Pfizer’s Lyrica GP reimbursement plan under scrutiny by industry self-regulator

Controversial proposal to pay GPs comes as High Court ruling on the second medical use of Pfizer’s Lyrica is pending.

The on-going battle by Pfizer (logo pictured) to protect its patent of Lyrica (pregabalin) as GPs voted for “urgent” legislation to end patent protection for specific indications for branded medicines.

Pfizer’s plan to reimburse GPs for extra work they undertake to protect the second medical use patent of the company’s drug Lyrica (pregablin) is under consideration by the UK pharmaceutical industry’s self-regulator. 

The Prescription Medicines Code of Practice Authority (PMCPA) regulates the Association of the British Pharmaceutical Industry (ABPI) code which sets the standards for the promotion of medicines to health professionals. It is weighing up whether Pfizer’s offer breaks the industry’s code of practice. 

The PMCPA confirmed on 2 September 2015 that it is investigating a complaint involving Pfizer, but would not give any more information. 

It has also emerged that GPs are being advised by the BMA not to accept any payment from Pfizer for any extra workload around prescribing Lyrica for neuropathic pain for which the branded drug has a secondary use patent. 

Andrew Green, a GP who chairs the BMA’s GP Committee’s clinical and prescribing subcommittee, said: “We would encourage GPs to follow the prescribing guidance issued by the Department of Health and the BMA GPC, but would stress that this is based on a pragmatic decision to protect GPs from potential difficulties rather than being an endorsement of the drug company’s position.”

He said the BMA remained concerned by the “continued pressure” that Pfizer is bringing over the issue. “We believe it would be unwise for GPs to [be] accepting money from Pfizer,” he said.

“This is not about remuneration, it is the principle of accepting money from a company that is pressurising GPs to change their prescribing in a way that has nothing to do with improving the health of their patients, and by doing so will add considerably to the cost burden.”

Pfizer’s medical director of established pharmaceuticals, Seema Patel, said in a statement: “Some health care professionals may have concerns about the principles related to reimbursement and are aware these concerns have already been raised with the PMCPA.” 

The BMA’s concerns, however, had not been made officially to Pfizer, she said. 

She said the drug company was in discussions with NHS England, the Department of Health and the PMCPA “to advise us on whether reimbursement might be appropriate for additional administrative work undertaken to review and update repeat prescriptions where pregabalin has already been prescribed for neuropathic pain, and therefore the clinical prescribing decision already made by the GP.” 

She added: “This would not include any clinical assessment or clinical change in treatment.” 

Sue Sharpe, the chief executive of the Pharmaceutical Services Negotiating Committee, said in a statement that it was essential that health professionals are paid by the NHS for NHS services. 

“Payment by pharmaceutical manufacturers as a contribution to the additional costs borne by health professionals should be made to the NHS, which can then reach agreement on how to reimburse the additional costs,” she said. 

The proposal to reimburse GPs or their practices comes as a High Court ruling on the second medical use of Lyrica is still pending. The case has been taken by Pfizer against a number of generic suppliers, and focuses on the infringement and validity of the patent. 

Lyrica was originally marketed for the treatment of general anxiety and epilepsy. That patent has now expired but a secondary medical use for the treatment of neuropathic pain does not run out until July 2017.

The High Court decision is not expected until October 2015 at the earliest.  

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Citation
The Pharmaceutical Journal, September 2015;Online:DOI:10.1211/PJ.2015.20069308