Change is a constant when it comes to market access. Over the years, the biopharmaceutical industry has experienced its share of disruptions, from innovative payer controls to a global pandemic. 2022 concluded with a large-scale bill, the Inflation Reduction Act, but its major healthcare provisions have yet to be enacted. The industry also contended with continued margin pressures, increasing patient access barriers, and controversial approvals and launches -- the effects of which will influence margins and strategies in the years ahead.

As we head into 2023, the IQVIA Market Access Center of Excellence is paying attention to 10 events and trends that could shape the future market access landscape.

Health policy and the Inflation Reduction Act

The Inflation Reduction Act (IRA) is the most recent legislation from a government that is increasingly focused on pharmaceutical spending and attuned to market access dynamics. As of January 2023, the IRA requires free recommended vaccines, $35 monthly caps on patients’ insulin spending, price inflation penalties, and adjusted biosimilar reimbursement in Medicare. Over the next several months, U.S. policymakers and government organizations such as the Centers for Medicare & Medicaid Services (CMS) and the Department of Health & Human Services (HHS) are expected to provide even more clarity on many of the IRA’s key provisions through rulemaking.

Focus remains on the details:

• It is currently unclear how prices will be negotiated in Medicare. While guidelines have been released that indicate the floor of the negotiated discount (maximum fair price ranging from 25-60% off of the price), manufacturers are looking to understand what the ceiling might be and how either side of the negotiation will justify its recommendations. For now, CMS plans to publish the first 10 drugs covered under Medicare Part D that have been selected for the Medicare Drug Price Negotiation Program by September 2023.
• Maximum Fair Price implementation is another area of interest because negotiations will not influence products’ wholesale acquisition costs (WACs). A fair expectation is that manufacturers will be responsible for providing additional rebates to payers who will float the unnegotiated cost at the point of sale. Still, uncertainty in the drug acquisition chain can challenge forecasts and planning.
• Congressional Budget Office (CBO) estimates indicate that premiums will offset the greater payer liabilities from Part D redesign, but that could require sizable increases that may not be feasible for CMS to offset. The industry must be prepared for the possibility that manufacturers will be asked to absorb some of those costs either by higher rebates or tighter utilization management.
• CMS is currently requesting and reviewing comments from the industry. Stakeholders are likely to use this time before rulemaking is finalized to petition for their interests as well as legally challenge some of the process and provisions of the IRA.

Meanwhile, pharmaceutical manufacturers and other stakeholders must anticipate and plan for IRA impact. Scenario-based modeling will play a crucial role in early strategy decision making. Stakeholders must also look to other political activities such as executive orders, rules, and bills that are likely to tackle healthcare transparency, pricing, and inequality.

Demonstration of value

The IRA opens the door for more government oversight, but the industry has grappled with the question of value for years - either through alternative contracting, indication-based access, or previous attempts on drug price control. Now CMS will stand up its Drug Price Negotiation Program which will conduct pharmacoeconomic analyses and negotiate Medicare prices with drug manufacturers as part of its charter. While limited to Medicare for now, markets are primed more than ever for clinical and economic evaluation of costs and manufacturers will need to be prepared. At minimum, some evolution beyond the traditional price and payer access approach is to be expected and may even open the door for third parties to weigh in or for Health Technology Assessment debates to begin.

Leqembi sets the tone in 2023 as a brand defending its pricing decision at approval. Time will tell whether public price justification becomes part of general launch strategy and whether other stakeholders will agree with the evaluation. Despite a brand’s reasoning, payer coverage may not follow, or other organizations, such as the Institute for Clinical and Economic Review (ICER,) may have a different assessment. Even more challenging, the industry does not have a uniform understanding of value.

It may not be possible to simply define value. Rather, as market access professionals, we must ask, value to whom? Pharmaceutical innovation is on the precipice of novel, sometimes curative, developments where patients are eager for a chance at disease management if the coverage and costs can only support it.

