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This PQI will discuss the initiation and management of patients receiving avapritinib

Background:

Avapritinib is a tyrosine kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Avapritinib was approved in January 2020 and is the first therapy approved for patients with GIST with a PDGFRA exon 18 mutation. The NAVIGATOR trial included patients with a confirmed diagnosis of GIST and received 300 mg or 400 mg orally once daily until disease progression or unacceptable toxicity. Patients starting at 400 mg were later reduced to 300 mg due to toxicity. The primary endpoint was overall response rate (ORR), and 43 patients who had exon 18 PDGFRA mutations were included in the ORR analysis. For GIST patients with PDGFRA exon 18 mutations, ORR was 84% with complete response in 7% of patients and partial response in 77% of patients. Patients with PDGFRA D842V mutations had an ORR of 89% (CR 8% and PR 82%; n=38). There were 22 patients with a PDGFRA exon 18 mutation with a duration of response  6 months (61%) and 20 patients with a PDGFRA D842V mutation with a duration of response  6 months (59%). Dose reduction due to an adverse reaction occurred in 49% of patients who received avapritinib with a median time to dose reduction of 9 weeks.  The most common adverse reactions (≥ 20%) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness.1

PQI Process:

  • Confirm diagnosis and Verify genetic testing for PDGFRA exon 18 and PDGFRA D842V mutations for patients with GIST

Upon receiving a prescription for avapritinib:

  • Recommended dosage is 300mg orally once daily on an empty stomach, as least one hour before and two hours after a meal
    • No dose adjustment recommended with mild/moderate renal or mild/moderate hepatic impairment
    • Dose modifications:
First dose reduction200mg once daily
Second dose reduction100mg once daily
Third dose reductionPermanently discontinue in patients unable to tolerate 100 mg daily.
  • Assess patient for antiemetic regimen; consider regular option for patient use as needed
  • Avoid avapritinib administration with strong or moderate CYP3A inhibitors. If combination with moderate CYP3A4 is unavoidable, reduce dose of avapritinib to 100 mg once daily.
  • Avoid avapritinib administration with strong or moderate CYP3A inducers.
  • Dose modifications for specific adverse reactions:
    • Intracranial Hemorrhage
      • Grade 1 or 2:
        • First Occurrence: Withhold avapritinib until resolution and resume at reduced dose
        • Subsequent Occurrence: Discontinue
      • Grade 3 or 4: Permanently discontinue
    • Central Nervous System Effects:
      • Grade 1:
        • Continue avapritinib at same dose or withhold until improvement to baseline or resolution. Resume at same dose or reduced dose
      • Grade 2 or 3:
        • Withhold avaprintinib until improvement to baseline, grade 1, or resolution. Resume at same or reduced dose.
      • Grade 4: Discontinue
    • Other adverse reactions at Grade 3 or 4:
      • Withhold avapritinib until improvement to less than or equal to Grade 2. Resume at same or reduced dose, as clinically appropriate.

Patient Centered Activities:

  • Provide Oral Chemotherapy Education Sheet
  • Counsel patient that medication should be taken on empty stomach
  • Educate patient that a missed dose needs to be taken within 8 hours of the regular dosing time.
  • Counsel patient on potential drug interactions with avapritinib
  • Monitor patient for central nervous side effects such as dizziness, trouble sleeping, changes in mood or behavior as well as any neurological signs and symptoms related with intracranial hemorrhage
    • Educate the patient and their caregiver network to be alert for cognitive changes such as memory loss, forgetfulness and confusion
  • Monitor patient for laboratory changes associated with common adverse reactions such as decreased hemoglobin and increased bilirubin

Supplemental Information:

  • Patient Support Program: YourBlueprint (https://www.yourblueprint.com/hcp/)
    • Dedicated Case Manager available at 1-888-258-7768 (1-888-BLUPRNT)
    • Monday-Friday 8AM-8PM ET
  • Co-Pay Assistance Program
    • Eligible, commercially insured patients may reduce their out-of-pocket costs (as much as $0 per month)

References:

  1. AYVAKITTM (avapritinib) [prescribing information]. Cambridge, MA: Blueprint Medicines Corporation; January 2020.
  2. Heinrich MC, Jones RL, von Mehren M et al. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open- label, phase 1 trial. Lancet Oncol. 2020 Jul;21(7):935-946.
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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MISSION STATEMENT/PHILOSOPHY:

Our Mission

Helping people live the healthiest lives possible®

Our Vision

Be a model health system by providing extraordinary care and superior service at an affordable cost.

