Examining US Pricing As a Function of Clinical Trial Outcomes

Author(s)

Levy J
EvaluatePharma USA, Inc., Boston, MA, USA

OBJECTIVES: The price of prescription medications has drawn increased scrutiny in recent years. The objective of this research was to assess the relationship between clinical trial outcomes and average sales price (ASP) in the US. ASP is net of any rebates paid by the manufacturer.

METHODS: Pharmaceutical price transparency in the US is greatest for physician-administered products covered under Medicare Part B, because the ASP for these products is reported on a quarterly basis to the Centers for Medicare and Medicaid Services. Across a range of therapeutic areas going back to 2010, the earliest reported ASP was identified for each product following the launch of the target indication. Taking frequency and quantity of dosing into account, the ASP for each product was normalized based upon a monthly supply per patient. Within therapeutic area, phase II/III clinical trial outcomes of shared primary endpoints were compared to normalized ASP for each product. Studied therapeutic areas included Breast Cancer and Rheumatoid Arthritis.

RESULTS: Across therapeutic areas, the strength of the relationship between clinical trial outcomes and ASP launch pricing varies widely. For example, among Breast Cancer products there is no meaningful correlation between clinical trial outcomes and ASP launch pricing (r = 0.02); while among Rheumatoid Arthritis products clinical trial outcomes are inversely proportional to ASP launch pricing (r = -0.58).

CONCLUSIONS: Pharmaceutical pricing in the US does not typically vary as a function of clinical trial outcomes. Specifically, products exhibiting greater efficacy as measured by patient survival or improvement criteria are not necessarily the ones to command a greater sales price.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)

Code

PMU1

Topic

Clinical Outcomes, Economic Evaluation

Topic Subcategory

Comparative Effectiveness or Efficacy, Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Multiple Diseases

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