Author Archives: Todd Cooperman

In November there were a total of eight new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were five supplemental drug approvals. The FDA had assigned five new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include […]

In October there were a total of seven new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was for a biosimilar of Humira, which due to patents, is not slated to be launched until 2023. In addition, there were five supplemental drug approvals, two of which were […]

In September there were a total of six new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had assigned six new products for review. Finally, there was one complete response letter with no current data on expected resubmission date. Drugs included […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New Q-Codes Effective October 1, 2018 New C-Codes for Hospital OPPS use Effective October 1, 2018 CMS News: Medicare Influenza Vaccine Pricing 2018-2019 Season NEW Influenza CPT® Code 90689 Effective January 1, 2019 Medicare Coverage Indicator Change for Q9994 Drug Reimbursement Code Price Updates Drugs/Devices: New Clinical […]

RJ identified a total of seven new FDA drug approvals specific to the specialty market in August 2018, and six supplemental drug approvals. The FDA had assigned four new products for review. Review the August 2018 RJ Health monthly specialty FDA actions newsletter below for more information. Drugs included in this review are generally regarded […]

In July there were a total of four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include […]

There were a total of three new FDA drug approvals in June that we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned six new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

May 2018 Specialty Drug FDA Actions In May there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were eight supplemental drug approvals. The FDA had assigned eight new products for review and assigned five potential specialty products with June 2018 PDUFA dates. […]

INSIDE THIS ISSUE Code Updates:         • NDC Crosswalk update for HCPCS Code(s) J7050, J7040, and J7030         • NEW HCPCS Q-Codes effective July 1, 2018  Drug Reimbursement Code Price Updates  Drugs/Devices:         • New Clinical and Billing Information     CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases […]

In April there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was a first-time generic approval for Zavesca®. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Finally, there were six potential specialty […]