The $84,000-a-patient cost of the Sovaldi hepatitis C treatment has intensified a national debate among lawmakers, insurers and economists about the value of expensive medicines to society at large. The dilemma sparked by Sovaldi, which is made by Gilead Sciences, GILD +0.74% is also presenting hard choices to state Medicaid programs. In Illinois, for instance, officials recently instituted a new set of 25 stringent criteria for using Sovaldi that includes treating only those patients with the most advanced stage of liver disease and limiting treatment for those with a history of drug use and alcohol abuse.
The Journal spoke with Arvind Goyal, medical director for the Illinois Department of Health Care and Family Services, about the process. Edited excerpts:
WSJ: What was your reaction when you heard about the Sovaldi price?
Dr. Goyal: If I were a patient who needed Sovaldi, I imagined what I would do about a 20% deductible, which would cost me $200 a day for 12 weeks. The state doesn't pay me that well... . My second reaction, at the time, was I could see a problem coming. We began to notice the number of requests for prescriptions going up. And nearly three months after Sovaldi hit market in January, we had 186 requests. None were denied and it was costing the program upwards of $1 million a week.
WSJ: How did you respond once you saw what was happening?
Dr. Goyal: When we learned the price, we decided to look at the quality of their studies and the research provided to FDA to understand the basis for thinking Sovaldi was for everybody and was equally effective. We had questions, because in the Medicaid population, many of the people we serve are minorities, and these people were not included in research that was conducted. We did not feel the drug was made for everybody with a diagnosis of hepatitis C.
So we could not see everybody getting a prescription, just because their own data says it's effective about 90% of the time. The previously used drugs were effective 75% to 80% of the time. There's an edge for Sovaldi, but is it effective for population we serve? We can't answer that today. Many of our patients have co-morbidities and take other meds. We did not find evidence that Gilead did research on that type of population.
WSJ: Tell me about your Medicaid population? How many have hepatitis C?
Dr. Goyal: There are 12 million people living in Illinois, and we have 2.9 million-plus on Medicaid at this moment. That's about one of four individuals on the street. Of those, I am extrapolating... but if you look at Medicaid numbers nationally, I would say 250,000 to 300,000 in our state. It's my wild guess.
WSJ: Tell me about the spending.
Dr. Goyal: In the previous year, we spent $6.7 million for all hepatitis C therapies. In the first six months of this year, we have spent between $22 million and $23 million, which includes Sovaldi. Of that, $16 million plus was on Sovaldi alone, through June.
WSJ: How did you come up with the criteria for your policy?
Dr. Goyal: We recognized…in January and we resolved by beginning of April something had to be done but it must be rational, responsible and compassionate. So we assembled a team. We analyzed the package insert approved by the FDA, the research literature, and we spoke with other states and shared information. We vetted the criteria not only internally but with a hepatitis C legislative task force that was appointed by the Illinois legislature before and after we developed the criteria.
WSJ: Let's talk about the restrictions. One mentions patients can't have been abusing drugs or treated for alcohol or illicit drugs for 12 months prior to requesting Sovaldi. But during that time, those folks who go untreated can transmit the virus to others.
Dr. Goyal: Remember that one-third of the population for which we were approving Sovaldi take drugs or alcohol, and nobody ever studied if Sovaldi could be safe or effective for such people. But the disease can be dormant and not show symptoms or signs for up to 30 years after getting in the system. Why is it so bad to tell them they should be sober and take the drug in a dependable fashion? If someone is using a street drug such as heroin I can't be sure they are compliant taking Sovaldi. It's a total waste.
WSJ: There is also a requirement for a score of four, which means only the sickest patients are eligible to be treated with Sovaldi. That's very limiting, yes?
Dr. Goyal: Yes, that's right. They must have the most advanced stage of liver disease. But the idea is not to find an excuse to withhold service.
WSJ: Is prior authorization really another form of rationing?
Dr. Goyal: Look, if I want to buy furniture or a refrigerator or a car, I don't go blindly to the market with a credit card and buy this no matter what. Do you? So the answer is that cost versus benefit is on our minds constantly whenever we're shopping... I am torn. On one hand, I recognize that everybody should be able to get reasonable medical services without thinking of cost when they're sick. Life is much more precious than that. On the other hand, if we decide that the cost doesn't matter because someone else is paying for it, then we've become irresponsible and irrational.
You can do rationing blindly where your purpose is to only cut cost and not worry about anything else or you can do so in a manner where you don't hurt the patient and in a reasonable fashion where it serves the most people in the most compassionate manner.... You need to weed out those on the fringes where use may not be appropriate or another treatment may come out of the pipeline at a better cost and do a better job. Criteria can help us decide who should be treated today versus those who can be treated with medications that come out next year. Sovaldi may not be the best treatment.
Write to Ed Silverman at Ed.Silverman@wsj.com


I Team Italia says

Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.
Ristori G, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P, Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M, Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti M.
Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
PMID:
24306002
[PubMed - indexed for MEDLINE]
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BCG is safe, cheap and effective for a variety of purposes. See eg faustmanlab.org and pubmed.org faustman dl.

In Illinois, the only thing that is safe, cheap and highly effective is ammunition. Shoot BCG or blow  your your brains out after spending all your money and expensive drugs  see also Gilenya

Here is to the holes in the heads and not the brains