State of the nation

Comparative effectiveness
The addition of new patients to the healthcare reimbursement system will be beneficial financially to some segments of the pharma industry. Many prescriptions are not filled or refilled because of a lack of insurance. With reimbursement more widely available, there should be increased sales, with a built-in bias for less expensive products. Hopefully, however, even as cost containment becomes more of a national priority, the incentives and demand for breakthrough new products will remain.

With the government, either federal or state, paying still more of the national healthcare bill, it will seek every avenue available to contain costs. Some form of price control or price negotiations on government-reimbursed pharmaceuticals may be inevitable. This is something the research-based segment of the industry has been able to avoid thus far. The healthcare reform bill may prove to be the proverbial writing on the wall.

One section of the new law pharma needs to focus on for the long term is the provision for comparative effectiveness trials. Comparing the effectiveness of treatments and of specific products and regimens could prove to be substantially more challenging than simply demonstrating safety and efficacy for an individual product – though the latter is by no means simple. Soon, companies will need to demonstrate not just safety and efficacy, but also superiority to existing drugs in order to establish a market foothold. How long will it be before the FDA seeks superiority data rather than just safety and efficacy data? Some say the FDA already is leaning in that direction and that healthcare reform will just accelerate adoption of a new approval standard.

More important to the marketplace is how comparative effectiveness data will be used. If it is used to deny general access to treatments found less effective in a comparative effectiveness trial, the outcome could be one-size-fits-all medical care, including the use of prescription drugs. Patients for whom a particular drug is the best choice may be denied access if data shows it to have inferior outcomes in a majority of patients.

Using comparative effectiveness data as a vehicle for cost savings and limiting prescribing options is a real threat, even though the government has said that won’t happen.

It remains to be seen how the comparative effectiveness provision is implemented, but I suspect we will be discussing comparative effectiveness trials for many years to come, and that the debate about how to design valid trials and how to use the data has barely begun.
Wayne L Pines , president, regulatory services and healthcare, APCO Worldwide

We have to embrace innovative technologies for medical records and prescribing. We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less than the current $1bn plus delivery charge. We need innovation in access and reimbursement policies that rewards speed-to-best-treatment rather than more lower-cost patients per hour.

Woody Allen said that we should always expect change – except from vending machines. But a more germane thought comes from W Edwards Deming who said that: “Change is not required. Survival is not mandatory.” We’d better start taking innovation – both incremental and discontinuous – seriously. That means spending more on harder developmental R&D (with concomitant higher investment risks). In this regard, the new legislative language on the development of biosimilars, is a good thing. Twelve years of patent exclusivity both protects investment and incentivizes innovation.

The law pays lip service to robust comparative effectiveness research – although this is a battle yet to be either defined (comparative effectiveness or cost effectiveness or clinical effectiveness?) or fought (do we need a US version of NICE?). And a battle royal it will be. L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. As Winston Churchill said: “Americans always want to do the right thing – after they have tried everything else.”

Cui bono? Congress has given the healthcare industry as many as 32 million additional paying customers in the next few years. That means millions more Americans buying private health insurance and better able to pay for their hospital stays, doctors’ visits, prescription drugs and medical devices.

A windfall for big pharma? Perhaps. But let’s not focus on commercial winners and losers. Let’s keep our eye on the prize – creating a chronic healthcare culture that embraces prevention and prophylactic care. We will not survive as a nation of obese, hypertensive diabetics. Rather than wasting time on spin, let’s redouble our efforts on innovation. When we succeed through brainpower and teamwork, the circus surrounding the past year’s partisan political warfare will be but a footnote in American political history.
Peter Pitts, partner and director, Global Health, Porter Novelli

We can all play a role
It’s going to take quite a while for non-profits, foundations, associations and corporate clients to understand the real effects of health reform.  Virtually all of our clients’ platforms have been touched in some fashion by the legislation, and now the question is how the healthcare reform implementation process will unfold and what changes will be directly felt by their constituencies.

Our clients’ issues range from covering the uninsured, to the role of nurses amid a shortage of healthcare workers, to advocating an integrative medicine model, to implementing electronic health records to ensure co-ordinated care. The diverse organizations and companies that champion these critical issues have contributed enormously during the debates over where health and healthcare should go in this country, and will no doubt be equally involved in the implementation stages.  

The influential thought leaders we represent have taken part in these discussions as stakeholders, as well as strategists, and it is our job to ensure that the important health-related work that our clients are engaged in is properly understood while decisions are being made.

