Wednesday, June 18, 2014

Biosimilars Looming on the Horizon: How Will Payers React?

Stanton R. Mehr, President, SM Health Communications LLC

The Food and Drug Administration has been working on this for years, and the expectation is that they will get it right. Particularly since the European Medicines Agency has had a pathway for the approval of biosimilar products since 2007 and has used it successfully to introduce structurally similar biologic products to compete with expensive brands like Neupogen®, Remicade®, and others. When the first biosimilars are approved through the 351(k) pathway in the US, payers will be ready. Market research shows that payers will be itching to review these agents for formulary inclusion, and manufacturers of innovator or “reference” products will need to be on their toes if they want to remain in the game.

One defensive stance of manufacturers is that the biosimilars may not be approved for the full list of indications that was earned by the innovator product. Manufacturers shouldn’t kid themselves—if the price advantage is sufficient, the payers will be willing to either not restrict the biosimilar’s prescribing by indication or they will be ready to review prior authorization requests on a case-by-case basis.

Another line of defensive thinking is that the biosimilar may not have the same safety profile as the innovator product. That may be true, but payers will be ready and willing to act upon FDA approval, relying on both the FDA’s judgment and any European experience to help them gauge the risk. And if there are separate safety issues, these may not show up for years—putting the innovator product’s position at risk right at biosimilar launch.

Payers are looking to biosimilars as a long-awaited opportunity to pare some of the costs of biologic therapy. They know the utilization of biologics continues to rocket upwards, and payers understand that their overall pharmaceutical costs will continue to rise (especially on those covered under the medical benefit). As a result, they are moving more biologics under the pharmacy benefit for reimbursement or for management, so they can at least employ more pharmacy tools that have proven successful in the past. In other words, biosimilars and their innovator products will be defined principally by cost, contracting, and net cost.

Does this mean that aggressive contracting can save the day for the innovator products? Maybe, but don’t count on it. Payers will want parity in net costs, and they’ll want price guarantees to protect themselves against inevitable price increases. And this won’t prevent biosimilar manufacturers from taking aggressive pricing action to counter this strategy.

Make no mistake. When it comes to biosimilars, the payers are in the driver’s seat, and they can’t wait to hit the road.

Questions:
1. Does your organization have a plan for addressing biosimilar launches in the rheumatoid arthritis, Crohn’s disease, growth hormone, or oncology space?
2. Do you know how payers will view your innovator product and how they will approach your contract towards biosimilar launch?
3. What steps can you take to meet the challenges posed by biosimilars?


SM Health Communications provides writing, consulting, and innovative market research services for the payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. We’ve participated in many market research projects involving biosimilar development and launch, from the point of view of the biosimilar and the innovator drug manufacturer. For more information, please visit www.smhealthcom.com or contact Stanton R. Mehr, President, at stan.mehr@smhealthcom.com.

Thursday, April 17, 2014

Demonstrating Specialty Pharmaceutical Value and an Opportunity to Meet the Challenge

By Stanton R. Mehr
President, SM Health Communications
stan.mehr@smhealthcom.com
www.smhealthcom.com

