sharon willsThese innovative treatments often come with high price tags, and demonstrating their value to payers can be complex. This is further complicated by the fact that the effectiveness of these treatments can vary significantly among different patient subgroups. After the FDA accepts a manufacturer’s application for approval, the company may begin outreach to payers and PBMs to discuss the new therapy. Each P&T committee will meet several times to evaluate the drug’s clinical use and efficacy, the applicability of regulatory mandates, and whether the drug provides sufficient benefits or clinical differentiation to justify its cost. A good market access strategy also needs to be tactical—it has to take many factors into consideration, like geographies, payers, messages and tools, in order to win access.
As you move into clinical trials, market access data will help you understand payers more deeply to mitigate financial risks. One well-known example in the pharma industry is Dupixent, a drug created for atopic dermatitis, asthma, and several other indications. Their team chose atopic dermatitis, specifically, because there wasn’t a non-generic product with preferential access. It was a large, wide-open market during their discovery and development phases, but by the time they were preparing for launch, there was more competition than anticipated. On the higher end of the hierarchy, VP market access jobs and market access director jobs entail more strategic responsibilities. They play a pivotal role in shaping the company’s market access policies, managing teams and interfacing with key stakeholders both within and outside the organization.
In Europe, where healthcare is nationally sponsored in most markets, it is important to achieve nationwide reimbursement in the shortest timeframe possible to ensure rapid product uptake. For example, six years ago when hepatitis C treatments became available in the United States, there was excitement in the global public health community and an unanticipated significant pent-up demand. But in the US market, a high percentage of the patient population was covered by state Medicaid programs, whose budgets vary in size from state to state but are generally quite constrained.
Exchanges are organized marketplaces where stocks, commodities, derivatives, and other financial instruments are traded. As roles with global responsibilities often require a higher level of experience and expertise, the Global Market Access Manager can expect an average salary of approximately $130,000 to $150,000 per year. Market access is everyone’s responsibility in each company, throughout the lifecycle of the technology, from early phases until the so called Loss of Exclusivity (LoE). Furthermore, new drugs, especially in cancer, are now approved based on the targeted mutation and not on the indication (e.g. pembrolizumab, larotrectinib), which complicates even more the initial price setting and subsequent reviews. Therefore, access for new indications and new forms, including new embedded technologies such as RFID or similar, are vital elements in achieving the total life-time value of a product.
Gain unlimited access to more than 250 productivity Templates, CFI’s full course catalog and accredited Certification Programs, hundreds of resources, expert reviews and support, the chance to work with real-world finance and research tools, and more. Market regulators such as the Financial Industry Regulatory Authority (FINRA) oversee all of the market’s trading activities and have raised some concerns over the sharing or sponsored access agreements offered by sell-side firms. A complete different discussion should be opened for medical devices, which follow different approval pathways and generally have shorter life spans due to the quick advancement of technologies. This study would not have been possible without our research participants who graciously agreed to be interviewed. “Value-based contracting doesn’t work if you make people work too hard. If it’s performance-based and it’s a huge population and you have to monitor test results of individual patients, forget about it. If it’s population-based, it can work.”
The technology and infrastructure required to develop a direct market access trading platform can be expensive to build and maintain. Sell-side investment banks have trading groups that execute trades with direct market access. The order is accepted by the exchange for which the security trades and the transaction is recorded on the exchange’s order book. Intermediary brokerage firms are known to have direct market access for completing trade orders. Some of the most well-known exchanges are the New York Stock Exchange (NYSE), the Nasdaq, and the London Stock Exchange (LSE). While trade execution is usually immediately enacted, the transaction is fulfilled by an intermediary brokerage firm.
In the developed markets, the market access function has steadily attained importance due to increased awareness of the need for value over existing treatments among regulatory and reimbursement agencies. To deal with this dynamic regulatory environment, pharmaceutical companies have started to establish the market access function as an integral part of the organization. However, only a handful of companies currently have a dedicated market access team with well-defined roles and responsibilities (10, 11).
