophilic factor [recombinant]) AlphaNine SD (coagulation factor IX [human]) Monoclate-P (antihemophilic factor [human]) Alprolix (coagulation factor IX [recombinant], Fc Mononine (coagulation factor IX [human]) fusion protein) NovoEight (turoctocog alfa) Bebulin (factor IX complex) NovoSeven RT (coagulation factor VIIa [recombinant]) BeneFix (coagulation factor IX [recombinant]) Nuwiq (simoctocog alfa) Coagadex (coagulation factor X [human]) Obizur (antihemophilic factor [recombinant], Corifact (factor XIII concentrate [human]) porcine sequence) Eloctate (antihemophilic factor [recombinant], Fc Profilnine (factor IX complex) fusion protein) Rebinyn (coagulation factor IX [recombinant], Esperoct [antihemophilic factor (recombinant), glycoPEGylated) glycopegylated-exei] — precertification Recombinate (antihemophilic factor [recombinant]) required effective 4/1/2020 RiaSTAP (fibrinogen concentrate [human]) FEIBA, FEIBA NF (anti-inhibitor coagulant complex) Rixubis (coagulation factor IX [recombinant]) Fibryga (fibrinogen, human) Sevenfact (coagulation factor VIIa [recombinant]­ Helixate FS (antihemophilic factor [recombinant]) jncw) — precertification required effective Hemlibra (emicizumab-kxwh) 7/9/2020 Tretten (coagulation factor XIII a-subunit Hemofil M (antihemophilic factor [human]) [recombinant]) Humate-P (antihemophilic factor/von Willebrand Vonvendi (von Willebrand factor [recombinant]) factor complex [human]) Wilate (von Willebrand factor/coagulation factor Idelvion (antihemophilic factor [recombinant]) VIII complex [human]) Xyntha, Xyntha Solof (antihemophilic factor [recombinant]) Proprietary Other drugs and medical injectables For the following services, providers call 1-866-752-7021 for precertification and fax applicable request forms to 1-888-267-3277, with the following exceptions: • For precertification of pharmacy-covered specialty drugs (noted with *) when the member is enrolled in a commercial plan, call 1-855-240-0535. Or fax applicable request forms to 1-877-269-9916. • Providers can use the drug-specific Specialty Medication Request Form located online under “Specialty Pharmacy Precertification.” • Providers can submit Specialty Pharmacy precertification requests electronically using provider online tools and resources at our provider portal with Aetna. • See our Medicare online resources for moreinformationabout preferred products or to find a precertification fax form. • Providers should use the contacts below for members enrolled in a Foreign Service Benefit Plan, MHBP or RuralCarrierBenefitPlan: − For precertification of pharmacy-covered specialty drugs — Foreign Service Benefit Plan, call Express Scripts at 1-800-922-8279. For MHBP and Rural Carrier Benefit Plan, call CVS/Caremark at 1-800-237-2767. − For precertification of all other listed drugs — Foreign Service Benefit Plan, call 1-800-593-2354. For MHBP, call 1-800-410-7778. For Rural Carrier Benefit Plan, call 1-800-638-8432. Abraxane (paclitaxel) – precertification required for Calcitonin Gene-Related Peptide (CGRP) receptor Medicare Advantage members only inhibitors Acthar Gel/H. P. Acthar (corticotropin) Vyepti (eptinezumab-jjmr) — precertification for the Adakveo (crizanlizumab-tmca) – precertification for drug and site of care required effective 5/28/2020 the drug and site of care required effective Cardiovascular — PCSK9 inhibitors: 2/13/2020 Praluent* (alirocumab) Adcetris (brentuximab vedotin) Repatha* (evolocumab) Alpha 1-proteinase inhibitor (human) Chimeric Antigen Receptor T-Cell Therapy (CAR-T) (precertification for the drug and site of care — Contact National Medical Excellence at required): 1-877-212-8811 Aralast NP (alpha 1-proteinase inhibitor) Kymriah (tisagenlecleucel) Glassia (alpha 1-proteinase inhibitor) Yescarta (axicabtagene ciloleucel) Prolastin-C (alpha 1-proteinase inhibitor) Crysvita (burosumab) — precertification for Zemaira (alpha 1- proteinase inhibitor) the drug and site of care required Amyotrophic Lateral Sclerosis (ALS) drugs: Cyramza (ramucirumab) Radicava (edaravone) — precertification for the Darzalex (daratumumab) drug and site of care required Darzalex Faspro (daratumumab and Avastin (bevacizumab) — precertification required hyaluronidase-fihj) — precertification required effective 7/1/2020 effective 8/6/2020 Aveed (testosterone undecanoate) Dupixent* (dupilumab) Belrapzo (bendamustine HCl) — precertification Empliciti (elotuzumab) required
Recommended publications
  • Spinraza™ (Nusinersen)
    Spinraza™ (nusinersen) (Intrathecal) Document Number: IC-0291 Last Review Date: 08/03/2021 Date of Origin: 01/31/2017 Dates Reviewed: 01/2017, 02/2017, 01/2018, 08/2018, 06/2019, 08/2020, 08/2021 I. Length of Authorization Coverage will be provided annually and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: • Loading: 1 vial on D1, D15, D29, and D59 • Maintenance: 1 vial every 112 days B. Max Units (per dose and over time) [HCPCS Unit]: • Loading: 120 billable units on D1, D15, D29, and D59 • Maintenance: 120 billable units every 112 days III. Initial Approval Criteria1-12 • Submission of medical records related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation via direct upload through the PA web portal or by fax. Coverage is provided in the following conditions: Spinal Muscular Atrophy (SMA) † Ф • Patient must not have previously received treatment with SMA gene therapy (i.e., onasemnogene abeparvovec-xioi); AND • Patient will not use in combination with other agents for SMA (e.g., onasemnogene abeparvovec, risdiplam, etc.); AND • Patient must not have advanced disease (complete limb paralysis, permanent ventilation support, etc.); AND Moda Health Plan, Inc. Medical Necessity Criteria Page 1/5 Proprietary & Confidential © 2021 Magellan Health, Inc. • Patient must have the following laboratory tests at baseline and prior to each administration*: platelet count, prothrombin time; activated
