image-title
Contact: Kevin Scorsone
NCODA Legislative & Policy Liaison
(919) 903-2057
kevin.scorsone@ncoda.org

Statement From NCODA Legislative & Policy Advisory Committee
October 28, 2021

Patients Are The Priority: A Call For A Medically Integrated Community

 

CAZENOVIA, NY – New York State is the home of NCODA, and at one time locally owned pharmacies were commonplace. But now a system that allows certain Pharmacy Benefit Mangers (PBMs) to wield their power has put these pharmacies on the brink of permanent extinction.

Over the summer, NCODA educated our membership about a New York State Legislature bill that was passed with support on both sides of the aisle. The bill would establish increased oversight, accountability, and transparency for all PBMs throughout New York State. Former Governor Andrew Cuomo vetoed a similar bill in 2019, but since his exit from office, the current PBM bill has a chance to finally be signed into law at the hands of current Governor Kathy Hochul.

NCODA will always put patients first and look for solutions that lead to a medically integrated community that can achieve sustainability for patients in the years to come. Consistent with NCODA’s history and guiding values, announced last week was a first-of-its-kind collaboration with NOCDA and Prime Therapeutics, a PBM that servers more than 33 million members. Prime’s new IntegratedRx™ Oncology Program coupled with NCODA’s Center of Excellence (CoE) Medically Integrated Pharmacy (MIP) Accreditation Program will allow for a revolutionary shift of streamlined delivery of oncology treatment. Read the full press release here. Going Beyond the First Fill within a medically integrated oncology practice has been proven to enhance patient compliance and satisfaction, quality of care delivered, and cost avoidance and waste reduction to the healthcare system.

It is our belief that the oncology landscape needs to always be evolving and making life better for our patients; that includes reforming PBMs. One thing we always ask of our legislature, our government and the elected officials who mold the landscape of patient access to care is to be accountable. Accountability is necessary and we must hold PBMs accountable and help them address a system that needs change.

There are certain PBMs that control much of the pharmacy market. They are focused on profit instead of patients and have deals in place that are focused on eliminating independent pharmacies that were once pillars of our communities in New York. NCODA believes in a collaborative, patient-focused approach; one that we believe could include a revamping of the PBM system to make access to quality care and medication a realization for all patients.

NCODA is encouraged by the progress that has been made in New York State with support to rein in a few rogue PBMs and their non-patient centric practices. We hope that New York will follow the lead of other states including Texas, where NCODA President Jim Schwartz, RPh, had significant influence in the successful passage of PBM legislation in the state. The NYS bill would make patients the priority, and it would make medication more accessible and affordable to every patient in the state who is battling cancer.

NCODA’s Legislative and Policy Advisory Committee (LPAC) will be discussing this topic during their upcoming Legislative Roundtable on November 30, 2021 at 7PM Eastern. If any progress is made regarding the NYS bill prior to that, we will be the first to inform our membership.

 

# # #

 

About NCODA

NCODA is a leading nonprofit organization dedicated to empowering medically integrated oncology practices to deliver positive, patient-centered outcomes by providing leadership, expertise, quality standards, and best practices. For more information about NCODA, its Executive Council, and general updates, visit www.ncoda.org or follow @NCODAorg on Twitter.

 

Read More

Written by: Alyson Leonard, PharmD, BCPS, BCOP Cone Health
Download Here

Description: Cabazitaxel is indicated for treatment of patients with metastatic castration-resistant prostate (mCRPC) cancer previously treated with a docetaxel-containing treatment regimen in combination with prednisone.1 The purpose of this PQI is to provide guidance for initiating cabazitaxel.

Background: Cabazitaxel was FDA approved in 2010 based on the phase 3 trial TROPIC that compared cabazitaxel plus prednisone to mitoxantrone in patients with mCRPC previously treated with a docetaxel-based treatment.2 The recommended dose of cabazitaxel is now 20mg/m2 every 3 weeks. The higher dose of 25mg/m2 can be used at provider discretion for select patients.1,3 The CARD trial evaluated the use of cabazitaxel with prednisone/prednisolone and G-CSF for patients with mCRPC previously treated with docetaxel and an androgen signaling targeted inhibitor (abiraterone or enzalutamide) who had progressed within 12 months. The study compared cabazitaxel to initiation of another androgen- signaling -targeted inhibitor not previously used. The median radiographic progression-free survival was 8 months with cabazitaxel treatment group and 3.7 months with androgen receptor inhibitor group (HR 0.54, p<0.0001). When comparing median overall survival, cabazitaxel had a longer overall survival compared to androgen-signaling-targeted inhibitor, 13.6 months vs 11 months. Overall, cabazitaxel was associated with a 36% risk of death reduction.  Secondary objectives of improvement in progression free survival, pain response, and time to symptomatic skeletal events favored cabazitaxel.1,4