The extent of the problem is considerable. Even those tracking it for many years are alarmed at its size and how fast it’s growing. In 2012, only 1-2% of patients used specialty pharmaceuticals, yet they accounted for 28% of total pharmacy expenditures. By the year 2019 or 2020, specialty pharmaceuticals will account for one half of all pharmacy costs. This will be fueled by their high costs and the magnitude of the drug pipeline, pushing new drug launches every year. To add to the cost nightmare for payers, most of the specialty drugs require regular monitoring and lab testing.
            I used the term cost nightmare because it really is. But not just for payers. For patients and providers as well. Payers acknowledge that for many disorders, like rheumatoid arthritis and cancer, the specialty pharmaceuticals represent some of the most effective medications available. However, costs for these products are so radically higher than for traditional drugs, that they feel obligated to apply crude utilization management tools, like prior authorization and step therapies, to try to restrain inappropriate use. The problem is, in doing so, they are viewed by patients as preventing access to necessary treatments for serious disorders, even if that is not the case. Furthermore, they cannot cost shift much more than is already being done.
How much can patients afford to pay? Is 20% of a therapy that costs $2,500 each month reasonable? Jan Berger, MD, JD, a well-respected editor and former medical executive, said it best: “How many times will a patient write that $500 check? Maybe for the first month. Possibly for the second month. I’d don’t see it happening in the third month.”
And providers are not immune to challenges associated with specialty drugs. The average oncology office spends hours each day working through the insurance bureaucracy of precertification, prior authorization, and step therapy call backs. They are pressured to relinquish their buy-and-bill revenue stream (if one remains) and are heeding the call of consolidation with other like-minded physicians or selling their practice to hospital systems.
As of March 31, 2014, 7 million newly insured Americans have entered the health system, and according to Express Scripts, the early returns show that a greater proportion than expected are utilizing specialty drugs. The system cannot sustain these costs for very long.
All of these stakeholders are turning to the manufacturers. The spotlight on them has brightened recently because of the attention paid to outsized prices for the medications they are introducing. Gliead’s oral hepatitis C medication, at a retail price of $84,000 per course of treatment, or $1,000 a pill, helped set the fuse. Assuming that over the course of time, Sovaldi is found to actually save money by avoiding other treatments like liver transplant, there is still no explanation of how patients will afford the co-insurance upfront. For the patient and provider, the least cost-effective medication is the one that is never taken. That may not be the case for the payer.
In any case, the burden of proof will be on the manufacturer to demonstrate value (not incremental value but real, significant value for the money paid). For the manufacturer of specialty drugs, that generally means one of two approaches: (1) Finding a subgroup of patients in whom real, or at least optimal, improvement is seen, which implies biomarker identification and patient testing and (2) proving that the downstream benefits of the specialty product exceed its costs. As we’ve already discussed, the downstream benefits need to be astounding to convince payers. For example, if Sovaldi cost $8,000 for a course of treatment, no one would question its value in therapy and perhaps even when it should be used. Even at that price, some patients may balk at a $1,600 out-of-pocket price tag.
However, manufacturers need to pay for clinical trial development and consider the number of patients who may benefit from a specialty drug (and calculate a tidy profit for the shareholders). The question of patient affordability will eventually enter into the equation, because it certainly is not yet present. Yet, physicians in several specialties are acknowledging that the question of affordability has entered the doctor’s office, and with a drug formulary, this can dictate which treatments are prescribed.
The manufacturers have avoided another approach that helps payers cope with the large price tag of specialty products: Outcomes- or risk-based contracting. This “putting your money where your mouth is” approach attacks the challenge head on. If the drug works, based on contractually agreed upon markers of improvement, the manufacturer is paid full price (and perhaps can justify a higher price than originally considered attainable). If the drug does not achieve this outcome, it is free of charge. There might be some middle ground as well, depending on the disorder treated (e.g., partial payment for a degree of function or improvement). Agreeing on outcomes measures, the amount of administrative work needed by payers to measure outcomes, and the ability to employ better therapy decision making models are the devilish details that must be mentioned.
For the payer, this is value. For the manufacturer, it enforces a focus on the right patient for their specialty agent. For the health system, it helps control an unsustainable cost trend.

Questions:
1. How do you define a specialty medication? What are its characteristics?
2. Do you believe we're approaching a reckoning, where the cost of these agents will be unsustainable?
3. How does your organization try to ensure the value it receives from a hepatitis C drug like Sovaldi?

SM Health Communications provides writing, consulting, and innovative market research services for the payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. For more information, please visit www.smhealthcom.com or contact Stanton R. Mehr, President, at stan.mehr@smhealthcom.com.  

Tuesday, March 18, 2014

Social Context and Payer Market Research

Stanton R. Mehr, President, SM Health Communications LLC

Market research organizations, which I’ll call MROs, try very hard to evolve their craft according to current trends and the shifting tides of popular technology. Traditional in-depth telephone interviews are highly effective and, armed with a honed set of screening questions, can be the best method of meeting the sponsor’s objectives. Effective? Yes. Sexy? No way. Surveys enhanced by Web distribution and on-line responses (think Survey Monkey®) still are commonly used and extremely cost effective. But this doesn’t tap into the nature of today’s popular media.

