Generics expand their impact
Problems with supply are largelyÂ resolved, and the generics industry isÂ developing, reflecting the focus of theÂ wider pharmaceutical industry intoÂ the manufacture of more complexÂ molecules, such as biosimilars, the industry hasÂ said.
Speaking at a conference hosted byÂ wholesaler and distributor SigmaÂ Pharmaceuticals last month, Warwick Smith,Â director general of the British GenericÂ Manufacturers Association (BGMA), said:Â â€˜Biologics are an example of one class ofÂ medicines where we can see the futureÂ developing already. We are also seeing greaterÂ incremental innovation, frequently based onÂ developments such as innovative deliveryÂ systems, combination products or additionalÂ patient care packages.â€™
The valuable role of generic medicines in dayto-day medicines continues to reap rewards, saysÂ the BGMA. In January 2014, a World HealthÂ Organization (WHO) report recommended anÂ optimal 80 per cent availability of affordableÂ essential medicines, including generics, requiredÂ toÂ treatÂ majorÂ noncommunicableÂ diseases. TheÂ genericsÂ market isÂ currently boomingÂ in the UK and the NHS has one ofÂ the highest generic penetration levelsÂ in the world.
In July 2014, dataÂ released by the Health andÂ Social Care InformationÂ Centre (HSCIC) revealed thatÂ over three-quarters of NHSÂ prescriptions are now for genericÂ medicines. Dispensing by brand,Â where no generic exists, has fallen to 8.7 perÂ cent. According to the HSCIC report, genericÂ prescribing reduces the number of items to beÂ stocked in the pharmacy and can potentiallyÂ reduce delays in supplying medicines to theÂ patient.
Without generics, the NHS drugs billÂ would be approximately twice its current level.Â â€˜The use of generic medicines already savesÂ the NHS in England more than Â£12 billion perÂ year,â€™ says Mr Smith. â€˜Generic usage allowsÂ financial headroom to enable the NHS to affordÂ newer treatments, as well as providingÂ competition to incentivise the development ofÂ innovative medicines.Â For many conditions,Â generics remain the gold standard of care.â€™
However, funding mechanisms for the genericsÂ industry need to keep pace with change, saysÂ Mr Smith. For example, biologics are oftenÂ marketed as branded generics to enableÂ prescribers to choose them, but â€˜the PPRS andÂ its allied statutory pricing scheme treat allÂ branded generics the same, failing to recogniseÂ that competition already significantly reduces theÂ price of these productsâ€™.
John Beighton, CEO of AMCo (AmdipharmÂ Mercury) and a past chairman of the BGMA,Â says the UK has a much better developedÂ generics penetration than most other countries.
â€˜This is as a result of a pro-generic approachÂ taken through all levels of the healthcare system,â€™Â he says.
â€˜Right from medical school, doctors areÂ taught to prescribe by the generic name, andÂ then when they are qualified they are givenÂ financial incentives to continue this in realÂ practice. Pharmacists also have financialÂ incentives to dispense generic medicines. HenceÂ the system works very well to ultimately benefitÂ the patient and the taxpayer, as well as bothÂ branded and generic pharmaceutical industries.â€™
Generic medicines are more than economicallyÂ beneficial, as they also widen patient access. â€˜TheÂ lower cost ensures that medicines are moreÂ accessible and affordable and for a wider rangeÂ of patients,â€™ says Michael Cann, vice presidentÂ of Accord Healthcare and former chairman ofÂ the BGMA.
â€˜In particular, we have seen thisÂ with the use of statins. Since pravastatin,Â simvastatin and atorvastatin have all lost patentÂ protection, and the cost to the NHS has fallenÂ significantly, the use of statins has grown andÂ prescribing guidance has changed as they haveÂ become more affordable.â€™
Supply and demand
According to Mr Smith, last yearâ€™s genericsÂ supply issues have now been resolved. â€˜There
were some issues with the production of genericÂ medicines by twoÂ large companies,â€™Â he says.Â â€˜ThereÂ have also beenÂ some increases inÂ price and a lack ofÂ supply at pre-existing prices.Â But the manufacturing issues leading toÂ the supply problems have tailed off.â€™
Mr Cann says that in general the genericsÂ industry has responded well to the recentÂ disruption. â€˜The British Association ofÂ Pharmaceutical Wholesalers estimates a 95 perÂ cent product availability of generic medicines atÂ any given time, due to the range ofÂ manufacturers that supply generic medicines,Â and any shortages have been transient and shortÂ term,â€™ he says.
