Fair Access to Cancer Treatment (FACT) Act

Today I am going to discuss oral cancer treatment insurance coverage and what we do and do not know about Ibruvica (formerly ibrutinib, formerly PCI-32765).

The Fair Access to Cancer Treatment (FACT) Act addresses outdated insurance company benefits that have not kept up with the times. Cancer treatment is cancer treatment – whether it is given intravenously or orally. Physicians and patients should be given the choice of cancer therapy based upon their best chance of survival. Today patients are forced to choose a less appropriate treatment option because of insurance coverage.

The Leukemia and Lymphoma Society is working to communicate this message to state legislators. I am asking those who understand the benefits of drugs like Ibruvica and Gleevac (which was FDA-approved years ago for CML patients) to call their representatives and senators to educate them on the FACT initiative.

As you recall, I began the clinical trial with Ibruvica 18 months ago at the National Institutes of Health. I was untreated, 17p deleted, chemo-resistant, symptomatic, and having less than 1% chance of finding a bone marrow donor. The risks of taking the drug outweighed any other cancer treatment for me personally. What are the long-term risks? How long before the drug stops working? What then? These are questions in which we have some answers based on educated guesses and scientific knowledge, and no definitive answers for others.

This is what we do know:

1.    1.  Ibruvica is a kinase inhibition drug that permanently and irreversibly blocks Bruton’s Tyosine Kinase (BTK) and Interleukin 2 Inducible T-cell Kinase (ITK) for specific cells daily. Translation: BTK is hijacked and T-cells are altered. Kinases are used in the normal cell functioning. The cancer cell that won’t die gets the message to die, regardless of prognostic markers (17p, 13p, trisomy 12, 11q).

2.     2. The drug begins to shrink lymph nodes within 24 hours.

3.     3.  Frontline patients on Ibruvica fare better than frontline patients on chemotherapy, because healthy B-cells are not destroyed in the treatment.

4.     4. The drug must be taken on a daily basis in order to work.

5.     5.  Ibruvica will probably cost over $100,000 per year.

6.     6. Insurance companies provide less coverage (if any at all) for cancer treatment drugs administered by mouth than they do for cancer treatment administered intravenously.

7.     7. Ibruvica is not a cure, but after four and a half years of clinical trials, many frontline patients have received partial remission. A few have received complete remissions, but there is not 100 percent progression free survival (PFS).

8.     8. The good news: There are several new oral drugs in the clinical trial pipeline that will offer options for patients who relapse.

What we don’t know:

1.     1. We do not know how this drug affects one’s ability to make novel antibodies to new health threats or what it does to one’s adaptive immune system on a long-term basis.

2.     2. We do not know how long the drug will continue to work before the cancer finds a new path.

3.     3. We don’t know what the health insurance companies will do with the payment of this drug.

In summary, taking a cancer treatment by mouth or intravenously are both viable options. So let’s offer access to cancer patients.