Recently there have been concerning revelations about the data being collected on browsers like Google and sites like Facebook to create a profile of the viewer, with an eye towards customizing the advertising they see. The collection of data for external uses, such as that publicized on the March 10th broadcast of CBS’s 60 Minutes, may finally tamp down the fires of social media market research. Much of this market research is based around singular data points (e.g., a person “liking” a particular service, or posting about their experience at a particular resort or hotel).  These data points can help profile the person and, if large and consistent enough in their personal network, a group. This is the essence of social media. It can be very useful in marketing health care products to specific consumers, like proton pump inhibitors to those searching for information on acid reflux.

If you join a special interest group on the Web, such as a patient-support group for (fill in just about any disorder), you can bet the pharmaceutical companies and their market researchers are crawling over the site, collecting information about what you like, what you don’t, and every bit of demographic data they can extract from your participation. These folks are self-selected for this specific interest, and obtaining market research on these like-minded group members can be a very effective endeavor., If the MRO formulates and conducts the research well, it collects not only singular data points from singular individuals, but also data and social context to the market research results. That’s what old-style, one-way mirror focus groups have always sought to achieve.

Let’s take this consumer-based approach and apply it to health executives. If there were on-line community sites in which health plan executives (payers) joined voluntarily and where they discussed frequently a range of topics in conversational style, this community engagement might just put a market research project into overdrive. The group think, coupled with individual responses, on qualitative topics may yield fascinating insights and do it in a very cost-effective environment.

The resulting lengthy discussion, filled with nuance, agreement, disagreement, and insight, can be a challenge for most. The trick is the ability to tease out the social context as well as the top-line responses so as to yield more informed payer market research, but using “sexy” social media so many clients crave today. 

Questions:
1. Does your MRO have a vehicle for payer interest groups to freely discuss matters of importance to them?
2. Can the MRO use this type of social media to report the social context in which responses are made?
3. What is your greatest challenge in meeting social media-related research requests by your executives?


SM Health Communications provides writing, consulting, and innovative market research services for the payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. For more information, please visit www.smhealthcom.com or contact Stanton R. Mehr, President, at stan.mehr@smhealthcom.com.

Sunday, January 19, 2014

Decision Making on Specialty Pharmaceuticals: P&T Committee, Technology Assessment Committee, or Something New?

Stanton R. Mehr, President, SM Health Communications LLC

We have all seen the trend data. The situation is likely to become more complicated, not less so, in the coming years. The annual report by CVS Caremark anticipated that by 2015, specialty drugs will account for 27% of the prescription spend, and that annual growth in the spend can be as high as 22% for 2013, matching the figures for the past few years.1 The data from Express Scripts shows that although the trend for the major traditional product categories was only 0.1% in 2011, the trend for the specialty pharmaceutical category (e.g., anti-inflammatories, multiple sclerosis, cancer, HIV, etc.) was 17.1%.2 Ample evidence now exists that the specialty pharmacy utilization and cost growth will continue in the healthy double-digit range, for at least the next few years. It will be fueled not only by the large number of specialty products in the later stages of clinical development, but other factors as well, including slowly evolving expertise (and commitment) by payers to control access to these products.
A few years ago, I worked on an annual publication sponsored by Bristol-Myers Squibb.3 Similar to other trend reports, we surveyed payers (including corporate employers) to determine how they were reacting to several trends in the industry. We asked them about how they managed specialty pharmaceuticals (in 2008) and what changes they intended to make in 2009 and beyond. Back in 2008, 40% of those surveyed indicated that they already shifted any injectable/infused agents from the medical to the pharmacy benefit, and an additional 16% planned to do so in 2009. At that time, 51% said that by 2008, they had already assigned injectable agents to specialty pharmacy management and an additional 14% said they would do so in 2009.3 It is clear that many health plans and insurers have turned to pharmacy benefit management to manage the growth of the specialty pharmacy category. However, many of these injectable/infusible products would traditionally be part of the medical, not pharmacy, benefit. In some large plans, drugs covered by the medical benefit are evaluated by a dedicated technology assessment committee (or rely on other independent resources, such as private consultants or a national technology assessment body, like Blue Cross and Blue Shield’s). If pharmacy coverage decisions are made by the Pharmacy & Therapeutics (P&T) Committee, does this mean that this body is the de facto tech assessment committee in most plans? This seemed to be the case in the last decade, particularly when it came to certain devices and diagnostics.4 Or will technology assessment committees, when available, decide on pharmacy benefit coverage for these specialty pharmaceuticals? The move to pharmacy benefit management of specialty products clouds the discussion considerably.
It would also help if a universal definition of specialty pharmaceuticals was well accepted, based on cost, distribution, storage, and/or route of administration. I’m showing my age here, but I clearly recall when the term specialty pharmaceuticals generally referred to blood products only, which were almost universally covered through the medical benefit. Fast forward to the 1999 introduction of TNF inhibitors and then similar other office-administered and self-injectable products. By 2013, we’ve added oral agents into the specialty mix.
Today, are payers equipped to determine whether a specialty medication offers real value (or even a reasonable value proposition)? And yet another critical question for payers: In light of recent trends, should the coverage decision making body be removed from the shackles of pharmacy or medical benefit classifications altogether? This infers that a merged group of coverage decision makers, with a composition distinct from that of a traditional P&T Committee or technology assessment committee, may contribute further to the discussion.
            Clearly, the P&T Committee backbone of pharmacy decision making in managed care is being tested. In recent years, the need for device (specifically drug-delivery systems) and diagnostic coverage decisions is weighing it down. A new evolutionary step may be needed to help payers meet the challenges of specialty pharmacy products.