PQI Process:

  • Review the medical record:
    • Review past treatments for documentation of previous docetaxel administration
      • If docetaxel was not previously given, evaluate the reason for non-use, per guidelines, patients who are not candidates for docetaxel can still be considered for cabazitaxel. (ex. pre-existing mild neuropathy prevented docetaxel use)5
    • Review labs for a recent CBC. Cabazitaxel is contraindicated in patients with neutrophil counts ≤1,500 cells/mm31
  • Review treatment plan: 1
    • Verify premedication orders:
      • Antihistamine: diphenhydramine 25 mg or equivalent antihistamine
      • Corticosteroid: dexamethasone 8 mg or equivalent steroid
      • H2antagonist: famotidine 20 mg or equivalent H2 antagonist
    • Verify cabazitaxel dosing:
      • 20 mg/m2administered every three weeks as a one-hour intravenous infusion
      • Dose adjustments needed for hepatic impairment; no adjustment for renal impairment
    • If provider is starting dosing as 25 mg/m2, strongly consider G-CSF and CINV prophylaxis
      • Incidence of grade 3-4 nausea at this dose was 2% and grade 3-4 vomiting was 2%1
    • Verify prescription for prednisone has been entered
    • Verify prescription or order for antiemetic: prophylaxis recommended as needed (PO or IV)
    • Evaluate the need for primary prophylaxis with G-CSF
      • Recommended for patient with high-risk clinical features such as previous episodes of febrile neutropenia, older patients, extensive prior radiation, poor performance or nutritional status, or other serious comorbidities
    • Monitoring:1
      • CBC: baseline, weekly during cycle one, then before each treatment cycle
    • Preparation:1
      • Cabazitaxel requires two dilutions for preparation
      • Mix cabazitaxel vial with the entire contents of the included 5.7 mL diluent vial
      • Withdraw the patient specific dose of cabazitaxel
      • Inject dose into a 250 mL PVC-free container of 0.9% sodium chloride (NS) or 5% dextrose (D5W)
        • If dose is >65 mg use a larger volume solution so the concentration is ≤0.26 mg/mL
      • Mix the final infusion solution by gently inverting the bag
    • Administration:1
      • IV over one hour with a 0.22-mcm nominal pore size inline filter

 

Patient Centered Activities:

  • Patient Education:
    • Review the risk of infusion reactions, which will most likely to occur during first or second infusion
      • Signs of a reaction may include rash/itching, feeling dizzy, chest or throat tightness, breathing problems, face swelling
    • Instruct patient to report any adverse events, such as fever, diarrhea, nausea/vomiting, numbness/tingling of the hands or feet, or fatigue
    • Ensure patient has access to supportive medications
      • Anti-nausea (ex. 5-HT3 receptor antagonist, metoclopramide, or prochlorperazine)
      • Anti-diarrheal (ex. loperamide)
    • Provide written information to patient on medication

Supplemental Information:

  • CareASSIST Patient Support Program
    • Program can assist eligible patients with no insurance coverage or who lack coverage
      • Medicare Part B patients with no supplemental insurance coverage may be eligible
    • CareASSIST Copay Program
      • Available to commercial insurance patient to help decrease out of pocket cost

References:

  1. Jevtana® (cabazitaxel) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC.
  2. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147-1154.
  3. Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017;35(28):3198-3206.
  4. de Wit R, de Bono J, Sternberg CN, et al. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019;381(26):2506-2518.
  5. National Comprehensive Cancer Network. Prostate Cancer. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
Read More

Written by: Jeff Engle, PharmD, MS
Download Here

Description: This PQI will discuss effective management of adverse effects of sorafenib in the treatment of hepatocellular carcinoma and discuss data supporting the sequencing of patients to second-line therapy with regorafenib for increased survival benefit.

