Essentially, market access is synonymous with patient access: ensuring that patients have the right access to the right therapy at the right price and the right time. The role of a manufacturer’s market access team is to secure appropriate payer coverage for their products. The teams must also lay the groundwork for each drug’s pricing, contracting, reimbursement and fulfillment strategies.
The cornerstone of a manufacturer’s market access strategy is the process of defining and communicating a product’s clinical and economic value to payers, providers and patients, as each is involved in the decision to initiate therapy. Market access is a critical function of a drug’s development and go-to-market strategy, as it sets the stage for a successful product launch.
Utilization management refers to the process in which health insurance companies manage healthcare utilization and control costs. Utilization management often imposes barriers to access for patients.
If a payer has placed utilization restrictions on a medication, a pharmacy will be unable to dispense it at the point of sale unless those restrictions have been met. For example, a quantity limit restricts the amount of a particular medication that can be dispensed within a given time frame. This restriction is usually aligned with the directions on the drug’s label; a drug that is given twice daily might have a quantity limit of 60 tablets within 30 days.
Prior authorization (PA) restrictions are commonly used for expensive medications, drugs that have dangerous side effects, or drugs that a payer considers to be overused. To prescribe these drugs, the provider must first complete a PA request and receive advance approval from the payer.
While PA may be appropriate for certain drugs, this restriction can act as a powerful deterrent to providers. Despite recent legislation supporting electronic PA standardization, the PA process is still complex, time-consuming and highly manual. Providers are often unsure if they are including the right documentation with the request, which contributes to denials and unnecessary care delays. As a result, the presence of a PA restriction can lead providers to prescribe a different medication altogether.
Payers can also impose step therapy restrictions, sometimes called “fail first” requirements, to ensure that patients try a generic or less expensive drug before a more expensive one. If only one step is mandated, issuing a prescription for the higher-cost medication will not necessarily require PA. When a patient tries to fill the prescription, the pharmacy’s adjudication platform will automatically review past claims to determine if the patient has already tried the first-step therapy and is compliant with their plan’s coverage rules.
Investing in a strong market access strategy—and the data necessary for market access analysis—is essential for commercialization and to overcome barriers to market access. There are so many ways that market access can go wrong, from poor product differentiation to unfavorable formulary placement to underestimating providers’ willingness to switch therapies. With a data-driven game plan, pharma companies can better anticipate and solve these challenges in advance.
Here’s what manufacturers need to know ahead of and during product launch, and why it matters:
For a successful launch, manufacturers need to start market access planning 12-18 months prior to FDA approval. Otherwise, companies risk launching their product without firmly establishing their coverage, distribution, or reimbursement strategies—which can lead to low uptake and suboptimal sales figures upon launch.
In recent years, the FDA has begun to reject drug applications if the pharma company hasn’t yet established a valid manufacturing and distribution strategy. If this occurs, resubmitting on the FDA’s timeline can cost a company millions of dollars in forecasted revenue.
To help you develop a market access strategy and ensure favorable access to your product at launch, contact MMIT.
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