Engage in Good Thoughts, Good Words, and Good Deeds

APRIL 17, 2019
Troy Trygstad, PharmD, PhD, MBA, Pharmacy Times Editor in Chief
I recently traveled to Las Vegas to speak at the annual MHA business summit, which required a 5-hour flight—with no internet access.
I am not sure how those of us who travel for work got along before in-flight Wi-Fi, but I survived nonetheless. After contemplating whether to ask Delta for a refund, I browsed through the in-flight movies, which, given the recency of those awards, featured several Oscar nominees.

I decided on Bohemian Rhapsody, a biopic about the band Queen and the life of its lead singer Freddy Mercury. It is a pretty good movie that ends in a reenactment of what is widely considered the best live musical performance in modern history: 1985’s Live Aid at London’s Wembley Stadium. As the movie ended, it occurred to me that I had read an article fewer than 8 hours earlier declaring the second person in human history had achieved sustained HIV remission after being infected.

Freddie Mercury died in 1991 of the type of pneumonia that is a common complication from HIV infection and progression. It appears that we are nearing the final breakthroughs in a more than 3-decades-long progression of biopharmaceutical and medical advancements in treating HIV.

“CURE” IS A POWERFUL WORD
It is hard to avoid thinking about what might have been with Farrokh Bulsara, Freddie Mercury’s real name, had a cure been available in the early 1980s, which is when most of us first learned of the horrors of AIDS and HIV, both medical and through derived social stigma. Would anthem rock still be alive had Freddie been cured? What sort of pain and suffering among millions would have been avoided? Those who are infected are no longer ostracized and outcast, but in the 1980s and 1990s, some people neglected and even spurned the afflicted. But as Freddie’s father said in the movie, “Good thoughts, good words, and good deeds,” a reference to one of the core Zoroaster religious maxims, which reinforces the idea of doing the right thing, and worldly rewards will follow.

CURES DO MORE THAN END DISEASE
Imagine a world without blindness, diabetes, paraplegia, or psychotic episodes. There are more than 3000 gene therapies in the development pipeline. We are now directing our own cells to attack cancer. Imagine no Alzheimer disease or autism, less pain and suffering, and hundreds of billions of dollars of increased productivity. It is coming soon, but with a really big price tag.

DEATH THROUGH INABILITY TO PAY IS JUST AS POWERFUL
There is a lot of finger pointing, and every time somebody is invited to Capitol Hill, that is on display. On February 26, the House called in executives of biopharmaceutical companies and lambasted them for rising drug prices. The manufacturers pointed to rebates that come through the spreadsheet analysts who create (ironically) drug pricing spreads. That leads to pharmacy benefit managers pointing at manufacturers for their huge market influence. That results in legislators leaning toward blunt legislative instruments, such as reimportation or prices based on committee proceedings in big concrete buildings, which leads to increases in development and regulatory costs.

Meanwhile, the future of pharmacy is left in the lurch, because everyone lumps pharmacists into the cost of everything, from getting raw materials to patient administration, without any regard for the need for services that ensure that curative agents actually produce the intended result and not conflicting therapies, partially completed courses of therapy, or wasted physician visits.

WHAT IS THE WAY FORWARD?
Our policymakers need to get out of the conventional financing mindset. With continued, increasing rates of generic drug use and higher and higher concentrations of specialty products consuming the whole of the pharmacy dollar, the existing model will become outdated. We can avoid cliff conversions and radical change if we are planning for the future and being clear-eyed about the reality of what is ahead. The prevalence of chronic diseases is growing, not shrinking. Innovative medications must continue to be developed, not stifled. Cures greater than $1 million per person will come to the marketplace, in droves, at the same time that our national debt is likely to start choking our ability to insure ourselves as a country against storms, economic events, and other catastrophic events, let alone the costs associated with fantastical advances in medicine.

WE NEED INNOVATIVE THINKING
Fee for service is dying. Fee for product should be, too. Accountability, at-risk contracting, performance, and skin in the game are here to stay.

Examples of innovation or alternative value-based arrangements might include the following:
•Carve outs and insurance captives. For chronic diseases, where the need for a product is maintained over many years, the value proposition is delay of disease progression or reductions of costs and reinfection over many years. Because our system of insurance and public payer funding, such as Medicaid, typically cycles on annually, it is difficult for manufacturers to express the value of a drug over time. By creating insurance “captives,” or arrangements, with specific patients with conditions such as diabetes, manufacturers may be able to carve out taking a particular portion of the risk of the whole and separating it out from the traditional system of insurance, particularly with government payers and employers where the governmental entity or sponsor will carry that risk for most of the patients, regardless of insurer. That creates a direct relationship between the government or sponsor and the manufacturer.

• Colicensing and distribution agreements with govern- ments and sponsors. Hepatitis C is the best example of a disease in desperate need of big thinking and big pools of dollars for up-front investments that pay dividends over many years and decades. There are about 3.5 million Americans living with hepatitis C, with about half unaware that they have it, according to the CDC.1 The way we cover and finance medications is at absolute odds with the economic and humanistic benefits of these treatments. Much like vaccinations, we should be taking a “treat everyone and eradicate the disease” and “community-level immunity/treatment” approach. That requires pooling resources and contracting with manufacturers. Why don’t employers, foundations, and government spend a few hundred billion dollars for an unlimited supply of treat- ment that costs nickels incrementally to produce but results in trillions of dollars in economic savings and productivity across future decades?

• Outcomes-based reimbursement. Amgen’s arrangement with Harvard Pilgrim in 2017 for reimbursing the plan if a member had a heart attack was the first major splash in this area. Since that time, the number of these types of arrange- ments have grown. According to a webinar last May,2 68% of partner/payer/sponsor leadership would entertain an outcome or value-based relationship with a manufacturer and nearly a third already had some experience with these types of arrangements.

REFERENCES
1. Hepatitis C kills more Americans than any other infectious disease [news release]. Atlanta, GA: CDC; May 4, 2016. cdc.gov/media/releases/2016/p0504-hepc-mortality. html. Accessed March 23, 2019.
2. Drummond M, Sampsel E, Kenney JT, Rice T. Devising outcomes-based contracts. Is the devil in the details? Academy of Managed Care Pharmacy website. amcp.org/ WorkArea/DownloadAsset.aspx?id=23443. Published May 2, 2018. Accessed March 22, 2019.

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