 

Background: Hepatocellular carcinoma (HCC) is associated with a high mortality rate and historically the treatment options have been limited. Prior to 2018, sorafenib was the only Food and Drug Administration approved targeted therapy for the initial treatment of unresectable HCC in patients diagnosed with late stage or metastatic disease.7 Second-line treatment options, though growing in number, have limited and at times conflicting survival data; and all factors of options should be considered.14, 16 A retrospective study of the RESORCE trial ascertained median time from start of sorafenib to death in patients receiving sequential therapy to regorafenib. Exploratory analysis revealed time from sorafenib initiation to death as 26 months for regorafenib patients vs. 19.2 months for placebo patients.16

 

PQI Process: Upon receipt of a prescription for sorafenib:

  • Obtain CBC with differential, metabolic panel including magnesium and phosphorus, liver function tests, lipase and amylase prior to starting therapy and then monthly until labs have stabilized
  • Consider obtaining thyroid stimulating hormone level at baseline, every 4 weeks for 4 months, and then every 2-3 months thereafter
  • Monitor blood pressure at baseline and weekly during the first 6 weeks of sorafenib, and then monitor blood pressure, utilizing clinic appointments and treat any developing hypertension as needed
  • Treatment associated hypertension and dermatologic toxicity are managed with dose interruptions and reductions.8 Grade 1 dermatologic toxicity may not require dosage adjustments (see table 3 for dose reductions due to toxicity)
  • Consider proactively discussing 2nd line treatment options following progression or intolerance

If regorafenib is considered for 2nd line tyrosine kinase inhibitor transitioning

  • Ensure recovery from sorafenib mediated adverse effects and that patient did not permanently discontinue sorafenib due to toxicity or inability to tolerate doses
    • RESORCE trial required that patients be able to tolerate at least 400 mg a day of sorafenib for 20 days of the last 28 days prior to withdrawal to be eligible
  • Determine Child-Pugh Class status and make appropriate recommendation for therapy
  • If underlying hypertension exists or developed while on sorafenib, ensure appropriate blood pressure control prior to starting regorafenib
  • Refer to Regorafenib (Stivarga®) In the Treatment of Hepatocellular Carcinoma PQI for managing adverse effects

 

Patient Centered Activities:

Counseling for sorafenib

Counseling for regorafenib

 

Supplemental Information:

Table 1: Dose Adjustments for Baseline Hepatic Dysfunction15*

Degree of Hepatic ImpairmentCriteriaSorafenib Dose
MildBilirubin >1 to ≤1.5 times ULN and/or AST >ULN400 mg twice daily
ModerateBilirubin >1.5 to ≤3 times ULN; any AST200 mg twice daily
SevereAlbumin <2.5 g/dL with any bilirubin/AST200 mg once daily
Bilirubin >3 to 10 x ULN with any ASTNo tolerable dose identified

*Reference used differs slightly from sorafenib prescribing information reference

 

Table 2: Dose Adjustments for Baseline Renal Dysfunction15

Baseline Creatinine ClearanceSorafenib Dose
40-59 mL/min400 mg twice daily
20-39 mL/min200 mg twice daily
< 20 mL/minUnable to define dose
Hemodialysis200 mg once daily

 

Table 3: Dose Reduction Levels for Adverse Effects*

Dose ReductionSorafenib Dose
Starting400 mg twice daily
1200 mg twice daily
2200 mg once daily or 400 mg every other day
3Discontinue

Patient Assistance

Sorafenib patients can utilize the REACH support program while on therapy

  • Nurse counselors are available for answering questions and providing patient education including Patient Starter Kits
  • Service counselors are available to discuss patient access services including co-pay assistance

 

References:

  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34.
  2. Cronin KA, Lake AJ, Scott S, et al. Annual report to the nation on the status of cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800.
  3. Morgan TR, Mandayam S, Jamal MM. Alcohol and hepatocellular carcinoma. Gastroenterology. 2004; 127: S87–96.
  4. El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012;142:1264–73.e1.
  5. Marrero JA, Kulik LM, Sirlin CB, et al. Diagnosis, staging, and management of hepatocellular carcinoma: 2018 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750.
  6. National Comprehensive Cancer Network. Hepatobiliary cancers version 1.2019. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf.
  7. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-390.
  8. Nexavar® (sorafenib) [prescribing information]. Wayne, NJ: Bayer Healthcare Pharmaceuticals Inc.
  9. Bruix J, Qin S, Merle P, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389:56-66.
  10. El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMat 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389:2492-2502.
  11. Zhu AX, Finn RS, Edeline J, et al. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018;19(7):940-952.
  12. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018;379:54-63.
  13. Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):282-296.
  14. Merck Provides Update on KEYNOTE-240, a Phase 3 Study of KEYTRUDA® (pembrolizumab) in Previously Treated Patients with Advanced Hepatocellular Carcinoma. Merck. Published February 19, 2019. https://bit.ly/2SQ6J45.
  15. Miller AA, Murry DJ, Owzar K, et al. Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. J Clin Oncol. 2009 Apr 10;27(11):1800-5.
  16. Finn RS et. Al Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC. J Hepatol.2018 Aug;69(2):353-358. doi: 10.1016/j.jhep.2018.04.010.
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.

