AUTH/3258/10/19 - Complainant ex-employee v Novo Nordisk

Promotion of Ozempic

  • Received
    10 October 2019
  • Case number
    AUTH/3258/10/19
  • Applicable Code year
    2019
  • Completed
    18 May 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A contactable complainant complained about the promotion of Ozempic (semaglutide) by Novo Nordisk Limited. The complainant originally acted alone but subsequently stated that an ex-employee of Novo Nordisk had agreed to join him/her to help and possibly lead the complaint.

The complainant stated that a Novo Nordisk representative approached him/her to submit Ozempic to the local hospital formulary which Novo Nordisk medical and market access personnel helped to write and should not have and for which they received a commission. A former medical liaison divulged that he/she received incentive upon acceptance, for assisting the writing of faster acting insulin as part of formulary applications. The complainant stated that he/she could not distinguish medical personnel from representatives. The complainant stated that he/she was given the guidelines in practice formulary decision guide (UK/SM/0818/0304) but was disappointed to note that Novo Nordisk had deliberately misled formulary applicants with regard to the safety of semaglutide by omitting that it caused a significant (76%) increase in retinopathy, including blindness. The complainant referred to the post-authorisation safety study (PASS) that the regulators had imposed on Novo Nordisk specifically in retinopathy hence the grave concerns about this but this vital information on safety was deliberately omitted in this critical piece for formulary application. The representatives were not able to provide a summary of product characteristic (SPC) or a detailed explanation about retinopathy when requested. The complainant queried whether representatives (sales, market and medical) were briefed to downplay retinopathy, to coax/seek formulary champions and to help write the formulary application.

The complainant further stated that the costs in the prescribing information were misleading. The formulary leavepiece and another leavepiece were given by 2 separate representatives at the end of 2018 but the complainant stated that he/she was explicitly told not to prescribe Ozempic until 1/1/2019 as it was not in supply until then.

The complainant explained that a named employee told him/her at the European Association for the Study of Diabetes (EASD) conference that he/she should ’save’ patients from then, knowing that semaglutide was coming which was outrageous behaviour and there were prescribing issues in January- April 2019 that caused patients to be without medication. Further, the complainant was informed that direct switching from GLP-1 was allowed ie switching from dulaglutide 1.5mg directly to semaglutide 0.5mg the following week; but this caused many issues with hypoglycaemia in 4 of his/her patients. The complainant alleged that the named employee had given advice outwith the Ozempic licence and had no evidence to support that advice and clearly Novo Nordisk had no regard for patient safety let alone cost implications of hypoglycaemia. Many months following his/her complaint to the company and reporting of these adverse effects, the employee had since changed his/her response to state switching involved starting at semaglutide 0.25mg dose. Unfortunately, many patients suffered as a result of negligence by pharma. These behaviours and disregarding safety continued to draw that divide/trust amongst pharmaceutical companies. The complainant stated that the ‘semaglutide discussion was at a GLP-1 advisory board in 2017. The question and discussions were around interclass switching ie from one GLP-1 to semaglutide where the employee stated that ‘direct’ switching from another GLP-1’s (dulaglutide) maintenance dose to semaglutide lowest maintenance dose of 0.5mg’. The complainant subsequently confirmed that the advisory board was not at the EASD conference. It was in London where the subsequent discussions took place.

The complainant stated that he/she requested information from the representative and the response had taken more than ten days.

The detailed response from Novo Nordisk is given below.

The complainant had not named the representative nor any of the other staff to which the complaint referred other than the one named employee. The complainant appeared to use the term representative to describe employees of Novo Nordisk, referring to market access, medical and sales. The Panel considered the allegations as follows

1 Role of Novo Nordisk employees in formulary applications

The Panel noted that it was not necessarily a breach of the Code for a company or its staff to provide information and material to support a health professional in an application for its medicine/s to be included on formulary. It was important that the role of the company be made clear in such circumstances.

