Featured Health Business Daily Story, Jan. 20, 2014

2014 Outlook: New Drugs in Hepatitis C, MS, Oncology Are Expected This Year

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products.

By Angela Maas, Managing Editor
January 2014Volume 11Issue 1

The specialty pharmacy pipeline has shown no signs of slowing, and 2014 should be no different. Hepatitis C, which has seen four new therapies since 2011, is a category that industry experts expect will remain hot. But other top-spend classes such as oncology, multiple sclerosis (MS) and inflammatory conditions also are likely to gain new therapies over the next year.

“Hepatitis C will be on everyone’s radar in 2014,” says Rachelle Wan, vice president of specialty pharmacy solutions at Prime Therapeutics LLC. “Numerous launches of the next wave of curative agents…will definitely drive spend,” she says, citing last month’s approval of Sovaldi (sofosbuvir), which will cost $1,000 per pill (SPN 12/13, p. 1).

“Drugs in the pipeline will allow for shorter treatment durations and potentially higher cure rates,” Wan tells SPN. “Additionally, we may see the arrival of the first ‘all-oral’ regimens, which would remove pegylated interferons, a previous cornerstone of therapy, from the regimen.”

According to Helen Sherman, Pharm.D., vice president at Solid Benefit Guidance, there are more than 25 potential hepatitis C agents in Phase II and III clinical trials. In addition to providing an all-oral regimen for some genotypes, the drugs are aimed at “shortening treatment courses, treating all genotypes and subpopulations, less toxicity, improving cure rates and re-treating previous treatment failures. The market is expected to substantially expand with additional multiple options in the second half of 2014. Similar to HIV therapy, medications will be used in various combinations or ‘cocktails.’”

Among the oncology drugs will be therapies for chronic lymphocytic leukemia and non-small cell lung cancer, says Beckie Fenrick, Pharm.D., pharmacy practice leader at Cambridge Advisory Group, who adds that oncology is a category “we continue to watch overall. When health plans, government entities and employers are looking at their top spend [categories], typically oncology is in their top three.”

“Within the next six to 10 months, cancer medications and drugs to treat orphan conditions will dominate new drug approvals with several potential new oral and IV drugs to include Boehringer Ingelheim’s nintedanib, the first anticipated drug for treatment of idiopathic pulmonary fibrosis, and Bristol-Myers Squibb’s nivolumab, a novel PD-1 blocking antibody for use with patients with advanced melanoma,” says Stephen Cichy, founder and managing director for Monarch Specialty Group, LLC.

In addition, Cichy tells SPN, “Near-term highlights for 2014 will include the anticipated commercialization of new drugs for inflammatory conditions including Celgene’s apremilast for psoriatic arthritis, Novartis’s secukinumab for psoriasis and rheumatoid arthritis, and Takeda’s vedolizumab for ulcerative colitis.”

Another therapeutic category that tends to be in the top three as far as plans’ specialty spend will see a crowded class get even more crowded. “Starting in 2014, monoclonal antibodies (mAbs) are forecasted to enter the market for multiple sclerosis,” says Sherman. “These mAbs are anticipated to diversify the MS category in terms of targeting treatments for late-stage or aggressive disease. These products are anticipated to offer substantial improvements over current therapies, but safety profiles will need to be established through real-world market experience. The price of these new therapies is expected to be higher than existing options, particularly for the mAbs, but this is unlikely to hinder their uptake for use in patients that have likely failed other conventional treatment options.” Genzyme Corp.’s Lemtrada (alemtuzumab) was among the expected entrants to the class, but the FDA recently refused to approve it (see story, p. 1). Other potential additions, she says, include Teva’s laquinimod, Biogen Idec and Abbott Laboratories’ daclizumab and ocrelizumab from Biogen Idec and Roche.

© 2014 by Atlantic Information Services, Inc. All Rights Reserved.

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