This is because patients have to bear the additional cost of high-priced drugs through co-payments (in such cases, they become payers as well). In addition, Patients are more concerned about the effectiveness of the drug than earlier, and they are not satisfied with just receiving treatment but also demand a cure. Indeed, the importance of drug effectiveness will further increase if there is no reimbursement or only partial reimbursement.

They may also be involved in preparing reimbursement submissions and engaging with key stakeholders such as healthcare professionals and patient groups. Over the last 10 years, healthcare systems have seen increased pressure on their budgets, a trend toward greater transparency, and the introduction of increasingly complex and expensive technologies in the market. Both with expensive oncology drugs and very costly orphan drugs for treating rare diseases. For instance, a gene therapy approved for the treatment of the hereditary blood disease thalassemia, among others in the EU, the cost is approx. The price for the most expensive ATMP approved in the USA to date is approximately $2 million US dollars per patient. As a result, health authorities in Europe continue to incorporate new regulations and controls to evaluate and cover them, and to improve efficiency while closely monitoring health expenditure.

A proper balance between these components allows companies to receive adequate compensation for their medical advancement, encouraging further growth, while allowing patients to access new and effective therapies as soon as possible and at a reasonable cost. Essentially, market access means that patients get the proper medication at the right time and for a fair price. It also encompasses reasonable prices for drugs that align with the drug’s effectiveness in treating disease.

Benefit must be always expressed as additional value compared to the Standard of Care (SoC) as identified by the payer, not the company itself. Amid unprecedented uncertainty and change across the industry, stakeholders are looking for new ways to transform the journey of care. Deloitte’s US Life Sciences and Health Care practice helps clients transform uncertainty into possibility and rapid change into lasting progress. Comprehensive audit, advisory, consulting, and tax capabilities can deliver value at every step, from insight to strategy to action.

Other European payers are building coalitions and systems to gather information on a new product launch as early as 30 months in advance, depending on the potential impact of the product on the healthcare system. For example, the International Horizon Scanning Initiative, sponsored by the Beneluxa Initiative, is building a system to scan drugs in development that will allow companies to engage earlier with manufacturers. The cities of Amsterdam, Basel, Dublin, London, Munich, Zug, and Zurich have all attracted several promising innovative biopharma companies in the fields of rare diseases, oncology, and gene therapies. This activity is making it more complex to gain market access for a product because of both internal complexity caused by mergers and external complexity caused by companies’ presence in so many different markets.

Thus, access in emerging markets is largely a function of price, channels, marketing to doctors, and government stakeholders. However, companies working in these emerging markets focus on either individual functions or none at all. A market access strategy will help you avoid these pitfalls by outlining what your product needs to succeed. And with the right partner, you can feel more confident you will have defined a successful strategy. While the country’s ongoing drug pricing debate keeps drug pricing in the public eye, the industry continues to shift. Formally introducing the payer to the final product should include covering FDA studies and approvals, dosage, adverse effects, main applications, distribution model, and promotional strategy.

Many controllers use new-to-market blocks to allow for the collection of additional real-world evidence of efficacy and success. They might also track which payers are covering the drug and determine how patients are using it before making a coverage decision. This wait-and-see period is quite common for drugs that have been fast-tracked by the FDA, which do not yet have long-term efficacy data.

Complex benefit designs, increasingly sophisticated utilization management practices, and payers’ rising market power due to industry consolidation have put market access at the center of launch success. This raises the stakes for launch teams and requires intentional and careful planning around potential access challenges early in the development process and throughout the product life cycle. He brings more than 20 years of Life Sciences What is Direct Market Access Dma Commercial and Market Access Strategy experience, having served most of the world’s largest life sciences clients, in the areas of market access, commercial and launch strategy. He has dedicated his career to advancing new perspectives on the growing challenge of sustainable affordability, access, and value capture for traditional, specialty, oncology and increasingly transformative drug therapies in cell & gene therapy and rare diseases.

