Balancing Pharmaceutical Reimbursement & Market Access: 5 Steps to Success
This article is supported by D2's market access team.
The success of a prescription drug hinges on market access.
Pharmaceutical and biotechnology companies often struggle to ensure that the right treatments reach the right patients at the right prices. This process requires careful planning and execution to be effective - a true market access strategy.
Understanding Market Access Strategy
Market access strategy is complex and requires a large allocation of resources to properly navigate.?Strategizing market access involves generating critical data (ranging from market information and pricing to patient utilization) and communicating that data to the appropriate parties, including both private payers and government programs. Market access strategies can also have major long-term implications on patient experience, such as patients having rapid and sustained access to their medications for as long as they need.
One vital component of these market access strategies is pricing and reimbursement rates as they have a profound impact on profitability. The challenge is finding the right balance in pricing so that therapies are appealing to private and public insurers while remaining profitable throughout their lifecycle. Arguably, lower drug prices might mean greater adoption by insurers, while higher prices might prevent patients from being able to afford and purchase drugs.
Many larger manufacturers navigate these processes on their own, typically having in-house teams dedicated entirely to strategizing market access, determining drug pricing, and reimbursement. Most small to medium-sized drug manufacturers, however, need to work with a partner to ensure they have the necessary expertise to create a successful strategy, especially if entering the market for the first time.
The Impact of Public and Private Insurance
Each market a manufacturer works with has its own unique challenges.
The federal market is one of the largest in the industry,?covering more than 100 million Americans . Public insurance, however, is ruled by federal guidelines and comes with stipulations. For example, Medicaid Medicaid mandates a rebate of 23.1% off the wholesale acquisition cost to introduce a product to the federal market.
While Medicare and Medicaid services are covered by government health funds, commercial insurance is often distributed through employers and paid for in part (or entirely) by those being covered.
Though a drug's public insurance coverage is critical to its commercial success, tailoring pricing and market access strategy to the needs of your target market (commercial, Medicare, Medicaid, etc.) should be a key priority.
"I have vendor relationships that are just good enough, but D2 has been instrumental in our launch and we would not be successful without them. They're on my dream team for commercialization. I know they'll get things done."
Kenneth Rankin, Vice President of Market Access, Distribution & Reimbursement at CT Biopharma
5 Steps to Developing a Powerful Market Access Strategy
A robust market access strategy starts long before the introduction of the product to the market and follows the product’s entire lifecycle. The goal is to create a smooth path to market and ensure long-term financial stability.
Here are 5 key steps our market access team would recommend:
1. ?Meet Key Payers
The first step is to introduce the product to key payers in your market. Through a series of formal meetings, you can help payers understand your business and products. Be prepared to share a plethora of information, including clinical efficacy, what therapeutic option the new product replaces and if possible, what cost this product takes out of the system. In addition, be prepared to discuss the distribution model, the potential number of patients who will benefit from the therapy, and the estimated timing of when the product is coming to market in addition to other key elements of your go-to-market strategy.
Here are the 3 crucial questions to have answered before engaging with payers:
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A partner like?D2?Solutions ?will simplify this process by helping develop a targeted message and getting you in front of the right payer to drive market access. While setting up these meetings can be difficult, the right partner opens doors and facilitates the conversations that seem out of reach.
2. ?Define the Burden of Disease
As you meet with payers, you’ll need to analyze the burden of disease for the product. Both parties will need to understand the disease state, the challenges faced by patients dealing with the illness, and how the product aims to alleviate these issues.
Your market access strategy should include a thorough review of the average price paid (APP) for comparable medications—and either the savings potential of the new product or the clear clinical benefit, along with specific local guidelines. For example, because Medicaid is administered by the states, the maximum allowable cost for drugs might differ from one state to the next.
3. ?Introduce the Product
Formally introducing the payer to the final product should include covering FDA studies and approvals, dosage, side effects, and main applications. This process has become easier in recent years as the FDA has allowed more open discussions between manufacturers and payers.
Ideally, at this point in the process, you can move forward without worry, especially if you are opting into the federal market where limitations are readily apparent, and pricing may be steeper and therefore represent more risk for the brand.
4.? Define Clinical Advantage
When necessary, your market access partner will put payers in touch with clinical specialists. This can be a critical connection on the route to approval and formulary inclusion, particularly with specialty drugs. The ability to clearly define a clinical advantage can greatly accelerate payer acceptance and speed the process of attaining product coverage.
5.? Determine Drug Cost Coverage
The final goal is to determine the lowest out-of-pocket costs for patients and cost to payers. Coverage will also impact how this product will affect the provider and patient experience.
The research conducted will be helpful in this step, as you may already have local and national coverage policies for comparable products from which to draw comparisons. Data about the burden of disease and other important information will also be important to support a positive coverage decision.
Common Market Access Pitfalls
D2 has been partnering with manufacturers since 2008, helping successfully launch over 350 products and supporting more than 60% of the drug launches across the US. Having seen a wide array of roadblocks and mishaps that are important to keep top of mind:
"Every day I'm dedicated to building relationships based on integrity, credibility, trust, and industry knowledge."
David Saunders , Senior Vice President Market Access and Reimbursement at D2 Solutions
The Right Relationships: Don't Launch Alone
In a shifting industry, the connections you make and relationships you build can change the game for your organization or therapy.
At D2 Solutions , we're dedicated to helping organizations like yours drive access. With centuries of cumulative experience and an unmatched National Account Team, D2's market access team can help you the right treatments to the right patients at the right prices.