IntegriChain delivers the life science industry’s largest and only data and business process platform for therapy commercialization and access. Manufacturers rely on our analytics, applications, managed services and expert advisors to power their operations and harness the value of their channel, patient and payer data.
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From the first launch to ongoing market access execution, IntegriChain solves some of the most complex and pressing challenges associated with drug commercialization. We are the data and application backbone for market access departments of Life Sciences manufacturers, enabling them to accelerate their commercialization process, digitalize their operations, and get therapies to patients faster.
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To ensure you get the most out of your access and commercialization investment, IntegriChain provides a complete set of professional Advisory and Systems Integration Services designed to further your business and success.
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We help all stakeholders in the life sciences industry drive access. We do this through our relentless focus on unifying all of the critical business functions for therapy commercialization and access – contracts and pricing, gross-to-net, channel, and patient services – unlocking strategic payer, provider, pharmacy and patient access insights for our life sciences customers.
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September 17, 2020 | integrichain
This the Advisory Market Update for September 2020 from IntegriChain. We want to keep you up-to-date with relevant, timely industry insights and regulatory updates that may impact your business. If you have questions on any of the content found in this or other newsletters, reach out to your IntegriChain Advisory Lead or advisory@integrichain.com and we would be happy to talk you through it.
AZ is jumping on the bandwagon in a rally against 340B covered entities (“CE”) that partner with multiple contract pharmacies. In our August market update, we noted that Eli Lilly had stopped providing 340B pricing to covered entities that provided their product, Cialis, to multiple contract pharmacies. AZ is now following suit, by refusing to offer 340B to covered entities across all their products where the CE uses multiple contract pharmacies. The refusal of 340B pricing to CEs with multiple contract pharmacies will go into effect on 10/1.
You can read more about their recent decision here.
The FDA Reauthorization Act of 2017 enacted on August 18, 2017, recently added section 506I to the Federal Food, Drug, and Cosmetic Act. Section 506I imposes additional reporting requirements on new drug application (NDA) and abbreviated new drug application (ANDA) holders regarding the marketing status of approved products, including:
You can access the complete guidance and required formats here.
CMS is currently conducting product data reviews, comparing the FDA NSDE Structured Product Labeling [SPL] drug report to the Medicaid Drug Listing database. Several manufacturers have received notification the FDA product data and the CMS Medicaid Drug Listing data do not reconcile. Advising the manufacturer they have 60 days to remediate/correct the product data or be subject to MDRP termination.
As part of the Per CMS manufacturer program release notes, [Mfg. Rel.# 084] they “strongly encourage” manufacturers to review the FDA SPL drug report and ensure CMS Medicaid Drug Listing data is reconciled. As an example, products listed in the FDA database are not listed in the Medicaid Drug Listing database; market dates differ; products terminated in the FDA SPL drug report are listed as active in the Medicaid Drug Listing database.
You can access the CMS Memo and FDA SPL drug report here.