Protecting Patients from Non-Medical Switching EMILY LEMISKA OPERATIONS MANAGER & DIRECTOR OF COMMUNICATIONS U.S. PAIN FOUNDATION

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1 Protecting Patients from Non-Medical Switching EMILY LEMISKA OPERATIONS MANAGER & DIRECTOR OF COMMUNICATIONS U.S. PAIN FOUNDATION

2 Protecting Access to Treatment U.S. Pain Foundation is made up of 90,000 members, but we represent the interests of 100 million Americans living with chronic pain. We are the leading patient advocacy group for chronic pain. Protecting access to treatment is a major theme for us.

3 My Story I live with muscle, joint and nerve pain due to a rare spine and spinal cord defect Pain started suddenly in 2011 and never went away Like many patients, I rely on my prescribed treatments to manage my health Same two medications for six years A lot of trial-and-error to find meds that worked

4 What is Non-Medical Switching? Imagine: your worst cold never goes away. you find an effective medication that is covered by your insurance. after you ve already signed up for the plan, the insurer decides it no longer will cover that medication.

5 This Is Non-Medical Switching. Increasingly, insurers, or their pharmacy benefit managers (PPMs), are cutting costs by reducing or eliminating coverage for medications in the middle of a contract year, long after open enrollment. Patients are forced to switch to an insurerpreferred medication, regardless of the health impact or clinical advice. In most cases, the patient has little recourse to fight the change. They re locked into a plan that doesn t meet their needs.

6 How Does Non-Medical Switching Happen? Non-Medical Switching

7 Personal Experience Received letter in mail in February 2017 from insurer about midyear change to how much of a topical cream I could use

8 Why Is it a Problem? Aside from being inherently unfair, evidence is clear that non-medical switching can lead to: Devastating health outcomes Higher overall health costs Negative societal consequences

9 Devastating Health Outcomes Non-medical switching can lead to increased symptoms, side effects and even relapse. Switching can lead people with epilepsy to experience more breakthrough seizures. For Crohn s disease patients, even voluntary switching was associated with a loss of One way insurers can force a non-medical switch is by raising patient co-pays, making a treatment effectiveness within one financially year. inaccessible. Generally speaking, research shows that doubling copays reduces treatment adherence by 25 to 45%, and that obviously leads to poorer outcomes.

10 Higher Health Costs Increased need for doctors visits, ER trips, and even hospitalization increases utilization costs. People with epilepsy who were switched required more inpatient/er care. Rheumatoid arthritis patients switched experienced 42% more ER visits and 12% more outpatient visits over six months. Patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or Crohn s who were switched incurred 26% higher total health costs than patients who weren t.

11 Negative Societal Consequences Quantifiable consequences/costs: Indirect costs of medication nonadherence exceed $1.5 billion annually in lost patient earnings and cost $50 billion in lost productivity. Psychiatric patients who stop medications because of coverage changes are three times more likely to be homeless. They are more than twice as likely to be incarcerated or detained in jail. Unquantifiable consequences: Emotional toll Erodes patient-provider relationship Flies in the face of evidence-based medicine

12 Patients Experiences It was extremely frustrating and unfair. There are very few medications that have actually helped me. I can use the help of the ones that work when my pain is especially severe. But after YEARS of having access to this medicine, a letter simply took it away. It is like doing everything right, researching everything, and buying the right car only to find out it has been stripped inside and falls apart the second you drive it off the lot. I currently now have to take a much less effective medication that is limited in quantity amounts by insurance. My episodes are more intense, and last longer as a result of not being able to obtain the medication that works best. This also impacts my productivity at home and at work.

13 Opposition Is Growing Working group published report last year recommending against nonmedical switching. AMA, and coalition the coalition made includes up of16 the: other American groups, Academy of Child and Adolescent Psychiatry, American Academy including of the Dermatology, American American Academy Academy of Family of Family Physicians, American College of Cardiology, American College of Rheumatology, American Hospital Association, American Pharmacists Association, Physicians, American Hospital Association, American Society of Clinical Oncology, Arthritis Foundation, Colorado Medical Society, Medical Group Management American Pharmacists Association, Medical Association, Society American of the State of New York, Minnesota Medical Association, North Carolina Society Medical of Clinical Society, Oncology Ohio State released Medical 21 Association and Washington State Medical Association. utilization management principles, including one against nonmedical switching.

14 Other Groups Against Non-Medical Switching American Autoimmune-Related Diseases Association Arthritis Foundation Coalition of State Rheumatology Organizations Creaky Joints Disability Coalition Epilepsy Foundation Global Healthy Living Foundation Lung Cancer Alliance Lupus and Allied Diseases Organization Lupus Foundation of America National Alliance on Mental Illness National Alliance of State & Territorial AIDS Directors National Fibromyalgia & Chronic Pain Association National Hemophilia Foundation National Kidney Foundation National Multiple Sclerosis Society National Organization for Rare Disorders National Patient Advocate Foundation National Psoriasis Foundation The Leukemia & Lymphoma Society U.S. Pain Foundation

15 State Policy: Growing Opposition CA & NV prohibit nonmedical switching; TX & LA have partial protections Yellow states have taken unique steps (COvoluntary recommendations, MAstudy commissioned) Green states proposed bills in 2017, may be retrying in 2018 Blue states have coalition activity

16 State Policy: Model Language During the policy year, a health insurance entity that covers prescription drugs shall not: 1. Remove a covered prescription drug during the policy year, unless the Food and Drug Administration (FDA) has issued a statement about the drug which calls into question the clinical safety of the drug, or the manufacturer of the drug has notified the FDA of a manufacturing discontinuance. 2. Reclassify a drug to a more restrictive drug tier or move a drug to a higher cost-sharing tier or a tier with a larger deductible, copayment or coinsurance, unless a generic equivalent becomes available. 3. Reduce the maximum coverage of prescription drug benefits. This section does not prohibit the addition of prescription drugs to a policy s list of covered drugs during the plan year. This Act does not impact or in any way limit generic substitution.

17 State Policy: Unique Considerations Between States Should protections apply to private and public insurance(larger fiscal note)? Should there be special protections for specific patient populations (e.g. chronic / rare conditions)? If no way to prohibit changes, can exceptions process be standardized? Should beneficiaries be protected from drug coverage changes during the renewal period (grandfathering)?

18 State Policy: Myth vs. Fact MYTH: This will increase health care costs. FACT: States with related laws (CA, NV, LA, TX) have reported no fiscal impact. In addition, Medicare actually has excellent patient protections. All negative midyear formulary changes must be approved and patients are allowed to remain on the drug for the remainder of the year. MYTH: The appeals process already protects patients. FACT: Even if patients realize they have the ability to appeal and have the know-how to do so, the process can be complicated and lengthy, and, of course, the appeal is not always successful.

19 State Policy: Myth vs. Fact MYTH: Non-medical switching legislation affects generic substitution. FACT: Non-medical switching legislation in no way affects or limits generic substitution. MYTH: Insurers need to be able to respond to rising drug costs. FACT: Insurers and PBMS are sophisticated entities who are wellequipped to negotiate prices during the appropriate period and take into account market changes over the course of the year. MYTH: This is a mandate. FACT: This is closing a loophole that shouldn t exist in the first place.

20 Non-Medical Switching: Turning Tides The tide is changing, but there is still a lot of work to be done. For more information about U.S. Pain For more information about non-medical switching