It’s no secret that copay maximizer and accumulator programs have come under fire since their inception, and for good reason: In theory, these programs aim to help manage costs, but oftentimes accumulators can end up shifting the cost of medications to patients while maximizers can shift the cost of care from the patient to the manufacturer.

Now, amid the relentless tug of war between payers and pharmaceutical manufacturers, a relatively new type of patient assistance program has emerged. These programs—such as Paydhealth and MedMonk—work like savings aggregators, finding the maximum amount of savings possible to help patients pay less for their medications. Also, like copay accumulators and maximizers, they’re often a built-in feature within an employee benefits plan.

While the U.S. has been frustratingly slow to embrace biosimilars, the next few years are poised to see a veritable boom in new market entrants. Only six biosimilars were available at the end of 2018. There are now around 40 biosimilars approved in the U.S. across multiple indications. Plus, enrollment in the FDA’s Biosimilar Development Program has increased nearly 60% since October 2015, with more than 90 proposed biosimilar products in the program.

While COVID-19 has left no industry untouched, it’s safe to say that healthcare has been hit the hardest. Yet despite this reality, there are plenty of exciting advancements happening within the industry, even amid the lingering effects of the global pandemic.

To get an idea of what’s to come in market access, I asked four of my colleagues to weigh in on upcoming challenges and opportunities within healthcare. Their answers—which cover topics from evolving payer strategies to gene therapies to digital therapeutics—are full of insights for the year ahead.

The shift in care toward outpatient settings has led to increasingly more complex coverage policies, spurring an even greater demand for transparency among payers.

To stay competitive, the leaders at a global provider of healthcare solutions and supplies needed to bolster their understanding of the coverage landscape, including insight into policy and restrictions data on products across multiple payers.

Over the past decade, the life sciences industry has undergone transformative change that has disrupted everything from early drug discovery to post-launch treatment monitoring. Driven by the proliferation of real-world data (RWD) and technology like AI and machine learning, these innovations are changing our understanding of drug value and enabling life-saving medications to get into the hands of patients faster.

When it comes to medical reimbursement, there are several challenges that both payers and providers face in today’s rapidly changing regulatory environment. With new drugs and generics entering the market at breakneck speed and supply chain issues continuing to plague manufacturers, it can be difficult for stakeholders to keep up with the Healthcare Common Procedure Coding System (HCPCS), especially considering that July will mark the eighth consecutive quarterly update to HCPCS codes. While HCPCS codes used to be updated on an annual basis, more recently CMS has moved to a quarterly schedule, increasing the frequency with which providers and payers must check for new coding requirements.

After the FDA called for additional warning labels on anti-inflammatory drugs known as JAK inhibitors this September, pharma companies in the immunology space have been waiting with bated breath to see how payers will react to this news. Will insurers start requiring step-edits or prior authorization? Will payers alter their management strategies for rheumatoid arthritis and ulcerative colitis? What will potential restrictions mean for newly diagnosed patients or those who are seeing success with JAK inhibitors? What will the impact be to pipeline agents?

When launching a new drug, especially one that addresses a high unmet need, the barriers to access are numerous. Cost, formulary placement, and prior authorization and step therapy restrictions can all prevent patients from picking up their medication at the prescription counter.

There are many challenges that manufacturers face when launching a new drug: Will physicians prescribe the drug? Will they have any legal issues? Will patients request the drug? How should they market and distribute it?

The list goes on and on, but one of the most critical questions to answer is this: Will patients be able to access the drug? A manufacturer can have all other elements of a product launch accounted for, but if there are tight restrictions in place then the launch team’s efforts will be in vain.

While payers’ formulary decisions can make or break a drug’s success, manufacturers within oncology face an additional obstacle to gaining market access: clinical pathways, or guidelines that determine which treatments and procedures should be prescribed along the patient journey. While pathways were developed to help standardize treatment and ensure quality care, oftentimes they limit physicians’ prescribing decisions by restricting their choices to the products on the pathway.