 

Read More

Written by: Derek Gyori, PharmD and Julianne Orr, PharmD
Download Here

Description: Abemaciclib is FDA-approved in combination with an aromatase inhibitor, fulvestrant, and as a single agent in early high-risk, advanced, or metastatic breast cancer. This PQI will address effective practices for the management of abemaciclib associated diarrhea, a common toxicity with this therapy.

Background: Abemaciclib is an FDA approved Cyclin Dependent Kinase (CDK) 4 and 6 Inhibitor approved for use in hormone receptor (HR) positive and human epidermal growth factor 2 (HER2) negative metastatic breast cancer.1-3 Although the mechanism of abemaciclib-induced diarrhea is not fully understood, management of diet along with drug therapy remains the standard of care in patients with abemaciclib-associated diarrhea. In clinical trials, abemaciclib associated diarrhea most frequently occurred in the first cycle of treatment, with a median onset between 6 and 8 days. Diarrhea was often managed in the clinical trials using anti-diarrheal agents sparing the need for dosage reductions or interruptions in the majority of the population.1,2,3

PQI process: Upon receipt of abemaciclib prescription:

  • Screen for appropriate antidiarrheal medication:4,5,6
    • Loperamide (OTC)
      • Take two caplets (4 mg) followed by one caplet (2 mg) every four hours until diarrhea-free for 12 hours
      • Do not exceed 8 caplets (16 mg) per day
        • If diarrhea does not improve during the first 24 hours of taking loperamide, the patient should contact their health care provider
      • May take up to 12 caplets per day for chemotherapy-induced diarrhea under medical supervision
        • May schedule loperamide around the clock before adding another agent
    • Diphenoxylate/atropine (Rx)
      • Take 2 tablets (5 mg) three to four times daily (max of 8 tablets per day)
      • May alternate with loperamide to achieve around the clock coverage
      • Common side effects: dry skin and mucous membranes, tachycardia, urinary retention, hyperthermia
        • Although uncommon, respiratory depression can occur due to the diphenoxylate
    • Tincture of opium (Rx)
      • Deodorized tincture of opium 10 mg/mL of morphine – Take 0.6 mL (6 mg) in water every 3- 4 hours
      • Common side effects: CNS depression, drowsiness, urinary retention, constipation, nausea, headache
        • Although uncommon, respiratory depression can occur
  • Follow-up with patient by phone after the first week of therapy
    • If severe diarrhea (≥ 7 stools per day), may require inpatient admission for fluid and electrolyte administration

Abemaciclib Dose Modifications

CTCAE Grade of diarrheaAbemaciclib dose modification
Grade 1No dose modification required
Grade 2If toxicity dose not resolve within 24 hours to

≤Grade 1, suspend dose until resolution. No dose

reduction required

Grade 2 that persists or recurs after resuming the

same dose

Suspend dose until toxicity resolves to ≤Grade 1.

Resume at next lower dose

Grade 3 or 4 or requires hospitalizationSuspend dose until toxicity resolves to ≤Grade 1.

Resume at next lower dose

 

Patient Centered Activities:

  • Patient Education
    • Provide Oncology Chemotherapy Education (OCE) sheet for abemaciclib and Oncology Chemotherapy Education Supplemental Sheet for diarrhea
    • Explain abemaciclib associated diarrhea’s median time to onset in the trials was 6-8 days
    • Instruct patient to call their provider at the first sign of diarrhea
    • Encourage patients to take loperamide at the onset of a loose, watery stool and every two hours until resolution of diarrhea
      • If diarrhea hasn’t improved within 24 hours with treatment, consider reducing dose
    • Diet Recommendations:4,5,6
      • Avoid greasy, spicy, or fried food
      • Avoid milk, caffeine, alcohol, and high fiber vegetables
      • Eat small frequent meals
      • B.R.A.T Diet – Bananas, Rice, Apple Sauce, Toast
      • Drink three or more liters of clear fluid per day
        • Water, clear liquids, soup, sports drinks

