Hematologist Kenneth R . Adler , MD , of Summit Medical Group MD Anderson Cancer Center in New Jersey , has a patient who has been taking the branded version of lenalidomide to treat her myelodysplastic syndromes for nearly a decade . The drug has been a “ magic bullet ” for the patient , who , through her husband ’ s employer-provided private insurance , only pays a $ 20 copay for each 28-day supply – which would cost about $ 20,000 per month without insurance .

“ The patient started crying because her husband wants to stop working and retire but can ’ t because he will lose his insurance and prescription coverage ,” Dr . Adler said . “ I can ’ t understand why these companies have to continue to raise the price of a drug that has been on the market for so long .”

Unfortunately , this patient ’ s situation is not unique . She is an example of the many victims of the financial toxicity associated with long-term treatment .

But , according to legislators and some clinicians , she could benefit from a change in public policy to ease the financial burden of a chronic disease : importation of cheaper drugs from foreign countries .

In recent years , several legislators have proposed changes in public policy that would permit the wholesale or individual importation of drugs to the U . S . These proposals have highlighted the reasons U . S . drug prices dwarf those in other developed countries and raised concern over the safety of imported pharmaceuticals .

ASH Clinical News spoke with various stakeholders to see how increased access to pharmaceuticals through importation could affect U . S . patients .

Our Neighbors to the North

The idea to import lower-priced drugs from other countries to help the U . S . better manage price hikes and supply shortages is not new , and interest in the approach was high in 2017 when Congressional lawmakers put forth two bills related to drug imports .

Sen . Bernie Sanders ( I-VT ) sponsored the Affordable and Safe Prescription Drug Importation Act ( S . 469 ), which would amend the Federal Food , Drug , and Cosmetic Act to permit importation

of affordable and safe drugs by wholesale distributors , pharmacies , and individuals . 1 This legislation was intended to help lower the “ skyrocketing cost of prescription drugs by allowing Americans to import safe , low-cost medicine from Canada .” 1 The non-partisan Congressional Budget Office estimated that , if passed , the bill would save $ 6.8 billion over 10 years . 2

Another importation bill , the Safe and Affordable Drugs from Canada Act of 2017 ( S . 64 ), was sponsored by Sens . John McCain ( R-AZ ) and Amy Klobuchar ( D-MN ) and was intended to introduce “ greater competition into the pharmaceutical marketplace .” 3 This bill proposed legalizing “ personal importation ” ( or bringing a product that is not for further sale or distribution into the U . S . through personal baggage or international mail ) from licensed pharmacies in Canada .

Despite the appeal of this approach , both bills are stalled in legislative review .

How Did We Get Here ?

Hematologists and oncologists are wellaware that many medications essential to treating serious medical conditions like cancer can be prohibitively expensive . The average price of anti-cancer drugs at launch – adjusted for inflation – has increased by approximately 10 percent per year from 1995 to 2013 . 4

“ We have made a lot of progress in developing novel drugs in recent years ,” Dr . Adler said . “ The issue with novel drugs , though , is that when patients do well on them , they are often going to be on them indefinitely , with prices increasing every year .”

In a 2013 survey of patients with cancer who contacted a national copayment assistance foundation , 42 percent of participants reported “ significant or catastrophic subjective financial burden ” and 24 percent avoided filling prescriptions because of cost . 5 Similarly , a 2015 study in The Lancet Haematology showed that financial toxicity was common in patients with multiple myeloma , with 71 percent of patients reporting at least minor financial burden , and 21 percent reporting having to borrow money to pay for medications . 6 And , in a

discrete-choice experiment published in Blood Advances , patients living with chronic lymphocytic leukemia said they were willing to accept drugs that are less effective if they carry lower out-of-pocket costs . 7

Americans often pay two to six times what the rest of the world pays for the same brand-name prescription medications , according to a 2015 report released by insurance industry group International Federation of Health Plans . 8 The report listed several examples of price differences , including the anticoagulant Xarelto ® ( rivaroxaban ), which had an average price per 30-day supply of $ 292 in the U . S . and just $ 126 in the U . K ., and the anti-cancer therapy Avastin ® ( bevacizumab ), which had an average price of $ 2,289 for a 400 mg vial in the U . S . and just $ 470 in the U . K .

Why the Difference ?

Medicare covers all newly approved anticancer drugs , regardless of cost or costeffectiveness , and does not directly negotiate with drug manufacturers over prices . In fact , the 2003 Medicare Modernization Act barred the government from negotiating pricing with pharmaceutical companies . Instead , the legislation depended on large private insurers to negotiate discounted drug prices . 9

“ In other countries with large healthcare systems , like the National Health Service ( NHS ) in the U . K ., [ officials ] have consciously decided to exclude known effective anti-cancer drugs due to cost alone ,” said Joseph Alvarnas , MD , director of value-based analytics at City of Hope National Medical Center in Duarte , California , and chair of the American Society of Hematology ’ s Committee on Practice .

The National Institute for Health and Care Excellence ( NICE ) in the U . K . evaluates cost-effectiveness of new drugs and restricts funding for drugs if their benefits are deemed too small , compared with the cost . The possibility of noncoverage is a bargaining tool for the British government to negotiate discounts with drug manufacturers .

A recent press release from NICE announced that NHS will now offer a drug

combination of lenvatinib plus everolimus for people with advanced renal cell carcinoma . This decision came only after “ a revised offer from the company ” that passed NICE ’ s cost-effectiveness analysis . 10 A similar decision was made regarding two breast cancer drugs after the companies lowered the prices . 11

“ Drug prices are lower in Canada because the national government , through the Patented Medicine Prices Review Board , uses reference pricing ,” explained Gabriel Levitt , president of Pharmacy- Checker . com , and a public advocate for prescription drug affordability . “ It ’ s surprisingly simple , and Canada ’ s prices on brandname drugs are often the median of the following countries : France , Germany , Italy , Sweden , Switzerland , the U . K ., and the U . S .”

Through this program , the price of patented drugs in Canada decreased in 2016 by 2.6 percent . 12 However , Mr . Levitt acknowledged that generic medications in Canada are often more expensive than generics in the U . S ., given the smaller market , lower competition among manufacturers , and the fact that the U . S . government does not control generic pricing .

Open the Borders

Though it prohibited price negotiations , the Medicare Modernization Act of 2003 included a provision that allowed for the import of prescription drugs from Canada . The law tasked the U . S . Secretary of Health and Human Services ( HHS ) with two important responsibilities : ensuring that the drugs “ pose no additional risk to the public ’ s health and safety ” and that importation would lead to cost-savings for U . S . consumers .

Representatives from Pharmaceutical Research and Manufacturers of America ( PhRMA ), a trade group representing biopharmaceutical researchers and biotechnology companies , pointed out that 15 years have passed and this has yet to happen .

“ No HHS Secretary has felt comfortable approving importation because [ he or she ] cannot guarantee safety ,” said Caitlin Carroll , director of public affairs at PhRMA .