    [Show full text]
  • 2017 ANNUAL REPORT | Translating SCIENCE • Transforming LIVES OUR COMMITMENT Make Every Day Count at PTC, Patients Are at the Center of Everything We Do
    20 YEARS OF COMMITMENT 2017 ANNUAL REPORT | Translating SCIENCE • Transforming LIVES OUR COMMITMENT Make every day count At PTC, patients are at the center of everything we do. We have the opportunity to support patients and families living with rare disorders through their journey. We know that every day matters and we are committed to making a difference. OUR SCIENCE Our scientists are finding new ways to regulate biology to control disease We have several scientific research platforms focused on modulating protein expression within the cell that we believe have the potential to address many rare genetic disorders. OUR PEOPLE Care for each other, our community, and for the needs of our patients At PTC, we are looking at drug discovery and development in a whole new light, bringing new technologies and approaches to developing medicines for patients living with rare disorders and cancer. We strive every day to be better than we were the day before. At PTC Therapeutics, it is our mission to provide access to best-in-class treatments for patients who have an unmet need. We are a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. Founded 20 years ago, PTC Therapeutics has successfully launched two rare disorder products and has a global commercial footprint. This success is the foundation that drives investment in a robust pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. As we celebrate our 20th year of bringing innovative therapies to patients affected by rare disorders, we reflect on our unwavering commitment to our patients, our science and our employees.
    [Show full text]
  • Spinraza® (Nusinersen)
    UnitedHealthcare® Commercial Medical Benefit Drug Policy Spinraza® (Nusinersen) Policy Number: 2021D0059I Effective Date: July 1, 2021 Instructions for Use Table of Contents Page Community Plan Policy Coverage Rationale ....................................................................... 1 • Spinraza® (Nusinersen) Documentation Requirements ...................................................... 3 Applicable Codes .......................................................................... 3 Background.................................................................................... 4 Benefit Considerations .................................................................. 5 Clinical Evidence ........................................................................... 5 U.S. Food and Drug Administration ............................................. 8 References ..................................................................................... 9 Policy History/Revision Information ........................................... 10 Instructions for Use ..................................................................... 11 Coverage Rationale See Benefit Considerations Spinraza® (nusinersen) is proven and medically necessary for the treatment of spinal muscular atrophy (SMA) in patients who meet all of the following criteria: 1-4,22,23 Initial Therapy Diagnosis of spinal muscular atrophy by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; and Submission of medical records (e.g., chart notes, laboratory values)
    [Show full text]
  • DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
    Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic)
    [Show full text]
  • Duchenne Muscular Dystrophy (DMD) Agents
    Therapeutic Class Overview Duchenne muscular dystrophy (DMD) Agents INTRODUCTION • Duchenne muscular dystrophy (DMD) is 1 of 4 conditions known as dystrophinopathies, which are inherited, X-linked myopathic disorders due to a defect in the dystrophin gene that results in the primary pathologic process of muscle fiber degradation. The hallmark symptom is progressive weakness (Darras 2018[a], Darras 2018[b], Muscular Dystrophy Association [MDA] 2019). The other 3 conditions include: Becker muscular dystrophy (BMD), which is a mild form of DMD; an intermediate presentation between BMD and DMD; and DMD-associated dilated cardiomyopathy, which has little or no clinical ○ skeletal or muscle disease (MDA 2019). • DMD symptom onset is in early childhood, usually between the ages of 2 and 3 years old. The proximal muscles are affected first, followed by the distal limb muscles. Generally, the lower external muscles will be affected before the upper. The affected child may have difficulties jumping, walking, and running (MDA 2019). • The prevalence of DMD ranges from 1 to 2 per 10,000 live male births; female-manifesting carriers are rarer, but can present with a range of symptoms that vary in their severities (Birnkrant et al 2018, Darras 2018[a], Emflaza Food and Drug Administration [FDA] Medical Review 2017). • The clinical course and lifespan of patients with DMD is relatively short. Individuals are usually confined to a wheelchair by age 13, and many die in their late teens or twenties from respiratory insufficiency or cardiomyopathy. Although survival until adulthood is more common now, very few patients survive past the 3rd decade (Darras 2018[a]).
