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Pfizer defends withholding generic Lyrica from patients in pain

Gary Choo: Pfizer’s patent restrictions could compromise patient care

Numark's head of information Gary Choo says pharmacists face a temptation to defy Pfizer’s patent for the treatment of pain if they run out of the branded version

EXCLUSIVE


Pfizer has defended its decision to prevent the generic version of Lyrica being prescribed for pain, in the face of concerns from pharmacists.


Numark told C+D on Thursday (February 19) it had received more than 20 queries in two days from pharmacists about the continuation of Pfizer's Lyrica patent to treat pain, despite a generic version coming onto the market.


The general patent for Lyrica expired in July 2014, but Pfizer will retain the product's patent for the treatment of pain until July 2017. The manufacturer told C+D it appreciated this was an “unusual and complex situation” and said it was in “continuing discussions” with NHS England to issue guidance on how the drug should be prescribed.


Gary Choo, head of Numark’s information service, said some pharmacies were only able to order two packs of Lyrica each week. If they ran out of the brand, there would be a “temptation” to dispense the generic alternative pregablin for pain-related prescriptions as it was the duty of the pharmacist to supply medicines without undue delay, he pointed out.


“At the end of the day, we are here to supply and look after our patients. If that is being compromised by a commercial agreement, then where do we stand?” Mr Choo added.


But Pfizer said it “did not foresee this being an issue”. The manufacturer routinely monitored purchases to “ensure continuity of medicines supply at all times” and anticipated that pharmacies would always be allocated more of the product than they needed, it said.


If pharmacists were unsure whether a prescription for pregabalin was intended for the treatment of pain, they should contact the prescriber, Pfizer said. “We appreciate this creates an administrative burden for pharmacy staff,” it said.


Pharmacists would no longer need to contact the prescriber once central prescribing guidance was created, the manufacturer said, as it would remove the potential for prescribers "unwittingly infringing" the patent.


Last month, PSNC said all pharmacists had to supply the branded product for pain-related conditions, even if the prescription was for the generic drug. Pfizer’s direct-to-pharmacy distribution model meant the manufacturer would be aware if pharmacists were ignoring the restrictions, PSNC warned.


All generic manufacturers had agreed to write to clinical commissioning groups (CCGs) to ensure they were aware that pregabalin could not be prescribed for pain, PSNC said. “A CCG or other party that promotes the supply of generic pregabalin for the patented indication risks facing legal action by Pfizer,” the negotiator added.

 

 


What do you think about Lyrica's patent?

 

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22 Comments

Ian Kemp, Community pharmacist

Let me just get this straight. If I have been prescribed pregabalin, Pfizer are claiming the right to be imformed what it has been prescribed for?! Not a legal expert but I would have thought anyone providing that information to Pfizer would be in clear breach of the Data Protection Act not to mention patient confidentiality. Perhaps C + D could ask someone with more legal expertise.

Z ZZzzzz, Information Technology

According to a letter I've seen from Pfizer it is data supplied by IMS Health using data from approx 10,900 retail pharmacies used to measure sales along with returns from a panel of approx 500 GPs in the UK which is used to estimate the number of drugs that are used to treat different indications by recording the diagnosis given by the GP when prescribing. IMS look for the data provide by ICD 10 code (International Classification of Diseases). Pfizer and IMS agreed a set of allocations several years ago that would allow prescriptions to be divided between different disease and indication categories. The letter goes on but you can ask Pfizer for the same data which shows after manipulating the figures to suit themselves that they reckon 79% of scripts are prescribed for pain; 2% for epilepsy; 4% other diseases and 15% for psychiatry. I suppose we have to trust that the data supplied by IMS Health cannot identify individual patients. The first period used to determine categories was between September 2005 - July 2009. The latest figures are based on a re-run of the analysis between June 2012 - May 14. The DH are aware of all that IMS Health do with regards to this type of data.

Ian Kemp, Community pharmacist

So, presumably this panel of 500 GPs will all be prescribing Lyrica by brand name if they are prescribing for pain [ assuming IMS make them aware Pfizer will be suing them if they don't ] so the data will show that ALL prescriptions for pain are prescribed by brand so pharmacists can assume if it's generic it's not for pain. Apart from that how can Pfizer possibly sue a prescriber or a supplying pharmacy without access to patient notes for diagnoses. They can extrapolate data as much as they like but without that access there is no way that can prove the generic is being used outside its licensed indications. Use of pregabalin for pain might drop like a stone but who is to say that's not because prescribers have taken an intense dislike to Pfizer due to its bullying tactics whist psychiatric use might rocket because it's now more cost effective. The burden of proof might be lower in civil law than criminal law but it's not that low in this country though they might just possibly get away with it in the States.

Z ZZzzzz, Information Technology

Exactly. Glad to see someone else gets it. PSNC don't seem to or they would have pointed this out. Perhaps their hands are tied as it is clear they did not want to give any sort of legal advice if you check the Q&A on their website, and they wanted "others" like you and I to point people in the right direction of how weak Pfizer's position truly is. Still no comment from Pfizer's MD as already challenged.

I have heard a view expressed the the prescriber can prescribe a generic outwith it's product licence - surely this would infringe Pfizer's patent if it was for neuropathic pain?

Leon The Apothecary, Student

Would someone be able to enlighten me to the details regarding how a manufacturer would be able to access confidential dispensing information in a pharmacy? PSNC's warning sense make not much of.

