Case Summary
A pharmacist submitted a complaint about an email which was sent to a nurse in the clinical commissioning group (CCG) and stated that following an update to the NHS Sunderland CCG formulary, Abasaglar (insulin glargine), Europe's first biosimilar insulin glargine was now available to prescribe. The complainant stated that Abasaglar was not on the Sunderland Joint Formulary. The email was issued by Boehringer Ingelheim and Eli Lilly and Company.
The detailed response from Boehringer Ingelheim and Lilly is given below.
The Panel noted that the email with the subject heading 'Biosimilar insulin glargine is approved for use in NHS Sunderland CCG' was sent to primary care prescribers and referred to an update to the NHS Sunderland CCG formulary. There did not appear to be an NHS Sunderland CCG formulary as stated in the email. Given that Abasaglar was on the Sunderland CCG guideline but not on the Sunderland Joint Formulary it considered that irrespective of which took precedence it was misleading to state that the product was on the Sunderland CCG formulary. The Panel thus ruled a breach of the Code as acknowledged by the companies.
CASES AUTH/2855/7/16 and AUTH/2856/7/16 PHARMACIST v BOEHRINGER-INGELHEIM AND LILLY
Promotion of Abasaglar
A pharmacist submitted a complaint about an email which was sent to a nurse in the clinical commissioning group (CCG) and stated that following an update to the NHS Sunderland CCG formulary, Abasaglar (insulin glargine), Europe’s first biosimilar insulin glargine was now available to prescribe. The complainant stated that Abasaglar was not on the Sunderland Joint Formulary. The email was issued by Boehringer Ingelheim and Eli Lilly and Company.
The detailed response from Boehringer Ingelheim and Lilly is given below.
The Panel noted that the email with the subject heading ‘Biosimilar insulin glargine is approved for use in NHS Sunderland CCG’ was sent to primary care prescribers and referred to an update to the NHS Sunderland CCG formulary. There did not appear to be an NHS Sunderland CCG formulary as stated in the email. Given that Abasaglar was on the Sunderland CCG guideline but not on the Sunderland Joint Formulary it considered that irrespective of which took precedence it was misleading to state that the product was on the Sunderland CCG formulary. The Panel thus ruled a breach of the Code as acknowledged by the companies.
A pharmacist submitted a complaint about an email (Ref UK/GLA/00177) advertising Abasaglar (insulin glargine) issued by Boehringer Ingelheim and Eli Lilly and Company Limited.
The email (dated 5 July 2016) was sent to a nurse in the clinical commissioning group (CCG) and stated that following an update to the NHS Sunderland CCG formulary, Abasaglar, Europe’s first biosimilar insulin glargine was now available to prescribe.
COMPLAINT
The complainant stated that Abasaglar was not on the Sunderland Joint Formulary.
When writing to Boehringer Ingelheim and Lilly the Authority asked them to consider the requirements of Clause 7.2 of the Code.
RESPONSE
Boehringer Ingelheim and Lilly each submitted identical responses on behalf of the Boehringer Ingelheim and Eli Lilly Diabetes Alliance (the Alliance).
The Alliance stated that the email at issue was part of an email campaign to inform primary care health professional’s within CCGs (where Abasaglar was approved on the local formulary) that Abasaglar was now approved by the local formulary and available to prescribe. The health professionals from these CCGs were selected for the email campaign in collaboration with a third party which held an upto-date database of health professionals agreeing to receive emails in this way. A list of the CCGs to whom the email was sent was provided.
The objectives were to raise the awareness of health professionals who were practising in CCGs where Abasaglar was available on formulary, of the efficacy of Abasaglar and its cost compared to Lantus (insulin glargine, Sanofi). Each area’s email was localised by showing the name of the CCG, the formulary status of Abasaglar and the annual Lantus sales in that CCG.
The email was certified in the final form as a template with another CCG as an example. The additional instructions on and the information for the email campaign flow for individual CCGs where Abasaglar was on the formulary were provided.
The Alliance stated that its investigation found that in December 2015, NHS Sunderland CCG published guidelines on prescribing hypoglycaemic agents for adult patients with type 2 diabetes. These guidelines included, and as of 20 July 2016 still included, Abasaglar as a treatment option for type 2 diabetes patients. The Alliance pointed out that the Sunderland CCG guidelines were issued by Sunderland CCG and were different from the Sunderland Joint Formulary although the joint formulary website’s home page had a link to the guidelines recommending Abasaglar but Abasaglar was not on the Sunderland Joint Formulary.
The email campaign in Sunderland started on 5 July 2016. On 6 July the Alliance was notified by a pharmacist in Sunderland CCG that Abasaglar was not on the Sunderland Joint Formulary. The Alliance stated that an immediate investigation was launched.
The Alliance accepted that the information in the email describing Abasaglar being on the NHS Sunderland CCG formulary was wrong as it did not reflect the actual status of Abasaglar in Sunderland CCG. The Alliance therefore accepted this was in breach of Clause 7.2 of the Code.
The Alliance submitted that it had taken immediate corrective measures. The Abasaglar campaign was halted until the full investigation was completed and a corrective email was issued to all those emailed in Sunderland which included an apology for any confusion caused.
PANEL RULING
The Panel noted that the NHS Sunderland guideline (‘Prescribing of Hypoglycaemic Agents for Adult Patients with Type 2 Diabetes: Sunderland’) stated that Abasaglar was now available, it was biologically similar in action to Lantus and that other biosimilar preparations would follow. Biosimilar insulin was only to be used in new patients and patients with suboptimal control where a review of therapy was being considered. Patients should not be rountinely switched between brands.
The Panel noted that according to a presentation about the email campaign Lilly key account managers were responsible for providing information about the status of Abasaglar on CCGs’ formularies.
The Sunderland Joint Formulary website stated that this consisted of medicines recommended by the Joint Formulary Committee in consultation with consultants, GPs and other prescribers. This formularly was supported by Sunderland CCG, City Hospital Sunderland and Northumberland Tyne and Wear NHS Foundation Trust. The Alliance stated that Abasaglar was not listed on the Sunderland Joint Formulary.
The Panel noted that the email with the subject heading ‘Biosimilar insulin glargine is approved for use in NHS Sunderland CCG’ was sent to primary care prescribers and referred to an update to the NHS Sunderland CCG formulary. The Panel was unsure which took precedence, the Sunderland Joint Formulary or the Sunderland CCG guideline.
There did not appear to be an NHS Sunderland CCG formulary as stated in the email. Given that Abasaglar was on the Sunderland CCG guideline but not on the Sunderland Joint Formulary it considered that irrespective of which took precedence it was misleading to state that the product was on the Sunderland CCG formulary. The Panel thus ruled a breach of Clause 7.2 as acknowledged by The Alliance.
Complaint received 8 July 2016
Cases completed 11 and 12 August 2016
