CINV prevention is critical to managing costs and quality in the value-based care setting1

The Oncology Care Model (OCM)

There is an ongoing shift toward value-based care models such as the OCM, which are intended to improve health outcomes and produce higher quality care, while reducing healthcare expenditures.2,3

Participating OCM practices are compensated for addressing the complex care needs of patients receiving chemotherapy with enhanced services, while maintaining performance accountability2

CINV control remains an unmet need, according to the 2020 Evaluation of the OCM: Performance Periods 1-3

  • There is a need to reduce emergency department visits and hospitalizations due to chemotherapy toxicity4
  • No change in patient-reported experience with care was seen4
For clinics participating in the OCM, uncontrolled CINV may have a substantial impact
Clinical: CINV is a major cause of cancer treatment delay or premature discontinuation5
Economic: CINV can increase the overall cost of cancer care due to associated office visits, ED visits and hospitalization, and additional supportive care6
Humanistic: CINV is associated with reductions in patient quality of life and impairments in activities of daily living7,8
3 CINV-related measures have been proposed for future quality sets9
  • Symptom control during chemotherapy—nausea
  • Appropriate treatment for high and moderate emetic risk
  • Appropriate treatment for low and minimal emetic risk
Considering that more than 1.6 million new cases of cancer are diagnosed each year in the United States, adopting the standards of care established by the OCM can provide significant benefit to both patients and oncology practices3
CINV=chemotherapy-induced nausea and vomiting; ED=emergency department.

INDICATION

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

IMPORTANT SAFETY INFORMATION

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.

Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.

Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.

References:
  1. Soefje. Am J Manag Care. 2018.
  2. Centers for Medicare & Medicaid Services. Updated June 23, 2015. Accessed December 22, 2020. https://innovation.cms.gov/innovation-models/oncology-care.
  3. Centers for Medicare & Medicaid Services. Oncology Care Model fact sheet. June 29, 2016. Accessed December 23, 2020. https://www.cms.gov/newsroom/fact-sheets/oncology-care-model.
  4. Evaluation of the oncology care model: performance periods 1-3. Abt Associates. May 2020.
  5. Van Laar et al. Support Care Cancer. 2015.
  6. Schwartzberg et al. Am Health Drug Benefits. 2015.
  7. Burke et al. Support Care Cancer. 2011.
  8. Hawkins et al. J Clin Oncol Nurs. 2009.
  9. Consensus core set: medical oncology. Core Quality Measures Collaborative. Updated October 9, 2020. Accessed December 23, 2020. http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=88911.
  10. Schnadig et al. Future Oncol. 2016.
  11. Zhou et al. Ther Clin Risk Manag. 2015.
  12. SUSTOL [instructions for use]. Heron Therapeutics, Inc., 2017.




INDICATION

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

IMPORTANT SAFETY INFORMATION

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.

Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.

Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.