DKP’s Strong Partnership for Ultra-Orphan Market Launch Success

A company’s new agent for an ultra-orphan indication was pending FDA approval, with only months to go before launch.

The company realized that their staffing was very limited for supporting an effective launch. With only two field reimbursement managers to handle all payer communications and patient access challenges, they needed to identify other options to help them succeed.

DKP Role

With only a few months remaining to launch, DKP first wanted to understand the clinical implications for the product entering the market – especially since there was another current treatment option. DKP initiated its Clinical Services, utilizing Senior Consulting expertise from prior work experience at several of the CMS-recognized clinical compendia such as Clinical Pharmacology, DrugDex, and NCCN.

DKP conducted a deep-dive analysis of the clinical compendia for the competitive environment, helping the client understand how their clinical data may stack up against it – and where they may need to be prepared to dig deeper to support clinical positioning.

We also immediately prepared all new product communications directed at Medicare, Medicaid, and commercial payers, as well as for pricing compendia, key medical practices, and societies. With a network of decision makers established through years of product launches, DKP utilized electronic communications for most of the targets, enabling the recipients to internally distribute product information as needed.

DKP was accountable for direct outreach to Medicaid agencies, supporting individual state uptake of the new drug and alleviating the need for the manufacturer’s staff to focus on those payers. DKP ensured that the drug’s pricing and NDC were in each agency’s system and that patient access options were identified during the early stages while the biological was billed using a miscellaneous Healthcare Common Procedure Coding System (HCPCS) code.

DKP PayerScope® market monitoring services kicked into gear immediately after FDA approval to begin tracking payer uptake. With its real-time tracking reports, the PayerScope team caught market changes – some that required immediate action by the manufacturer due to misinterpretation of product label information, which could have precluded appropriate patients from accessing treatment. The PayerScope team developed DKP e-Alert® communications to outline the scenario, its implications, and the recommended action steps.

Value to the Manufacturer

DKP’s partnership with this manufacturer served to help the field reimbursement team ensure they could focus on their priority payers at the right time, working to support patient access through appropriate payer coverage.

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"Though DKP has a number of clients, I always feel that if an issue or question arises, I can reach out via email or phone to get the help I need."

Associate Director, Market Access & Reimbursement
Pharmaceutical Company