Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.
Read the full FDA announcement here.
On August 16, 2018, the Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival.
Read the full FDA press release here.
Starting January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) is giving Medicare Advantage (MA) Plans the option to utilize step therapy for Part B drugs. For example, in 2019, MA Plans may now require that a beneficiary who is newly diagnosed with a condition begin treatment with the plan's most preferred, most cost-effective drug therapy before progressing to a more costly drug therapy if the initial treatment is ineffective. This change will only apply to newly prescribed medications.
As part of the policy announced on August 7, 2018, Medicare Advantage plans that also offer a Part D benefit will be able to cross-manage across Part B and Part D.
Medicare Advantage plans that choose to offer this approach to enrollees in 2019, must explicitly communicate this to beneficiaries through the Annual Notice of Change and Evidence of Coverage documents. Patients that do not want to participate in a plan that elects to adopt this step therapy approach will have the option to select a different plan.
The ACCC policy team is currently analyzing this policy change and will provide an update to members.
Read CMS memo to Medicare Advantage plans.
Read CMS fact sheet on Medicare Advantage Plans and step therapy for Part B drugs.
During this listening session, CMS experts will briefly cover three provisions from the proposed rule and address clarifying questions to help formulate written comments for formal submission:
Participants are encouraged to review the proposed rule prior to the call, as well as the following materials on the provisions to be covered: