Radar on Drug Benefits

The FDA on Aug. 4 approved Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD), making it the first oral pill available to treat a condition that affects an estimated 500,000 people annually. While that ostensibly would be good news for the drug’s manufacturers — Biogen Inc. and Sage Therapeutics, Inc. — Sage’s shares plummeted amid the FDA’s decision not to approve Zurzuvae for major depressive disorder, which affects a much larger patient population.

That setback, plus the FDA’s addition of a boxed warning that cautions patients not to drive or operate heavy machinery for at least 12 hours after taking Zurzuvae, led analysts to express significant concerns about the sales potential of the drug. Meanwhile, from a coverage standpoint, experts tell AIS Health, a division of MMIT, that rebates will play a significant role in whether payers choose to put the new drug on their formularies.

After the introduction of newly FDA-approved, competing products in their therapeutic classes, the net price growth rate of select medications declined, according to an analysis published in the August issue of Health Affairs. The findings suggest that both “me too” therapies and PBM rebate negotiation might have an important role to play in reducing costs, researchers say.

The study found there was an estimated $10.4 billion reduction in net commercial spending for the existing therapies in the first three years after the introduction of the new medications. The authors noted that represented an 18.5% decline in projected spending on the existing therapies compared with if the new medications had never hit the market.

Brand-name medications introduced from 2013 to 2017 across 12 therapeutic classes reduced net commercial spending by over $10 billion on existing medications, according to a new Health Affairs study.

Entry of new therapeutic competition led to a lower net price growth for 10 of the 12 drugs studied. Four of the medications showed a statistically significant decrease in the growth rate of net prices, including the long-acting insulin Levemir (insulin detemir) and the asthma inhaler Advair (fluticasone/salmeterol). Overall, the introduction of new drugs was associated with a 4.2% decrease in annual net price growth and a 6.8% immediate decrease in the mean net price of the existing drugs.

UnitedHealth Group has promoted Patrick Conway, M.D., to CEO of Optum Rx, the company’s PBM. Conway revealed the new role in a LinkedIn post. He was previously the CEO of Care Solutions at Optum, UnitedHealth’s health care services division. Heather Cianfrocco, Optum Rx’s CEO, is now the president of Optum. Before coming to UnitedHealth, Conway served as CEO of Blue Cross Blue Shield of North Carolina and as director of the Center for Medicare and Medicaid Innovation.

Mark Cuban Cost Plus Drug Co. has formed a partnership with Scripta Insights, a health care software company that works with health plans and self-insured employers to lower pharmacy benefit costs. Scripta plans on integrating the Mark Cuban company’s discounted pricing into its Med Mapper product. Alex Oshmyansky, CEO of Mark Cuban Cost Plus, said the companies “share a common goal of providing consumers the lowest possible price for their prescription medications.” The Mark Cuban company primarily sells generic medications at a discount, but earlier this year it began offering brand-name drugs from Janssen, a division of Johnson & Johnson Co., and IBSA Institut Biochimique SA, a pharmaceutical company based in Switzerland.

Two congressional committees advanced notable PBM legislation, moving one step closer toward comprehensive changes to PBMs’ dominant business model.

The Senate Finance Committee, with a near-unanimous bipartisan majority, advanced a major Medicare- and Medicaid-focused PBM reform bill on July 26. D.C. insiders tell AIS Health, a division of MMIT, that the committee’s move bodes well for notable commercial market PBM reforms. So does the fact that senators of both parties are emphatically in favor of it, despite reluctance by some Republican members of the House of Representatives to make aggressive changes to PBM regulations.