(Bloomberg) -- England’s drug pricing regulator declined to recommend GSK Plc’s long-acting HIV prevention injection, asking the company for more data, in a decision that further delays access to the medicine for patients in the country.
If the regulator, the National Institute for Health and Care Excellence, had recommended the shot, it would have been the first HIV prevention drug available in England that can be taken every two months, rather than daily pills.
Draft guidance, now open for consultation, said trials show that the drug, called cabotegravir, reduces the risk of HIV infection compared with oral treatments. However, NICE said there are difficulties in determining who would have cabotegravir within the National Health Service and how to identify people who can’t have oral HIV prevention drugs.
The evidence that NICE assessed didn’t cover everyone who could have cabotegravir and therefore the regulator said it is “not possible to determine the cost-effectiveness estimate for the whole population without further analyses from the company.”
Cabotegravir, also known by the brand name Apretude, has been developed by ViiV Healthcare Ltd., which is majority owned by GSK. ViiV is continuing to work with NICE on a path froward for the prevention option, a spokesperson said. The next meeting to assess the drug is being held in November, which could see the current guidance changed.
Long-acting HIV drugs are seen as the future of HIV prevention and treatment. ViiV is in fierce competition with Gilead Sciences Inc. over the market. “There can be no debate that long-acting is going to become the core of the market in HIV,” GSK Chief Executive Officer Emma Walmsley said in an interview this week.
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