Pricing & market access
12 articles
Lilly Lets Hims & Hers Prescribe Zepbound and Foundayo at Self-Pay Prices
- Lilly will offer Zepbound and its oral Foundayo through the Hims & Hers telehealth platform at the same self-pay prices available elsewhere, starting at $299 and $149 a month respectively.
- Hims previously sold cheaper compounded GLP-1s and changed course in March after a legal challenge from Novo, which struck a similar deal with it.
Both big GLP-1 makers now use Hims as a cash-pay channel, which turns a former adversary into distribution and removes the compounded-versus-branded argument from the telehealth funnel. For Lilly the signal is price discipline: self-pay tiers are set low enough that volume, not margin per script, is the bet. Watch whether Hims keeps compounded options for 'clinical necessity'.
Lilly, Hims reach GLP-1 deal; Alnylam sales chief to step down ↗
CMS Finalizes Medicare 340B Cut at ASP Minus 28% for 2027
- CMS finalized its 2027 outpatient rule: Medicare will pay 340B participants the average sales price minus 28%, a smaller cut than proposed, which the agency estimates lowers drug spending by about $5.5 billion in 2027.
- The cut is budget neutral, so payments for non-drug services rise by the same amount; imaging without contrast moves to site-neutral rates. The American Hospital Association called it an assault on 340B.
The money moves from 340B hospitals to non-participating ones, not out of the system, so the effect on drugmakers is indirect: less hospital margin may push 340B systems to fight rebate-model changes harder. Manufacturers get no price relief here, but the rule gives them a data point that CMS will cut 340B reimbursement administratively, without Congress.
Medicare will cut billions from 340B, expand site-neutral payments in 2027 ↗
Revolution Medicines books $198M in first five weeks of Rasonque sales
- Rasonque, approved in late August for previously treated metastatic pancreatic cancer, generated $198M in Q3 sales, far above analyst forecasts of $19M to $100M.
- More than 5,000 patients were reached, helped by early-access conversions; management says it is too early to judge the steady-state trajectory.
- Revolution reported a $407.5M quarterly net loss and $3.7B in cash, while Phase 3 first-line trials continue to advance.
A $198M first quarter in a second-line pancreatic indication, part of it a one-time early-access conversion bump, says less about steady state than about unmet need: few drugs target RAS this directly. The real prize is first-line, where the Phase 3s and zoldonrasib sit. With $3.7B in cash, Revolution can fund that fight, and the bigger-pharma suitors will be watching.
RevMed's Rasonque shatters analyst estimates with $198M quarter ↗
CVS Will Split Into Two Listed Companies, Separating Retail Pharmacy From Aetna and Caremark
- CVS Health will separate into two public companies, with shareholders owning both; completion is expected in the first half of 2028.
- The new CVS Health keeps Aetna, the Caremark PBM, Oak Street, Signify and specialty pharmacy; CVS Pharmacy takes roughly 9,000 stores, mail order and walk-in clinics.
- CEO David Joyner said the move is not driven by regulatory pressure and that Aetna–Caremark ties will continue under commercial agreements; it came with a raised 2026 outlook.
For drugmakers the interesting part is Caremark staying with the insurer: the PBM rebate and formulary leverage is intact, while a standalone pharmacy becomes a cleaner counterparty for dispensing and margin negotiations. Analysts also see the split easing state scrutiny of vertical integration, so expect policymakers to ask whether commercial agreements between the halves recreate the same incentives. Timeline to 2028 leaves room for this to change.
CVS to split into two companies in stunning strategic about-face ↗
FDA tentatively approves Dr. Reddy's generic lenacapavir, a $40-a-year HIV prevention shot for poorer countries
- The FDA gave tentative approval to Dr. Reddy's Laboratories to make a generic version of lenacapavir, an injectable for HIV prevention.
- The company plans to begin shipping next month, with global health organizations helping speed delivery to lower-income countries.
- The annual cost is put at $40 per person.
- One dose every six months gives near-complete protection; Gilead's branded version won FDA approval in June 2025, so the generic's tentative approval came about 16 months later, unusually fast.
About $40 a year against a branded US price in the tens of thousands is the point. But this is tentative approval, not full, so supply depends on Gilead's voluntary-license territories. Watch real procurement volumes and whether twice-yearly dosing reaches clinics, since delivery, not price, may become the bottleneck.
