Issue Brief Rising Drug Costs & Persistent Drug Shortages ISSUE SUMMARY Rising pharmaceutical drug costs and an increasing number of drug shortages have had a tremendous impact on the treatment of ophthalmology patients in recent years. Frequent, large, and often unexplained increases in the costs of both brand name and generic prescription drugs for patients are forcing physicians to prescribe alternatives to recommended therapies. Practices have also seen spikes in the cost of the diagnostic drugs they use in their offices. In other instances, commonly-used, inexpensive drugs are suddenly being discontinued or going into shortage, causing disruption to patient care, comprising patient outcomes and leaving ophthalmologists searching for alternative treatments. Request: To increase competition and options for ophthalmic patients, the Academy encourages members of Congress to cosponsor the Creating and Restoring Equal Access to Equivalent Samples Act (S.340/H.R.965). The Academy is also urging Congress to continue working with the Academy and other key stakeholders to identify solutions to drug shortages to ensure patients and physician practices have access to all the treatments that they need. BACKGROUND Drug Pricing: In recent years, the Academy has expressed growing concern over unexpected and spiking costs of both brand name and generic drugs, which are driving up practice expenses and leaving patients with higher out-of-pocket expenses. Ophthalmologists have seen dramatic price increases for commonly used generic drugs that have been low cost for more than a decade. One such example is the ophthalmic preparation of phenylephrine which has increased in cost by 1000% over the past few years. The dramatic increase in price for phenylephrine has created problems for ophthalmic clinics, ambulatory surgery centers and hospitals because there is no alternative. Similarly, other drugs that are most commonly used by ophthalmologists have also experienced dramatic price increases, including: • prednisolone acetate • doxycycline • pilocarpine • atropine • dorzolamide Patients are adopting varied methods to cope with the financial burdens brought on by rapid price increases in pharmaceutical drugs. In recent years, as generic drugs have surpassed their brand name counterparts in price, patients have requested to change prescriptions to brand name drugs from the physician prescribed generic. In other instances, patients have begun rationing their medications by taking them less often than prescribed or delaying treatment altogether due to the cost of postoperative medications. Rationing medications or delaying treatment can have severe implications for patient outcomes, including vision loss. The Academy finds these reports alarming as they highlight the disruptive nature that rapid price spikes can have on patients and the providers seeking to provide them with the best possible care. As the broader ophthalmology community looks to alternative low-cost drugs, the shift to these substitute drugs can, in turn, create new problems. For example, supply issues are created because less frequently used drugs are suddenly in great demand due to cost factors. This has led to dramatic price increases for alternative drugs and has been a driver of significant drug shortage challenges impacting ophthalmology. Drug Shortages: Drugs shortages have become a major challenge for ophthalmology practices. Ophthalmic diagnostic and glaucoma medications, specifically fluorescein strips and dorzolamide, have faced extended shortages in 2018 and 2019. As of April 2019, ophthalmology had over 10 drugs listed on the Food and Drug Administration’s (FDA) drug shortage list as in shortage or discontinued. Ophthalmologists have reported significant impacts on patient care, including delays in treatment and suboptimal outcomes stemming from reliance on less effective medications. The impact on patients has been felt across the country, in small practices, large health systems, and veterans’ and military medical centers. Examples include: • An ophthalmologist at a major military medical center in Washington highlighted the problem recently, stating; “we have a grand total of 90 fluorescein strips left in stock, with no prospect of resupply. This will have a significant impact on our ability to reliably care for our veterans with glaucoma, as well as our soldiers presenting with eye trauma and concerns for open globe injuries.” • A poll of California ophthalmologists found that a shortage of prednisolone acetate resulted in three cases of corneal transplant rejection, one case of keratitis, and dramatic increases in intraocular pressure in children due to use of a less effective alternative. One of the underlying drivers of these shortages is