As we prepare to turn the proverbial page on 2018, we reflected on how this newsletter should close one of the most dynamic (and sometimes fraught) years in recent healthcare history. After much deliberation, we netted out with a healthcare yearbook. A yearbook has one foot in the past, even as it raises one hopeful step toward the future. It memorializes accomplishments and catalogs the hopes of where we’ll go.

In this edition of The Year That Was, we capture the trends that shaped the industry in 2018 and our predictions for the New Year. Oh, and check out our superlative “Most Likely To…” nominees. You’ll need to read to see who made the short list! 

  1. Year of the woman. As the #MeToo movement hit headlines, study after study revealed concerning trends about women’s health being overlooked or under-addressed. But hope may be on the horizon: more therapies are approved or in development to treat gender-specific conditions.
  2. Nothing’s protected. Have public views on drug pricing become so extreme that certain classes of medicines risk losing protected status? CMS says maybe so.
  3. Privacy for the people. Riddled with leaks, privacy issues and allegations of “black ops” PR tactics, Facebook flunked ethics class. But healthcare companies should take note: between GDPR and the rapid move toward digital health, protecting patient privacy is key to making the grade.
  4. Stakeholders hail for sunshine. It’s been ten years since the Sunshine Act was passed, but physicians, advocates, drug makers and publishers found themselves on the wrong side of Congressional and media scrutiny for lacking transparent disclosure of monetary relationships. Advocate / pharma relationships are the next wave of scrutiny.
  5. Populism meets policy. Taking action on drug pricing polled well on the right and the left, so it’s no surprise politicians had a lot to say about the costs of medicines. But 2018 may have been a warm-up act. Get ready for new Committee heads and hearings on the affordability of drugs in 2019.


Read on for more details, superlatives and winter break reading lists…


►HEAD OF THE CLASS: TAKING ON HEALTHCARE BIAS  

2018—the “Year of the Woman”—brought gender issues, including those in healthcare, to the forefront. Headlines frequently focused on the Health Gap: the fact that women are less likely than men to be taken seriously when it comes to their health needs. Stories and studies reported the medical establishment’s historical dismissal of women’s health conditions and descriptions of pain. Stories noting the persistent phenomena of “medical gaslighting” included how women’s heart problems often are attributed to panic attacks, endometriosis symptoms ascribed to infections, and pain blamed on hysteria (a word whose etymology involves the phrase “suffering in the uterus”). 

It’s not a surprise, therefore, that healthcare was the top issue among women voters this year. Along with voting patterns catalyzed by healthcare, women are enrolling in med school in greater numbers than ever, helping to shape a female future for healthcare—with meaningful results. Women are more likely to survive a heart attack when treated by a female physician, likely owing to recognition of symptoms that are common in women. These results are echoed in other studies showing improved health outcomes among all patients (male or female) treated by female doctors, suggesting that female communication and listening habits may also play a role.


►MOST LIKELY TO CHALLENGE THE ESTABLISHMENT

Heading into 2019, we already see some movement toward inclusion. Recently released research shows more scientists are using female cells and female animals in preclinical studies. However, this progress isn’t reflected throughout the drug development pipeline: pregnant women are often excluded from clinical trials, and NGOs and governments use the absence of trial data related to pregnant women to recommend against their inoculation, including vaccinating against Ebola. But a number of bioethics experts are calling for a change, and the FDA has indicated some agreement in draft guidance addressing pregnancy-specific research. In another attempt to fill in knowledge gaps, Congress has just passed a bill to tackle the maternal mortality crisis in the United States by funding state-level committees that will investigate all maternal deaths to understand the causes and devise solutions. As the midterm elections welcomed the most racially diverse, most female Congressional freshman class ever, we anticipate the incoming class to shine even more light on issues that affect subsets of women, including a focus on pregnancy and on racial disparities in healthcare.


