AUTH/2020/7/07: Anonymous v Merck Sharp & Dohme – Januvia budget impact cost model (no breach on appeal) | PMCPA Case

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Key facts

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Case number	AUTH/2020/7/07
Parties	Anonymous v Merck Sharp & Dohme
Product	Januvia (sitagliptin)
Material	Computer budget impact (cost) model
Setting / audience	PCT meeting; appropriate PCT personnel / medicines management
Main allegations	Unsubstantiated/misleading hospital costs (heart failure and other costs); competitor medicine costs incorrect due to dose errors
Applicable Code year	2006
Clauses considered	Clause 7.2 and Clause 7.4
Panel decision	Breaches ruled (Clauses 7.2 and 7.4; and Clause 7.2 regarding national vs local costs)
Appeal outcome	No breach of Clauses 7.2 and 7.4 (appeal successful)
Complaint received	16 July 2007
Case completed	11 January 2008
Other notable facts	Model screens included a disclaimer; PROactive in-patient vs non-in-patient heart failure figures were transposed; MSD said the model was withdrawn from use from 7 December and would not be recommissioned in its original form

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, non-contactable member of a primary care trust (PCT) medicines management team complained about a computer “budget impact” cost model for Januvia (sitagliptin) presented at a PCT meeting.
The model aimed to answer: “What is the financial impact of using Januvia in my local area?” (one-year budget impact model).
The complainant alleged the model could mislead PCTs because it included unsubstantiated hospital cost assumptions (notably heart failure) and competitor medicine costs that appeared incorrect due to dose errors (sulphonylureas overstated; glitazones understated).
The Panel reviewed printouts of model screens (not the model itself) and noted a prominent disclaimer stating MSD took “no responsibility” for omissions/errors/inaccuracies.
The Panel identified a transposition error in PROactive study heart failure figures (in-patient vs non-in-patient) and questioned the robustness/clarity of assumptions and the use of national (not local) competitor cost inputs.
MSD appealed; it also stated the model had been withdrawn from use from 7 December and would not be recommissioned in its original form.

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Final outcome (Appeal Board): No breach of the Code.
The Appeal Board ruled no breach of Clauses 7.2 and 7.4 (appeal successful).
The Appeal Board accepted that health economic models provide estimates and that the intended audience (appropriate PCT personnel) would understand the constraints.
The Appeal Board considered the in-patient/non-in-patient transposition a “most unfortunate error” but not material to the outcome (difference <0.1% of calculated cost).
The Appeal Board did not consider the heart failure costs misleading and considered them capable of substantiation within accepted limits of a health economic model.
The Appeal Board did not consider the use of national weighted competitor costs misleading to the intended audience.

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