- Rather than relying on market-making firms and broker-dealers to execute trades, some buy-side firms use direct market access to place trades themselves.
- A reimbursement landscape assessment should also be done early in order to determine the payer mix and market basket in the space and what value your product offers over the competition.
- As companies struggle to spend quality time with these important traditional channels, it will be a challenge to effectively engage and explore areas of common interest.
- Several criteria could impact market access including pricing, competition, reimbursement status, health technology assessments (HTAs), supply chain and logistics, among others.
- So, engaging early with the payers early will help you determine the type of benefit coverage you need and how soon you might be able to obtain coverage/reimbursement and be added to their formulary or coverage list.
- Furthermore, while the lower cost of biosimilars can make them more attractive to payers, they often face stiff competition from the original biologic drugs, which may have well-established safety and efficacy profiles and strong brand recognition.
Today, more than ever, pharmaceutical companies must demonstrate how a new drug improves patient outcomes, reduces the burden of the healthcare system as a whole and is worth its price. As the drug development process progresses, market access considerations continue to shape the research and development strategy. This can include decisions about the design of clinical trials, the selection of endpoints, and the generation of health economic and outcomes research (HEOR) evidence. By considering market access from the earliest stages of drug development, companies can align their research and development strategies with the needs and preferences of payers, healthcare providers, and patients.
The more certain the patient population size is, the more confident payers will be in estimating their budget impact, on the basis of the negotiated price. For this reason, early collaboration with payers or independent institutions that would allow conflicts-of-interest-free judgement is critical for later pricing and access conditions negotiations. This research reinforces the fact that market access strategy and execution is the primary driver behind launch success.
They are responsible for developing and articulating the value proposition of a product, conducting health economics and outcomes research, and leading price and reimbursement negotiations. They also play a significant role in stakeholder engagement, working closely with healthcare professionals, patient advocacy groups, What is Direct Market Access Dma and other relevant bodies. And, most of all, to transform patients’ lives, who will gain better health, better quality of life and better experiences within the NHS systems. The pharmaceutical market is highly competitive, and companies need to continuously innovate and differentiate their products to gain market share.
In the US, it is about evolving policy in access and coverage, from upcoming Medicaid payment changes to Medicare coverage and payment for innovative drugs. In many parts of Europe, it is more about evidence generation and value communication and being able to reflect the product’s value both from a clinical and financial perspective to get the product reimbursed and priced. The increasing demand for cost-effectiveness and health technology assessment (HTA) also poses a challenge.
Setting an optimal price, one that justifies the value of the drug while being affordable for patients and acceptable to payers, is a complex process. It requires a deep understanding of the value of the drug, the competitive landscape, and the willingness and ability of payers to cover the cost. Pricing strategies for pharmaceutical products are complex and involve balancing the need to reflect the value of a drug with the need to ensure that it is affordable for patients and cost-effective for payers.
These data sources are particularly useful when making decisions regarding endpoints, biomarkers, sample size, trial sites, participant diversity, and selection criteria. Using market access data from the get-go gives you a deeper and broader view of the landscape you are working within, making it much easier to anticipate roadblocks, pivot your strategy, and make decisions with confidence. Banks and other financial institutions provide clients with direct market access to electronic facilities and order books of exchanges to facilitate and complete trade orders. With the advent of electronic trading, direct market access has made the process of executing trades much more efficient for traders as they can gain access directly without having to rely on an intermediary.
In addition to private traders, users also include buy-side firms, such as hedge funds, mutual funds, pension funds, and private equity funds. Buy-side firms may use the technology infrastructure provided by sell-side firms (i.e., investment banks) to get direct market access. Inizio’s chief operations officer discusses how pharmaceutical companies are tailoring their product launch strategies to meet the diverse needs of stakeholders. Pharma companies can avoid similar dilemmas by combining market access data and RWD to create an education plan for physicians. By analyzing physician lab testing patterns through data pulled from both national labs and hospital resources, you can create a comprehensive education program that helps prescribers understand why and when they should use your drug compared to others.
sharon wills