On Hold PEGASYS Peginterferon Formulary Submission Dossier

This is a readable CD which includes the following information in PDF:

PEGASYS (Peginterferon Alfa-2a) Learn about therapy, dosing, and safety information, as well as resources for US patients and healthcare professionals.

TABLE OF CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

I: PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

II: USE OF PEGASYS FOR TREATMENT OF CHRONIC HEPATITIS C INFECTION . . . . . 14

III: CLINICAL AND ECONOMIC EFFICACY OF PEGASYS . . . . . . . . . . . . . . . . . . . . . 17

IV: IMPACT MODEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

V: CLINICAL VALUE AND OVERALL COST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

VI: REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

VII: SUPPORTING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

INTRODUCTION

This formulary dossier was prepared according to the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions. Sections I to III of this formulary dossier present clinical information from efficacy and safety evaluations of PEGASYS used as a single agent and as combination therapy with ribavirin.

• Section I includes information found in a typical product monograph.
• Section II includes a description of chronic hepatitis C with approaches to treatment.
• Section III provides a summary of the pivotal safety and efficacy trials. Reprints of the published data are provided in this dossier, when possible. Economic information, which is suggested for inclusion by the AMCP Format for Formulary Submissions, will be included in this dossier at its next revision.
  
  Data on PEGASYS monotherapy and PEGASYS in combination with Roche ribavirin tablets (COPEGUS) for the treatment of chronic hepatitis C in patients with or without cirrhosis, with compensated liver disease, who have not been treated previously with interferon alpha, and who are at least 18 years of age, have been submitted to the FDA for review. Please refer to the complete prescribing information, when available. Any indication not included in the prescribing information is not FDA approved.
  
  Please add $1.50 for shipping/handling in USA. $5.50 for s/h in others.
  
  PayPal, bidpay or Money Order is accepted.
  
  Thanks for looking.