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Bill on seeking licences for drug following patent expiry raises questions over off-label use of drugs in the UK

29 December 2014 Kavita Rainova

In early November a bill was put in front of the British parliament, for second reading, proposing that new licences should be sought by the government for drugs the patent of which have expired. The bill was put forward by MP Jonathan Evans and was supported by the Breast Cancer Campaign.

What exactly was bill looking into …
The bill suggested that pharmaceutical companies do not have the incentive to seek new licences for drugs after their patent has expired, even if these drugs were shown to be effective in the given indication for which they have not been licensed. Using these off-patent drugs in other indications, in which they have been shown to be effective but for which they do not have a license, would allow to lower treatment costs. The breast cancer campaign brought forward the example of tamoxifen. Tamoxifen has been licensed for the treatment breast cancer once it has developed. The drug however does not have a licence for the prevention of development of breast cancer, even though, according to the charity, there is evidence demonstrating that drug was associated with a reduction in the risk of developing breast cancer in high risk women by nearly a third.

However, once a drug is off patent, pharmaceutical companies may not have the incentive to seek approval in additional indications. At the same time, as noted in the bill, there is no organisation that would seek these licences. The bill would thus require the Department of Health to seek the licences.

Support for the bill?
The bill has not only received support from the Breast Cancer Campaign but also several other charities, such as Alzheimer's Society and the Association of Medical Research Charities, had also stated their backing for the bill. The Multiple Sclerosis (MS) Society representative, Clare Keeling, as cited by the BBC had for instance pointed out that high cholesterol treatment simvastatin, had also been demonstrated to be effective in MS treatment in a recent trial. Keeling further reportedly suggested that in the event that it is successful, it could potentially help address unmet patient need considering that there is "currently no treatment that can slow or stop the deterioration seen in progressive MS".

Questions over off-label use?
In contrast, however, a Department of Health representative, also cited by the BBC, had stated ahead of the bill's second reading in the parliament, that licencing "was not the real problem" but alternative ways of "supporting off-label prescribing of drugs" needed to be considered.

Is this a valid concern?
The prescribing of a medication off-label is allowed in the UK as long as the doctor is satisfied about the available evidence. However, the proposed bill would raise questions for example in the event that an on-patent drug is available for the condition, and recommended by NICE, especially when viewing it from the Avastin- Lucentis case from 2012. Lucentis (ranibizumab), developed by Swiss firm Roche and marketed by Novartis in Europe, is the approved treatment of wet age-related macular degeneration (AMD). Cancer drug Avastin, also developed by Roche, and not approved for ophthalmology indications, is still on-patent. Avastin costs less than Lucentis in the doses required for wet AMD treatment and due to its similar mechanism of actions has been used off-label to treat wet AMD. In 2012, Novartis challenged in court the decision of the Southampton, Hampshire, Isle of Wight, and Portsmouth (SHIP) Primary Care Trust cluster board at the time to allow using Avastin for treating wet AMD. So while off-label use of medicines is allowed in the UK there are clearly obstacles to its practical application. And savings that could be made are not always achieved.

The debate will no doubt intensify as the bill comes in for a second reading debate - on a date to be announced.

Kavita Rainovais a life sciences analyst for IHS
Posted December 29, 2014

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