Cystic Fibrosis Module #4: Adherence, Access, Education: Current Challenges and Overcoming Barriers in CF Medications

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Adherence, Access, Education: Current Challenges and Overcoming Barriers in CF Medications Dr. Jeffery T. Zobell, Pharm.D., BCPPS Dr. David C. Young, Pharm.D. Objectives Define adherence Describe the medication
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Adherence, Access, Education: Current Challenges and Overcoming Barriers in CF Medications Dr. Jeffery T. Zobell, Pharm.D., BCPPS Dr. David C. Young, Pharm.D. Objectives Define adherence Describe the medication access programs available for CF patients Discuss the role of education in improving medication adherence in CF patients 1 Adherence There are well designed clinical trials that demonstrate that you have to take the medication for it to be effective Dr. Wayne Samuelson Professor Division of Respiratory, Critical Care and Occupational Pulmonary Medicine Defining Adherence The extent to which a person s behavior (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice. Haynes, 1979 Riekert, NACFC Adherence Rates Individual pulmonary medications 31-79% Unknown rates across the lifespan Significant during adolescence adherence rates associated with BMI Quittner et al. Chest 2014; Shakkottai et al. Ped Pulm 2015 Adherence Rates by Age Quittner et al. Chest Adherence Rates by Medicine Quittner et al. Chest 2014 Adherence Rates by # of Medicines Quittner et al. Chest Adherence Rates Outcomes dornase alpha adherence associated with hospital length of stays and respiratory exacerbation cost ($10,815) number of inhaled tobramycin dispenses associated with hospitaliza ons (OR 0.40), outpa ent service costs ($251-5,979), and outpa ent rx costs ($14,201-24,772) Nasr et al. J Med Econ 2013; Briesacher et al. BMC Pulm Med 2011 Adherence Rates Outcomes CF-related hospital costs ($1171) for inhaled tobramycin users; ($1829) for high users CF-related hospitalizations 24-35% in low to moderate adherence rates Wertz et al. J Med Econ Adherence Rates Outcomes CF-related hospitalizations 25-35% in moderate to low adherence rates Low to moderate adherence rates are associated with increased healthcare utilization costs ($14,211-8,493) Quittner et al. Chest 2014 Ways to measure adherence Clinician assessment Parent/child or personal self report Medication count Electronic monitor Pharmacy data Medication Possession Ratio Days supply of Medication Dispensed/Total Number of Days in Interval-Days Hospitalized 6 Adherence Rates Self and clinician reported adherence does not predict adherence Self-reported 80% vs. 36% electronic monitoring Clinician-reported 50-60% Daniels et al. Chest 2011 Adherence Barriers Healthcare system factors (e.g. co-pays, prior authorizations, lack of access to provider) Patient factors (e.g. depression, health beliefs, knowledge, communication) Treatment burden Accidental or purposeful forgetfulness No perceived benefit Lack of time Access? Eakin et al. Curr Opin Pulm Med. 2013; George et al. Journal of Cystic Fibrosis 2010; Modi et al. Journal of Cystic Fibrosis 2006; Bregnballe et al. Patient Prefer Adherence Adherence We will develop a multi-pronged approach to increase adherence that will include enhanced data collection and information sharing. Used with permission from CFF CFF 5-year goals Adherence programs will be integrated and sustained within the CFF, CF Care Centers, and CF community. Effective and efficient adherence programs tailored to individual patients and families will be disseminated and implemented. A technology platform will be created to support and facilitate multi-level adherence programs and information sharing among stakeholders. Used with permission from CFF 8 CFF Adherence Key Components Broad stakeholder engagement (including pharmacists) Communication campaign to raise awareness Develop and implement a validated adherence barriers assessment related to patients, families, providers and health systems Develop multi-channel adherence interventions Adopt adherence metrics and measures Incorporate into quality improvement programs Used with permission from CFF Survey of US CFF Accredited Care Centers 64% discussed adherence at each clinic visit 82% of centers used clinical impression 72% of centers asked direct questions (e.g. How many doses of TOBI have you missed in the past 2 weeks?) 44% of centers asked indirect questions (e.g. Have you had any problems with your TOBI in the past 2 weeks?) 8% objectively measured adherence Riekert et al. Adolesc Health Med Ther Adherence Counseling Activities Educational strategies Ask if patient/parent has questions or concerns about their treatment (88%) Review the dosing schedule for each prescribed medicine (86%) Discuss consequences of nonadherence (78%) Behavioral strategies Include the patient/parent in decisions about changes to the regimen (87%) Ask about barriers that make it hard to follow treatment regimen (73%) Riekert et al. Adolesc Health Med Ther Adherence Counseling Activities Social support strategies Ask a nonadherent patient/parent to return to clinic sooner (80%) Riekert et al. Adolesc Health Med Ther Supporting Partnerships for Sustaining Daily Care https://www.cff.org/care/clinician-resources/network-news/fall- 2016/Supporting-Partnerships-for-Sustaining-Daily-Care/ Self-Management Education 2 Cochrane database reviews (Savage 2011, 2014) Insufficient quantity & quality to draw firm conclusions Patient-centered treatment plans Simplify, individualize plans, shared-decisions, involve multidisciplinary team & family Technology & application development Applications