Knowing which entity is responsible for assessing a drug’s efficacy and price point is of critical importance for manufacturers hoping to influence coverage decisions. For example, an employer group might have a payer-managed medical plan benefit, but the payer has relegated drug formulary and coverage decisions, in addition to claims processing, to a PBM. Finally, a company’s senior market access professional must have enough experience and confidence to negotiate strongly with different payers and stakeholders at the highest level.

The ultimate goal of market access is to ensure that patients who would benefit from a particular drug can access it. This involves not only making the drug available on the market but also ensuring that it is affordable for patients and that its cost is covered by health insurance providers or national healthcare systems. While market access is the process of making a pharmaceutical product available to patients, HEOR provides the data and evidence needed to support this process. One of the first key aspects of pharmaceuticals market access is health technology assessment (HTA). HTA is a systematic evaluation of the properties and effects of a health technology, with a focus on the direct and intended effects of this technology, as well as its indirect and unintended consequences.

• Look for a partner who can focus on integrating and understanding the needs of both payers and the manufacturers.
• In addition to deciding which drugs to cover and which will require utilization management restrictions, a controller is also responsible for reviewing any formulary exceptions or appeals.
• The stagnant developed markets have forced pharmaceutical companies to focus more on the emerging markets, which are touted as being the next engines of growth.
• Using direct market access, it allows traders to bypass a broker and access the stock exchange directly.
• Although setting up these meetings can be difficult, the right partner opens doors, helps define a market acceptable message, and facilitates the conversations that are frequently out of reach for the smaller pharma and biotech companies.
• For example, the new cloud technology provides an improved framework for real-time decision-making in MA.

Through your market access strategy, you will prove the value of your product, achieve optimal pricing and reimbursement, and successfully deliver your product to the patients who will benefit. This step needs national, regional, and local expertise and includes the type of health care provided, its organization and expenditure, the possible commercial and dispensation channels, the specific regulations, and main bodies. It is also about understanding the different access pathways, the different HTA and pricing and reimbursement processes and pathways, the level of evidence required, the key decision drivers and the different pricing mechanisms. Some markets may become available earlier than others that require significant data collection regarding unclear value endpoints.

Join us as Mohit Manrao, SVP and head of US oncology at AstraZeneca, shares his patient-centered approach to transforming cancer care, bridging the gap between innovative science and tangible patient outcomes across all populations on a global scale. It is important not only to understand the current standings of the market you are looking to launch into but also what it will look like in the future. If you purchase an asset that has yet to go through clinical trials, it may take four or five years to go to market. Think of all that can change within those few years—enough to completely change your strategy. A direct market access order is a trade placed by a trader directly with an exchange on its order books without having to go through a brokerage as an intermediary. To address these trading risks, the Securities and Exchange Commission (SEC) requires firms that provide direct market access to maintain a system of risk management controls over the trading actions allowed through sponsored access.

Most importantly, pharmaceutical companies must adopt a market-access-oriented organizational mindset. Doing so, however, requires that manufacturers no longer treat commercialization as an afterthought, which creates a chaotic rush to market and missed performance expectations. The cornerstone of a manufacturer’s market access strategy is the process of defining and communicating a product’s clinical and economic value to payers, providers and patients, as each is involved in the decision to initiate therapy.

And a good market access strategy should also be connected with downstream promotional activities to make the most of the access, or find ways to supplement the lack of payer access. They must also determine what it takes to achieve access, whether it is rebates, uniqueness of clinical data or more choice for the patients covered by the payer. There are two places, in our experience, that senior executives can most successfully look. Furthermore, as the market access role has become more important, increased demand has meant that it’s not uncommon for market access professionals to receive multiple offers from different companies. As more and more innovative companies pop up on the landscape, the competition for these individuals will only become more intense. In the United States, stakeholders have asked for greater transparency of pricing considerations.