Prevision Policy Clips | Novartis Launches New Era For Curative Gene Therapy With New Price Milestone

First Amendment Challenge To Trump DTC Price Disclosure Rule Under Debate: First Response Is “Comply With Context”

Prevision Policy Clips | Friday, May 24, 2019

Part D Government Share In Catastrophic Slides Down To 20%, Co-Pay Caps For Beneficiaries In High-Cost Range Included In High-Level Bipartisan House Bill

FDA Benefit-Risk Discussions With Sponsors Should Occur Early In NDA/BLA Process: Addressing When And How May Be Topic For 2020 Guidance

Senate Health Discussion Draft Would Mandate 100% Rebate Sharing By PBMs; Drug Price Reforms Focus On Limited FDA Patent Process Issues

“Patent Thicketing” Bill Relies On Tangled Definitions, Thin Prospect Of FTC Intervention; Start Of Conversation – Or Sign That Legislation Won’t Work?

Prevision Policy Clips | HHS Accelerating Medical Product Development Hearing June 20-21

Rebate Rule And Part D Bids: CMS Offers More Guidance To Plans Amid Uncertainty About Key Pricing Policy

Biosimilar Comparative Analytical Assessment Guidance Includes Recommendations To Test For Variability Of Reference Products, Use Of Ex-US Reference Products

Prevision Policy Clips | Rebate Final Rule Will Not Be Out Before Part D Bids Are Due, CMS Confirms

Drug Price Transparency: Murky Outlook For Justification Bills After House Hearing, But Federal Pre-Emption Could Be Attractive For Pharma

“Parent-Child” IND Framework For Cell-Based Therapies Proposed In FOCR White Paper; Flexible Manufacturing Standards Are Key For Sponsors

Prevision Policy Clips | Mallinckrodt Acthar Medicaid Rebate Dispute With CMS Goes Public; “Re-Pricing” Model

Drug Price Increase Justification Bills Will Be Discussed In House Hearing; Other “Transparency” Measures More Likely To Move Forward

Prevision Policy Clips | Seven Drug-Pricing Bills on Deck for E&C Legislative Hearing Tomorrow

Gilead CEO O’Day Calm Under Fire In Defense Of Truvada PrEP Price At AOC-Driven House Oversight Hearing

Protected Classes Stay Protected: Formulary Rules For Medicare Part D Unchanged For 2020 Under New Rule; Price Transparency Tool Pushed To 2021

FDA Oncology Expanded Access Program (“Project Facilitate”) Will Launch Later In May; Agency Will Track Requests, Reasons For Denial

Prevision Policy Clips | Protected Classes Stay Protected, Again: CMS Does Not Finalize Part D Formulary Changes

Prevision Policy Clips | Aimmune Peanut Allergy Therapy Heads To Advisory Committee September 13

CMS Tries To End “Spread” Pricing In Medicaid Managed Care; Guidance Makes Clear Drug Rebates Must Be Accounted For In Medical Loss Ratio

Quiz Fails ODAC Test: Daiichi Refractory Leukemia Therapy Quizartinib Needs More Efficacy Data After Negative Vote, “Pazdur Moment”

Daiichi Turalio (Pexidartinib) Gets Strong 12-3 Benefit/Risk Vote From ODAC; FDA Gets Support For Liver Warning, Monitoring – Future Actions If Needed

Prevision Policy Clips | Drug Supply Chain Transparency Bills Will Be Focus Of House Subcommittee May 21