Mike Hennessy Jr. is the President and CEO of 

Mike Hennessy Jr.

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The 340B Drug Pricing Program was created by Congress back in 1992 as a way to help vulnerable patients have access to hospital services and more affordable medicines; however, the savings that hospitals are gaining are not always finding their way to the patient via the intended pathway (1). This discrepancy is leading some drug manufacturers to change their drug-discount models.

French drug manufacturer, Sanofi, is the latest to announce their changing plans for drug discounts to certain US hospitals, which will require the institutions seeking the discounted drugs to provide specific information up front (2). “The changes we are making are consistent with the 340B program’s mission ... helping to eliminate prohibited duplicated discounts and diversion of 340B drugs away from eligible patients,” said Sanofi in the news release (2).

Earlier in November, lawsuits were raised by Eli Lilly (3) and Johnson & Johnson (4) against the Health Resources and Services Administration (HRSA) as a result of the government agency’s actions to block their reduced drug price models, which both companies assert will provide greater transparency for drug access. The actions being taken by drug manufacturers to innovate the discounted drug payment structure should not only improve transparency but also help to reduce any potential abuse of the funding received, and these actions, as reported in 

, should be considered by legislators (5).

In a study assessing the cost of the 340B program, IQVIA used a model to quantify the potential financial impact of the drug discount program. Through their analysis, IQVIA found that there are increased costs for self-insured employers and their workers of around 4.2% versus if the program did not exist (6).

Given the outcomes of IQVIA’s analysis and recent litigation cases, the 340B program is under greater scrutiny and reforms are generally expected as a priority. In an interview with the 

, Lindsay Baelor Greenleaf from ADVI Health stated that a Republican-led Congress and Republican White House are more likely to lead to some significant 340B reforms enacted into legislation (7).

1. PhRMA. The 340B Drug Pricing Program. 

 (accessed Nov. 25, 2024).
2. Reuters. Sanofi Plans to Change Hospital Drug-Discount Program. News Release, Nov. 22, 2024.
3. Eli Lilly. Lilly Statement on New 340B Litigation. Press Release, Nov. 14, 2024.
4. Johnson & Johnson. Why Transparency is Critical for Patients. Press Release, Nov. 12, 2024.
5. Numerof, R. Rethinking 340B: Johnson & Johnson’s Bold Challenge to HRSA and What it Means for Healthcare Transparency. 

, Nov. 22, 2024.
6. Sun, C.; Zeng, S.; Martin, R. The Cost of the 340B Program Part 1: Self-Insured Employers. IQVIA White Paper, March 12, 2024.
7. Caffrey, M. The Trump Sequel: What to Expect on PBMs, 340B, Drug Pricing, and RFK Jr. 

Mike Hennessy Jr is president and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Rethinking Drug Pricing. 

Articles

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

Rethinking Drug Pricing

The 2024 fall season has already seen perilous weather conditions impacting many areas of the world, none more so than the southeastern coastal states of the United States. Towards the end of September, the US was hit by Hurricane Helene, which underwent rapid intensification as it traveled over warm ocean waters, and was then swiftly followed by five further hurricanes, including Hurricane Milton (1).

These recent storms have caused significant damage, with major efforts already underway to provide assistance to affected areas. However, for the healthcare industry, there are wider-reaching issues arising from the devastation of the storms.

In North Cove, Marion, NC, Baxter’s largest manufacturing facility was flooded, and bridges accessing the site were damaged, resulting in the facility being forcibly closed. This facility is, in fact, the largest manufacturing site for intravenous and peritoneal dialysis solutions in the US, and its closure has led to nationwide shortages of certain medicines (2).

“Our goal is to begin restarting North Cove production as soon as possible and in phases by the end of this year. We do not yet have a timeline for when we expect production to be fully restored to pre-hurricane levels,” Baxter stated in a progress update press release (3).

Responding to the shortages, FDA has added three new parenteral products to its drug shortages list and released guidance for the temporary compounding of certain parenteral products to help fill any supply gaps. Additionally, FDA is assessing potential imported products to help meet patient needs within the US (4).

However, the disruption being caused by this weather-related emergency should further intensify governmental assessments of the fragility and opacity of the US pharma supply chain—facets that have been under scrutiny for some time (5).

1. Poynting, M.; Dale, B.; Rivault, E.; Rogers, L. How Unusual Has this Hurricane Season Been? 

, Oct. 11, 2024.
2. Baxter. Baxter Provides Update on North Cove, N.C., Facility and Hurricane Helene Relief Plans for Community. Press Release, Sep. 29, 2024.
3. Baxter. Hurricane Helene Updates. Press Release, Oct. 21, 2024.
4. FDA. 

