NCODA PQI IN ACTION

Steven L. D’Amato BScPharm, CEONew England Cancer Specialists

Wayne Ormsby, M.D.Utah Cancer Specialists

NCODA PQI IN ACTION

Steven L. D’Amato BScPharm, CEONew England Cancer Specialists

NCODA PQI IN ACTIONNCODA team came to NECS to interview our team and review NCODA PQI in Action

SOME NUMBERS• Oral oncolytics comprise 25% of agents in the pipeline

• Oncology practices dispensing oral oncolytics:• 24% in 2013• 58% in 2016

• Oral agents represent 39% of the $27.8 billion spent on targeted agents in 2015 (up from 26% in 2010)

IMS Institute for Health Informatics. Global Oncology Trend Report: A Review of 2015 and Outlook to 2020

https://www.iqvia.com/media/iqvia/pdfs/institute-reports-global-oncology-trend-report-2016.pdf

• Goals and Objectives of the NCODA PQI in Action

• Support and enhance education for healthcare providers on current and emerging clinical advancements

• Improve the overall management of patients receiving oral cancer medications by highlighting appropriate drug therapy

• The NCODA PQI in Action will promote higher quality patient care through increased speed to therapy, reduced cost and hospitalization, and by improving persistence and adherence

• Provide a educational and tangible document to be used by personnel of the sponsoring partner as well as NCODA members and nationwide practices

• Maximize patient care by providing resources, identified standards and best practices centered on the NCODA PQIs to highlight the NCODA PQI in Action

INTRODUCTION

NEW ENGLAND CANCER SPECIALISTS• Private practice for over 50 years

• Three clinic sites

• 14 physicians and 14 advanced practice providers

• Dispensing program since 2013 (ACHC accredited 2017)

• QOPI Certified, CancerLinQ, PracticeNet, OMH

• Pharmacy• Pharmacists, Certified Pharmacy Technicians

• Physicians

• Advanced Practice Providers

• Registered Nurses – ONS Certified

• Financial Advocates

MEDICALLY INTEGRATED DISPENSING TEAM AT NECS

• Chemotherapy Induced Diarrhea• CLL and Del17p• Drug Induced Hand and Foot Syndrome• EGFR Inhibitors• Management of Abemaciclib Associated Diarrhea• Managing Myelofibrosis Patients• MCRC Regorafenib Updated• MCRC – Trifluridine and Tipiracil• NSCLC Afatinib Management• Olanzapine Use in CINV

NCODA PQIS

• Polycythemia Vera• Stomatitis• Neratinib Diarrhea• Regorafenib in the Treatment of Hepatocellular Carcinoma

NCODA PQIS (CONT)

• Description of PQI: Describes why proper monitoring can prevent cardiovascular events and establishing follow ups and lab reviews are recommended to ensure positive outcomes

• Background: Provides disease information and common treatments (aspirin, phlebotomy, hydroxyurea, interferon (not commonly used), or a JAK2 inhibitor, ruxolitinib. Hydroxyurea (HU) is considered the gold standard treatment to start with for high risk patients. Patients that still have high blood counts or cannot tolerate HU may benefit from ruxolitinib.

• High risk: Age <60 and no previous history of blood clots• Low risk: Age >60 or previous history of a blood clot

PQI: MANAGING TREATMENT OF POLYCYTHEMIA VERA(1/4)

• Background (cont.)

• One of the treatment goals is to reduce the cardiovascular risk of patients

• Clinicians try to maintain a HCT <45% and often target < 42% for women

• A study published in the NEJM showed that patients with a HCT in the 45-50% range had a 4 times greater risk of cardiovascular events than patients with a HCT less than 45%

• Proper follow up and review of CBCs are required when patients are started on HU. Dose adjustments and possibly additional phlebotomies should be considered for these patients. Identifying the proper time to switch to another therapy is important to help manage the disease

• 20-60% of patients remain on HU even though they are not having a proper response.

PQI: MANAGING TREATMENT OF POLYCYTHEMIA VERA(2/4)

• PQI Process:

• Review CBC with refill every time to ensure HCT < 45%

• Assess patients for adverse events and document in HER• Use the MPN-SAF total symptom score scale

• If HCT > 45 or symptoms are worse:• Low risk patients not taking HU: Consider recommending HU for low risk patients (1-2 g/day in 1-3

divided doses)• High risk patients: If patient has been on HU for longer than 12 weeks and is still requiring

phlebotomies then recommend possibly switching to second line therapy. Ask prescriber if they want to consider ruxolitinib 10 mg bid.

