Bringing biotech innovation to market: 5 steps to accelerated delivery

Next-generation biopharma products are entering the market in growing volumes, meaning that biotechs are in competition with more established pharma companies for market access and the best pricing and reimbursement terms, despite limited resources.

Compared to traditional blockbuster drugs, these novel treatments are more tightly targeted, resulting in a smaller overall market opportunity, and they’re more expensive to develop - costs that must be justified in patient benefits. A robust strategy for market access is essential, then - particularly in Europe given the region’s size, diversity and complexity.

Success will require:

1. A fit-for-purpose market access strategy.

Highly targeted, personalised medicines involving living cells and genes, will invite different parameters for assessing, vetting and commercialising these products. Specific expertise will be required then, to conduct a finely-tuned pharmacoeconomic impact study on the community and communicate the benefits of innovative new therapies and treatments to the various authorities, commissions, payers/insurers and potential financial backers.

Market access support will need to be appropriately tailored to maximise success and secure the best pricing and reimbursement terms for the given company and product type - understanding which countries to target first for the particular treatment, and what it will take to get a dossier to the top of a fast-growing pile for priority investigation at a particular authority.

1. A joined-up strategy for registration & market access.

Applying for marketing authorisation for a new product involves collating a lot of valuable detail. To ensure efficiency, this activity should seamlessly feed into market access strategy, processes and content. Working on the two streams of activity in parallel will focus thinking, strengthen the narrative, accelerate progress and save duplication of effort.

1. A strong core dossier that can be finely tuned for each market.

Although European market access will be approached by country, it’s a good idea to start with a core set of benefits and a core dossier, with around 80 per cent of agreed messaging and content which will be the same for all markets. This can be developed in parallel with marketing authorisation preparations, ensuring close alignment and optimal potential for resource and content sharing.

1. A strong initial target market, based on maximum opportunity.

Commercial strategy teams can then build out the market access dossier for the primary target market (that with the best potential for optimal pricing/reimbursement for the given product), identified based on:

• The size of the given market, in particular its target population of patients with the particular condition/demand for the new treatment;
• The attitude of the local authority towards innovative treatments, and any policies or ‘fast-track’ processes designed to accelerate market access and/or more generously compensate drug developers;
• What’s already in the market and what room there is for a new entrant; and
• The company’s existing activity or relationships (affiliates/partners) in that market, including any plans to manufacture the product locally.

1. A powerful template dossier using the primary country as the model.

With the core dossier already developed, the final finessing can be done with the primary market in mind, drawing on local knowledge – e.g. about the particular priorities and preferences of the given authority’s key decision-makers.

Once the dossier has been approved for the primary country, it can serve as a template for other markets – minimising rework. Again, local experts will be able to help adapt the final 20 per cent of input that is market specific, optimising access and terms in each country.

Clinical & funding factors

Navigating the options will require additional specialist expertise too. This could include advocating the best clinical trial objectives, or gaining access to alternative funding mechanisms or equivalents (e.g. risk/benefit-sharing with the authorities or a hospital or health centre), to bring a new drug to market.

The right strategy and approach, tailored to the needs of biopharma and geared to addressing regulatory/registration and market-access requirements holistically, could prove critical in accelerating delivery of important new treatments to the patients who need them most, so it’s important to hone this from the start.