Thought Leadership

Across indications, biosimilar uptake is rapidly accelerating, with the number of biologics facing biosimilar competition more than doubling by 2026. This year’s impending launch of adalimumab biosimilars will serve as a case study for manufacturers, who will be studying the market’s response. Humira biosimilars have great potential to disrupt immunology market baskets, especially if multiple competitors employ aggressive discounting strategies.

Welcome back to MMIT’s Market Access 101 series, in which we unpack the complexities of market access via a series of blog posts. In our first post, Understanding the Basics, we covered the difference between the pharmacy and medical benefit structure, the typical timeline for drug review, and why it’s critical to determine which entity makes formulary and coverage decisions.

In this post, we’ll address how to research and articulate your drug’s value proposition, how to overcome access barriers like prior authorization, and how to engage controllers during formulary decision-making.

Given the growth of specialty pharmaceuticals, manufacturers will need to develop more aggressive contracting strategies to secure optimal market access for their medical benefit drugs. Shifting market dynamics, driven in part by the influx of lower cost biosimilars on the pharmacy benefit, will require pharma companies to focus more on rebating and cost minimization.

Many manufacturers are interested in which factors can give them an edge on obtaining preferred coverage with payers. This is especially true given the increasing competition in saturated categories such as immunology, diabetes care and breast cancer.

We scoured recent MMIT research to gain a better grasp on the factors that are top of mind for payers—those that will truly move the needle in terms of coverage determination.

For many pharmaceutical companies, planning for commercialization only begins in earnest when a drug has been submitted for FDA approval—which is far too late. Ideally, a company’s commercial and market access teams should be fully functional long before the approval stage, as many decisions must be made in the early phases of the drug development life cycle.

According to Deloitte, the average cost of bringing a pharmaceutical asset to market is $2 billion, yet more than a third of all product launches in the U.S. fail to meet expectations, due in large part to insufficient market access strategy and execution.

As if medical billing and coding wasn’t challenging enough, 2023 brings a new layer of complexity: the establishment of unique HCPCS codes for generic drugs. Specifically, the new codes affect generics approved under the FDA’s 505(b)(2) new drug application (NDA) and biologics license application (BLA) pathways.

In its Q3 2022 HCPCS Coding Cycle documentation, CMS issued 36 new HCPCS Level II codes to identify these products, effective Jan. 1, 2023. The agency also declared its intention to review additional 505(b)(2) drugs and release new codes on a quarterly basis. As generics approved via this pathway are not rated as therapeutically equivalent to their reference drug, they are considered single source drugs. Each will now carry a unique HCPCS Level II billing and payment code, also known as a J code.

Despite the challenges of the pandemic, the pharma industry has enjoyed steady growth during the past two years, which is expected to continue in 2023. The global pharmaceutical market is forecast to expand at a CAGR of 5.7% between now and 2028. Hundreds of products are currently awaiting FDA approval, and new modalities, including cell and gene therapies, have increased to 21% of the drug development pipeline.

Of course, plenty of existing hurdles remain, along with several new challenges and opportunities. To better understand what 2023 will bring, I asked three of my colleagues to weigh in on upcoming market shifts. Their answers provide key insights into the year ahead.

The FDA has created a number of pathways to bring drugs for serious conditions onto the market sooner than the traditional approval process would allow. These include priority review, accelerated approval, fast track and breakthrough therapy designations, as well as emergency use authorizations, which are used in emergency situations, such as the COVID-19 pandemic.

One of the most popular routes is accelerated approval, which allows the agency to approve drugs using surrogate endpoints that are thought to predict a clinical benefit. Manufacturers bringing these agents to market must conduct confirmatory clinical trials, which may result in either a drug being withdrawn or the accelerated approval being converted to traditional approval.

According to the National Institutes of Health (NIH), approximately 80% of research studies fail to meet their enrollment goals within the stated timeframes. Recruitment and trial design challenges can prolong the timeline for phase III studies, driving up costs and delaying market entry.

While many sponsors use aggregated data and predictive analytics to improve the trial process, one data source is often overlooked: lab data. By analyzing normalized lab data sourced from both commercial and inpatient labs, pharma companies can optimize clinical trial design and feasibility, streamline the recruitment process, and reduce overall spend—both in the development stage and beyond.

With rebates now a common pharma practice, and generics and biosimilars launching in oncology, payer management of once-untouchable cancer drugs is growing. As the FDA continues to approve a large number of cancer drugs, resulting in increased competition in various tumor types, and spending on these agents continues to rise, PBM and payer formularies are now excluding some oncolytics while designating others as preferred.