Navigation Links
IROs Help Decide Medically on Approved Uses of Off-Label Drugs for Cancer
Date:3/24/2009

LANSDALE, Pa., March 24 /PRNewswire/ --- As the Food and Drug Administration (FDA) approves new cancer fighting drugs for the market, researchers often study their use for non-approved, or off-label, treatments. When the studies show promise for combating other forms of cancer, physicians may prescribe these drugs to patients. By some estimates, nearly 20 percent of all drugs prescribed in the United States are for off-label use. Oncologists prescribe cancer drugs off-label about 60 percent of the time.

"Researchers continually explore the effectiveness of off-label drugs on cancer, which changes the boundaries of the standard of care," said Joyce Muller, president of NAIRO, a national trade organization of independent review organizations (IROs). "Because cancer drugs are often expensive, off-label use requires that health plans look closely at whether these drugs meet plan language for patient reimbursement or are investigational or experimental."

What is Off-label Use?

The FDA approves a drug for a specific treatment and considers any other use "off-label." Because applying for FDA approval is expensive, it often doesn't make financial sense for the drug manufacturer to pursue multiple uses. Although the use of many drugs off-label has been thoroughly researched and often considered the standard of care, this doesn't mean the FDA approves their off-label use.

A few promising cancer drugs are approved by the FDA for multiple use, including Avastin, Revlimid, Imatinib and Erbitux. For example, the agency initially approved Avastin for metastatic colorectal cancer. Then later it approved the drug for non-small cell lung cancer (2006) and breast cancer (2008). Used off-label, however, some doctors see Avastin as a "miracle drug" and may prescribe it for treating other cancers, including prostate, renal cell, head and neck, pancreatic, ovarian and hepatocellular.

Determining Appropriate Off-label Use

Deciding whether an off-label drug is medically necessary for cancer, matches health plan language and is the standard of care requires an oncologist specializing in that specific treatment. "When a drug's off-label benefits are supported by the latest peer-reviewed medical literature, it alters the standard of care," Muller said. "Through an IRO, payers can access oncologists up-to-date on the latest off-label cancer drug studies."

How a drug was studied can be an issue, however. To determine the validity of a study, an oncologist must understand its parameters, including its clinical characteristics, current laboratory studies and monitoring studies. Because IROs provide oncologists who also work at leading research centers, they can determine which studies support off-label drug use as the accepted standard of care for plans. This helps health plans and UR professionals approve or deny patient reimbursements based on the latest medical evidence, as well as update their plan language and coverage policy. This may reduce the number of appeals for off-label drug coverage and any associated administrative costs a plan incurs.

"When deciding if it's appropriate to reimburse patients for using off-label cancer drugs, health plans should tap into the oncology expertise of an IRO," Muller said. "Because plans cannot afford to hire every oncology specialist needed, an IRO can provide supporting evidence that will show whether the off-label use is experimental, investigational or the standard of care."

For help finding an IRO to review the off-label use of cancer drugs, contact NAIRO (www.nairo.org).

About NAIRO

NAIRO works to promote the value and integrity of the independent medical review process. Its members embrace an independent, evidence-based approach to medical review for resolving coverage disputes between enrollees and their health plans. For more information, visit www.nairo.org.


'/>"/>
SOURCE NAIRO
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Genetics Should Decide Warfarin Dose, Study Reiterates
2. Trying to Decide? Forget the Facts and Phone a Friend
3. Genes May Decide Which Smokers Get Lung Disease
4. Popular or Not? Your Genes May Help Decide
5. Decide for Me When I Cant, Most People Say
6. Undecided Voters Not So Undecided After All
7. CSHL neuroscientists glimpse how the brain decides what to believe
8. Which Candidate Has the Perfect Smile, Senator Obama or McCain? TransMedia Group to Publicize Special Election So Florida Voters Can Decide
9. Democrat Mike Turner Backs Single-Payer Healthcare; Opponent Feder Undecided
10. Men Can Take Their Time to Decide on Prostate Cancer Treatment, Reports the Harvard Mens Health Watch
11. Who Decides How to Save Your Life?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... , ... October 13, 2017 , ... The American Board ... become its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon ... beginning July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the Law ... organization of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our ... a forum to network with elder law attorneys nationwide,” said Somekh. , ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Ellevate Network, ... in business to advocate for action towards gender equality at their inaugural Summit in ... around the globe, and reached a social audience of over 3 million. To watch ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/7/2017)... Texas , Oct. 6, 2017   Provista, ... with more than $100 billion in purchasing power, today ... news and information. The Newsroom is the ... and industry trends, infographics, expert bios, news releases, slideshows ... having access to a wealth of resources at their ...
(Date:10/4/2017)... LAWRENCE, Mass. , Oct. 4, 2017 /PRNewswire/ ... developer of single-use, self-contained, illuminating medical devices, today ... National Health Surveillance Agency (or Agência Nacional ... ®. The first single-use, cordless surgical retractor with ... ONETRAC provides optimal access, illumination and exposure of ...
Breaking Medicine Technology: