Managed Care

 

The Biologics Wave Has Come Ashore

MANAGED CARE May 2014. © MediMedia USA
The Formulary Files

The Biologics Wave Has Come Ashore

Michael D. Dalzell

For years, payers, benefit-design specialists, and others have talked about the “biologics wave” — a tsunami of costly targeted biologics and other specialty drugs achieving FDA approval. In 2013, the wave crashed ashore.

Of the 27 drugs receiving FDA approval in 2013, 13 are biologics and specialty drugs. A new report from Evaluate Pharma predicts that six will be blockbusters within five years. The authors estimate that, collectively, the six will rack up $17 billion in annual sales by 2018.

6 ‘billion-dollar babies’

Annual sales in 2018 (in billions)

Source: Pharma & Biotech 2013 in Review, Evaluate Pharma, London, March 2014

Sales predictions are based in part on a drug’s potential for expanded labeling. Several of the Big 6 are under study for uses beyond their initial indication:

Out of the pipeline, ready to grow
Approved in 2013 Initial indication Current clinical studies
Sofosbuvir Hepatitis C (HCV) HCV, as part of a fixed-dose combination with ledipasvir (phase 3)a
HCV, as part of a fixed-dose combination with GS-5816 (phase 2)a
Ado-trastuzumab emtansine HER-2+ metastatic breast cancer in previously treated patients HER-2+ metastatic breast cancer in treatment-naïve patients (phase 3)b
Ibrutinib Mantle cell lymphoma Multiple studies of hematological cancersc
Obinutuzumab Treatment naïve patients with chronic lymphocytic leukemia Diffuse large B-cell lymphomab
Front-line indolent non-Hodgkin lymphomab
Refractory indolent non-Hodgkin lymphomab
Front-line chronic lymphocytic leukemiab
Sources: aGilead Sciences; bGenentech; cNational Cancer Institute

Of course, unforeseen events — emergent safety issues that result in market revocation, a patent suit, or FDA rejection of a new indication — mean all sales bets are off.

Meetings

Private Health Insurance Exchanges Conference Washington, D.C. October 7–8, 2014
National Healthcare Facility Management Summit Palm Beach, FL October 16–17, 2014
National Healthcare CFO Summit Las Vegas, NV October 19–21, 2014
National Healthcare CXO Summit Las Vegas, NV October 19–21, 2014
Innovative Member Engagement Operations For Health Plans Las Vegas, NV October 20–21, 2014
4th Partnering With ACOs Summit Los Angeles, CA October 27–28, 2014
2014 Annual HEDIS® and Star Ratings Symposium Nashville, TN November 3–4, 2014
PCMH & Shared Savings ACO Leadership Summit Nashville, TN November 3–4, 2014
World Orphan Drug Congress Europe 2014 Brussels, Belgium November 12–14, 2014
Medicare Risk Adjustment, Revenue Management, & Star Ratings Fort Lauderdale, FL November 12–14, 2014
Healthcare Chief Medical Officer Forum Alexandria, VA November 13–14, 2014
Home Care Leadership Summit Atlanta, GA November 17–18, 2014