Innovation pipeline

It is an exciting time in biopharma with breakthroughs in Alzheimer’s, gene therapy, metabolic diseases, and vaccines. The list goes on. It is exciting, but also challenging given the market’s conflict between the need for innovation and the finite capacity for cost. This capacity is strained by an aging population, rising costs, and epidemics. History has demonstrated that a cure (as with Hepatitis C) is not enough to earn widespread access. Aduhelm’s more recent, troubled launch has further and undeniably changed the way manufacturers are evaluating their portfolios.

The stakes to invest and launch are higher than ever, necessitating careful pipeline management. Manufacturers will have to consider the clinical positioning of their products and market access strategy much earlier in the pre-launch process as the boundaries between both aspects are blurring. The clinical profile of a drug will have bearing on its prospects in the market and ultimately affect the long-term viability of a drug’s development.

Expanding payer control

Payer control has been on the rise for years as restriction rates are growing and fewer, select products achieve preferential status. Already, the number of unique formulary exclusions averaged over 600 across 2023’s national preferred formularies. But that is only one piece of the full control picture. Formulary restrictions and exclusions are expanding into new markets that have previously been considered untouchable, such as oncology and even some protected classes. This could be an unexpected shift with sizeable access and margin implications for many pharmaceutical brands, particularly as payers must compensate for new cost liabilities under IRA. Monitoring and forecasting will prove vital to long-term success.

While formulary levers are already an established form of control, it is IQVIA’s expectation that the industry will also see payers add to their toolkits. One way the industry might expect to see payers manage access is through triaging patients or limiting treatment populations. National coverage determinations (NCDs), coverage with evidence determinations (CEDs), and self-administered drug exclusion lists (SAD lists) are existing mechanisms within CMS. Though not commonly used today, they provide an option, or inspiration, for future access management.

New sites of care and acquisition

With payer rejections and cost-sharing on the rise, patients are looking beyond their benefits in order to fill prescriptions. As one example, pharmacy discount cards may account for less than 6% of all prescriptions, but more than 10% of insured patients use at least one. They have nearly doubled in prevalence since 2017 and are on track to grow as patients encounter more barriers to access and are compelled by the potential savings out-of-network. Cost Plus Drugs, identified as a public-benefit corporation, is an emerging variation on the discount card, offering a streamlined supply chain and transparent pricing on many generics. We expect to see more such entries into this space in the future.

Demand for these solutions reflect a growing trend among patients taking advantage of their options. Manufacturers might find opportunities for future partnership with such emerging organizations as they look to support patients more directly and improve access to their treatments. Perhaps one example exists with telemedicine, which saw a boost after COVID-19. Some companies now use online platforms to diagnose, prescribe, and even distribute medicines – mostly generics for now – to specific populations. Now more than ever, patients are one online advertisement away from being diagnosed for a mental health disorder and prescribed an SSRI.

New access points are not without their challenges. Cost containment companies are also making headway in the market, moving prescriptions through pharmacy discount cards and other channels to keep spending. It will be challenging but necessary to measure these alternative sites in order to ensure that treatments are as accessible as forecasts might expect.

Modern practices for launch

Given rising payer control, manufacturers are having to adjust their expectations for launch. Success, in whatever way it is defined, may not be achievable for several years or even longer after launch depending on payer access. Many of today’s forecasts do not properly account for the delay in formulary uptake that has taken place over the years, putting launch brands in a position to offer vouchers and bridge programs to bypass delayed coverage.

However, these programs can have long-term effects on the performance of a brand as well as the sustainability of its support program when they struggle to transition patients to insurance. Of the top 10 most successful launches between 2020-2022, nearly all had aggressive patient support programs with sometimes as much as 80% of volume being fully offset by manufacturer support.

Pricing pressures from the IRA make the stakes even higher in 2023. Manufacturers will have to pay rebates to Medicare for any price increases that exceed the consumer price index (CPI), making launch price particularly important. Manufacturers will also have to consider how the timing of price negotiation will affect the longevity of a brand. Notably, small molecules stand to face negotiation sooner than large molecules, at 9 years after launch instead of 13.

Combined with margin pressures that continue to impact the industry, launch price pressures will be a hot topic in the coming years. With 1/3 of recent launches priced above $200,000 per year, a growing number of products launched at prices above $1 million, and the robust pipeline of innovation set to launch in the next few years, we expect the launch price debate to intensify. Manufacturers must begin preparing their evidence strategy now.

