Janssen: ‘Invokana available to prescribe’ letter misled some GPs about local prescribing restrictions (AUTH/2732/9/14)

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Key facts

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Case number	AUTH/2732/9/14
Company	Janssen
Product	Invokana (canagliflozin)
Material	‘Dear Doctor’ letter/email (ref PHGB/VOK/0714/0029a)
Issue	Letter stated Invokana was approved and “available to prescribe” in named CCGs; in 39 CCGs only consultant physicians could initiate, so GPs did not necessarily have prescribing freedom
Geography / audience	GPs in 150 CCGs (39 affected by restriction; 111 where GP freedom existed)
Key dates	Letter sent 16 September 2014; complaint received 18 September 2014; case completed 20 October 2014
Applicable Code year	2014
Breach clauses	Clause 7.2; Clause 9.1
Panel findings	Misleading; likely created confusion and additional work; high standards not maintained
Sanctions	Undertaking received; additional sanctions: Not stated
Appeal	No appeal

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

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Janssen sent a ‘Dear Doctor’ letter about Invokana (canagliflozin) to GPs across 150 clinical commissioning groups (CCGs).
The letter headline and opening stated Invokana had been approved by the local formulary process and was “available to prescribe” in the named CCG, following NICE Technology Appraisal Guidance (TAG).
In 39 CCGs, although Invokana was on the formulary, GPs did not necessarily have freedom to prescribe because only consultant physicians could initiate therapy.
The letter intended for CCGs with full GP prescribing freedom was, due to an internal oversight/human error, also sent to those 39 CCGs.
A GP prescribing lead complained; Janssen identified the error and initiated a corrective action plan (apologies and offers to issue a corrective/retraction communication agreed with each CCG).

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The Panel ruled the letter was misleading for recipients in CCGs where GPs could not initiate/prescribe as implied.
The Panel considered the error likely created confusion and additional work in some CCGs.
Breach of Clause 7.2 was ruled.
Breach of Clause 9.1 was ruled.
No appeal.

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