    [Show full text]
  • Vyondys 53™ (Golodirsen)
    UnitedHealthcare® Commercial Medical Benefit Drug Policy Vyondys 53™ (Golodirsen) Policy Number: 2021D0088C Effective Date: April 1, 2021 Instructions for Use Table of Contents Page Related Commercial Policy Coverage Rationale ....................................................................... 1 • Provider Administered Drugs – Site of Care Applicable Codes .......................................................................... 2 Background.................................................................................... 2 Community Plan Policy Benefit Considerations .................................................................. 3 • Vyondys 53™ (Golodirsen) Clinical Evidence ........................................................................... 3 U.S. Food and Drug Administration ............................................. 3 References ..................................................................................... 4 Policy History/Revision Information ............................................. 4 Instructions for Use ....................................................................... 4 Coverage Rationale See Benefit Considerations Vyondys 53 (golodirsen) may be covered for the treatment of Duchenne muscular dystrophy (DMD) in patients who meet all of the following criteria: For initial therapy, all of the following: o Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD; and o Submission of medical records (e.g., chart notes, laboratory
    [Show full text]
  • New Brunswick Drug Plans Formulary
    New Brunswick Drug Plans Formulary August 2019 Administered by Medavie Blue Cross on Behalf of the Government of New Brunswick TABLE OF CONTENTS Page Introduction.............................................................................................................................................I New Brunswick Drug Plans....................................................................................................................II Exclusions............................................................................................................................................IV Legend..................................................................................................................................................V Anatomical Therapeutic Chemical (ATC) Classification of Drugs A Alimentary Tract and Metabolism 1 B Blood and Blood Forming Organs 23 C Cardiovascular System 31 D Dermatologicals 81 G Genito Urinary System and Sex Hormones 89 H Systemic Hormonal Preparations excluding Sex Hormones 100 J Antiinfectives for Systemic Use 107 L Antineoplastic and Immunomodulating Agents 129 M Musculo-Skeletal System 147 N Nervous System 156 P Antiparasitic Products, Insecticides and Repellants 223 R Respiratory System 225 S Sensory Organs 234 V Various 240 Appendices I-A Abbreviations of Dosage forms.....................................................................A - 1 I-B Abbreviations of Routes................................................................................A - 4 I-C Abbreviations of Units...................................................................................A
    [Show full text]
  • SPECIALTY MEDICATIONS Available Through Accredo Health Group, Inc., Medco’S Specialty Pharmacy Call Toll-Free (800) 803-2523, 8:00 A.M
    SPECIALTY MEDICATIONS available through Accredo Health Group, Inc., Medco’s specialty pharmacy Call toll-free (800) 803-2523, 8:00 a.m. to 8:00 p.m., eastern time, Monday through Friday, to confirm that your medication is covered. Effective as of July 1, 2011 Abraxane® (paclitaxel protein-bound particles) Berinert® (C 1 esterase inhibitor [human])* (PA) (QD) Actemra ™ (tocilizumab) (PA) Betaseron® (interferon beta-1b) (PA) Actimmune® (interferon gamma-1b) (PA) Botox® (botulinum toxin type A) (PA) Adagen® (pegademase bovine) Carbaglu ™ (carglumic acid) Adcirca® (tadalafil) (ST) (QD) Carimune® NF (immune globulin intravenous [human]) (PA) Advate® (antihemophilic factor [recombinant]) (CPA) Cerezyme® (imiglucerase) (CPA) (ST) Afinitor® (everolimus) (PA) (QD) Cimzia® (certolizumab pegol) (ST) Aldurazyme® (laronidase) (CPA) Copaxone® (glatiramer acetate) (PA) Alphanate® (antihemophilic factor [human]) (CPA) Copegus® (ribavirin) (ST) AlphaNine® SD (coagulation factor IX [human]) (CPA) Corifact® (factor XIII [human]) (CPA) Amevive® (alefacept) (PA) Cystadane® (betaine) Ampyra ™ (dalfampridine) (PA) CytoGam® (cytomegalovirus immune globulin Apokyn® (apomorphine hydrochloride) (PA) (QD) intravenous [human])* (CPA) Aralast® (alpha[1]-proteinase inhibitor [human]) Cytovene® IV (ganciclovir sodium)* Aranesp® (darbepoetin alfa) (PA) Dacogen® (decitabine) Arcalyst® (rilonacept) (PA) (QD) Dysport® (abobotulinumtoxinA) (PA) Arixtra® (fondaparinux sodium)* Egrifta ™ (tesamorelin) (PA) Arranon® (nelarabine) Elaprase® (idursulfase) (CPA) Arzerra® (ofatumumab)
    [Show full text]
  • Refreshing the Biologic Pipeline 2020
    news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease.
