England moves forward on generic substitution
pharmafile | January 8, 2010 | News story | Sales and Marketing |Â Â NHS, generics, substitutionÂ
The UK Department of Health has started a consultation on proposals that would allow generic medicines to be substituted for branded medicines in primary care in England.
The measure, which is open for comment until March 30, would allow pharmacists to dispense a generic in place of the named drug in a prescription, unless the prescriber specifically opts against any substitution.
The target is to hike the generic prescribing rate from a current level of 83% of prescriptions to 88%. At the moment 17% of prescriptions dispensed in the UK are for branded medicines, most of which have no generic alternative, but the DH estimates there is a 5% block that could be substituted.
Some of these are likely to be medicines which have only recently come off patent and so could provide the significant savings, according to the consultation paper (which can be downloaded here).
An impact assessment accompanying the consultation document estimates the cost of implementing the system would be £4.5 million a year, with start-up costs of £9.1 million, but it would lead to average annual savings of around £49 million.
The move is one of a series of measures aimed at cutting back the UK’s £9 billion a year prescription medicines bill (£5.5 billion for England alone) that were put forward in the 2009 Pharmaceutical Price Regulation Scheme. The others included a 3.9% price cut in February 2009 and another 1.9% reduction this month.
Three options are on the table. The first is to maintain the status quo. The second is to allow substitution, but with a negative list of products that cannot be swapped. Finally, the third is to allow substitution only for selected medicines, i.e. a positive list approach.
The DH says it favours the third option, and has prepared a draft positive list to accompany the consultation document. Scotland, Wales and Northern Ireland will draw up their own policy regarding generic substitution.
Industry response to generic substitution proposals
Industry’s immediate response to the proposals was positive on the whole.
The Association of the British Pharmaceutical Industry, representing the branded drug industry, said it appreciated the emphasis on patient safety and reiterated its opinion that certain product groups – including controlled-release formulations, drugs with a narrow therapeutic index, biosimilars, vaccines and controlled drugs – should be exempted.
The British Generic Medicines Association also came out in support of the proposals, and particularly the DH’s preferred positive list option, which it said provided a “perfect balance” between the need to make savings and the “unfounded fears” of a number of stakeholders.
Earlier consultations on generic substitution raised a number of concerns, including a greater workload for doctors and pharmacists having to explain to patients why changes to their medication have been made, and whether any significant savings will be achieved given the already-high rate of generic prescribing in the UK.
There are also serious considerations for certain medicines, such as anti-epileptics, whose effects seem to be particularly sensitive to the subtle changes in formulation between products.
Medical charity Epilepsy Action welcomed the fact that epilepsy drugs have been excluded from the proposed positive list, but said it was concerned that the draft would allow the DH to add additional drugs to it without further public consultation.
“We will be campaigning strongly to ensure that there is public consultation over any future changes to the proposed list of drugs that can be substituted,” said the charity’s deputy chief executive Simon Wrigglesworth.
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