Hep C Discussion Forum

Isiscat2011 · Guru

RE: CVS Reports 8% Discontinuation of Sovaldi

Isiscat2011 · Guru

Good question, Gator Man. Cost is certainly part of the equation but remember also that the S/O combo is off-label. Many docs were hesitant to prescribe off-label because it had not been well studied. Off label raises concerns not only about efficacy and safety but also potential legal concerns for docs in clinical practice.

When Sovaldi was first approved there was much discussion at the FDA hearings ( the transcripts are available if you are interested) about the need for an interim tx for the sickest patients who could not wait for the S/L combo. It was known at that time that the all orals would be arriving by the end of 2014. The FDA actually cut Gilead a ton of slack in terms of the testing it had performed at that point, thus, giving its detractors plenty of ammunition to complain about the lack of evidence.

When you read the transcripts you get a real sense that what the committee wanted to accomplish when it approved Sovaldi (and Olysio at about the same time) was to make something available that was an improvement over the first gen protease inhibitors, because they were proving to be problematic, especially for the sicker patients. There was actually a bit of desperation to replace the Interferon combos asap. The same committee members who had voted to approve the first gen PIs were voting to approve Sovaldi. Very interesting stuff.

The idea of warehousing the less sick to wait for the all orals was already in the works when Sovaldi and Olysio were FDA approved. It wasn't so much a question of cost, however, but a question of efficacy and safety for the docs in clinical practice. I don't think docs are directly concerned about cost; they are concerned to the extent that payers may not cover it. If by "health care industry" you also mean the insurance industry then, yes, they probably are hoping costs will decrease.

Gator Man · Senior Member

Isiscat2011 wrote:
The CVS Report has gained some momentum in the media. No doubt CVS's agenda includes cost containment (nearly all who prepare studies have a vested interest). 8%, however, is actually a very low number and a vast improvement over the discontinuation rates prior to Sovaldi--which was a reported 54%.
http://www.washingtonpost.com/blogs/wonkblog/wp/2014/09/18/the-new-84000-hepatitis-c-treatment-is-losing-momentum-for-now/

Figure 1 in the article shows approximately twice the initial demand with Sovaldi as compared to Incivek's roll out in 2011 with CVS, but still under 10k patients. It surprises me that even with the cost of Sovaldi and Olysio, only a small percentage of HCV patients have been treated in the last 9 months, particular at ~90-95% effectiveness with potentially 3+ million sufferers in the U.S. alone. Is the health care industry that confident that tx costs will significantly decrease in the near future with new DAAs and there will be more "bang for the buck"? We are at the small tip of a very big iceberg; the cost is going to be in the billions no matter how many DAAs are available.

-- Edited by Gator Man on Tuesday 23rd of September 2014 10:13:19 PM

Isiscat2011 · Guru

The CVS Report has gained some momentum in the media. No doubt CVS's agenda includes cost containment (nearly all who prepare studies have a vested interest). 8%, however, is actually a very low number and a vast improvement over the discontinuation rates prior to Sovaldi--which was a reported 54%.

http://www.washingtonpost.com/blogs/wonkblog/wp/2014/09/18/the-new-84000-hepatitis-c-treatment-is-losing-momentum-for-now/

tomyboy · Senior Member

Well said Isascat. There is definitely a stigma related to hep C and my Tom and MANY others we know are infected are hard working people who either made a mistake while they were young, or not quite sure where they contacted the virus. Not all are drug addicts and shouldn't be subject to the stigma that comes from it. Although the treatment is very expensive, everyone should have the opportunity to live a healthy life.

Huey · Guru

Isiscat2011 wrote:
I don't think it is constructive to consider it a question of blame, which is probably why I find it so irritating to constantly read the media reports suggesting that the infected population is comprised primarily of drug abusers who are diverting public health funds away from the more deserving people (and will naturally often fail to adhere to the tx protocol). Not to mention the prisoners!
I recall having this conversation with my PCP. He asked me if I thought there was a stigma attached to HCV to which I responded, "absolutely." He agreed but also said that none of his patients who are seeking tx fall into that category. The overwhelming majority, he concluded, are responsible baby boomer aged people who work and support families. This seems closer to the reality to me.
The fact is HCV tx drugs are not perfect nor is the delivery system. That isn't an assignment of blame, however, but an acceptance of the reality. Hopefully, if HCV patients understand that they will be able to deal with the obstacles better.

-- Edited by Isiscat2011 on Friday 19th of September 2014 07:42:20 PM

Absolutely!

Isiscat2011 · Guru

I don't think it is constructive to consider it a question of blame, which is probably why I find it so irritating to constantly read the media reports suggesting that the infected population is comprised primarily of drug abusers who are diverting public health funds away from the more deserving people (and will naturally often fail to adhere to the tx protocol). Not to mention the prisoners!

I recall having this conversation with my PCP. He asked me if I thought there was a stigma attached to HCV to which I responded, "absolutely." He agreed but also said that none of his patients who are seeking tx fall into that category. The overwhelming majority, he concluded, are responsible baby boomer aged people who work and support families. This seems closer to the reality to me.

The fact is HCV tx drugs are not perfect nor is the delivery system. That isn't an assignment of blame, however, but an acceptance of the reality. Hopefully, if HCV patients understand that they will be able to deal with the obstacles better.

-- Edited by Isiscat2011 on Friday 19th of September 2014 07:42:20 PM

wmlj1960 · Moderator

Gator Man wrote:
My doctor, who participated in the initial COSMOS study and had other off label patients like myself, told me was aware of a few patients who quit tx with S/O primarily for personal reasons unrelated to sx. We have to keep in mind that many who suffer from HepC are still battling their substance abuse demons and dealing with the collateral problems that it creates. Not always the best group to get strict adherence to tx protocols.