This year-end focus on maternal mortality is especially relevant to intersectionality, as black women are three to four times as likely to die from pregnancy-related causes as white women. Black women are also twice as likely to be diagnosed with uterine cancer and more likely to die from the disease, and physicians routinely undertreat their pain. For African Americans, as for pregnant women of all races and ethnicities, their inclusion in clinical trials falls short, particularly in trials for the revolutionary cancer drugs that have come to market in recent years. Even when a disease is far more prevalent in black patients—like multiple myeloma—black patients are underrepresented in clinical drug trials for these diseases. As more of these health disparities come to light, we hope—and expect—greater efforts for inclusion by the healthcare community.

YOUR 2018 READING LIST: 


►WILL THE PROTECTED CLASS GRADUATE?  

Since releasing the Blueprint to Lower Drug Prices in May, the Trump Administration has been full steam ahead on its agenda to lower drug costs and reduce patient out-of-pocket expenses. Often taking a back seat to Commissioner Gottlieb and the FDA’s many, many proposals and guidances this year, the Centers for Medicare and Medicaid (CMS) released its own proposal last month to allow for more negotiation for drug discounts in the six “protected” class categories in Medicare Part D: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics. Currently, health plans are required to include all drugs in these protected classes on formulary; for all other therapeutic categories, plans are only required to cover a minimum of two drugs. CMS said that its proposed rule would allow Part D plans to exclude drugs from formularies in the "protected" classes if their price increase is greater than inflation, or if CMS determines a new drug formulation isn’t a “significant innovation over the original product.” It also would allow “broader use” of step therapy and prior authorization—policies currently not in place for the protected classes. In a conference call with reporters, CMS Administrator Seema Verma said the proposed “flexibilities could save the government $1.85 billion and save Medicare enrollees $692 million in cost sharing over the next decade.”


►MOST LIKELY TO SUCCEED IN CONGRESS

Backlash was fast and furious. Groups from Mental Health America to the Medicare Rights Center and the American Cancer Society questioned the savings—nothing that the proposal could ultimately shift more costs more to patients as a result of access barriers. It’s not the first time advocates rallied around these classes—thwarting the Obama Administration’s attempts to reduce protections in 2014. Expect more agitation from advocacy and stakeholder groups through January when the comment period closes. However, of the proposals coming from CMS this year (DTC price disclosures and international reference pricing), we predict that this one gets the most traction on the Hill next year as the divided Congress finds common ground on drug pricing initiatives.
Drugs in these classes have two tremendous assets to help preserve patient access: highly engaged stakeholder groups and health economics. Research shows that moving stable patients off successful treatments—particularly for mental health conditions—will likely cost the system in more ER and office visits and additional pressures on social programs and services. Manufacturers with medicines in these categories should call on their HEOR teams to help weave these data into value narratives for meetings with advocates and partners, KOLs and on the Hill. When battling bureaucratic budgeting proposals, the best arguments have hard numbers behind them.

YOUR 2018 READING LIST: 


►FACEBOOK LANDS IN DETENTION...AGAIN 

 Facebook most definitely didn’t make Honor Roll this year. CEO Mark Zuckerberg got called to the principal’s office aka Congress when he had to testify about Facebook’s role in the 2016 election, and their ties to Cambridge Analytica. 

Unfortunately for Zuck, that was just the beginning of a downward spiral. In November, the New York Times revealed that Facebook knew about many of these issues earlier than they let on and how to handle it created a great deal of discord among FB leadership. Then in December, another report found that Facebook had been sharing more user data with certain advertiser-partners. And a new story is still developing about a Photo API bug that accidentally exposed millions of users’ unposted photos. Whoops.

