• Chinese (Simplified, PRC)
Payer needs

I recently took part in a panel discussion at the BIO-Europe Spring 2016 international partnering conference. On the panel with me were a representative from an industry association, a patent attorney and a CBO from a biotech. Our task was to discuss the innovation challenge our industry faces.

True innovation in areas of primary care therapy such as hypertension and depression have been difficult, as the so-called ‘low-hanging fruit’ have all gone, and the market is now heavily genericized. However, in other areas, such as the growth in the diseases associated with old age, and the rise in emerging and re-emerging infectious diseases, we are beginning to see the challenge for innovation increase. Meeting these challenges (or making the most of these opportunities) requires new solutions. New solutions to these old and new problems will require innovation beyond a simple pill, for example devices, drug and device combinations, biologics, tailored and personalized medicine, and cell and gene therapies.

Finding new solutions

Smaller biopharma and medtech companies could offer the key to unlock these challenges. They are exciting places to be, bringing innovation from universities and research institutions from the bench and into clinical trials. However, in the midst of the push towards clinical success, these young and focused companies don’t always think about the practicalities of commercialization, from IP protection, through regulatory approval, to pricing, reimbursement and marketing. As these companies approach drug commercialization and market access for the first time, there are three key factors that they need to keep in mind:

  1. Value
  2. Affordability
  3. Practicality.

Confirmation of the value of a new drug is important to all stakeholders, but each has different needs, and companies heading towards commercialization need to bear these different perspectives in mind. As an example, patients are likely to look for increased safety, efficacy and tolerability, whereas payers want cost-effectiveness (and ideally lower costs) and healthcare professionals look for shorter patient stays or easier routes of administration.

Drug budgets are not unlimited, and the budgets are only ever going to get more pressured, as populations age and drugs costs rise. This will create a challenge to companies trying to launch innovative (and often high-price) drugs, especially drugs such as gene therapies that could potentially only be needed once in a lifetime. Companies will need to ensure that they can communicate a message of affordability and cost-effectiveness, irrespective of individual drug cost. One of the solutions to budget pressures could be alternative funding models, such as private payments, co-payment schemes or private health insurance. However, this could be controversial.

Practicality is important. Innovative therapeutics may involve new and unfamiliar devices or delivery routes, or need to be administered by a healthcare professional in a hospital or clinic rather than by the patient at home. As part of the market access development process, companies need to look at how the treatments will fit into the existing healthcare ecosystem, and whether they change the patient pathway.

A word to the wise

There are a few pieces of advice that will help companies new to commercialization find their way through the market access maze.

  1. Start early, during early-to mid-stage clinical trials – understandings about value, affordability and practicality may feed into clinical trial design to improve the resulting data
  2. Spend a lot of time talking to the stakeholders all the way through the value chain, to understand the value and unmet need for providers, physicians, patients, and payers
  3. Get any guidance available, from regulators, healthcare assessment bodies, payers and providers
  4. Start the dialogue about affordability early, especially where disruptive medicines are concerned
  5. Look into accelerated approval pathways – these speed medicines to patients and require fewer participants in clinical trials, but may not supply the data required to back the value proposition
  6. Look into partnerships between industry and providers to create solutions
  7. Understand which markets to prioritize as national reimbursement processes can be unpredictable in terms of timelines and outcome
  8. Be prepared to capitalize on good news, and change direction if needed on bad news

Making a success of the solutions

For the companies that are meeting the challenges of commercialization for the first time, the process of market access can seem complex and daunting. By thinking about it early, talking to the right people, and getting the best help possible, new and innovative drugs can be as successful at the bedside as they are on the bench.

Topics in this blog post: Biopharma, Commercialization, Market Access, Payers