IMPACT OF CARDIOVASCULAR OUTCOME TRIAL (CVOT) DATA ON EU5 ACCESS FOR NEW TYPE 2 DIABETES DRUGS

Author(s)

DiModica L1, O'Connor E2
1Decision Resources Group, Burlington, MA, USA, 2Decision Resources Group, London, UK

OBJECTIVES:  Empagliflozin was the first glycemic-lowering therapy to demonstrate a reduction in cardiovascular (CV)-related mortality in a dedicated CV outcome trial (CVOT), the EMPA-REG OUTCOME study. Liraglutide has subsequently demonstrated CV benefit in the LEADER CVOT. Lixisenatide and sitagliptin have shown non-inferiority for CV events in patients with a history of CV disease (CVD). We sought to determine the impact of CVOT data on EU5 pricing and reimbursement (P&R) decisions and access for T2D drugs. METHODS:  In January 2016, 270 endocrinologists and general practitioners across the EU5 were surveyed regarding their views on current and expected T2D prescribing and the extent to which it is impacted by payer policy. Additionally, 15 payers who influence national/regional reimbursement were interviewed. RESULTS:  Surveyed physicians indicated that the potential target population for empagliflozin far exceeds the number of patients currently treated with sitagliptin (28-33% vs. 3-8%, respectively). However, respondents anticipate that national or local coverage, patient eligibility requirements, and budgetary factors may limit empagliflozin access, likely in earlier lines of therapy. Nevertheless, 37-61% of respondents would prescribe empagliflozin as the second-line therapy of choice behind metformin in high-risk CVD patients. More respondents would switch GLP-1-treated patients to an in-class agent showing CV benefit (38-58%) than would increase prescribing of lixisenatide based on its non-inferiority data from the ELIXA CVOT (12-23%). Physicians’ anticipated prescribing suggests that reductions in CV events and mortality seen with liraglutide in the LEADER CVOT will drive its increased use in T2D. Interviewed payers report that positive effects on hard clinical outcomes such as CV-related mortality will improve new T2D drugs’ chances of favorable findings on health technology assessment. CONCLUSIONS:  Primary research with EU5 payers and physicians suggests that T2D drug developers that demonstrate CVOT benefit may use this as a lever to more favorable P&R terms and market uptake.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PDB86

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Diabetes/Endocrine/Metabolic Disorders

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