FOR IMMEDIATE RELEASE
December 23, 2020

 

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

MOST FAVORED NATION: TEMPORARY RESTRAINING ORDER ISSUED

NCODA has been in opposition of the Most Favored Nation (MFN) model for Medicare patients since it was announced late last month. The model would negatively affect patient access to Part B drugs – the anti-cancer (oral and infused) treatments that are administered in oncology practices.

Today, it was announced that US District Court Judge Catherine Blake (Maryland) issued a two-week temporary restraining order (TRO) which delays the implementation of the MFN model. The two-week reprieve allows the court time to consider implementing a preliminary injunction against the MFN model.

This mandatory 7-year payment model would establish reimbursement to providers based on an MFN price for the 50 highest cost Part B drugs. The MFN price would be phased in to replace the current ASP reimbursement model and would be based on international pricing from other similar countries.

This model would create a potentially insurmountable challenge for oncology practices, and it would hurt the people who matter most – the patients. NCODA continues to oppose this model and will monitor and update our membership as progress is made on this decision.

Michael Reff, RPh, MBA
Founder & Executive Director | NCODA, Inc.

Read the full release HERE.

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FOR IMMEDIATE RELEASE
December 18, 2020
STATEMENT FROM EXECUTIVE DIRECTOR: MICHAEL REFF

Contact: Kevin Scorsone, NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email:
kevin.scorsone@ncoda.org
https://www.ncoda.org

MOST FAVORED NATION MODEL: NOT THE ANSWER FOR PATIENTS

NCODA is in opposition of the Most Favored Nation (MFN) model for Medicare patients that would negatively affect patient access to Part B drugs – the chemotherapy and infusion treatments that are administered in our community oncology member practices.

Scheduled to begin January 1, 2021, this mandatory 7-year payment model proposed to lower drug costs would establish reimbursement to providers based on an MFN price for the 50 highest cost Part B drugs.  The MFN price would be phased in to replace the current ASP reimbursement model and would be based on international pricing from other countries.

Under the MFN model, practices administering these drugs would be purchasing and administering these drugs at a cost exceeding the proposed MFN reimbursement.  These losses would be unsustainable and force practices to close their doors and send patients to more expensive treatment locations. Life-saving treatment options would not be as readily available to many seniors who would be forced to forgo treatment.

We are still in the midst of the COVID-19 pandemic which has resulted in thousands of deaths. The MFN model will promote additional limitations on seniors’ access to standard of care therapy for their cancer diagnoses.

NCODA does not support the implementation of this mandatory model on cancer patients and the oncology community. Not only would this 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.


Michael Reff, RPH, MBA
Founder and Executive Director

Full Press Release HERE

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Written by: Houston Holmes, MD, Texas Oncology

Download Here

Positive Quality Intervention: Tazemetostat (Tazverik) management in Relapsed/Refractory Follicular Lymphoma 

Description:

This PQI will discuss the initiation and management of tazemetostat in the treatment of relapsed or refractory (r/r) follicular lymphoma (FL)

Background:

Tazemetostat is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for completed resection and adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test, such as via the cobas® EZH2 Mutation Test, and who have received at least 2 prior systemic therapies or who have no satisfactory alternative treatment options. For r/r follicular lymphoma, mutation status was determined using the cobas EZH2 mutation test to detect: Y646X [S,H,C], y646F, Y646N, A682G, and A692V. Patients in trials received 800mg of tazemetostat orally twice daily until disease progression or unacceptable toxicity with tumor assessments every 8 weeks. For EZH2 mutant FL patients the ORR was 69% (n=42) with a CR of 12% and PR of 57%. EZH2 wild-type FL patients had an ORR of 34% (n=53) with a CR of 4% and PR of 30%1,2.

In trial the median PFS was 13.8 months by both investigator and an independent review committee (IRC) assessment in patients with EZH2 mutations. In the EZH2 wild-type group, the median PFS was 5.6 months by investigator review and 11.1 months by IRC review. Main usage is currently within 3rd or greater line treatment with mutation typically seen in 2nd/3rd line r/r. Mutation is identified in 2nd or 3rd line if patient is positive. The treatment is fairly well tolerated; the most common adverse reactions (≥20%) in patients with r/r FL were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain1. Only 8% of patients permanently discontinued therapy due to adverse events, and 9% of patients required dose reductions. A well tolerated medication such as tazemetostat can be considered without testing for mutation if other alternatives are deemed too intolerable2,3.

