Wednesday, May 11, 2011

Health economics sub-study of PLATO shows Brilique to be cost effective treatment versus generic clopidogrel

 AstraZeneca announced new health economics data from a sub-study of the PLATO trial showed that treating a broad spectrum of Acute Coronary Syndrome (ACS) patients with Brilique (ticagrelor) was more cost-effective than treatment with generic clopidogrel.

The study demonstrated that ticagrelor provided a cost-effective gain in Quality-Adjusted Life Year (QALY) compared to generic clopidogrel based on the approved ticagrelor label in the European Union (EU). Specifically, ACS patients treated with ticagrelor and aspirin, compared with generic clopidogrel plus aspirin for one year on average were projected to gain an additional 0.13 QALYs at a cost range of €2,350 ($3,110)–€5,700 ($7,550) per QALY. The PLATO trial (A Study of PLATelet Inhibition and Patient Outcomes) was the pivotal phase III study that formed the basis of the EU label.

Cost per QALY is an important measure used by national governments and their reimbursement agencies to assess cost effectiveness of medical treatments. While no universal threshold for cost effectiveness exists, generally, a cost per QALY in the range of €25,000 ($33,000) to €38,000 ($50,000) is considered cost effective.

“The PLATO health economics substudy accounts for both the clinical effect observed in PLATO as well as cost considerations for treating ACS patients with ticagrelor versus clopidogrel,” said Dr Lars Wallentin, director and Professor of Cardiology, Uppsala Clinical Research Centre & University Hospital, Sweden. “What is particularly impressive about this sub-study is that even at a higher price, ticagrelor was a cost effective treatment for ACS patients compared to generic clopidogrel.”

The price of generic clopidogrel €0.17 ($0.23) per day was compared with the price range of Brilique of €2.25 ($3.00) to €3.50 ($4.65) per day and applied in the analysis to form the price component of the health economics sub-study. Using individual patient data from PLATO and event rates, health care costs based on Swedish base-case analysis and QALYs were estimated for the first year. The analysis showed that the overall cost impact of using ticagrelor instead of clopidogrel was cost effective.

The analysis is now published in the May/June issue of the International Society for Pharmacoeconomics and Outcomes Research’s Value in Health and will be presented at the organisation’s international annual meeting on 23 May.

AstraZeneca also announced that ticagrelor has been accepted for reimbursement by the Scottish Medicines Consortium (SMC) for patients in Scotland. The Ministry of Health and Prevention in Denmark also recently approved ticagrelor as the first branded oral anti-platelet therapy to achieve national reimbursement for a broad ACS population.

Health technology assessments ongoing in the remainder of the UK and in Germany are expected later this year by NICE and IQWiG, respectively, however healthcare professionals are able to prescribe ticagrelor in accordance with local guidance. Markets where a price has been approved but the reimbursement process is ongoing include Finland, Norway, Portugal, and Austria.

“These new data help further demonstrate the compelling value proposition ticagrelor offers versus a widely used generic. We also welcome the positive decision in Scotland and Denmark to reimburse ticagrelor and believe it will become an attractive option for physicians seeking another antiplatelet treatment to reduce their ACS patients’ risk of heart attack and cardiovascular death,” said Tony Zook, executive vice president of AstraZeneca’s Global Commercial Organisation. “Further reimbursement processes are underway according to local rules and regulations and timings will differ from market to market. We will continue to work with the appropriate health organisations, formulary and protocol review boards, and clinicians to ensure patients have access to this important medicine as soon as possible.”

Brilinta is an oral anti-platelet treatment for Acute Coronary Syndromes (ACS). It is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). It is the first reversibly-binding oral ADP receptor antagonist.

Brilinta is currently under regulatory review in 33 countries, including the United States. The product has been approved in 32 countries, including in the European Union, Iceland, and Norway under the trade name Brilique and in Brazil under the trade name Brilinta.

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.

Source: Pharmabiz

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