US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
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Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
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50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.


UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

 

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.

Cuban: Drugmakers Are More Afraid of PBMs Than Trump

 
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The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.


Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
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Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.


Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
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Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
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Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
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Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.


Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
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Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

Leqembi Facing 15% Price Cut In Japan

 
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Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

 
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The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.