FDA OKs generic HIV prevention shot, widening access for lower-income countries ↗
BridgeBio readies US launch of BBP-418 for LGMD2I/R9 ahead of Nov 27 FDA decision
- The FDA is due to rule on BridgeBio's oral BBP-418 for limb-girdle muscular dystrophy type 2I/R9 by Nov 27 under priority review, with no advisory committee planned; it would be the first approved therapy for the condition.
- The Phase 3 FORTIFY study in 112 patients met its interim biomarker endpoint (glycosylated alpha-dystroglycan) and secondary endpoints including lower serum CK.
- The company already has field teams in place, is targeting about 150 MDA centers and has identified over 500 prospective US patients; pricing is undisclosed, and genetic testing is expected on the label.
The approval hinges on a biomarker: glycosylated alpha-dystroglycan was the interim primary endpoint, so the label will show how much clinical weight FDA gives it versus CK and function data. Commercially, 500-plus identified patients across roughly 150 centers is a small, tightly mapped pool, which makes price and the genetic-testing requirement the swing factors.
BridgeBio gears up for rare muscular dystrophy launch with FDA approval in sight ↗
Keytruda biosimilars near FDA review, but payer dynamics and low uptake loom
- The FDA accepted Formycon's FYB206, the first publicly disclosed Keytruda biosimilar filing, in October 2026; approval could come as early as Q3 2027, ahead of key patent expiries starting in 2028.
- Zydus will commercialize FYB206 in the US and Canada, and the FDA reportedly agreed a pathway without a comparative phase 3 efficacy trial; about a dozen other candidates are in development.
- Obstacles include uncertainty over which of Keytruda's 30-plus indications will be covered, PBM formulary preference for high-rebate brands, and biosimilar share still under 20%; Keytruda earned Merck $31.7 billion in 2025.
A skipped comparative phase 3 lowers the cost of entering, but it does nothing for the harder problem: Merck's rebate leverage with PBMs. Biosimilar share under 20% suggests price cuts alone don't move formularies. Watch the label scope FDA grants FYB206 and whether Zydus pairs it with an aggressive net-price or private-label PBM arrangement.
Keytruda biosimilars are coming — but they face an uphill battle ↗
Alnylam Stock Drops a Quarter as Amvuttra Uptake Lags and 2027 Guidance Slips to February
- TTR franchise revenue grew strongly year on year, but the CEO conceded demand is short of hopes and the CFO expects full-year revenue at the low end of guidance; no Q4 growth should be assumed.
- BridgeBio's Attruby and Pfizer are taking share, and a proposed 340B rule due in 2027 could cause ordering volatility.
- 2027 guidance is pushed to February, after the usual J.P. Morgan window. Shares fell about 25% in a day, prompting analyst talk of Alnylam as a takeover target, with Sanofi named as a likely buyer.
Alnylam sold the market on a fast ATTR-CM switch from competitors; the data now say adoption is gated by prescriber habit, not by efficacy. Pushing guidance past J.P. Morgan is itself a message. A depressed price makes it a candidate for a bid, but any acquirer would be paying for the same uptake problem plus a litigious, price-pressured category.
'We need to do better,' Alnylam CEO admits, as uncertainty looms over transthyretin franchise ↗
Labor Department Finalizes Rule Forcing PBMs to Disclose Rebates and Spread Pricing to Employers
- Starting in July 2027, PBMs serving large self-insured employer plans must disclose payments from drugmakers and pharmacies, including rebates and spread, at contract signing or renewal and every six months. Employers may audit annually.
- Regulators project $22 billion in savings over a decade; noncompliance risks penalties and contract invalidation.
- PBM trade groups argue the department lacks authority and that the rule duplicates the 2026 appropriations-act reforms.
For manufacturers this is indirect but real: once employers see the rebate flow, pressure builds to move toward net-price contracts and away from high-list, high-rebate structures. Expect litigation on authority grounds, and expect mid-sized PBMs, with the heavier compliance burden, to be the ones that consolidate.
