Written By: Jeremiah Moore, PharmD, BCOP

Download Here

Description: This PQI will provide background information on umbralisib’s novel mechanism of action and discuss effective practices to maximize the use of umbralisib therapy in the management of relapsed refractory follicular lymphoma.

Background:  Phosphatidylinositol-3-kinase (PI3K) dysregulation is thought to be a driver of B cell malignancies. Multiple PI3K inhibitors (idelalisib, duvelisib, copanlisib) have shown efficacy in non-Hodgkin lymphoma (NHL) however, toxicities have limited their use.  Umbralisib (Ukoniq®) is an oral medication indicated for patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.  Umbralisib is a novel dual inhibitor of (PI3K) δ-isoform and casein kinase-1ε (CK1ε) with an improved side effect profile.  In the phase IIb UNITY-NHL trial involving patients with marginal zone and follicular lymphoma, umbralisib showed a favorable response rate with a manageable side effect profile.1-3

PQI Process:

Upon receiving a new prescription for umbralisib:

  • Confirm appropriate dose of umbralisib 800 mg (4 x 200 mg tablet) by mouth once daily with food
  • Confirm that patient does not have a history of allergic reactions due to FD&C Yellow No. 5. If the patient does have a history of allergic reactions to FD&C Yellow No. 5 contact prescribers office before dispensing
  • Verify that the patient has prophylaxis for Pneumocystis jirovecii (PJP) during treatment with Interrupt umbralisib therapy in patients with suspected PJP and discontinue in patients with confirmed PJP3
  • Consider prophylactic antivirals during treatment to prevent cytomegalovirus (CMV) infection, including CMV reactivation. Hold umbralisib therapy until CMV infection or viremia resolves, then resume at same or reduced dose.  If umbralisib is resumed, monitor CMV reactivation by PCR or antigen test at least monthly3
  • Verify monitoring parameters:
    • CBC with differential – at least every 2 weeks for the first 2 months and at least weekly in patients with neutrophil counts <1 x 109/L
    • CMP at baseline and as clinically necessary
    • Consider monitoring CMV PCR or antigen test monthly

Patient Centered Activities:

  • Provide Oncology Chemotherapy Education (OCE) sheet
  • Provide patient with the umbralisib (Ukoniq®) medication guide
  • Ensure patients understand how to take their umbralisib dose
    • Administer once daily with food and a glass of water

Patient Centered Activities Continued:

  • Medication should not be crushed, broken or chewed, but should be swallowed whole
  • If a dose of umbralisib is missed, take a missed dose unless it is less than 12 hours until the next scheduled dose
  • Verify PJP prophylaxis and review importance with patient
  • Ensure patients understand how to monitor for signs and symptoms of side effects of umbralisib, including: Infections, diarrhea or non-infectious colitis, hepatotoxicity, and skin rash and when to call their provider
  • Monitor for adherence and adverse effects throughout treatment

 

Supplemental Information:

TG Co-Pay Assistance Program and Patient Support:

  • Patients with commercial or private insurance may be eligible to receive umbralisib for $5 per prescription
  • Quick start/bridge program
    • Provides free umbralisib to eligible patients who experience delays of at least 5 business days
  • No insurance or underinsured
    • Provides free umbralisib to eligible patients

References:

  1. Fowler NH, Samaniego F, Jurczak W, et al. Umbralisib, a dual PI3Kδ/CK1ε inhibitor in patients with relapsed or refractory indolent lymphoma.  Journal of Clinical Oncology.  2021; 39:1609-1618.
  2. Hanlon A and Brander DM. Managing toxicities of phosphatidylinositol-3-kinase (PI3K) inhibitors.    2020; 346-56.
  3. Ukoniq (umbralisib) [package insert]. Edison, NJ: TG Therapeutics, Inc; 2021.
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: Doug Braun, PharmD and Emily Gallagher, PharmD | AON

Download Here

This PQI serves to review the use of the combination product Akynzeo® for patients with acute and delayed chemotherapy-induced nausea and vomiting (CINV).

Background1-5: Nausea and vomiting from chemotherapy can occur acutely (within 24 hours) or have a more delayed onset (>24 hours up to several days after therapy). CINV is an avoidable toxicity that often leads to increased acute care visits, re-evaluation of the chemotherapeutic regimen (such as dose reductions or delays to chemotherapy), increased healthcare costs, and ultimately a significant reduction in a patient’s quality of life.