The Panel noted that Novo Nordisk provided two documents. Firstly the Ozempic Supporting Information Formulary Application document (ref UK/OZS/0618/0025(1)), the objective of which was to support clinicians or prescribing decision making committee members in submitting a formulary application. The second document was the Ozempic Formulary Decision Guide (UK/SM/0818/0304), the objective of which was an overview of key information required to make a formulary submission in the UK. It included the ‘Guidelines in Practice’ logo. It was for UK payers and health professionals.

It appeared from the objection handler (ref UK/SM/1118/0395, November 2018) that representatives were asked to call upon health professionals who were ‘important stakeholders in the formulary submission process’ as Ozempic was not currently available for prescribing and the company was focussed on getting formulary submissions prepared and submitted. The objection handler did not include any instructions about writing formulary applications. It encouraged health professionals to use Victoza whilst waiting for Ozempic to become available.

The Panel noted Novo Nordisk’s submission that it was not the role of representatives, market access or medical staff to write formulary applications or complete formulary applications on behalf of a health professional. The role of the representatives was to support the formulary applicants either by introducing them to the local diabetes outcomes director (field based market access role) or providing information directly as appropriate.

The key purpose of the market access role was provided. The Panel considered that it was difficult to see that the market access role was anything other than promotional as defined in the Code.

The Panel noted Novo Nordisk’s submission that the regional medical advisors’ role with regard to formulary support was the provision of clinical data upon request by a health professional to support a formulary application.

The Panel key purpose of the regional medical advisor role was provided. The Panel considered that this role appeared to include the promotion of medicines.

The Panel did not consider that the complainant had established that any Novo Nordisk employee had written a formulary application as alleged or had not been appropriately briefed in relation to the company’s role with regard to formulary applications. The Panel noted that the complainant had not detailed why in his/her view the activity constituted disguised promotion; it was not for the Panel to make out a complainant’s allegations. The Panel noted its comments above and therefore ruled no breaches of the Code.

2 Alleged incentives for formulary applications

With regard to the allegation that staff including medical were incentivised upon acceptance of formulary applications that they helped to write, the Panel noted its rulings above; the complainant had not established that any Novo Nordisk employee wrote formulary applications on behalf of health professionals.

The Panel noted that it appeared that market access and sales staff were incentivised to obtain formulary status for products which was not necessarily a breach of the Code. Medical staff were not included in the incentive scheme. The Panel did not accept that paying a bonus which appeared to be capped and did not appear to constitute an undue proportion of the representatives remuneration meant that Novo Nordisk had failed to maintain a high standard and no breach of the Code was also ruled.

3 Content of Ozempic Formulary Decision Guide (Guidelines in Practice document)

The Panel noted its comments above regarding the printed material. The first document (not the subject of this allegation), (ref UK/OZS/0618/0025(1), included proposed formulary wording, clinical evidence including comparisons with other medicines in relation to glycaemic control, weight loss and cardiovascular benefits. The adverse events and tolerability section included information about diabetic retinopathy. Early worsening of retinopathy symptoms was reported in a small proportion of a subset of patients with a previous history of diabetic retinopathy.

The second document, the formulary decision guide (UK/SM/0818/0304) included an overview of the key information required for a formulary submission in the UK. This two-page document did not specifically refer to diabetic retinopathy other than a reference in the prescribing information. The Panel considered that the failure to mention diabetic retinopathy in the formulary decision guide was concerning, particularly given the company was required to do a further study at the request of the regulatory authorities in this regard. The available evidence was not reflected in the formulary decision guide and the Panel therefore ruled a breach of the Code. The Panel considered that the absence amounted to a failure to maintain high standards and a breach of the Code was ruled. On balance the Panel did not consider that its ruling above meant that in addition the material was misleading as alleged and therefore ruled no breach of the Code.

The Panel noted that whilst the information on retinopathy was only in the prescribing information in the summary document, fuller information was provided in the detailed supporting information for formulary application and other materials. On balance the Panel decided that the circumstances did not amount to a breach of Clause 2.

