Developing effective pharmaceutical and medical device market access has become the key element in ensuring uptake of new products at a national and regional level. The evolving requirement for a cost-effective approach to approval, along with clinical efficacy and safety ensure the need for a multi-faceted approach to market access strategy that is underpinned by focused personnel training and effective communications.
Alan Crofts outlines the flexible market access strategies needed to address the needs of clinical and non-clinical decision makers
There has been a spate of recent
articles in the pharmaceutical press describing market access and the need for
the corporate sector to align marketing and relationship strategies to meet the
organizational developments in the customer base.
This debate is necessary and timely.
The organization of UD Federal and EU
buying policy is evolving with decision making apportioned to emerging
departments that encompass both clinical and non-clinical functions.
Furthermore, the direct access to
these stakeholders through corporate representation is dwindling due to time
constraints and policy at local, regional, and national levels.
The focus of the recent debate has
largely been on the need for a change in business strategy to align with the
developments in funding organization.
There is no doubt of the requirement
for industry communications to be assigned and targeted to meet strategic funding
realignment, but are pharmaceutical companies making the most of their existing
resources in order to achieve this?
The access to healthcare prescribing
professionals and to non-clinical decision makers is becoming increasingly
limited.
For clinicians, this is largely due
to time restrictions imposed on secondary care hospital specialists and
regional policy that actively prevents primary care practitioners from holding
meetings with pharmaceutical representatives.
Furthermore, the effectiveness of the
representative in terms of gaining uptake of their product during meetings is
diminished due to a transfer of prescribing decision making from the healthcare
professional to non-clinical officials.
Nevertheless, the sales professional
maintains an important role in increasing product awareness (particularly
during the first six months after launch) and in securing prescribing for
established products within an established pharmaceutical class.
Access to the healthcare management
system for the purposes of securing product market share is now multi-faceted,
and the field activities of the pharmaceutical company must reflect this by
adopting a multi-level, flexible strategy that utilizes the particular talents
of available personnel to address the specific needs of clinical and
non-clinical decision makers.
The role of the medical science
liaison
The activities of the medical science
liaison (MSL) function align well to contribute to contemporary market access
strategy.
These individuals are highly trained
in therapy and product science and should have either a PhD in research or
medical or a pharmacy background.
Able to interact with NHS clinical
personnel on a peer-to-peer level (in terms of their scientific and medical
knowledge), they are well placed to influence and prepare the clinical market
prior to product launch.
With KOLs as their principal
contacts, they ensure that new products are clinically assessed but their
activities may encompass more than this.
The MSL should be the coordination
point for gaining hospital and PCT formulary status for products after launch.
Here, the MSL team may co-ordinate
with the sales force to identify clinical sponsors within specialist departments
to facilitate the application to the Drug and Therapeutics Committee.
This is an essential function because
a key gatekeeper in this process is the hospital pharmacist who requires a
complete understanding and comprehensive access to the available developmental
data in order to construct an informed decision to new drug acquisition
The MSL should also act as a
facilitator in providing information to secure the inclusion of therapeutics
onto regional (and local) guidelines and to provide local prescribing audit
data for inclusion into NICE and SMC technical appraisals the gaining of which
is a key element in gaining regional prescribing uptake.
Within this environment, the MSL
should also form an essential relationship with the regional NICE
Implementation Lead.
The role of the market access
representative
The industry field interaction with
many non-clinical decision makers falls to the market access representative.
The role of this function is to
communicate on a business-to-business level health economic, product placement
and pricing information to healthcare commissioners and business manager,
prescribing advisors and medicines management officials.
One important issue here is the
competency of the healthcare representative to leverage product uptake via their
interaction with these key officials.
The market representative is trained
to be able to discuss pricing and budget implications (of particular interest
to prescribing advisors) but is often not adequately competent to discuss
complex strategic components such as health economic modelling or to discuss
clinical data (as it pertains to product displacement) to hospital pharmacists
or national guidance implementation leads.
It is essential that internal
training for these activities be addressed to maximize the results of
discussions with non-clinical decision makers to drive product uptake. Key
elements here are the provision of a focused value product value dossier where
essential questions likely to be posed by the payer are answered. Following
this is the development of a negotiation handler where market access
representatives are trained specifically to negotiate on the basis of
cost-effectiveness by clear and effective communication of the budget impact
model.
It is also essential that there is
coordination with the MSL function to ensure that clinical data is delivered
accurately and to the depth required.
The role of the market access manager
The fundamental process to achieve
the objectives of the market access strategy through clinical and non-clinical
official interaction is the appropriate internal cross-functional coordination
as discussed above.
A key question here is who is
responsible for overseeing this within the pharmaceutical company.
Large pharma remains notoriously
bunkered into sales, marketing, and medical affairs functions.
Cross-functional synergy requires a
managerial overview of each department and sanction to develop market access
strategy based on the best-coordinated use of each function.
The relatively new position of market
access manager should be well placed to achieve this.
Though often recruited from a sales
background, the market access manager needs to look beyond this pathway and to
see the fundamental value in utilizing all available field function to achieve synergistic,
multi-directional market access policies.
Drug development strategy
A genuine stratification to the
corporate market access policy must begin with a drug development policy that
not only satisfies the regulatory bodies for product approval but that also
addresses the requirements of decision makers to sanction product uptake.
This does involve risk in the design
of clinical trials to meaningfully showcase the therapeutic attributes of the
new product.
