Market Access: An overnight sensation, 20+ years in the making

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Market access: An overnight sensation, 20+ years in the making

By Megan Hall, Entrée Health.

Market Access, Entree HealthTo say I worked in market access marketing before it was cool is an understatement. In fact, until a few years ago, when I’d tell people (even pharma people and advertising friends) what I did for a living, I’d be met with blank stares. Suddenly though not a moment too soon market access is ultra-hot. Making sure that patients get the benefit of the products that are changing health care has value not just for the brand but for career development.

In its most basic form, market access means ensuring patients can physically get a product. Sounds simple, right?

But for that to happen, a million things must go right: an HCP must believe that not only is this the right product for this patient, but that it will come at a cost the patient can afford (through insurance, coupons, savings programs, free drug, or a myriad other programs). The distributor must get the product from the manufacturing facility to the pharmacy or the HCP office, making sure it stays at the appropriate temperature along the way. The pharmacy must have it in stock and understand how much they’ll be reimbursed for getting it to the patient. If the patient is using insurance, their insurance company needs to have understood the benefits and cost of the product and have chosen to cover it. The patient needs to believe they can afford it and know what help is available to help them do so. The list goes on.

How did we get to a system like this? Market access emerged as a crucial commercial function in the early 2000s as a response to the increasing influence of third-party payers in the U.S. healthcare ecosystem. At that time, the market was dominated by mass-market, primary-care blockbusters with stiff competition. Payers jumped at the chance to influence prescribing habits to help keep costs low for employers and members, and in so doing, they superseded HCPs as the most influential decision makers in health care.

Fast forward 20 years and those blockbusters have lost exclusivity. The revenue and profits they provided to manufacturers have been eroded by generics. But the science supporting personalized medicines, orphan drugs, combination regimens, and cell and gene therapies all crucial medications for much smaller patient populationshas exploded, and manufacturers have shifted their focus accordingly. But even with government incentives and (slightly) reduced R&D timelines granted for tackling healthcare problems for underserved patient populations, the cost to bring a drug to market can still mean an investment of more than $2 billion. Specialty drugs are increasingly targeted and pointed at orphan indications to hedge against these pressures and maximize the value of the portfolio. It’s a perfect storm: small target patient populations + high investment costs + Wall Street pressure to replace blockbuster revenues = high drug prices.

Payers are shifting focus in turn, looking at how to best provide access to cutting-edge health care without bleeding our collective wallets dry. They use the strategies they honed on cholesterol medication and birth control to restrict access to oncolytics and gene therapies. Reference pricing and centralized decision making, models borrowed from Europe, are taking hold in the United States, while abroad, third-party payers are on the rise (as they have dominated in the U.S. for decades). Market access today is about ensuring that suitable patients get through the restrictions while demonstrating products’ clinical, economic, and social value in all segments and to all stakeholders.

The broader social context has had an impact on the market as well. The COVID-19 pandemic increased demand for care that comes to the patient: telemedicine and prescription digital therapeutics are on the rise. Conversations about social justice and historic oppression are part of everyday life, and health equity is a cornerstone of the most forward-
thinking brands’ strategies. Global economic pressures mean that patients should be viewed holistically to ensure things like financial toxicity aren’t impacting care when patients can’t afford food or transportation because they’re paying for their medicines.

Today, working in market access can mean government/regulatory affairs, pricing, health economics, patient support, distribution, pharmacy networks, value communications, data analytics, technology-driven pull-through, stakeholder engagement, market research, and more. It’s an advantage for market access teams at biopharmaceutical manufacturers to work with integrated teams of market access partners who think about a product’s access from an ecosystem perspective rather than in silos. And it’s a lot more fun.

The following is a high-level historical timeline of market access.

2003 – 2008: Expansion and innovation

  • Increased R&D efforts at pharmaceutical companies result in the introduction of breakthrough drugs in a multitude of conditions.
  • Market access focuses on securing regulatory approvals and market authorizations.
  • Companies invest heavily in clinical trials, data generation, and evidence-based medicines.
  • Pharmacy benefit managers (PBMs) start to emerge, bringing formularies, tiering, and contracts into the conversation.
  • Manufacturers seek to change the conversation by offering holistic disease support to payers.
  • Marketing agencies specialize in the creative necessary to support relationships between pharma and payers focused on more than dollars and cents.

2009 – 2012: Cost control and market consolidation

  • The global financial crisis of 2008 leads to cost-containment measures that impact access to medication.
  • Payers and healthcare systems begin expecting evidence of the value and cost-effectiveness of drugs.
  • “Market access” becomes the preferred term for the work being done to eliminate barriers between patients and their prescribed medications.

2013 – 2016: Expanding access to information and products

  • Increasing focus on global health challenges prompts efforts to improve access to essential medicines in developing countries.
  • Initiatives like the Memorial Sloan Kettering drug price “calculator” allow some transparency for patients to understand the value of their drugs.

2017 – 2019: Personalized medicine and value-based pricing

  • Advances in genomic research and precision medicine lead to the emergence of targeted therapies and personalized treatments.
  • Market access strategies begin incorporating value-based pricing models, aligning drug prices with clinical benefits and patient outcomes.
  • Data analytics emerges as a meaningful differentiator in understanding the key determinants of market access success.

2020 – 2023: Digitalization and real-world evidence

  • The COVID-19 pandemic accelerates the adoption of digital health technologies, telemedicine, and remote patient monitoring.
  • Real-world evidence (RWE) gains prominence, leveraging data from electronic health records, wearables, and patient-reported outcomes to inform market access decisions.

2023 and beyond: Streamlined patient, distribution, and reimbursement journeys

  •   To find future commercial success, manufacturers will need to incorporate streamlined, consistent, and comprehensive global market access strategies throughout the product life cycle. These approaches must start long before commercialization: clinical development decisions need to be made with access considerations in mind. They continue well past the loss of exclusivity, as manufacturers must understand the impact of biosimilar competition, authorized generics, controlled distribution networks, and more to maintain the long tail of revenue. At a high level, this means a consolidated, informed approach to three parallel journeys will be needed:
    • The reimbursement journey: to ensure medications will be covered financiallyfrom payer decisions to copay support.
    • The distribution journey: to ensure that drugs physically reach patients through the most appropriate, efficient channels: in-office, in-pharmacy, and in-home.
    • The patient journey: to eliminate (educational, financial, logistical) barriers to access from the time of diagnosis through ongoing treatment.  medadnews
Megan Hall, Entree Health Megan Hall is executive VP and executive creative director at Entrée Health.