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Last week, NAVLIN Daily brought you key market access developments from across the globe. Manufacturers discussing MFN/tariff agreements during Q1 2026 earnings calls shifted focus toward ex-U.S. reimbursement increases rather than U.S. policy changes, while the White House announced that it predicts $64.3B in federal and state savings from MFN In Europe, the HTACG granted Ipsen’s Ojemda (tovorafenib) the first-ever JCA approval under the joint HTA Regulation CMS extended the GENEROUS Model application deadlines for manufacturers and states, while Brazilian industry representatives raised concerns over pricing the newly implemented drug pricing regulation
China rolled out a sweeping plan to improve children’s healthcare through drug development incentives, faster marketing approvals, and streamlined reimbursement decisions. Local and foreign drugmakers benefit from the measures, with added perks such as expanded patent protection and market exclusivity periodsHowever, some areas of the policy aim to benefit the domestic industry, including measures to reduce reliance on foreign combination vaccines and relaxed rules for Chinese clinical dataOther specific aspects of the policy include expanded use of real-world evidence (RWE) and prioritized centralized procurement and entry onto the National Reimbursement Drug List (NRDL)
Torrent Pharmaceuticals has emerged as an early leader in India’s fast-growing generic semaglutide market, capturing nearly 38% market share within a month of launch“Torrent’s early lead appears to be driven by oral semaglutide,” Aasim Maldar, consultant endocrinologist and diabetologist at PD Hinduja Hospital, told The Economic Times“Many patients would prefer a tablet over an injection, given the choice,” he said
A new analysis published by White House economists predicts that the U.S. administration's voluntary deals with drugmakers will save the U.S. economy billions across all payer channels over the next 10 yearsOverall, the report predicts $64.3B in federal and state savings over the next 10 years stemming from applying MFN prices to state Medicaid programs and an estimated $529B in domestic savings across all markets (inclusive of commercial insurance) stemming from manufacturers offering all new drugs launched in the U.S. at prices comparable to those in other high-income countriesThe analysis also reiterates the administration's commitment to getting other countries to pay more for medicines, and highlights the recent U.S./UK deal as an example of what the U.S. is looking to "replicate" with other nations
Throughout recent Q1 2026 earnings calls, executives of companies that have struck Most Favored Nation (MFN)/tariff deals with the U.S. administration have demonstrated a shift in focus when it comes to MFN policy Instead of discussing U.S. policy developments and the potential implications of the U.S. administration’s proposed MFN pricing models (like GLOBE and GUARD), pharma leaders are homing in on efforts to increase reimbursement rates in ex-U.S. nations Keep reading for NAVLIN Daily’s round-up of the key policy and pricing-related conversations from this quarter’s earnings calls
The Danish Medicines Council has recommended four new drugs as standard treatment across oncology and rare diseases in April: Perjeta (pertuzumab), Rubraca (rucaparib), Loqtorzi (toripalimab) and polihexanide Two drugs were not recommended due to pricing and evidence concerns, while one oncology drug was placed on hold for further price negotiationsIn the same meeting, the Council adopted a new model that will enable access to PD-(L)1 inhibitors within 10 days of marketing authorization, replacing the previous 14-week individual assessment process
Last week, Germany made progress on the GKV reform bill, which will now move to the Bundestag for debate before final approval, and Japan decided to push ahead with FY2027 drug price cuts, despite MFN threats, while Brazil implemented the first overhaul of its drug pricing system in 20 yearsRegeneron signed 17th voluntary MFN deal with the White House, gaining relief from future pricing mandates and tariffs for three yearsIn Europe, Novartis’s Itvisma became the first ATMP undergoing the JCA process to receive a positive CHMP opinion, while speakers at the ABPI conference in London revealed that there are currently approximately 54 topics scheduled to enter the new MHRA-NICE aligned pathway
The Centers for Medicare & Medicaid Services (CMS) will extend the deadline for drug manufacturers to apply to the GENEROUS Model for a second timeThe new deadline for manufacturers to apply to the model, which implements Most Favored Nation (MFN) drug pricing in State Medicaid programs, is June 11, 2026. The previous deadline was April 30, 2026Additionally, CMS is extending the deadline for states to apply to the GENEROUS model from July 31, 2026, to September 10, 2026
Brazil has revamped its drug pricing system for the first time in 20 years, placing more emphasis on innovation, competition, and transparencyDrug pricing categories were expanded, therapeutic gain criteria were updated, provisional pricing rules were introduced, and patent requirements for premium pricing were removed. More reference countries were added for price comparisons, increasing international price pressureThe new system applies to new, ongoing, and provisional applications from Wednesday. ATMPs were excluded from the changes, with future guidance promised
Germany's Federal Cabinet has adopted the draft bill to stabilize the contribution rates in the statutory health insurance (GKV) from 2027The draft will now be debated and negotiated in the Bundestag, the lower house of the parliament, before being finalizedFederal Chancellor Friedrich Merz, stated in a post on X “We can't just continue as we have done for the last 20 years. We have to show that we can change. Health, long-term care and pension insurance are three major reform projects. We hope that this will lead to more confidence”
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