Roche & GSK Bonviva Once Monthly slide kits: NICE wording and ‘class effect’ fracture efficacy implied

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Key facts

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Case numbers	AUTH/1803/2/06 & AUTH/1804/2/06
Complainants	Procter & Gamble and Sanofi-Aventis (The Alliance for Better Bone Health)
Respondents	Roche Products Ltd; GlaxoSmithKline UK Limited
Product	Bonviva Once Monthly (ibandronate)
Materials	Slide kit P117414 (“Osteoporosis, bisphosphonates and Bonviva (ibandronic acid)”); slide kit P117413 (“Slides for hospital sales force… monthly for postmenopausal osteoporosis”)
Main issues	Implied NICE recommendation/inclusion for ibandronate; implied non-vertebral efficacy/class effect; MOBILE study conclusion overstated comparator context
Applicable Code year	2003
Breach clauses	Clause 7.2 (x 3) and 7.4 (x 3)
Sanction	Undertaking received
Complaint received	22 February 2006 (site listing); also stated as 23 February 2006 in the report
Case completed	20 April 2006 (site listing); also stated as 21 April 2006 in the report
Appeal	No appeal

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

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Procter & Gamble and Sanofi-Aventis (suppliers of Actonel/risedronate) jointly complained about two Bonviva Once Monthly (ibandronate) slide kits issued by Roche and GlaxoSmithKline.
Slide kit P117414 (“Osteoporosis, bisphosphonates and Bonviva (ibandronic acid)”) included a slide (slide 11) stating that NICE recommended “bisphosphonates” as first-line therapy for secondary prevention of osteoporotic fragility fractures, without clarifying that NICE Technology Appraisal 87 covered only alendronate, etidronate and risedronate (not ibandronate).
The same slide stated that bisphosphonates had demonstrated vertebral and non-vertebral fracture reduction efficacy in clinical trials, which was considered to imply this applied to Bonviva too, despite Bonviva’s SPC indicating vertebral fracture risk reduction only (efficacy on femoral neck fractures not established).
A second slide kit P117413 (“Slides for hospital sales force…”) used for formulary submissions included MOBILE study slides; under “MOBILE Study: Conclusions” it stated: “Once-monthly ibandronate can provide an effective, well-tolerated and practical alternative to daily and weekly oral bisphosphonates,” even though MOBILE compared monthly vs daily ibandronate (not other daily/weekly bisphosphonates).

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The Panel ruled slide 11 was misleading and not capable of substantiation because it implied ibandronate was included in NICE guidance when it had not been assessed by NICE.
The Panel ruled the “vertebral and non-vertebral efficacy with bisphosphonates” statement misleading because it would be assumed to apply to all bisphosphonates including Bonviva, which was not supported by Bonviva’s licensed indication.
The Panel ruled the MOBILE “Conclusions” statement misleading in context because it compared to daily/weekly bisphosphonates under a heading implying it was a MOBILE study conclusion, when MOBILE did not compare against those products.
No breach was ruled for Clause 3.2 (the Panel did not consider the statement per se was outside the marketing authorisation or inconsistent with the SPC).

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