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PostPosted: 08 May 2016 17:26 
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Two drugs found to lower cholesterol significantly has now been approved by NICE for NHS patients. The drugs alirocumab (Praluent) and evolucumab (Repatha) which lower cholesterol significantly will now be available for NHS patients who are unable to take statins because of crippling side effects from it (severe muscle pain, rhadomyolysis, liver damage and increased diabetes risk).

Whereas statins work by reducing the production of cholesterol by the liver, alirocumab and evolucumab work by (PCSK9 inhibitor) blocking a protein called PCSK9, allowing the liver to remove cholesterol from the blood.

The recommended starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks, since the majority of patients achieve sufficient LDL-C reduction with this dosage. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg administered every 2 weeks.

Although FDA and European Regulators approved the drug nearly a year ago, NICE did not recommen the drug. The committee was concerned that alirocumab had not been compared with the combination therapy of ezetimibe plus a statin, in the large population of people with non-familial hypercholesterolaemia. They also noted that the trials were not able to provide robust information on important cardiovascular outcomes. The cost was also taken in to consideration.

However, in a revised appraisal consultation document, NICE is now backing Repatha, alone or in combination with other lipid-lowering therapies, as an option in various scenarios, but only at a dosage of 140mg every two weeks and as long as the company continues to offer discount agreed in the patient access scheme.

Today the treatment will cost a minimum of £4000 per patient per year compared to around £350 per year for statins. It is unlikely that the drugs will be used widely in the rest of the world where cost matters, unless the price comes down drastically.

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