Time to Market: Accelerating Market Access

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1 unit
Publication Date:
December 2018
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Building the most effective strategy for fast track market access

Getting to market faster clearly has benefits, but there are also potential downsides for drug companies too. You need to know the options and consider the wider implications. The options for faster market access multiplied in the last three years, with new opportunities available both before and after regulatory approval, as well as new ways to speed up the reimbursement process. Deciding the right way forward is more complex than ever before.

This report covers all the options but has focused on talking with the experts who have really achieved faster access and finding out their views on the newest initiatives such as the UK's Early Access to Medicines Scheme (EAMS). It offers a powerful combination of extensive independently researched data plus 'lived experience' from 7 experts who have already gone through the process. Be guided on the following:

  • The latest thinking: Are you fully aware of all of the new opportunities to speed up market access in Europe and the US? Whether you're considering one or multiple territories, get up-to-speed on all your options and find out how you could take advantage.
  • Evaluating various routes: What are the strategic pros and cons for gaining early access before regulatory approval, expediting the regulatory approval process, or speeding up reimbursement? Which option (or options) will best suit your drug and market?
  • Taking a balanced viewpoint: Take a step back and gain a better understanding of the potential negatives further down the line. What possible downsides or unforeseen consequences must you also consider? What should your exit plan be?
  • Cover all bases: Tackle silo thinking with one comprehensive report that gives the full picture from all perspectives whether your team is focused on compassionate use, regulatory approval, or market access.

What to expect from this report

Use this report to identify and evaluate the multitude of options and build a robust plan to best suit your drug. You'll gain detailed insight into the options across the routes to market access: before and after regulatory approval plus faster reimbursement. You'll also find out just which companies and which drugs in which indications have already achieved FDA and EMA expedited approvals from 2015 to 2017—the fastest way to see which competitor products in your therapy area are pushing ahead.

Use Time to Market: Accelerating Market Access to ensure you are taking the right route for your drug and maximising your speed to market.

How did we do it?

  • We identified 30 current issues relating to accelerated market access strategies
  • We explored these via secondary research plus 14 targeted questions put to 7 experts with up-to-date experience
  • We used all of this to identify 51 unique new insights
  • Insights are supported by 62 directly quoted comments

Example insight included in Time to Market: Accelerating Market Access

"Weigh up the costs of EAMS with the benefits. Consider not only the fees for the EAMS scheme but the cost of providing stock at no charge to the NHS, including supply-chain and distribution issues too. Companies will need to consider the whole range of costs and work across departments to make sure that the full costs are considered and that these are not so high as to make EAMS unattractive."

Example insight included in Time to Market: Accelerating Market Access

"Early approval throws the reimbursement process into quite a bit of mayhem. The path you set out on in terms of your clinical data, matching that up to real-world data, and being able to bring forward for budget impact and all the other various models get messed about a bit. It can be difficult to explain to payers why you have changed your trials from being very controlled to more open-label, almost like a Phase IV, ongoing study. You really have no choice in these types of patients in rare diseases, because the benefits are there and can be seen early."

The expert panel for Time to Market: Accelerating Market Access

  • A director working in Market Access and Government Affairs at a biotech company in Italy.
  • A manager working in Market Access at a top 25 pharmaceutical company in Ireland.
  • A senior manager working in Market Access at a top ten pharmaceutical company in the UK.
  • An analyst working in Market Planning and Competitive Intelligence at a small pharmaceutical company in the US.
  • A manager working in Market Access at a top 10 pharmaceutical company in the UK.
  • A director working in Market Access at a small biopharmaceutical company in the UK.
  • A HEOR expert working for a pharmaceutical company covering Europe.

Why buy now?

Accelerating market access isn't a new concept—but the plethora of ways to do so is more complex than ever. It's risky too. This report gives a cool and clear assessment of the pros and cons of each potential route; it's also packed with practical real world experience from experts who have taken this path in the last 3 years. If you are considering any kind of fast track market access strategy, this report will help you decide the best way forward.

Why FirstWord reports are different

  • 100% new content: You won't find old research presented as new. Guaranteed.
  • Opinions you need to hear: We only interview experts with current, relevant experience.
  • Professional researchers: The knowledge, experience and contacts to get the answers you need.