PQI Process:

  • Confirm acceptable diagnosis and associated indication. EZH2 testing may not be required for all patients
    • Patient who has received 2 systemic therapies
      • Consider testing patient for EZH2, if positive, would be considered eligible candidate
    • No satisfactory alternative treatment options
      • Patient that has received 2 previous lines of therapy, and is evaluated to not to be a good candidate for additional chemoimmunotherapy or other treatments, testing for an EZH2 mutation would not be necessary
    • Speak with provider as a potential alternative treatment to current pathway
  • Recommended dosage of Tazverik is 800mg orally twice daily with or without food
  • Dose modifications for adverse reactions
    • First Dose Reduction -> 600mg orally twice daily
    • Second Dose Reduction -> 400mg orally twice daily
    • Patients unable to tolerate 400mg orally twice daily should permanently discontinue tazemetostat

PQI Process Continued1:

  • Cytopenia dose modifications
    • Neutropenia (Neutrophil count less than 1×109/L)
      • Withhold until neutrophil count is greater than or equal to 1×109/L or baseline
      • First occurrence, resume at same dose
      • Second and third occurrence resume at reduced dose
      • Permanently discontinue after third occurrence
    • Thrombocytpenia (Platelet count less than 50 x 109/L)
      • Withhold until platelet count is greater than or equal to 75 x 109/L or baseline
      • First and second occurrence, resume at reduced dose
      • Permanently discontinue after third occurrence
    • Anemia (Hemoglobin less than 8 g/DL)
      • Withhold until improvement to at least Grade 1 or baseline, then resume at same or reduced dose.
    • Other adverse reactions (Grades 3 and 4)
      • Grade 3
        • Withhold until improvement to at least Grade 1 or baseline
        • For first and second occurrence, resume at reduced dose
        • Permanently discontinue after third occurrence
      • Grade 4
        • Withhold until improvement to at least Grade 1 or baseline
        • For first occurrence, resume at reduced dose
        • Permanently discontinue after second occurrence

Patient Centered Activities1:

  • Provide Oral Chemotherapy Education Sheet and counsel patient on potential drug interactions with tazemetostat
  • Counsel patient on common side effects (>20%) including pain, fatigue, nausea, decreased appetite, vomiting, and constipation
  • Monitor patient’s laboratory values for decreased hemoglobin and decreased lymphocytes and increased glucose in r/r follicular lymphoma patients

Supplemental Information:

  • Information on FDA-approved tests for detection of EZH2 mutation in r/r follicular lymphoma: FDA.gov/CompanionDiagnostics

Patient Support:

  • Quick Start, Bridge Supply, Patient Assistance and Co-Pay Assistance Programs available for eligible patients
  • EpizymeNOW Patient & Product Support Website: www.tazverik.com/hcp/follicular-lymphoma/resources
  • Patient Support Contact: Monday-Friday (9 am to 6 pm ET) at: 1-833-4EPINOW (437-4669)

References:

  1. TAZVERIKTM (tazemetostat) [prescribing information]. Cambridge, MA: Epizyme, Inc.; July 2020.
  2. Morschhauser F, Tilly H, Chaidos A, et al. Phase 2 multicenter study of tazemetostat, an EZH2 Inhibitor, in patients with relapsed or refractory follicular  Blood. 2019;134(suppl 1):123. doi:10.1182/blood-2019-128096
  3. Burke, JM, Bucholtz, E, et al. New Developments in Follicular Lymphoma: Treatment Guidance and Clinical Resources. Clinical Care Options Oncology.
Important notice: National Community Oncology Dispensing Association, Inc. (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.
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FOR IMMEDIATE RELEASE
December 11, 2020
STATEMENT FROM EXECUTIVE DIRECTOR: MICHAEL REFF

Contact: Kevin Scorsone, NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email:
kevin.scorsone@ncoda.org
https://www.ncoda.org


SUPREME COURT RULES UNANIMOUS: REGULATES PHARMACY BENEFIT MANAGERS
Decision confirms that states will have the right to regulate; brings clarity and optimism

Yesterday, December 10, 2020, the United States Supreme Court (Rutledge, Attorney General of Arkansas VS Pharmaceutical Care Management Association) unanimously decided that states can regulate Pharmacy Benefit Managers. Pharmacy Benefit Managers (PBM’s) are companies that oversee the prescription drug benefits on behalf of insurance companies along with Medicare Part D drug plans.

NCODA believes that this decision by the Supreme Court marks a significant day for pharmacists and pharmacies everywhere. Most importantly, this ruling provides patients the ability to have complete transparency when dealing with Pharmacy Benefit Managers and track the cost of their medications.

Read the full press release here.

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Written by: Trey McNiel, PharmD, Georgia Cancer Specialists

Download Here 

Description:

The purpose of this PQI is to discuss the clinical considerations around the use of acalabrutinib (Calquence) to optimize the outcomes for patients with CLL/SLL.

