ICER Update 03.04.2019

Hello, everyone, and welcome to this week’s edition of Excelsior Solutions’ ICER Weekly Update.

Here is this week’s ICER recap:

  1. ICER released an Evidence Report assessing the comparative clinical effectiveness and value of nusinersen (Spinraza®, Biogen) and onasemnogene abeparvovec (Zolgensma®, Novartis/AveXis) for the treatment of spinal muscular atrophy (SMA). Spinraza was approved in 2016 for treatment of SMA in both children and adults. Zolgensma is a gene therapy that has been studied in infants with Type I SMA, and an FDA decision is expected in the first half of 2019.

    “Both of these treatments appear to dramatically improve the lives of children with SMA, as well as the families who take care of them,” said David Rind, MD, ICER’s Chief Medical Officer. “And while Spinraza has a broader body of evidence that provides more certainty around the health benefits patients may receive, the limited data on Zolgensma suggest that the gene therapy has the potential to deliver large benefits through a one-time treatment. Unfortunately, at its current pricing, Spinraza far surpasses common thresholds for cost-effectiveness. Among the various companies that are now bringing gene therapies to market, Novartis has a real opportunity here to demonstrate both scientific and ethical leadership by setting the launch price of Zolgensma in line with the benefits patients will likely receive.”

    This Evidence Report will be the subject of an upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), in Boston on March 7, 2019. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

    EXCELSIOR ACTION POINT: This report has been gaining some traction in the lay press as it describes the large gap that exists between manufacturer pricing and ICER estimates of cost-effective pricing. For Zolgensma, ICER calculates cost-effective pricing to be in the range of $310,000 to $900,000, and pre-marketing info from the manufacturer hints at actual pricing of $5,000,000. For Spinraza, ICER calculates Year 1 cost-effective pricing to be in the range of $72,000 to $130,000, and in the range of $36,000 to $65,000 annually in subsequent years. Actual manufacturer pricing is $750,000 in Year 1, and $375,000 annually in subsequent years.

  2. ICER issued a Final New Evidence Update for alirocumab (Praluent®, Regeneron/Sanofi), an injectable PCSK9 inhibitor used for the treatment of high cholesterol in certain patient populations. This New Evidence Update is based on further analysis of results from the ODYSSEY Outcomes trial, which have now undergone peer review and were published recently in the New England Journal of Medicine.

    Based on these new analyses, ICER is revising its value-based price benchmark ranges for alirocumab to $2,300-$3,500 per year if used to treat all patients who meet ODYSSEY trial eligibility criteria, and $2,700-$4,000 per year if only used to treat higher-risk patients with LDL cholesterol (LDL-C) ≥ 100 mg/dL despite intensive statin therapy.

    EXCELSIOR ACTION POINT: It seems that Pharma is listening to ICER, and that ICER continues to evaluate new PCSK9 data as it emerges, with the result being that this long-languishing therapeutic category may be closer than ever to assuming an important, but tightly constrained place in treatment.

If you would like to discuss these ICER activities, or any other aspects of your Pharmacy Benefit Plan, simply reach out to your Excelsior Solutions account team and we will be happy to quickly set up a call.

Until next week!

Bob has more than 30 years of diverse experience in the pharmacy industry. Over the course of his career, Bob has led clinical and PBM operations teams in successfully managing more than $4 billion in annual drug spend. This was also while limiting per-member-per-year spending growth to levels that have simultaneously drawn industry acclaim and consistently high levels of member and payer satisfaction.

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