The Un-Special World of Specialty Medications

Transcription

1 The Un-Special World of Specialty Medications Manpreet Chahal, PharmD, PhD Oncology Pharmacist, Medical Oncology Associates, Spokane WA Adjunct Clinical Instructor, WSU College of Pharmacy WSPA Annual Meeting November 20, 2015

2 Disclosure Speakers Bureau Pfizer Cubist

3 Objectives List pros and cons of the limited distribution drug model Recognize barriers patients overcome in obtaining specialty medications Identify opportunities to improve outcomes for patients being treated with specialty medications

4 Our Setting Medical Oncology Associates, PS Outpatient Oncology Clinics Spokane WA Spokane Valley WA Post Falls ID Satellite Once-a-month clinics Colfax WA Colville WA 5 Medical Oncologists, 2 NPs 2 Radiation Oncologists Infusion Center Specialty Medication Dispensing Radiation Radiology Clinical Trials

5 Specialty Medications No single definition payors, manufacturers, PBMs Oral, topical, inhaled and injected routes of administration Treat complex, rare and/or life threatening conditions High cost Average cost/month $10,000 (oral oncolytics) Significant out of pocket cost to patients Payers cost more than $600/month Require special storage, handling, and administration Involve significant degree of patient education, monitoring and management (REMS) Limited distribution

6 Specialty Medications - Diagnosis Asthma Cancer Crohn s Disease CF Hemophilia and Bleeding Disorders Hepatitis C HIV Immune disorders Infertility MS RA Transplant

7 Limited Distribution Drug Model Drug Wholesaler Manufacturer Specialty Distributor Hospital Pharmacy Specialty Pharmacy Physician Dispensing Patient

8 Limited Distribution Drug Model Designated by manufacturer with or without FDA mandate Rationale Small patient population Complex dosing requirements and monitoring REMS Majority of Oncology Specialty Medications are Limited Distribution Medications

9 Specialty Pharmacy How do you become one? Ability to acquire specialty medication(s) through specialty distributors Ability to participate in PBM s specialty pharmacy network Accreditation

10 Specialty Pharmacy PBM-owned CVS Caremark Accredo, Curascript (Express Scripts) Right Source (Humana) Optum Rx Aetna Cigna Non PBM-owned Diplomat Biologics Avella Walgreens

11 Specialty Pharmacy in News Valeant Pharmaceuticals PBMs canceling contracts with Specialty Pharmacies Novartis paid $390 million for specialty pharmacy kickback NYT: Specialty pharmacies proliferate, along with questions

12 Case Study 1 Pt X is diagnosed with multiple myeloma and prescribed the following regimen: Lenalidomide 25 mg po daily x 21 days, then 7 days off Dexamethasone 40 mg po once weekly Lenalidomide REMS embryo-fetal toxicity Prescriber must be enrolled in REMS program Each prescription is assigned a unique authorization number that is valid for 7-30 days Prescription has zero refills

13 Case Study 1 Celgene REMS for Pharmacy Pharmacy must enrolled in the REMS program Not accepting new pharmacies At each dispense, pharmacy to acquire a unique confirmation number Patients are counseled at each dispense Medication monograph is provided at each fill Inventory reconciled after each fill Pharmacy audited every 1-2 years by Celgene Celgene REMS for Patients Patients are enrolled in the REMS program Patients conduct a survey every 1-6 months Pharmacy unable to dispense if survey not completed

14 Case Study 2 Pt Y is 66 yrs and diagnosed with advanced breast cancer and prescribed the following regimen: Lapatinib 1250 mg po daily x 21 days, then 7 days off Capecitabine 1000 mg/m2 po BID x 14 days, then 7 days off Lapatinib is a limited distribution medication Dispensed by specialty pharmacy Covered under Medicare Part D benefits Out of pocket cost deductible, coverage gap (donut hole) Capecitabine is not a limited distribution medication Dispensed by retail or specialty pharmacy Covered under Medicare Part B benefits Out of pocket cost 20% co-insurance

15 Challenges Access which specialty pharmacy to dispense? Financial toxicity Coordination of care Counseling Monitoring Adverse reaction management Adherence

16 Adherence Drugs don t work in patients who don t take them C. Everett Koop US Surgeon General

17 Results of Nonadherence Increased utilization of healthcare resources Treatment failure Suboptimal response Disease progression Death

18 Improving Adherence Identify high-risk patients Education (and re-education) Use of pill boxes and pill reminders Simplification of regimen Reinforcement of adherent behaviors Access to healthcare team

19 Case Study 3 Pt Z is diagnosed with mantle cell lymphoma and prescribed the following: Ibrutinib 560 mg po once daily Ibrutinib is a limited distribution medication Dispensed by 4 specialty pharmacies None are PBM owned Significant capture rate for physician dispensing sites Improves outcomes

20 What can be done? Advocate For the patients and the clinic/pharmacy/health system Reduce barriers to treatment Access, cost Legislate The system needs attention and change Educate Yourself, patients, providers, legislators, manufacturers, payors Communicate The key to success

21 Questions??? Go Cougs!!