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Mid-size Biopharmaceutical
Market Access, HEOR, Medical Affairs
Phase III
Oncology
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Mid-size Biopharmaceutical
Market Access, HEOR, Medical Affairs
Phase III
Oncology
A mid-size biopharmaceutical company was 18 months from launching a therapy for a rare oncologic disease with no prior approved treatments.
To minimize time to coverage following FDA approval, the team needed to clearly position clinical value with both payers and national guideline committees.
The client engaged Alkemi to develop a payer dossier and a parallel guideline strategy to support rapid post-approval adoption.
1. Conducted targeted analyses to position trial and subgroup data for both payer and guideline audiences.
2. Synthesized literature and clinical data into a differentiated value narrative formatted for AMCP submission.
3. Developed guideline positioning tools and supporting materials for use in NCCN and other compendia discussions.
4. Built a submission roadmap and tracker to support efficient follow-up and process management.
Align payer and guideline strategy before approval to shorten time to adoption.
“Not only were they knowledgeable of guideline processes, but also internal dynamics that can delay launch. Very impressive.” - Global Market Access Lead
AMCP dossier approved for distribution within two days of FDA approval.
A favorable NCCN guideline update advocating for use of the therapy was issued within 10 days of approval.
Additional clinical compendia issued positive recommendations following communication efforts.