Pharmacy biosimilars

One of the largest brands in the history of biopharma, Humira, will face direct competition in 2023 as biosimilars of adalimumab enter the market. Amgen’s Amjevita will lead with exclusivity in January and several others will follow in July. Adalimumab is unlike insulin glargine, the first pharmacy biosimilar, in many ways and is therefore an event to watch in 2023. Stakeholders across the industry will be watching to see what strategies both innovator and biosimilar manufacturers employ for pricing, contracting, marketing, and patient support. Current expectations may have settled on modest discounts and brand-like strategies, but it remains to be seen what each company will do. Biosimilar success lies in the eye of the beholder as there are many ways that one can view the market.

From the inside, we will also be watching the market’s response. The extent to which payers cover biosimilar adalimumab, as well as the frequency of pharmacy substitution, remains uncertain and unstable. Despite current dynamics that favor Lantus over its biosimilars, dynamics could change depending on the competitive market for adalimumab and shifting payer liabilities with the IRA. Regardless, this first year will have implications for future biosimilar launches as well as the favorability of biosimilar development altogether.

Deductible accumulators and copay maximizers

The number of deductible accumulators and copay maximizers are growing every year. They cost support program budgets billions of dollars in total and account for a majority of specialty drugs’ copay card spending. They also continue to play a growing role in payer budgets, both becoming a strategic lever and presenting a contracting pitfall for brands subject to the control.

To counter manufacturer and patient mitigation, these programs have evolved over time. Some use variable copays while others might resemble a traditional coinsurance benefit, making it difficult for manufacturers to budget appropriately. The use of variable copays also creates a challenge to identify patients that are better suited for rebate programs or debit cards instead of traditional copay cards. In 2023, manufacturers must analyze their accumulator and maximizer exposure, even going so far as to incorporate these dynamics into their pre-launch forecasts. They must also strategize to ensure the long-term sustainability of their support programs.

Given the recent growth of these programs, the industry response, the regulatory response of more and more state bans, patient advocacy, and more public awareness, these controls will remain controversial. Treating products like oncologics, HIV anti-virals, Hepatitis C, and multiple sclerosis drugs as non-essential medication is bad for patients and public health. Legislators are well within their rights to seek bans for programs that hurt patient outcomes.

Patient access disparities

Health equity is a priority for the industry, including IQVIA. For now, industry is only beginning to address disparities, but already policies are influencing clinical trial design and investigating health deserts. Market access also has a role to play, by identifying and addressing structural access barriers across populations.

Several drug manufacturers pledged funds to address disparities and disadvantages in healthcare. As market access practitioners, we see this as an opportunity to look at equity as a whole - from symptom to treatment. As solutions are developed that will hopefully bridge gaps in representation and diagnosis, the industry already has many tools at its disposal to minimize barriers to access. These tools could see major innovations in the coming years as investments in equity continue.

Persisting 340B challenges

340B remains one of the largest margin-mitigating concerns for drug manufacturers today. Explosive growth in the channel has doubled utilization over the last 5 years with little sign of abatement. The financial incentive for covered entities to expand the use 340B is high and there is little appetite from legislators or regulators to make changes to the system.

In recent years, public legal disputes have challenged practices within the 340B program and the Health Resources and Services Administration’s (HRSA) authority to penalize manufacturers for limiting 340B distribution. In the absence of clarity around 340B scope, manufacturers are attempting to limit 340B to the 1996 patient definition while providers are pushing to expand the program. Pressure is on lawmakers to better clarify the scope and rules, as the scale of this program could not have been anticipated when it was first designed.

Adding to the intensity of the issue are provisions in the IRA that allow for 340B-reimbursed prescriptions to be excluded from inflationary discounts. Given the general lack of visibility into 340B transactions, the large preponderance of Medicare claims that are also transacted through the 340B channel, and the complex debate surrounding the issue, the program will continue to be controversial.

For more information, or if you have questions about this topic, please reach out to us at market_access_thought_leadership@iqvia.com.