This week’s Innovation Partners BioBlog looks at changes to California’s Medicaid program that may shake up the current Medi-Cal system. Debate continues on step therapy in Medicare, Part B and Medicare unveiled a new app intended to help people determine what is covered. Oncologists and others require more information and education about oncology biosimilars, a new study finds, and more in this week’s Innovation Partners BioBlog.


California Makes Waves With Pharma Benefits, Purchasing Plan

California is shifting its Medicaid program to an entirely fee-for-service drug benefit system, a move which is causing some concern. Currently Medi-Cal beneficiaries have their needs met by private insurers and PBMs. Governor Newsom’s order directs state agencies to create bulk-purchasing arrangements for high-priority drugs and establish a framework for letting private businesses and insurers join the state’s buying pool. The move is expected to have a negative impact on PBMs and potentially, MCOs that provide Medicaid services throughout California.
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Payers, providers clash on CMS’ plans for step therapy in Medicare Part B

Both payers and providers are split when it comes to CMS’ proposals to allow step therapy for Part B drugs. Insurers want to the agency to take its plans for negotiation in Part D’s protected classes further. CMS announced last summer its plans to allow Medicare Advantage (MA) plans to implement step therapy in Part B. Humana has long backed such policies to stimulate competition in the Part B market and lower prices for beneficiaries. Humana claims that existing Medicare policies made it impossible for MA plans to leverage market-based tools of competition to lower cost.
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More Research Finds Low Awareness of Biosimilars Among Oncology Providers

As more anticancer biosimilars gain FDA approval, it is becoming apparent that oncologists need more education on these products. Newly published studies have found that understanding of biosimilars remains low among oncologists, pharmacists, and advanced practice providers. More education is needed before biosimilars are introduced in a clinical setting.
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Cummings, Grassley vow to combat rising drug prices in dueling hearings

It was a busy week on Capitol Hill for healthcare concerns. Committees from the Democratic-controlled House and Republican-run Senate held hearings on rising drug prices, with both sides discussing old and new ideas to combat them. Representative Cummings (MD – D) expressed a desire for a bipartisan approach. Senator Grassley expressed concern and disappointment over the low number of drug company representatives who agreed to testify before the Senate committee. Only two so far have agreed to testify. Additionally, the House Ways and Means committee discussed health insurance for pre-existing conditions.
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The barriers to harnessing data to accelerate the transition to value-based care

Although real-world evidence may be the driving force behind value-based payments, the healthcare system is far from making that a reality. Mark McClellan, former commissioner of the FDA, spoke on a panel recently hosted by the Bipartisan Policy Center. McClellan spoke about the many barriers to value-based care nationwide and what various areas are doing to overcome these barriers.
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CMS unveils app for Medicare beneficiaries to view coverage details

A new app will help Medicare beneficiaries track their coverage details.
The app, called “What’s Covered,” was unveiled by the Centers for Medicare & Medicaid Services, is available for iOS and Android-based devices. It is part of the agency’s eMedicare initiative. The app provides details on coverage as well as specific items, such as medical devices, to determine how much is covered.
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Stand Up to Cancer Tackles T-Cell Lymphoma with Dream Team Focused on CAR-Based Strategies Launched in Honor of Meg Vosburg

Stand Up To Cancer announced the creation of an $8 million Dream Team of top scientists focused on finding therapies for T-cell lymphoma, a rare cancer of the blood and immune system. These therapies will use chimeric antigen receptors (CARs) to trigger the immune system to attack and destroy cancerous cells. Helen Heslop, MD, Baylor College of Medicine (BCM) and Gianpietro Dotti, MD, University of North Carolina Chapel Hill (UNC-CH), lead the team.
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U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults.1 This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and marks the tenth FDA approval for IMBRUVICA since its U.S. launch in November 2013. The approval expands the label for IMBRUVICA in frontline CLL/SLL beyond its use as a monotherapy to include combination use with obinutuzumab. IMBRUVICA, a Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.
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