Z ZZzzzz, Information Technology

Interesting to note the lack of any comment from Pfizer reiterating the threat to sue in response to comments on here. Wonder if C&D can squeeze such a comment from the MD with regards to how many pharmacists or gps Pfizer are prepared to sue.

Uma Patel, Community pharmacist

Pharma Co's are as popular as banks. I suggest Pfizer would not dare to go to court as the resultant bad publicity would do it more harm. We have had these kind of threats in the past

Dave Downham, Manager

True - but who's going to put their head above the parapet and dare them?

Join me - I'm a Pfizer despiser!! They have never shown interest in patients except when there's a profit to be had. They represent the lowest form of Big Pharma life (although Roche come close). Remember all the scaremongery rubbish they produced to support their inhaled insulin which turned out to be as much use as an ashtray on a motorbike.

Kevin Western, Community pharmacist

"But Pfizer said it “did not foresee this being an issue”. The manufacturer routinely monitored purchases to “ensure continuity of medicines supply at all times” obviously going for some sort of comedy award?

Ranveer Bassey, Community pharmacist

Full judgement here: http://www.bailii.org/ew/cases/EWHC/Patents/2015/72.html "Remarkably, Warner-Lambert [Pfizer] obtained a supplementary protection certificate which extended protection for pregabalin to 17 May 2018, but allowed it to lapse for non-payment of fees." Pfizer asked that "the pharmacy shall use reasonable endeavours not to supply or dispense Lecaent [generic pregablin] to patients who have been prescribed pregabalin for the treatment of pain, by making reasonable enquiries of a person presenting a prescription for 'pregabalin' as to whether the prescription is for pain and/or making reasonable checks of pharmacy records for the same."

Dave Downham, Manager

Good luck proving that "reasonable" checks weren't taken.

Gerry Diamond, Primary care pharmacist

The DT price usually lags by several months in terms of the generic versus branded price. In good time the price will be readjusted and the costs will be less onerous on the NHS drug budget. Grab it while they can as usual.

Daniel Pharmacist, Community pharmacist

One point that has been missed is that the Drug Tariff part VIII price will have to remain at the Lyrica cost otherwise we would be losing money by giving the brand. It will be interesting to see what happens to the DT price.

Gareth Rowe, Community pharmacist

This has to come down to LHBs (in Wales) and CCGs (in England) contacting all GP surgeries in their locality to notify them that those patients having pregabalin for pain MUST have it prescribed as Lyrica, or else they are sanctioning the use of the drug outside of it's licensed indication. I have notified both of my local surgeries and the LHB of the situation. Once the LHB has notified surgeries of the correct prescribing requirement , if the generic is prescribed we should be able as pharmacists to supply the generic on the grounds that we have notified the prescriber of it's use outside it's licensed indication and they take responsibility for it. We CANNOT have a situation where the generic is dispensed (and reimbursed) but we have to give Lyrica because the LHBs do not enforce the correct prescribinhg. We already lose money on items due to clawback, surely we can't fund the drug-budget any more?

Uma Patel, Community pharmacist

This is sabre rattling by Pfizer. I dispense what the doctor prescribes. Unless there are safety issues, it is not my job to query the clinical indication with the prescriber. PSNC is out of touch with the reality of day to day dispensing. It is upto Pfizer or PSNC if it wishes to inform doctors of the licensing of a product, NOT me. It would be a very interesting legal case if Pfizer went to court.

Angela Channing, Community pharmacist

Agree with you Sir. We do not know which of the 3 indications it is being used for. Maybe Pfizer would like to write to all GPs and tell them this so they can prescribe generic or Lyrica accordingly.

Kassim K, Community pharmacist

This is a company that pleaded guilty to misbranding drugs "with the intent to defraud or mislead" and obviously paid their way out of trouble to the tune of $2.3 billion. If they are prepared to undertake illegal activities then I doubt they care for patients, pharmacies and the NHS. They will not sympathise with our situation as pharmacists and will make an example of a handful of us despite the fact that we would have put patient care first.

Stephen Griffiths, Community pharmacist

Faced with the decision of supplying generic pregabalin, or NO pregabalin to a patient who needed it, I would inform the patient of the situation; - then abide by their decision. (which is exactly what I would do any other time when the prescribed brand is not available, and the choice is between generic or nothing.) When you work evenings and weekends as a locum, the luxury of contacting the prescriber is seldom available!

Z ZZzzzz, Information Technology

I call for all pharmacists and GPs to ignore Pfizer's, PSNC's et al guidance. I'm sure even a company the size of Pfizer don't have the resources to take every pharmacist that dispenses the generic every time or a GP that prescribes the generic everytime to court - it's laughable. As for asking the prescriber everytime - if it's not a legal or clinical requirement then why should we. It's just Pfizer being Pfizer trying to squeeze as much as they can out of taxpayers. Remember the patent extension granted around Lipitor. That was granted because essentially they promised to bring a paediatric version to market. 6 months later when the extension ran out there was still no paediatric version brought to market in Europe or the UK. Despite them already having a paediatric version available in the 'States at the time. They pocketed around $700m extra in that 6 month's period I believe. I will be surprised if this "call to arms" comment remains live after today.

Tariq Atchia, Pharmacy Area manager/ Operations Manager

Naivity in the extreme! "Pharmacists would no longer need to contact the prescriber once central prescribing guidance was created, the manufacturer said, as it would remove the potential for prescribers "unwittingly infringing" the patent."

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