Truth be told, it’s pretty tough to sum up The Year That Was for Facebook. But perhaps a quick look at where they are now might help:

  • Recent reporting featured a number of ex-Facebook employees, who are being contacted by current Facebook employees at unprecedented rates, as they search for new jobs.
  • Lean In (the organization) is now apparently trying to “distance itself” from founder and Facebook COO Sheryl Sandberg.
  • Some have speculated as to whether or not Mark Zuckerberg should step down at CEO of Facebook. Interestingly, a recent Morning Consult study found that a CEO stepping down after a privacy crisis may be an appealing outcome to consumers. But there seems to be no hint of Zuckerberg walking away anytime soon. Take his SNL-character’s word for it. When asked about stepping down earlier this year, he quipped: “No way homie, because according to our data sets, I don’t have to.”


►MOST LIKELY TO GET UNFRIENDED

Facebook is perhaps the year’s most topical, cautionary tale for corporate America—showing that there is such a thing as too many apologies. At a certain point, a lack of action and meaningful change discredits any creative messaging that seeks to achieve transparency, particularly when it comes to issues around privacy and data collection. While data-collection is becoming the new norm – and a critical necessity for surviving in a transparent market – the practice puts companies at a huge risk for consumer concerns and even activist targeting.

In 2019 we can expect this trend to come closer to home, especially for healthcare companies with privacy and security protocols that leave something to be desired. Also at risk are companies collecting sensitive health information. Given the already sub-par trust ranking of our industry, healthcare companies must avoid a transparency “scandal.” Our advice? Over-communicate with all your users as to what your policies are and translate into terms that the average person can understand.


YOUR 2018 READING LIST: 


►COMMENCEMENT ADDRESS: STAKEHOLDER TRANSPARENCY REIGNS  

Make no mistake, scrutiny of the relationship between third-party influencers and pharmacos intensified in 2018. In the news, we heard calls and saw tangible action for greater transparency and more comprehensive disclosure policies. Notable highlights include:

  • Outgoing Missouri Democrat Claire McCaskill criticized the relationship between industry and advocates, introducing the Patient Advocacy Transparency Act. Losing her re-election bid, McCaskill leaves the bill without co-sponsors to pick up the mantle in 2019.
  • The Laura and John Arnold Foundation worked with Kaiser Health News to create Pre$cription for Power, a database tracking charitable giving reports on pharmaco websites and federal 990 regulatory filings to advocacy groups.
  • Memorial Sloan Kettering’s Chief Medical Officer resigned this year following reports that he did not disclose millions in financial associations with at least a dozen drug companies in notable journals.
  • Transparency has been such a major theme this year that you won't be surprised to read it is also a key component of another major 2018 trend: working with “microinfluencers,” those with small, loyal follower counts, who are highly-trusted in their niche markets. For years we’ve heard about “influencer” engagement – getting people with large social media followings to talk about your brand. But what more healthcare companies are realizing is that bigger doesn’t necessarily mean better. Around Thanksgiving, STAT covered this growing trend in a piece that quoted the CEO of Wego Health, which represents microinfluencers and helps facilitate introductions with interested collaborators.

                                     


►MOST LIKELY TO MAKE AN ENCORE
As a holiday gift, we asked our friends in the Syneos Health Digital and Social Strategy (DSS) Practice share some pointers for approaching influencer, advocacy, professional society, and KOL communications in 2019: 

  1. Be transparent about the relationship! When working with influencers who are posting content online and in social media channels, be certain they include written disclosure of their relationship to the pharmaco in every post.  Facebook and Instagram (owned by Facebook) offer a “branded content tool” that lets users easily tag a pharmaco’s Facebook or Instagram page, making the relationship abundantly clear. On other platforms they can use an #ad or #sponsored hashtag.
  2. Emphasize the “relation” in influencer relations: Pharmacos can look impersonal from the outside. But if you offer the influencer some transparency into who you are and what your company stands for (i.e., you actually get to know each other), you can form the foundation of a trusting relationship.
  3. Be prepared to respond: Every good influencer relations campaign must be equipped with a monitoring and response plan – this should apply to activities both online and off. Company execs should be ready to respond (transparently!) to questions about funding and tie the response back to its value and mission statements.


