NICE plans to restrict use of BMS’ Daklinza follow funding delay for Gilead's Sovaldi
As World Hepatitis Day draws to a close, Bristol-Myers Squibb has hit back at NICE's decision to restrict use of its new hepatitis C treatment Daklinza (daclatasvir) to a sub-population of patients.
In draft guidance released today, NICE has said that the NS5A replication complex inhibitor, in combination with other treatments, is recommended for HCV genotypes 1 and 4 who have significant fibrosis (liver scarring) without cirrhosis, if that patient has been previously treated with the injectable treatment interferon, or is ineligible or intolerant to interferon..
NICE issues appraisal consultation documents for three new hepatitis C therapies
The National Institute for Clinical Excellence (NICE) has today issued appraisal consultation documents for three new hepatitis C therapies; ledipasvir-sofosbuvir (Harvoni), daclatasvir (Daklinza, and ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).
A summary of the recommendations, which at this stage are preliminary, are below:
Ledipasvir-sofosbuvir
Genotype 1
Recommended for use on treatment-naïve patients without cirrhosis for 8 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.
Genotype 4
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.
The full document can be read here.
Daclatasvir
Recommended for use on genotype 1 and 4 treatment-experienced patients and patients who are interferon-ineligible or intolerant if the patient has significant fibrosis (METAVIR fibrosis stage F3-F4).
The full document can be read here.
Ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)
Genotype 1b
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients with compensated cirrhosis for 12 weeks.
Genotype 1a
Recommended for use (with ribavirin) on treatment-naïve patients without compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients without compensated cirrhosis for 12 weeks.
The full document can be read here.
A consultation process will now occur whereby interested parties, including The Hepatitis C Trust, will provide comments on these recommendations. All comments must be submitted by 19th August, with further Appraisal Committee meetings being held on 3rd September. Final Appraisal Determination documents (which represent the final NICE recommendations) will then be published within 6 weeks of this meeting.
We would like to assure all patients that The Hepatitis C Trust will continue to argue for access to new treatments to be as wide as possible, and this will be reflected in our response to these preliminary recommendations.
Source - Hepatitis C Trust
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