Browsing “April, 2020 | EVERSANA”

ICER Analysis of Vertex’s 4 CFTR Modulators Hails Benefit of Trikafta but Suggests 73% Discount

Country: UNITED STATES | Region: NORTH AMERICA | Type: Cost Effectiveness | Keywords: #cftrmodulator #clinicaleffectiveness #drugprices #healthbenefitpricebenchmark #icer #value #vertex PRICENTRIC BRIEF: The Institute for Clinical and Economic Review (ICER) published its assessment of the comparative clinical effectiveness and value of Vertex’s four CFTR modulators for cystic fibrosis (CF): Trikafta (elexacaftor/tezacaftor/ivacaftor), Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), and Symdeko (tezacaftor/ivacaftor) David Rind, MD, ICER’s Chief Medical Officer, explained that findings showed Trikafta […]

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Czech Republic Allows Pre-Authorized Use of Zolgensma

Country: CZECH REPUBLIC | Region: EUROPE | Type: Regulation | Keywords: #avexis #chmp #earlyaccess #ema #genetherapy #novartis #pediatrics PRICENTRIC BRIEF: The Ministry of Health is allowing the implementation of a specific treatment program for pre-authorized use of spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec) by AveXis, a Novartis company Zolgensma will be allowed to treat pediatric patients under the age of two with SMA with a survival motor […]

EVERSANA™ launches data & analytics business to drive next-generation integrated commercial services

Company appoints healthcare data & analytics innovator Brigham Hyde, Ph.D. to lead platform launch CHICAGO – April 23, 2020 – EVERSANA™, the leading independent provider of global commercial services to the life sciences industry, today announced the appointment of Brigham Hyde, Ph.D. to President, Data & Analytics (D&A). Hyde will lead the company’s expansion into […]

Japan’s PMDA Evaluates Side Effects of Insulins, Cancer Drugs

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Regulation | Keywords: #astrazeneca #cancer #elililly #insulin #janssen #novonordisk #pmda #sideeffects PRICENTRIC BRIEF: Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is currently investigating new side effect risks for 15 insulins and two cancer drugs The PMDA is examining risks associated with Eli Lilly’s Humalog/Lyumjev (insulin lispro) and Novo Nordisk’s Xultophy (insulin degludec + liraglutide) and Fiasp (insulin aspart) Also under review […]

FDA Grants Priority Review to Merck’s Keytruda, Use Based on Biomarker Regardless of Tumor Type

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #biomarker #fda #immunotherapy #merck #priorityreview PRICENTRIC BRIEF: The application is for Merck’s Keytruda (pembrolizumab) as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment […]

EMA to Mitigate Drug Supply Shortages Through i-SPOC System

Region: EUROPE | Type: Regulation | Keywords: #covid19 #drugshortages #drugsupply #ema #executivesteeringgroup #i-spoc #pharma PRICENTRIC BRIEF: To mitigate supply disruptions, the EU Executive Steering Group of Shortages of Medicines Caused by Major Events, is currently setting up, along with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between the industry and EU Executive Steering Group The […]

Germany to Mandate E-Prescriptions by 2022

Country: GERMANY | Region: EUROPE | Type: Regulation | Keywords: #bill #bmg #cdu #digital #e-prescription #law #pdsg PRICENTRIC BRIEF: The newly formulated paragraph 360 of SGB V of the Patient Data Protection Act (PDSG) says doctors and dentists who participate in contract medical care or prescribe from clinics are obliged only to do so in digital form from January 1, 2022, with some exceptions The obligation does not apply to […]

ICER Indefinitely Postpones Public Meetings for Sickle Cell Disease and Cystic Fibrosis; Expands Other Assessment Timelines Up to Three Months

BOSTON, March 18, 2020 – The Institute for Clinical and Economic Review (ICER) today announced several changes to its timelines for upcoming assessments. ICER’s review process involves significant engagement across a variety of external stakeholders — health care providers, life sciences companies, health insurers, and patient advocacy groups — the same types of organizations that […]