10 Topics pharma execs were talking about in Q3
Despite deals being few and far between, as well as the usually slow news flow of the summer months, pharmaceutical news continued to trickle out over the third quarter. Three of BioPharma Dive’s five biggest stories of the July through September period were related to drug pricing in some form — whether that meant finding the right price or what drugs third-party payers preferred.
Other major events, including historic drug approvals, huge pipeline restructurings and clinical holds, also dominated the quarter.
Here’s a look at BioPharma Dive’s top 10 stories from the last three months:
Novartis AG gained approval from the Food and Drug Administration for the first CAR-T therapy for the treatment of a rare pediatric cancer. The regulatory agency dubbed Kyrmiah (tisagenlecleucel) the first gene therapy to hit the U.S. market, and the company priced the one-time use drug at $475,000 per patient.
Even though there have been a number of ups and downs for the closely-watched therapeutic area, CAR-T promises to offer a new, revolutionary way to treat cancer — as long as companies can conquer manufacturing challenges and successfully commercialize the drugs.
Pharmacy benefit manager (PBM) Express Scripts released its annual exclusionary list for its 2018 formulary this year, shutting out 64 branded drugs.
More than 45 of the drugs kept off the formulary list have generic or biosimilar competitors on the market. The formulary list gives the PBM power over the market and pricing — companies can lose an edge to competing drugs if a competitor is included and doctors and pharmacies prescribe that drug over their own. These formulary lists also give PBMs power over pricing, providing them leverage to negotiate higher rebates and discounts.
Competing PBM CVS Health released its own formulary list the same week, removing only 17 drugs for 2018. Last year, CVS made biosimilars preferable over their reference product on its formulary, while this year the PBM expects to expand value-based deals to add further benefit for its some 90 million U.S. customers.
Some of the exclusions revolved around the highly competitive type 2 diabetes market, favoring Johnson & Johnson’s SGLT-2 inhibitor Invokana (canagliflozin) over Eli Lilly & Co.’s offering in the space — Jardiance (empagliflozin) and combination therapy Synjardy.
Meanwhile, the outcomes-based deals will revolve around drugs for chronic obstructive pulmonary disease (COPD), non-small cell lung cancer (NSCLC), breast cancer and obesity.
In an effort to defend its hemophilia franchise from a hotly-watched competitor, Shire International plc filed a suit against Swiss pharma Roche AG for allegedly disseminating "inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab," as well as misinformation about "the appropriate management of breakthrough bleeds" related to its once-monthly emicizumab.
While Shire couched the lawsuit in the guise of concern for patient safety, Roche wasn't having it, and called the allegations "categorically false." The Phase 3 drug could potentially head to review by regulators in 2018.
Drug pricing has been top of mind for the last couple of years, as regulators and government officials get pitted against industry execs on how best to handle the problem.
Yet, most people don’t understand the complex ingredients that go into determining the wholesale acquisition cost (WAC) of a drug. Companies insist that these prices aren’t chosen at random, but instead involve years of input from a variety of sources. After all that, they face discount and rebate negotiations with PBMs.
GlaxoSmithKline plc’s new CEO Emma Walmsley isn’t wasting any time trying to bring the British drugmaker back to its former glory. The first woman to helm a big pharma, Walmsley announced during the second quarter earnings call in July that the company would be redirecting resources to clearly defined core therapeutic areas — respiratory, HIV, inflammation and oncology.
Those resources would be shifted away from more than 30 pipeline programs that don’t fit into those core areas or no longer seem to hold commercial potential, including the company’s rare disease offering and its already-marketed gene therapy.
While Novartis gained the first approval in the CAR-T space, other developers have experienced a variety of setbacks. Cellectis announced over the Labor Day holiday weekend that the Food and Drug Administration had put a clinical hold on two of its clinical trials for its gene-edited allogeneic CAR-T therapy following a patient death.
Cellectis said it is working with clinical trial investigators and the FDA to resume the trials with an amended trial protocol that includes a lower dose of UCART123.
These weren't the first patient deaths in the CAR-T universe; both Juno Therapeutics and Kite Pharmaceuticals have reported safety issues as well.
The U.S pharma sales force hit its peak in the early part of the century, with more than 100,000 reps in the field at the time. Now, that numbered has dwindled down to about 70,000. Yet, sales reps still play a pivotal role in how drugs are marketed to physicians.
The advent of digital technologies and big pharma’s shift to rare disease and specialty drugs have fundamentally changed how these agents operate. It has meant fewer physicians are willing to see the reps, and even those still opening doors are spending less time with them.
It started with a tweet from Hillary Clinton and has spiraled dramatically. Now, Congressmen from a variety of states are proposing legislation, companies are making pledges to keep price hikes at a minimum, and new models are being put in place to base rebates on drug performance.
Drug pricing is a topic that has dominated the conversation for the last two years and is unlikely to go away anytime soon. Despite the number of stakeholders putting their two cents in about the issue, solutions still don’t grow on trees.
Fortune magazine put out its annual 'Most Powerful Women' list, highlighting the lack of women in the pharma and biotech industries. Only three women from the industry made the list, including Johnson & Johnson's Group Worldwide Chair Sandra Peterson and Company Group Chairman Jennifer Taubert, as well as Mylan’s CEO Heather Bresch.
What was most striking were the women that didn’t make the list — namely, all of the women of biotech, or big pharma’s first female CEO Emma Walmsley. The list is a telling reminder that the gender gap in the upper ranks of pharma and biotech continues to persist, despite efforts to increase the number of women in the sciences.
Follow Lisa LaMotta on Twitter