On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective immediately—by almost unanimous vote in September 2018.

While many states have already prohibited the use of these clauses, this is the first such action on a federal level.

Gag clauses are sometimes found in contracts between pharmacies and insurance companies, pharmacy benefit managers or group health plans and bar pharmacists from telling customers that they could save money by paying cash for their prescriptions rather than using their health insurance. If pharmacists violate the gag rule, they risk penalties and/or contract termination. Under the new legislation, pharmacists are not required to tell patients about the lower cost option, but they also cannot be contractually prohibited from engaging in the cost conversation.

The legislation is consistent with the position of the Centers for Medicare & Medicaid Services (CMS), which, in May of this year, issued guidance stating that “gag clauses” are unacceptable in the Medicare Part D program.

WHAT HAPPENED

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC, discussing how to bolster competition from biosimilars while maintaining innovation.

The Commissioner noted the absence of true competition among biologics from biosimilar products in the United States, similarly to what the country experienced 30 years ago with respect to generics. The Commissioner said that this situation is caused, in part, by what he views as anticompetitive practices implemented by branded manufacturers, such as:

  • Rebating schemes in which drug manufacturers bundle discounts to health insurers and employers across different pharmaceutical products;
  • Multi-year contracts granting important rebates to payors, often entered into right before the entry of a biosimilar on the market;
  • Volume-based rebates;
  • Tying rebates, i.e., when rebates are offered if a product is bought together with a biologic;
  • Patent thickets, i.e., when branded manufacturers’ own dense portfolios of overlapping intellectual property rights cover biologics; and
  • Bundling biologics with other products, i.e., when a product is sold together with a biologic.

The Commissioner then introduced a plan (Biosimilars Action Plan) intended to apply some of the lessons learned by the FDA with respect to generic drugs to accelerate competition from biosimilars. He presented the four core action items of the Plan:

  • Improve the efficiency of biosimilars and of the approval process;
  • Maximize scientific and regulatory clarity for companies developing biosimilars;
  • Develop communications to improve understanding of biosimilars among patients, providers and payors; and
  • Reduce tactics implemented by branded manufacturers to unfairly delay market competition.

With respect to this last action item, the Commissioner said that the FDA would work hand in hand with the US Federal Trade Commission (FTC) in order to address perceived anticompetitive behavior. 

WHAT THIS MEANS

Pharmaceutical companies and biotechs should bear in mind that the FTC could start looking more closely at competition among biologics and take action against branded manufacturers who are implementing strategies to delay the entry of biosimilars on the market.

These companies should thus assess their current contracting, discounting and patent protection strategies to ensure that they manage their exposure to antitrust risk.

McDermott is gearing up for an exciting week of programming during the 2018 BIO International Convention. A number of McDermott partners will on the ground as panelists and moderators across a range of programs during BIO and we hope to see you there!

Thursday, May 31 | Al Sokol will moderate a panel discussion on “Getting and Leveraging Funding” at Mass Life Sciences Innovation Day.

Friday, June 1 | Dale Van Demark will co-moderate the panel “Digital Health – Hospital of the Future” during the IBA 6th Annual World Life Sciences Conference.

Saturday, June 2 | Emmanuelle Trombe will moderate the panel, “Biopharmaceutical Market: Collaboration vs. M&A,” and Al Sokol will be a speaker on the panel “Hot Topics in Venture Capital Investments,” during the IBA 6th Annual World Life Sciences Conference.

Sunday, June 3 | Emmanuel Trombe will moderate, and Veleka Peeples-Dyer will be on the panel, “What is Your Regulatory Strategy?” during the Boston-Paris Biotechnology Summit.

Monday, June 4 | Byron Kalogerou and Jennifer Bock will speak to business investors about the legal issues involved with establishing or expanding an operation in the United States during the SelectUSA FDI Seminar at BIO 2018.

Roger Kuan and Kristina Bieker-Brady will present “Operation Valuation: Maximizing the Value of your Asset Portfolio” during the Redefining Early Stage Investments (RESI) Conference.

Tuesday, June 5 | Sarah Hogan will moderate “Paths to Success in Life Sciences: A Conversation with Women Leaders,” a panel discussion with women executives from across the Life Sciences industry. The Women’s Executive Breakfast will be held at McDermott’s Boston office.

Wednesday, June 6 | Join us for “Connecting the Dots: A Cross-Border Mergers and Acquisitions Case Study, Linking Life Sciences Hubs in Europe, Asia and North America.” Our panel, led by Al Sokol, will connect the dots between the structuring and closing of a cross-border life sciences transaction, focusing on a hypothetical case study involving the auction of a US biotech company with platform technology. The panel will discuss the context, cross-border dynamics, practicalities, opportunities and challenges, underlying the growing volume of international life sciences transactions. Register here.

Immediately following, we hope you’ll join us for an evening of live music by Men In Black, fun in the sun, and networking with life sciences executives during the McDermott Beach Bash. RSVP here.

#BIO2018

Specialty pharmacy is not going away any time soon – by 2020, it’s expected that the pharmacy industry’s revenue will exceed $483 billion, with almost all growth as a result of specialty drugs (high-cost medications used to treat chronic conditions, such as cancer). It’s also estimated that the next generation of pharmaceutical “blockbusters” will be primarily specialty products. As the make-up of the pharmaceutical market shifts, we’re also seeing changes with the role of pharmacy benefit managers and other medical groups in the process. How are these shifts in specialty pharmacy impacting the health care system as a whole?

We asked Karen Gibbs, McDermott partner and former VP and Senior Counsel at CVS, to share her expertise on the subject and her thoughts on what’s to come.

Q.  Investments in niche sectors of pharmacy services, specialty pharmacy and pharmacy benefit management have gained huge traction recently. What’s driving the shift away from more traditional pharmacies?   

A.  Traditional pharmacies are retail establishments and have been suffering from the same earnings pressure that all retail establishments have endured. Pharmacy benefit managers (PBMs) typically own mail and specialty pharmacy operations, which generate revenue in a manner complementary to that derived from the pharmacy benefit management services. The margin on specialty pharmacy and PBM services is significantly more than retail pharmacy. Continue Reading Q&A: Shifting Trends in Specialty Pharmacy to Continue in 2018