NICE to recommend three new treatments for hep C
pharmafile | October 16, 2015 | News story | Medical Communications | AbbVie, BMS, Bristol-Myers Squibb, Exviera, Gilead, NICE, Viekirax, daklinza, harvoni, hepatitis C
NICE has recommended Bristol-Myers Squibb’s Daklinza, Gilead’s Harvoni and AbbVie’s Viekirax, with or without Exviera, as treatments for some adults with hepatitis C.
The final appraisal determinations mean that many of the sickest patients will be eligible for NHS treatment, despite earlier concerns about the drugs’ costs. The manufacturers of the drugs supplied additional evidence of the cost-effectiveness of their drugs, and thrashed out deals with the UK healthcare watchdog, to ensure their drugs were approved.
Gilead says it worked closely with NICE to provide more evidence to support a positive final recommendation, and make Harvoni (ledipasvir/sofosbuvir) “available for all eligible patients as quickly as possible through the special delivery networks put in place by NHS England.”
Harvoni is now recommended in final guidance for the majority of adult patients with chronic hepatitis C genotype 1 and 4 in England and Wales. Stelios Karagiannoglou, general manager, of Gilead Sciences UK and Ireland, says: “We are pleased with NICE’s final appraisal which represents Gilead’s commitment to innovation in the areas of great unmet need, and reinforces the value of Harvoni as a clinical and cost effective treatment for the majority of genotype 1 and 4 adult hepatitis C patients. This decision means that a broader group of hepatitis C patients will have the chance to be cured impacting the future burden of this disease on those individuals, their families and the NHS.”
BMS also supplied additional clarification of its cost-effectiveness data for Daklinza (daclatasvir), which is set to be recommended for certain patients with genotypes 1, 3 and 4.
Johanna Mercier, general manager of Bristol-Myers Squibb UK and Ireland comments: “Before now hepatitis C patients have had limited treatment options and we are delighted that NICE has taken the decision to recommend daclatasvir-based regimens. BMS and clinicians alike have seen the positive impact this treatment has had among some patients in the UK to date and it is therefore good news that it will now be available to a wider group of people who are in much need of new treatment options.”
The NICE decisions also confirm that AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) is recommended as treatment option for adults in England and Wales living with genotype 1. Viekirax is also recommended for all adults with genotype 4 chronic HCV infection.
Dr Neil Pumford, UK medical director at AbbVie, says: “We welcome the NICE decision as we believe that all-oral, interferon-free treatments, like Viekirax and Exviera, have an important role to play in helping people clear the hepatitis C virus and move on with their lives. We look forward to implementing the NICE guidance swiftly and in full as soon as possible to benefit all eligible patients.”
The NHS in England and Wales have been given extensions in order to raise the money to fund the new hepatitis C treatments, which can cost more than £30,000 for a course of treatment.
And Charles Gore, chief executive of The Hepatitis C Trust, says the NICE decisions will mean little “if people who are living with hepatitis C in England and Wales do not come forward and discuss their treatment options with their doctor.
“People living with hepatitis C have been eagerly awaiting these new interferon-free treatments and it is now vital that NHS England ensures patients have access to them as quickly and widely as possible. These drugs are cost-effective and allow patients to be cured in as little as 12 weeks, so there really is no excuse for delaying treatment and continuing to allow ever-increasing numbers of hepatitis C patients to progress to end-stage liver disease and liver cancer.”
In 2012, healthcare costs associated with the condition were estimated at £82.7 million in the UK. A study has found that by 2035 this figure is projected to rise to £115m, if current treatment levels remain the same.
Lilian Anekwe
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