Biopharma

The Changing Specialty Drug Reimbursement Landscape

Advancements in medicine have led to the development of new specialty drugs treating a greater number of rare conditions. In the early 1990s, specialty drugs were limited to a small number of populations, with only 30 drugs available in the market. Presently, more than 400 specialty drugs are available and the developing drug pipelines indicate […]

Building A Market Access Advantage During Early Stage Development

How can pharma companies build market access advantage during early stage development? The market access environment in the US has become tougher than ever for innovative pharma companies with payers and policy makers increasingly scrutinizing the drug prices and demanding cost-effectiveness data to justify the heavy price tags. Therefore, it is of vital importance for […]

Growing Patient Involvement in Health Technology Assessment (HTA)

Health technology assessment (HTA) agencies such as National Institute for Health and Care Excellence (NICE – UK), Scottish Medicines Consortium (SMC – Scotland), Pharmaceutical Benefits Advisory Committee (PBAC – Australia) and Pan-Canadian Oncology Drug Review (pCODR – Canada) have been at the forefront of incorporating user input and feedback in drug reviews. Patient and caregiver […]

Cystic fibrosis: Market shake-up to come?

This article, a Cortellis Market Insight report, is adapted from the author’s comprehensive Cystic Fibrosis Disease Report. Publication of the report coincides with Cystic Fibrosis Awareness Month in May in the U.S. and Canada, which aims to raise awareness and improve understanding of the disease. Cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies have transformed […]

Oncology landscape stays hot for dealmakers

Intense competition for dealmaking in oncology “shows no sign of abating.” That’s the key takeaway from recent analysis developed by Jamie Munro and Helen Dowden, of Clarivate Analytics. Their article, “Oncology dealmaking trends,” was featured in the Biopharma Dealmakers supplement to Nature Biotechnology and Nature Reviews: Drug Discovery. Munro, global practice leader, portfolio and licensing, […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

Virginia and West Virginia Ban Copay Accumulators. What’s Next?

In March 2019, Virginia and West Virginia became the first states in the nation to ban copay accumulators—an increasingly common benefit adjustment that prevents manufacturer drug coupons from paying-down patient deductibles and out-of-pocket maximums. Many employers and managed care organizations adopted these programs for the 2019 benefit year, and more are expected to follow in […]

Boost in Paragraph Four patent challenges drives competitive generics marketplace

Much attention has been given recently to the volume and pace of generic drug approvals by the FDA as that agency has prioritized increasing competition in the market to control costs.  Less attention has been given to the number of first-time Abbreviated New Drug Applications (ANDAs) and the outlook for competition in those generic drug […]

In multiple myeloma, B-cell maturation antigen emerges as promising target

This is a Cortellis Market Insight report, an ongoing series featuring expert reviews of hot topics in the biopharma field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis were gathered from Cortellis from Clarivate Analytics. There remains an unmet need for patients with multiple myeloma (MM), particularly […]

Will Specialty Drug Exclusions by PBM Giants Bring Down Drug Spending for 2019?

Formulary drug exclusion is a well-known utilization tool used by the largest pharmacy benefit managers to control rising drug costs. Besides providing payers and PBMs greater negotiating power with drug manufacturers, formulary exclusion can impact sales revenue of key brands and could force patients to switch their prescription drugs. PBMs Express Scripts and CVS Caremark […]