AbbVie Scores HCV First Under UK’s Early Access Scheme
Executive Summary
AbbVie’s investigational hepatitis C treatment has become the latest therapy to get the green light under the UK’s early access to medicines scheme. The scheme enables patients to access the treatment ahead of it receiving an EU marketing authorization.
AbbVie has become the first company to receive permission to use an investigational treatment for hepatitis C under the UK’s early access to medicines scheme (EAMS), meaning the therapy can be made available to UK patients while it undergoes accelerated assessment for marketing throughout the EU.
Glecaprevir/pibrentasvir, a pan-genotypic, ribavirin-free regimen that AbbVie is developing as cure for hepatitis C virus, has received a positive scientific opinion under EAMS from the Medicines and Healthcare products Regulatory Agency, the company and regulator revealed on May 10.
It is not clear yet when Glecaprevir/pibrentasvir will be used to treat the first patients under EAMS. “We can’t specify a timing as we don’t know when the first request will come in,” an AbbVie spokesperson told the Pink Sheet.
Meanwhile, a marketing authorization application for Glecaprevir/pibrentasvir is undergoing an accelerated assessment by the European Medicines Agency. “We anticipate a decision later this year – second half of 2017,” the AbbVie spokesperson said. EAMS products that subsequently receive marketing approval and that are found to be cost-effective following a health technology appraisal by the National Institute of Health and Care Excellence (NICE) are commissioned by NHS England within 30 days of the NICE guidance, rather than the standard three months, AbbVie noted.
EAMS was launched in April 2014. The scheme aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need. It has two stages: companies must first apply for and receive a promising innovative medicine (PIM) designation before they can go on to apply for a scientific opinion. An opinion lasts for a year and can be renewed. Forty-six applications have been submitted for entry in the scheme, according to the latest data from the MHRA covering April 2014 to May 2017. Thirteen applications have gone on to receive a positive opinion and the others are still pending (either at the PIM or scientific opinion stage) or have been rejected or withdrawn.
Thirteen applications have received a positive opinion under EAMS to date.
MHRA Committed To Supporting EAMS
The MHRA, as part of its Business Plan 2017-18, has committed to continue developing and supporting EAMS, which it describes as a success. It said it wanted to provide “more formal opportunities for patients to input into agency and licensing decision making, particularly as part of the EAMS process.” In addition, it said it would aim to ensure applications for the scheme are processed within the fast-tracked timetable.
MHRA chief executive Ian Hudson speculated recently that the PIM designation component of the early access scheme “could be potentially broadened”. Speaking at a seminar in London on March 1 entitled “The future of the life sciences sector in the UK – funding, regulation and the impact of Brexit”, Hudson also suggested that regulators could perhaps “do much more in terms of holding people’s hands through the development phase”. One possibility, he suggested, was allowing “rolling reviews of data, for example”.
Industry’s Ambitions
The Association of the British PharmaceuticaI Industry said that with more than a dozen medicines now receiving a positive scientific opinion through EAMS, the scheme had provided hundreds of patients access to much-needed new treatments before they go through NICE appraisal.
The ABPI continues to have concerns about the scheme. It told the Pink Sheet: “We continue to work with the Office for Life Sciences and all stakeholders to review and appraise its functioning, with the hope of improving the scheme and getting more medicines through the system as quickly as possible. We can maximise the potential of EAMS through central government reimbursement, as well as greater clarity on the commissioning process, to ensure both patients and industry benefit from the development of the most ground breaking therapies. Our ambition is for the UK to be country where there are speedy and effective ways, using paths such as EAMS, for bringing the latest innovative medicines to patients.”
Why AbbVie’s treatment passed
As for AbbVie’s HCV treatment, an estimated 214,000 people in the UK are thought to be infected with the hepatitis C virus and, although now curable, without treatment people with HCV can develop potentially fatal liver cancer or end stage liver disease, the company said. Under EAMS, Glecaprevir/pibrentasvir may be used to treat adults with compensated cirrhosis and at least one of the following:
- Genotypes 1, 4, 5 and 6 with compensated cirrhosis previously treated with NS5A inhibitors.
- Genotypes 2, 3, 5 or 6 with chronic kidney disease (stage 4 and 5)
- GT 3-infected patients previously treated with peg-interferon, ribavirin, and/or sofosbuvir.
As for why AbbVie’s treatment was given the positive EAMS scientific opinion, the MHRA said: “Glecaprevir/pibrentasvir 100mg/40mg film-coated tablet on its own has been shown to be “highly effective” in clearing the hepatitis C virus from the blood of patients compensated cirrhosis. The agency said that treatment was well tolerated with a favorable safety profile and that it considered “the benefits of Glecaprevir/pibrentasvir in this serious condition and concluded that the benefits are greater than the risks.”
From the editors of Scrip Regulatory Affairs.