Hep C Discussion Forum

Hey Isis,

I like your documentation on the description of IFN ineligibility. However, I need to add one that you left off. Believe it or not, this is being considered a qualifying event. Ready for this? The patient that doesn't want to take Interferon or the subjects who were self-defined Interferon unwilling.. The fear of negative IFN side effects qualifies it for the list of considerations. After all of the anecdotal evidence, I support the addition of it. But the need for treatment still has to be an important consideration for recommending it. I'm one of the lucky one's to obtain SVR with an IFN backbone treatment. Were it not for IFN, I would be still waiting for the good news. The number of reports providing these types of considerations is growing overnight. I'm sure, aside from the proof of improved therapies, the manufacturers have been quick to condemn the older SOC's as well. The fact will remain though that IFN has provided great successes in the medical field and will continue to be utilized for years to come.

Tig

New Evidence (6/13)

 Intolerant patients are somewhat self-defined as patients who either stopped therapy because of adverse events (AEs) or had an AE that led a physician to discontinue treatment with IFN. The definition of an unwilling patient is very subjective and generally includes patients who have heard about the AEs associated with IFN and are not willing to take it. With careful monitoring and good counseling, most patients can get through IFN-based therapy but it can certainly be difficult for both the patient and the physician.

kurt wrote:

I think much has to do with the way your MD frames the requests. 

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I think you are right, Kurt.  Doctors generally play a key role in determining what meds will be paid for and hep c tx is no exception.  

Some doctors are "warehousing" patients who are willing and able to wait for newer treatment options. For deciding what to prescribe now doctors are following guidelines promulgated by medical societies; specifically they are following the recommendations set forth by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA).  (I am speaking of  US physicians; I don't know how they are handling this in other countries.) The guidelines can be viewed at:  www.hcvguidelines.org 

For those who are genotype 1 your doctor will, in all likelihood, need to determine that you are "Interferon Ineligible" to get third party payers to pay for the off label combo.  The medical guidelines define "Interferon Ineligible" and docs have some discretion in interpreting and applying this definition.  Some doctors will be liberal with their interpretations while others will be conservative.   Insurance providers should have guidelines that parallel the medical guidelines or simply defer to medical guidelines.  

IFN ineligible is defined as one or more of the below:

• Intolerance to IFN
• Autoimmune hepatitis and other autoimmune disorders
• Hypersensitivity to PEG or any of its components
• Decompensated hepatic disease
• Major uncontrolled depressive illness
• A baseline neutrophil count below 1500/L, a baseline platelet count below 90,000/L or baseline hemoglobin below 10 g/dL
• A history of preexisting cardiac disease

As you can see the definition of "Interferon Ineligible" is designed to limit off label prescriptions to patients on a "need" basis.  People who have treated unsuccessfully with Interferon before and/or who have more severe liver disease are most likely to be approved.  

Having said that, some creative interpretation by a physician will go a long way with getting an insurance company to pay, and many doctors are willing to go the extra mile for their patients as long as the believe it is not in opposition to their patients' interests to do so.  Other doctors are not so willing, particularly when there are newer and possibly better treatments on the horizon.