• Document intervention in HER

PQI: MANAGING TREATMENT OF POLYCYTHEMIA VERA(3/4)

• Patient Centered Activities:

• Stress importance of adherence• Schedule follow up calls• Maintain adherence to treatments of secondary health conditions

• Provide education:• Laboratory monitoring will be required with refills• Possibility of dose adjustments• Importance of staying hydrated

• Infection prevention – call clinic for any fever > 100.4F

• Monitoring skin for patients on ruxolitinib: important to notice all skin lesions (examine skin at baseline and make note of any new lesions that arise on therapy).

PQI: MANAGING TREATMENT OF POLYCYTHEMIA VERA(4/4)

NECS MEDICALLY INTEGRATED DISPENSING

REASONS TO CONSIDER MEDICALLY INTEGRATED DISPENSING

• Medically Integrated Dispensing (in-office dispensing) provides coordinated care for patients

• Waste reduction

• Provides additional revenue

• Quality

WASTE IS A COMMON PROBLEM WITH SPECIALTY PHARMACY DISTRIBUTION

$172,000 wastedon a single prescription 9/7/18 at NECS

PATIENT BENEFITS OF MEDICALLY INTEGRATED DISPENSING PROGRAMS

• Continuity with the patients established care team

• Financial advocate assistance resulting in decreased cost to the patient and the ability to conduct cash transactions

• Patient satisfaction, improved adherence and toxicity management

• Timely access to therapy

RECOMMENDATIONS FOR SUCCESSFUL IMPLEMENTATION OF MID

• Employ a pharmacist to run the program and engage other members of the multidisciplinary team to discuss goals and vision

• Don’t restrict dispensing to oncolytics, provide supportive care medications as well

• Utilize available resources

RESOURCES FOR MEDICALLY INTEGRATED DISPENSING PROGRAMS

• NCODA – National Community Oncology Dispensing Association • www.ncoda.org

• COPA – Community Oncology Pharmacy Association• www.coapharmacy.com

• GPOs

Presented by:

CONCLUSIONS/TAKE-AWAY POINTS

• Oral agents will continue to proliferate and enter the market

• Cancer therapies are more complex and expensive

• Implementing medically integrated dispensing provides improved continuity of care, better adherence rates and toxicity management, as well as significant cost savings to patients

• NCODA PQI in Action fosters better care for patients

NCODA POSITIVE QUALITY INTERVENTION IN ACTIONWayne Ormsby, M.D.Utah Cancer Specialists

PQI IN ACTIONThe Utah Cancer Specialists approach

• The use of oral chemotherapy drugs is becoming more and more prevalent.

• Between June 2017 and May 2018 twenty nine new indications or approvals were given for new or existing oral medications specific to Hematology/Medical Oncology.

• Game changers in a variety of malignancies including, but not limited to, chronic lymphocytic leukemia, myeloproliferative neoplasms, non-Hodgkin lymphoma, melanoma, and renal cell carcinoma.

FIRST A LITTLE BACKGROUND

• 20 years ago – Hydroxyurea, busulfan• In 2001 the game was changed with the approval of imatinib (Gleevec).• Now – Dasatinib (Sprycel), nilotinib (Tasigna), bosutinib (Bosulif),

ponatinib hydrochloride (Iclusig), omecetaxine mepesuccinate (Synribo)

CHRONIC MYELOID LEUKEMIA (A CASE IN POINT)

• Greater convenience to patients.• In some cases dramatic improvement in progression free survival and

overall survival.• In some cases significantly less toxicity than traditional therapies.

ADVANTAGES

• Cost• Reimbursement• Monitoring• Distinct toxicities from traditional chemotherapy• Compliance• Education

DISADVANTAGES

THE BLACK BOX

• Send prescription based upon insurance requirement.• Did they get it (the prescription)???• What is the timeline for prior authorization???• When will the medication be delivered to my patient???• What about out of pocket cost???• Will anyone help my patient to identify grant funding or co-pay

assistance???• Will anyone follow-up with my patient if there are problems???• Is any additional education or monitoring offered???

TRADITIONAL INTERACTION WITH SPECIALTY PHARMACY

MORE OFTEN THAN NOT MY EXPERIENCE WITH SPECIALTY PHARMACY CUSTOMER SERVICE

OR SADLY….

