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VIEW UP TO 120 WEEKS OF DATA ON ORKAMBI® (lumacaftor/ivacaftor) FROM TRIALS 1 AND 2 AND EXTENSION STUDY

Lung Function
Safety Profile

Trials 1 & 2 Study Design: Trials 1 and 2 were 24-week, Phase 3, randomized, double-blind, placebo-controlled trials of patients with CF who were homozygous for the F508del mutation and age 12 years and older. The primary endpoint was mean absolute change in percent predicted FEV1 at Week 24. Patients received either ORKAMBI (lumacaftor 400 mg/ivacaftor 250 mg q12h) or placebo and continued to take their prescribed CF therapies.1

Extension Study Design: Patients who completed Trials 1 and 2 were eligible to enroll in a 96-week Extension Study. Of patients from Trials 1 and 2, 340 patients continued to receive ORKAMBI during the Extension Study and 176 rolled over from placebo to ORKAMBI. The primary endpoint was safety of long-term treatment with ORKAMBI.2

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BREAKTHROUGH TREATMENT FOR THE UNDERLYING CAUSE OF CYSTIC FIBROSIS (CF)

ORKAMBI targets the complex protein defects of the F508del-CFTR protein1

Lumacaftor and ivacaftor work directly on the CFTR protein to increase chloride ion transport. In vitro responses do not necessarily correspond to in vivo pharmacodynamic response or clinical benefit.1

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MANAGING THERAPY IN YOUR PATIENTS TAKING ORKAMBI

Discover professional tools to help you initiate conversations with patients taking ORKAMBI

Interactive guides for healthcare providers to help initiate a dialogue on patient beliefs and adherence and patient education.

MEDICATION COVERAGE

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Most common plans by state

Select your patient’s state, then download the PDF to view contact information for some of the most common insurers and Medicaid (current as of 08/2016).

  • A member of your team or the patient can contact his/her payer to verify coverage and out-of-pocket expenses
  • Depending on the patient’s insurance plan, benefits may be administered either through the payer or a Pharmacy Benefits Manager (PBM)
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Vertex GPS™: Guidance and Patient Support

Access and reimbursement support for your eligible patients.

Contact Vertex GPS

Specialty pharmacies distribute ORKAMBI

Authorized Distributors
References:
  1. ORKAMBI [prescribing information]. Boston, MA: Vertex Pharmaceuticals Incorporated; September 2016.
  2. Konstan MW et al. Lancet Respir Med. Published Online December 20, 2016. DOI:10.1016/S2213-2600(16)30427-1.