NICE / Europe - Hepatitis C (chronic) - sofosbuvir and velpatasvir [ID921]
In development [GID-TA10064] Expected publication date: January 201
Hepatitis C (chronic) - sofosbuvir and velpatasvir [ID921] : Appraisal consultation
The Department of Health has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using sofosbuvir-velpatasvir in the NHS in England. The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees and commentators, clinical experts and patient experts.
This document has been prepared for consultation with the consultees. It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from the consultees and commentators for this appraisal and the public. This document should be read along with the evidence (see the committee papers).
The appraisal committee is interested in receiving comments on the following:
• Has all of the relevant evidence been taken into account?
• Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
• Are the recommendations sound and a suitable basis for guidance to the NHS?
Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
Note that this document is not NICE's final guidance on this technology. The recommendations in section 1 may change after consultation.
• The appraisal committee will meet again to consider the evidence, this appraisal consultation document and comments from the consultees.
• At that meeting, the committee will also consider comments made by people who are not consultees.
• After considering these comments, the committee will prepare the final appraisal determination (FAD).
• Subject to any appeal by consultees, the FAD may be used as the basis for NICE's guidance on using sofosbuvir-velpatasvir in the NHS in England.
For further details, see NICE's guide to the processes of technology appraisal.
The key dates for this appraisal are:
Closing date for comments: 14 October 2016
Second appraisal committee meeting: 26 October 2016
• Committee papers
• Appraisal consultation document
• Committee papers Committee meeting slides
This page was last updated: 23 September 2016
NICE backs Gilead's hepatitis C drug Epclusa
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has recommended Epclusa (sofosbuvir-velpatasvir), from US biotech major Gilead Sciences (Nasdaq: GILD), as a treatment option for all genotypes of hepatitis C in draft guidance published today.
Sofosbuvir-velpatasvir is one of the newer direct acting anti-viral treatments for hepatitis C and works by blocking the virus from multiplying and infecting new cells. As trials for the drug showed high cure rates of 89% and above, the NICE appraisal committee concluded that sofosbuvir-velpatasvir was clinically and cost-effective, and should be routinely available on the National Health Service.
The committee also recognized that there was a need for treatment without adverse side effects, particularly for patients with genotype 3, who account for around 44% of the patient population with chronic hepatitis C. This population are currently treated with the earlier types of anti-viral treatments, such as peginterferon alpha with ribavirin, which can cause adverse side effects.
"The decision by the independent NICE appraisal committee to recommend sofosbuvir-velpatasvir is great news. The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly," said Carole Longson, director of the NICE Centre for Health Technology Evaluation.
Professor Longson continued: "Sofosbuvir-velpatasvir, a newer type of direct acting anti-viral treatment, can be used to treat all genotypes of hepatitis C. Other drugs currently available treat only certain genotypes or can cause unwanted side effects if they have to be taken in combination with earlier anti-viral treatments." Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C."
NHS cost discount agreed
The cost for sofosbuvir-velpatasvir, a tablet taken once daily, is listed as 38,980 ($51,064) for a 12 week course of treatment. The drug may also be taken in combination with ribavirin; the combination costs around 40,000 - also for a 12 week course of treatment. The company has agreed a confidential discount to the NHS for sofosbuvir-velpatasvir.
The NICE has previously published guidance recommending the following direct acting anti-viral treatments for hepatitis C:
• daclastavir with sofosbuvir or peginterferon alfa, and sometimes with ribavirin to treat genotypes 1, 3, and 4 (November 2015);
• ombitasvir-paritaprevir-ritonavir with or without dasabuvir to treat genotypes 1a, 1b and 4 (November 2015);
• ledipasvir-sofosbuvir to treat genotypes 1 and 4 (November 2015);
• sofosbuvir with peginterferon alfa and/or ribavirin to treat all genotypes (February 2015);
• simeprevir with peginterferon alfa and ribavirin to treat genotypes 1 and 4 (February 2015);
• boceprevir with peginterferon alfa and ribavirin to treat genotype 1 - with compensated liver disease (April 2012); and
• telaprevir with peginterferon alfa and ribavirin to treat genotype 1 - with compensated liver disease (April 2012).
NICE has also recently recommended elbasvir-grazoprevir in draft guidance published in early September 2016.
The draft guidance for sofosbuvir-velpatasvir recommends that the decisions to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritize treatment for people with the highest unmet clinical need.
Consultees, including the company, healthcare professionals and members of the public are now able to comment on the preliminary recommendations on sofosbuvir-velpatasvir, which are available for public consultation. Comments received during this consultation will be fully considered by the appraisal
Gilead's Epclusa cost-effective in hep C - NICE
23 September 2016
NICE has recommended Gilead's Epclusa as a treatment option for all genotypes of hepatitis C in first draft guidance.
Trial data has shown recently-approved Epclusa (sofosbuvir+velpatasvir) gives cure rates of 89% of above, and can be used without interferon, and in most cases without ribavirin - reducing side effects. NICE's independent appraisal committee recognised the need for treatment without side effects for patients with genotype 3, who account for around 44% of the population with chronic disease. At the moment, patients with this genotype must rely on a drug combination involving interferon, with unpleasant side-effects for treatment.
Epclusa costs nearly 39,000 for a 12-week course and 40,000 when taken in combination with ribavirin. NICE recommended Epclusa in all but one of its indicated uses - saying it was not cost effective in people with untreated genotype 2 chronic hepatitis C who do not have cirrhosis and who can have interferon treatment. Gilead has agreed a confidential discount to the National Health Service.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: "The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly. "Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C." NICE has previously recommended several other hepatitis C drugs, including Gilead's Sovaldi (sofosbuvir), in combination with peginterferon alfa and/or ribavirin to treat all genotypes.
However, it remains to be seen how many patients will benefit from Epclusa, as NHS England has kept a tight limit on the number of patients receiving the hepatitis C drugs, despite the positive recommendations from NICE. There are around 160,000 hepatitis C patients in England, but the NHS has decided to treat only 10,000 patients per year with the latest drugs, because of their high cost. The charity Addaction has called on the NHS to review the decision, saying rationing hepatitis C drugs is a "potential death sentence for thousands".
Just ahead of Epclusa in the NICE review process is a new rival - Merck, Sharp and Dohme's Zepatier (elbasvir+grazoprevir), which could help drive down prices further.
Zepatier's list price is 36,500 per patient for a 12-week course, around the same price as its rivals - but MSD is likely to be undercutting Gilead and AbbVie's hep C products on price, as it is in the US.
NHS England has been using a competitive tendering system to help drive down prices in England, and this is likely to continue with the arrival of the new treatments.
NICE will consult further on both drugs, publishing a second draft in the coming months, followed by final and binding guidance.