REMS Removed: Why CAR-T’s Expansion into Community Oncology Could Benefit the Big Three Wholesalers

By Greis Kapexhiu and Adam J. Fein, Ph.D.

In June 2025, the FDA announced that CAR-T therapies would no longer be subject to a REMS program.

The FDA’s removal of CAR-T REMS requirements eliminates one obstacle to expanding treatment beyond traditional academic medical centers. That change could disproportionately benefit the Big Three wholesalers, which have spent billions building positions in community oncology while simultaneously investing in cell-and-gene-therapy distribution and support infrastructure.

Read on for our review of this dynamic sector and ponder how wholesalers’ community oncology roll-up activities could interact with their cell and gene therapy (CGT) investments. Will wholesalers capture a growing share of CAR-T’s economics, or will hospitals continue to hold the upper hand?

The State of the Specialty Market 2023: Reflections, Trends, and Photos from #Asembia23

Last week, Paula and I had the pleasure of attending Asembia’s 2023 Specialty Pharmacy Summit at the wonderful Wynn Las Vegas.

As I do every year, I will violate Vegas code and tell you what happened there. I offer reflections on my keynote session with Seema Verma, share my experiences during the featured session, and highlight some crucial specialty industry trends.

You’ll also find a link to my general session slides and some fun photos. FYI, Managed Healthcare Executive (accurately) described my presentation as "mixing jokes with data and PowerPoint slides." Yes, that sounds about right.

Enjoy!

A New JAMA Study Misleads About Drug Prices—And Launches a New Attack on Patients with Ultra-Rare Diseases

Last week, the authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” Their research, along with a simultaneously released New York Times op-ed, received widespread media coverage. Links below.

But as I explain, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.

Most notably, the authors discount the fact that the most expensive new drugs treat ultra-rare conditions affecting extraordinarily small patient populations. Their policy recommendations would therefore have a devastating impact on these patients and their hope for treatments and cures.

As Nobel prize winner Ronald Coase observed: “If you torture the data long enough, it will confess to anything.” Read on and consider what the data are really saying.

Drug Channels News Roundup, December 2021: CAR-T Profits, UM Boom, Health Plans vs. Experts, Confused Physicians, and Health Insurance Explained

Happy New Year, everyone! We made it through a challenging 2021. Ring in 2022 with these noisemakers from the Drug Channels party bag:

• Hospitals earn incredible markups on CAR-T therapies

• Utilization management booms

• Health plans often ignore clinical guidelines

• Benefit designs flummox physicians

Plus: an awesomely concise summary of U.S. health insurance.

P.S. Please join the more than 13,100 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter. You can also find my daily posts on LinkedIn, where I have more than 22,000 followers.

Six Crucial Trends Facing U.S. Drug Wholesalers

During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. Pharmacy and healthcare provider markets experienced unprecedented volatility. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country.

This year has demonstrated the underlying resilience of U.S. distribution channels for prescription drugs. Pharmaceutical wholesalers have maintained shipments and operational capacity. They are now poised to play a vital role in distributing COVID-19 vaccines and therapeutics as they become available. However, there are substantial uncertainties about the timing and level of financial impact on wholesalers’ economics.

Below, I highlight six trends that will affect the U.S. drug wholesaling industry. I hope you enjoy this summary as we look toward the new year.

How Express Scripts Plans to Disrupt the Emerging Cell and Gene Therapy Channel (rerun)

This week, I’m rerunning some popular posts before the holidays. Click here to see the original post and comments from October 2019. Commercial strategies for the new cell and gene therapies will be a hot topic in the coming years. Revisit this article for a look at how one major insurer / PBM / specialty pharmacy is attempting to pre-disrupt the channel.

Express Scripts is on a roll. ICYMI, it will be taking over Prime Therapeutics' formulary contracting and pharmacy network management. Manufacturer rebates will grow, pharmacy margins will be under more pressure, and the gross-to-net bubble will inflate. 

Get ready for more volatility with the DRUG CHANNELS OUTLOOK: WHAT YOU NEED TO WATCH IN 2020. During last week's event, I even discussed PBM consolidation scenarios for sub-scale players like Prime. Click here to hear what you missed and download the slides.

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Cell and gene therapies are poised to transform the treatment of many serious and previously untreatable conditions.

As this new market develops, payers and PBMs are laying the groundwork for disruptive channel models. Below, I examine how Cigna’s Express Scripts business has begun to shape this channel’s development. Its new models show the promise of private market innovation for the financing and commercialization of novel therapies.

These approaches will also shake up existing channels. If payers rub this magic lamp, these innovative channel models would: 1) enhance the role of the vertically-integrated insurer/PBM/pharmacy companies, 2) reduce or eliminate buy-and-bill by providers, and 3) minimize the role of the largest wholesalers. Consider the examples below to be early warnings of change.

FYI: Today’s post is an excerpt from Chapter 6 of our new 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

How Express Scripts Plans to Disrupt the Emerging Cell and Gene Therapy Channel

Cell and gene therapies are poised to transform the treatment of many serious and previously untreatable conditions.

As this new market develops, payers and PBMs are laying the groundwork for disruptive channel models. Below, I examine how Cigna’s Express Scripts business has begun to shape this channel’s development. Its new models show the promise of private market innovation for the financing and commercialization of novel therapies.

These approaches will also shake up existing channels. If payers rub this magic lamp, these innovative channel models would: 1) enhance the role of the vertically-integrated insurer/PBM/pharmacy companies, 2) reduce or eliminate buy-and-bill by providers, and 3) minimize the role of the largest wholesalers. Consider the examples below to be early warnings of change.

FYI: Today’s post is an excerpt from Chapter 6 of our new 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.