Household income too high for compassionate access! Advice?
 

My doctor recommended Opdivo this week since I'm developing a resistance on Halaven. He said it's available whenever we need it so we decided it's our next drug. The office called me today saying the pharmaceutical company is asking for 2014 tax return to determine my eligibility- in other words, it's income based. I know our household income is above their limit but how much money do you have to make to afford $15,000/month medicine, not knowing if Opdivo will work for me. Plus my husband and I got married in 2014 and added me to his insurance. Our finance is separate although we filed jointly. So I'm pretty stuck here. I hate to get a divorce just for that reason but what else can I do? Did anyone else run into the same situation? Pls put in your advice. Thanks!!

Re: Household income too high for compassionate access! Advice?
 

yanyan,

You stated that you are now on your husband's insurance. Have you checked to see if they will cover it? If they won't I know that there are appeal procedures that can be used. I did use an appeal process years ago to get the insurance company to pay for a very expensive drug for my husband. It was a pain but it did get approved.

Good luck,
Brenda

Re: Household income too high for compassionate access! Advice?
 

It's been a wide-spread problem. Hopefully they will fix it soon. Call your local Congressman and Senate‘s office. They should have staff who can work it out on your behalf.

Clin Cancer Res. 2015 Oct 15;21(20):4561-8. doi: 10.1158/1078-0432.CCR-14-3246.
The Urgent Need for Clinical Research Reform to Permit Faster, Less Expensive Access to New Therapies for Lethal Diseases.
Stewart DJ1, Batist G2, Kantarjian HM3, Bradford JP4, Schiller JH5, Kurzrock R6.
Author information
Abstract
High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs. If it is exorbitantly expensive to bring new therapies to approval, fewer agents can be developed with available resources, impeding the emergence of urgently needed treatments and escalating prices by limiting competition. Excessive regulation produces numerous speed bumps on the road to drug authorization. Although an explosion of knowledge could fuel rapid advances, progress has been slowed worldwide by inefficient regulatory and clinical research systems that limit access to therapies that prolong life and relieve suffering. We must replace current compliance-centered regulation (appropriate for nonlethal diseases like acne) with "progress-centered regulation" in lethal diseases, where the overarching objective must be rapid, inexpensive development of effective new therapies. We need to (i) reduce expensive, time-consuming preclinical toxicology and pharmacology assessments, which add little value; (ii) revamp the clinical trial approval process to make it fast and efficient; (iii) permit immediate multiple-site trial activation when an eligible patient is identified ("just-in-time" activation); (iv) reduce the requirement for excessive, low-value documentation; (v) replace this excessive documentation with sensible postmarketing surveillance; (vi) develop pragmatic investigator accreditation; (vii) where it is to the benefit of the patient, permit investigators latitude in deviating from protocols, without requiring approved amendments; (viii) confirm the value of predictive biomarkers before requiring the high costs of IDE/CLIA compliance; and (ix) approve agents based on high phase I-II response rates in defined subpopulations, rather than mandating expensive, time-consuming phase III trials. Clin Cancer Res; 21(20); 4561-8. ©2015 AACR.See all articles in this CCR Focus section, "Innovations to Speed Drug Development."

Re: Household income too high for compassionate access! Advice?
 

FInd out from the company the exact amount - they are usually on your side for drug assistance. Then, meet with your accountant and see what kind of a statement he/she can provide, that documents income WITH medical deductions, etc. There are different kinds of statements that accountants can provide, that show profit and loss, and perhaps this will help you qualify if presented in context. I am crappy with numbers but make sure that I have good advisors :)

Re: Household income too high for compassionate access! Advice?
 

Thank you ladies for your input! We are waiting for my insurance company to make a decision. It's scary without any treatment while we are waiting but it doesn't make sense to have me continue on a drug that is already failing on me. Hopefully I'll get lucky with the insurance. If not I'll have to provide a hardship letter. My husband does our tax return because our income is pretty cut and dry.. Easy calculation with turbo tax. We did file joint return for 2014 the year we got married so it's hard to prove our finance is separate. Like many others we are the ones that get stuck in the middle :(