YOUR 2018 READING LIST: 


►WILLS & PROPHECIES: 2018 RHETORIC TURNS INTO 2019 ACTION   

Despite heated rhetoric for the last three years, legislative and administrative changes impacting drug prices have been modest. Policymakers are promising that next year will be different, and we’re tracking how changes may affect every part of the life sciences industry:

  • The return of the medical device tax, which needs to be suspended or repealed next year or it will automatically go live in 2020. That’s in addition to the impact by tariffs on foreign goods.
  • Makers of office-administered drugs may be subject to the Administration’s proposed International Pricing Index. The rule, which is expected to be formally introduced in the spring, would benchmark Medicare payments to an average of other advanced economies. If the Administration sticks to its timeline, the rule would be enacted by the end of 2019.
  • Several Senate Democrats want to take the concept further, and apply a similar model to all drugs.
  • The FDA will continue to make rules and issue guidance aimed at making generic and biosimilar medicines more readily available. And they won’t be shy about publicly shaming branded companies seen as erecting needless barriers to the entrance of cheaper alternatives.

Oh, and some version of Medicare for all could pass the House next year.
Will this be the year that reinvents the American healthcare system? Eh, we’re not holding our breath. But with public opinion so strongly anti-industry, and a White House and at least one house of Congress determined to take action on drug prices, we expect a ton of debate, with at least some policy and regulatory action in the coming year.


►MOST UNDERRATED CHANGE IN WASHINGTON
The industry has rightfully focused on the change in control of the House of Representatives, and the need for POTUS to show results in the second half of his term. But changes in the Senate are also meaningful –specifically the replacement of Senator Orrin Hatch with Senator Chuck Grassley as Chair of the Finance Committee. Grassley has been a reliable critic of drug pricing, and will have a larger voice on key policies.
So, what’s a life science company to do? Here are the traits that separate the best: 

  • Ask yourself whether you standout. Taken larger price increases recently, even if it’s to pay rebates? Become a bigger share of the federal budget or a state’s? Start building the narrative for the societal value you deliver soon. Because there’s a high likelihood you’ll find yourself in at least one set of policymaker talking points.
  • Align with advocates. Advocacy organizations have been criticized by pricing hawks for not being aggressive enough in calling for lower prices. If patient groups you work with on other issues don’t understand your approach to pricing, be proactive in fixing that.
  • Update your monitoring protocols. Patients struggling to pay for medicines are finding new niche forums to discuss their challenges – often anonymously. Are you sure that you’re looking for emerging issues in all the right places?


YOUR 2018 READING LIST: 

 

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We’ll be on hiatus until January 7. But don’t worry—we’ll be tracking politics, policy and pricing over the break so we can all hit the ground running in 2019. Happy holidays and thanks for reading

 

Who Are We, Anyway?

Syneos Health Communications' Reputation & Risk Management Practiceis a team of healthcare communications consultants, policy-shapers and crisis response specialists. Drawing on our professional experiences from Congress, CMS, HHS, hospitals, health technology and biopharmaceuticals—we provide unique solutions to the evolving communications challenges in today’s healthcare industry. We support trade associations, biopharmaceutical and consumer goods companies’ in evidence-based approaches to successfully navigate the most sensitive of situations facing their industries. In our spare time, we drink too much coffee, geek out on healthcare news, and obsess over Sunday morning political TV.    

About the Author:

We are a team of healthcare communicators, policy-shapers and crisis response specialists. Drawing upon professional experiences from Congress, CMS, HHS, hospitals, and health technology—and our collective work in rare disease, oncology, diabetes, gene therapy, pain management and infectious disease—we provide unique solutions to the evolving messaging challenges in today’s healthcare industry. We support our clients with evidence-based approaches to preventing pricing pushback, protecting brands from modern activism, establishing and communicating clear policies surrounding expanded access to medicines, and a proactive approach to value frameworks. Our offerings also include product safety, litigation, regulatory risks, ex-U.S. considerations and policymaker investigations.