An Informed Approach to New-to-Market Drugs Protecting Members and Plan Sponsors through Expert Clinical Guidance

February 16, 2021 -

Protecting Members and Plan Sponsors through Expert Clinical Guidance
A new-to-market drug is precisely what it sounds like – a drug that has recently been approved and released for sale in the United States market. In the past five years (2016-2020), the U.S. Food and Drug Administration (FDA) has approved an average of 46 new drugs per year. This is a 28% increase in the average number of annual drug approvals compared to the previous five-year period (2011-2015). ¹

Source: U.S. Food and Drug Administration

New-to-market drugs can have a significant impact on member health outcomes as well as member and plan sponsor drug costs. Appropriate clinical management is crucial to promote safe and appropriate utilization of these drugs.

Promoting Sound Clinical Decisions
Global Reach Health conducts careful analysis of all new-to-market drugs to determine both their clinical applications and potential financial impact. As part of this process, Global Reach Health pharmacists adds new-to-market drugs to our New to Market List each month as they become available.

Drugs will remain on the list for a period of six months to a year while our clinical experts evaluate their potential formulary placement and whether the drugs should be included in specific clinical programs, such as step therapy, quantity limits, and clinical review for prior authorization. During this period, new information may become available regarding the drug’s use in a broader population outside of clinical studies that impacts the medical community’s understanding of its safety and efficacy. This information is taken into account when determining the best approach to appropriate clinical management through the pharmacy benefit.

New-to-market drug evaluations include close examination of uses approved by the FDA as well as manufacturer guidelines for use of the drug. In 2020, 40% of all new drugs approved were the first of their kind to receive FDA approval, and 58% were indicated to treat rare diseases. 1 Such drugs require careful review to make certain they are used appropriately and produce the best possible health outcomes for the individual member.

Understanding the Financial Implications
Global Reach Health experts also consider the potential financial impact of each new-to-market drug. Often, these products are high-cost drugs that can significantly affect member and plan sponsor prescription expenses. Often, new-to-market drugs have high price tags. It is Global Reach Health concern not only to help identify whether these drugs are used according to clinical guidelines, but whether they offer the best value to the member and plan sponsor. In some instances, a drug already on the market may deliver equal or better health outcomes at a lower net cost to both the member and the plan.

The Benefit to Plan Sponsors
Plan sponsors can choose to exclude drugs on the New to Market List from their plan coverage for either six months or one year. This helps manage the potential financial impact of these drugs while Global Reach Health pharmacists incorporate them into the appropriate clinical programs to drive responsible utilization. Through these programs, our clinical team works with members, prescriber, and dispensing pharmacists to identify the most clinically appropriate, lowest-net-cost option for each individual’s specific situation.

Accessing New-to-Market Drugs During the Exclusion Period
The inclusion of a drug on the New to Market List does not automatically mean a member who needs the drug cannot access it. Coverage exceptions can be granted when appropriate when a plan sponsor chooses to exclude new-to-market drugs from coverage.

Upon receipt of a request for an exception, our pharmacists will work with the member’s prescriber to determine the clinical necessity of the new-to-market drug. This clinical review process allows Global Reach Health to understand the rationale for the drug’s use and work with the client to grant coverage exceptions when a new-to-market drug is the most clinically appropriate choice for the member.

Global Reach Health is clinically driven, and our approach to new-to-market drugs is just one way we do our due diligence to partner with our clients to provide the most efficient prescription benefit possible.