 (Note: This blog was first published in January 2013 for the Health Payer Council [www.healthpayercouncil.com]).

REFERENCES
1. 2011 Insights: Changing Rules Changing Roles. Scottsdale, AZ, CVS Caremark, 2011.
2. 2011 Drug Trend Report. St. Louis, MO: Express Scripts, April 2012.
3. 2009 Biotechnology Monitor & Survey. Princeton, NJ: Bristol-Myers Squibb, March 2009.
4. Mehr SR: The evolutionary role of the pharmacy and therapeutics committee in
technology assessment. Manag Care Interface 2006;19(1):42-45.

Questions:
1. Does your P&T Committee or Medical Technology Assessment Committee decide whether to cover specialty pharmaceuticals?
2. If a unique body were assigned to making specialty pharmacy coverage decisions, how would its composition differ from that of today’s P&T Committee?
3. What is your greatest challenge (other than the cost trend) in terms of managing the specialty category? 

SM Health Communications provides writing, consulting, and market research services for the long-term care and payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. For more information, please visit www.smhealthcom.com or contact Stanton R. Mehr, President, atstan.mehr@smhealthcom.com.

Tuesday, September 3, 2013

The 5 Critical Features of an Excellent Payer Market Research Network

Stanton R. Mehr, President, SM Health Communications LLC

The vast majority of US pharmaceutical executives understand that managed care plans, health insurers, and pharmacy benefit managers (PBMs)—the payer market—have a dominant say over whether their products’ annual revenue will be $10 million, $100 million, $1 billion, or more. Although the market has been changing over the past few years, particularly with the introduction of new specialty biopharmaceutical products, the message remains the same: Access to managed markets and improving product reimbursement by payers are essential to maximizing product revenue in the United States.
            
With the proliferation of Sunshine Laws, which seek to make the consulting/financial relationships between the pharmaceutical industry and healthcare providers (and executives) more transparent, pharmaceutical companies have to come to rely on the services of market research providers to produce, in blinded environments, the business intelligence and marketing feedback that they desperately need to better understand payer markets. In the past, Advisory Boards were relied on heavily for this role, but Sunshine Laws have created another weighty concern for pharmaceutical company attorneys, and the very nature of how Advisory Board information can be obtained may have to undergo a revolutionary change to adapt to the new environment.

One profound result of these changes has been an abundance of managed care market research providers, each jostling for the attention of pharmaceutical product personnel and reimbursement and access units. However, the number of targeted payers—commonly medical directors and pharmacy directors within the health plans, health insurers, and PBMs—is relatively stable. The issue becomes, what are the critical success factors for gaining the best access to this limited (approximately 300) group of key decision makers?

