ICER Update 09.16.19

Hello, everyone, and welcome to this edition of Excelsior Solutions’ ICER Update. Here is this week’s ICER recap:

  1. ICER released an Evidence Report assessing the comparative clinical effectiveness and

value of rivaroxaban (Xarelto®, Janssen Pharmaceuticals) and icosapent ethyl (Vascepa®, Amarin Pharma) as additive cardiovascular disease (CVD) therapies.

“Cardiovascular disease is the leading cause of death in the United States,” said David Rind, MD, ICER’s Chief Medical Officer. “Tremendous health gains have been achieved with now inexpensive treatments such as aspirin and statins, but high-risk patients have substantial rates of cardiovascular events even on these treatments. Our evidence review suggests that treatments like rivaroxaban

and icosapent ethyl can provide additional benefits for such patients, and have prices that reflect those benefits.”

This Evidence Report will be reviewed at an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in St. Louis, MO on September 26, 2019. The Midwest 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: Since both rivaroxaban and icosapent ethyl achieve commonly cited thresholds for cost-effectiveness, plans ought to review this report and adjust their coverage rules as necessary to facilitate access by appropriate patients.

  1. ICER also released a Draft Evidence Report assessing the comparative clinical effectiveness and value of oral semaglutide (Ozempic, Novo Nordisk) and other treatments for Type 2 diabetes mellitus. This draft report will be open to public comment until 5pm ET on October 8, 2019. Based on stakeholder feedback, ICER may revise key assumptions and findings for its Evidence Report, which will be published on

October 31, 2019. The Evidence Report will be subject to deliberation during a public meeting of the New England Comparative Effectiveness Public Advisory Council (NE CEPAC), one of ICER’s three independent evidence appraisal committees, on November 14, 2019.

EXCELSIOR ACTION POINT: This is an important Draft Report for several reasons that are important to every Excelsior Client. From a clinical perspective, oral semaglutide is expected to produce incremental benefit versus alternative T2DM treatments in terms of MACE prevented. However, the complexity of T2DM, its large number of co- morbidities, and its patient-specific clinical management mean that MACE prevention is only part of the treatment puzzle, and other treatments may provide better overall benefit and at lower cost. Based on the current clinical evidence, with limited follow- up, and without knowing the eventual price for oral semaglutide, ICER is unable to draw conclusions on its cost effectiveness at this time. The ultimate value of oral semaglutide will be determined by the price that is set by the manufacturer and

its long-term effectiveness. Also, although the total cost of diabetes care may be somewhat mitigated by the launch of authorized generic versions of certain insulins, the GLP-1 agonist and SGLT2 inhibitor categories will be devoid of generic options for the foreseeable future. Making well-informed formulary choices will be one of the only tactics available to manage net cost in those two categories in the meantime. I recommend this Draft Evidence Report for your review and comment.

  1. Finally ICER posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value treatments for crizanlizumab and voxelotor, both of which will be indicated for sickle cell disease (SCD). Crizanlizumab, a P-selectin inhibitor, is currently under FDA priority review with an anticipated decision expected in the first half of 2020. Global Blood Therapeutics is planning to initiate and complete a rolling NDA for voxelotor, an HbS polymerization inhibitor, before the end of 2019.

EXCELSIOR ACTION POINT: Rates of SCD and sickle cell trait vary considerably by geography with the highest rates found in populations arising from areas where, historically, resistance to plasmodium falciparum malaria conferred a survival advantage. These include equatorial Africa, Brazil, Saudi Arabia and central India. The incidence of SCD is estimated at 300,000 to 400,000 live births globally. In the United States (US), the current best prevalence estimate is approximately 100,000 individuals with SCD, although comprehensive surveillance and reporting is lacking and the true number of cases in the US is unknown. Based on these thumbnail

estimates of prevalence, the impact of these novel pipeline treatments will bring incremental costs when launched, since no substantive current drug treatments exist.

If you would like to discuss this particular, or any prior, ICER report, 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 time!

Bob Kordella, RPh, MBA

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