The Trump administration has temporarily halted work on Medicare rules aimed at lowering drug spending, CNBC reports, including a proposal that would enable Medicare plans to negotiate down prices of drugs in the protected class. According to the report, the administration also stopped work on a […]
House OKs Bills on ACA, Drug Prices
The House this week pushed through a host of new health care bills aimed at supporting the Affordable Care Act and reducing prescription drug prices, the New York Times reports. Democrats, according to the report, had hoped tying prescription drug prices to the ACA would pull some support from […]
Article: Rule on Pharma’s DTC Ads is ‘Tiny Baby Step’ in Right Direction
The Trump administration's recent rule requiring pharmaceutical companies to include a drug's list price in direct-to-consumer ads is a step in the right direction, albeit a "very tiny baby step," American Council on Science and Health Senior Fellow Charles Dinerstein writes in a recent […]
Report Spotlights U.K.’s New Pricing Bill
A recent report by PMLiVE offers a look at the U.K.'s recent drug pricing deal introduced in January, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The arrangement, according to the report, addresses patient access to some medicines. Value assessment is also a key component […]
What Has Trump Accomplished on Drug Prices?
The Trump administration has been a vocal critic of prescription drug prices in the U.S., and has on numerous occasions vilified the pharmaceutical industry as being responsible for high prices. But what has the Trump administration accomplished on that front? Recent actions include requiring […]
FDA OKs Jacobus Pharmaceuticals’ LEMS Treatment
Following much controversy over Catalyst Pharma's decision to put a $375,000 price tag on a Lambert-Eaton myasthenic syndrome (LEMS) treatment that was originally being provided for free by Jacobus Pharmaceuticals, Jacobus has received the Food and Drug Administration's (FDA) green light on a […]
Podcast Outlines Potential Implications of Rebate Proposal for Pharma
A recent Relentless Health Value podcast spotlights what could be in store for the pharmaceutical industry as the Department of Health and Human Services continues to work on its proposal to eliminate rebate payments to pharmacy benefit managers. The podcast features Kuo Tong, managing director of […]
Report: Pelosi Working on Drug-Pricing Negotiation Proposal
Sources tell Inside Drug Pricing that House Speaker Nancy Pelosi's office is crafting a new drug-pricing negotiation bill that would work in arbitration in price negotiations between the Department of Health and Human Services (HHS) and pharma companies, InsideHealthPolicy reports. According to the […]
Trump Administration Gives Final OK to Drug Prices in TV Ads Rule
The Trump administration has given the final OK to a heated proposal that requires drugmakers to include a drug's list price in television ads, STAT reports. The proposal was finalized Tuesday, May 7. Officials have been working on the proposed rule since it was first discussed in May 2018. Per […]
Senate Committee to Host Hearing on Drug Pricing Reform
The Senate Judiciary Committee is slated to hold a hearing on drug pricing reform 10 a.m. Tuesday, May 7. Representatives slated to testify during the hearing, titled "Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition," include South Carolina Department […]
Sharpless Looks to Keep FDA on Current Track
Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless during two recent events showed interest, according to a Regulatory Affairs Professionals Society, in keeping the agency on a similar path as former chief Scott Gottlieb. Sharpless recently spoke at the Food and Drug Law […]
Trump Rebate Proposal Sees Mixed Reactions
The Trump administration's proposal to eliminate rebates between pharmaceutical companies and pharmacy benefit managers has seen a flurry of mixed reactions, but most key health care groups say Medicaid should be left alone, STAT reports. The administration argues that cutting out some of the […]
Policymakers Slam Trump’s Step Therapy Proposal
Republicans and Democrats on a House Energy & Commerce Committee subcommittee recently criticized the Trump administration's proposal to introduce step therapy into parts of Medicare, Modern Healthcare reports. The proposal, committee members said, could threaten patient access to key […]
Opinion: Take Advantage of Cost Effectiveness to Cut Prices
Cost effectiveness assessments should be more widely used as a way to wrangle rising drug prices, the author of a recent opinion piece published in The Inquirer writes. Using cost effectiveness is one solution that could help cut drug prices without creating conflict with the pharmaceutical […]
Trump, Dems Discuss Action on Drug Prices in Meeting
President Donald Trump and Democrats during a recent meeting agreed that both parties should work together toward bipartisan solutions to lower drug prices, The Hill reports. White House Press Secretary Sarah said the discussion at the White House meeting led to some agreement about meeting again […]
HHS Initiative Aims to Transition Primary Care Out of Fee-for-Service
