Monday, April 4, 2011

Expensive new hepatitis c drugs may restrict use in some countries

The investment site bloomberg has an article the HCV community will be interested in reading.

In the article the co-columnists Naomi Kresge and Carol Matlack discuss the cost of HCV therapy, but more importantly the ramifications these expensive drugs may cost patients. What was alarming is that  U.K.’s National Institute for Health and Clinical Excellence may have patients who failed treatment be tested with the genetic test (IL28B) to see if they will respond to therapy.

The authors write;

The U.K.’s National Institute for Health and Clinical Excellence may restrict the new drugs to patients who have tried existing treatments without success, Thursz said. The agency may also require genetic tests to determine whether patients are likely to respond to the medicines, he said at the meeting of the European Association for the Study of the Liver.

Italy and Spain also may delay or restrict use, Craxi said. Italy spends about 350 million euros a year on existing hepatitis C treatments, he said. “If you triple the cost, that would be more than 1 billion euros,” he said.

Continue reading at bloomberg..........
Patients in the HCV community may have asked themselves this question; I wonder if my insurance company will pay for telaprevir/boceprevir if I have treated previously and have the TT allele; which is considered to have the poorest response to HCV treatment.

The good news has been seen in the data presented at the EASL, for example in boceprevir;
IL28B genotype

In pre-specified analyses of the pivotal Phase III studies, researchers found that IL28B status (CC, CT or TT) was a strong baseline predictor of viral response at treatment week 4, week 8 and SVR among patients receiving boceprevir.iv Among those carrying the CC gene allele, 89 percent of treatment-naïve patients and 82 percent of treatment-failure patients had an early response, defined by undetectable virus (HCV-RNA) at treatment week 8, and were eligible for a shorter duration of therapy. Among those with the less favourable gene allele (CT or TT), 52 percent of treatment-naïve patients and 48 percent of treatment-failure patients had an early response and were eligible for a shorter duration of therapy.iv
The analyses also showed that response after the 4-week lead-in was a stronger predictor of SVR than any single baseline variable, including IL28B status.iv The analyses included data from 63 percent of patients (912/1442) in the pivotal Phase III studies who received at least one dose of boceprevir or standard therapy and consented to genomic analysis to test for IL28B polymorphisms. In total, 28 percent of tested patients carried the CC allele, while 54 percent carried the CT allele and 18 percent carried TT
As for telaprevir

From ;Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College and principal investigator for the ADVANCE study.
“Doctors sometimes use IL28B genotype status to decide
which patients should be treated with currently available medicines
because people with the CT and TT variations of IL28B tend to have
substantially lower viral cure rates compared to those with the CC
variation, In this study, telaprevir was associated with a substantial
improvement over currently available medicines, regardless of IL28B
status, and the greatest improvement was observed in patients with
the CT and TT variations.”
Recently on the blog ; Scripps Health ;IL28B Genetic Testing to Hepatitis C Patients Now Available

In the end how do you really feel about the genetic test ? I wonder if what started out so promising is quickly becoming a possible nightmare?
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