Highlights from the Current Issue

Cover Story

Stacking Hope Against Dollars

When it comes to treating cancer, physicians pull out all the stops. In the face of escalating and exorbitant costs, though, what works and what doesn’t must be sorted out.
Katherine T. Adams

Copay Subsidies

Payers are struggling to find an appropriate way to respond to copayment subsidies. Aggressive ­tactics to counteract them run the risk of keeping drugs from people who need them.
John Carroll

Cost-Sharing Reform: Searching for Equity

The healthcare reform debate has included discussion of some cost relief for patients by subsidizing their out-of-pocket costs. But employers and payers are looking at other options, such as linking the value of a healthcare intervention to its copayment, to try to improve healthcare delivery and make its cost more equitable for all.
William Atkinson

The Impact of the Patient-Centered Medical Home on the Biologics Industry, Employers, and Third-Party Payers

A strong primary care system is a critical element of healthcare, but its current state is anything but efficient. One promising model of change is the patient-centered medical home.
John Greenwood, MD, and David B. Nash, MD, MBA, FACP

IOM Likes Its CER List; Others Might if It Suits Them

The Institute of Medicine, charged with helping health plans and providers choose best treatments, suggests 100 priorities for CER research interest. The use of biologics or the study of biomarkers make up just 4 of the 100 priorities.
Frank Diamond

Departments

Openers

Ch... Ch... Changes...

Michael D. Dalzell

Editorial

Think Globally, Act Locally

David B. Nash, MD, MBA

Personalized Medicine

KRAS Testing: Optimizing Cancer Therapy

Bob Carlson, MHA

Drug Track

Research, Conferences, and FDA Actions

Specialty Pharmacy

Mixing Personalized Medicine and CER, One Specialty Pharmacy Plows New Ground

John Carroll

Trends

Adherence: A Measure of ROI

Amy Rossi

Latest Biotechnology News

FDA Approves Dalfampridine, Improves Walking in MS Patients

01/25/10 – Acorda Therapeutics, Inc. announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.

Review Period for Erlotinib Application Extended by FDA

01/18/10 – OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for erlotinib (Tarceva) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. The extension follows OSI’s submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010. The companies now anticipate FDA action on the sNDA by April 18, 2010.

FDA Advisory Committee Recommends Expanding Miglustat Use to Niemann-Pick Disease Type C

01/13/10 – Actelion announced that the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted (10 yes to 3 no) in its final vote in question that the benefit/risk profile of miglustat (Zavesca) supports its approval for the treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C (NP-C) disease. NP-C disease is a very rare, relentlessly progressive and eventually fatal neurodegenerative genetic disorder for which no specific treatment is currently approved in the US.

FDA Approves Phase 3 Study Protocol for Angiogenesis Agent

01/12/10 – The U.S. Food and Drug Administration (FDA) has approved the Special Protocol Assessment (SPA) agreement for a Phase 3 clinical trial of its Collategene(TM) angiogenesis product for patients with advanced peripheral arterial disease (PAD). The study will be multinational, randomized and placebo-controlled with a target population of 560 patients.

FDA Approves Tocilizumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

01/11/10 – Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) approved tocilizumab (Actemra) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).