The Department of Health and Human Services (HHS) on Monday, April 29, announced a new initiative which will look to move primary care out of a fee-for-service model and into a global fee model, according to a Modern Healthcare report. During an event in Washington, HHS Secretary Alex Azar said the […]
Trump: No Funding from Pharma for 2020
Gearing up for his 2020 re-election campaign, President Donald Trump last week said he would refuse any campaign contributions from pharmaceutical companies, FiercePharma reports. "They didn't give to my campaign," Trump said during an April 24 event in Atlanta. "They gave to a lot of other […]
CMS Looks to Tighten Gap on CAR-T Costs for Hospitals
The Centers for Medicare and Medicaid Services (CMS) this week proposed a new rule which could change how hospitals are reimbursed for high-cost CAR-T therapies, Axios reports. According to the report, hospitals can lose a significant amount of money on CAR-T therapies administered to Medicare […]
Post Outlines Cost Comparisons Between Medicare, Private Insurance Plans
A recent post by Skyview Development's Denny Weinberg outlines some of the arguments on cost comparisons between Medicare and private health insurance plans. Ultimately, Weinberg writes it's "nearly impossible" to establish a solid comparison between the two sectors. "However, it also appears […]
NICE to Discuss New META Module at Med-Tech Innovation Expo
The National Institute for Health and Care Excellence (NICE) is slated to discuss a new module to its Medtech Early Technical Assessment (META tool) during the upcoming Med-Tech Innovation Expo in Birmingham, U.K. Jeanette Kusel, director for the National Institute for Health and Care Excellence […]
Health Canada Increases Interest in RWE, Encourages Submissions
Health Canada is walking in tandem with the U.S. as it is looks to evaluate how it could better implement real-world evidence and tackle some key concerns, according to a Regulatory Affairs Professionals Society report. "We encourage RWE submissions (1) that aim to expand evidence-based indications […]
NHC Spotlights FDA’s Roadmap on Patient-Focused Outcome Measurement
The National Health Council (NHC) in a recent post outlines the Food and Drug Administration's (FDA) Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The council also recently hosted a webinar on the FDA's effort "to help researchers understand and then develop new or adapt […]
Report: Trump’s Push to Scrap ACA Would Interfere With Drug Pricing Efforts
President Donald Trump's latest effort to do away with the Affordable Care Act could throw a wrench in his goals of wrangling high prescription drug prices, according to a Bloomberg Law report. Eliminating the ACA would scrap a pathway, the Biologics Price Competition and Innovation Act, which […]
AARP Targets Pharma in Stop Rx Greed Campaign
AARP is putting increased pressure on the pharmaceutical industry after launching its Stop Rx Greed campaign last month, according to an MM&M report. The organization found in a survey before the campaign's launch that 72 percent of individuals age 50 and above expressed concern about the cost […]
New FDA Initiative Expands Testing of RWE
The Food and Drug Administration is launching a new initiative aimed at further testing use cases for real-world evidence by predicting the outcomes of randomized controlled trials, FierceBiotech reports. "This project will play a major role in determining the future of how drugs are developed and […]
BIO’s Greenwood: Transparency in Pharma Value Chain ‘Overdue’
Jim Greenwood, president and CEO of the Biotechnology Innovation Organization, in a recent column published on The Hill writes that increased attention by policymakers on pharmacy benefit managers is movement toward "overdue transparency within the pharmaceutical value chain." While PBMs were […]
PBMs Point Fingers at Pharma for High Prices
Representatives from the top pharmacy benefit managers looked to shift blame off itself for high drug prices onto pharmaceutical companies during a Senate Finance Committee hearing on Tuesday, CNBC reports. Five executives representing CVS Health, Cigna, Prime Therapeutics, Human and […]
Hospitals, Insurers Eye Drug Rebate Rule
Insurers and hospitals say the Centers for Medicare and Medicaid Services (CMS) should include in a recently-proposed rule some new requirements for pharmaceutical companies, Modern Healthcare reports. Organizations in response to the rule suggested that eliminating safe harbor for Medicare Part D […]
PBMs Testify Before Senate Finance Committee
Pharmacy benefit managers mostly dodged questions from policymakers during a Senate Finance Committee hearing Tuesday, STAT reports. However, Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) floated the possibility of legislative action. "Ranking member Wyden and I are committed to working on […]
PhRMA Responds to OIG’s Rebate Proposal
PhRMA on Monday, April 8, submitted comments on the Department of Health and Human Services Office of Inspector General's proposed rule for addressing the current rebate system. The rule, "Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe […]