Novo Nordisk May Have Landed a Sweeter Deal in Medicare's GLP-1 Bridge Pilot
- Medicare's GLP-1 Bridge pilot, launched under the Trump administration, sets a flat $50 monthly co-pay for obesity drugs — including Novo Nordisk's Wegovy and Eli Lilly's Zepbound and orforglipron — for Part D beneficiaries from July 2026 to December 2027.
- STAT reporting suggests Novo Nordisk's negotiated terms under the pilot may be more advantageous than initially disclosed, potentially outperforming Lilly's arrangement.
A pricing edge over Lilly in this two-horse race is worth more than the headline $50 co-pay — share captured under a fixed-price pilot compounds fast, and better fine print (rebates, volume triggers) beats a flashier price point. Read this as both companies treating government-negotiated terms as a template to refine, not a one-off concession, ahead of oral GLP-1 competition.
Novo may be getting a better deal than expected with Medicare's Bridge program ↗
NHS England to Fund AstraZeneca's Enhertu After UK-US Pricing Deal
- NICE, which sets drug-funding recommendations for NHS England, will fund Enhertu (trastuzumab deruxtecan) for HER2-low metastatic or unresectable breast cancer after chemotherapy, reversing a July 2024 rejection on cost grounds.
- The reversal follows a UK-US pharmaceutical pricing deal that led NICE to raise its cost-effectiveness threshold and revise its appraisal methodology, making some costlier innovative drugs newly reimbursable.
- Enhertu, an antibody-drug conjugate co-developed by AstraZeneca and Daiichi Sankyo, has been reported in studies to meaningfully extend survival for this patient group versus chemotherapy alone, though the size of the benefit varies.
- An estimated 1,000 patients in England are expected to gain access, with treatment available within days of the decision.
NICE just permanently loosened its willingness-to-pay bar — as a negotiated line item in a bilateral trade deal, not a one-off cost-effectiveness review. That's the story here, not the roughly 1,000 patients gaining access: expect other governments squeezed between fiscal discipline and access pressure, and other pharma negotiators facing NICE, to point to this precedent. For AstraZeneca and Daiichi Sankyo, it de-risks Enhertu's ex-US rollout playbook: reimbursement fights in other cost-constrained markets (Canada, Australia, parts of Europe) just got a stronger comparator to cite. More broadly, this nudges the ceiling on what NICE will pay for high-cost ADCs and next-gen oncology assets generally, benefiting the wider oncology ADC pipeline queuing up for UK launch, not just this one drug. Watch whether AZ/Daiichi price other Enhertu indications, or future ADCs, against this new threshold.
England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal ↗
NHS England to Reimburse AstraZeneca's Enhertu for HER2-Low Breast Cancer After US-UK Pricing Deal
- Enhertu (trastuzumab deruxtecan), an AstraZeneca/Daiichi Sankyo HER2-targeting antibody-drug conjugate, will now be reimbursed by NHS England for HER2-low metastatic breast cancer.
- The move reverses NICE's July 2024 rejection of the drug for this indication, ending a years-long access dispute.
- It follows a new NICE agreement made possible by a broader U.S.-U.K. drug pricing deal (announced December 2025), which raised NICE's cost-effectiveness thresholds from about £20,000-£30,000 to £25,000-£35,000 per quality-adjusted life year.
- A new quality-of-life assessment methodology, published August 27, 2026, also supported the reassessment.
- About 1,000 women a year in England with HER2-low metastatic breast cancer are expected to now qualify, with studies reporting an average survival gain of roughly six months.
The science and data here are unchanged from NICE's 2024 rejection — this is a payer-economics win, not a clinical one, and it's easy to conflate the two. What actually moved was NICE's cost-effectiveness ceiling, from roughly £20-30K to £25-35K per QALY, engineered by the broader US-UK pricing deal, not new trial results. That's the real story: the first tangible commercial outcome traceable to that trade agreement, and it hands every company with a NICE-rejected asset a concrete playbook for reopening the case. Commercially, ~1,000 patients/year in England is a rounding error for AZ/Daiichi's global Enhertu franchise — the payoff is precedent, not revenue. Watch for ripple effects: rival ADCs and other HER2-low contenders now face a materially easier cost-effectiveness bar, reshaping competitive dynamics in an increasingly crowded ADC pipeline.
England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal ↗