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In this week’s Innovation Partners BioBlog, we update a few of 2019’s top stories regarding the ACA and proposals to lower the cost of prescription drugs. A new partnership between Massachusetts BCBS and Amazon’s PillPack moves ahead, and Johnson & Johnson acquired TARIS with an eye to expanding treatment for bladder cancer.

Innovation Partners Weekly BioBlog Year end 2019

Amgen, Allergan Submit BLA for Proposed Biosimilar Rituximab ABP 798 to FDA

Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan. Rituxan is a CD20-directed cytolytic antibody that is approved to treat multiple diseases, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis with glucocorticoids, and rheumatoid arthritis (RA). While the companies did not say which indications it was pursuing in its statement, the companies referenced the first four indications, but not RA. Amgen currently has ten biosimilars in its portfolio.

HHS releases proposed rule to import drugs from Canada to lower the price for consumers

The Department of Health and Human Services released the proposal to allow imports of Canadian-made drugs into America to lower drug prices for consumers. They also announced the availability of new draft guidance for the industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and initially intended for sale in that foreign country. The Canadian plan has met with skepticism from many quarters, including the Canadian government, which claims the country doesn’t make enough excess medications for export.

Guardant’s cancer blood test receives expanded Medicare coverage for most solid tumors

Guardant Health has received an expanded Medicare local coverage determination for its Guardant360 liquid biopsy test. This expansion broadens its coverage to all solid tumors outside of the central nervous system. This new policy makes the blood test available for all fee-for-service Medicare patients with advanced cancer who would otherwise receive complete genomic profiling of their tumor but have insufficient tissue available or are unable to undergo a traditional biopsy exam. Tissue insufficiency can be a barrier to as many as 30% of advanced cancer patients.

PillPack, BCBS of Massachusetts offer direct integration for drug delivery

Amazon Pharmacy’s PillPack and Blue Cross Blue Shield of Massachusetts are partnering in what BCBS calls the first integration with PillPack for direct delivery. The plan is available to covered BCBS commercial plan members. Members will be able to use the MyBlue app to order, track, and pay for prescriptions at no additional cost. The target customer for the integration is a BCBS member who takes multiple daily medications. PillPack ships 30-day supplies of medicines in presorted containers with customized information.

Johnson & Johnson Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

Johnson & Johnson announced today the acquisition of TARIS Biomedical LLC (TARIS), a privately-owned biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer. The company’s lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. The terms of the transaction were not released. Bladder cancer is the sixth most commonly occurring cancer in men and the 17th most commonly occurring cancer in women. There were nearly 550,000 new cases of bladder cancer diagnosed worldwide in 2018. The majority of bladder cancers are diagnosed in the early stages.

Appeals court strikes down individual mandate, but not entire ACA

Fifth Circuit Court of Appeals ruled that the individual mandate, part of the Affordable Care Act, is unconstitutional. However, they declared that it does not invalidate the entire law. They requested that the Texas District Court, where the case originated, reconsider its decision to declare the ACA as a whole invalid. The remainder of the ACA remains in effect, and coverage will stay in place throughout 2020 for people who purchased insurance under the ACA.