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Cancer Pathways Will Help Inform Drug Performance Measures, Payers Say

 
• By Cathy Kelly

Over the last two years, UnitedHealthcare and Aetna have launched cancer pathway programs with the overall goals of standardizing and improving care and lowering cost. Drug therapy is a key focus.

Current payer experiments with standardized oncology care programs known as cancer pathways aim to develop an information base that would enable better comparisons of chemotherapy drug performance, executives with UnitedHealthCare and Aetna Inc. said during a March 20 webinar sponsored by research and consulting group Value & Innovation.

UnitedHealthcare and Aetna are among the larger payers now involved in sponsoring versions of cancer pathway programs. Over the last...

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Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes

 
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Heavy lobbying produced relief for orphan drugs in President Trump's budget reconciliation law and the cost of the changes to Medicare now is becoming clearer.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 
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A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

Australian Govt To Start HTA System Overhaul – One Year After Major Review

 
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The Australian government says it is taking “immediate actions” to overhaul its health technology assessment system. This will include updating guidelines around using the lowest cost comparator drug in HTAs, a practice that industry has long opposed.

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

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EU Critical Medicines Act May Include Investigational Products & Mandatory Redistribution Measure

 
• By Neena Brizmohun

The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 
• By Eliza Slawther

A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.