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Many hepatitis C patients with serious liver disease to be denied a chance of a cure* as NICE announces decision to restrict use of the daily oral pill, Daklinza® (daclatasvir)1,2
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Press release for UK medical media
Embargoed until 00:01, Wednesday 29 July 2015
· Nearly 100,000 patients in the UK are thought to have hepatitis C genotype 3. This group could suffer severe treatment inequality from this decision3,4
· Daclatasvir based regimen is recommended for genotype 3 patients in 2015 European guidelines 5
Recent Approval Holds Promise for Genotype 3, but Hurdles Anticipated - Editorial - (08/14/15)
EASL Recommendations on Treatment of Hepatitis C 2015..........
http://www.natap.org/2015/EASL/EASL_02.htm
UXBRIDGE, UK - 29 July 2015- Bristol-Myers Squibb is disappointed that the draft guidance issued by the National Institute for Health and Care Excellence (NICE) has restricted the use of Daklinza® (daclatasvir) in the UK for the treatment of adult patients with chronic hepatitis C infection.1 Published data show that daclatasvir-based regimen can offer a cure of hepatitis C infection in patients with a difficult-to-treat and often aggressive form of hepatitis C (genotype 3). 6 Based on the most recent data, The European Association for The Study of the Liver (EASL) recommended daclatasvir-based regimen for genotype 3 patients in April 2015.5
Around 215,000 people in the UK are thought to have hepatitis C.3 The draft NICE guidance will not allow access to patients with hepatitis C genotype 31, which accounts for around 45% of all cases in England.4 Hepatitis C genotype 3 is associated with faster disease progression (liver damage) and is more difficult to treat with oral regimens than other genotypes. 7, 8
Commenting on the guidance, Liz Carroll, Chief Executive of The Haemophilia Society said, "This decision by NICE does not appear to be in the best interest of patients, particularly for those with genotype three. This is a difficult-to-treat subtype, with little other treatment options available, especially for those who have already undergone extensive treatment previously. Those who are living with serious liver damage need rapid, tolerable and effective treatment to prevent further progression of their disease. It is imperative that NICE reviews its stance on this regimen to avoid endangering very unwell people who are in real need of support."
Hepatitis C is a preventable and treatable blood-borne viral infection which, if left untreated, can lead to potentially fatal cirrhosis or cancer of the liver.6 Deaths from hepatitis C have nearly quadrupled between 1996 and 2013 in the UK.9 However, it has been estimated that only 3% of those infected are treated each year.9 Hepatitis C is usually asymptomatic in the early years, which contributes to the fact
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* "Cure" corresponds to an undetectable HCV RNA 24 weeks after the end of therapy, SVR24, [SVR = Sustained Virological Response] which corresponds to a definitive cure of HCV infection in more than 99% of cases. The concordance between SVR12 and SVR24 has been shown to be 99% 5
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that as many as 50% of people living with the disease may be undiagnosed.9 Furthermore, 60% of all those infected will go on to develop some level of damage to their liver.5 Cirrhotic patients with HCV can progress to develop liver cancer liver failure and may require liver transplantation.
Johanna Mercier, General Manager of Bristol-Myers Squibb UK & Ireland commented, "This is a disappointing decision by NICE, which contrasts with the assessments from other clinical and regulatory bodies across the UK, and does not provide equality of access across the UK. Daclatasvir provides an important option for some of the most in-need patients who, without effective treatment, face an uncertain future. We will be working closely with NICE to see if a solution can be found, and hope that this decision can be urgently reassessed so that patients do not suffer as a result."
Notes to editors
About the NICE draft guidance for daclatasvir and supporting data1
Following a submission by Bristol-Myers Squibb, NICE has issued draft guidance on the use of daclatasvir, in combination with other medicinal products, for use within NHS England for the treatment of chronic HCV infection in adults. Use is restricted. NICE has recommended its use for patients with HCV genotypes 1 and 4 who have significant fibrosis (METAVIR score ³ F3) without cirrhosis, if that patient has been previously treated with interferon or is ineligible or intolerant to interferon. However, NICE has not recommended the use of daclatasvir-based regimens to treat adult patients with HCV genotype 3. For further information on the guidance, please visit: https://www.nice.org.uk/.