Phase III trials that are
specifically designed to gain regulatory approval are necessary but often have
soft endpoints with clinical outcomes of little significance to healthcare
decision makers.
This is particularly true of new
products within an established pharmaceutical class or new products with a novel
mode of action where there are an existing variety of safe and efficacious
drugs.
Often Phase III trials encompass safe
populations within the mainstream indication where the drug is trialed against
placebo or an old established product (though often superseded in practice) to
demonstrate comparable efficacy.
The results of these trails are
limited in convincing formulary committees to sanction the inclusion onto
formulary or hospital specialists to trial the prescribing of the drug in their
clinic where adequate therapies are already in use.
Furthermore, they fail to convince national
approval bodies committees to approve a positive technical appraisal or
specific inclusion onto therapeutic guidelines.
To facilitate these operations, it is
crucial that developmental budget is invested to represent the use of the
product in the actual (novel) clinical settings: within therapeutic niches, in
distinct realistic populations and against appropriate competitors.
A farsighted approach is to invest in
investigator initiated trials both to achieve the above and to engage the wider
clinical community in product development, a strategy that pays dividends for
future advocacy and clinical use.
A wider portfolio of useful trial
data may be generated by investing in publishable proof of concept and
biomarker studies that may generate interest in a wider therapeutic application
and act as a taster for future outcome trials.
A further associated development in
securing market access through meaningful data has arisen as the result of the
shift in focus for the requirement of actual efficacy data derived from
in-clinic use (rather than generated in a trial setting) to contribute to
gaining a positive technical appraisal or guideline inclusion.
This data may be gained by the
distribution of a clinical audit questionnaire to both primary and secondary
care prescribers and may capture crucial prescribing data concerning
therapeutic displacement, algorithmic placement, and cost effectiveness as well
as actual efficacy and safety data and overview of patient demographics.
The success in this strategy is
dependant on the quality of the cross-functional relationships forged between
practitioners and the sales, healthcare, and MSL functions.
Remote market access
Innovative product communications and
delivery methods are a key issue for the pharmaceutical company to overcome the
dwindling face to face details opportunities imposed on the sales force, to
improve sales force training, and to provide healthcare professionals with quality
education to meet their continuing professional development needs.
Database-driven electronic
communications provide imaginative pathways for remote detailing and key data
updates and may be distributed to secondary and primary care professionals that
are recruited via a robust acquisition strategy.
The decision for the clinician to
subscribe to these remote resources circumvents local and regional policy that
limits face-to-face detail meetings.
Importantly, electronic communication
systems provide a two-way conduit of information.
Once the remote relationship is
established, the healthcare professional may be requested to provide the actual
clinic prescribing data for drugs that are becoming critical for regional
regulatory audits (technical appraisals and guideline incorporation), which
significantly enhance the reputation of the drug within the clinical and
non-clinical healthcare community.
Here, the use of social networking
can play an important role if properly developed.
Remote information delivery is also
of essential value for key non-clinical decision makers.
Again, these remote systems are
database driven and represent a unique pathway to transfer health-economic and
product displacement data to drive positive decisions.
Continuing medical education
The electronic delivery of
accredited, continuing medical education programs to healthcare workers may be
established as a key element in an overall market access strategy.
The requirement for professional
accredited CME is a growing mandate stipulated by the federal law with a need
for professionals to achieve annual credits to fulfil their commitment to their
ongoing professional development.
The most effective programs deliver
education tailored to optimal access and knowledge transfer according to the
needs of each professional sector.
Though the educational material must
be unbiased toward a specific product, when well developed the provision of CME
programmes can act as a platform to raise therapy area awareness, particularly
in new therapeutic development and so convey educationally important
evidence-based developmental data.
The American model for CME provision
by the healthcare industry has demonstrated that ultimately these programs are
fundamental in satisfying the needs of clinicians to remain fully appraised of
evolving approaches to therapy.
Thus, the provision of CME has
indirectly proven to be an essential element in the overall market access
toolkit.
Addressing rep training
Just as innovation in the development
and delivery of CME is important, so is the similar provision of ongoing
training to the industry sales and healthcare field forces.
There is now a depth of knowledge
required to discuss new therapies with unintuitive modes of action and
complicated medical development programs that far exceeds a working knowledge
of the detail aid.
Nothing saps the confidence of a
doctor more than watching a representative flounder when asked fair questions
on information that lies slightly outside the remit of the details aid.
Detail meetings are becoming harder
to come by with severe time restrictions.
It is essential that the
representative is educationally equipped to make the most of the detail
opportunity.
This point is amplified for the
healthcare representative who, having often been recruited from the sales
force, may be called upon to discuss complex health economic issues, in-depth
clinical data, and product displacement models.
Field force training therefore must
be at the forefront of the comprehensive market access strategy with regular
revisions and not the by-the-numbers (almost afterthought) training that so
often exists.
Remote training linked to
assessment/profiling databases can progressively equip the representative to be
optimally effective in client meetings and effect a real improvement in product
uptake.
Coordination, foresight, and
innovation
For the pharmaceutical, biotechnology
and medical device company, three principles drive the success of market
access: coordination, foresight, and innovation:
· Coordination to make the best
strategic use of all field functions to break down the market barriers by
synergistically accessing and engaging key clinical and non-clinical decision
makers;· Foresight to ensure meaningful
clinical developmental programs geared to future market access;· Innovation to provide the remote
communication conduits to provide quality CME, representative training and to
drive access to the key decision makers within the evolving payer environment.