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The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).
The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).
But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).
Rivaroxaban
Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.
Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.
The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.
“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”
Pomalidomide
NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.
Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.
“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.
NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.
Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.
However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.
The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.