(1) The ability to get them to answer your call.  The average age of these payer decision makers is between 40 and 65. Many have been in their present positions for more than 10 years and have established relationships with market research companies based on long-term familiarity, trust, and a well-earned confidence that their personal opinions and sensitive, corporate proprietary information will not be shared inappropriately.
            The number of these desired executives is few (compared with physicians of nearly any specialty), and they are inundated with requests to participate in market research projects. A market research provider who can get on their schedule and gasin their commitment to participate can be invaluable to obtaining the business intelligence the pharmaceutical executive needs.

(2) The size and variability of the network.  A pharmaceutical manufacturer may focus on one large segment (e.g., commercial) of the payer market, but they may need feedback regarding other significant market segments (e.g., Medicare parts B and D, Medicaid, Veterans Affairs, TriCare, long-term care). It is critical that the market research provider’s network include executives who can shed light on managed care organizations’ approaches to these varied markets and can speak to the differences that may be seen in their firms’ formularies for these separate products.

(3) Solid relationships with the consultant community. Also of importance is the market research organization’s ability to reach out on occasion to industry consultants (often former payer executives) who can provide helpful, fuller insights into what current payer executives may think about new products. This can be useful for both questionnaire development and validation of responses.

(4) A provider who understands the payer market. Many in the pharmaceutical community may believe that managed markets research is a commodity business—so many providers are available, that prices can be driven down. To some extent, this is true, but the value of a provider who truly understands the payer market becomes quickly apparent once the survey development process begins. With the knowledgeable input and understanding of not only the disease state but with an informed view of how most health plans, insurers, and PBMs will approach the area in question, much time can be saved in developing the questionnaire and this can result in briefer survey instruments and importantly, smaller honoraria or other incentives needed to convince busy executives to participate.

(5) The ability to obtain feedback through classic and innovative methods. Time is invaluable to the pharmaceutical sponsor and to the payer executives. In many cases, the sponsor requires far faster turnaround times than can be afforded through conventional survey means. This may prompt the market research organization to consider a different approach than the standard in-depth telephone interviews (which often require weeks to schedule). Innovative products are necessary to meet the needs of the pharmaceutical industry, and to fit the busy timeframes of the targeted payers. A market research organization that can provide flexible ways to obtain critical information and can make it as easy as possible for their network to participate will continue to offer the best mix of services and outcomes for the sponsor.

Every pharmaceutical manufacturer wants to know whether their pipeline product will be reimbursed on copayment tier 2 or the lowest possible specialty tier (and what it may take to get it there). For most new agents, this is the penultimate criteria for whether a US launch will be deemed a success. Getting this information before the FDA makes an approval decision is critical. Partnering with the right market research to reach the real decision-makers within the payer market can make all the difference in the world.


SM Health Communications LLC provides marketing research and specialized communications for healthcare services and pharmaceutical companies. Our comprehensive capabilities provide clients with the essential insights and competitive intelligence that are critical in today’s healthcare environment.

Friday, July 26, 2013

The Technology Assessment Committee: Coverage Decision Making for the Medical Benefit

Stanton R. Mehr, President, SM Health Communications, Valley Cottage, NY
stan.mehr@smhealthcom.com

According to PhRMA, 901 biotech medicines are currently in development. Of these, 300 are monoclonal antibodies and 298 are vaccines, followed by recombinant hormones and proteins (78), cell therapies (64), and gene therapies (50). In today’s medical pipeline, the vast majority of investigational products (>350) are biologics aimed at treating cancer and related disorders, and these have been covered most often by the medical benefit, as they are commonly administered in hospitals or provider’s offices.

Health technology assessment describes the evaluation performed by informed professionals to decide on the safety, efficacy, effectiveness, and value of medical interventions. This is the principal activity of Pharmacy & Therapeutics Committees. The P&T Committee traditionally focuses on pharmaceuticals like anti-infective agents or hypercholesterolemia drugs, which are readily available through the pharmacy (or through “specialty pharmacies” in some cases) and are covered under the health plan’s pharmacy benefit. 

A problem exists for many health plans and insurers: Many do not have a body similar to a P&T Committee to evaluate products and interventions potentially covered by the medical benefit, such as biologics, diagnostic tests (including new genetic tests), and medical devices. Often, their P&T Committees will be asked to review these interventions, although they are not well structured to do so. Without others to turn to, the P&T Committee may become the de facto decision-making body for products covered by the medical benefit in many smaller organizations.

