Pricing Debate
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Amgen’s Ian Thompson On Payer Shifts, Obesity Opportunity And The Future Of Blockbusters
Scrip spoke with Amgen’s senior VP of US business operations about the impact of drug pricing and reimbursement pressures coming from government policy changes and commercial payers.
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CDC Advisors Vote For More COVID-19 Vaccines For All Despite Cost-Effectiveness Concerns
The CDC's Advisory Committee on Immunization Practices voted for a universal COVID-19 vaccine recommendation for 2024-2025, but said the decision would have been easier with a lower-cost product.
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As India Scales CAR-T Efforts, Can It Innovate Commercial Models?
As India seeks to build on early gains in CAR-T cell therapy, experts call for ecosystem reform and also the need to demonstrate value to payer models of large economies to potentially back international reimbursements.
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US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo
The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials.
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US Product Hopping Legislation Could Offer $3bn In Savings
A bill that would prevent product hopping was estimated to save US taxpayers $3bn by the US Congressional Budget Office, increasing the likelihood it could be enacted to help pay for other congressional priorities.
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England’s NICE Not Planning To Include Societal & Genericization Factors In HTAs – For Now
England’s NICE should factor in the impact of patent expiry on future drug prices when analyzing the cost effectiveness of new medicines and should also take account of societal benefits, a group of health economists has said.
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340B Drug Diversion: Sanofi Suit Seeks Evidence In Pharmacy Contracts With Hospitals
Drug maker pursuing novel approach to establishing that contract pharmacies are improperly taking ‘title’ to 340B-discounted drugs, leading to diversion, which is prohibited by law.
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US NIH And Drug Pricing: Still Seeking A Balance
“Access Plans” are the US NIH’s new idea to address calls to take a more hands-on role in regulating the prices of products developed with taxpayer funding, but what the policy would actually mean for prices is hard to pin down, and that is probably deliberate.
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Looming Step Therapy Ban In Illinois Is ‘Game Changer,’ Could Start Trend
Federal legislation on PBM reforms has stalled, but state efforts remain active. Illinois’ Healthcare Protection Act includes several other limits on insurer power, including prohibiting prior authorization for inpatient mental health care.
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Bipartisan House Support Remains Elusive In 340B Reform Effort
Republicans continue to take the lead on advancing reforms, while Democrats warn proposals could endanger a government program supporting safety-net care.
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Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More
Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.
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BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More
Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.
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House 340B Reform Bill Would Require Discount Pass Through, Define Patient, Hospital Eligibility
Legislation is the fruit of PhRMA’s lobbying collaboration with the National Association of Community Health Centers. It would also require manufacturers to supply contract pharmacies, within limits.
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Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock
Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.
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NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional
Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.
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