CMS sought input on its draft guidance related to the Medicare Drug Price Negotiation Program (MDPNP) for initial price applicability in 2027. Working with rare cancer groups convened under the Protecting Innovation in Rare Cancers (PIRC) Coalition, CLL Society provided feedback to CMS by:
- Thanking CMS for refining its stakeholder engagement approach to enable more robust and meaningful patient participation;
- Urging CMS to modify its definition of qualified single source drug and use its discretion in implementing the new negotiation program so as not to erode incentives for new rare disease approvals of existing treatments;
- Asking CMS to remove ambiguity and inconsistencies with respect to considering off-label uses of selected drugs as it prepares an initial offer; and
- Recommending CMS enforce Part D plan requirements to base utilization management tools on evidence and include all, or substantially all, products within protected classes on plan formularies.