LOCATION(S):

MEDICAL ONCOLOGY Offices

3131 La Canada Street, Ste 140

Las Vegas, NV 89169

(702) 735-7154

(702) 735-7153 Fax

 

2650  Tenaya Way, Ste 201

Las Vegas, NV 89128

(702) 735-7154

(702) 869-8103 Fax

 

8285 W. Arby Avenue, Ste 100B

Las Vegas, NV 89113

(702) 735-7154

(702) 405-1860 Fax

RADIATION ONCOLOGY

 

6160 S Fort Apache Rd

Las Vegas, NV 89148

(702) 730-5480

(702) 730-5495 Fax

 

PRACTICE DETAILS (how many providers, how many employees, etc):

3 Medical Oncology Clinics

8 Hem/Oncs with 4 Advanced Practitioner Providers;

1 Radiation Oncology Clinic

1 Rad Onc, 1 Rad Onc Nurse Practitioner

75-80  employees

INTRODUCTION TO PHARMACY SERVICES STAFF W/ BRIEF BIO:

2  Medically Integrated Dispensaries

2 Dispensing Technicians

RN Navigator

Financial Counselor

*The only Celgene REMS certified MID in the State of Nevada

DISPENSING TYPE (RETAIL VS DISPENSARY):  MID

SERVICES PROVIDED (BONE MARROW, RADIATION, CHEMO):

Radiation Oncology

Medical Oncology

Clinical Hematology

Chemotherapy

Immunotherapy

On-site Laboratory Services

On-site PET/ CT scanning

Physician Dispensing Pharmacy Services

WHY DID  YOU JOIN NCODA?

We needed guidance from a group of experts from the Pharmacy world  to optimize our MID program in physician office setting. The NCODA intuitive tools and oncology specific drug educational resources has made our caregivers’ daily work easier which are then passed along to our patients ensuring they are getting highest level of quality care.

HOW DID YOU BECOME A MEMBER?

Back in 2015, I attended an educational presentation on “Promoting Patient Adherence to Oral Chemotherapy” presented by Mike Reff here in Las Vegas. He showed real life scenarios and pointed out the ongoing challenges in managing Oral treatment for Cancer in a physician office setting.  He invited us to join NCODA and explained the services provided. It was a unique offering as Oral Oncolytics has started gaining traction in the industry. I took the invitation from Mike Reff to sign me up and became a member.

HOW DID YOU HEAR ABOUT US?

Through an invitation from the founder, Mike Reff.

HOW CAN NCODA HELP YOU?

  • Continue to have a robust accessible Oncology specific drug educational resource to provide effective patient education ensuring they are getting highest level of quality care
  • Continued support in networking opportunities to share best practices and learn from each other

HOW WOULD YOU LIKE TO BE MORE INVOLVED WITH NCODA?

Will continue to assist in promoting the program as I have in the past. I actively attend GPO conferences, was able to network with other practices, I spread the word as to how NCODA has been there to help with Oncology resources for the practice and the patients. About 4 practices from our GPO joined NCODA and found it very helpful to be part of the association.

WHAT ARE SOME CHALLENGES YOU FACE NOW OR WILL FACE IN THE FUTURE OF ONCOLOGY?

EHR integration. There is still not a perfect EHR that could integrate with different systems in the local network. We belong to a huge multi-specialty group taking care of same group of patients in value based model. Other specialties are still operating under different EHR, PMS. Collecting data becomes a challenge when you are having to pull from different resources to come up with a true meaningful analytic report

 Financial toxicity. Majority of the new drugs in the market are very costly. For our geriatric population who only have government backed insurance, they cannot take advantage of the manufacturer copay programs and are faced with very high financial burden when the Foundation assistance fund is exhausted.

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FOR IMMEDIATE RELEASE

Cazenovia, NY – On November 12th, after feedback from healthcare professionals, UnitedHealthcare (UHC) announced that the implementation of their Accumulator Adjustment – Medical Benefit Program for their commercial members will NOT take effect on Jan. 1, 2021. This program would have prevented manufacturer assistance and co-pay programs from being accounted towards patient deductibles and the resulting out-of-pocket maximums.

NCODA was the first organization to develop a resource for healthcare providers and patients regarding co-pay accumulators in 2018. Over 10,000 of these tri-fold resources have been distributed across the country to date. We have always brought education of these accumulator programs to our membership and other stakeholders. NCODA has hosted live webinars on this topic with practice and industry leaders, and we have also created easy-to-understand educational videos.

We are proud to continue supporting our membership through timely education on the impact of this issue and others like it that result in obstacles to patient assistance.

To request copies of our proprietary accumulator tri-fold resource, click here. NCODA will keep our members and stakeholders informed and updated of any future developments.

Email us at contact@ncoda.org for more information.

See official press release here.

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