The Alliance

The Weekly Dose | 06.21.19

June 21, 2019 2:00 pm

The U.S. Senate Health, Education, Labor and Pensions Committee debated a health-care bill this week that goes a long way toward reforming pharmacy benefit manager (PBM) practices. Unfortunately the legislation, which the committee plans to mark up next week, also contains a provision to create a nongovernmental review board on drug pricing.


These boards often limit access to important medicines and de-value life for people with disabilities. For example, their models assign a lower value for the life of a disabled person because “most therapies will never restore a disabled person to perfect health.” We have seen this unfold in Britain, which has used cost-benefit analyses for cancer drugs. British cancer patients have some of the worst access to new cancer treatments in all of Europe.


We have more on these types committees below, and who is behind this idea, but if you need more info for a story or have questions, please email us.


Also on our radar next week: The Hill will host a “Future of Health Care Summit” on Wednesday, starting at 9 a.m. Panelists will discuss health care access, affordability, and value of care. Click here to learn more. We hope to see you there!



Patrick O’Connor – Executive Director

Rosemarie Calabro Tully – Communications Director




The Alliance to Protect Medical Innovation was featured this week in POLITICO’s “Prescription Pulse.” Regarding the Senate’s Lower Health Care Costs Act of 2019, our Executive Director Patrick O’Connor said while the legislation’s efforts to rein in pharmacy benefit managers are helpful, a provision to establish a nongovernmental review board that “sounds an awful lot like the Institute for Economic and Clinical Review,” the nonprofit cost-effectiveness group criticized by patient groups. (Continuing reading for APMI’s recent blog post on ICER.)



“The #LifeSciences sector employs 5 million workers; ~22% are researchers trying to develop drugs. Many ... spend their entire lives dedicated to research and still don’t have payoff. This industry is fundamentally about #innovation.” -@sjezell #ITIFdrugpricing Click here to RT.

“#Drugspending in the US, Canada, and Europe together in the next decade will be less than 10% of [total] healthcare spending. We all want reduced prices, but ... #DrugPrices are [not] what’s taking down the healthcare system.” -@AndrewRSpiegel #ITIFdrugpricing Click here to RT.

“Research shows on average, the biotech [industry] invests $100 per every $1 from the public sector.” - @sjezell at #ITIFdrugpricing briefing on Capitol Hill #innovation #biotechnology #healthcare Click here to RT.



“Maybe It’s Worth It” – Why Does An Insurance-Funded Group Get To Decide? In a Boston Globe article this week, the Institute for Clinical and Economic Review (ICER) concedes the price set for Zolgensma “might be worth it.” But why does this health insurance company-funded organization get to decide, and, if they do, what will it mean for children, disabled Americans and the elderly? We explore. Read the full blog post here.

The Risks Of Importation. A handful of states, including Maine and Florida are considering or have considered legislation to allow drug importation from other countries. This idea has been attempted, and has failed, when implemented in cities and states across the nation, and it is a threat to the safety of the entire U.S. drug supply. Read the full blog post here.


In case you missed them, here are some other recent posts on the APMI blog:

Incremental Or Secondary – It’s Incredibly Valuable. Lawmakers in the U.S. Senate reportedly are (wisely) rewriting a bill concerning drug patents. Click here to dismantle some of the common myths surrounding this issue.

What Is A PBM? New York state passed a bill to rein in pharmacy benefit managers, but what are these entities anyway? Click here to learn.

A Look At Recent Polling. What do Americans really want when it comes to health care and drug pricing? Click here to read what recent polls indicate.



American Consumer Institute: Price Controls Would Hurt Patients. The American Consumer Institute Center for Citizen Research (ACI) released a white paper this week called, “How International Reference Pricing for Prescription Drugs Would Hurt American Consumers.” Steve Pociask, President of ACI and co-author of the paper, said “Proposals to peg U.S. drug prices to an international benchmark may seem sensible on the surface, but our research reveals that these price controls carry heavy costs.”

Patient Groups: ICER Cost-Benefit Analysis Model Could Restrict Access, Result In Discrimination. As POLITICO reported last Friday, a coalition of 38 patient and disability groups has written to the Arnold-funded Institute for Clinical Economic Review asking it to change its cost-effectiveness analyses. The letter alleged ICER’s method for assessing value could fuel restricted access and discrimination.

Cost-Benefit Analyses Used To Deny Care To Britons. In an op-ed in USA Today, Mary Vought, who has a daughter living with cystic fibrosis explains how Britain uses cost-benefit analysis to deny access to a drug that could help improve her daughter’s life. Vought notes, “The denials come not because the treatment does not work; the European Medicines Agency approved Orkambi in November 2015. And in the United States, where the drug is available, those suffering from this ailment have seen improvements in lung function and a decrease in dangerous lung infections. Instead, Britain’s National Institute for Health and Clinical Excellence — which goes by the Orwellian name of NICE — has denied patients access to this treatment on cost grounds alone.”

Without Patents And Strong IP Protections, There Would Be Less Innovation. Former Food and Drug Administration commissioner Peter Pitts explains in the Jamestown, N.Y., Post-Journal why a strong patent and intellectual property system are important to drug innovation. Pitts says, “America’s IP protections encourage investors to fund medical research despite the risks. Investment in the U.S. biopharmaceutical industry hit more than $70 billion in 2017. Nearly 4,000 new medicines are currently being developed in the United States, including 1,100 that will treat cancer,” but notes “not every country values IP. Many nations arbitrarily cap what they’re willing to pay companies for prescription drugs. Meanwhile, developing nations tend to disregard U.S. patents to save a few bucks on domestically produced knock-off drugs.”

New York Passes Tough Law To Rein In Pharmacy Benefit Managers. According to POLITICO Pro (subscription required), New York state has passed the “nation’s toughest law” regarding pharmacy benefit managers (PBMs). The bill, which was passed unanimously and is now headed to the governor’s desk, would require PBMs to pass on to patients any rebates received from drug manufacturers.



At Forbes, Standish Fleming, founding managing member of Forward Ventures, describes how government intervention into the drug market will affect innovation:

“Even modest price controls could produce a catastrophic drop in innovation. To make an investment, a manager in venture or pharma must calculate the potential returns; to do that, he estimates future sales. Though the analysis can get quite complex, the methodology is simple: market size multiplied by expected price. In the current market-driven system, prices are related to the value of the drug, measured in quality-of-life and avoided treatment costs. If, instead of value, commissions set prices according to affordability, early-stage investors would have no way of estimating returns. In trying to guess what commissions 10-15 years in the future might do, bio-pharma investors would have to take political risk on top of technical and business risk, something that few are equipped to do.”


Alnylam CEO John Maraganore in FierceBiotech discusses how all entities within the pharmaceutical supply chain can work together to ensure Americans have access to, and can afford, the treatments they need:

“When you put it all together and think about the patient impact of a drug like Zolgensma, ... this is what insurers, government, and healthcare are meant to do. To have a system that can reward innovation as it needs to be rewarded while making sure we have no economic burden on patients and their families. … And the rest of us paying premiums or tax dollars to commercial insurers or governments are going to do what we have to do as members of society to secure our own protection and the protection of others when catastrophes occur.”



June 26, 9 a.m.: The Hill

Location: Long View Gallery, 1234 9th Street, NW, Washington, D.C.

Topic: Future of Health Care Summit

Agenda: Medical breakthroughs and innovative therapies are transforming America's healthcare system, creating new opportunities. Yet, issues related to access, affordability and the value of care continue to be top of mind for patients. How are leaders in the industry working to ensure that the patient is at the center of innovation and what role can public and private sector collaboration play in reaching this goal?