Ensuring Medicaid Access for a New Oncology Drug

A new biopharmaceutical manufacturer was bringing its first physician-administered cancer drug to market. Although Medicare and commercial payers accounted for the primary payer mix, Medicaid still impacted about 10% of the potential patient population. Also, because more adults were expected to be covered as Medicaid expands within various states, the manufacturer was concerned that their exposure to Medicaid would be beyond the anticipated 10%. As they had learned from other colleagues, even though Medicaid doesn’t affect as many patients, when a Medicaid patient can’t get access to a drug, it can reflect negatively on the manufacturer.

As a new manufacturer with no drugs on the market, DKP identified the disparities in access that would occur until each Medicaid agency reflected the new manufacturer’s signed CMS Rebate Agreement, required to set status as a rebate labeler. Agencies had the autonomy to choose to cover the new drug within a set range of time, so there was inconsistent access across the US.

DKP Role

First, DKP developed a Medicaid strategic targeting plan, helping the manufacturer understand where the biggest delays could occur. This allowed the manufacturer to develop internal expectations-management messaging and determine how this delay could affect any forecasting.

Upon FDA approval, DKP initiated a formal communication to each state agency and key Medicaid managed care organizations on behalf of the manufacturer announcing the approval of the new product.

DKP then tapped into strong developed relationships within each Medicaid agency’s pharmacy staff to confirm timing for the company’s rebate labeler uptake for the new drug.

Once the rebate labeler input was confirmed for each agency, DKP worked with the physician-administered drug decision makers to document confirmed patient access and billing and coding requirements between the time of initial drug acknowledgement and full product coverage (which, in many states, is not until the drug has a permanent HCPCS code).

Value to the Manufacturer

The manufacturer, as a new entity in the market, needed to develop a strong market presence of supporting patient access to care, so the launch was critical across all payers – including Medicaid. DKP’s partnership supported that access in what can be a very challenging payer environment. Although many manufacturers are comfortable with the pharmacy benefit under Medicaid, the management of physician-administered oncology drugs can bring many more nuances for management.


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