There are several exceptions. The Technology Assessment Committee of the Blue Cross Blue Shield Association is a structured unit whose sole purpose is to evaluate treatments that will be covered through the medical benefit, and any member Blues plan can access and utilize its recommendations. UnitedHealthcare has its own Technology Assessment Committee for its regional affiliates. Some integrated health systems have the resources to make these coverage decisions, based on the available hospital and health plan staff.

It is important to understand and recognize the difference between a P&T Committee and a Technology Assessment Committee; this goes well beyond the type and number of panelists at the meetings. Clearly, pharmacy professionals cannot contribute as much to decision making on diagnostic testing or medical devices (other than drug delivery systems), so a Technology Assessment Committee will be more heavily represented by medical professionals compared with a P&T Committee. Since the breadth of diseases treated with medical devices and diagnostics is wide (and those treated with biologics is increasing), there may well be more physician specialists asked to serve on a Technology Assessment Committee.

Another key difference is that many P&T Committees will not only decide on coverage but will recommend where the new agent will be placed on its copayment tiering system. The Technology Assessment Committee will recommend whether the product should be covered—not necessarily how it will be covered or if patients will be asked to share part of the costs (which may not exist at all for interventions covered by the medical benefit).

The Technology Assessment Committee sometimes be asked to consider expensive new technologies for which there are limited similar interventions for comparison. As a result, their decisions can have great implications for health plans and insurers’ budgets, their member populations, and the manufacturers’ bottom lines. Therefore, it is critically important to understand how the technology assessment committee will approach newly introduced technologies before they are actually reviewed.


SM Health Communications provides marketing research and specialized communications for healthcare services and pharmaceutical companies. Our comprehensive capabilities provide clients with the essential insights and competitive intelligence that are critical in today’s healthcare environment.

Monday, July 8, 2013

What Is a Mock P&T Committee and What Is the Best Way to Conduct Them?

Stanton R. Mehr, President, SM Health Communications LLC

In the course of a pharmaceutical launch program, most savvy product managers and brand directors will want to test, compare, and evaluate their managed markets launch strategy in a way that gives them a realistic understanding of how their strategy will fare in the real rough-and-tumble world of health plans, insurers, and pharmacy benefit managers. For most products provided in ambulatory settings in the US, these payer institutions control the majority of coverage decision-making and reimbursement. Therefore, at some time prior to product launch, a litmus test of marketing plans is necessary.
            That final overarching answer—will my product be placed on formulary and on what copayment/coinsurance tier?—is the $1 billion question for most pharma companies. This is everyone’s goal, but few well-proven options exist to obtain strong, reliable response to the question. Even the term that pharma executives use to describe how they will obtain the answer is vague in the minds of most. “We will hold a ‘mock Pharmacy & Therapeutics Committee”: What exactly does that mean? Is it a separate tactic or something that is part of another more common managed markets tool?
            Primarily, a P&T Committee is the coverage decision-making body within a health plan, insurer, hospital, or PBM that evaluates whether a product is safe, effective, and of sufficient value to be considered for reimbursement by the plan for its members. In many ways, it is a technology assessment committee, comparing new pharma products and/or delivery devices against what the organization already covers to decide whether the new technology is of sufficient value to its members. In an actual health plan or PBM setting, the P&T Committee meets on a regular basis (e.g., monthly or quarterly) and spends time deemed sufficient to explore the product in question and vote its assent or dissent on coverage. Therefore, if the objective to holding a mock P&T Committee is to obtain a response as close to that seen in a real Committee setting, it is best to emulate the latter as closely as possible.

What a Mock P&T Is, and What It Isn’t. This means that one broad requisite for holding an effective mock P&T Committee is that it is a live meeting of managed markets experts. However, this can be done in a multitude of ways, and each of which carry their own rewards (but risks, too).  

