Buprenorphine is an opioid primarily used to treat chronic pain. Low-dose skin patches of buprenorphine (low-dose transdermal buprenorphine, or LDTB) are an effective way to administer buprenorphine continuously, and are particularly useful in patients that are unresponsive to oral analgesics.

There is a significant market for such patches. In the UK, it is estimated that over 40% of the population live with chronic pain, rising to over 70% of individuals aged 65 or over.

Analysis recently published in the British Medical Journal’s open access journal [1] assessed cost savings to the NHS England following the market entry of generic versions of these patches.

The company Napp pharmaceuticals held the UK patent for  LDTB patches, sold as BuTrans, since 2005. When their patent expired in February 2016, Napp launched a generic version, under the name Butec, for 15% less than the originator product.

At the same time, Sandoz obtained marketing authorisation for their own LDTB generic called Reletrans. Napp however claimed breach of patent, preventing the launch of all other generic LDTB patches.

In August 2016, the case went to appeal and ruled in favour of Sandoz, allowing them to begin selling their generic in the UK. The following month, Sandoz’s Reletrans, Dr Reddy’s generic Panitaz, as well as non-branded generics of LDTB patches, were all launched.

The analysis assesses the impact of the delay in entry of these generics on savings made by the NHS. Case scenarios were modelled to estimate the cost savings made from the entry of generic Butec only (the real scenario) compared to the potential savings if all generic LDTB patches had entered the market at the same time. Case scenarios were based on real data and market reaction to the entry of generic medicines.

The cost savings from the introduction of Butec alone were GBP 0.7 million. However, the model predicted that if all the generics had entered the market at the same time, total savings could have reached GBP 1.2 million. Thus, the delayed entry of generic LDTB patches over the six-month period cost the NHS GBP 0.5 million.

The authors conclude that patent protection strategies used by Napp delayed the entry of multiple generics, reducing competition and significantly reducing the cost savings made by the NHS in England.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

Editor’s comment
Readers interested to learn more about market dynamics are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Biosimilars: achieving long-term savings and competitive markets

The generic medicines system in Italy: scenarios for sustainable growth

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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Reference
1. Chapman SR, Aladul MI, Fitzpatrick RW. Lost cost savings to the NHS in England due to the delayed entry of multiple generic low-dose transdermal buprenorphine: a case scenario analysis. BMJ Open. 2019;9(8):e026817

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