Hurricane Helene: Baxter’s Manufacturing Recovery in North Carolina

Short Supply: The Health and National Security Risks of Drug Shortages

When referring to this article, please cite it as Hennessy, M. Weathering the Storms. 

Recent hurricanes in the US close Baxter plant, shining a spotlight on supply chain fragility again.

Weathering the Storms

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It’s an election year in the United States, and it’s not just the cost of groceries that Americans are concerned with. The cost of medications has been a long-standing debate in the US government. How the Republican and Democrat presidential candidates might appeal to voters on this topic is starting to be seen. But will pharmaceutical companies take a hit?

In the past, according to Allison Gatlin of 

, the previous administration under Donald Trump proposed an approach whereby the Medicare prices for drugs given in doctor’s offices are linked to an international pricing index. There was also a plan to pass rebates to Medicare enrollees that would go to insurers and pharmacy benefit managers (1). If Trump is elected for a second term, it is possible that he could seek to implement the use of international price referencing for prescription drug costs, which had failed to get approval during his first term in office (2).

The current Administration, which includes Democrat presidential nominee, Vice President Kamala Harris, is jumping into the ring by announcing lower prices for the first 10 drugs selected for Medicare price negotiation (3). Medicare can negotiate prescription drug prices as part of the power given to it by the Inflation Reduction Act, which was signed into law by President Biden in August 2022.

Harris has also backed a draft guidance to allow federal agencies to exercise “march-in rights” (4). This guidance, if approved, would mean that federal contractors could retain the rights to patents for innovations developed with federal financial backing. Essentially, this is aimed at enabling greater competition within a specified market, such as healthcare.

However, this is not the first time that market competition has been assessed in the US. In fact, this year sees the 40th anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984, which was created to increase market competition between generic-drug companies and pharmaceutical companies. This Act, according to Darby Kozak, PhD, deputy director for the Center for Drug Evaluation and Research, Office of Generic Drugs, in FDA, resulted in a growth in the generic-drug market, with generic drugs increasing from 19% of the market in 1984 to 90% in 2024 (5).

Whichever way the pendulum swings in November 2024, the bio/pharma industry should probably brace itself for an impact.

1. Gatlin, A. 2024 Election: Drug Prices Remain a ‘Hot Topic’. Can Pharma Stocks Withstand the Pressure? 

2. Cohen, J.P. Trump Plans to Rescind Funds for IRA Law’s Climate Provisions, but May Keep Drug Price Measures. 

FACT SHEET: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation to Lower Costs for Millions of Americans. 

March-In Rights Under the Bayh-Dole Act: Draft Guidance. 

5. FDA. 40th Anniversary of the Generic Drug Approval Pathway. CDER Conversations. 

, Sept. 23, 2024 (accessed Sept. 25, 2024). 

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Drug Prices on Debate. 

How the Republican and Democrat presidential candidates might appeal to voters on this topic is starting to be seen. 

Drug Prices on Debate

On Aug. 14, 2024, the World Health Organization (WHO) declared mpox (previously called monkeypox) as a public health emergency of international concern (PHEIC) as a result of the increasing rates of infection that are being witnessed in African countries (1). The International Health Regulations Emergency Committee of independent experts had advised WHO on the level of concern about the spread of the virus and the potential for the virus to penetrate other continents.

Two years ago, in July 2022, the multi-country outbreak of mpox was also declared a PHEIC; however, after less than a year, in May 2023, that PHEIC was declared over as a sustained decline in global cases was seen (1). A new virus strain of mpox, clade 1b, has emerged and has been rapidly spreading.

When the first PHEIC was declared for mpox in 2022 for a less deadly strain of the virus, the bio/pharma industry went to bat quickly and utilized experience from the COVID-19 pandemic to work efficiently. One of the main players from the 2022 outbreak, Bavarian Nordic, is proving its worth once again, committing to donate 40,000 doses of its mpox vaccine to the Africa Centers for Disease Control and Prevention (2). “Mpox is spreading at an alarming rate in Africa, calling for further action from the international community,” said Paul Chaplin, president and chief executive officer of Bavarian Nordic, in a press release (2).

The 40,000 vaccines from Bavarian Nordic will form part of a larger donation of 215,000 doses that will be provided by the European Commission’s Health Emergency Preparedness and Response Authority (3). However, many more vaccines will be needed, and WHO has triggered the Emergency-Use Listing process for mpox vaccines and started working with countries and vaccine manufacturers on potential donations (1).

“The emergence of a new clade of mpox, its rapid spread in eastern DRC [Democratic Republic of Congo], and the reporting of cases in several neighbouring countries are very worrying,” warned Dr Tedros Adhanom Ghebreyesus, director-general of WHO, in his PHEIC declaration announcement (1). “On top of outbreaks of other mpox clades in DRC and other countries in Africa, it’s clear that a coordinated international response is needed to stop these outbreaks and save lives.”

