pharmaceutical-technologyJanuary 18, 2017
Tag: drug approval , myeloma drugs
Drug approval body the Scottish Medicines Consortium (SMC) has rejected two life-prolonging indications of new myeloma drugs, Kyprolis (carfilzomib) and Darzalex (daratumumab), for use in the country.
The decision will not allow patients in Scotland to access either of these treatment indications routinely.
SMC declined the recommendation of these two indications, saying that the company’s evidence about the overall survival benefits offered was not strong enough to justify its cost to the NHS.
For Darzalex, it was concerned that uncertainties in the company’s evidence on its benefits meant that it would not be a good use of NHS resources.
Myeloma UK policy and public affairs manager Kate Morgan said: "Myeloma UK made a strong case to the SMC for the approval of both indications and we are very disappointed by the decision not to recommend them for use.
"Despite the welcome approval of new drugs in recent years, there is still an urgent need for new myeloma treatments; especially for relapsed patients who have exhausted other standard treatment options such as Velcade and Revlimid."
"Kyprolis and Darzalex are effective new treatments that can deliver real benefits in improving survival and quality of life.
"We will continue to work with the companies and contribute to future appraisals involving these two drugs to help deliver access for patients."
Darzalex was considered for use as a monotherapy in relapsed, as well as refractory patients who have previously been treated with Velcade and Revlimid or thalidomide.
Myeloma patients who have received at least one treatment will receive Kyprolis as part of a combination treatment with Revlimid and dexamethasone.
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