Cell therapy weekly: Social value decreases with delay of CAR-T delivery

This week: NIH grant for biotech company’s stem cell-derived retinal therapy program, CAR-T cell therapies to be covered under Medicare and second call for Collaborate to Innovate campaign.

Aug 15, 2019
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The news highlights:

Social value decreases with delay of CAR-T cell therapy delivery
Biotech company receives NIH grant for stem cell-derived retinal therapy program
CAR-T cell cancer immunotherapies to be covered by Medicare
Second call for participation in program to progress advanced therapy research

Social value decreases with delay of CAR-T cell therapy delivery

New research has observed that the benefits of CAR-T cell immunotherapies – for the treatment of diseases such as pediatric acute lymphoblastic leukemia and diffuse large B-cell lymphoma – may be offset by their delayed delivery to patients. The social value of a therapy balances manufacturer costs and profits versus a patient’s improvement in quality-adjusted life years. Researchers employed an economic framework for therapy valuation to assess resultant patients’ social value from timely or delayed CAR-T cell therapy delivery. When therapy delivery was delayed by 6 months, compared with 1 month, patients’ social value from the therapy was lessened by more than 40%.

In the study, the authors concluded: “The social value of CAR-T [cell therapy] is significantly limited by treatment delays. Efficient payment mechanisms, adequate capital, and payment policy reform are urgently needed to increase patient access and maximize the value of CAR-T.”

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Biotech company receives NIH grant for stem cell-derived retinal therapy program

Lineage Cell Therapeutics (CA, USA) has received a National Institutes of Health (NIH; MD, USA)-funded Small Business Innovation Research (SBIR) grant for the advancement of their Vision Restoration Program. The project is working to develop pluripotent cell-derived, 3D human retinal tissue for use in vision restoration. Early program data demonstrated that the devised retinal tissue successfully engrafted in a rat model of severe retinal degeneration; this was achieved without tumor generation and functional retinal improvement was noted.

Francois Binette, Senior Vice President and Head of Global Development at Lineage Cell Therapeutics, commented: “Grants for ophthalmology research from the NIH are highly competitive and we believe this new award and funding of our Vision Restoration Program serves as external validation of the potential of our approach to restore retinal tissue and provides continued proof of progress which builds upon prior SBIR grant awards received to date.”

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CAR-T cell cancer immunotherapies to be covered by Medicare

The Centers for Medicare and Medicaid Services (CMS; MD, USA) has rule that Medicare recipients nationwide are to receive Medicare coverage for CAR-T cell therapies provided by healthcare institutions enrolled in the FDA Risk Evaluation and Mitigation Strategy (REMS), for FDA-approved use indications. The ruling aims to ensures consistency in patients’ access to these potentially transformative therapies. Further, the law will also provide Medicare coverage for off-label therapy uses if these are supported by CMS-approved sources.

Seema Verma, CMS Administrator, commented: “…CAR-T cell therapies are an important scientific advancement in this promising new area of medicine and provide treatment options for some patients who had nowhere else to turn…Today’s coverage decision provides consistent and predictable patient access nationwide. CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”

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Second call for participation in program to progress advanced therapy research

The Collaborate to Innovate program, centrally managed by MedCity (London, UK), has announced a second call for participation; the current, second round of the program seeks to progress advanced therapy research through funding – of up to £150,000 – collaboration between small and medium sized enterprises (SMEs) and academic institutions.

In an exclusive interview with RegMedNet, Elias Zapantis, Program Manager of Collaborate to Innovate, explained: “Advanced therapies offer the potential for a step-change in the treatment of many diseases, including conditions that are currently intractable or poorly-treated by existing approaches…Until now, there has been a relative lack of investment in research and innovation by SMEs due to challenges in accessing funds and knowledge gaps about the relevant expertise within academic institutions. The project aims to help overcome these challenges by promoting engagement between SMEs and the research base, alongside creating inter-university research collaborations and providing the optimum conditions for commercialization.”

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.

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