2026 Drug Pricing Shockwave: Medicare Names 15 New Negotiation Targets as PBM Reform Accelerates

02-Feb-2026

If you work in pharma market access, you can feel the ground shifting. This week’s Drug Price headlines aren’t just another policy cycle—they’re a roadmap for how U.S. reimbursement power is being re-wired in real time.

Below is what changed, what’s coming next, and how teams should move—fast—before the negotiation calendar turns into a fire drill.

What did CMS announce and why is it a big deal for pharma?

The Centers for Medicare & Medicaid Services (CMS) announced the next set of 15 drugs entering Medicare’s third negotiation cycle, with resulting negotiated prices slated to take effect January 1, 2028.

Why this is a big deal (even if your product isn’t on the list):

• The program is expanding in impact and signal strength. This cycle includes products reimbursed through both pharmacy and clinician-administered channels—meaning the “negotiation lens” is widening beyond the traditional retail lane.
• The dollars are enormous. The selected medicines accounted for roughly $27B in combined Medicare spending across the measurement period cited in coverage, which makes the policy pressure very real for leadership teams.
• The list is a strategic preview. Even if you’re not selected today, the criteria (high spend, limited competition) act like a spotlight—showing every manufacturer what kinds of assets are “next.”

The 15 selected products span a mix of conditions and settings; notable inclusions include Trulicity (a GLP-1 drug), Biktarvy (widely used for HIV drugs), and Botox (covered for certain indications and often billed as a Part B drug).

What is the negotiation timeline—and what are the key dates teams can’t miss?

This is the part that catches teams off guard: the window between “selection announcement” and “internal readiness” is shorter than most governance cycles.

Here are the key milestones for the 2028 applicability year (third cycle), straight from the program’s fact sheet:

• February 1, 2026: Deadline for the agency to publish the selected-drug list (and any renegotiation selections).
• February 28, 2026: Manufacturer agreement deadline (sign participation agreements).
• March 1, 2026: Manufacturer-specific data submission deadline and public input deadline on therapeutic alternatives/unmet need/population impacts.
• June 1, 2026: Initial offer sent (with justification).
• July 1, 2026: Manufacturer response due (accept or counter).
• September 30, 2026: Final offer issued by the agency.
• October 31, 2026: Manufacturer accept/reject deadline.
• November 30, 2026: Negotiated (or renegotiated) prices published.
• March 1, 2027: Agency publishes the public explanation narrative.
• January 1, 2028: Prices become effective.

Operational takeaway: If you wait until “after agreement signature” to mobilize, you’ve already lost critical weeks for evidence packaging, scenario modeling, and stakeholder alignment.

What is “Maximum Fair Price” and how does it affect net price strategy?

Maximum Fair Price is the statutory name for the negotiated Medicare price ceiling that applies once the price becomes effective. The ripple effect is bigger than a single government rate card:

1. Net price architecture gets stress-tested. If your contracting strategy relies heavily on rebates to achieve access, a government-set ceiling changes the anchor point—and can compress your ability to “buy” incremental share in the same way.
2. Reference dynamics intensify. Even when MFP only applies in Medicare, the market watches. Commercial stakeholders can use it as leverage in negotiations, and internal brand teams will feel pressure to “explain the delta.”
3. Channel math changes. The operational mechanics of making the price available add new process friction and data requirements—especially when you consider how dispensing entities and manufacturers reconcile price availability.

One phrase you’ll hear repeatedly in internal meetings is Medicare MFP—because it becomes shorthand for the new “floor/ceiling” debate across pricing, access, and forecasting.

What will PBM reform change—and why does it matter at the same time as negotiation?

Here’s why the timing is brutal: drug negotiation is targeting what Medicare pays, while parallel PBM reform efforts are targeting how savings and incentives flow through the system.

Recent federal proposals and legislative text emphasize themes like transparency, limits on spread pricing, and stronger accountability mechanisms.

Why it matters simultaneously:

• Your “rebate story” may get harder to defend. Negotiation pushes prices down;

PBM-focused changes push stakeholders to justify why rebates exist, who benefits, and how they translate (or don’t) to the pharmacy counter.

• Contract strategy could be forced to simplify. If reporting requirements tighten or compensation models change, complex rebate constructs may become less attractive—even before regulation is finalized.
• The access playbook may split by channel. Medicare dynamics move one way; employer/commercial coalitions and state actions may move another, creating fragmentation that’s painful for national contracting teams.

In short: negotiation hits the price ceiling; PBM Reform reshapes the pipes the money moves through.

How should Market Access & Contracting teams respond right now?

Treat this like a launch—because it behaves like one.

1. Stand up a negotiation “war room” with clear owners. Not a committee. A working team that meets weekly and can make decisions.
2. Map the evidence that supports value in Medicare specifically. Utilization patterns,

site-of-care economics, avoidance of downstream costs, and outcomes in older adults can matter more than broad real-world claims.

1. Run contract scenario drills. What happens if your Medicare economics compress by X%? Which commercial agreements become unsustainable? Where do you need guardrails.
2. Re-check operational readiness. Data exchange, chargeback-style processes, and eligibility verification are not optional details—they’re failure points. Build the same discipline you’d use for DSCSA compliance: controls, audit trails, and clear exception handling.

How should HEOR/Medical Affairs support negotiation readiness?

HEOR and Medical Affairs become the “value translation engine” when pricing pressure rises. Focus areas that tend to move the needle:

• Comparative framing. Be prepared to discuss therapeutic alternatives and clinical differentiation in plain language and in evidence-backed detail, because the process explicitly invites alternative-therapy input.
• Population impact narratives. The timeline includes public submission on unmet need and specific populations—teams should anticipate external narratives and pre-build response grounded in data.
• Indication and lifecycle vigilance. The guidance highlights renegotiation eligibility factors like new indications and material changes—meaning label evolution can change your negotiation posture.

If you’re in oncology, this is also the moment to pressure-test how clinical benefit, sequencing, and combination strategies will be communicated under a tighter pricing regime.

How should Finance, Forecasting, and Leadership communicate the impact?

This is where calm, credible communication wins.

• Create a single “source of truth” model. One version of assumptions, updated on a cadence tied to program milestones (not quarterly cycles).
• Separate effective date from market behavior date. Prices become effective in 2028, but perception and negotiation leverage shift immediately.
• Message with discipline. Leadership should avoid two extremes: “this won’t matter” and “this breaks everything.” A stronger line is: We understand the timeline, we have scenarios, and we’re protecting access while planning for sustainable economics.

FAQs

1)Do negotiated prices apply right away?

No—this cycle’s negotiated prices are scheduled to become effective in 2028, even though negotiation activities happen during 2026.

2)Can companies opt out of the process?

There is a formal participation agreement step with a defined deadline; missing it creates major consequences under the program rules.

3)What should teams do first if their drug is selected?

Lock the timeline, assign accountable owners, and start evidence + contracting scenario work immediately—before internal governance slows you down.

4)Why does the public get a role in the process?

The program explicitly allows public submissions about therapeutic alternatives, unmet need, and population impacts, which can influence how products are evaluated.

5)Is this only a Medicare issue?

Medicare is the direct mechanism, but the indirect effects (contract leverage, reference conversations, stakeholder expectations) can show up across channels.