Washington, DC—In the past 6 years, more than $4 billion in charitable assistance has been dedicated to patients in need. In 2015 alone, the Patient Access Network (PAN) Foundation provided $950 million in cancer care support. The only people with deep enough pockets to support this type of assistance are drug manufacturers, adding to an already complicated regulatory environment for charitable assistance programs, said Daniel J. Klein, President and Chief Executive Officer, PAN Foundation, at the Sixth Annual Conference of the Association for Value-Based Cancer Care.
Although many manufacturers offer their own patient assistance programs, they differ from charitable programs. Whereas manufacturer programs typically only cover their drugs, foundations provide assistance with other expenses in addition to drugs.
The PAN Foundation also assists Medicare beneficiaries—something drug manufacturer programs cannot do. Approximately 85% to 90% of the people the PAN Foundation assists are Medicare beneficiaries, many of whom are under 500% of the federal poverty level.
“Why is this important? Everybody here knows how much the cost of oncology treatment has increased over the past decade. It’s gone from about $5000 a month to $10,000 a month in terms of treatment cost…we’re particularly concerned about that within Medicare,” said Mr Klein.
In 2016, Medicare drug plans had deductibles totaling less than $360, with an initial cost-sharing of $825. People who are caught in the coverage gap pay approximately $1875 out of pocket, according to Mr Klein.
“A little over $3000 out of pocket just to get into the catastrophic period that picks up pretty much all of the costs, except for 5%,” he said. Mr Klein explained that that 5% can be a significant barrier for patients.
“When you’re down at 200% of the federal poverty level, which is above the level that you can get low-income subsidy in Medicare, even a drug costing $7500 a year is going to push you into being underinsured. Just that single drug.”
Patient assistance programs lower the financial barriers to cancer care, which, in turn, improves access, adherence, and patient outcomes, Mr Klein said.
“People who are cutting their dosage of medication in half or skipping it tend not to get the maximum benefit from treatment. There’s lots of research on the impact of lowering the financial barriers to care,” Mr Klein said. “We provide the safety net, the only safety net, available for Medicare patients. Under the various rules and regulations, there’s really no other place for Medicare patients to go to who are struggling with out of pocket costs,” he added.
Access to Costly Drugs
Lack of access to drugs is something that Pamela Gavin, Chief Operating Officer, National Organization for Rare Disorders (NORD), Danbury, CT, knows all too well.
“Prior to the establishment of NORD, there were only 10 therapies on the market for rare diseases developed in the 10 years prior to the movement that led to the Orphan Drug Act,” she said.
“If we look at the Orphan Drug Act, and the therapies approved under that law prior to 1983, and you look at the next 30 years, and how that’s progressed, it’s been probably one of the most successful pieces of healthcare legislation, when it comes to innovation that we’ve experienced in this country,” Ms Gavin added.
According to Ms Gavin, in the past 2 years alone, there have been nearly 90 drugs approved under the orphan drug designation.
Ms Gavin and Mr Klein argue that the emergence of innovative drugs, however, does not fix the root of the problem.
“In the environment that we’re operating in right now, the demand greatly outweighs the capacity for us even collectively—if we look at Dan’s organization, NORD, and many others that are out there—the demand greatly outweighs the need. It’s not a fix. It’s not a solution long-term,” said Ms Gavin.