â€˜At Accord, we have made realÂ progress in responding to changes in theÂ demands on us by working very closely with ourÂ manufacturing sites and making diverseÂ investments in infrastructure, to ensure shorterÂ lead times when required.â€™
At the end of January, Actavis announced itsÂ acquisition of Auden Mckenzie. The acquisitionÂ will make Actavis the number one supplier ofÂ generic pharmaceuticals in the UK. Also inÂ January, Actavis launched newly licensedÂ Aripiprazole Conventional Tablets andÂ Orodispersible Tablets for the treatment ofÂ schizophrenia.
â€˜Throughout our 175 years ofÂ manufacturing medicines in the UK, we haveÂ always put our customers at the heart of ourÂ business and by expanding our portfolio we canÂ better cover pharmacistsâ€™ needs and save themÂ both time and costs,â€™ says Jonathan Wilson,Â managing director of Actavis UK.
What do pharmacistsÂ say about generics?
Problems remain around the supply ofÂ generics, according to UK pharmacists.Â Independent pharmacist Reena BaraiÂ says that community pharmacies areÂ â€˜plagued by shortages and price hikesâ€™.
The pharmacy team is having to giveÂ additional time to buying and to be veryÂ aware about price changes. â€˜We have toÂ be on our toes at all times, and prices areÂ varying between wholesalers. Itâ€™s beyondÂ a joke.â€™ Without monitoring prices,Â pharmacies risk losing out, she suggests.
In one example, there was a difference ofÂ Â£14 between the wholesaler price andÂ what was reimbursable. Time spentÂ chasing prices takes away from patientÂ care. â€˜Itâ€™s a really unfair position to put usÂ in,â€™ she says.
Independent pharmacist Fiona McElreaÂ says that a once-monthly bulk buyingÂ scheme, through buying groupÂ Inphaserve, usually allows them to avoidÂ running out of product during the month.
But another difficulty is with customersÂ who specifically request a certain genericÂ product, perhaps because they areÂ sensitive to an ingredient. â€˜You alwaysÂ want to help your patient, but do youÂ accept a loss?,â€™ she asks.
Over the years, research has revealed that someÂ people get confused if their medicines vary inÂ appearance from month to month. In July 2014,Â authors of a US study published in the Annals ofÂ Internal Medicine urged pharmacists to warnÂ patients about the variation in the shapes andÂ colours of generic tablets.
Among patientsÂ discharged from hospital following a heart attack,Â changes to the colour or shape of unbrandedÂ medication posed a risk for non-adherence toÂ treatment, particularly among elderly patients.
According to Toby Capstick, chair of theÂ UKCPA Respiratory Group, the genericÂ prescribing of inhaled devices may affect asthmaÂ control. â€˜There is often confusion in using asthmaÂ devices, and changing these without patientÂ agreement could affect concordance,â€™ he says.
â€˜Community pharmacists are ideally placed toÂ check a patientâ€™s asthma technique, during anÂ Medicines Use Review, for example, and workÂ out which is the best device for them.â€™Â The generics industry believes that withÂ appropriate patient education, MURs and theÂ New Medicines Service, generic medicinesÂ shouldnâ€™t lead to compliance issues.
â€˜SometimesÂ the colour of the tablets changes or the shapeÂ varies slightly through different manufacturers,â€™Â says Mr Smith. â€˜This can lead to confusion if theÂ right information isnâ€™t available. However,Â pharmacists are normally very good at explainingÂ generics to patients. The product informationÂ leaflets should be the same, irrespective ofÂ manufacturer, and the BGMA has strived veryÂ hard to produce patient-focused packaging.â€™
Accord plans to further expand its own rangeÂ of medicines in the future and continue toÂ support pharmacy by making product informationÂ available through its website.
â€˜In the coming years, more specialist medicinesÂ are coming off patent, such as retrovirals for theÂ treatment of HIV,â€™ says Mr Cann.
These will require a different dialogue betweenÂ treatment specialists and pharmacists. BiosimilarsÂ are another area where different preparations areÂ now available from a wider range ofÂ manufacturers than the originator.
Accord recently launched Accofil (filgrastim)Â for the treatment of neutropenia in the
Netherlands, and other countries acrossÂ European markets are expected to launch in the
coming weeks, including the UK.
TheseÂ treatment protocols are already well established,
but ensuring the maximisation of genericÂ medicines or biosimilars in more specialist arenas
will also mean that the NHS, pharmacy andÂ patients continue to benefit from the continuedÂ supply of more cost-effective medicines.â€™