Very true. I try to keep this condition in mind for my own situation especially when it comes to staying in compliance with my Tx guidelines and for what to blame Sx's on. Usually, when all of the facts are considered, most of the blame usually gets rightfully put on a worn out, long-time abused body and on a history of low priority to healthcare, including 20+ yrs of poor HIV Tx management, and also the fact that in 53 yrs I have seldom followed a major decision with 24 weeks (in my Tx case) of adherence to the rules. And I'm not in a clinical trial where activity is much more closely monitored than my real world actions are = very limited.

Although Tx is different for each individual case, in my opinion, too much blame is placed on Rx's and not enough on 'real world' circumstances. Hence I take this into consideration when viewing most of these %'s being reported.

Isiscat2011 · Guru

Tig56 wrote:
I think more effort should be made to encourage people to stay the course once the decision to treat is made. Patients need to be made aware of the potential for SFX, what they might be and how to handle them. Handing a patient two bottles of medication and an order for blood work in two weeks is woefully short of what's required (monitoring), especially during the first half of Tx.

I agree, Tig. IMHO, minimizing the potential difficulties of tx does a disservice to people who are considering tx. Patients should be aware that side effects can be harsh for some people and that being on tx can intefer with work and other aspects of daily life. The idea that these meds are a miracle in a bottle, and all one needs is to get their hands on the miracle, needs to be tempered by a bit of realism.

I particularly find distasteful the idea that the patient group is somehow compromised due to their substance abuse problems and have seen no evidence to support this assertion. Also, the CVS study had established criteria and included only those who had contiguous eligibility to the tx drugs via CVS. A mid tx change in pharmacy, therefore, seems an unlikely explanation :

"We identified all patients who were continuously eligible and started a Hepatitis C regimen with Sovaldi on or before 5/15/14 in order to assess rates of discontinuation or completion of the regimen."

Gator Man · Senior Member

maddie wrote:
I'm kind of surprised the percentage is so high in the S/O group. Maybe some of these are people forced to change Rx providers in middle of tx? Or some due to non compliance? I just think that 4.2% is high for medications with few sides that are not tolerable. Hmmm??

I was actually forced to change my Rx provider from a local specialty pharmacy to CVS Specialty after the initial 28 day period. Some of you may recall a few of my posts about how CVS was not going to fill my final 4 weeks of S/O until I got the HR department with the plan administrator to override their decision. My doctor, who participated in the initial COSMOS study and had other off label patients like myself, told me was aware of a few patients who quit tx with S/O primarily for personal reasons unrelated to sx. We have to keep in mind that many who suffer from HepC are still battling their substance abuse demons and dealing with the collateral problems that it creates. Not always the best group to get strict adherence to tx protocols.

Tig · Admin

It will be interesting to monitor these numbers going forward. Using a totally unscientific method of determination (a hunch), these people would likely have discontinued Tx regardless of protocol if the side effects of Sovaldi + ? were responsible. I think more effort should be made to encourage people to stay the course once the decision to treat is made. Patients need to be made aware of the potential for SFX, what they might be and how to handle them. Handing a patient two bottles of medication and an order for blood work in two weeks is woefully short of what's required (monitoring), especially during the first half of Tx.

Tig

TomF · Member

>>I'm kind of surprised the percentage is so high in the S/O group.

Maybe they ran out of money?

maddie · Senior Member

On page 2 of the link it states "Among those patients who began Sovaldi in combination with other medications, Sovaldi

discontinuation rates were approximately four times greater than the rates observed in clinical trials

(Table 2): Sovaldi+Peg-IFN+RBV (10.2 percent of patients discontinued), Sovaldi+Olysio (4.2 percent),

and Sovaldi+RBV (9.0 percent). Across regimens, treatment-naïve patients were 64 percent more

likely to discontinue therapy with Sovaldi than treatment-experienced patients: 8.7 percent treatmentnaïve

patients discontinued therapy vs. 5.3 percent for treatment-experienced patients (p<0.05)."

I'm kind of surprised the percentage is so high in the S/O group. Maybe some of these are people forced to change Rx providers in middle of tx? Or some due to non compliance? I just think that 4.2% is high for medications with few sides that are not tolerable. Hmmm??

Thanks for the link Gator.

Gator Man · Senior Member

Here is the article directly from CVS Health's website:

http://cvshealth.com/sites/default/files/hepatitisCutilization.pdf

skewedButNotBroken · Senior Member

Very interesting. I'm having minor symptoms on the S/O therapy (day 14) such as heartburn and a little indigestion. Occasionally if I don't drink enough water then I feel a little tired and weird, but if I drink too much water then my heart starts to flutter (not enough electrolytes) but overall I feel much better than before I started therapy.

More than likely the people who discontinued were the ones on the triple therapy.

Just my two cents.

Cheers,

Isiscat2011 · Guru

According to a recent CVS study 8.1% of Sovaldi patients have discontinued tx; the total number of CVS patients was 1,965. The clinical trials saw only a 2% discontinuation rate. The article doesn't specify the percentage of those who were also using Interferon vs all orals.

Just doing some quick math and that's over 13 million bucks down the drain on the Sovaldi alone (assuming the discontinuations occurred in the final month)! The article indicates that the reasons for discontinuation include sicker patients and less medical supervision in the real world.

http://www.modernhealthcare.com/article/20140917/NEWS/309179963/f-patients-stop-taking-sovaldi-cvs-study-finds

Hep C Discussion Forum

Legal Disclaimer: