March 2018 – Drug and Device Digest

Market Authorizations: HIZENTRA, ADCETRIS, ILUMYA, ACUMEN Software


HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid

CSL Behring

SUPPLEMENTAL INDICATION: Treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
Limitations of Use: HIZENTRA maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Maintenance therapy beyond these periods should be individualized based upon the patient’s response and need for continued therapy


  • Serious nature of CIDP
  • Clinically clinically meaningful benefits in neurologic function


  • Multicenter, double-blind, randomized, placebo-controlled, parallel-group,  2 different weekly doses of HIZENTRA vs. placebo, n=172
  • Main endpoint: % subjects who had CIDP relapse or withdrawn from study
  • Superiority over placebo: 32.8% for 0.4 g/kg HIZENTRA and 38.6% for 0.2 g/kg HIZENTRA, p<0.001 or p=0.007, respectively


  • Compare favorably to the known and observed risks of Hizentra, which include local infusion site reactions, hypersensitivity reactions, aseptic meningitis, headache, etc., and the remote theoretical risk of adventitious infectious agent transmission


  • First approved in 2010 for  primary humoral immunodeficiency (PI)


  • Medicare, Medicaid, and most insurers cover Hizentra for PI
  • Covered as Medicare Part B benefit with claims considered for payment by the four regional Durable Medical Equipment Medicare Administrative Contractors (DME MACs). Medicaid coverage policy varies by state, payer and provider contract
  • Coverage for supplemental indication: TBD



 ADCETRIS (brentuximab vedotin)

Seattle Genetics, Inc.

INDICATION: Treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy


  • 8,260 people in US diagnosed with Hodgkin lymphoma in 2016; 1,070 patients with non-Hodgkin lymphoma died from disease in 2017
  • Improvement in initial treatment regimens of advanced Hodgkin lymphoma
  • Advancements in treatment that give prescribers and patients different options for care

MECHANISM OF ACTION: Combines antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.


  • Open label, 2 arm trial, Clinical trial comparing Adcetris plus chemotherapy vs. chemotherapy-only regimen common for cHL treatment, n=1,334 patients
  • Primary endpoint: Modified progression-free survival (mPFS)
  • Patients treated with Acteris + chemotherapy were 23% less likely to experience progression, death, or initiation of new therapy


  • Boxed Warning: Risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, or PML
  • Serious risks: Perpheral neuropathy; anaphylaxis or infusion-site reactions; hematologic, pulmonary and hepato-toxicities; serious or opportunistic infections; tumor lysis syndrome; serious dermatologic reactions and gastrointestinal complications
  • Common side effects: Neutropenia, anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting and fever (pyrexia)


  • Previously approved in 2011 to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment
  • This application granted Priority Review and Breakthrough Therapy designations


  • Payor coverage when determined to be medically necessary by meeting predefined medical criteria and guidelines


CaptureILUMYA ( (tildrakizumab-asmn) injection, for subcutaneous use

Merck and Sun Pharma

INDICATION:  Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

MECHANISM OF ACTION: Humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits release of proinflammatory cytokines and chemokines


  • Two multicenter, randomized, double-blind, placebo-controlled trials, n= 926, ILUMYA vs. placebo. Subjects had Physician Global Assessment (PGA) score of ≥3 moderate) on a 5-point scale of overall disease severity, Psoriasis Area and Severity Index (PASI) score ≥12, and a minimum body surface area (BSA) involvement of 10%
  • Improvement in psoriasis-related parameters


  • May increase the risk of infection
  • Adverse reactions: Upper respiratory infections, injection site reactions, diarrhea


  • Required pediatric assessments
  • Postmarket requirements:  Registry-based observational exposure cohort study on maternal, fetal, and infant outcomes of women,  retrospective cohort study using claims or electronic medical record to assess major congenital malformations,  spontaneous abortions, stillbirths etc, observational study of long-term safety



ACUMEN Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences

INDICATION FOR USE: Provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics.

The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made based solely on HPI parameter.

GENERIC DEVICE TYPE: Adjunctive predictive cardiovascular indicator

  • Prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.


  • Delayed or incorrect treatment due to erroneous device output resulting from software malfunction or algorithm error : Software verification, validation, and hazard analysis, Non-clinical performance testing, Clinical performance testing,  Labeling
  • Delayed or incorrect treatment due to user misinterpretation or over-reliance on indicator: Usability assessment, Labeling


  • Software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment
  • Scientific justification for the validity of predictive cardiovascular indicator algorithm(s);  verification of algorithm calculations and validation using an independent data set
  • Human factors and usability engineering assessment to evaluate risk of misinterpretation of device output
  • Clinical data assessment
  • Labeling


  • Regulation Number: 21 CFR 870.2210
  • Regulation Name: Adjunctive predictive cardiovascular indicator
  • Regulatory Class: Class II
  • Product Code: QAQ

REIMBURSEMENT: Will initiate a targeted launch of this first-of-its-kind technology


Image credit: CSL Behring, Seattle Genetics, Merck/Sun, Edwards

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