    [Show full text]
  • Spotlight on Market Access Actionable Understandings from AIS Health’S In-Depth Coverage
    Spotlight on Market Access Actionable understandings from AIS Health’s in-depth coverage September 16, 2019 Recent Situations Stress That Data Is More Important Than Ever to FDA, Drug Uptake 2 Clinical Trials by Indication: Q2 2019 A pair of drugmakers and the FDA found themselves in the news lately, but it’s safe to say it wasn’t for the reasons they would prefer. Both situations Reality Check: PCSK9 Inhibitors 8 stress the importance of data needed to secure product approvals, and, per- haps, payer and provider uptake. On Aug. 6, the FDA put out a statement addressing “data accuracy issues” with Zolgensma (onasemnogene abeparvovec-xioi), a new gene ther- apy to treat spinal muscular atrophy in people less than 2 years old who have bi-allelic mutations in the survival motor neuron 1 gene, including those who are presymptomatic when diagnosed. The one-time therapy has the distinction of being the most expensive drug in the world, with a price tag of $2.1 million. The FDA approved the drug from AveXis, Inc. on May 24 (SMA 7/1/19, p. 6). On June 28, AveXis — which was acquired by Novartis AG last year — notified the agency that there was “a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals sub- mitted in the biologics license application (BLA) and reviewed by the FDA.” continued on p. 3 Report Reveals That Almost 100 RM/AT Products Are in Phase III Clinical Trials This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy (SMA 7/1/19, p.
    [Show full text]
  • Somatropin Adult Mcp004d
    Subject: Recombinant Human Growth Hormone Original Effective Date: 7/5/2007 (somatropin)_ADULT Growth Hormone Deficiency ° GHD ° HIV/AIDS-associated wasting and cachexia ° Short Bowel Syndrome (SBS) Policy Number: Revision Date(s): 4/28/2010, 4/27/2011, MCP-004-D 3/14/2017 Review Dates: 4/28/2010, 4/27/2011, 3/14/2017, 7/10/2018 DISCLAIMER This Molina Clinical Policy (MCP) is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this MCP document and provide the directive for all Medicare members.
    [Show full text]
  • Increased Dystrophin Production with Golodirsen in Patients with Duchenne Muscular Dystrophy
    Published Ahead of Print on March 5, 2020 as 10.1212/WNL.0000000000009233 ARTICLE OPEN ACCESS CLASS OF EVIDENCE Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy Diane E. Frank, PhD, Frederick J. Schnell, PhD, Cody Akana, BS, Saleh H. El-Husayni, BS, Correspondence Cody A. Desjardins, PhD, Jennifer Morgan, PhD, Jay S. Charleston, PhD, Valentina Sardone, PhD, Dr. Muntoni Joana Domingos, MD, George Dickson, PhD, Volker Straub, MD, Michela Guglieri, Eugenio Mercuri, MD, [email protected] Laurent Servais, PhD, and Francesco Muntoni, MD, on behalf of the SKIP-NMD Study Group Neurology® 2020;00:1-13. doi:10.1212/WNL.0000000000009233 Abstract MORE ONLINE Objective Class of Evidence To report safety, pharmacokinetics, exon 53 skipping, and dystrophin expression in golodirsen- Criteria for rating treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping. therapeutic and diagnostic studies Methods NPub.org/coe Part 1 was a randomized, double-blind, placebo-controlled, 12-week dose titration of once-weekly golodirsen; part 2 is an ongoing, open-label evaluation. Safety and pharmacokinetics were primary and secondary objectives of part 1. Primary biological outcome measures of part 2 were blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry. Results Twelve patients were randomized to receive golodirsen (n = 8) or placebo (n = 4) in part 1. All from part 1 plus 13 additional patients received 30 mg/kg golodirsen in part 2. Safety findings were consistent with those previously observed in pediatric patients with DMD.
    [Show full text]