1. WHO. WHO Director-General Declares Mpox Outbreak a Public Health Emergency of International Concern. Press Release, Aug. 14, 2024.
2. Bavarian Nordic. Bavarian Nordic Receives Order from HERA and Announces Significant Donation of Vaccines in Response to the Mpox Outbreak in Africa. Press Release, Aug. 13, 2024.
3. EC. Mpox: HERA to Donate Over 215,000 Vaccines to Africa CDC Amid Urgent Outbreak. Press Release, Aug. 14, 2024.

When referring to this article, please cite it as Hennessy, M. Responding to Mpox. 

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

Responding to Mpox

This year has indeed been a bountiful year of sport already, with the recent finale to the EURO 2024 soccer competition seeing Spain setting the record for the most titles and the United States co-hosting the T20 World Cup cricket tournament for the first time, to name but a few. However, the most impressive sporting events that have a global audience are the Olympic and Paralympic Games, which are taking place in Paris, France from July 26 until Aug. 11, 2024 and Aug. 28–Sep. 8, 2024, respectively.

Host city Paris has waited 100 years to welcome the Olympic Games back and has never before been the host for the Paralympic Games, which should make for some historic and memorable occasions over the next few months. Sanofi, which is a giant in the field of vaccines and anti-inflammatory treatments, is not usually involved with sporting or cultural events, but has made an exception for the 2024 games being held in the city where the company is headquartered (1).

Younger viewers are increasingly being attracted to watch the games—thanks to the inclusions of sports such as breakdancing and skateboarding—which is something that Sanofi, as a premium sponsor for the 2024 games, hopes to use to its advantage. “We’re using the Olympics to show that we are [cool],” said Josep Catlla, head of corporate affairs at Sanofi, when speaking with Reuters (1).

It is hoped that, through the increased awareness gained from sponsoring the games, the company will be able to attract new talent and remove its conservative image (1). In 2022, Sanofi committed to its ‘ignite the potential in everyone’ campaign for the Paris 2024 games (2). This campaign is aimed at demonstrating the similarities between science and sport, such as overcoming challenges to continue to progress forwards, and to make science inclusive and open to all (3).

We will have to wait and see whether Sanofi’s investment in the Olympics and Paralympics will pay off in the long run with the public or their investors, and whether or not it will be possible to ignite the potential of pharma for the next generation of scientists.

1. Naidu, R.; Burger, L. Drugs Group Sanofi Makes Olympic Jump in Rebrand Bid. Reuters, Jan 10, 2024.
2. Sanofi. Sanofi Commits to Ignite the Potential in Everyone. 

When referring to this article, please cite it as Hennessy, M. Igniting Pharma’s Potential. 

Will Sanofi’s plan to recruit the younger generation through its participation in the upcoming 2024 Olympic and Paralympic Games, being held in Paris, pay off?

Igniting Pharma’s Potential?

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On June 20, 2024, FDA announced that it had expanded its approval of delandistrogene moxeparvovec-rokl (Elevidys), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD), to cover both ambulatory and non-ambulatory DMD patients of four years and older with a confirmed mutation in the DMD gene (1). This expanded approval will allow for a greater number of patients suffering from DMD, which is a rare and serious genetic condition that progresses over time, to be treated. In addition, the expanded approval will help to meet the urgent unmet medical need of this patient population.

The area of rare, difficult-to-treat diseases is where cell and gene therapies truly shine, offering treatment options where there have previously been none and in some cases, even the potential to eliminate the disease altogether. Given the promise of these advanced therapies, it is no wonder that the global market is expected to witness significant double-digit growth over the next few years (2).

However, as the cell and gene therapy sector continues to mature, greater attention is being paid to increasing therapeutic efficacy while also improving patient safety. This particular topic has been explored in this issue’s cover story on pages 10–12 (3), where experts reveal some of the strategic approaches being used to overcome constraints and challenges related to emerging therapies, such as reducing vector tropism to reduce liver damage or regulating the immunoreceptor complex with a dimerizing agent.

As researchers from all over the industry and regulatory bodies continue to focus on their investigations into approaches and strategies to improve not only the therapies themselves, but also methods to test these novel drugs, their efficacy and safety for patients will be optimized, and more unmet medical needs will be fulfilled.

1. FDA. FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy. Press Release, June 20, 2024.
2. Research and Markets. 

Cell and Gene Therapy Global Market Report 2024

. Market Report, February 2024.
3. Mirasol, F. Taking Stock of a Maturing CGT Sector. 

When referring to this article, please cite it as Hennessy, M. With Age Comes Wisdom. 

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.