Akynzeo® is a combination product containing a 5-HT3 receptor antagonist and a neurokinin-1 (NK-1) receptor antagonist that is available in both oral (netupitant-palonosetron) and injectable (fosnetupitant-palonosetron) formulations. Palonosetron is a highly selective 5-HT3 receptor antagonist that prevents nausea and vomiting during the acute phase. Netupitant is a selective substance-P/NK-1 receptor antagonist that prevents nausea and vomiting during both the acute and delayed phase after chemotherapy; fosnetupitant is a prodrug of netupitant.  Administered as a single-dose, Akynzeo® simultaneously targets two critical antiemetic pathways, providing simplified efficient dosing and preventing CINV for up to 5 days.

In a clinical study involving 135 patients who were taking cisplatin-based chemotherapy, patients given an oral dose of Akynzeo® with dexamethasone were compared against patients given an oral dose of palonosetron, a different antiemetic treatment, with dexamethasone:

  • 90% of patients who received Akynzeo® had no vomiting up to 5 days post chemo.
  • 99% of patients who received Akynzeo® had no vomiting within 24 hours of chemo.

Akynzeo® is used with dexamethasone for the prevention of acute and delayed CINV associated with initial and repeat courses of chemotherapy, including, but not limited to, highly emetogenic chemotherapy. The capsules and injection have been studied in patients receiving platinum-based chemotherapy; however, only the oral formulation has been studied in patients receiving anthracycline and cyclophosphamide-based chemotherapy. NCCN guidelines list both  Akynzeo® capsules and injection as a category 1 antiemetic agent for highly and moderately emetogenic chemotherapy regimens.

PQI Process:

  • Determine which formulation is most appropriate for each patient:
    • Consider using the oral regimen when the patient’s prescription insurance covers the medication
    • Consider the IV formulation in patients who have difficulty swallowing or have poor adherence to oral medications
      • Akynzeo® injection contains no polysorbate 80 which may be useful for patients with egg allergies. In contrast, fosaprepitant injection contains polysorbates and aprepitant injection contains soy2
      • It requires no reconstitution or refrigeration, providing operational efficiency
  • Dosing and administration:1-2
    • Oral: Take one capsule (netupitant 300 mg; palonosetron 0.5 mg) PO as a single dose approximately 60 minutes prior to chemotherapy
    • IV: Administer 1 vial (fosnetupitant 235 mg; palonosetron 0.25 mg) IV over 30 minutes, given as a single dose approximately 30 minutes prior to chemotherapy
      • Withdraw contents from the vial and dilute into an IV bag containing NS or D5W
      • Akynzeo® is compatible with dexamethasone IV solution and may be mixed in the same bag or infused simultaneously
      • At the end of the infusion, flush the infusion line with the same carrier solution to ensure complete drug administration
  • Drug interactions:1-2
    • Netupitant is extensively metabolized primarily by CYP3A4 so the pharmacist must carefully screen for potential drug interactions
    • There is a potential drug-drug interaction with concomitant use of Akynzeo® and dexamethasone. The package insert recommends limiting the dexamethasone dose to 12 mg on day 1, and 8 mg on days 2-4 (if needed)
    • Risk of serotonin syndrome is increased with concomitant use of serotonergic drugs
  • Special populations:1
    • Avoid use of Akynzeo® in pregnancy, severe hepatic impairment, severe renal impairment, and end-stage renal disease

Patient Centered Activities:

  • Patient counseling:1-2
    • If providing the oral formulation, please remind the patient not to take the dose too soon before treatment. Advise the patient to bring the dose to the appointment if possible, and to take the dose once administration of chemotherapy is confirmed (to avoid wasting a dose)
    • Oral capsules may be taken with or without food
    • Side effects are generally mild but may include headache, asthenia, dyspepsia, fatigue, constipation, and erythema
  • Financial assistance available through Helsinn Cares:
    • Prescription savings cards for eligible commercially insured patients (up to $150 for each Rx).
    • Patient Assistance Program (US residents uninsured, underinsured or no covered Akynzeo® benefit) that meet income eligibility requirements

References:

  1. Akynzeo®. Package insert. Helsinn Birex Pharmaceuticals; 2020.
  2. Akynzeo®. Clinical Pharmacology powered by ClinicalKey. Elsevier. July 21, 2021. http://www.clinicalkey.com.
  3. Rapoport BL. Delayed Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Incidence, and Current Management. Front Pharmacol. 2017;8:19. doi:10.3389/fphar.2017.00019.
  4. Navari RM, Binder G, Bonizzoni E, Clark-Snow R, Olivari S, Roeland EJ. Single-dose netupitant/palonosetron versus 3-day aprepitant for preventing chemotherapy-induced nausea and vomiting: a pooled analysis [published online ahead of print, 2021 Apr 21]. Future Oncol. 2021. doi:10.2217/fon-2021-0023.
  5. National Comprehensive Cancer Network. Antiemesis (Version 1.2021). https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. July 21, 2021.
Read More
image-title

FOR IMMEDIATE RELEASE

AUGUST 10, 2021

  

NCODA Structures Medically Integrated Pharmacy Accreditation

 

Cazenovia, New York – As the leading not-for-profit association for the patient-centered medically-integrated oncology community, NCODA, Inc. is excited to announce the new NCODA Center of Excellence (CoE) Medically Integrated Pharmacy (MIP) Accreditation Program. The program, based on compliance with the ASCO/NCODA Patient-Centered Standards for Medically Integrated Dispensing, focuses on enhanced patient care and quality of services. An Executive Accreditation Council and an Accreditation Working Group will provide guidance, insight and support for the new CoE MIP Accreditation Program.

“NCODA’s focus from day one has been patient-centered; to always deliver quality, value and financial viability resources to medically integrated oncology centers that will in turn enhance patient care,” said Jim Schwartz, RPh, NCODA Executive Council President. “Providing this Center of Excellence accreditation will only accelerate our Mission to bring the best care possible to every cancer patient and improve overall outcomes.”

Elizabeth Bell, NCODA’s Director of Medically Integrated Pharmacy Accreditation, will lead this initiative and work closely with both the Accreditation Executive Council and the Accreditation Working Group. Bell has over twenty years experience in healthcare accreditation, compliance and management. Elizabeth has managed quality and accreditation departments, developed healthcare quality initiatives and led statewide compliance audit teams. Most recently she served as the VP of Consulting Services for a healthcare accreditation consulting company.

“We are thrilled to have Elizabeth lead this program,” said Michael Reff, NCODA Executive Director. “Elizabeth’s background aligns perfectly to NCODA’s Mission and we look forward to how she will use her previous experience to enhance our resources to the benefit of our patients, our members and all stakeholders in the oncology community.”

NCODA holds itself accountable to serving the medically integrated dispensing community by delivering positive, patient-centered resources and programs to ensure the highest of quality and best practice standards are provided to the patient. NCODA set out on this accreditation process as a commitment to empower oncology centers to deliver the highest level of performance that brings sustainability and value. Over the past several months, program groundwork has been laid and gained great support from stakeholders including: community and health system oncology practices, pharmaceutical partners, professional and advocacy organizations, as well as PBMs and plans. Further details on NCODA’s Center of Excellence (CoE) Medically Integrated Pharmacy (MIP) Accreditation Program will be announced in the coming weeks.

 

#####

 

About NCODA

NCODA, Inc. is a 501(c)(3) organization. Our Mission is to empower the medically-integrated oncology team to deliver positive, patient-centered outcomes by providing leadership, expertise, quality standards and best practices. For more information about NCODA’s Executive Council and general updates, visit www.ncoda.org.

Read More

FOR IMMEDIATE RELEASE
August 9th 2021

STATEMENT FROM NCODA Legislative & Policy Advisory Committee
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email: kevin.scorsone@ncoda.org
www.ncoda.org

BIDEN ADMINISTRATION PROPOSES WITHDRAW FROM MOST FAVORED NATION

 

NCODA has been in opposition of the Most Favored Nation (MFN) model for Medicare patients since it was announced late last year. The model would have negatively affected patient access to Part B drugs – the chemotherapy and infusion treatments that are administered in our community oncology practices. NCODA is thrilled to report that the MFN rule has been set for elimination by the Biden administration.

Late last week President Biden proposed the rule to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register. *

In a year that has been highlighted with substantial victories for the oncology community in various legislatures, this announcement is an exclamation point on the hard work that has been set forth to make quality care for all patients a reality.

NCODA will never support the implementation of a mandatory model on cancer patients and the oncology community. Not only would a mandatory model create a potentially insurmountable challenge for oncology practice it would hurt the people who matter most, the patient. Our Passion for Patients is not just a statement it continues to be our mission and focus.

* = Via the U.S. Department of Health and Human Services

Read More