Companies looking to replicate a drug’s EU market success in the US will face significant hurdles unless they are fully aware of the ever-changing national and state requirements and regulations, says Two Labs’ Howard Miller.
As the world’s largest single pharmaceutical market, the US should – at least at first glance – provide a simplified pathway for companies looking for a stateside translation of their successes in Europe’s patchwork quilt of countries. Unfortunately, that’s anything but the case.
In reality, the US provides plenty of hurdles for the unwary with ample consequences. These are counterparts to the different regulations and requirements found across Europe.
Howard Miller is CEO of the Ohio-based strategic consulting and commercialisation firm, Two Labs, a division of Envision Pharma Group.
“When working with EU based pharma manufacturers that are bringing drugs into the US market, there are specific challenges that need addressed,” he notes. “For example, in order to distribute products in the US market you have to obtain a license or waiver from each individual state and all of the states have unique requirements. That process can take more than a year to complete. Further complicating things is that a manufacturer must have identified a third-party logistics partner even before initiating the licensing process. While there may be commonalities in the patients’ need for a drug, the route it takes to get to the patient is different from the EU to the US.”
Amid these regulatory complications, several shifts have occurred within the pharmaceutical space, including the rise of speciality medicine, that require smaller patient populations to be addressed.
“Twenty years ago, the pharmaceutical industry was focused on marketing blockbuster drugs to broad patient populations. Those drugs were distributed through the traditional wholesale/retail channel. Today the market is focused on rare and orphan drugs that are being delivered through a specialty distribution model,” says Howard.
“One of the downstream impacts of this shift is that payers have become much more assertive in managing the utilisation of drugs within the orphan market. This requires a completely different strategy in the US versus the EU.”
There are also key differentiators to consider when choosing a partner in the US, according to Howard, including that a company’s partner should not only have deep subject matter knowledge, but also – and just as importantly, be able to identify the interdependencies between different workstreams.
“Experience in the market is key. Being involved in over three hundred product launches gives us depth in virtually every therapeutic class,” says Howard. “That depth of experience manifests itself in a typical launch plan of 1,500 line items, which we strategise, implement and execute against. What we see all too often is pharma manufacturers engaging with a company to restore their launch plan mid-stream because they felt they were consigned to making less than optimal decisions due to lack of experience and planning from their launch partners. The ultimate consequence of that approach is that unnecessary challenges and costs are foisted upon the patient.”
Whether a company or patient population is large or small, it’s important to understand that compliance aspects of bringing a drug to market in the US are vastly different than in the EU.
“In addition to the licensing issues, manufacturers have to be able to deal with other compliance requirements such Government Price Reporting. This mandates that the manufacturer submit their “best price” to the federal government on a quarterly basis. It is essential that you work with a highly experienced partner because the consequences associated with inaccurate submissions are not only civil but also criminal in nature,” Howard explains.
“Other compliance requirements such as Drug Pricing Transparency are administered by the individual State Boards of Pharmacy. In each case, Two Labs has a distinct team of subject matter experts in their respective areas to assure that we constantly provide best in class support to our clients.”
In 2020, UK-based Envision Pharma Group, a global provider of evidence-based communication services and industry-leading technology solutions, acquired Two Labs, creating an opportunity for the US-based organisation to further expand its portfolio of services they provide to biopharmaceutical companies.
“Being able to partner with Envision, which has a world-class competency in medical communications and medical affairs services lines, and a global presence, makes us a premier partner for manufacturers preparing for a US launch,” says Howard. “Even when only looking at the US market, it’s ideal to contextualise a launch globally. The decisions you’re going to make in one part of the world will impact the other markets you are going to serve.
“While we work with large and mid-size pharma organizations, our true sweet spot is with an emerging manufacturer that is bringing their first product to market. In these cases, we serve as an outsourced commercial launch team for our clients for potentially up to five years. Being able to maintain a team throughout a multi-year engagement is especially key to success.”
Taking a longer-term approach means that the entire team becomes invested in understanding the product, the client team, the competitive landscape and, most importantly, the needs of prospective patients, who might number in the tens or the millions. The promise of cell and gene therapy, in particular, will then provide an opportunity to develop effective, individual solutions for patients.
“As an industry, we need to continue to evolve in order to meet those needs,” says Howard. “While the challenges and requirements to launch a new drug are relatively the same for manufacturers looking to launch first in the US or bring their established EU drug to the US market, there is not a one-size-fits-all solution. The commercialisation strategy should be built for each drug’s journey to market access, curated and customised based on the needs and requirements of payer, prescriber, pharmacy, and patient population for that specific drug.”
Howard Miller is chief executive officer of Two Labs and has over 30 years in the pharma industry. He believes in a patient-centric approach to every client relationship and his company has experience of over 250 new product launches, across retail, specialty treatments, orphan drugs, and cell and gene therapies. Prior to joining Two Labs in 2007, Howard served as VP of sales at the US biotech Novavax.
Two Labs is a leading pharmaceutical services company that provides a portfolio of commercialisation, strategic consulting, and government price reporting services to pharmaceutical manufacturers. Since its inception in 2003, Two Labs has led 200+ new product launches and more than 300 in-market projects from pre-launch to loss of exclusivity. For more information, visit www.twolabs.com.
Founded in 2001, Envision Pharma Group is a global, innovative technology and scientific communications company serving pharmaceutical, biotechnology, and medical device companies. Envision is a leading provider of evidence-based communication services and industry-leading technology solutions (iEnvision) that have applicability across many areas of medical affairs and related functional responsibility. Envision Pharma Group provides services and technology solutions to more than 90 companies, including all of the top 20 pharmaceutical companies. To find out more, visit www.envisionpharmagroup.com.