There is a clear correlation between fast access, patients access to new technologies and company commercial/ financial success. Benefit also needs to be considered relative to ‘future’ SoC – new interventions that might change the clinical practice and not licensed yet when a Phase II/III trial is going to be rolled out. This requires careful Phase II/ III design to enable the appropriate indirect treatment comparisons are put in place. In addition, network meta-analyses should be conducted to answer these important questions. Some gaps might be filled up with ad-hoc RWE studies or ad-hoc Phase 3/4 studies that would optimally complement missing data, especially at local country level. Respondents stressed the importance of presenting a compelling story about the burden of illness and unmet needs.
While this desire is valid, manufacturers’ hands are tied by regulations that inhibit or prohibit discussions about price. The unintended consequence can be a severe budgetary crisis for large payers that carry the bulk of the patients who require treatment. Ken Abreu is a pharma/biotech industry veteran with 23 years of pharma and 20 years of managed markets experience. Integrating real-world lab and claims data with coverage and clinical pathways data reveals a new world of opportunity for manufacturers.
Payers with constrained budgets, such as state Medicaid programs, also need time to include pricing considerations in budgets where such discussions are legally allowed. The year-over-year growth of Medicare Advantage in the United States offers manufacturers a growing patient population in which to target new products. In order to support access to new products, payers can request that they be paired with companion diagnostic tests to help identify which patients will have the highest probability of the intended outcome. In this sense, companion diagnostic testing options in combination with innovative new products offer the ability to improve patient outcomes in subsets of populations.
- These roles are central to ensuring that the right patients get the right drugs at the right time.
- A disciplined approach to market access begins with formulating the objectives for the brand and how these objectives will support the overarching commercial goals.
- For instance, an early launch could be planned by implementing early access programs (EAPs) for pharmaceutical products and patient level data could be derived from these EAPs and further analyzed and used in local HTAs when applying for reimbursement.
- These roles usually involve more responsibilities than internships or trainee positions and serve as a stepping stone towards more senior roles.
A Market Access Writer, who is responsible for creating communication materials related to market access strategies, can expect to earn an average of $80,000 annually in the United States. On the one side, it is necessary to understand how healthcare systems value medicines and new developments. Surrogate endpoints (PFS, HbA1c, LDLc) have been traditionally considered as valid end points to demonstrate superiority of one technology vs. another. However, payers are increasingly demanding for hard end points to confirm the superiority of one technology versus another in Randomized Clinical Trials (or in RWE studies), mainly looking at Overall Survival, Mortality rates reductions, etc. Composite end points (i.e. MACE reductions + HR-QoL + CV death or hospitalization) and Patient Reported Outcomes (via HR-QoL studies) could also be significant if developed appropriately and with the right approach.
These include understanding the market dynamics, identifying opportunities, developing strategic pricing, and working with regulatory agencies. An expert market access professional is expected to develop and implement strategies for the successful entry and presence of a drug in the market. How could new drugs be valued at the beginning of their life, when the real value will be realized over their entire life cycle and when cheaper generics and biosimilars continue to deliver that value for more patients at a lower budget impact?
Whatever your commercialization obstacles may be, you can anticipate and plan for them by arming yourself with insights gleaned from rich data sources that deepen your understanding of market access. With the average clinical trial costing $19 million, according to a 2018 article in JAMA Intern. Med.,1 it’s imperative that you carefully outline the outcomes and evidence you plan on collecting during your trial based on what payers want or need to see. If you unknowingly collect the wrong information, you may need to conduct another trial, costing you both time and money. Using market access data from day one of your drug development and commercialization journey puts your brand in the best position to succeed at launch. In general, professionals in the pharma market access field can expect to earn competitive salaries that reflect their level of expertise, responsibility, and the strategic value they bring to their organizations.