for tracking, information, communication, incorporate self-reported health data into EMR, Identify social media tools Bishay et al. Adolesc Health Med Ther Improve CF health service model Discuss adherence during visits or phone calls, consider home visits, develop community-based initiatives, address social determinants Bishay et al. Adolesc Health Med Ther Benefits of a dedicated CF Pharmacist discharge medication availability time reduced by 84% Improved access improvement in communication between secondary and primary care reduction in medication errors improvement optimization drug therapy Improved adherence medication cost-savings improved tobramycin monitoring cost savings in central intravenous additives audit Redfern, J., J R Soc Med, Benefits of a dedicated CF Pharmacist & Pharmacy Technician 52% of adult patients were unable to access 1 medication prescribed by their CF provider 98% of these patients were able to access their prescribed medication(s) via pharmacist & pharmacy technician as CF team members Improved access Anstead, M., Pediatr Pulmonol, Intermountain Specialty Pharmacy (ISP) mail-order pharmacy specializes in high-cost diseases January 1, ISP begins collaboration with Intermountain Cystic Fibrosis Pediatric Center to manage mutual patients Schwab, L et al., Pediatr Pulmonol, Effects of Integrated Pharmacy Team on Adherence OR Wald Chi- Square df p-value CF Clinic Pharmacist (yes) ISP (yes) Outcome: Compliance Predictor Variables: CF Pharmacist & ISP Schwab, L et al., Pediatr Pulmonol, CF Exacerbation rate: total and low dornase alfa MPR subgroups N= Q Q Q Q Q Q Q CF Exacerbation rate MPR 0.8 Total CF exacerbation rate Schwab, L et al., Pediatr Pulmonol, Patients filling with ISP were 0.25 times less likely to be admitted compared to non-isp (OR = 0.253) ( 0.001) No statistically significant differences for compliance or CF pharmacist influencing admission Hospitalizations decreased by 68% in 2016 compared to 2015 Schwab, L et al., Pediatr Pulmonol, Access Barrier Solutions Pulmozyme Access Solutions https://www.genentechaccess.com/hcp/brands/pulmozyme.html Tobi Podcare+ Vertex GPS Cayston Access Program https://www.cayston.com/cayston-access-program/ Live2Thrive https://www.live2thrive.org/ CF Care Forward https://www.creon.com/cfcareforward HealthWell 15 Pancreatic Enzyme Assistance Programs Creon CFCareForward Zenpep Live2Thrive Pertzye Chiesi CareDirect Creon CFCareForward Available to all patients with commercial prescription insurance and Tricare that covers Creon pancreatic enzymes Provides copay assistance Provides no cost CF-specific multivitamins MVW Complete Formulation Libertas DEKAs Provides no cost nutritional supplements 16 Zenpep Live2Thrive Available to all patients with commercial prescription insurance that covers Zenpep pancreatic enzymes Provides copay assistance Provides no cost CF-specific multivitamins Aquadeks Provides no cost nutritional supplements Pertzye Chiesi CareDirect Available to all patients with commercial prescription insurance that covers Pertzye pancreatic enzymes Provides copay assistance Provides $75 per month Nutrition Debit Card To cover nutritional supplements and food gs-support/chiesi-caredirect/ 17 Mucolytic Assistance Program Pulmozyme Access Solutions Available to all cash-pay patients or with commercial prescription insurance that covers Pulmozyme Pulmozyme Co-pay Card Program Provides copay assistance Genentech Access to Care Foundation (GATCF) Provides medication directly from Genetech Co-pay Assistance Foundations refer you to an independent co-pay assistance foundation that might help pay for your Genentech medicine https://www.genentech-access.com/hcp/brands/pulmozyme.html Inhaled Antibiotic Assistance Programs Cayston Assistance Program Kitabis Pak TOBI Podcare Plus 18 Cayston Access Program Available to all patients with commercial prescription insurance that covers Cayston Provides copay assistance Coordinates with specialty pharmacies https://www.cayston.com/hcp/cayston-access-program/ Kitabis Pak Assistance Program Available to all patients with commercial prescription insurance that covers Kitabis Pak Provides copay assistance 19 TOBI Podcare Plus Assistance program Available to all patients with commercial prescription insurance that covers TOBI Podhaler Provides copay assistance Coordinates with specialty pharmacies CFTR Modular Assistance Programs Vertex Guidance and Patient Support (GPS) Ivacaftor Lumacaftor/ivacaftor 20 Vertex GPS Available to all patients with commercial prescription insurance that covers Kalydeco or Orkambi Provides copay assistance Coordinates with specialty pharmacies HealthWell Foundation Cystic Fibrosis Fund Available to all U.S. CF patients who have insurance that covers the cost of medications and whose household income is 500% of the Federal poverty level Income verification occurs during enrollment process $15,000/year Coverage list can be accessed on site https://www.healthwellfoundation.org/fund/cystic-fibrosis/ 21 CF Foundation Compass Cystic Fibrosis Foundation Compass is a personalized service to help you with the insurance, financial, legal and other issues you are facing. https://www.cff.org/assistance-services/insurance/your-insurance-plan/find-resources--cf-foundation-compass/ Conclusions Adherence rates to CF medications are suboptimal Low adherence to CF medications leads to poor health outcomes and increase heathcare utilization The complexity of CF care has increased the burden of adherence, access, and education Pharmacists can play a key role in improving care for patients with cystic fibrosis 22
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