By Lindsay Lorenzen
VP of Solution Consulting, Norstella
Payers drive an increasingly large portion of the decision-making surrounding patient access. They determine how a drug is placed on formulary, what restrictions should exist, how and when patients qualify, etc., before patients can access a life-saving therapy or treatment.
This means that pharma manufacturers who want their products widely used by patients must take a more proactive approach to obtain the right data, evidence and answers throughout the entire drug development and commercialization process.
It’s also imperative to understand what barriers to access exist and how you can avoid them to set yourself up to successfully develop, launch and market your product. Here are three of the biggest barriers:
The level of investment required to bring a drug to market for pharma is astronomical — one study estimates that drug development ranges from $314 million to $2.8 billion.
With the stakes this high, making the right decisions is crucial. A lack of data, planning, or even a small misstep in your forecast can lead to massive financial losses and deter you from bringing a product to market.
While creating and launching a treatment or therapy is a costly endeavor, you can mitigate financial risks and barriers to patient access by planning earlier in the drug development life cycle. To combat the financial risks created by high costs, it’s essential that pharma manufacturers conduct and analyze extensive price sensitivity studies and forecast models.
Pricing sensitivity studies look across various payers and provide insight into what they are willing to pay depending on the product type. These studies are incredibly impactful during phases two and three, as they deliver timely and necessary answers about market access ahead of regulatory review and manufacturing.
Additionally, forecasting models tell you what sales you can expect by delivering an in-depth look into drugs that launched under similar market conditions, including:
• Its price at launch
• The consensus forecast
• How payers have covered it over time
• How it changed the commercial potential from a future forecast standpoint
The rich data and insights gleaned from both pricing sensitivity studies and forecast models provide the actionable answers needed to maximize sales and improve patient access.
The shift away from blockbuster and generic drugs and the move toward developing specialized drugs for rare diseases or unmet needs has led to an evolving landscape for patient access that affects payers, pharmaceutical manufacturers and patients.
Payers have to regularly reassess their coverage and formulary decisions, forcing them to become more creative in managing plans and get stricter on patient requirements. Payers determine which drugs are covered and how they need to control access to the drug, what tests or documents patients must obtain before gaining approval from the payer to cover the drug, if or when they need reauthorization to continue their therapy, etc. As you can imagine, these barriers can discourage patients from utilizing potentially life-saving drugs–or stop them from being prescribed the right medication in the first place.
For pharma manufacturers, this changing landscape can significantly affect the success of their launch and their revenue goals. Without the right data, information and answers to inform their decisions and strategies, they risk decreased market share, lost revenue and more.
Pharma manufacturers strive to make their therapies more accessible for patients, but it doesn’t come easy. It’s increasingly important for them to have the right intelligence throughout the life cycle to make decisions and shift strategy.
By leveraging analytics on patient access, pharma manufacturers can use these insights to identify patient patterns (i.e., patients dropping the use of their product). These patterns give them the predictive intelligence they need to develop or shift their drug development and commercialization strategy.
Another tactic is to conduct market research with payers ahead of launch. By consulting with a panel of payer decision-makers, manufacturers can glean insight into how payers make decisions to help inform their drug development and go-to-market strategies.
Break down the barriers to patient access with answers you can act on
High costs and a changing definition of patient access have made it increasingly difficult for manufacturers to develop, launch and market their products successfully.
However, smart pharma companies are leveraging tools like predictive analytics, real-world data and machine learning to inform their drug development and commercialization strategies from the outset. As a result, innovative medications get into the hands of patients much quicker.
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