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. Learn more about the holistic approach to market access.
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.
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.