ICER started doing value assessments of new drugs. Not long after, the American Society of Clinical Oncology (ASCO) came out with a tool to help doctors and patients assess the value of various cancer treatments. As these “value frameworks” started rolling out, patient groups recognized their influence over insurance coverage, and that they needed to talk to the people behind them. ICER and ASCO provided patient groups with “a point of focus,” says McCleary.
One group that reached out to ICER was the National Psoriasis Foundation (NPF). (Like most patient groups, the NPF receives funding from several drug companies.) The two organizations worked together in 2016 as ICER evaluated eight different psoriasis drugs; seven were FDA-approved at the time. The foundation had patients and doctors talk with ICER staff about the challenges of both having and treating the disease.
ICER’s draft report concluded that only one of the eight drugs under review was cost-effective. But after public input and feedback from the NPF, ICER adjusted some key drug price data in its models. It also heard from the NPF about how psoriasis can lead to other health problems and lower quality of life, and that some of the draft report’s assumptions didn’t capture the real-world uses of certain drugs.
After all this input, ICER’s final report came to a very different conclusion at the end of 2016: all eight drugs were of good value.
ICER made other recommendations favorable to patients, too. For example, it urged limiting or eliminating the insurers’ practice of step therapy—which requires patients to first try cheaper drugs, then “step up” to the one prescribed by their doctor only if the cheaper ones failed to work.
“We were pleased to see that individual patient perspectives and our overarching perspectives were a factor in [ICER’s] decision-making process,” says National Psoriasis Foundation chief operating officer Leah Howard.
ICER says it includes input from patients and patient groups in all of its drug reviews. “When we include information that’s important to patients, then we’re doing a better job of determining what high-value treatments look like,” says Sarah Emond, ICER’s executive vice president and chief operating officer.
Howard of the NPF says her group has been citing ICER’s report in its discussions with payers, and she hopes ICER’s recommendations will soon have an impact on coverage decisions on the drugs in the report.
The NPF hasn’t taken a public position on high drug prices, but Howard says in recent years her group has ramped up its policy work and lobbying at the state and federal level. The foundation has supported state legislation to curb step therapy, limit out-of-pocket expenses, and boost access to biosimilar drugs. (See articles from the New York Times and Stat on actions taken by states on drug pricing)
PUSHBACK PAYS OFF
In 2015, the National Multiple Sclerosis Society conducted a survey of nearly 9,000 people with MS and was struck by the results. Nearly 40 percent said they had trouble affording their medications. Patients reported they had cut back on other necessities, failed to pay bills, or skipped doses of their drugs.
After the survey, the NMSS released its recommendations to improve drug access, despite feedback from a couple of donor pharma companies to be careful about what it said publicly on the topic (as first reported by the New York Times). (Five percent of the NMSS’s funding comes from pharma companies).
The NMSS’s recommendations include limiting price increases and out-of-pocket costs and lowering prices of drugs that have seen large price hikes. Trying to move on these recommendations “has been a major focus of ours,” says Talente.
The society’s efforts are starting to pay off. After more than a year of talks with Roche, the international drug maker decided to price an MS drug—Ocrevus, which the FDA approved last year—nearly 20 percent below the average of other MS “disease-modifying therapies.” The company did not increase the list price, $65,000 per year, for 2018.
And Sanofi Genzyme, which makes two approved MS drugs and was also in discussions with the NMSS, pledged last year to be more transparent and provide a clear rationale for its pricing decisions. It also promised to keep price increases at or below the rate of medical inflation. (Both Roche and Sanofi provide funding to the NMSS.)
WALKING THE LINE
The NMSS has had to figure out how to address the pressing needs of patients while also acknowledging its funding from pharma. Talente says the key has been open lines of communication with drug companies. “There are some places where we align and other places, like around prices, where we generally don’t,” says Talente. “But we’ve had some really productive conversations around prices.”
The Leukemia and Lymphoma Society, which relies on drug companies for 18 percent of its funding, took a similar approach with its drug access recommendations. The LLS decided not to blame any one of its “partners” in the drug pricing debate. “To point fingers at any one of our partners was not our intent,” says LLS chief medical officer Nichols.
Instead, it targeted its recommendations broadly. For example, the LLS called on cancer patient organizations to be more vocal about patients’ financial struggles, drug companies to adopt value-based payment models, and pharmacy benefit managers (PBMs; they run prescription drug programs and negotiate drug prices) to pass along to patients more savings from negotiated drug rebates. (See this Wall Street Journal article about UnitedHealthcare’s recent announcement to share some of its drug discounts with customers.)
Mitchell of Patients for Affordable Drugs is skeptical of LLS’s approach. He says he’s grateful to the LLS for supporting research that led to the drugs that have kept him alive (LLS is focused on all blood cancers, including multiple myeloma.). But he says its recommendations are not focused enough to make real change. “They’re not targeting the root cause,” says Mitchell—the high prices set by drug companies, and their tactics to keep generic competition off the market. Mitchell also calls for greater price transparency from both drug companies and PBMs. (In recent speeches, Health and Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb also emphasized the need for greater price transparency. And some states have passed legislation on this.)
Mitchell’s group is focused on building a community of patients, training them to be advocates, and lobbying for bills such as CREATES, which is aimed at boosting generics competition. He has also formed a new group to support political candidates who are pushing for lower drug prices.
Mitchell and his group are also talking with ICER about the price of Novartis’s CAR-T leukemia therapy ($475,000). In a recent draft report, ICER called the cell therapy cost-effective. But Mitchell and others published an article arguing that the price should be $160,000.
John Rother, CEO of the National Coalition on Health Care, a nonprofit funded by insurers and healthcare provider and consumer groups, says drug pricing recommendations from patient advocacy groups are welcome, but to really have an impact, these groups need to “support new legislation in Congress that can be more effective in restraining drug prices.”
Whichever approach patient groups take, McCleary of FasterCures says there is at least “a growing sense of responsibility to represent the patient community in this dialogue.” And Rother hopes that this will translate into more action, because patients have a lot of credibility and can sway public opinion. “Patients have the most at stake,” says Rother.