References:

  1. Dickler MN, Tolaney SM, Rugo HS et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res 2017; 23(17): 5218-5224.
  2. Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine J Clin Oncol 2017; 35:2875-2884.
  3. Goetz, MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017; 35:3638-3646.
  4. National Comprehensive Cancer Network. Palliative Care (Version 1.2018). https://nccn.org/professionals/physician_gls/pdf/palliative.pdf. Accessed May 16, 2018.
  5. Rangwala F, Zafar SY, Abernathy AP. Gastrointestinal symptoms in cancer patients with advanced disease: new methodologies, insights, and a proposed approach. Curr Opin Support Palliat Care 2012; 6:69-76.
  6. Richardson G, Dobish R. Chemotherapy induced diarrhea. J Oncol Pharm Practice 2007; 13:181-198.
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
Read More

Written by: Jan Montgomery, PharmD, South Carolina Oncology Associates and Jacob Dygert, South University School of Pharmacy
Download Here

Description: To identify appropriate eligible patients for abemaciclib therapy based upon specific prognostic factors.

Background: Abemaciclib is indicated for the treatment of postmenopausal women with HR-Positive, HER2- Negative in early high-risk, advanced, or metastatic breast cancer.  Abemaciclib may be used as monotherapy or in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy and in combination with fulvestrant with disease progression following endocrine therapy. In an exploratory analysis of the Monarch 3 and Monarch 2 (placebo + fulvestrant vs abemaciclib + fulvestrant) benefit was seen specifically in prognosis concerning: liver metastases, P-gR negative tumors, or high-grade tumors. The greatest benefit over placebo was seen in Monarch 2 among the subsection of patients with baseline liver metastases; the median progression free survival increased from 3.09 months (placebo) to 11.64 months (abemaciclib).6

PQI Process:

  • Obtain CBC with differential and platelets at baseline, every 2 weeks for the first 2 months, monthly for the next 2 months, then as clinically indicated
  • Identify patients with prognostic factors that may benefit patient outcomes in areas such as:
    • Visceral Liver Metastases
    • P-gR Negative Tumors
    • High-grade Tumors
  • Consider review of EMR for all current advanced breast cancer patients and those already on CDK4/6 inhibitors to assess for the prognostic factors above
  • Provide input with medically integrated team as needed to help benefit patient
  • Check liver function following the same schedule as CBC
  • Abemaciclib should not be given to pregnant women
    • Ensure proper use of birth control prior to and during therapy and 3 weeks past last dose
  • Monitor and educate patient to be aware of signs and symptoms of diarrhea, dehydration, venous thrombosis, or pulmonary embolism
  • Dosing Guideline Summary:
    • When used in combination with either an aromatase inhibitor (AI) or fulvestrant, abemaciclib 150 mg orally twice daily with or without food
    • When used as monotherapy abemaciclib 200 mg orally twice daily with or without food
    • See dose modification based on strong CYP3A4 inhibition
    • Be aware of dose adjustments for patients with severe hepatic impairment
    • Significant adverse effects to monitor include neutropenia and venous thromboembolism
    • Continue treatment until disease progression or unacceptable toxicity

Patient Centered Activities:3

References:

  1. VERZENIO ® [Package Insert]. Eli Lilly and Company , Indianapolis, IN. Accessed at: http://uspl.lilly.com/verzenio/verzenio.html#pi.
  2. https://nccn.org/professionals/physician_gls/default.aspx#breast.
  3. Lexicomp Online, Hudson, Ohio: Lexi-Comp, Inc.
  4. https://www.ncoda.org/Management-of-Abemaciclib-Associated-Diarrhea/.
  5. Gold Standard, Inc. Abemaciclib. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com.
  6. The benefit of abemaciclib in prognostic subgroups, presented by Matthew P. Goetz 12-/5/2017. Available at: https://lilly-medcomms.veevavault.com/ui/approved_viewer?token=1904-23eda912-9a67- 4a3a-847c- dab99ef3e133&email=a300f000005In3MAAS&orgid=00DG0000000BmPLMA0&AppDocId=a2u0f0000006
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
Read More