Pre-Certification Requirements for Procedures, Programs & Drugs
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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 -
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. -
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) -
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) -
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]). -
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 -
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 -
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) -
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. -
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. -
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. -
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.