While we eat the leftover Halloween candy (that’s why we get the Reese’s), the team at TWTW is getting amped up for our next big event of the season: the midterm elections. We’ve studied the ballots, analyzed the commercials and even pondered if Beto singing a duet with Willie is the Clinton sax solo for millennials (Beto wisely avoided donning “cool guy” shades—so 90s).
There’s a lot to consider when watching the returns. But we’ll get to that a little later. First, let’s check out some newsy nuggets, including pharma’s pivot back to “normal” pricing and how pills get their colors (hint: it’s more complicated than asking Sherwin-Williams). Welcome to The Week That Was:
- Business as usual: Following much presidential fanfare around its decision to freeze prices in July, outgoing Pfizer CEO Ian Reade expects the company to return to “business as normal” for 2019—meaning traditional price increases are back on the table. While the President has yet to react, the move suggests that pharma may no longer fear the Trump tweet—indeed independent research by the Syneos RRM team shows that a POTUS tweet no longer moves the stock price of large companies for more than a few hours.
- From the club to the clinic: Ketamine, an animal anesthetic and street party drug, is finding a new role in treating depression, off-label for now. Clinics specializing in ketamine therapy are popping up around the country, with patients paying around $500/treatment out-of-pocket. While traditional antidepressants can take weeks to kick in, the relief from ketamine is immediate—sparking concern about overuse. Pharma is working to “harness the high,” with both Janssen and Allergan currently developing ketamine-like drugs for depression. Time will tell if these treatments fare better than Alkermes’ investigational opioid-based major depressive disorder drug. An FDA Advisory Board last week voted against ALKS 5461, citing a lack of efficacy data.
- Pharma Pantone: Is purple the color of heartburn relief? There’s complex psychology—and big business—behind pill color, which, along with the drug’s logo, is often determined years before launch based on robust consumer insights. Research, though limited, shows patients are more likely to take a pill when it suggests the desired effect: warm colors are stimulating, blue colors are calming. “What about that little blue pill?” you might ask. Viagra was originally studied for use in hypertension by relaxing blood vessel walls, which can explain the blue color despite the less-than-tranquil effect. Sildenafil, the active ingredient in Viagra, is now used to treat pulmonary arterial hypertension under the name Revatio.
►OPEN ENROLLMENT: FEWER MANDATES COULD MEAN HIGHER COSTS FOR PATIENTS
Although cries for “repeal and replace” have subsided (for now), the Trump Administration has enacted a number of changes to Obamacare that will impact Open Enrollment for 2019. Notably, the individual mandates are gone, and a new rule that took effect October 1 will increase the availability of short-term, 12-month health insurance plans that offer fewer services and can deny those with pre-existing conditions. Moreover, people can opt into these plans year-round, not just during the Open Enrollment period. And while premiums are lower across the board, the federal premium assistance for more comprehensive gold-level plans will be eliminated. In the end, analysts predict Obamacare enrollment to remain flat year over year.
These changes may appeal to younger and healthier people, who can select a cheaper plan with fewer benefits or forgo coverage altogether. Given that insurance is based on pooling risk, premiums for patients with greater health needs will likely spike, as folks in better health downgrade their coverage. A shift to less generous coverage with more patient out-of-pockets could tax the limits of patient assistance programs and lead to adherence challenges for people who may struggle to cover their share of costs. Pharmacos need to closely follow coverage trends to better understand which populations may be going without—and communicate thoroughly to ensure that patients understand coverage and eligibility under these new policies.
►HUMIRA DROPS PRICE IN EU, AS US BIOSIM COMPETITION LURKS AHEAD
AbbVie announced late this past week that it will lower the price of its blockbuster drug, Humira by 80 percent in European markets to compete with approved biosimilars in the region. That’s great for folks across the pond, but what does that mean for Americans? Not much—at least, not yet. Although the FDA just greenlit Sandoz’s Hyrimoz, the third Humira copycat to be approved in the U.S., Americans will not benefit until at least 2023 when AbbVie patents expire in the U.S.
The news, which comes just days after President Trump announced plans to end “global freeloading,” will effectively increase the disparity between U.S. and ex-U.S. pricing for the biggest-selling drug in the world. Along with recent comments about its strategy to prolong Humira’s patent protection, the price drop could make AbbVie the next target for Twitter infamy. While fellow pharmacos are expressing skepticism about the President’s plan to tie certain Medicare drug prices to an international average, Democrats have already set their agenda to crack down on the industry, should they take the House this week, and Humira might be the common ground they need to start moving the agenda...
► MIDTERM MANIA: WHAT WE'RE WATCHING ON TUESDAY
Once or twice, we’ve mentioned that the TWTW team likes politics (okay, we may have called ourselves “Sunday morning political news junkies”). During election season, we’re like E! News at the Oscars. And like the vast majority of Americans, we’re wondering what the midterms will mean to healthcare. Here are some of the things we’ll be thinking about as we watch the returns on Tuesday:
Medicaid is on the ballot in a big way: What do Georgia, Florida, Kansas, Oklahoma, South Dakota and Wisconsin have in common? These Republican-led states have opted not to expand Medicaid, despite federal funding to do so —and now all six states have competitive gubernatorial races. Several of these states, in addition to Arizona, Michigan, and Ohio, are also considering work requirements (and, in the case of Wisconsin, drug testing) for Medicaid beneficiaries as well—making the governor’s race a key predictor of the future of Medicaid policy. Additionally, Idaho, Nebraska and Utah have Medicaid expansions on the ballot—putting the decision directly in the hands of voters.
Committee chairs—and priorities—could turn over: If Democrats do take back control of the House, key committee chairmanships will change, and so will policy priorities. New York Democrat Nita Lowey, who is poised to become the first-ever female chair of the Appropriations Committee, historically has rejected cuts to social services, and favors federal investments in NIH research. New Jersey’s Frank Pallone, who was closely involved in crafting the Affordable Care Act, likely would take over Energy and Commerce. Notably Pallone has been vocal about lowering drug prices, despite hailing from a pharma-heavy state. Marylander Elijah Cummings—long in favor of more checks on the pharma industry—would take over Oversight and Government Reform. And Massachusetts Dem Richie Neal, who has lobbied hard against corporate inversions, would step into the top spot on Ways and Means.
Pre-existing conditions will continue to be a flashpoint: While “Repeal and Replace” was the battle cry of much of the past two years, pre-existing conditions have taken center stage in Congressional races. The POTUS has been traveling the country stumping for GOP candidates (and his own 2020 bid) on a promise of protections for patients with pre-existing conditions. At the same time, the Trump Administration is backing a lawsuit claiming the protections are unconstitutional. Beyond midterm talking points, pre-existing conditions are prevalent in Americans’ lives: Kaiser Family Foundation estimated that more than 25 percent of adults under age 65 have a condition that would prevent them from accessing individual health coverage under pre-ACA rules. As more and better genetic tests come online—and as the popularity of services like 23andme grow—the more likely people are to get flagged long before they may have symptoms or require treatment. If science and policy continue to diverge on this issue, we expect this to become a sticking point in 2020.
We’ll leave you with wise words from famed suffragist Susan B. Anthony: “Someone struggled for your right to vote. Use it.”