the limited number of manufacturers making ophthalmic products. With many products having a single manufacturer, any disruption to their production facilities or supply line can result in a shortage. In instances where a product has two or more manufacturers, a breakdown with one can result in a brief shortage until the other manufacturer(s) can increase production. Drug manufacturers have also discontinued making various ophthalmic products due to financial or market considerations. Many of the products currently in shortage or having been discontinued are low-cost drug products, providing little financial incentive for new companies to enter the market. WHAT THE ACADEMY IS DOING The Academy has supported multiple pieces of legislation related to drug prices, including those aimed at increasing price transparency for patients and increasing competition. In the 115th Congress, the Academy supported legislation to eliminate the “gag rule,” by prohibiting health insurance plans from restricting pharmacists from informing patients of differences in drug prices both covered and not covered under a healthcare plan: • Know the Lowest Price Act (S.2553/H.R.6144) sponsored by Sen. Debbie Stabenow (D-MI) and Rep. Lloyd Doggett (D-TX) (Public Law 115-262) • Patient Right to Know Drug Prices Act (S.2554) sponsored by Sen. Susan Collins (R- ME) (Public Law 115-263) Both bills were signed into law in October 2018. In the new 116th Congress, the Academy is supporting the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, bipartisan legislation introduced by Senators Chuck Grassley (R-IA) and Patrick Leahy (D-VT) and Reps. David Cicilline (D-RI) and James April 2019 Sensenbrenner (R-WI). S. 340/H.R. 965 would eliminate barriers for generic drug developers to enter the marketplace, by ensuring timely access to samples from brand companies. This legislation closely aligns with the Academy’s goal of improving competition in the generic drug marketplace. See the attached cosponsor list to see if your elected officials have cosponsored these bills. The Academy has also prioritized the issue of drug shortages in our advocacy activity. In 2018, the Academy secured congressional support for House and Senate letters to the FDA that called on the agency to convene its Drug Shortage Task Force to identify and recommend solutions to address drug shortage issues. The House letter, led by Reps Brett Guthrie (R-KY) and Mike Doyle (D-PA), had more than 100 co-signers. The Senate letter, led by Senators Bill Cassidy, MD, (R-LA) and Chris Murphy (D-CT), had over 30 co-signers. See the attached list of cosigners to check if your elected official signed these important letters. In response to these letters, FDA Commissioner Scott Gottlieb convened a meeting of the Drug Shortage Task Force on October 12, 2018. The Academy was invited to participate in the meeting on behalf of ophthalmology, and Dr. David Glasser, the Academy’s Secretary for Federal Affairs, outlined the clinical impact these shortages were having on the ophthalmic community and our patients. The Academy expects the FDA Drug Shortage Task Force to release its report to Congress by the end of 2019. The Academy will be working with other physician organizations, FDA, and Congress to implement policy recommendations included in the report that can improve the availability of key ophthalmic drug products. POSSIBLE QUESTIONS FROM POLICYMAKERS Does the Academy support allowing the reimportation of drugs? • The Academy does not have a formal position on allowing the reimportation of drugs. As policymakers consider policies such as reimportation, the Academy believes that mechanisms to ensure the safety and efficacy of drugs imported from other nations must be in place to protect patients from counterfeit drugs. The Academy also does not believe that importation of drugs would solve all of ophthalmology’s shortage woes, as many ophthalmic drugs are also unavailable in other countries. Does the Academy support allowing the Medicare program to negotiate drug prices? • The Academy does not have a formal position on allowing the Medicare program to negotiate drug prices. The Academy will evaluate any legislative proposals for their potential impact on ophthalmic drug prices and availability. WHAT TO TELL CONGRESS • Share a personal story about how rising drug prices or drug shortages have impacted your patients and the care you are able to provide them. • Urge your members of Congress to consider cosponsoring the Creating and Restoring Equal Access to Equivalent Samples Act (S. 340/H.R. 965). The legislation will promote competition in the pharmaceutical marketplace and achieve lower drug costs for patients. • Be sure to thank your elected official if he/she has already cosponsored