About the Bristol-Myers Squibb HCV portfolio
Bristol-Myers Squibb research efforts are focused on advancing late-stage compounds to deliver the most value to patients with HCV. At the core of our portfolio is daclatasvir, a potent pan-genotypic (in vitro) NS5A replication complex inhibitor.2
Daclatasvir continues to be investigated in combination with sofosbuvir in patients with high unmet medical needs, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3 infection, as part of the ongoing Phase III ALLY programme. 10, 11, 12
For further information on the portfolio, please contact the Bristol-Myers Squibb Medical Information Hotline Tel: 0800 7311736 (UK only freephone number)
+ 44 1895 523000 (international number) Email:
medical.information@bms.com
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* "Cure" corresponds to an undetectable HCV RNA 24 weeks after the end of therapy, SVR24, [SVR = Sustained Virological Response] which corresponds to a definitive cure of HCV infection in more than 99% of cases. The concordance between SVR12 and SVR24 has been shown to be 99% 5
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About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
For further information or to speak to a spokesperson, please contact:
Reynolds-MacKenzie:
Nikki Malnick
Office: 020 7861 2810
Email: nmalnick@reynoldsmackenzie.com
BristolMyers Squibb:
Sarah Jones
External Communications Manager
Office: +44 (0)1895 523749
Email: sarah.jones@bms.com
References
1 The National Institute for Health and Care Excellence, ACD for Daklinza. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-tag487 last accessed July 2015
2 Daklinza Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/29129 last accessed July 2015
3 NHS Choices. Hepatitis C. Available at: http://www.nhs.uk/conditions/Hepatitis-C/Pages/Introduction.aspx. Last accessed July 2015
4 Public Health England. Hepatitis C in the UK. 2014 report. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/337115/HCV_in_the_UK_2014_24_July.pdf Last accessed July 2015
5 European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2015. Available at:
http://www.easl.eu/_clinical-practice-guideline last accessed May 2015
6 Sulkowski, M et al. (2014). Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection. NEJM. 370 (3), 211-221
7 Ampuero J, et al. HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther. 2014;39:686-98
8 The Hepatitis C Trust. Sofosbuvir plus pegylated interferon/ribavirin is highly effective for people with hard-to-treat genotype 3 hepatitis C. Available at: http://www.hepctrust.org.uk/news/may-2015/sofosbuvir-plus-pegylated-interferonribavirin-highly-effective-people-hard-treat last accessed July 2015
9 The Hepatitis C Trust. The Uncomfortable Truth. Available at: http://www.hcvaction.org.uk/resource/uncomfortable-truth-hepatitis-c-england-state-nation last accessed July 2015
10 ClinicalTrials.gov. Phase III Daclatasvir, Sofosbuvir and Ribavirin in Cirrhotic Subjects and Subjects Post-Liver Transplant (ALLY 1). Available at: http://clinicaltrials.gov/show/NCT02032875 last accessed July 2015
11 ClinicalTrials.gov. Phase III HIV/HCV Co-Infection Daclatasvir (DCV) + Sofosbuvir (SOF) (ALLY 2). Available at: http://clinicaltrials.gov/ct2/show/NCT02032888?term=ALLY+2+daclatasvir&rank=1 last accessed July 2015
12 Clinicaltrials.gov.uk. Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3). Available at: https://clinicaltrials.gov/ct2/show/NCT02032901?term=daclatasvir&rank=8 last accessed July 2015
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* "Cure" corresponds to an undetectable HCV RNA 24 weeks after the end of therapy, SVR24, [SVR = Sustained Virological Response] which corresponds to a definitive cure of HCV infection in more than 99% of cases. The concordance between SVR12 and SVR24 has been shown to be 99% 5
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