Even before a diagnosis, manufacturers can identify patients that have tested positive for a particular lab test or combination of tests, including genetic, genomic and biomarker tests. Given the cost of specialty therapies, locating even a handful of potential patients via lab data can provide a healthy ROI. Integrating lab data into the market access data mix introduces another dimension of the patient journey. Many manufacturers are beginning to use normalized lab data early in the development lifecycle to optimize site selection for clinical trials and improve recruitment and enrollment. Advocacy groups are gradually beginning to exert their influence as stakeholders in market access, especially in niche therapies where the cost of treatment is very high (e.g., in rare diseases).
They oversee the company’s market access strategies at a national or global level and lead a team of market access professionals. Their responsibilities include negotiating pricing agreements with healthcare providers, developing patient access initiatives, and advocating for favorable healthcare policies that support the availability of the company’s products. This role requires a deep understanding of the healthcare market, excellent leadership skills, and the ability to manage complex stakeholder relationships.
They also emphasized the importance of generating evidence that addresses those needs through carefully developed endpoints in randomized controlled trials or targeted evidence development using real-world data. This sets the foundation for evidence-backed value discussions with stakeholders down the line. Natasha Elsner, Deloitte Services LP, is a research manager with the Deloitte Center for Health Solutions. With extensive experience in research methodology and data analysis, Elsner conducts cross-sector research at the Center. Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors.
Payers are increasingly requiring evidence of a drug’s cost-effectiveness before they agree to cover its cost. This requires pharmaceutical companies to invest in data and evidence generation and to develop robust economic models to demonstrate the value of their products. The other reason to start the search early is that, as the role has become more complex, it often takes senior leaders longer to find the right person—and demand for market access executives is outpacing supply. One company that began searching for a head of market access in Europe late in the process ultimately had to delay What is Direct Market Access Dma its product launch by 15 months, not only costing the company money but also keeping the drug from patients. One of the many lessons learned was that estimating the true size of a patient population and developing a deep understanding of the payer mix for a given disease requires time and study early in the market access strategy for the product. The team can be expanded, step-by-step, after launch, as it will usually take 1-3 years to secure excellent payer coverage – as payers gain claims experience and your organization’s value proposition with clinical support further improves over time.
When necessary, your market access partner will put payers in touch with clinical specialists, which can be a critical connection on the route to approval and formulary inclusion, particularly with specialty drugs. The ability to clearly define a clinical advantage can greatly accelerate payer acceptance and speed the process of attaining product coverage. Entering the market for the first time can be challenging for midmarket pharma and biotech companies because there is a lot of market preparation work that needs to be done in parallel to clinical development. The ever-evolving nature of health care and the pharmaceutical industry can greatly affect a drug manufacturer’s approach to market access, as well. Recent changes to Medicare under federal law include a historic rise in premiums, access to mental health services through telehealth, and more affordable insulin options through prescription drug plans. New products and technologies are being introduced which are influencing the future market.
While the discipline of market access continues to evolve, we propose a set of principles12 that should underlie market access strategy. The last step before entering the market and after following the steps 1-3 above is the pricing and reimbursement negotiations with the reimbursement agencies. We always recommend the company to be well prepared with appropriate material preparation and market investigation and good negotiating planning to avoid any unforeseen challenges or setbacks. To target each market appropriately we recommend stakeholder mapping, consisting of relevance and roles in the decision process of different HTA and pricing and reimbursement bodies, KOLs, and patient representatives.
While brokerage firms can work on a market-making quote basis, it has become more common since the 1990s for brokerage platforms to use direct market access for completing the trade. With direct market access, the trade is executed at the final market transaction phase by the brokerage firm. Salaries in the field of market access can vary significantly due to factors such as the level of experience, the size and type of the employer, and the geographical location. However, it’s generally recognized that these roles offer competitive remuneration, reflecting the high level of expertise required. Additionally, market access internships provide an excellent opportunity for students and fresh graduates to gain valuable industry experience. These internships offer a glimpse into the workings of the market access field and can be a stepping-stone for full-time positions.
As with all salary figures, these are approximations and can vary based on numerous factors. It is always advisable to conduct thorough research and negotiate effectively to ensure fair remuneration. The Market Access Specialist is a technical role, often responsible for conducting research and providing analytical insights to support market access strategies.