Background:

Acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor initially indicated for mantle cell lymphoma (MCL) patients who have received one prior therapy. In late 2019, it received an indication for the treatment of CLL/SLL either as monotherapy or in combination with obinutuzumab.1

Efficacy in the front-line setting was established by the Elevate-TN trial, demonstrating progression-free survival advantage of acalabrutinib when administered with or without obinutuzumab, when compared to obinutuzumab plus chlorambucil.2

  • At a median follow up of 28.3. months, acalabrutinib plus obinutuzumab improved PFS and ORR compared with obinutuzumab plus chlorambucil in the ELEVATE-TN trial (ORR 93% vs. 78.5%, PFS 93% vs. 47% respectively)2

The ASCEND trial displayed advantage in progression-free survival of acalabrutinib monotherapy in the relapsed/refractory setting when matched against investigator’s choice of rituximab product plus idelalisib or bendamustine.3

  • As monotherapy, acalabrutinib significantly improved PFS, but not ORR, in both the ELEVATE-TN and in the ASCEND trial. ELEVATE trial ORR, 85% vs. 78.5%, ASCEND trial ORR 80 % monotherapy vs. 84% idelalisib plus rituximab (I-R) or bendamustine plus rituximab (B-R), ASCEND trial PFS: Not reached in monotherapy vs. 16.5 months for the I-R/B-R arm).3

PQI Process:

Upon the receipt of a new prescription of acalabrutinib for CLL/SLL:

  • Verify dosage: the recommended starting dose of acalabrutinib is 100 mg every 12 hours, taken whole with water and with or without food. If dose is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time.
    • Avoid in severe hepatic impairment.
    • No dose adjustment needed in mild to moderate hepatic or renal impairment (use in severe renal impairment has not yet been evaluated in patients with severe renal impairment or renal impairment with dialysis.)
  • Review patient medication list for possible drug-drug interactions
    • Taken with strong CYP3A4 inducer: if use cannot be avoided increase dosage to 200 mg every 12hours
    • Taken with strong CYP3A4 inhibitor: avoid use, but if the inhibitor is a short-term medication, (i.e. 7 days of anti-infective) stop acalabrutinib and resume after inhibitor is complete.
    • Taken with moderate CYP3A4 inhibitor: reduce dosage to 100 mg daily
  • Acalabrutinib should be avoided with proton pump inhibitors. If other gastric reducing agents are used, recommend taking acalabrutinib 2 hours prior to taking a H2 receptor antagonist, if using an antacid separate dosing by at least 2 hours.
  • If being used in combination with obinutuzumab, acalabrutinib should be taken BEFORE the obinutuzumab when taken the same day.

Adverse Events and Management1

CategoryOccurrenceAction
Fatal and serious infections, including opportunistic infections, have occurred.Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 19% of 1029 patients in clinical trials.Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat promptly.
Fatal and serious hemorrhagic events have occurred in patientsMajor hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in 0.1% of 1029 patients in clinical trials. Bleeding events of any grade, excluding bruising and petechiae, occurred in 22% of patients.Monitor patients for signs of bleeding. Consider the benefit-risk of withholding acalabrutinib for 3-7 days pre-and post-surgery depending on type of surgery and the risk of bleeding.

Caution in patients on antithrombotic agents

Grade 3 or 4 cytopeniasNeutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients. Grade 4 neutropenia developed in 12% of patients.Monitor complete blood counts regularly during treatment. Interrupt treatment, reduce the dose, or discontinue treatment as warranted.
Cardiac FactorsGrade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection.Monitor for symptoms of arrhythmia (e.g., palpitations, dizziness, syncope, dyspnea) and manage as appropriate.
Skin CancerThe most frequent second primary malignancy was skin cancer, reported in 6% of patients.Monitor patients for skin cancers and advise protection from sun exposure.

Dose Modifications1

EventAdverse Reaction OccurrenceDose Modification

(Starting dose = 100 mg approximately every 12 hours)

Grade 3 or greater non-hematologic toxicities,

Grade 3 thrombocytopenia with bleeding,

Grade 4 thrombocytopenia,

or

Grade 4 neutropenia lasting longer than 7 days

First and SecondInterrupt Calquence

Once toxicity has resolved to Grade 1 or baseline level, Calquence may be resumed at 100mg approximately every 12 hours.

ThirdInterrupt Calquence

Once toxicity has resolved to Grade 1 or baseline level, Calquence may be resumed at a reduced frequence of  100 mg daily.

FourthDiscontinue Calquence

Patient Centered Activities:

  • Patient Education
    • Provide Oncology Chemotherapy Education (OCE) sheet and review with patient
    • Instruct patient to report any signs or symptoms of atrial fibrillation or flutter such as palpitations, dizziness, faint, chest discomfort
    • Patient should be made aware of the increased bleeding risk associated with acalabrutinib. Due to this risk, they may need to hold their medication prior to any procedures
    • Ensure patient has access to supportive medications for diarrhea such as loperamide
  • AstraZeneca Access 360™ Program
    • Calquence Co-Pay Savings Program (Commercially insured patients)
    • AZ&Me Prescription Savings Program
      • Provides AstraZeneca medicines at no cost to qualifying patients.
    • Patient Assistance foundations (Federally insured patients)
  • CALQUENCECares™
    • Service through AstraZeneca to provide education and support during treatment

References:

  1. Calquence (acalabrutinib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2019.
  2. Sharman JP, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. 2020 Apr 18;395(10232):1278-1291.
  3. Ghia P, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020;
Important notice: National Community Oncology Dispensing Association, Inc. (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.
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