Having worked diligently to ensure an appropriate introductory price, HLS also received notification by the PMPRB that, further to its review, Vascepa's price did not trigger the investigation criteria for excessive pricing.
Many patients may benefit as this recommendation helps make available a new treatment option
'We are very pleased to see Vascepa's benefit be recognized as a relevant agent to reduce the risk of major adverse cardiovascular events for patients that have documented cardiovascular disease. HLS, with the support of leading physicians, medical societies and other patient care advocates, is working to expand CADTH's recommendations in the future to address other groups of high-risk patients who have been shown to benefit from treatment with Vascepa, in particular those patients with diabetes and at least one risk factor, as approved by
Vascepa studied and indicated to help multiple groups of at-risk patients beyond conventional therapies
The clinical effectiveness and related safety profile of Vascepa was demonstrated in REDUCE-IT1, a global cardiovascular study. The results of REDUCE-IT, a five-year outcomes study involving 8,179 patients at risk, have been broadly published and following a priority review, led to the approval of Vascepa in
'The CADTH recommendation to separate the diabetic population in two and exclude high-risk patients is perplexing to us as it is not rooted in good clinical practices and evidence-based medicine,' said
REDUCE-IT showed that the use of Vascepa prevented more than 159 major cardiovascular events for every 1000 patients treated, or effectively one fewer major adverse cardiovascular event (MACE), like a heart attack or stroke, per six patients treated over a period of five years. Such events are painful, and potentially deadly to patients and expensive to society. These compelling clinical results prompted
'Cardiovascular trials with this magnitude of benefit are not often seen. Highly statistically significant, and clinically important, relative and absolute risk reductions were observed in REDUCE-IT, including cardiovascular death,' said Dr.
Over the past 18 months, the highly qualified
'As much as we are very pleased with the reimbursement recommendation for patients with established cardiovascular disease, diabetic or not, high-risk diabetic patients who rely on public health plans should not have to wait to have a cardiac event before they can get access to a drug intended to prevent those very events. This mentality negates the principles and the benefits of prevention,' said
Vascepa's benefits and long-term potential remain strong
Fortunately, in the past, divided recommendations from CADTH have not always prevented the full in-label reimbursement of new therapies, especially when they have demonstrated such compelling clinical results. 'We remain confident that public payors in
In order to increase the economic value of Vascepa, and in order for all patients for which the drug has been approved by
ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug's ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from
ABOUT
Formed in 2015, HLS is a specialty pharmaceutical company focused on the acquisition and commercialization of late stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages.
FORWARD LOOKING INFORMATION
This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as 'may', 'will', 'expect', 'plan', 'anticipate', 'intend', 'potential', 'estimate', 'believe' or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated
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Tel: (416) 247-9652
Email: dave.mason@loderockadvisors.com
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