Examining accelerated approval of cancer drugs
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Monday, September 19, 2022 | The Latest Research, Commentary, And News
From Health Affairs
Dear John,
This week is Peer Review Week
, and to
celebrate, Health Affairs Executive Editor Don Metz will host a
Professional Development event tomorrow for Health Affairs Insiders,
"Criticism Is Critical: Introduction To Peer Review.
"
Accelerated Approval Of Cancer Drugs
The US Food and Drug Administration's (FDA's) accelerated Approval
Program allows for expedited approval of drugs that treat serious
conditions, and that fill an unmet medical need so long as they meet a
surrogate endpoint.
Surrogate endpoints are markets or measures that are thought to predict
clinical benefit, but are not themselves a measure of clinical benefit.
Richard Frank and coauthors hypothesize that positive confirmatory
trials should increase the price of cancer drugs
that were originally approved on the basis of limited evidence through
the FDA's accelerated approval process, as the efficacy of those drugs
has now been demonstrated.
Yet, analyzing Medicare Part B data from 2012-2018, the authors find
no price effect.
The authors indicate that this is a failure in the market that
undermines a key economic incentive for drug companies to conduct and
complete confirmatory trials for cancer drugs approved through the
FDA's accelerated pathway.
In their article, Frank and coauthors describe two pathways to remedying
this situation.
Read More
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Elsewhere At Health Affairs
Today in Health Affairs Forefront, Beth Shyken-Rothbart and Derek Ayeh
write that Medicare's appeals system can be a significant barrier to
accessing care. The authors argue that that appeals processes must be
improved in order to realize Medicare and Medicaid integration
.
This article is part of the Forefront series
, produced with the support
of Arnold Ventur e
s , on
Medicare and Medicaid Integration.
Richard Hughes IV and Kala Shankle discuss how access to Paxlovid may be
limited
by a requirement that pharmacists access patient records and the absence
of a pathway to reimbursement for the required patient assessment.
Are you enjoying articles from Forefront? Join Health Affairs Insider
to show your support for high value health policy news, commentary, and
analysis.
[link removed]
Daily Digest
Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers
That Conduct Confirmatory Trials
Richard G. Frank et al.
Integrated Appeals Are Essential, But Challenges Remain
Beth Shyken-Rothbart and Derek Ayeh
Pharmacists Can Now Prescribe Paxlovid, But Barriers Persist
Richard Hughes IV and Kala Shankle
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