I'm wondering if going from 740 to 750, if some of

I'm wondering if going from 740 to 750, if some of those 10 extra patients were from the Expanded Access Program for Leronlimab. I assume once leronlimab is approved for combo, there will be patients that push their doctors to use leronlimab for cancer (I know I would want to check if it is ccr5 positive if I had cancer)


I've been researching off-label. It seems oncology off-label is a mess. I read that oncology, HIV, and pediatrics is the three that use the most off-label. For reference below, I tried to look up the compendium for biomarkers at https://www.nccn.org/professionals/biomarkers/default.aspx but it requires an account
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https://www.cancer.org/treatment/treatments-a...g-use.html

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Reimbursement

The biggest problem is getting insurance plans to pay (reimburse) for off-label drug use. Many insurance companies will not pay for an expensive drug that’s used in a way that’s not listed in the approved drug label. They do this on the grounds that its use is “experimental” or “investigational.”

In cancer treatment, these issues have been largely addressed through 1993 federal legislation that requires insurance to cover medically appropriate cancer therapies. This law includes off-label uses if the treatment has been tested in careful research studies and written up in well-respected drug reference books or medical journals. In 2008, Medicare rules were changed to cover more off-label uses of cancer treatment drugs.

Still, the health insurance coverage laws and regulations are complex. If your doctor is thinking about off-label drug use, you and your doctor should carefully check your health plan’s coverage. If you are denied coverage, it might help if the doctor sends the insurer copies of peer-reviewed journal articles or other respected sources that support the off-label use.

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https://www.cancer.gov/about-cancer/treatment.../off-label

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Health Insurance Coverage of Off-Label Drugs in Cancer Treatment

Medicare and many insurance companies pay for off-label drugs for cancer treatment, as long as the off-label uses are listed in an approved compendium . A compendium is a collection of drug summaries put together by experts who have reviewed data about the drug’s use in patients.

If your doctor prescribes an off-label drug for your treatment, check your plan to make sure the drug is covered. If coverage is denied, it may be helpful for the doctor to provide the insurance company with copies of documents that support the suggested off-label use.

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https://www.cancertodaymag.org/Pages/Summer20...erapy.aspx

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Payment Pushback

Off-label use of drugs can raise financial and logistical concerns for patients. By law, Medicare is required to cover any off-label treatment that is supported by one of five compendia. These reference guides, published by private organizations such as the NCCN, recommend therapies based on clinical evidence. Private insurers determine which drugs they will cover off-label on a case-by-case basis, but they usually do cover treatments that are considered standard.

Patients whose claims for off-label drugs are denied can go through the appeals process with their insurance company. This may include providing evidence of the drug’s effectiveness in the form of research papers or conference presentations. At the same time, patients may want to apply for financial assistance from the drug manufacturer. Each drug company handles financial assistance differently, but patients may need to supply information on their finances and income.

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https://www.healio.com/hematology-oncology/pr...k-evidence

Researchers: Off-label cancer treatment recommendations often based on weak evidence

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Prasad and colleagues sought to determine the differences between recommendations by National Comprehensive Cancer Network (NCCN) guidelines and FDA approvals of 47 molecular therapies the FDA approved between 2011 and 2015 for adult hematologic or solid cancers.

During the period analyzed, FDA approved these therapies for 69 indications; however, NCCN recommended those same therapies for 113 indications.

Of note, FDA did grant additional approval for six (14%) of the additional NCCN-recommended uses during a 21-month follow-up period.

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