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High Stakes Healthcare: Who’s Gambling With Your Health? Evelyn L. Lewis, MD, MA, FAAFP Deputy Director USU Center for Health Disparity Research and Education Medical Director Pfizer, Inc Therapeutic Switching Pay for Performance What Everyone Should Know Objectives 1. 2. 3. 4. Defining Drug Switching Drug Switching Practices and Trends Clinical Risks of Drug Switching Other Considerations DEFINING DRUG SWITCHING Several Terms Are Commonly Used to Refer to Drug Switching Generic Substitution Therapeutic Substitution Substitution Substitution of a drug with the same active ingredient and mechanism of action, but produced by a different manufacturer Generic Substitution of a drug that treats the same medical condition according to guidelines outlined in a drug formulary The drug products have different active ingredients and/or mechanisms of action One version, called therapeutic interchange, requires the consent of the prescribing physician Therapeutic Substitution Drug Switching Affects Patients and Physicians and Has the Potential to Increase Overall Healthcare Costs Patient Experience Increases likelihood of poor clinical outcomes Can hurt patient experience Can particularly effect vulnerable populations Healthcare Costs May drive additional physician visits, tests Drug Switching May create greater Physician Experience Can interfere with MD - patient relationship Can decrease ability to provide personalized care need for acute care ̶ May raise overall healthcare costs Drug Switching Means That A Patient Does Not Receive the Drug Originally Prescribed by Their Physician Generic Substitution Physician Prescribes: Prozac Therapeutic Substitution Patient Receives: fluoxetine Therapeutic Substitution Patient Receives: Zoloft Generic Substitution Patient Receives: Sertraline (Zoloft) Generic Substitution Law - 2007 Permitted Mandatory Source: National Association of Boards of Pharmacy, “2007 Survey of Pharmacy Law” Patient Consent is Not Required Patients Face Various Risks Depending on the Type of Switching Patient risk factors age health status current medications Tiered formulary, prior authorization, step therapy, generic substitution, therapeutic interchange Patient receives drug prescribed Patient receives generic version Patient receives different drug Potential Consequences Potential Consequences Potential Consequences Delayed access to medications Administrative burden for patient, physician, pharmacist Adverse reaction to substitute Lack of patient awareness Less risky Decreased efficacy Drug-drug interactions Intolerable side effects Adverse reaction to substitute Lack of patient awareness More risky DRUG SWITCHING PRACTICES AND TRENDS Public and Private Payers Are Using A Variety of Approaches to Promote Drug Switching Drug Switching Strategy Definition Example Tiered Formulary (differential costsharing) Each formulary tier has higher cost sharing to encourage patients to choose lower priced drugs. Generics typically have the lowest cost sharing requirement. Patient goes to pharmacy for Prevacid but told lansoprazole is cheaper. Patient chooses Lansoprazole due to lower price. Generic Substitution Substitution of a generic product for a branded drug with the same active ingredient. A patient goes to the pharmacy and receives simvastatin (generic) instead of Zocor (brand). Therapeutic Interchange Substitution of a drug with different active ingredient for prescribed drug. Patient gets prescription for Mobic (meloxicam) but pharmacist dispenses Toradol (ketorolac). Prior Authorization Requires a provider to provide clinical justification in order to obtain permission from payer to prescribe a medication. Doctor prescribes Bevacizumab but must first call patient’s health plan to obtain permission. Step Therapy Requires use of one or more drugs in a graduated manner before other drugs used to treat the condition will be covered. Patient with psoriasis must take methotrexate for 90 days before they can be reimbursed for Humira. Generics Only Policy A plan only covers generic brands on their formulary. Patient gets prescription for Zyrtec but insurance only covers generic, cetirizine. Private Plans Are Using Financial Incentives and Other Strategies to Support Drug Switching Programs Strategy Definition Example Pay for Performance (P4P): Switching brand to generic Physicians are financially rewarded for prescribing drugs on a plan’s formulary BCBS of Michigan paid physicians $100 per patient switched from brand to a generic statin1 P4P – Payment Withholds/Physician “Risk Pools” Payer withholds portion of perpatient payment If physician payment is $100 per patient, insurer pays $80. The doctor receives