ICER news September 2020
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Final report on CF therapies ICER has released a Final Evidence Report and Report-at-a-Glance on the effectiveness and value of elexacaftor/ ivacaftor/tezacaftor [Trikafta; Vertex Pharmaceuticals] for the treatment of cystic fibrosis (CF).2 The report also includes updated data on three other CF transmembrane conductance regulator (CFTR) stimulants manufactured by Vertex: ivacaftor [Kalydeco], ivacaftor/lumacaftor [Orkambi] and ivacaftor/tezacaftor [Symdeko]. ICER’s report on these therapies was reviewed at a public meeting of the California Technology Assessment Forum (CTAF) in August 2020. "Trikafta is a remarkable advance for the majority of people living with CF, and we encourage public and private US payers to maintain a simple process for all eligible patients to access this important treatment," said Dr David Rind, ICER’s Chief Medical Officer. Unfortunately, the drug price set by the manufacturer "is far out of proportion to the treatment’s substantial benefits," he added. At the CTAF meeting, members voted that evidence demonstrated that Trikafta is superior to best supportive care alone in patients with CF who are homozygous for the F508del mutation, heterozygous for the F508del mutation with a residual function mutation, or heterozygous for the F508del mutation with a minimal function mutation. They voted that evidence demonstrated that Trikafta is superior to Symdeko in patients who are homozygous for the F508del mutation, but a slight majority voted that evidence was inadequate to demonstrate that Trikafta is superior to Symdeko in those who are heterozygous for the F508del mutation with a residual function mutation. Members voted that evidence provides high certainty that Kalydeco provides a substantial net health benefit, Orkambi provides a small net health benefit, and Symdeko provides a small health benefit but has the potential for a substantial benefit, in their indicated populations. CTAF members did not vote on the long-term economic value of Trikafta because at its current price the treatment greatly exceeds cost-effectiveness thresholds. ICER’s recommended health benefit price benchmark for Trikafta is between $67 900 and $85 500 per year, which would require a 73% discount off the current list price. ICER is issuing an Access and Affordability Alert for Trikafta because if all eligible patients currently receiving older CFTR modulators switched to Trikafta, only 35% of newly eligible patients could receive the drug at its current price before ICER’s potential budget impact threshold of $819 million per year is exceeded. At a roundtable discussion after the voting at CTAF, two of the key recommendations were "the manufacturer, which has benefitted from monopoly pricing power, should lower the price of Trikafta to align fairly with its demonstrated benefits" and patient organisations "should demand commitments from manufacturers for sustainable pricing of the products patients helped bring to the market".
Supervised injection facilities ICER has released a Draft Evidence Report on the effecti
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