A yes for Gilead, AbbVie and BMS hepatitis drugs, but NICE restricts use

NICE has given the green light to three new hepatitis C treatments, but has specified precisely which patients can receive which drugs, based on the patient’s genotypes, and the progression of their disease.

The draft decision covers BMS’ Daklinka (daclatasvir), Gilead’s Harvoni (Ledipasvir-sofosbuvir) and AbbVie’s Viekirax (ombitasvir-paritaprevir-ritonavir) with or without Exviera (dasabuvir).

Gilead’s Harvoni and AbbVie’s Viekirax and Exviera look to have emerged as the winners, gaining the most approvals across the different patient sub-types.

BMS’s Daklinka did not fare so well, being approved in fewer sub-groups: NICE recommends it in genotype 1or 4 patients who had previous drug treatment, or who were ineligible or intolerant to interferon.

Gilead in pole position

Harvoni has grabbed the biggest prize, gaining recommendation for an 8 week course in previously untreated genotype 1 patients, the most common type in the UK, as well as genotype 4.

The decision puts Gilead in pole position – its other drug Sovaldi (sofosbuvir) is already recommended across all four genotypes, either for 12 or 4 weeks.

Harvoni is likely to be the leader in revolutionising hepatitis C care in the UK, but the high cost of all of the treatments, and the high number of patients in need means access to all the drugs will remain a battleground.

Patients in England will gain access to Sovaldi from August; the drug was approved by NICE in February, but NHS England asked for the health service to be given extra time to prepare for uptake – undoubtedly influenced by the huge cost implications involved. Another player is Janssen’s Olysio, also recommended in February, and not subject to an extended delay in NHS uptake.

Harvoni is even more effective than Sovaldi for patients with untreated genotype 1, as it allows them to be treated more quickly and without the need for interferon, which causes serious side-effects.

However the 2-in-1 Harvoni won’t cannibalise Sovaldi sales across the board just yet – Sovaldi is NICE approved more broadly across all six subtypes (1-6) of the disease.

BMS criticises decision on Genotype 3 patients

None of the three newly appraised drugs have been approved in genotype 3, which leaves just Sovaldi approved in these patients.

Bristol-Myers Squibb says it is disappointed at NICE’s decision not to recommend its drug in genotype 3. Around 215,000 people in the UK are thought to have hepatitis C, and around 45 per cent of all cases in England are genotype 3. This sub-type is associated with faster disease progression (liver damage) and is more difficult to treat with oral regimens than other genotypes.

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.

She called on NICE to review its decision to help these “unwell people who are in real need of support.”

Deaths from HCV have nearly quadrupled between 1996 and 2013 in the UK. However, it has been estimated that only 3 per cent of those infected are treated each year, as Hepatitis C is usually asymptomatic in the early years. This contributes to the fact that as many as 50 per cent of people living with the disease may be undiagnosed.

In addition, 60 per cent of all those infected will go on to develop some level of damage to their liver. 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.

She added that BMS would work with NICE to see if a solution could be found.

Read the full NICE draft appraisal here

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