The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection A Technology Assessment (offical name)
Draft Report for March 10, 2014 Meeting Completed by:Institute for Clinical and Economic Review
DATE OF PUBLICATION: February 12, 2014
California Technology Assessment Forum
I tried my best to abbreviate the topic
the costs of treatment are expected to increase substantially, as treatment regimens
with the two new agents are expected to cost between $70,000 and $150,000 per course of
therapy.4,5 Accordingly, the California Technology Assessment Forum has chosen to review the
evidence on the comparative clinical effectiveness and comparative value of new DAA agents
for chronic hepatitis C in relation to the existing standard of care in multiple patient
The DRAFT Report is quite detailed including charts with trial results in the first part them projected cost broken down to specfic subclass geno, tx, results, cost, cost per 1000 and projected savings for SVR over 5 years and 20 years. This will take some time to read it's 107 pages with charts.
This may give you some idea of what government, insurance companies, medical providers and others are going through right now. They have to consider many factors including cost and that probably effects the waiting time for answers, who gets treatment with what drugs. (my opinion)
Someone with geno 3 was trying to decide on a phase 3 trial wondered why they were getting SOF + PR (12) instead of SOF + R (24) so I only provided an example of a couple of cost charts. There is so much information please take the time to read in total the information and charts that apply to a particular situation.
Table 27. Clinical and Economic Impact of Treatment Options Among 1,000 60 year-old Patients with Hepatitis C Genotype 3 (Treatment-naïve).
IFN-eligible SVR Initial Rx pp a b c d e f
PR (24) (pre-DAA) 62% $24,936
SOF + PR (12) 92% $96,468 $110,576,160 $18,626,400 (14) (58) ($7,180,260) ($23,188,685)
SOF + R (24) 93% $176,352 $188,696,640 $96,746,880 (15) (60) ($7,419,602) ($23,961,641)
SOF + R (24) 61% $176,352 $245,129,280 $245,129,280 (29) (117) ($14,599,862) ($47,150,326)
Table 28. Clinical and Economic Impact of Treatment Options Among 1,000 60 year-old Patients with Hepatitis C Genotype 3 Who Have Been Treated
IFN-eligible SVR Initial Rx per patient
PR (24) (pre-DAA) 62% $24,936 $61,593,840
SOF + PR (12) 83% $96,468 $112,867,560 $51,273,720 (10) (40) ($5,026,182) ($16,232,079)
SOF + R (24) 77% $176,352 $198,539,640 $136,945,800 (7) (29) ($3,590,130) ($11,594,342)
SOF + R (24) 61% $176,352 $245,129,280 $245,129,280 (29) (117) ($14,599,862) $47,150,326)
NOTE I provided most of the information on these tables but please verify
It's hard to reproduce a table here. The letter place holders above that I used refer to the numbers after the total drug cost per patients above and are
a Total drug cost per 1000 patients *Includes costs of initial therapy and retreatment with most effective regimen available for those not achieving SVR initially
b Incremental cost (vs. pre-DAA)
c estimated liver events after 5 years
d estimated liver events after 20 years
e Total Estimated Cost Offset after 5 years
f Total Estimated Cost Offset after 20 years
†Total estimated cost offset includes cost savings from liver events averted and reduced annual costs from greater numbers of patients achieving SVR
For these two tables The cost of SOF + PR (12) is $79,884 cheaper per patient IFN-eligible than SOF + R (24) and the SVR rate in only 1 % different for tx Treatment-naïve. For Treatment-experienced IFN-eligible the SOF + PR results in 6% increase in SVR.
Since adding IFN to the treatment is only 12 weeks there is a good chance IFN-eligible patients can complete tx with reduced side effects as opposed to 24 or 48 week INF tx. The available money for treatment is limited at this time. The projection(educated guess) by using this tx for those that are eligible will allow almost twice as many patients to be treated with the same total initial cost.
For the other genotypes and specific situations browse the pdf file. Remember it's only a draft in california This may be why so many members are hearing that they have to wait for 6 to 9 months while this gets sorted out and decisions are made by the insurance companies. For those who are waiting, if there isn't an urgent or serious reason to get treated within that time frame try to be patient. Those who need treatment ASAP within that time use as many resources as possible. contacts, internet phone, email, appropriate friends, doctors, insurance plans. assistance plans drug companies and any other ideas. Don't give up I wish you the best.
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