4 Provision of the summary of product characteristics and detailed explanation of retinopathy

The Panel considered that the lack of detailed information from the complainant including who he/she had asked for the SPC, meant that he/she had not provided evidence to show that the SPC had not been provided upon request. The Panel therefore ruled no breach of the Code.

With regard to the allegation concerning the failure of the representative to provide a detailed explanation about retinopathy, the Panel noted that the two current leavepieces (ref UK19OZM00122 and UK19OZM00181) and an e-detailer (ref UK/OZS/0318/0001) provided by Novo Nordisk included information in sections headed ‘diabetic retinopathy’. A leavepiece used in 2018(ref UK/OZS/0318/0005) included very brief details in a general paragraph headed ‘common side effects’. The objection handler gave further information including encouraging representatives to proactively discuss diabetic retinopathy upfront when describing the safety and tolerability profile. Regional medical advisers were also available to discuss diabetic retinopathy. It was not known what materials the medical advisers used in such circumstances. However, the Panel considered that the lack of detailed information from the complainant including who he/she had asked for information on retinopathy, meant that he/she had not provided evidence to show on the balance of probabilities that there was a breach of the Code. The Panel therefore ruled no breach of the Code.

5 Cost and promotion prior to availability

The Panel considered that the complainant was not clear with regard to the allegations about the cost of the medicine. Novo Nordisk submitted that the costs in the prescribing information were accurate. The Panel did not consider that the complainant had shown on the balance of probabilities that the information about costs was misleading. The Panel therefore ruled no breach of the Code.

The Panel noted that it appeared that Ozempic received its marketing authorization in February 2018 (according to information on the eMC). It was not available until January 2019 according to the complainant and various documents provided by Novo Nordisk. The objection handler encouraged health professionals to use Victoza whilst waiting for Ozempic to become available.

The Panel did not consider it was necessarily a breach of the Code to promote a licensed medicine before that medicine was available for supply. Obviously in such circumstances companies needed to be clear about the position. The Panel considered that the complainant had not shown that Novo Nordisk had been misleading in this regard and no breach of the Code was ruled.

6 Alleged conversations with named employee

The Panel noted that the parties’ accounts differed; it was difficult in such cases to know exactly what had transpired. The complainant had provided no supporting evidence in relation to his/her allegations.

The Panel noted that the complainant had not detailed why in his/her view the medical lead in allegedly stating that the complainant should ‘save’ patients from knowing that semaglutide was coming, was in breach of the Code. Nor did the complainant provide evidence of the prescribing issues referred to in his/her complaint. The objection handler for some staff was clear that they were to encourage health professionals to consider Victoza whilst waiting for Ozempic to become available. It would be concerning if a company employee had suggested deferring treatment for patients with diabetes until Ozempic was available. The Panel did not consider that the complainant had provided evidence to show that on the balance of probabilities that there was a breach of the Code or that high standards had not been maintained. The Panel therefore ruled no breaches of the Code in this regard including Clause 2.

In relation to the advice regarding switching from other GLP-1 receptor agonists to Ozempic, the Panel was concerned that the complainant alleged he/she was given different advice to that set out in the undated medical information document and that allegedly following that advice had led to patients having problems with hypoglycaemia. The complainant had initially stated the advice was given at one meeting and then that it was at a different meeting, an advisory board meeting. Novo Nordisk denied that the topic had been raised at the advisory board meeting. The Panel noted that no evidence was provided by the complainant to support the allegations and therefore ruled no breach of the Code.

7 Medical information enquiry

The Panel did not have the details with regard to the allegation concerning the failure of Novo Nordisk to respond to a medical information query within 10 days. The Panel did not know what the query was, when it had been asked or if or when a response had been received. It considered that the complainant had not provided evidence to show on the balance of probabilities that there was a breach of the Code. The Panel therefore ruled no breach of the Code.

8 Cummulative effect

In relation to the allegation that Novo Nordisk’s conduct was in breach of Clause 2, the Panel noted its rulings above. It did not consider that the circumstances warranted a ruling of a breach of Clause 2 which was used as a sign of particular censure and reserved for such use. The Panel therefore ruled no breach.