How a Product NDC Change Impacts Your Rare Disease Patients

In the Rare Disease space, a product NDC may change for several reasons. Whether it’s a new product formulation on the market or a new company inheriting a previously established product, it’s imperative to think through the potential impact that a product NDC change may have on your established patient population. Here are a few things to consider that could reduce potential therapy gaps for patients when an NDC change is imminent.

Here are a few ways that utilizing a HUB with experienced clinical staff may be able to assist in helping to overcome/address authorization denials:

1. Existing Prior Authorizations/Authorization Renewals may be affected If the product requires a Prior Authorization from the payer, there is a high probability that the new NDC will cause claim rejections because it is unrecognized by the plan. This could cause patients to experience delays in receiving refills. For patients just starting treatment with the product, “drug not covered” rejections may occur until the payer has added the new NDC to their formulary. Also, if your product/program offers a “Bridge” program to allow for free-goods, you may see an uptake in utilization due to authorization denials, or product not covered rejections.

2. Communicating the ChangeAn NDC change requires mass communication to many parties involved. Payers, Patients, Healthcare Providers (HCP), even the Home Health Nurse (if applicable to your product) should be made aware of the change. There are several ways to partner with your HUB team to ensure the word is spread and that you have a targeted list identified so that the information is sent quickly and clearly.

If your product is limited distribution, it may be possible to obtain a targeted list of payers to expedite changes to formularies.

If your product is an injectable (self, or by HCP), will new injection training be involved? Your HUB team may be able to provide an exhaustive list of HCP’s or other caregivers that need to be re-trained.

You may be able to rely on your HUB team for mass mailings and/or call campaigns, to interact with targeted individuals that will potentially be impacted by any NDC change

3. Transition Timeline If the product is changing formulation, it’s important to know the timeline for phasing out the existing product and how long it may be still available to prescribers. Payers will need to allow for both the old and new NDC numbers in their system as pharmacies exhaust their existing inventory of product.

Additionally, if your product has a specific enrollment form, it’s also important to ensure that any changes in the formulation are updated so that prescribers are utilizing the most current prescription for dosing purposes. From a “Buy and Bill” perspective, will the NDC change also cause a drug pricing change? Alerting facilities to these changes and how they may impact pricing will be important to ensure their ongoing access to products.

These are just a few of the many things to consider when a product NDC change will occur. Ultimately, the primary goal of both the HUB team and Pharma partner should be to ensure a smooth transition for patients. Reducing potential delays or therapy gaps, while ensuring product access, is paramount to a successful transition. Be sure to engage your HUB management partners for additional insights and potential areas of impact for your product.