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 (with dasabuvir) on treatment-naïve patients without cirrhosis for 12 weeks.
  • Recommended for use (with dasabuvir) on treatment-experienced patients without cirrhosis for 12 weeks.
  • Recommended for use (with ribavirin and dasabuvir) on treatment-naïve patients with compensated cirrhosis for 12 weeks.
  • Recommended for use (with ribavirin and dasabuvir) on treatment-experienced patients with compensated cirrhosis for 12 weeks.

 Genotype 1a

  • Recommended for use (with ribavirin and dasabuvir) on treatment-naïve patients without compensated cirrhosis for 12 weeks.
  • Recommended for use (with ribavirin and dasabuvir) on treatment-experienced patients without compensated cirrhosis for 12 weeks.

Genotype 4

  • 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.