Why oncology market access models must evolve
The proliferation of stakeholders makes oncology market access increasingly complexand successful models increasingly essential. Peter Mansell reports.
By on Sep 7, 2010The complexities of oncology multiply in a market access environment characterized by a proliferation of stakeholders with varying or conflicting agendas from regulators to healthcare professionals and politicians to payers or other arbiters of product choice, such as health technology assessment agencies or formulary committees.
At the end of the line is an increasingly vocal, informed, insistent, and sometimes desperate patient population, acting individually or through powerful lobby groups.
Multiple stakeholders do not necessarily mean broader, or better, access.
Indeed, one distinct facet of a multi-stakeholder environment is a shift in emphasis from the traditional customer base (i.e., prescribers), where access may now be much more limited, towards non-prescribing decision-makers.
These may be other healthcare professionals with a stake in oncology management, such as pharmacists or nurses, or they may be third parties reflecting the growth of a more patient-centric culture in the cancer field, such as the public, the media and politicians.
This is partly, at least, a result of some patients having to reach into their own pockets for new and premium-priced therapies.
As Uday Bose, European head of oncology for Eisai, pointed out at eyeforpharmas Oncology Market Access Europe 2010 conference in London, the market access model has to evolve.
Is market access the new marketing?
For example, with sales representative calls on physicians in many cases cancelled, cut short, or barely registering with the customer, and with tighter regulations limiting the scope for off-label discussions, companies need to ask themselves whether the sales force is really the most effective use of their resources.
Many of the leading big pharma players have already answered that question, with deep cuts to the battalions of sales reps that sustained the blockbuster drug phenomenon in the 1980s and 1990s.
But if not the sales force, who?
For Bose, the key is to put the patient at the center of every decision.
That is not the same as marketing directly or explicitly to the patient, which in Europe at least is out of the question and is likely to remain so.
Yet it does suggest a mindset that can productively inform relationships across the stakeholder base.
Tatjana Romanyk, president of TRM Oncology, prompted some spirited debate by asking whether, in the oncology category, market access is now the new marketing.
Not everyone agreed, but it is clear that marketing in a multi-stakeholder environment needs to incorporate a full understanding of the wider market access context.
Cultural shifts
Bose illustrated this cultural shift by outlining the differences between a typical pharmaceutical marketing plan in 1999 and 11 years later.
The former consisted essentially of the disease background, product profile, competitive landscape, product strategy, tactical plan, and financial elements.
Now, this plan has to cover those same areas plus the reimbursement landscape; defining an unmet need; product strategy on a global scale as well as local strategy adaptation; a market access plan that includes pricing and reimbursement strategies; and key performance indicators/tracking.
The changing market access landscape also has an important bearing on product differentiation in oncology.
As Bose emphasized, in an increasingly crowded categorythere are more than 800 molecules in development for oncology indicationsa clear differentiation is something no cancer drug can do without.
There are many compelling differentiators available to oncology marketers, he noted.
Outcomesideally overall survival, more likely to be progression-free survival or some other endpointcome at the top of the list.
But there is also the drugs mechanism of action (especially with the growing prevalence of targeted therapies), the disease target itself (e.g., the ErbB protein family), the supporting data, the volume of evidence (multiple clinical trials), the labeling, formulation (iv versus oral), and the mode of administration.
Differentiators and customers
However, Bose warned, no one differentiator will mean the same to an expanding network of customers.
Payers, for example, are likely to place more emphasis on budget impact, cost-effectiveness, and demonstrable added value.
Prescribers will emphasize efficacy, safety and personal experience, along with budget impact.
Patients will stress improved outcomes, access to treatment, reliable information, and costs.
Politicians will focus on the public health interest and associated story.
Even among healthcare professionals, product differentiators may not carry the same weight.
A monthly tablet formulation for breast cancer may mean less time in hospital for the patient and a less resource-intensive approach for the pharmacist that also saves on shelf space.
At the same time, though, it may represent less income for physicians and less frequent patient interaction with both physicians and nurses, which can aggravate the risk of poor compliance.
Customizing product messages
Customer segmentation and targeting in terms of specific needs is crucial, Bose said.
It is a waste of resources to hurl multiple messages at one customer and hope that one of them sticks.
Once the customer has been identified, a profile should be built up and product messages tailored accordingly.
But the real gatekeepers of market access in oncology are now the payers, Romanyk contended.
And these payers are confronted with increasingly difficult choices, leading them to push the demand out to industry.
What payers are focusing on is the medical importance of the disease, the therapeutic value of the product, value for money and affordabilitywith a corresponding shift towards performance-based payment, Romanyk said.
In this context, building value for the product across a range of parameters is paramount.
That includes value-centric clinical development, with early attention to issues such as pricing and reimbursement (P&R), conditions of use, brand strategy, interacting with multiple stakeholders to determine their particular needs and value drivers, or cultivating a network of key opinion leaders, who can also help to bring in patients for clinical trials.
Even as early as Phase I and II trials, companies should be planning appropriate data-mining activities to support an eventual P&R dossier, as well as developing scenarios for pricing and reimbursement in the major launch markets, Romanyk said.
That also means breaking out of the silo mentality still dominant in many pharmaceutical companies, she added, noting that market access can be a silo in itself.
And while different stakeholders will have varying requirements, companies should make sure they speak the same language across that spectrum of needs.
Network intelligence
One more consideration is that an evolving market access environment is forging new relationships not just between oncology marketers and a widening range of stakeholders but among those stakeholders themselves.
For example, Romanyk said, by 2020 the payer and provider value chains for pharmaceuticals will be much more closely intertwined.
Kilian Weiss, chief executive officer of Mederi Research, sees network intelligence as a useful means of reducing the complexity of market access decisions.
This is partly a matter of abstracting the real-life tangle of stakeholder relationships into a series of functions, such as prescribers, brand advocates, guideline makers, decision-makers (both on approvals and budgets) or advisers.
Network intelligence can also establish fruitful connections, Weiss pointed outmedical to market access activities, for example, or market access initiatives to marketing and sales functions.
Alternatively, the linkage may be between international, regional, and national activities, or between market access activities throughout the product lifestyle.
For Weiss, this kind of integration reflects an operating environment in which market access needs increasingly to inform not just international or national but regional and local strategies in areas such as product listing or reimbursement.
One thing industry may also need to think about is forming its own multi-stakeholder relationships as a gateway to that indispensable payer community.
Asked whether this community was ready to engage with pharmaceutical companies, Romanyk suggested payers would view a medical education program sponsored by industry alone very differently from one in which a number of stakeholders were involved; basically, they would see it as a platform for industry.
But the opportunity is there if it is handled right.
These people are as desperate for information as anyone, she commented.
For more on opinion leaders, see Marketing with opinion leaders in mind.
For more on data mining, see Health data and comparative effectiveness.