No doubt this dramatic shift will have implications for every single one of us, as patients, providers, as communities and companies, as a society. We all can play a role as catalyst, collaborator, change agent to realize a shared vision of a reformed and better performing healthcare system for the health of our nation.  

Looking ahead, we will have to ensure that our work is done through the lens of this emerging new system and that the very language we use resonates with providers, thought leaders, elected officials and the public – all of whom will be listening and watching with different expectations than they have ever had before. 
Pattie Yu, partner, GYMR Public Relations

The need for education
While dust is still settling from the current healthcare reform, there is a universal uncertainty about how the new law will impact people – whether you have health insurance, you are one of the millions of uninsured Americans, or you are an industry that depends on these reforms.  

Among women, who act as chief medical officers (CMOs) of their families, there is a desire to understand what this means for them and those they care for.  How women feel about the issue becomes more important when there is an information void.

For those who have insurance, that may mean fear that what they have will be taken away. For the uninsured, there is a mixture of hope and distrust regarding what type of coverage they’ll get and what it will cost them as a result. Playing into this mix will be the agendas of physicians, insurance industry, pharmaceutical and device companies and hospitals, and the need for them to communicate their messages to key stakeholders.

For the PR industry, change and uncertainty equals opportunity. Specifically, the need for education and communication is more important than ever.  Among the general public, and women as CMOs, there is a strong need for education to better understand:

• Insurance options, including what the law means to their insurance choices and legal rights
• Disease education for conditions with a major impact on the health system, such as diabetes and obesity
• Role of generic drugs, and why consumers should choose “branded” generics from major pharma companies.

In addition, healthcare reform will encourage and facilitate more Rx to OTC switches to transition costs from payors directly to the consumer. And there are many drugs in the pipeline with pending patent expirations, lining up to make the switch – including drugs to treat allergy, erectile dysfunction, cholesterol, stomach ailments and more.  This presents a huge opportunity for PR to educate consumers about appropriate use of these drugs.

Our messages may change, as may the people who communicate them, as result of healthcare reform. But the need to communicate is even more important than ever.
Megan Svensen, executive vice president, Marina Maher Communications

Specific opportunities
Those of us in healthcare communications roles have challenges and opportunities with the passage of the new legislation. There are complicating fear factors. The new law is big and complex. It passed after a highly political debate and it will have a widespread impact on coverage and care.

The public has formed hard opinions toward the reforms with little or no real understanding of their elements or impact. Those expressing satisfaction with their own current coverage and care are predisposed to view the reforms as their loss at someone else’s gain. The American distrust of “big government” further drives the bias against changes this sweeping. Our challenge will be to address these biases when trying to convey the law’s specifics.

Public trust in the private healthcare sector has fallen significantly. Our challenge will be how we can rebuild trust and confidence in our industries. Pharmaceuticals, in particular, played a key collaborative role in the final outcome. However, the public is not well informed regarding our desire to be part of the solution.

Here are some specific opportunities:

Translate the law into lay-friendly, relevant ramifications:  Between the law’s 1,200+ pages, and the healthcare sector workforce, there is a gap in understanding. Numerous organizations have summarized its provisions in lay language – but that’s only part of the challenge. What remains is to interpret the law’s requirements into practical ramifications, particularly from a patient access perspective. The  challenge is to know the law well enough to define patient access opportunities and communicate them effectively.

Leverage early deliverables: Within the law are an array of so-called “early deliverables,” which either came into effect upon passage, or will take effect six months after passage (this September) or in January, 2011. Some of these are insurance-facing, such as a new Patients’ Bill of Rights or the prohibition of coverage denials based on pre-existing conditions. Some are provider-facing, such as new free annual health risk assessments for Medicare eligibles. Others are pharma-facing: such as Medicare Part D rebates to those affected by the “donut hole,” as well as first-dollar no co-pay coverage for prevention and wellness services and therapies. The opportunity is to master the list of early deliverables, determine which align with company strategy, and then proactively communicate them to appropriate audiences.

Leverage new quality and cost-containment initiatives:  The law contains various new concepts intended to promote quality, cost containment or both. These include prevention and wellness incentives aimed at employers, consumers and others; so-called “continuity-of-care” initiatives aimed at ensuring smooth transitions from one care setting to another; and substantially increased comparative effectiveness research provisions intended to spur head-to-head comparisons of treatments. This represents an opportunity to distill from among these initiatives those that can be communicated proactively  and to integrate that oppor-tunity into the overall strategy.
Steve Lampert, executive director, corporate affairs, AstraZeneca