The UK’s National Institute for Health and Care Excellence says it will not recommend Amgen’s Repatha as an option for people with high cholesterol and mixed dyslipidemia.

The agency says it made the decision not to cover the PCSK9 inhibitor because there have been no clinical trials to measure the direct effect of the drug on cardiovascular disease.

The committee also has determined that the question of whether lowering LDL cholesterol with Repatha (evolocumab) would reduce angina, heart attacks and strokes remains unanswered.  Further, the committee says there is uncertainty regarding the cost-effectiveness of the drug.

In addition, NICE issued final draft guidance not recommending Roche’s breast cancer treatment Kadcyla (ado-trastuzumab emtansine) because the price of the drug remains too high. This comes despite Roche reaching an agreement with NHS England earlier this month to significantly reduce Kadcyla’s price to remain on England’s Cancer Drugs Fund.

The company had offered a different, smaller discount to NICE, the committee says. NICE Chief Executive Sir Andrew Dillon says that although Kadcyla has a place in treating some patients with advanced breast cancer, the price Roche is asking the NHS to pay is too high in the long-term.