AUTH/3283/11/19 and AUTH/3284/11/19 - CCG Senior Pharmacist v Bristol-Myers Squibb and Pfizer

Promotion of Eliquis

  • Received
    13 November 2019
  • Case number
    AUTH/3283/11/19 and AUTH/3284/11/19
  • Applicable Code year
  • Completed
    09 March 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

A senior pharmacist at a clinical commissioning group (CCG), complained about the conduct of a representative at a meeting which took place in a GP practice to promote Eliquis (apixaban) which was co-promoted by Bristol-Myers Squibb Pharmaceuticals Ltd and Pfizer Ltd (the Alliance). Eliquis was on the CCG formulary albeit that GPs were being asked to change eligible patients from Eliquis to Lixiana (edoxaban, Daiichi Sankyo UK Limited).

Eliquis and Lixiana were both anticoagulants indicated similarly, although not identically, for the prevention or treatment of various thromboembolic events in adults including deep vein thrombosis and pulmonary embolism.

The complainant noted that Lixiana was licensed and recommended by the National Institute for health and Care Excellence (NICE) for indications which the CCG was promoting its use. The representative asked the practice if its GPs and prescribers had ‘considered plans for litigation should they switch their Eliquis patients and the patients develop a bleed’.

Following a request for more information, the complainant noted that the meeting had taken place with the dispensary finance consultant who had explained to the representative that patients were being switched to Lixiana because a manufacturer discount scheme (MDS) on Lixiana made it less expensive than Eliquis. It was explained to the representative that another practice had been switching patients for some time with no problem. Patients had been switched by a pharmacist or GP who had followed the correct criteria to make sure there were no problems. The dispensary finance consultant further explained that Lixiana would be the preferred non-vitamin K antagonist oral anticoagulant (NOAC) within the CCG, and practices were being asked to switch suitable patients to Lixiana. On numerous times when it was raised that there was a bleed risk, the dispensary finance consultant stated that only patients who were suitable would be switched and only by a pharmacist or GP following a CCG policy.

The dispensary finance consultant stated that he/she was then asked, ‘Have you thought about litigation if a patient was switched and then had a bleed with the possibility of hospital admission and death?’. The dispensary finance consultant replied that he/she had not thought about it, and it did not concern him/her as the switches would be done by a pharmacist. The representative then mentioned lawsuits about which the dispensary consultant was concerned. The dispensary finance consultant stated that he/she would telephone the CCG which the representative thought was a good idea.

The detailed response from the Alliance is given below.

The Panel noted that the Constitution and Procedure stated that the complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties.

The Panel noted that there were two representatives at the meeting, one from Pfizer and one from Bristol-Myers Squibb. The Panel considered that they were both responsible for the conversation in question as far as the Code was concerned.

The Panel noted that the Alliance colleagues attended the meeting knowing that the local CCG guidance was that in the absence of any specific clinical considerations, Lixiana should be the first-line NOAC. The meeting was with a dispensary finance consultant who appeared not to be a prescriber or a health professional. Although there was some disagreement between the parties on the exact wording used during the conversation, it was clear from the call notes that the Pfizer representative had raised the issue of litigation when switching stable patients from one medicine to another based on cost. The Panel noted the submission from the Alliance that the question had only been asked in very general terms, it was not specifically related to switching patients from Eliquis to Lixiana and that the word ‘events’ had been used with no specific reference to ‘bleeds’ or ‘death’. In the Panel’s view, however, in the context of a promotional meeting set up to discuss the local CCG NOAC guideline and to review the key features of Eliquis, it was inconceivable that the dispensary finance consultant would interpret the question of litigation in any other way than being related to the switching of patients from Eliquis to Lixiana and that ‘events’ would be interpreted to be a reference to bleeding etc. The Panel noted that in his/her summary of the call, the Bristol-Myers Squibb representative clearly stated that his/her colleague had asked ‘where they would stand as health professionals, if they moved a stable patient from current direct oral anticoagulants [which would include Eliquis] to edoxaban [Lixiana] and the patient had an event (from a medical-legal viewpoint)’.

The Panel queried whether raising the issue of medico-legal consequences of any course of clinical action was an acceptable basis for promotion of medicines. It implied that the practicalities and consequences of the proposed clinical action had not been fully considered, potentially opening the door to the possibility of litigation. In that regard the Panel noted the Alliance’s submission that the dispensary finance consultant had been unable to clarify the criteria being used to identify patients suitable to be switched from Eliquis to Lixiana – this was not surprising given the role of the dispensary finance consultant. The Panel considered that it was clear that the switches were done by a pharmacist or a GP and not the dispensary finance consultant. In the Panel’ view, if the representatives were concerned that a broad cohort of patients in the practice might have been being considered for switch based on cost alone, and not in clear alignment with the medicines’ SPCs, then they should have followed up those concerns with one of the relevant health professionals. The Panel considered that the representatives had not maintained a high standard of ethical conduct and a breach was ruled.

In the Panel’s view, raising the issue of medico-legal consequences implied that patients stabilized on Eliquis would, per se, become unstable if they were switched to Lixiana. The Panel considered that such a position was not fair, balanced or objective and the suggestion that patients would experience ‘events’ if switched from Eliquis to Lixiana was disparaging. Breaches of the Code were ruled.

The Panel noted that the complaint was about what a representative had said during the course of a promotional discussion, it was not about a comparison in promotional material and in that regard the requirement for promotional material was not relevant to the matter in hand, the Panel therefore ruled no breach.

The Panel noted that the leavepiece used at the meeting did not refer to the possibility of litigation following a switch from Eliquis to any other NOAC. The Panel further noted the Alliance’s submission that some health professionals had previously discussed with the Pfizer representative the issue of responsibility should events occur following switching and that this was the trigger for him/her to raise the question with the dispensary finance consultant. There was nothing before the Panel to suggest that the Alliance had encouraged or sanctioned such discussions by representatives and therefore no breach of the Code was ruled.

The Panel was extremely concerned that the issue of litigation had been used in relation to the promotion of Eliquis and it considered that the conversation, particularly with someone who appeared not to be a prescriber or a health professional, was tantamount to scaremongering. It was clear that by the end of the meeting, the dispensary finance consultant was anxious about what had been discussed. In that regard, the Panel considered that the representatives had reduced confidence in, and brought discredit upon, the industry. A breach of Clause 2 was ruled.