the remaining $20 only if related medical and drug costs fall below a threshold value P4P – Generic Utilization Rates Doctors are rewarded financially for prescribing generic drugs Generic prescribing rate counts for 25% of physicians’ total quality scores in Anthem Quality Insights P4P program2; up to 6% bonus payment Promoting Formulary Compliance Payer or pharmacist attempts to influence prescribing behavior directly Fax or call physicians to advocate specific drug switches Incentives for Pharmacists Insurers reward pharmacists for recommending formulary drugs PCS Health Systems paid pharmacists up to $12 per Rx to recommend specific drugs3 In 2000, physicians filed largest healthcare class action suit against eight HMOs. Plaintiffs alleged insurers denied claims based on cost alone. Defendants have since settled for more than $1 billion. The Vast Majority of Medicaid Programs Are Using a Full Range of Mechanisms to Promote Drug Switching Frequency of Medicaid Drug Switching Approaches 2001 - 2008 100 Percetage of States 90 Prior Authorization 80 Generic Substitution 70 60 Preferred Drug List 50 40 30 20 10 0 2001 2002 2003 2004 2005 2006 2007 2008 Year Source: Avalere Health analysis using DataFrame®, a proprietary database of Medicare Part D plan features. 2008 data from November 2007; 2007 data from November 2006; 2006 data from July 2006. Some Medicaid Programs Have Explicit Therapeutic Interchange and Therapeutic Substitution Policies State Strategy Description Washington Therapeutic Interchange Under Washington’s Therapeutic Interchange Program (TIP), pharmacists must substitute a non-preferred drug with a preferred drug for prescriptions written by Medicaid-participating physicians who have endorsed the state’s PDL. Pharmacists must notify physicians of the substitution within 24 hours; physicians can override the substitution by writing “dispense as written” on the prescription. Non-preferred drugs prescribed by non-endorsing physicians are still subject to prior authorization. Wisconsin Therapeutic Interchange Pharmacists receive an enhanced dispensing fee if they contact a Medicaid prescriber and the prescriber agrees to change a prescription from a non-preferred drug to a preferred drug. North Carolina Therapeutic Interchange and Substitution Medicaid recipients with more than 11 monthly prescriptions must participate in the Focused Risk Management (FORM) program, facilitated by the recipients’ pharmacists. Under FORM, pharmacists perform a comprehensive drug regimen review to identify opportunities for therapeutic interchange. Source: State Medicaid websites Drug Switching Can Lead to Poor Clinical Outcomes and Higher Medical Utilization Drug Switching Can Lead To: 1. Less Effective Treatment 2. Side Effects 3. Drug Interactions Poor Clinical Outcomes Higher Medical Utilization Clinical Implications of Drug Switching Are Particularly Severe and Frequent In Certain Populations Populations Potential Problems Patients with multiple conditions Increased risk of adverse events from taking multiple medications1,2 Elderly patients Age and disease-induced changes can affect absorption, distribution, metabolism, and elimination of medicines2 Likely to have multiple comorbidities (In 2002 50% of Medicare beneficiaries had 5+ chronic conditions)2 Patients with certain conditions (List of conditions is not exhaustive) Mental illness HIV/AIDS Alzheimer’s Cancer Epilepsy Multiple Sclerosis Sources: 1NAMI comment letter on Formulary Guidance, 2005; 2“Medication Use by Aged and Disabled Medicare Beneficiaries Across the Spectrum of Morbidity: A Chartbook” The Peter Lamy Center on Drug Therapy and Aging, University of Maryland School of Pharmacy, 2007. OTHER CONSIDERATIONS Drug Switching Practices: Often Not Transparent To Patients and May Have Negative Impact on Their Experience Physician Prescribes Medication May not inform patient of potential switches due to: Limited time with patient Lack of familiarity with patient’s insurance plan May have undisclosed financial incentive Pharmacist Dispenses Medication May not inform patient of switches due to: Limited time with patient Pharmacy or insurance policies Patient Uses Medication Even when provided an explanation, patients may not understand reasons for drug switch or differences between medications When asked by reporters if patients moved from Lipitor to generic Zocor were aware that their physicians were paid $100 per patient switched, a spokeswoman for Blue Cross Blue Shield of Michigan said, “not specifically.” A former Lipitor patient’s response to the information? “I’m shocked. They’re paying the doctors?”1 Source:1The Boston Channel, “Doctors Paid to Switch Patients to Generic Drugs,” August 1, 2007