• A 71-year-old woman is sent for consultation by her primary care physician secondary to a hemoglobin of 18.1 g/dL on her annual wellness check.

• She has hyperlipidemia and hypertension, but is otherwise healthy.• Her hemoglobin at her annual wellness checks over the last 5 years have

ranged in the 13.0 to 14.0 g/dL range.• WBC and automated differential are within normal limits.• Platelet count is mildly elevated at 536 K/microliter.• She reports burning and stinging in her hands and feet and periods of

intense itching, particularly when she gets out of the bathtub/shower.

CASE

• Serum erythropoietin• JAK2 V617F mutation with reflex to JAK2 exon 12 mutation on peripheral

blood.

WHAT’S NEXT

• Hemoglobin greater than 16.5 g/dL in men or 16.0 g/dL in women. (Major)• Bone marrow biopsy/aspirate findings consistent with PV. (Major)• JAK2 V617F mutation or exon 12 mutation. (Major)• Serum erythropoietin below the reference range for normal. (Minor)

WHO DIAGNOSTIC CRITERIA FOR POLYCYTHEMIA VERA

• JAK2 V617F mutation positive.• Serum erythropoietin below the reference range for normal.• Bone marrow not performed.• Hemoglobin 18.5 g/dL on recheck• Positive erythromelalgia and “post-bath” pruritus.

CASE FOLLOW-UP

• Age (greater or less than 60).• History of thrombosis (arterial or venous)

RISK STRATIFICATION IN POLYCYTHEMIA VERA

• Started on hydroxyurea at a dose of 500 mg by mouth twice daily.• Phlebotomy to achieve a goal hematocrit of less than 42% (goal

hematocrit in PV patients is an ongoing debate beyond the scope of this presentation).

• Daily low dose aspirin therapy.

BACK TO THE CASE

• Persistent pruritus and erythromelalgia despite increasing aspirin to twice daily and adding a selective serotonin reuptake inhibitor and antihistamines.

• Developed symptomatic anemia when her hydroxyurea dose was uptitrated.

TROUBLE

• FDA approved in 2014 for hydroxyurea intolerant or resistant polycythemia vera patients based upon the results of the RESPONSE phase III trial.

• Typical starting dose for polycythemia vera patients 10 mg by mouth twice daily.

RUXOLITINIB (JAKAFI)

REMEMBER THE BLACK BOX

• Medically integrated pharmacy• Team care model integrating physician, pharmacist, nursing, and other

care staff to give each patient the best care possible while decreasing costs/hassle and increasing safety.

NOW WE TALK ABOUT HOW TO AVOID IT

• Prescription for ruxolitinib (Jakafi) 10 mg by mouth twice daily written and sent to the Utah Cancer Specialists medically integrated pharmacy.

• Initial ruxolitinib patient education performed by M.D.

• Ruxolitinib patient education handout provided.

• Direct M.D. communication with on-site pharmacy staff specialist.

• On-site pharmacy staff specialist meets with patient on the same day the prescription is written to introduce themselves and take the patient through the step by step process from prescription to initiation of therapy.

• Physician communicates urgency and follow-up plan to pharmacy staff.

THE UTAH CANCER SPECIALIST MODEL

• Appropriate levels of staffing (make the investment).• Specific pharmacy staff member is assigned the responsibility of prior

authorization for each patient started on a new oral cancer directed therapy.

• Trained on site pharmacy staff identify potential difficulties with out of cost and initiate measures to reduce cost such as copay cards, grants, etc.

• Cost issues as well as an updated on expect time table are communicated to the prescribing physician.

• Pharmacy staff reviews NCODA Positive Quality Intervention (PQI) to review high risk side effects and identify if appropriate supportive care/secondary medications have been prescribed.

UCS MEDICALLY INTEGRATED PHARMACY MODEL

• The patient starts ruxolitinib (Jakafi).• Physician reviews medication, laboratory monitoring, and follow-up plan.• Pharmacy staff contacts patient 72 hours after appointment, one week

later, and prior to refills to assess toxicity and adherence.• Concerns relayed immediately to nursing and physician.

UCS MID MODEL CONTINUED

• Better treatment• Better care• Better cost• Better safety• Better satisfaction

SUMMARY OF THE NCODA PQI IN ACTION

• Dr. William Mayo had it right when he said, “The needs of the patient come first.”

REMEMBER

• Questions???

THANK YOU