DrugS

The Journal of Clinical Oncology published clinical results from the KRYSTAL-1 study of adagrasib, a potent and selective KRASG12C inhibitor, demonstrating durable IC activity in patients living with KRASG12C-mutated NSCLC with untreated CNS metastases. This result is clinically meaningful as CNS metastases are present in 27%-42% of patients living with KRASG12C-mutated NSCLC at diagnosis and are linked to worse prognosis and higher rates of disease progression in the CNS.  Read the publication, here.

For the first time, the law provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic or biosimilar competition. Below is the list of 10 drugs covered under Medicare Part D selected for negotiation for initial price applicability year 2026, based on total gross covered prescription drug costs under Medicare Part D and other criteria as required by the IRA (Inflation Reduction Act). These drugs are branded and include the following:

1. Eliquis
2. Jardiance
3. Xerelto
4. Januvia
5. Farxiga
6. Entresto
7. Embrel
8. Imbruvica
9. Stelara
10. Fiasp; Fiasp FlexTouch; FiaspPenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

Details and time frames for this negotiation are laid out in this Fact Sheet.

AstraZeneca is pleased to announce that IMJUDO® (tremelimumab-actl) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and Average Sales Price (ASP) by the Centers for Medicare & Medicaid Services (CMS).

Effective for dates of services on or after July 1, 2023, the following code (J9347) can be used by providers to identify IMJUDO when billing across settings of care as noted in the (2023) Alpha-Numeric HCPCS file.  Read More.

In light of the critical drug shortages facing the U.S., The Association for Clinical Oncology (ASCO) has issued guidance for the treatment of gastrointestinal malignancies in the context of limited drug availability.

The guidance provides five general principles outlining reasonable drug substitutes and how to prioritize patient needs. The guidance focuses on:

1. Upper gastrointestinal malignancies
2. Pancreato-biliary malignancies
3. Small intestine malignancies
4. Colorectal cancer
5. Anal cancer

Read the full guidance for further details.

• NCCN Press Release on Chemotherapy Drug Shortages
• NCCN Chemotherapy Drug Shortages Survey Results
• NCCN Full Statement on Chemotherapy Drug Shortages

The American Society of Clinical Oncology and the Association for Clinical Oncology (collectively ASCO) are closely monitoring the current, acute shortages of cisplatin and carboplatin in the United States. ASCO has developed guidance for clinicians who are navigating the situation and offered recommendations to policymakers to help mitigate the current shortages and prevent similar situations in the future. 

ASCO has a dedicated drug shortages website that will be kept up to date as information on the availability of drugs in shortage is released from the Food and Drug Administration (FDA). The site also offers clinician resources and links to more information.

We strongly encourages our members to report drug shortages directly to FDA. While the agency is aware of critical shortages, it is important that it receives these reports to better assess the scope of shortages and use in mitigation activities.

ASCO will remain in close contact with FDA and will also continue to share its concerns and recommendations with Congress. Use the ACT Network to urge lawmakers to take the organization’s recommended steps to mitigate drug shortages.

Bookmark asco.org/drugshortages to stay up to date on the current shortage of cancer drug treatments, as well as breaking news, advocacy, and analysis on cancer policy. 

Coherus BioSciences, Inc., today announced that the single-dose (6mg/0.6mL), prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv) is now available for commercial sale in the United States.  Read More.

In follow up to the discussions held at the spring State Affiliate Council meeting, the Food and Drug Administration (FDA) expects additional releases of cisplatin from Accord Table of Contents Encourage your members to join the State Society Network Healthcare in the upcoming days. Providers and others can check on Accord supplies through their usual channels and can also contact the company directly at 866-941-7875, Option 2.

The FDA has additional information on the cisplatin shortage, including expected recovery dates from other manufacturers.

The FDA is exploring all avenues for additional supplies to ensure patient need will be met, including temporary importation. The American Society of Clinical Oncology will keep its members informed as supply becomes available.

Information from Merck announcing a new indication linked below.

Click to Download.

For prescribers: please click here for state-required price disclosures.

On January 27, 2023, the National Comprehensive Cancer Network® (NCCN®) revised its guidelines—now ribociclib (KISQALI®) is the only CDK4/6 inhibitor in combination with an AI designated as a Category 1 Preferred regimen in first-line HR+/HER2- mBC.1,2

Can we set up some time to further explore this major update and review the data that made the NCCN differentiate ribociclib (KISQALI) for first-line use in combination with an AI? Please feel free to contact me at (802) 735-7859 or via email. 

See the evidence that drove the update

Click here to read the NCCN Guidelines®.

Click here for full Prescribing Information for KISQALI.