(1)  Managed care advisory boards or webinars—well known, once ubiquitous, managed care advisory boards typically brought up to 15 managed care medical directors and pharmacy directors into one room, with pharmaceutical sponsors sitting either at the roundtable or in the back of the room. Sometimes run directly by the pharmaceutical marketing team or a professional facilitator, the goal of the ad board (which were often done as a series held in geographical regions or by types of plans or insurers) was to obtain responses to a specific list of questions posed by the marketing team. In some cases, a “mock P&T Committee” scenario is included in some portion of the ad board agenda, to try to tease out the whether the managed care executives will, in the end, place the product in question on a health plan formulary. The goal of an advisory board is not necessarily the same as that for the mock P&T Committee. In this setting, part of the problem resides in the very room where the mock P&T is held. In no managed care organization are pharmaceutical company representatives allowed to participate in P&T Committee meetings. This would bias the proceedings and would like inhibit directed, full discussion of the company’s product (or competition).
(2)  P&T “wargames”—P&T wargames are marketing activities in which pharmaceutical company personnel combine with managed care consultants to play the role of health plan executives, not to obtain accurate formulary decisions, but to devise marketing strategies and approaches in response to possible outcomes of the formulary decision. In other words, if one of the possible outcomes of a P&T Committee decision is that Product X will not be placed on formulary because it doesn’t provide sufficient value over presently covered agents, then the wargames team may suggest increasing contracted rebates or discounts to overcome this barrier. However, the P&T wargames is not focused on what outcome is most likely, only what to do in the event it occurs.
(3)  Product theatres—Product theatres, often run at major clinical and professional conventions, offers the chance for pharmaceutical companies to present their marketing story to large groups of managed care professionals. This can be accompanied by a staged P&T Committee review, where some of the issues that may be raised in a real P&T Committee may acted out for the benefit of the larger audience, along with some possible responses.
(4)  The virtual P&T Committee—In this format, a P&T Committee meets on a regular basis, just like a real P&T Committee, to evaluate specific products or drug classes for virtual health plan or PBM. That is, it may represent a specific type of plan, such as a 1-million member regional point-of-service plan, based on the East Coast, or a 500,000-member integrated health plan based in California. The committee members are usually blinded to which pharmaceutical company is sponsoring a session (as part of their regular meeting), and pharma executives are prohibited from attending the meeting in real-time (that is, no one but the Committee members are allowed in the conference room, no use of one-way mirrored observation rooms, and no satellite feed of the actual meeting to other sites). This minimizes inherent biases in discussions and decision making. It also assures that all discussions and comments are encouraged, with regard to how a real P&T Committee approaches the disease state, drug class, or specific product. The result of the virtual P&T Committee is a formulary decision based on a clearly developed scenario, which will set a standard for how real managed care organizations of similar type will most likely vote on the product. It is an outcomes report based on one scenario (which can be a certain pricing level, including specific assumptions on formulary positioning of competitive products, and of course, the value proposition).

It is therefore as important to remember what a mock P&T Committee is versus what it is not. What type of live meeting of managed care experts a pharma company chooses to achieve its goals really depends on what the expectations or objectives of that exercise. If seeking possible responses to a set of P&T Committee decisions, a “wargames” scenario may be most appropriate. If looking for general feedback on the managed care marketing strategy or trying to develop the initial strategy is main objective, an ad board or series of boards may be the ticket. But if the product team is seeking to understand what is the likeliest P&T Committee decision based on their product launch, the virtual P&T meeting is the best way to go.

Not Just for a New Product Launch. Although the most obvious use of a virtual P&T Committee meeting is for a pharmaceutical company seeking to test the outcome for their own new soon-to-be-launched agent, it can be at least as useful to better understand the effect of a competitor’s new entry on the company’s mature product. Virtual P&T Committees have enabled a marketing team to “pre-position” the competitor’s product, based on reaction from the committee members, as well as conduct essential business intelligence on the probability that the new agent will be (1) accepted onto the formulary, (2) at what copayment tier, and (3) what effect, if any, if will have on the rest of the product class. For example, will Product Y’s acceptance onto the formulary at the preferred tier require all other products of the class to require prior authorization before coverage can be obtained? The drug company can then determine if a new strategy is necessary, such as increased rebating or better comparative-effectiveness research will help mitigate these effects.

Again, what is the real objective of conducting a mock P&T? That should define which format provides the greatest chance of success in answering the question.


SM Health Communications provides writing, consulting, and market research services for the long-term care and payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. For more information, please visit www.smhealthcom.com or contact Stanton R. Mehr, President, at stan.mehr@smhealthcom.com.